Journal articles on the topic 'Australian Committee of Directors and Principals'

BACKGROUND: KappaMab is a chimeric IgG1 monoclonal antibody specific for Kappa Myeloma antigen (KMA), a tumour specific cell antigen exclusively expressed on the surface of kappa restricted MM cells. Early safety and efficacy signals seen with single-agent treatment in phase I/II studies in conjunction with observations that IMiD®-treatment upregulates the KMA target and enhances effector cell cytotoxicity, provide rationale for this proof-of principal immune-oncology (IO) approach in a kappa restricted MM population. AIMS: To establish the clinical benefit rate (CBR) of KappaMab alone (Stage 1) and in combination with lenalidomide (LEN) and low dose dexamethasone (DEX) (Stage 2). Secondary aims: to determine the safety of KappaMab in combination with LEN and DEX, in particular, the incidence of immunological adverse events (AEs); to evaluate kinetics of response (time to response [TTOR], PFS, OS). METHODS: Investigator initiated, phase IIb, multi-centre, open label sequential cohort study comparing KappaMab alone to KappaMab in combination with LEN and DEX in relapsed/refractory (RR) MM. Key inclusion criteria were kappa-restricted MM, 1-3 prior lines of therapy but no prior LEN. Recruitment was planned for 60 patients, with an initial intention to treat 30 patients per stage. In Stage 1, patients received KappaMab (10mg/kg IV infusion) weekly for 8/52 (induction), then every 4/52 (maintenance). [One cycle = 28d] For Stage 2, KappaMab dosing was as per stage 1 with the addition of LEN (25mg D1-21) and DEX 40mg weekly. In cycle 1 of Stage 2, LEN and DEX commenced 1/52 prior to KappaMab. [Cycle 1 = 35d: LEN 25mg D1-28 and DEX 40mg weekly (D1, 8, 15, 22, 29)]. Treatment continued until toxicity/progression. This is a planned interim analysis of the primary endpoint (CBR). RESULTS: Recruitment has completed (n=59), however only 40 patients are included in this analysis (Table 1), enrolled between November 2016 and January 2019. Following review by the DMC, recruitment to Stage 1 was terminated early (n=19). 40 patients have commenced treatment in Stage 2, however only the first 21 are included in this analysis: 14/21 had prior thalidomide (refractory =3), 19/21 had prior proteasome inhibitor (PI) (bortezomib = 19, ixazomib = 5; PI refractory = 7), 3/21 were double refractory. 12/40 patients remain on study (Stage 1=1, Stage 2=11). 20 patients have progressed (Stage 1=14, Stage 2=6), 6 withdrew consent (3 each stage), 1 other and 5 have died (Stage 1=2, Stage 2=3). Observed CBR in Stage 1 was 5.3% (1/19, PR=1) compared to 76.6% in Stage 2 (16/21, VGPR=2, PR=12, MR=2). Proof of concept (PoC) criteria were not met for Stage 1, but were met for Stage 2: observed CBR ≥55%, and the posterior probability that the true CBR exceeds 35% was >0.95 (PP=0.999). Observed overall response rate (ORR) for Stage 1 was 5.3% (1/19, PR=1) compared to 66.7% (14/21) for Stage 2. Median TTOR was not reached in Stage 1 (95% CI: 4.6m and above), and was 2.0m in Stage 2 (95% CI: 1.2 - 2.3m) (p<0.001). With an estimated median potential follow-up of 3.68m in Stage 1, 4.86m in stage 2, the median PFS for Stage 1 was 3.71m (95% CI: 1.68 - 5.52m), compared to 6.21m for Stage 2 (95% CI 3.88 - 11.0m) (p=0.010). Median OS for both stages was not reached: 95% CI 4.0m and above for Stage 1, and 4.9m and above for Stage 2 (p=0.500). AEs of interest: Infusion reactions: 3/19 patients in Stage 1 (grade 1=1, grade 2=2), compared to 4/21 patients in Stage 2 (grade 2=4). Hematologic toxicities: There were no hematologic toxicities reported in Stage 1 in comparison to anaemia 3/21, neutropenia 5/21 (grade 3=3), thrombocytopenia 4/21 (grade 3=1, grade 4=2) reported in Stage 2. Non-hematologic AEs (regardless of causality and >10% incidence): musculoskeletal pain (Stage 1=5, Stage 2=6), fatigue (Stage 1=4, Stage 2=4), infection: URTI (Stage 1=5, Stage 2=4); LRTI (Stage 1=2, Stage 2=2), abdominal pain (stage 2=4), muscle cramps (stage 2=3), presyncope (Stage 2=3) and hypophosphatemia (Stage 2=3). CONCLUSION: In a patient population with high prior IMiD (thalidomide) exposure and a median of 2 prior lines of therapy, KappaMab combined with LEN and DEX demonstrated a higher than expected ORR of 67%, comparing favourably with the MM-009/MM-010 trials of LEN and DEX, that demonstrated an ORR in patients with 1 prior line of 66.9%1. This novel IO combination may represent a promising new therapeutic option. This trial is ongoing. 1. E Stadtmauer et al European Journal of Haematology 2009; 82:426-432 Table 1 Disclosures Kalff: pfizer: Honoraria; Amgen: Honoraria; Celgene: Honoraria. Shortt:Takeda: Speakers Bureau; Celgene: Consultancy, Speakers Bureau; BMS: Consultancy, Speakers Bureau; Novartis: Consultancy, Speakers Bureau; Astex: Research Funding; Amgen: Research Funding; Gilead: Speakers Bureau. Reynolds:Alfred Health: Employment, Other: Biostatistician for trials funded by the Australian government and Abbvie, Amgen, Celgene, GSK, Janssen-Cilag, Merck, Novartis, Takeda, but sponsored by Alfred Health.; AUSTRALASIAN LEUKAEMIA & LYMPHOMA GROUP (ALLG): Consultancy; Novartis AG: Equity Ownership; Novartis Australia: Honoraria. Quach:Karyopharm: Membership on an entity's Board of Directors or advisory committees; Janssen: Membership on an entity's Board of Directors or advisory committees; Amgen: Membership on an entity's Board of Directors or advisory committees, Research Funding; GSK: Membership on an entity's Board of Directors or advisory committees; Sanofi: Research Funding; Takeda: Membership on an entity's Board of Directors or advisory committees; Celgene: Membership on an entity's Board of Directors or advisory committees, Research Funding. Walker:Peninsula Health: Employment; Alfred Health: Employment. Harrison:Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; GSK: Consultancy, Research Funding; Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; AbbVie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: investigator on studies, Research Funding; Novartis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen Cilag: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding. Dunn:Haemalogix: Employment, Equity Ownership, Membership on an entity's Board of Directors or advisory committees. Spencer:Amgen: Other: Consulting/advisory role, Research Funding; AbbVie: Other: Consulting/advisory role, Research Funding; Secura Bio: Other: Consulting/advisory role; Haemalogix: Other: Consulting/advisory role; Celgene: Other: Consulting/advisory role, Research Funding, Speakers Bureau; Sanofi: Other: Consulting/advisory role; Specialised Therapeutics Australia: Consultancy, Honoraria; Servier: Other: Consulting/advisory role; Janssen Oncology: Other: Consulting/advisory role, Research Funding, Speakers Bureau; Takeda: Other: Consulting/advisory role, Research Funding. OffLabel Disclosure: KappaMab - monoclonal AB directed against Kappa myeloma antigen

Purpose – This paper aims to investigate the incidence of remunerating Australian Securities Exchange (ASX)-listed non-executive directors (NEDs) with options and to determine whether companies that fail to adhere to NED remuneration recommendations share a common corporate governance profile. Despite corporate regulators condemning the practice of remunerating NEDs with stock options, there is a paucity of evidence regarding its prevalence in Australia. Design/methodology/approach – Focusing on ASX400 companies during 2008, a series of hypotheses relating NED stock option remuneration and corporate governance are tested using logistic regression. Findings – The study shows that the prevalence and quantum of NED option payments during 2008 was considerable with 73 of the ASX400 companies, including options in NED remuneration (option payers). Comparison of the corporate governance characteristics of option payers to that of a matched control group (non-option payers) highlighted both the existence and independence of the remuneration committee as critical in ensuring NED remuneration practices comply with regulator recommendations. Research limitations/implications – These results provide regulators and stakeholder groups with additional evidence to continue to call for corporate governance reforms to ensure that corporate remuneration practices are in the best interest of shareholders. Originality/value – This study is the first to highlight the extent to which Australian-listed company NED remuneration practices fail to comply with regulator recommendations and adds to the limited research on remuneration committee effectiveness.

Introduction: MAVORIC was an open-label, multicenter, randomized phase 3 study evaluating the safety and efficacy of mogamulizumab (moga) compared to vorinostat (vori) in patients with mycosis fungoides (MF) or Sézary syndrome (SS) who had failed at least one prior course of systemic therapy (NCT01728805). Primary results have been reported (Kim et al. Lancet Oncol 2018) and were based on a data cutoff date of December 31, 2016. The primary endpoint was progression-free survival (PFS); patients in the moga treatment arm experienced significantly longer PFS compared to patients in the vori treatment arm (median 7.7 months vs 3.1 months; p<0.0001). The most common treatment-emergent adverse events (TEAEs) of any cause or grade reported in patients randomized to moga were: infusion-related reaction (33.2%), drug eruption (ie, skin rash attributed to moga [23.9%]), diarrhea (23.4%), and fatigue (23.4%). This report provides the final safety results of MAVORIC as of the data available on January 3, 2019. Methods: Patients were randomized 1:1 to moga 1.0 mg/kg administered intravenously on Days 1, 8, 15, and 22 of the first cycle and on Days 1 and 15 of subsequent cycles or vori 400 mg administered orally once daily. Patients randomized to vori were allowed to cross over to moga upon progression or intolerable toxicity. Safety was assessed by reported adverse events (AEs), changes in physical examinations, vital sign measurements, electrocardiograms, and laboratory analyses. Results: In total, 372 patients were randomized (moga, 186; vori, 186), of whom 370 received study drug and were included in the safety analysis (moga, 184; vori, 186). For the final safety analysis, median duration of follow-up was 34.5 months (range, 0.13-70.0) in the randomized part of the study. Median treatment exposure was 170 days (range, 1-1813) for moga and 84 days (4-1230) for vori, which represent the same median values but broader ranges compared to the primary analysis (primary analysis, 170 days [1-1379] for moga and 84 days [4-1058] for vori). The type and frequency of AEs in either the moga or vori treatment groups (Table) were consistent with those reported in the primary analysis. TEAEs, regardless of causality, that were reported at similar rates in the two treatment groups included constipation, peripheral edema, headache, and anemia. TEAEs (all causality) that occurred at higher frequency in the moga vs vori arm included infusion-related reaction (33.2% vs 0.5%) and drug eruption (25.0% vs 1.1%); the majority of these events were grade 1 or 2 (Table). The types and frequencies of AEs attributable to moga (per Investigator assessment) included infusion-related reaction (33.2% [61/184]), drug eruption (23.9% [44/184]), and fatigue (18.5% [34/184]), and for vori, diarrhea (55.4% [103/186]), nausea (38.2% [71/186]), and fatigue (33.3% [62/186]). In patients who crossed over from the vori to moga arm and received study drug (n=135), the most frequently reported AEs attributable to moga were infusion-related reaction (37.8% [51/135]), drug eruption (24.4% [33/135]), fatigue (7.4% [10/135]), increased alanine aminotransferase (7.4% [10/135]), and increased aspartate aminotransferase (7.4% [10/135]). Discontinuation rates due to AEs were similar between treatment arms and in crossover patients (moga, 21.7% [40/184]; vori, 23.7% [44/186]; crossover, 25.9% [35/135]). The most common AEs leading to discontinuation were drug eruption in the moga arm (7.1% [13/184]) and fatigue in the vori arm (4.3% [8/186]). Overall, the rates of drug-related serious TEAEs were similar between treatment arms and in crossover patients (moga, 19.6% [36/184]; vori, 16.7% [31/186]; crossover, 11.9% [16/135]). After the data cutoff for the primary analysis, 1 additional patient randomized to moga (decreased appetite, general physical health deterioration, hypoalbuminemia) and 1 crossover patient (cerebral hemorrhage) experienced TEAEs with an outcome of death, all considered unrelated to study treatment per Investigator. Conclusions: This final safety analysis from the MAVORIC study in patients with previously treated MF and SS demonstrates that moga was generally well tolerated. Longer follow-up and treatment exposure did not identify any new safety signals. The type and incidence of treatment-related AEs among patients receiving moga after crossover were similar to those observed for patients initially randomized to moga. Disclosures Kim: Merck: Research Funding; Portola Pharmaceuticals: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Horizon: Research Funding; Corvus: Honoraria, Membership on an entity's Board of Directors or advisory committees; Galderma: Research Funding; Elorac: Research Funding; Soligenix: Research Funding; Kyowa Hakko Kirin: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Eisai: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Forty Seven Inc: Research Funding; Seattle Genetics: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Medivir: Honoraria, Membership on an entity's Board of Directors or advisory committees; Innate Pharma: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Trillium: Research Funding; Neumedicine: Research Funding; miRagen: Research Funding. Bagot:Innate Pharma: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding. Zinzani:MSD: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Eusapharma: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Sanofi: Consultancy; Celltrion: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Gilead: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Janssen-Cilag: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; BMS: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Servier: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Sandoz: Membership on an entity's Board of Directors or advisory committees; Immune Design: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Celgene: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Portola: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Roche: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Kyowa Kirin: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; TG Therapeutics: Honoraria, Speakers Bureau; Verastem: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Duvic:Seattle Genetics: Consultancy, Honoraria, Research Funding; Eisai: Research Funding; Shape: Research Funding; UT MD Anderson Cancer Center: Employment; USCLC Registry: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other: Secretary/treasurer of Item h; Spatz Foundation: Research Funding; Tetralogic: Research Funding; Millennium (formerly Takeda): Research Funding; Mallinckrodt Pharmaceuticals (formeraly Therakos, Inc): Research Funding; Kyowa Hakko Kirin Co., Ltd.: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Forty Seven Inc: Membership on an entity's Board of Directors or advisory committees; Cutaneous Lymphoma Foundation: Membership on an entity's Board of Directors or advisory committees; PleXus Communications: Speakers Bureau; Guidepoint Global: Consultancy; Evidera, Inc.: Consultancy; Cell Medica Inc.: Consultancy; Allos: Research Funding; Rhizen Pharma: Research Funding; Oncoceuticals: Research Funding; Soligenetics: Research Funding; Cell Medica Ltd.: Honoraria; Therakos: Speakers Bureau; Jonathan Wood & Assoc.: Speakers Bureau; Hawaiian Dermatology Society: Speakers Bureau; Hemedicus: Speakers Bureau; Janssen Pharmaceuticals (div of Johnson & Johnson): Speakers Bureau. Morris:Guys Hospital: Employment. Kim:Medimmune: Research Funding; Soligenix: Research Funding; Kyowa Kirin: Research Funding; Galderma: Consultancy, Research Funding; Actelion: Consultancy, Research Funding. Musiek:Menlo: Other: Investigator; Helsinn: Membership on an entity's Board of Directors or advisory committees; Soligenix: Other: Investigator; Pfizer: Other: Investigator; Elorac: Other: Investigator; Kyowa: Honoraria, Other: Above honoraria: for Ad Board; miRagen: Other: Investigator. Ortiz-Romero:Actelion: Consultancy, Membership on an entity's Board of Directors or advisory committees; Kyowa: Membership on an entity's Board of Directors or advisory committees; Takeda: Membership on an entity's Board of Directors or advisory committees; PLCG1: Patents & Royalties; miRagen: Membership on an entity's Board of Directors or advisory committees; MEDA: Research Funding; Innate Pharma: Membership on an entity's Board of Directors or advisory committees; 4SC: Membership on an entity's Board of Directors or advisory committees. Eradat:Kyowa: Research Funding; Kite: Research Funding; Pharmacyclics: Consultancy, Honoraria, Research Funding, Speakers Bureau; Roche: Research Funding; Genentech: Consultancy, Honoraria, Research Funding, Speakers Bureau; AbbVie: Consultancy, Honoraria, Research Funding, Speakers Bureau; Gilead: Research Funding. Magnolo:University Hospital of Muenster, Center of Innovative Dermatology: Employment. Scarisbrick:Kyowa Kirin: Consultancy, Membership on an entity's Board of Directors or advisory committees; Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees; Recordat: Consultancy; 4SC: Consultancy, Membership on an entity's Board of Directors or advisory committees; Innate Pharma: Consultancy, Membership on an entity's Board of Directors or advisory committees; Helsinn: Consultancy, Membership on an entity's Board of Directors or advisory committees. Dalle:Kyowa: Other: Principal Investigator in clinical trials promoted by Kyowa. Fisher:Kyowa Kirin: Consultancy. Poligone:Stemline Therapeutics: Consultancy, Speakers Bureau; Regeneron: Consultancy, Speakers Bureau; Actelion: Consultancy, Speakers Bureau; Astex Pharmaceuticals: Research Funding; Bioniz: Research Funding; Celgene: Consultancy; Helsinn: Research Funding, Speakers Bureau; Innate Pharma: Research Funding; Kyowa Hakko Kirin: Consultancy, Honoraria, Research Funding, Speakers Bureau; miRagen: Research Funding; Soligenix: Research Funding. Pro:Takeda: Consultancy, Honoraria, Other: Travel Expenses; Celgene: Consultancy, Honoraria; Kyowa Hakka Kirin: Consultancy, Honoraria; Seattle Genetics: Consultancy, Honoraria, Other: Travel Expenses, Research Funding. Quaglino:Actelion: Honoraria, Other: Advisory Board; Innate Pharma: Honoraria, Other: Advisory Board; Takeda: Honoraria, Other: Advisory Board; Kyowa Kirin: Honoraria, Other: Advisory Board; Helsinn: Honoraria, Other: Advisory Board; Therakos: Honoraria, Other: Advisory Board. Reddy:AbbVie: Honoraria; Janssen: Honoraria; KITE: Honoraria; Merck: Research Funding; Celgene: Honoraria, Speakers Bureau. Geskin:Merck: Other: Supported/Contracted Research; UpToDate: Patents & Royalties: Royalty, Receipt of Intellectual Property Rights / Patent Holder; Actelion: Other: Supported/Contracted Research; Helsinn: Consultancy, Honoraria, Other: Supported/Contracted Research; Stratpharma: Other: Supported/Contracted Research; Mallinckrodt: Consultancy, Honoraria, Other: Supported/Contracted Research; Medscape: Speakers Bureau; Medivir: Consultancy, Honoraria. Halwani:Amgen: Other: Investigator; Takeda: Other: PI; Seattle Genetics: Other: PI; Pharmacyclics: Other: Investigator; miRagen: Other: PI; Kyowa Hakko Kirin: Other: PI; Immune Design: Other: PI; Genentech, Inc.: Other: Investigator; Bristol-Myers Squibb: Other: PI; AbbVie: Other: PI. Khot:Peter MacCallum Cancer Centre: Employment; Amgen: Consultancy, Speakers Bureau; Celgene: Consultancy; Janssen: Consultancy; Kyowa Hakko Kirin: Consultancy. Korman:Genentech: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Dermira: Research Funding; Glaxo: Honoraria, Membership on an entity's Board of Directors or advisory committees; Immune Pharma: Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Kyowa: Research Funding; Leo: Research Funding; Menlo: Research Funding; Merck: Research Funding; Novartis: Consultancy, Honoraria, Speakers Bureau; Pfizer: Research Funding; Principia: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Prothena: Research Funding; Regeneron: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Rhizen: Research Funding; Sun: Honoraria, Membership on an entity's Board of Directors or advisory committees; Syntimmune: Research Funding; UCB: Research Funding; Valeant: Honoraria, Membership on an entity's Board of Directors or advisory committees; Eli Lilly: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Bristol-Myers Squibb: Research Funding; AbbVie: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Horwitz:Seattle Genetics: Consultancy, Research Funding; Affimed: Consultancy; Astex: Consultancy; Portola: Consultancy; ADCT Therapeutics: Research Funding; Kyowa Hakko Kirin: Consultancy; Infinity/Verastem: Consultancy, Research Funding; Miragen: Consultancy; Seattle Genetics: Consultancy, Research Funding; Forty-Seven: Research Funding; Celgene: Consultancy, Research Funding; Millennium/Takeda: Consultancy, Research Funding; Miragen: Consultancy; Innate Pharma: Consultancy; Kura: Consultancy; Corvus Pharmaceuticals: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Miragen: Consultancy; Infinity/Verastem: Consultancy, Research Funding; Millennium/Takeda: Consultancy, Research Funding; Portola: Consultancy; Kura: Consultancy; Celgene: Consultancy, Research Funding; Kura: Consultancy; Kyowa Hakko Kirin: Consultancy; Infinity/Verastem: Consultancy, Research Funding; Forty-Seven: Research Funding; Trillium: Research Funding; Corvus Pharmaceuticals: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Celgene: Consultancy, Research Funding; Astex: Consultancy; Affimed: Consultancy; ADCT Therapeutics: Research Funding; Aileron: Research Funding; Corvus Pharmaceuticals: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Kyowa Hakko Kirin: Consultancy; Trillium: Research Funding; Millennium/Takeda: Consultancy, Research Funding; Mundipharma: Consultancy; Millennium/Takeda: Consultancy, Research Funding; Kyowa Hakko Kirin: Consultancy; Portola: Consultancy; Aileron: Research Funding; Mundipharma: Consultancy; Celgene: Consultancy, Research Funding; Mundipharma: Consultancy; Seattle Genetics: Consultancy, Research Funding; ADCT Therapeutics: Research Funding; Portola: Consultancy; Kura: Consultancy; ADCT Therapeutics: Research Funding; Corvus Pharmaceuticals: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Infinity/Verastem: Consultancy, Research Funding; Aileron: Research Funding; Affimed: Consultancy; Trillium: Research Funding; Innate Pharma: Consultancy; Affimed: Consultancy; Astex: Consultancy; Mundipharma: Consultancy; Aileron: Research Funding; Miragen: Consultancy; Trillium: Research Funding; Innate Pharma: Consultancy; Forty-Seven: Research Funding; Forty-Seven: Research Funding; Innate Pharma: Consultancy; Astex: Consultancy; Seattle Genetics: Consultancy, Research Funding. Lamar:Seattle Genetics: Consultancy; Kyowa: Consultancy, Membership on an entity's Board of Directors or advisory committees. Moskowitz:Cell Medica: Consultancy; ADC Therapeutics: Consultancy; Merck: Research Funding; Erytech Pharma: Consultancy; Takeda Pharmaceuticals: Consultancy; Erytech Pharma: Consultancy; Merck: Research Funding; Kyowa Hakko Kirin Pharma: Consultancy, Research Funding; Erytech Pharma: Consultancy; Incyte: Research Funding; Kyowa Hakko Kirin Pharma: Consultancy, Research Funding; Merck: Research Funding; Erytech Pharma: Consultancy; ADC Therapeutics: Consultancy; ADC Therapeutics: Consultancy; Bristol-Myers Squibb: Consultancy, Research Funding; Bristol-Myers Squibb: Consultancy, Research Funding; Erytech Pharma: Consultancy; Bristol-Myers Squibb: Consultancy, Research Funding; miRagen Therapeutics Inc: Consultancy, Research Funding; Kyowa Hakko Kirin Pharma: Consultancy, Research Funding; Takeda Pharmaceuticals: Consultancy; Seattle Genetics: Consultancy, Honoraria, Research Funding; Cell Medica: Consultancy; Erytech Pharma: Consultancy; Seattle Genetics: Consultancy, Honoraria, Research Funding; Cell Medica: Consultancy; Merck: Research Funding; Kyowa Hakko Kirin Pharma: Consultancy, Research Funding; ADC Therapeutics: Consultancy; Merck: Research Funding; Cell Medica: Consultancy; Cell Medica: Consultancy; ADC Therapeutics: Consultancy; Incyte: Research Funding; Takeda Pharmaceuticals: Consultancy; Seattle Genetics: Consultancy, Honoraria, Research Funding; Cell Medica: Consultancy; Cell Medica: Consultancy; miRagen Therapeutics Inc: Consultancy, Research Funding; Bristol-Myers Squibb: Consultancy, Research Funding; Bristol-Myers Squibb: Consultancy, Research Funding; miRagen Therapeutics Inc: Consultancy, Research Funding; Erytech Pharma: Consultancy; miRagen Therapeutics Inc: Consultancy, Research Funding; Incyte: Research Funding; Incyte: Research Funding; miRagen Therapeutics Inc: Consultancy, Research Funding; miRagen Therapeutics Inc: Consultancy, Research Funding; Bristol-Myers Squibb: Consultancy, Research Funding; Kyowa Hakko Kirin Pharma: Consultancy, Research Funding; Bristol-Myers Squibb: Consultancy, Research Funding; Merck: Research Funding; Seattle Genetics: Consultancy, Honoraria, Research Funding; Kyowa Hakko Kirin Pharma: Consultancy, Research Funding; ADC Therapeutics: Consultancy; Merck: Research Funding; ADC Therapeutics: Consultancy; Bristol-Myers Squibb: Consultancy, Research Funding; Merck: Research Funding; Bristol-Myers Squibb: Consultancy, Research Funding; Cell Medica: Consultancy; Seattle Genetics: Consultancy, Honoraria, Research Funding; Seattle Genetics: Consultancy, Honoraria, Research Funding; Bristol-Myers Squibb: Consultancy, Research Funding; Bristol-Myers Squibb: Consultancy, Research Funding; Bristol-Myers Squibb: Consultancy, Research Funding; Incyte: Research Funding; Takeda Pharmaceuticals: Consultancy; Takeda Pharmaceuticals: Consultancy; Cell Medica: Consultancy; Cell Medica: Consultancy; Cell Medica: Consultancy; Incyte: Research Funding; Incyte: Research Funding; Erytech Pharma: Consultancy; ADC Therapeutics: Consultancy; Erytech Pharma: Consultancy; Erytech Pharma: Consultancy; Erytech Pharma: Consultancy; Bristol-Myers Squibb: Consultancy, Research Funding; Erytech Pharma: Consultancy; Erytech Pharma: Consultancy; Seattle Genetics: Consultancy, Honoraria, Research Funding; Kyowa Hakko Kirin Pharma: Consultancy, Research Funding; Merck: Research Funding; Takeda Pharmaceuticals: Consultancy; Merck: Research Funding; Seattle Genetics: Consultancy, Honoraria, Research Funding; Merck: Research Funding; Seattle Genetics: Consultancy, Honoraria, Research Funding; Seattle Genetics: Consultancy, Honoraria, Research Funding; miRagen Therapeutics Inc: Consultancy, Research Funding; Incyte: Research Funding; Seattle Genetics: Consultancy, Honoraria, Research Funding; Merck: Research Funding; Seattle Genetics: Consultancy, Honoraria, Research Funding; Bristol-Myers Squibb: Consultancy, Research Funding; miRagen Therapeutics Inc: Consultancy, Research Funding; ADC Therapeutics: Consultancy; miRagen Therapeutics Inc: Consultancy, Research Funding; Kyowa Hakko Kirin Pharma: Consultancy, Research Funding; Takeda Pharmaceuticals: Consultancy; Takeda Pharmaceuticals: Consultancy; Kyowa Hakko Kirin Pharma: Consultancy, Research Funding; Takeda Pharmaceuticals: Consultancy; ADC Therapeutics: Consultancy; ADC Therapeutics: Consultancy; Incyte: Research Funding; Seattle Genetics: Consultancy, Honoraria, Research Funding; ADC Therapeutics: Consultancy; Incyte: Research Funding; Cell Medica: Consultancy; Incyte: Research Funding; Takeda Pharmaceuticals: Consultancy; Incyte: Research Funding; Takeda Pharmaceuticals: Consultancy; Takeda Pharmaceuticals: Consultancy; Takeda Pharmaceuticals: Consultancy; Cell Medica: Consultancy; Cell Medica: Consultancy; Kyowa Hakko Kirin Pharma: Consultancy, Research Funding; Cell Medica: Consultancy; miRagen Therapeutics Inc: Consultancy, Research Funding; miRagen Therapeutics Inc: Consultancy, Research Funding; Takeda Pharmaceuticals: Consultancy; Incyte: Research Funding; miRagen Therapeutics Inc: Consultancy, Research Funding; Erytech Pharma: Consultancy; miRagen Therapeutics Inc: Consultancy, Research Funding; Kyowa Hakko Kirin Pharma: Consultancy, Research Funding; Kyowa Hakko Kirin Pharma: Consultancy, Research Funding; Kyowa Hakko Kirin Pharma: Consultancy, Research Funding; Merck: Research Funding; miRagen Therapeutics Inc: Consultancy, Research Funding; Incyte: Research Funding; miRagen Therapeutics Inc: Consultancy, Research Funding; Incyte: Research Funding; Takeda Pharmaceuticals: Consultancy; ADC Therapeutics: Consultancy; ADC Therapeutics: Consultancy; ADC Therapeutics: Consultancy; Erytech Pharma: Consultancy; Seattle Genetics: Consultancy, Honoraria, Research Funding; Bristol-Myers Squibb: Consultancy, Research Funding; Seattle Genetics: Consultancy, Honoraria, Research Funding; Kyowa Hakko Kirin Pharma: Consultancy, Research Funding; Merck: Research Funding; Merck: Research Funding; Kyowa Hakko Kirin Pharma: Consultancy, Research Funding. Wells:Takeda Pharmaceuticals Australia Pty Limited: Membership on an entity's Board of Directors or advisory committees; MSD Australia: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Akilov:Trillium Therapeutics: Consultancy, Other: PI on the clinical trials, Research Funding; Pfizer: Research Funding. Cowan:Kyowa Kirin: Consultancy. Dummer:Merck Sharp & Dohme: Other: Intermittent, project focused consulting and/or advisory relationships; Novartis: Other: Intermittent, project focused consulting and/or advisory relationships; Bristol-Myers Squibb: Other: Intermittent, project focused consulting and/or advisory relationships; Roche: Other: Intermittent, project focused consulting and/or advisory relationships; Amgen: Other: Intermittent, project focused consulting and/or advisory relationships; Takeda: Other: Intermittent, project focused consulting and/or advisory relationships; Pierre Fabre: Other: Intermittent, project focused consulting and/or advisory relationships; Sun Pharma: Other: Intermittent, project focused consulting and/or advisory relationships; Sanofi: Other: Intermittent, project focused consulting and/or advisory relationships; Catalym: Other: Intermittent, project focused consulting and/or advisory relationships; Second Genome: Other: Intermittent, project focused consulting and/or advisory relationships. Lechowicz:Kyowa Kirin Inc: Consultancy; Spectrum: Consultancy. Foss:Eisai: Consultancy; Seattle Genetics: Consultancy, Other: fees for non-CME/CE services ; miRagen: Consultancy; Acrotech: Consultancy; Mallinckrodt: Consultancy; Spectrum: Other: fees for non-CME/CE services . Wilcox:University of Michigan: Employment. Porcu:Innate Pharma: Honoraria, Other: Scientific Board, Research Funding; Viracta: Honoraria, Other: Scientific Board, Research Funding; BeiGene: Other: Scientific Board, Research Funding; Incyte: Research Funding; Daiichi: Research Funding; Kyowa: Honoraria, Other: Scientific Board, Research Funding; ADCT: Research Funding; Spectrum: Consultancy. Vermeer:Kyowa: Membership on an entity's Board of Directors or advisory committees, Research Funding; Takeda: Membership on an entity's Board of Directors or advisory committees, Research Funding. Abhyankar:Therakos: Other: Consulting, Speakers Bureau; Incyte: Speakers Bureau. Pacheco:University of Colorado: Employment. William:Techspert: Consultancy; Guidepoint Global: Consultancy; Defined Health: Consultancy; Celgene Corporation: Consultancy; Kyowa Kirin, Inc.: Consultancy. Fukuhara:Kyowa-Hakko Kirin: Honoraria; Bayer: Research Funding; Mundi: Honoraria; Janssen Pharma: Honoraria; Mochida: Honoraria; Ono Pharmaceutical Co., Ltd.: Honoraria; Takeda Pharmaceutical Co., Ltd.: Honoraria, Research Funding; Chugai Pharmaceutical Co., Ltd.: Honoraria; Eisai: Honoraria, Research Funding; Celgene Corporation: Honoraria, Research Funding; Nippon Shinkyaku: Honoraria; Zenyaku: Honoraria; AbbVie: Research Funding; Gilead: Research Funding; Solasia Pharma: Research Funding. Munoz:Pharmacyclics /Janssen: Consultancy, Research Funding, Speakers Bureau; Bayer: Consultancy, Speakers Bureau; Merck: Consultancy; Kyowa: Consultancy, Honoraria, Speakers Bureau; Seattle Genetics: Consultancy, Honoraria, Research Funding, Speakers Bureau; Celgene/Juno: Consultancy, Research Funding; Genentech: Consultancy, Research Funding, Speakers Bureau; Fosunkite: Speakers Bureau; AstraZeneca: Speakers Bureau; Portola: Research Funding; Incyte: Research Funding; Kite/Gilead: Consultancy, Research Funding, Speakers Bureau; Bristol-Myers Squibb: Consultancy; Alexion: Consultancy; Pfizer: Consultancy. Querfeld:Elorac: Other: Investigator, Research Funding; Trillium: Consultancy, Other: Investigator, Research Funding; Medivir: Consultancy; miRagen: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other: Investigator; Helsinn: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other: Investigator; Soligenix: Other: Investigator; City of Hope Cancer Center and Beckman Research Institute: Employment; Celgene: Other: Investigator, Research Funding; Kyowa: Membership on an entity's Board of Directors or advisory committees, Other: Investigator; Eisai: Other: Investigator; Bioniz: Membership on an entity's Board of Directors or advisory committees, Other: Investigator. Uhara:Kyowa Kirin Co., Ltd: Honoraria, Research Funding. Huen:Innate Pharmaceuticals: Research Funding; Galderma Inc: Research Funding; Rhizen Pharmaceuticals: Research Funding; Glaxo Smith Kline Inc: Research Funding. Tobinai:Meiji Seika: Honoraria; Takeda Pharmaceutical: Consultancy, Honoraria, Research Funding; Daiichi Sankyo: Consultancy, Honoraria; Janssen Pharmaceutical: Honoraria, Research Funding; Kyowa Kirin: Honoraria, Research Funding; Ono Pharmaceutical: Consultancy, Honoraria, Research Funding; Zenyaku Kogyo: Consultancy, Honoraria; Celgene: Consultancy, Honoraria, Research Funding; Mundi Pharma: Consultancy, Honoraria, Research Funding; Eisai: Honoraria, Research Funding; HUYA Bioscience: Consultancy, Honoraria; Bristol-Myers Squibb: Honoraria; AbbVie: Research Funding; Verastem: Honoraria; Chugai Pharmaceutical: Honoraria, Research Funding; Yakult: Honoraria; Solasia: Honoraria. Tokura:Kyowa Kirin Pharmaceutical Development, Inc.: Honoraria. Boh:Actelion: Other: Principal Investigator; Tulane University School of Medicine: Employment; Celgene: Other: Principal Investigator, Speaker, Grants; Sun: Other: Speaker; Janssen: Other: Principal Investigator, Speaker, Grants; Novartis: Other: Principal Investigator, Speaker, Grants; Soligenix: Other: Principal Investigator; Incyte: Other: Principal Investigator; Regeneron: Other: Principal Investigator, Grants; Ortho Dermatologics: Other: Speaker, Grants; Pfizer: Other: Principal Investigator; UCB: Other: Speaker, Grants; Elorac: Other: Principal Investigator; Abbvie: Other: Principal Investigator. Nicolay:Teva Pharmaceutical Industries: Honoraria, Other: Conference participation fees; Novartis AG: Consultancy, Honoraria; Biogen GmbH: Consultancy, Honoraria; Almirall Hermal AG: Consultancy, Honoraria; Actelion Pharmaceuticals: Consultancy, Honoraria; Innate Pharma: Consultancy; Kyowa Hakko Kirin: Consultancy, Honoraria; Takeda Pharmaceuticals: Consultancy. Leoni:Kyowa Kirin Pharmaceutical Development, Inc.: Employment. Ito:Kyowa Kirin Pharmaceutical Development, Inc.: Employment. Herr:Kyowa Kirin, Inc.: Employment. Sokol:EUSA: Consultancy.

The aim of this paper is to address the impact of certain audit committee characteristics identified by the ASX Corporate Governance Council on improving the effectiveness of corporate audit committees on the likelihood of financial distress. Using a sample of 155 listed Australian firms, this paper finds support for the argument that the adoption of some, but not all, recommendations concerning the formation of an audit committee is beneficial for firms, which in this paper is reflected in a reduced likelihood of financial distress. In particular, the presence of a financial expert and solely non-executive directors on audit committee are associated with lower financial distress likelihood. By contrast, chairperson duality is significantly positively related to the probability of financial distress

Purpose The purpose of this study is to examine whether audit committee characteristics influence the cost of equity capital. Design/methodology/approach Drawing on signalling theory, this study hypothesises that the presence of an AC with adequate characteristics serves as a market “signal” of the credibility of the effective monitoring process and hence affects the perception of capital providers on the cost of equity capital. The study uses a multiple regression analysis on data collected from a sample of top Australian listed firms. Findings The study finds that audit committee characteristics such as size, meeting frequency and independence are significantly and negatively associated with the cost of equity capital. However, there is no significant evidence that the financial qualifications of audit committee directors are associated with the cost of equity capital. Originality/value While there have been several studies examining the cost of equity capital, there is very limited research on the cost of capital in Australian firms. The study aims to fill this gap, in part, and contribute to the literature on corporate governance and signalling theory.

Purpose The Voice of the Clinician project commenced during an era when practitioner burnout, dissatisfaction, and turnover became an increasingly global health workforce concern. One key problem is clinical staff not being empowered to voice their concerns to decision-makers, as was found in this case study of an Australian public health organization. The following research question informed the present study: What is a better committee system for clinician engagement in decision-making processes? The paper aims to discuss this issue. Design/methodology/approach The Mid North Coast Local Health District in New South Wales aspired to improve engagement between frontline clinicians and decision-makers. Social network analysis methods and mathematical modeling were used in the discovery of how committees are connected to each other and subsequently to other committee members. Findings This effort uncovered a hidden organizational architecture of 323 committees of 926 members which overall cost 84,729 person hours and AUD$2.923 million per annum. Furthermore, frontline clinicians were located far from centers of influence, just 37 percent of committees had terms of reference, and clinicians reported that meeting agendas were not being met. Practical implications In response to the findings, a technological platform was created so that the board of directors could visually see all the committees and the connections between them, thus creating ways to further improve communication, transparency of process, and – ultimately – clinician engagement. Originality/value The breakthrough idea is that all organizational meetings can be seen as a system of engagement and should be analyzed to determine and describe the points and pathways where clinician voice is blocked.

Purpose The purpose of this paper is to contribute to the corporate governance literature by examining the aggregate effect of board and audit committee characteristics on earnings management practices, particularly in the period following the introduction of the second edition of the Australian Securities Exchange (ASX) Corporate Governance Principles and Recommendations. Design/methodology/approach This paper begins by embarking on an extensive review of extant empirical research on boards of directors and audit committees. Then, the paper reports on the use of a quantitative analysis approach to specify the relationship between board and audit committee characteristics (introduced by the ASX Corporate Governance Council) and the level of absolute discretionary accruals as a proxy for earnings management. Findings The findings suggest that greater compliance with board and audit committee principles is linked to lower earnings management, indicating that deliberate structuring of boards and audit committees is an effective approach for enhancing a firm’s financial reporting quality and providing support for the efficacy of the second edition of principles and recommendations related to boards and audit committees suggested by the ASX Corporate Governance Council. Practical implications This study significantly extends the literature and has notable implications for financial reporting regulators, as the findings regarding the monitoring role of boards and audit committees should be beneficial for future revisions of corporate governance principles and recommendations. Originality/value This study focuses on the aggregate effect of board characteristics recommended by the Australian Corporate Governance Council on earnings management practices, and the results support the effectiveness of the board and audit committee characteristics recommended by the ASX Corporate Governance Council. New directions for future improvements to the principles and recommendations are identified.

PurposeThe purpose of this paper is to investigate the effectiveness of recommendations made by the Australian Stock Exchange (ASX) relating to audit committees in Australia, and whether they have improved financial reporting quality for low‐ and mid‐cap listed firms.Design/methodology/approachThe authors examine the relation between characteristics of the audit committee and financial reporting quality for listed companies not mandated to comply with these requirements, i.e. low‐ and mid‐cap firms. For a sample of 288 firms, the authors regress measures of audit committee independence, expertise and activity and size on alternative measures of earnings management.FindingsA significant association is found between all three characteristics and lower earnings management. The significant measure for independence is the proportion of independent directors on the audit committee; for expertise, it is that at least one member of the audit committee has an accounting qualification; and for activity and size, it is the frequency of audit committee meetings.Practical implicationsThe results provide support for the mandatory establishment of audit committees for the top 500 (high‐ and mid‐cap) firms introduced by the ASX and suggest those audit committee characteristics which could improve financial reporting quality for low‐ and mid‐cap firms.Originality/valueThe paper examines low‐ and mid‐cap firms in order to complement previous similar studies done for high‐cap firms. It identifies the effects on financial reporting quality of voluntarily choosing to have an audit committee and of the choice of audit committee characteristics, in the period after substantial corporate governance reform. It includes a new measure among audit committee characteristics, industry expertise, which is required in Australia and is new to the literature.

This paper presents a synthesis and analysis of corporate governance guidelines of the twenty-five European Union (EU) member states. The paper focuses on observable and quantifiable aspects of corporate governance including key aspects pertaining to the composition and operation of the board of directors, audit committee, remuneration committee, nomination committee, and other corporate governance policies. Using an Australian corporate governance ranking system, contained in the Horwath Report, the Corporate Governance (CG) Guidelines were analysed and rated. Based on the rating system, thirteen of the twenty-five EU countries had guidelines that were considered to be lacking in several key areas. In contrast, Ireland and the United Kingdom have the most detailed and rigorous corporate governance guidelines. Countries with less developed economic frameworks have the least detailed and rigorous corporate governance guidelines. Finally the specificity of corporate governance guidelines varies greatly between the various countries either due to the system used (one or two tier systems) or whether the country’s legal system is predominately common or statutory law. The aim of the paper is not to determine the compliance of individual companies on their company’s CG Code but to rate the Codes of the countries so as to assess whether there ought to be stricter regulatory measures by the EU on its member states

Introduction Anaplastic large-cell lymphoma (ALCL) is a rare subtype of T-cell non-Hodgkin lymphoma, characterized by uniformly strong CD30 expression and further delineated by expression of the Alk protein. Standard first-line (1L) therapy is CHOP-based chemotherapy, with or without consolidative autologous stem cell transplant (ASCT) (Schmitz, Blood, 2010). Despite intensive chemotherapy approaches, 40-65% of patients experience relapsed/refractory disease, for which brentuximab vedotin (BV) as monotherapy has established efficacy (Pro, Blood, 2017) Recent results from ECHELON-2 (E2), led to FDA approval of BV in combination with CHP (CHP+A) as first-line treatment for CD30+ PTCL, based on a 34% reduction in risk of death compared to CHOP, an effect only demonstrable in ALCL (70% of the E2 cohort) (Horwitz, Lancet, 2019). Given this renewed treatment landscape, we investigated outcomes of unselected patients with ALCL treated in routine clinical practice. Methods/Study Population Consecutively diagnosed patients with systemic ALCL from 6 UK and Australian centres (n=166) were studied (Dec 2004-Dec 2018). Patients ≥16 years with ALCL were included irrespective of Alk status. Treatment allocation was clinician choice and included best supportive care (BSC). Post-mortem diagnosis and 10 patients treated on E2 were excluded. Principal outcomes were PFS and OS following 1L treatment. Additional outcome measures included frequency of ASCT and use of BV for r/r ALCL. Data were retrospectively collected following GDPR guidelines and in accordance with the declaration of Helsinki. Results Median age at diagnosis was 57.5 years (range 16-93), 62% were male, 19% had ECOG ≥3 and 53 (35%) patients were ALK positive. Median lines of therapy was 1 (range 0-6). Baseline patient characteristics are shown in table 1. The most frequent 1L treatment regimen was CHOP in 104 pts (67%), 26 (18%) received intensified regimens (CHOEP, CHOP/IVE/MTX, CODOX-M, ALCL99), 4 received other regimens (2.6%) and 14 had best supportive care (9%). Treatment-related mortality was 5.6% (8/142). 12 (8%) patients underwent ASCT in first response, of whom 10 had received intensified induction regimens. Of 141 evaluable pts, ORR was 71% and CR rate was 52%. Median follow up of all patients was 40 months, 3-year PFS and OS for 1L of treatment were 46% and 58% respectively. For the CHOP-treated cohort (n=104), 3-year PFS and OS were 47% and 57%. Outcomes for ALK-negative patients treated with CHOP (n=78) were inferior to ALK-positive; 3-year PFS, OS of 35% and 44% vs 66% and 82% respectively (p=0.003 for both, figure 1). BV was given to 24 pts (15%), mostly for second (16/24) line of therapy. Median doses received were 5 (range 1-14). ORR to BV was 11/24 (45%) and CR rate was 7/24 (30%). Median follow up after BV was 18 months, at which point the PFS and OS rates were 33% and 35% respectively (Figure 1). Bridging to ASCT or alloSCT occurred in 3 and 4 pts respectively, of whom 6 remain alive at data cutoff. 41 patients were staged with both CT and PET-CT, with concordant staging in 63%. 9/41 patients were upstaged by PET, 3 of which resulted in upgraded IPI score (extranodal sites not found on CT). 52 patients had PET-CT after first-line therapy. At data cutoff, 26/35 patients did not progress after PET-defined CR (74%), whereas 6/12 patients progressed after PET-defined PR (50%). Conclusions This study describes a large unselected cohort of ALCL treated in routine clinical practice prior to publication of the E2 study, observing a comparable baseline Alk pos/neg distribution. Notably, survival outcomes of our CHOP-treated cohort are similar to those in the E2 control arm, notwithstanding 28% of our patients with ECOG ≥3 (an E2 exclusion criterion) and also comparable to data from the prospective international T-cell lymphoma project (Shustov, Haematol Oncol, 2019). A minority of pts received intensified regimens and only 8% underwent ASCT consolidation. Achievement of CMR by PET-CT was still associated with a significant proportion of relapses. Outcomes of r/r ALCL treated with single-agent BV were inferior in our cohort as compared to the pivotal Phase 2 data (Pro, Blood, 2017). Our data represent an important benchmark as an unselected ALCL population treated with conventional chemotherapy in routine clinical practice; future studies of CHP+A in the real-world setting will be crucial in assessing the wider impact of the E2 study. Disclosures Martinez-Calle: ABBVIE: Other: Travel support. Manos:Janssen: Honoraria; Novo Nordisk Pharmaceuticals: Other: Travel. Bishton:Takeda: Other: Travel support, Research Funding; Janssen: Membership on an entity's Board of Directors or advisory committees; Celgene: Research Funding; AbbVie: Research Funding; Celltrion: Membership on an entity's Board of Directors or advisory committees, Other: travel support; Roche: Other: Travel support, Research Funding. Hawkes:Bristol-Myers Squibb: Research Funding, Speakers Bureau; Celgene: Membership on an entity's Board of Directors or advisory committees, Research Funding; Mundi pharma: Research Funding; Merck Sharp & Dohme: Membership on an entity's Board of Directors or advisory committees; Roche/Genentech: Membership on an entity's Board of Directors or advisory committees, Other: Travel expenses, Speakers Bureau; Roche: Research Funding; Astra Zeneca: Research Funding; Merck KgA: Research Funding; Janssen-Cilag: Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Gilead: Membership on an entity's Board of Directors or advisory committees, Research Funding; Takeda: Speakers Bureau. Osborne:Gilead: Consultancy; Pfizer: Honoraria, Speakers Bureau; Takeda: Consultancy, Honoraria, Other: Travel, Speakers Bureau; Novartis: Other: Travel; Servier: Consultancy; MSD: Consultancy; Roche: Consultancy, Honoraria, Other: Travel, Speakers Bureau. Collins:Gilead: Consultancy, Honoraria. Burton:Celgene: Membership on an entity's Board of Directors or advisory committees; Roche: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees; Bristol-Myers Squibb: Honoraria, Membership on an entity's Board of Directors or advisory committees. Fox:AbbVie: Consultancy; Gilead: Consultancy; Janssen: Consultancy; Celgene: Consultancy; Sunesis: Consultancy; Takeda Pharmaceuticals: Consultancy; Atara Biotherapeutics: Consultancy; Adienne: Other: Travel Support.

Background: Adeno-Associated Virus (AAV) based liver transduction has emerged as a potentially viable gene therapy approach for the treatment of hemophilia patients. Fidanacogene elaparvovec (previously SPK-9001) is a hepatotropic bioengineered AAV based vector that delivers a high activity factor IX (FIX) transgene driven by a liver specific promoter. The Phase 1/2a development consists of a dosing study where patients are followed for 52 weeks post vector infusion followed by a long-term follow-up study for an additional 5 years. Data on the first 10 patients were previously published and demonstrated safe and sustained expression of a high activity FIX protein with an associated decreased requirement for exogenous factor administration and markedly reduced annualized bleeding rate. Here we present data on 15 patients infused with fidanacogene elaparvovec with ≥ 1 year of follow-up, which represents the largest cohort of Hemophilia B (HB) patients treated with the same vector at the same dose. Methods: Fifteen (15) adult HB patients were infused with 5 x 1011 vg/kg of fidanacogene elaparvovec and followed for at least 1 year as part of the Phase 1/2a dosing study. FIX activity (FIX:C) levels were measured using a one-stage assay. Endpoints include: Safety and tolerability, steady-state activity calculated as the geometric mean of all observed FIX:C activity levels from week 12 through week 52; annualized bleeding rate (ABR) prior to and 52 weeks after vector infusion; T cell response to fidanacogene elaparvovec capsid and transgene monitored post-infusion using an interferon-γ enzyme-linked immunospot (ELISpot) assay. Results: Three of fifteen patients were treated with corticosteroids for elevations in hepatic transaminases of which 2 were positive for capsid reactive T cells by interferon-γ ELISpot. There were otherwise no treatment related adverse events. The mean post-infusion steady-state FIX:C was 22.9%±9.9% at 1 year post vector infusion as measured in a central laboratory by one-stage assay utilizing Actin-FSL. Mean ABR during the first 52 weeks following fidanacogene elaparvovec infusion was 0.4±1.1 compared to 8.9±14.0 in the 52 weeks preceding infusion (p<0.001). Twelve (12) out of 15 patients reported zero bleeds in the 52 weeks post-vector infusion. Five of 15 subjects infused factor for a total of 20 infusions. Additional follow-up data will be presented for all patients enrolled in the long-term follow-up study. Conclusions: Fidanacogene elaparvovec was well tolerated in 15 patients with no serious adverse events. Data for all patients at 52 weeks post-infusion demonstrated a marked reduction in bleeding frequency and exogenous FIX use. All hepatic transaminase elevations responded to treatment with corticosteroids. Collectively, to date, this represents the largest cohort of HB patients treated with the same AAV based gene therapy and at the lowest dose. Treatment has been efficacious for all patients with manageable immune responses when present. These data support progression to a pivotal Phase 3 study at the dose evaluated. Disclosures George: University of Pennyslvania: Employment; Avrobio: Membership on an entity's Board of Directors or advisory committees; Pfizer: Consultancy. Sullivan:Octapharma: Consultancy, Other: Advisory Board. Rasko:bluebird bio: Honoraria; Celgene: Honoraria; Novartis: Honoraria; FSHD Global Research Foundation: Membership on an entity's Board of Directors or advisory committees; Rarecyte: Consultancy, Equity Ownership; Gene Technology Technical Advisory, Australian Government: Other: Advisory committee; GSK: Honoraria; Takeda: Honoraria; Cynata: Honoraria; Genea: Equity Ownership; Cure The Future Foundation: Membership on an entity's Board of Directors or advisory committees; Gilead: Honoraria; Pfizer: Honoraria; Spark: Honoraria; Imago: Consultancy; Advisory Committee on Biologics, Australian Government: Other: Advisory Committee; NHMRC Mitochondrial Donation Expert Working Committee: Other: Advisory Committee; Australian Cancer Research Scientific Advisory Board: Membership on an entity's Board of Directors or advisory committees. Giermasz:Genentech/Roche: Consultancy, Other: Research, Speakers Bureau; uniQure: Consultancy, Other: Research; Bioverativ/Sanofi: Consultancy, Speakers Bureau; BioMarin: Consultancy, Other: Research; Sangamo: Other: Research. Samelson-Jones:The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania: Employment. Ducore:Bayer: Consultancy, Honoraria, Other: speaker (not bureau); Spark Therapeutics: Research Funding; Shire: Consultancy, Honoraria; Octapharma: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; HEMA Biologics: Consultancy, Honoraria; BioMarin: Research Funding; Bioverativ: Research Funding. Teitel:BioMarin: Consultancy; Bayer: Consultancy, Research Funding; Shire: Consultancy; Pfizer: Consultancy, Research Funding; Novo Nordisk: Consultancy; Octapharma: Consultancy; CSL Behring: Consultancy. McGuinn:Biogen: Research Funding; Roche/Genetech: Research Funding; Spark: Research Funding; Shire/Baxalta: Consultancy, Research Funding. Wright:Solid Biosciences: Consultancy; Yposkesi: Other: Senior Advisor, SAB; LogicBio Therapeutics: Other: Member, SAB; Memorial Sloan Kettering Cancer Center: Consultancy; Agilis Biotherapeutics: Consultancy; Axovant Sciences: Other: Chief Technology Officer, Gene Therapies; Akous Therapeutics: Consultancy; National Institutes of Health: Consultancy; Leland Stanford Junior University: Consultancy; Wright Biologics: Other; Sanofi Genzyme: Consultancy; Spark Therapeutics: Consultancy, Other: co-founder, Chief Technology Advisor/Officer, Member, SAB; Adrenas Therapeutics: Other: Member, SAB; Ambys Medicines: Consultancy; CEVEC Pharmaceuticl: Other: Member, SAB. Anguela:Spark Therapeutics: Employment, Equity Ownership, Patents & Royalties. High:Spark Therapeutics: Employment, Equity Ownership, Patents & Royalties. Rybin:Pfizer: Employment. Murphy:Pfizer Inc.: Employment. Rupon:Pfizer: Employment.

Objective The aim of the present study was to investigate the opinions and perceptions of senior allied health (AH) leaders in relation to AH leadership, governance and organisation from an Australian public health perspective. The target group was the New South Wales (NSW) Health AH directors or advisors, the most senior public AH professionals in NSW. Methods The study was conducted over a 6-month period in 2014–15 and comprised two parts: (1) data collection through a 46-question online survey that sought the views of AH leaders about the field of AH in NSW; and (2) two confirmatory focus groups with members of the NSW Health Allied Health Directors Committee. Results The online questionnaire generated novel information about the field of AH in the public sector of NSW, including the current organisation, governance and culture of AH. Focus group participants explored key findings in greater depth, including the effects of AH on and value of AH to the health system as a whole, as well as the attributes and competencies required by AH leaders. Participants identified the need to build and grow their influence, to more clearly demonstrate AH’s contribution and to realign efforts towards more strategic issues influencing governance, performance, professional standards and advocacy. This entailed broadening the vision and scope of AH Directors as well as across discipline leaders. Conclusion The results provide new information about Australian AH leadership, governance, culture and organisation, and highlight potential priorities for future leadership activities. What is known about this topic? Although leadership is considered an essential element in the provision of high-quality health care, leadership across AH remains underexamined. What does this paper add? There is a paucity of literature pertaining to AH leadership nationally and internationally. This paper describes the issues affecting AH leaders and leadership in NSW, as reported by senior AH leaders. What are the implications for practitioners? This study identifies key elements related to AH leadership and governance. Health systems and services can use this information to implement strategies that enhance AH leadership capability.

IntroductionChildcare settings have been widely identified as important venues for promoting healthy lifestyles to children. Out-of-school hours care (OSHC) is a rapidly growing childcare service, yet there has been limited research reported on healthy eating and physical activity (HEPA) environments within the Australian OSHC setting. This research aims to describe the HEPA environments related to foods and beverages served, staff behaviours and child physical activity levels across two local health districts within New South Wales, Australia. This study will provide evidence to support future interventions and policies in Australian OSHC settings.Methods and analysisA cross-sectional study design will be used to describe the food and beverages provided and child activity levels, and report on environmental correlates. OSHC programmes will be visited on non-consecutive weekdays between 2018 and 2020. The frequency of foods and beverages offered will be observed and categorised into food groups aligned to the Australian Dietary Guidelines. Children’s physical activity will be measured using ActiGraph wGT3X-BT accelerometers. Staff behaviour will be captured via direct observation and the System for Observing Staff Promotion of Activity and Nutrition. Short interviews with programme directors will gather contextual information about OSHC practices and policies.Ethics and disseminationFindings will be disseminated through peer-reviewed scientific journals, conference presentations and individualised feedback to each participating service. Ethical approval was granted by the University of Wollongong Human Research Ethics Committee (HE17/490).

Purpose The purpose of this paper is to examine and explain the complex interrelationships which influence the ability of firms to create value for their providers of finance and other stakeholders (loosely referred to in practice as “integrated thinking”). In doing so it examines the interrelationships between: environmental, social and governance (ESG) risk; delivering on corporate strategy; non-financial corporate reporting; and, board oversight. Design/methodology/approach Interviews were conducted with board chairs and non-executive directors of large listed companies on the Johannesburg Stock Exchange (where Boards are required to have a social and ethics sub-committee and approve integrated reports which have been mandatory since 2010) and the Australian Stock Exchange (where Board directors’ liability legislation results in Boards being reluctant to adopt integrated reporting which is voluntary). Findings The research finds that contemporary reporting processes, and in particular those set out in the King III Code and the International Integrated Reporting Framework, influence cognitive frames enhancing board oversight and assisting organisations in managing complexity. This results in increased awareness of the impact of ESG issues together with a broader view of value creation despite investor disinterest. Research limitations/implications A number of avenues of research are suggested to further examine the interrelationships identified. Practical implications The research assists the development of practice and policy by articulating and enhancing the understanding of linkages, which loosely fall under the vague practitioner term “integrated thinking”. Social implications The conceptualisation can inform national and global discussions on the appropriateness of corporate reporting and governance models to achieve sustainable development and contribute to the Sustainable Development Goals. Originality/value The paper conceptualises emerging and complex interrelationships. The cross-country comparison allows an assessment of the extent to which different national social contexts with differing governance and reporting frameworks lead to different perspectives on, and approaches to, value creation.

Research about lactation and breastfeeding has exploded since the Journal of Human Lactation ( JHL) began publishing in 1985. To discuss the 3-decade-long role of the Journal in promoting, supporting, and disseminating lactation research, editors convened a multidisciplinary group of lactation researchers and providers which comprised three senior researchers and one clinical practitioner, all of whom have a long history of lactation advocacy. Their discussion took place on July 1, 2019. Dr Aimee Eden is a medical anthropologist who leads the qualitative research efforts in a small research department. Her dissertation research focused on the maternal and child healthcare workforce, and the professionalization of breastfeeding support. She served on the Board of Directors of the International Board of Lactation Examiners (2010–2016) and currently serves on the board of the Monetary Investment for Lactation Consultant Certification. Dr Karleen Gribble has been conducting research for 15 years about infant and young child feeding in emergencies, long-term breastfeeding, milk sharing, early childhood trauma, adoption, and fostering. She is an Australian Breastfeeding Association community educator and breastfeeding counselor and a member of the Infant and Young Child Feeding in Emergencies Core Group. Elien Rouw is a practicing physician in Germany specialized in healthy infant care, with a long-standing specialization in breastfeeding medicine. She serves on the Board of Directors of the Academy of Breastfeeding Medicine, is a member of the German National Breastfeeding Committee and their delegate to the World Alliance for Breastfeeding Action. Dr Jackie Wolf is an historian of medicine, whose research focuses on the history of childbirth and breastfeeding practices in the United States and how those practices have shaped women’s and children’s health, as well as public health, over time. Her latest book, published by Johns Hopkins University Press and funded by a 3 year grant from the National Institutes of Health, is Cesarean Section: An American History of Risk, Technology, and Consequence. Dr Sara Gill moderated the discussion. She was a member of the Board of Directors of the International Lactation Consultant Association for 5 years, and has been an Associate Editor of the Journal of Human Lactation for the past 4 years. Her research has focused on breastfeeding among vulnerable populations. (Participants’ comments are noted as AE = Aimee Eden; SG = Sara Gill; KG = Karleen Gribble; ER = Elien Rouw; JW = Jacqueline Wolf).

Introduction The goal of betibeglogene autotemcel (beti-cel; LentiGlobin for β-thalassemia) gene therapy in patients with transfusion-dependent β-thalassemia (TDT) is lifelong, stable production of functional adult hemoglobin (Hb) sufficient for transfusion independence (TI) and reduction in ineffective erythropoiesis. 60 patients with TDT have been treated with beti-cel across 2 completed phase 1/2 studies (HGB-204, HGB-205) and in 2 ongoing phase 3 studies (HGB-207, HGB-212). After 2-yrs of follow-up in these 4 parent studies, patients were invited to enroll in a 13-yr long-term follow-up study, LTF-303 (NCT02633943). Interim results of patients enrolled in LTF-303 with follow-up as long as 6 years are reported. Methods Autologous CD34+ cells were transduced with BB305 lentiviral vector and infused into patients following single-agent, pharmacokinetic-adjusted busulfan myeloablation. Transduction in the phase 3 studies used a refined manufacturing process compared to the phase 1/2 studies. LTF-303 assessments include Hb, peripheral blood vector copy number (PB VCN), assessment of erythropoiesis and iron overload, quality of life, adverse events (AEs), replication-competent lentivirus (RCL), and insertion site analysis. Data are analyzed as median (min - max). Results As of 3 March 2020, all 32 patients who completed the parent studies (age at enrollment in parent study: 20 [12 - 35] yrs) enrolled in LTF-303 (22 treated in phase 1/2 studies, 10 treated in phase 3 studies). Follow-up post-infusion was 49.1 (23.3 - 71.8) months. PB VCN was detected in all patients at last follow-up (Phase 1/2: 0.4 [0.07 - 4.0] c/dg; Phase 3: 2.0 [0.13 - 3.0] c/dg). Gene therapy-derived Hb, HbAT87Q,in patients treated in the phase 1/2 studies was stable over time: 6.4 (0.5 - 10.1), 6.7 (0.4 - 10.1), 6.6 (0.5 - 10.7), and 7.1 (2.8 - 11.2) g/dL at months 24 (n=22), 36 (n=22), 48 (n=22), and 60 (n=10). Median HbAT87Q at month 24 in patients treated in the phase 3 studies was 9.5 (0.9 - 12.4) g/dL (n=10). Of the 32 patients enrolled in LTF-303, TI (defined as a weighted average Hb ≥9 g/dL without packed red blood cell transfusions for ≥12 months) was achieved in 14/22 (64%) patients treated in phase 1/2 (12 achieved TI during parent study, 2 during LTF-303) and in 9/10 (90%) patients treated in phase 3 (all achieved TI in parent study). All patients remain TI at last follow-up for 39.4 (19.4 - 69.4) months. Weighted average Hb during TI was 10.4 (9.4 - 13.3) and 12.5 (11.9 - 13.5) g/dL in patients treated in the phase 1/2 and phase 3 studies, respectively. In patients who achieved TI in the phase 3 studies, soluble transferrin receptor decreased from 144.1 (65.9 - 235.3) nmol/L at baseline to 54.1 (24.7 - 67.1) nmol/L at Month 24. Patients who achieved TI in HGB-207 had an improved health state today score from 65 - 96 at baseline to 90 - 100 at month 24 (n=8) on the EQ-5D-3L or EQ-5D-Y instrument. All patients were on iron chelation before beti-cel infusion, but post-infusion, only 26/32 (81%) patients restarted iron chelation; of these, 11 have since discontinued chelation. Phlebotomy was used for iron removal in 7/32 patients (22%; 3 patients treated in phase 1/2, 4 patients treated in phase 3) including 3 patients who also used iron chelation. Following an initial increase in liver iron concentration (LIC) after infusion, LIC in patients who achieved TI decreased, particularly in patients with an elevated baseline LIC (Figure). The median decrease in LIC from baseline to month 48 in patients who achieved TI was a 38% reduction (85% reduction to 269% increase; n=13). No drug-product-related AEs were reported &gt;2 years post-infusion. Serious AEs during LTF-303 included gonadotropic insufficiency, ectopic pregnancy, gall bladder wall thickening/polyp, bacteremia with neutropenia. and major depression (all n=1). No deaths, RCL, or insertional oncogenesis were reported. Insertion site analysis as assessed every 6 months until month 60 showed unique insertions accounted for &lt;30% of all insertions indicating polyclonal hematopoiesis. Summary These results demonstrate the durability and stability of response after beti-cel gene therapy in patients with TDT. Sustained levels of HbAT87Q and effective iron reduction with phlebotomy and/or iron chelation have resulted in improved hematologic parameters and iron burden. The paucity of gene therapy-related AEs observed beyond 2 years post-infusion study suggests a favorable long-term safety profile. Disclosures Kwiatkowski: bluebird bio,Inc.: Consultancy, Research Funding; Terumo Co: Research Funding; Novartis: Research Funding; Sangamo: Research Funding; Celgene: Consultancy; Apopharma: Research Funding; Imara: Consultancy; Agios: Consultancy; BMS: Consultancy. Walters:Editas: Consultancy; AllCells, Inc: Consultancy; Veevo Biomedicine: Consultancy. Locatelli:Bellicum Pharmaceutical: Membership on an entity's Board of Directors or advisory committees; Miltenyi: Speakers Bureau; Medac: Speakers Bureau; Jazz Pharmaceeutical: Speakers Bureau; Novartis: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Amgen: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Rasko:Novartis: Honoraria; Genea: Other; Imago: Consultancy; Rarecyte: Consultancy, Other; Gene Technology Technical Advisory, OGTR, Australian Government: Other; Advisory Committee on Biologics, Therapeutics Goods Administration, Australian Government: Other; NHMRC Mitochondrial Donation Expert Working Committee: Membership on an entity's Board of Directors or advisory committees; Cure The Future Foundation: Other; FSHD Global Research Foundation; Australian Cancer Research Foundation SAB: Membership on an entity's Board of Directors or advisory committees; bluebird bio, Inc.: Honoraria; Celgene: Honoraria; Pfizer: Honoraria; Cynata: Honoraria; Gilead: Honoraria; Takeda: Honoraria; GSK: Honoraria; CRISPR Therapeutics: Consultancy; Spark: Honoraria. Chen:bluebird bio, Inc.: Current Employment. Colvin:bluebird bio, Inc.: Current Employment, Current equity holder in publicly-traded company. Thompson:Novartis: Consultancy, Honoraria, Research Funding; bluebird bio, Inc.: Consultancy, Research Funding; Biomarin: Research Funding; BMS: Consultancy, Research Funding; Baxalta: Research Funding; CRISPR/Vertex: Research Funding.

Background Patients with transfusion-dependent β-thalassemia (TDT) may experience transfusional iron overload and end-organ damage. While potentially curative, allogeneic hematopoietic stem cell (HSC) transplantation is limited by transplant-related risks and donor availability. Transplantation of autologous CD34+ cells encoding a βA-T87Q-globin gene (LentiGlobin gene therapy for β-thalassemia) may overcome some of these limitations. βA-T87Q-globin is incorporated into adult hemoglobin (Hb), forming gene therapy-derived HbAT87Q, which can be distinguished from other Hb species. The phase 1/2 Northstar study (HGB-204; NCT01745120) using the original manufacturing process evaluated the safety and efficacy of LentiGlobin in adolescents and adults with TDT (≥100 mL/kg/yr of red blood cells [RBCs] or ≥8 RBC transfusions/yr) and non-β0/β0 or β0/β0 genotypes. Methods HSCs were mobilized with G-CSF and plerixafor and collected via apheresis. CD34+ cells were transduced with BB305 lentiviral vector. After busulfan myeloablation, patients were infused with transduced cells. Primary efficacy endpoints were sustained production of ≥2 g/dL HbAT87Q between months 18 and 24 and transfusion independence (TI; weighted average Hb ≥9 g/dL without RBC transfusions for ≥12 months). Patients were monitored for 2 years and subsequently enrolled in the 13-year long-term follow-up study, LTF-303 (NCT02633943). Results are shown as median (min ‒ max) unless otherwise indicated. Results Eighteen patients were treated (age: 20 [12 - 35] yrs) and followed for 40.7 (29.3 - 53.8) months as of 13 December 2018. In the 2 years prior to enrollment, patients had an annualized transfusion volume of 169.0 (124.0 - 273.0) mL/kg/yr and pre-transfusion weighted mean nadir Hb of 9.3 (7.0 - 10.1) g/dL. Neutrophil and platelet engraftment occurred at 18.5 (14 - 30) and 39.5 (19 - 191) days, respectively. No patient had graft failure. Grade ≥3 non-hematologic adverse events (AEs) reported in ≥25% of patients after infusion were stomatitis, febrile neutropenia, and pharyngeal inflammation. No replication-competent lentivirus or death has been reported. The vector integration site profile in all 18 patients has remained polyclonal. The number of unique integration sites (UIS) identified was 1646 (190 - 2888), 1677 (151 - 6935), 2484 (984 - 5511), 1773 (1260 - 2693) at Months 12 (n=18), 24 (n=18), 36 (n=11), 48 (n=4), respectively. The highest mean (SD) frequency of any UIS in patients across all visits was 11.5% (5.8%). No oncogenesis has been reported. In Northstar, 16/18 (89%) patients achieved the primary endpoint of ≥2 g/dL HbAT87Q between months 18 and 24. Eight of 10 (80%) patients with non-β0/β0 genotypes achieved and maintained TI; current duration of TI was 38 (21.2 - 45.3) months (Figure 1). The weighted average total Hb during TI was 10.3 (9.1 - 13.2) g/dL. Total Hb and HbAT87Q remained stable over time. Total Hb in patients with non-β0/β0 genotypes who achieved TI was 10.3, 10.4, 10.6, and 11.1 g/dL at Months 12 (n=8), 24 (n=8), 36 (n=7), 48 (n=3), respectively. Transfusion volumes were reduced by 73% and 43% in the 2 patients still receiving transfusions. Three of 8 (38%) patients with β0/β0 genotypes achieved TI with a current duration of 16.4 (16.1 - 20.8) months. Weighted average total Hb during TI was 9.9 (9.5 - 10.1) g/dL and HbAT87Q was 8.0 - 8.9 g/dL at last visit. One additional patient was transfusion-free for 13.7 months; however, total Hb was <9 g/dL. The 4 other patients had a transfusion volume reduction of 53% (10% - 72%). Patients who achieved TI resumed iron chelation 13 (2 - 15) months after infusion and all remain on iron chelation as of last follow-up. Serum ferritin and liver iron content (LIC) (Figure 2A, 2B) were reduced in patients who achieved TI by 55% (16 - 78%) and 56% (38 - 83%) from screening to Month 48 (n=4), respectively. Of these 4 patients who had a Month 48 visit, LIC values were 0.8 - 7.1 mg/g at Month 48 compared to 4.8 - 11.5 mg/g at screening. In patients who achieved TI, cardiac T2* ranged from 27.0 - 39.0 msec at screening and 31.4 - 57.6 msec at last visit. Summary With up to 4.5 years of follow-up after LentiGlobin gene therapy, generally stable HbAT87Q levels and durable TI were observed in 8/10 and 3/8 patients with TDT and non-β0/β0 and β0/β0 genotypes, respectively. Iron burden has improved over time in patients who achieved TI. The safety profile of LentiGlobin remains consistent with myeloablative conditioning. Disclosures Kwiatkowski: Imara: Consultancy; Agios: Consultancy; bluebird bio, Inc.: Consultancy, Research Funding; Terumo: Research Funding; Apopharma: Research Funding; Novartis: Research Funding; Celgene: Consultancy. Thompson:bluebird bio, Inc.: Consultancy, Research Funding; Celgene: Consultancy, Research Funding; Novartis: Consultancy, Research Funding; Baxalta: Research Funding. Rasko:GSK: Honoraria; bluebird bio: Honoraria; Imago: Consultancy; Novartis: Honoraria; Cynata: Honoraria; Spark: Honoraria; Takeda: Honoraria; NHMRC Mitochondrial Donation Expert Working Committee: Other: Advisory Committee; Gilead: Honoraria; Cure The Future Foundation: Membership on an entity's Board of Directors or advisory committees; Pfizer: Honoraria; Genea: Equity Ownership; Rarecyte: Consultancy, Equity Ownership; Gene Technology Technical Advisory, Australian Government: Other: Advisory committee; Celgene: Honoraria; Advisory Committee on Biologics, Australian Government: Other: Advisory Committee; Australian Cancer Research Scientific Advisory Board: Membership on an entity's Board of Directors or advisory committees; FSHD Global Research Foundation: Membership on an entity's Board of Directors or advisory committees. Schiller:Amgen: Other, Research Funding; Agios: Research Funding, Speakers Bureau; Astellas: Research Funding; Biomed Valley Discoveries: Research Funding; Bristol Myer Squibb: Research Funding; Celgene: Research Funding, Speakers Bureau; Constellation Pharmaceutical: Research Funding; Daiichi Sankyo: Research Funding; Eli Lilly and Company: Research Funding; FujiFilm: Research Funding; Genzyme: Research Funding; Gilead: Research Funding; Incyte: Research Funding; J&J: Research Funding; Jazz Pharmaceuticals: Honoraria, Research Funding; Karyopharm: Research Funding; Novartis: Research Funding; Onconova: Research Funding; Pfizer Pharmaceuticals: Equity Ownership, Research Funding; Sangamo Therapeutics: Research Funding. Cavazzana:Smartimmune: Other: Founder of Smartimmune. Ho:Celgene: Other: investigator meeting travel costs; Janssen: Other: investigator meeting travel costs; Novartis: Other: investigator meeting travel costs; La Jolla: Other: investigator meeting travel costs. Schmidt:German Cancer Research Center, Heidelberg, Germany: Employment; GeneWerk GmbH, Heidelberg, Gemrany: Equity Ownership. Vichinsky:Agios: Consultancy, Research Funding; Pfizer: Consultancy, Research Funding; GBT: Consultancy, Research Funding; bluebird bio: Consultancy, Research Funding; Novartis: Consultancy, Research Funding. Deary:bluebird bio, Inc.: Employment, Equity Ownership. Chen:bluebird bio, Inc.: Consultancy. Petrusich:bluebird bio, Inc.: Employment, Equity Ownership. Walters:Editas Medicine: Consultancy; TruCode: Consultancy; AllCells, Inc: Consultancy.

Abstract Background Advances in red blood cell (RBC) transfusion and chelation have improved the prognosis of patients with transfusion-dependent β-thalassemia (TDT); however, many patients experience organ damage due to iron overload and other complications. While potentially curative, allogeneic hematopoietic stem cell transplantation confers significant risks of morbidity and mortality and is limited by donor availability. Gene therapy (GT) has the potential to be an effective treatment option for patients with TDT without some of these limitations. LentiGlobin GT contains autologous CD34+ cells transduced ex vivo with the BB305 lentiviral vector (LVV) encoding a β-globin gene with a T87Q substitution. Initial data from the international, multi-center, phase 1/2 Northstar (HGB-204; NCT01745120) study evaluating the safety and efficacy of LentiGlobin in patients with TDT using the original manufacturing process has been published. Herein we present updated results with longer follow-up. Methods Northstar enrolled patients with TDT (history of ≥ 100 mL/kg/yr of RBCs or ≥ 8 RBC transfusions/yr) regardless of genotype. Autologous CD34+ cells were collected by apheresis after G-CSF and plerixafor mobilization and transduced with the BB305 LVV in a centralized facility. Patients received myeloablative conditioning with single-agent busulfan before the transduced cells were infused. Patients were monitored for engraftment, vector copy number (VCN), GT-derived hemoglobin (HbAT87Q), RBC transfusions, transfusion independence (TI; defined as weighted average hemoglobin [Hb] ≥ 9g/dL without RBC transfusions for ≥ 12 months), adverse events (AEs), vector integration, and replication competent lentivirus (RCL). Patients were followed in Northstar for 2 years and then were offered participation in the long-term follow-up study, LTF-303 (NCT02633943). Results Eighteen patients with TDT, 12 - 35 years old, treated with LentiGlobin GT have completed 2-year follow-up in the Northstar study and subsequently enrolled in LTF-303. As of March 7, 2018, the median follow-up duration was 32.1 (min - max: 23.1 - 41.9) months. The median DP VCN was 0.7 (min - max: 0.3 - 1.5) copies/diploid genome (c/dg), the median cell dose was 8.1 x 106 (min - max: 5.2 - 18.1 x 106) CD34+ cells/kg, and the median proportion of transduced CD34+ cells was 32% (min - max: 17 - 58%). All patients engrafted and the median duration of hospitalization from conditioning to discharge was 40 days (min - max: 27 - 69 days). The toxicity profile was typical of myeloablative conditioning. No grade ≥ 3 events were related to LentiGlobin and there was no graft failure, death, or vector-mediated RCL, and no evidence of clonal dominance. Serious AEs reported in ≥ 2 patients were thrombosis and veno-occlusive liver disease; each occurred in 2 patients. Eight of 10 patients with non-β0/β0 genotypes were able to discontinue transfusions at 0.3 - 5.8 months post-DP infusion and have sustained TI for a median duration of 33 months (min - max: 16 - 38 months). At last study visit, peripheral blood VCN for these patients was 0.1 - 1.0 c/dg, HbAT87Q was 3.8 - 10.1 g/dL and total Hb was 9.1 - 13.5 g/dL. Sustained HbAT87Q production was observed in all patients through last follow-up (Figure 1A). The 2 remaining patients with non-β0/β0 genotypes had a reduction in transfusion volume of 82% and 27%. Their peripheral VCN and HbAT87Q levels at last study visit were 0.1 and 0.1 c/dg and 2.9 and 1.1 g/dL, respectively. Of the 8 patients with a β0/β0 genotype, 3 no longer require chronic RBC transfusions for an ongoing duration of 16.4 - 22.1 months. Peripheral VCN, HbAT87Q and total Hb at last visit were 0.7, 0.4, 0.6 c/dg; 8.9, 9.7, 8.1 g/dL (Figure 1B); and 9.3, 10.3, 9.8 g/dL, respectively. The other 5 patients with a β0/β0 genotype experienced median transfusion volume reduction of 53% (min - max: 8 - 74%). Longer follow-up and other analyses including iron measures will be presented. Summary LentiGlobin GT in patients with TDT enrolled in the Northstar study continues to demonstrate a sustained clinical benefit with up to 3.5 years of follow-up. The safety profile is consistent with myeloablative conditioning and 8/10 patients with non-β0/β0 genotypes and 3/8 patients with a β0/β0 genotype remain transfusion free. LentiGlobin GT using refined manufacturing to improve DP characteristics and patient outcomes is being evaluated in 2 ongoing phase 3 studies, Northstar-2 and Northstar-3. Disclosures Rasko: Rarecyte: Consultancy, Equity Ownership; IMAGO Biosciences: Consultancy; Takeda: Speakers Bureau; Abbvie: Speakers Bureau; Gilead: Honoraria; Novartis: Consultancy, Speakers Bureau; Cynata: Consultancy, Honoraria; bluebird bio: Honoraria, Other: Clinical trials ; Spark: Consultancy; Genea: Equity Ownership; Current Cure The Future Foundation: Membership on an entity's Board of Directors or advisory committees; FSHD Global Research Foundation: Membership on an entity's Board of Directors or advisory committees; Gene Technology Technical Advisory, OGTR, Australian Government: Other: Chair; Advisory Committee on Biologics, Therapeutics Goods Administration, Australian Government: Other: Past Chair; International Society for Cellular Therapy: Membership on an entity's Board of Directors or advisory committees; GSK: Honoraria; Pfizer: Honoraria; Celgene: Honoraria. Thompson:Baxalta/Shire: Research Funding; La Jolla Pharmaceutical: Research Funding; Amgen: Research Funding; Biomarin: Research Funding; Celgene: Research Funding; bluebird bio: Consultancy, Research Funding; Novartis: Research Funding. Kwiatkowski:Apopharma: Research Funding; Agios Pharmaceuticals: Consultancy, Research Funding; Novartis: Research Funding; Terumo: Research Funding; bluebird bio: Consultancy, Honoraria, Research Funding. Schiller:bluebird bio: Research Funding; Astellas Pharma: Membership on an entity's Board of Directors or advisory committees, Research Funding. Ho:Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees; Takeda: Honoraria, Other: Travel to meeting; Celgene: Other: Travel to meeting . Schmidt:GeneWerk GmbH: Employment; German Cancer Research Center: Employment; bluebird bio: Consultancy. Leboulch:bluebird bio: Consultancy, Equity Ownership, Membership on an entity's Board of Directors or advisory committees, Patents & Royalties. Vichinsky:bluebird bio: Membership on an entity's Board of Directors or advisory committees; Global Blood Therapeutics: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Protagonist: Research Funding. Deary:bluebird bio: Employment, Equity Ownership. Chen:bluebird bio: Consultancy. Asmal:bluebird bio: Employment, Equity Ownership. Walters:Sangamo Therapeutics: Consultancy; ViaCord Processing Lab: Other: Medical Director; AllCells Inc.: Other: Medical Director; bluebird bio: Research Funding.

PurposeThe purpose of this paper is to examine the association between the existence of a risk committee (RC) in a firm and financial reporting quality. We also investigate whether having an RC has an effect on audit pricing. We argue that the existence of an RC in a firm contributes to higher financial reporting quality and this, eventually, affects audit pricing.Design/methodology/approachThis study uses two different proxies for RC measures and investigates the impact on financial reporting quality and audit pricing. Multivariate regression analysis and propensity score matching techniques are both applied to data from the Australian Stock Exchange's listed companies for the years 2001–2013.FindingsThe results indicate that the existence of an RC reduces the discretionary accruals; this means the financial reporting quality improves when RCs are in operation. Our findings also indicate that the existence of an RC increases audit fees.Practical implicationsThe findings from this study will be beneficial to the regulatory authorities responsible for improving the compliance of corporate governance (CG). An RC can serve as a risk-mitigating tool in the investment decision-making process. Finally, the results are beneficial for the development of best practices in CG by promoting the existence of an RC.Originality/valueThis study goes beyond the traditional focus on CG as we use the existence of an RC as an indicator of better governance practices to mitigate financial and non-financial risk factors. To the best of our knowledge, this paper is among the first to investigate the consequences for firms operating with RCs. This issue has implications for investors, auditors, directors and regulators.

Introduction: Recent studies suggest that incidence of multiple myeloma (MM) is increasing in Asian countries. Prevalence is also expected to rise due to ageing populations and advances in treatment. Therapeutic options continue to expand as new, targeted agents enter the market. However, despite advances in therapy and supportive care, MM remains incurable. Most patients receive care outside the setting of clinical trials. Therefore, the generation of Real-World Evidence (RWE) on practice, including long-term monitoring and evaluation of current and future treatment strategies, is important in informing optimal therapies for MM and enable benchmarking to improve outcomes, quality of life (QoL), and cost-effectiveness of care for patients. Some country-specific data are available in Asia, but few at regional level. We established the Asia-Pacific (APAC) Myeloma and Related Diseases Registry (MRDR) in 2018, as a regional collaboration and sister registry to the Australian and New Zealand MRDR (ACTRN12618000659202). The aims are collection of a standardised APAC dataset for analysis and benchmarking. Key opinion leaders from the participating countries were invited to form the steering committee to provide local clinical context and oversight of the registry. Early in the process, ethics committees and legal counsel were consulted to assist with challenges presented by the diversity in data privacy and ethical regulations across the APAC region. Participating hospitals are responsible for obtaining local ethics approval, patient recruitment, and data collection. Participants provide written informed consent before data collection. Methods: The APAC MRDR prospectively collects observational data on patient characteristics, diagnosis, medical history, treatment (including supportive therapies), and outcomes (overall and progression-free survival, and QoL using the EQ-5D-5L) on newly diagnosed MM (NDMM), plasma cell leukaemia, plasmacytoma, and MGUS patients via a secure, country-specific web-based database. Whilst the core dataset is standardised across countries to ensure comparability, regional differences such as units of measurements and local privacy laws were accommodated in the design of each country's database. Participants are reviewed 4-monthly for a minimum of 2 years. Longer-term outcomes will be collected through linkage with local cancer and death registries. Six-monthly hospital reports, providing de-identified, risk-adjusted outcome data at hospital- and country-level, will be provided to contributing hospitals. Preliminary APAC MRDR data from October 2018 to June 2019 were analysed. Results: Eleven hospitals now have Institutional Review Board approval to participate and patient recruitment has commenced at 6 hospitals in Korea and Singapore. Sites in Taiwan, Hong Kong, China, and Malaysia are in progress. To date, 182 patients have been enrolled and data collection on these patients is in progress. At the time of analysis, 85% (96/113) were NDMM. Median age was 66 years (IQR: 59-73) and 54% were male. Median EQ5D VAS Health State score at diagnosis was 70 (IQR: 50-80; self-report: 100=best health imaginable, 0=the worst). Comorbidities were present in 47%. Proportion of patients with main paraprotein type IgG: 64%, IgA: 17%, light chain only Kappa: 13%, light chain only Lambda: 6%. Median number of days from diagnosis to chemotherapy was 9.5 (IQR: 3-15). The top two most frequently used first-line regimens for NDMM patients in Korea and Singapore were: Korea: 1. bortezomib/thalidomide/dexamethasone (VTd: 39%), 2. lenalidomide/dexamethasone (Rd: 27%), and Singapore: 1. VTd: 41%, 2. bortezomib/cyclophosphamide/dexamethasone (VCD): 25%. Overall response rate to first-line chemotherapy (≥PR) was 86% (44/51). Conclusion: The APAC MRDR database is expanding and, as data mature and feedback is provided to participating sites, will provide RWE that will contribute to our understanding on current myeloma treatment strategies and patient outcomes in the Asia-Pacific region. Future plans include expansion to additional sites and countries, and linkage with local cancer and death registries. The registry can also serve as a regional resource by providing infrastructure and identifying eligible participants for clinical trials and other research. Disclosures Aoki: Janssen Asia-Pacific: Research Funding. Moore:Takeda: Research Funding; Gilead: Research Funding. Wood:Bristol-Myers Squibb: Research Funding; Novartis: Research Funding; Alexion: Research Funding; Roche: Research Funding; Takeda: Research Funding; Gilead: Research Funding; Janssen-Cilag: Research Funding; Amgen: Research Funding; CSL Behring: Research Funding; Sanofi: Research Funding; Celgene: Research Funding; Abbvie: Research Funding. McQuilten:Gilead Sciences: Research Funding; CSL Biotherapies: Research Funding; Celgene: Research Funding; AbbVie: Research Funding; Takeda Pharmaceuticals: Research Funding; Janssen-Cilag: Research Funding. Spencer:Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Haemalogix: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Janssen Oncology: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; AbbVie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Specialised Therapeutics Australia: Consultancy, Honoraria; Sanofi: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Secura Bio: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Servier: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees.

Abstract Abstract 114 Background: Romidepsin is a potent HDAC inhibitor approved by the FDA for patients (pts) with cutaneous T-cell lymphoma who have received at least 1 prior systemic therapy. Durable clinical benefit and tolerability of romidepsin in pts with recurrent or refractory PTCL have been previously observed in a phase 2 trial conducted by the National Cancer Institute. The aim of this phase 2, single-arm, open-label registration study was to evaluate the activity of romidepsin in a larger number of pts with progressive or relapsed PTCL. Methods: Pts with histologically confirmed PTCL (PTCL NOS, angioimmunoblastic T-cell lymphoma, ALCL [ALK-1 negative], other subtypes) who failed or were refractory to ≥ 1 prior systemic therapy, and had measurable disease and ECOG performance status 0–2 were eligible. Exclusions included inadequate bone marrow or other organ function and significant cardiovascular abnormalities. Pts received romidepsin 14 mg/m2 as a 4-h IV infusion on days 1, 8, and 15 every 28 days for up to 6 cycles; treatment could be extended for stable disease (SD) or response. The primary endpoint was rate of complete response (CR + CRu) as evaluated by a central Independent Review Committee (IRC) using International Working Criteria for non-Hodgkin's lymphoma. IRC assessment consisted of a 2-step process, with initial radiographic review of images (CT, MRI) followed by an overall clinical assessment based on the radiology evaluations, photographs, and relevant clinical parameters. Secondary endpoints included objective response rate (ORR): CR + CRu + partial response (PR), investigator-assessed responses, duration of response, time to response, and safety. Results: 131 pts from 48 US, European, and Australian sites were enrolled and received at least 1 dose of romidepsin (as-treated population); 130 patients had histologically confirmed PTCL by central review. Mean age of all pts was 59.4 y (range, 20–83) and median time since diagnosis was 1.25 y (range, 0–17). Median number of prior systemic therapies was 2 (range, 1–8). 21 pts (16%) had failed a prior stem cell transplant. Responses assessed by the IRC are noted in the table below. Longest duration of response is 26+ mo and 16 (94%) of the 17 pts with a CR had not progressed as of the data cutoff (March 31, 2010). Investigator-assessed responses included 21 pts (16%) with CR + CRu, 18 pts (14%) with PR for an ORR of 30%. Currently, 13 pts continue to receive treatment (range, 10–36 cycles). Adverse events (AEs) were reported in 126 of 131 pts (96%). AEs reported in ≥ 20% of pts were nausea (59%), fatigue (41%), vomiting (38%), thrombocytopenia (38%), diarrhea (35%), pyrexia (34%), neutropenia (30%), anorexia (28%), constipation (28%), anemia (23%), and dysgeusia (21%). AEs ≥ grade 3 were reported for 86 pts (66%), with the most common (≥ 5%) being pneumonia (5%), pyrexia (5%), sepsis (5%), and vomiting (5%). 60 pts (46%) had at least 1 serious AE: the most frequently reported (≥ 5%) were pyrexia (7%), pneumonia (5%), vomiting (5%), and sepsis (5%). 22 pts (17%) withdrew due to AEs. 8 pts (6%) died within 30 days of the last dose of romidepsin; 1 death, due to sepsis, was assessed as possibly related to treatment. Conclusions: Complete and durable responses were observed with single agent romidepsin in pts with relapsed PTCL. These data support the therapeutic potential for romidepsin in relapsed PTCL and suggest that romidepsin is a strong candidate for inclusion in future novel regimens for these diseases. As of the data cutoff (March 31, 2010), the median duration of follow-up for CR is 8.2 mo. Disclosures: Coiffier: Gloucester: Consultancy, Honoraria; Celgene: Consultancy, Honoraria, Research Funding, Speakers Bureau. Off Label Use: Romidepsin is indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy. Romidepsin is not currently approved for the treatment of peripheral T-cell lymphoma (PTCL). Pro:Celgene: Research Funding. Prince:Celgene: Consultancy, Honoraria, Research Funding. Foss:Celgene: Consultancy; Eisai: Consultancy, Speakers Bureau; Merck: Speakers Bureau; Allos: Consultancy, Speakers Bureau; Cephalon: Speakers Bureau. Sokol:Celgene: Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau. Caballero:Celgene: Membership on an entity's Board of Directors or advisory committees. Morschhauser:Roche: Consultancy, Honoraria; Bayer: Honoraria. Padmanabhan:Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau. Shustov:Celgene: Research Funding. Nichols:Celgene: Employment. Carroll:Celgene: Employment. Balser:Gloucester Pharmaceutical: Consultancy. Horwitz:Celgene: Consultancy, Honoraria.

Abstract Introduction Mesenchymal stem cells (MSCs) isolated from donated tissue have been widely investigated as a treatment for acute graft versus host disease (GvHD), but with mixed results. Factors including MSC donor variability and the effects of prolonged MSC culture expansion may have contributed to inadequate outcomes. Induced pluripotent stem cells (iPSCs) can proliferate indefinitely without loss of pluripotency. The novel Cymerus™ manufacturing process facilitates a virtually limitless supply of well-defined and consistent MSCs from a single donation. Production is achieved by differentiating iPSCs into MSCs using proprietary clonogenic progenitor-based technology. This avoids both donor to donor variability and the need for excessive culture expansion once MSCs are formed. We are undertaking a Phase I clinical trial of Cymerus iPSC-derived MSCs (CYP-001) in steroid-resistant acute GvHD (NCT02923375). We believe this will be the first completed clinical trial involving iPSC-derived cells. Methods This is a multi-center, open label, dose escalation study to assess the safety, tolerability and efficacy of CYP-001 in adults with grade II-IV steroid-resistant acute GvHD, following allogeneic hematopoietic stem cell transplantation. All subjects had failed to respond to at least three days of steroid treatment (≥1 mg/kg/day), administered in accordance with standard management at each center. The first eight subjects enrolled in Cohort A received two intravenous (IV) infusions of CYP-001 one week apart, at a dose of 1 x 106 cells/kg, in addition to standard of care medications. After an independent data and safety monitoring board review, the next eight subjects entered Cohort B, in which the MSC cell dose was doubled. Primary evaluation was performed over eight study visits to day 100. Subjects then entered a follow-up phase of up to two years. Data for subjects in Cohort A with a minimum of six months follow-up are presented here. GvHD was staged and graded according to the 1994 Consensus Conference on Acute GvHD Grading. A Partial Response (PR) was defined as improvement in the severity of GvHD by at least one grade compared to baseline, while a Complete Response (CR) was defined as the absence of any GvHD signs or symptoms. The Overall Response (OR) rate was defined as the proportion of subjects showing either a PR or CR. The primary objective was assessment of the safety and tolerability of two infusions of CYP-001. The secondary objective was efficacy, assessed by best response to treatment, by Day 28 and Day 100 and overall survival at Day 28 and Day 100. Results Four males and four females, with an average age of 57 years (range: 45-66) were enrolled in Cohort A during 2017. At baseline, subjects had Grade II (n=3) or Grade III (n=5) steroid-resistant acute GvHD. One subject had skin, gastrointestinal (GI) and liver involvement; four subjects had skin and GI involvement; two subjects had GI involvement only; and one subject had skin involvement only. The treatment was well tolerated in all cases, and there were no treatment-related Serious Adverse Events (SAEs) reported. Three subjects experienced SAEs that were not considered to be study drug related: (i) febrile neutropenia, hypokalemia and parainfluenza, each of which resolved; (ii) a lower respiratory tract infection, which resolved; (iii) pneumonia, which was fatal. All eight subjects showed at least a PR. Four subjects achieved a CR by Day 100. In all four cases where a CR was achieved, it was then sustained until Day 100. The median GvHD grade at Day 100 was 0 (range: 0-II), compared to a median grade of III (range: II-III) at baseline. Disease progression (an increase in the severity of GvHD by at least one grade compared to baseline) was not observed in any subject at any study visit. Overall survival was 7/8 (87.5%) six months after the first infusion of CYP-001. The best response rates by Day 28 and Day 100 are summarized in Table 1, while the maximal response by individual subject is illustrated in Figure 1. Conclusion Infusion of CYP-001 at 1 x 106 iPSC-derived MSCs/kg was safe and well tolerated in this patient cohort. Treatment response and overall survival rates are encouraging compared to previously published outcomes. The Cohort B primary evaluation period is expected to be completed by September 2018, and progression to a Phase II trial in this clinically challenging disease will then be considered. Disclosures Bloor: AbbVie: Research Funding; Janssen: Research Funding. Radia:Mallinckrodt: Research Funding. Yeung:Novartis: Honoraria, Research Funding; BMS: Honoraria, Research Funding; Pfizer: Honoraria; Amgen: Honoraria; Specialised Therapeutics Australia: Honoraria. Slukvin:Cynata Therapeutics Limited: Consultancy, Equity Ownership. Kelly:Cynata Therapeutics Limited: Employment, Equity Ownership. Rasko:Gilead: Honoraria; Abbvie: Speakers Bureau; Takeda: Speakers Bureau; International Society for Cellular Therapy: Membership on an entity's Board of Directors or advisory committees; Novartis: Consultancy, Speakers Bureau; Cynata: Consultancy, Honoraria; bluebird bio: Honoraria, Other: Clinical trials ; Spark: Consultancy; FSHD Global Research Foundation: Membership on an entity's Board of Directors or advisory committees; Current Cure The Future Foundation: Membership on an entity's Board of Directors or advisory committees; Celgene: Honoraria; Pfizer: Honoraria; GSK: Honoraria; Genea: Equity Ownership; IMAGO Biosciences: Consultancy; Rarecyte: Consultancy, Equity Ownership; Gene Technology Technical Advisory, OGTR, Australian Government: Other: Chair; Advisory Committee on Biologics, Therapeutics Goods Administration, Australian Government: Other: Past Chair.

Introduction Since primary mediastinal B-cell lymphoma (PMBCL) is a rare cancer, a prospective clinical trial is challenging and optimal therapy for relapsed/refractory PMBCL (rrPMBCL) has not been defined. The current clinical standard-of-care has been extrapolated from retrospective series or from subgroup analyses of prospective trials designed for diffuse large B-cell lymphoma. Novel salvage strategies are therefore urgently required in rrPMBCL. Methods This single-arm, open-label, phase II trial enrolled patients with heavily pre-treated, rrPMLBCL who have bulky disease (the longest diameter ≥5 cm) and have relapsed or refractory disease after ≥ 2 lines of prior therapy. All enrolled patients received combining PD-1 blockade using Camrelizumab with GVD chemotherapy (gemcitabine, vinorelbine and pegylated liposomal doxorubicin)every 3 weeks until the patients achieved second assessable complete response or up to 12 cycles, followed by maintenance camrelizumab monotherapy up to 1 year. Safety was assessed by CTCAE v5.0 in the population consisted of all patients who received ≥ 1 dose of study drug. Clinical response was evaluated by computed tomography (CT) every 2 cycles and by positron emission tomography-computed tomography (PET-CT) every 4 cycles according to the Lugano Response Criteria for Non-Hodgkin's Lymphoma. Peripheral blood samples were collected before every cycle and tumors were biopsied prior to initiation of therapy for relevant biomarker analysis. The primary end points were objective response rate (ORR) and safety/tolerability. Key secondary end points were complete response rate (CRR), progression-free survival (PFS) and overall survival (OS). Results At the analysis cutoff date (March 31, 2019), 27 rrPMLBCL patients were enrolled: median age 30 years (range: 18-45), 52% female (14/27), median 3 lines of prior therapy (range: 2-6), median 6 cycles of rituximab-containing regimens (range: 2-10). In all 27 response-evaluable patients with heavily pretreated rrPMBCL, Camrelizumab plus GVD achieved unprecedented OR (74.1% [95% CI 55.3-86.8]) and CR rates (55.6% [95% CI 37.3-72.4]), with rapid and lasting responses. The median time to response of 20 patients achieving response was 1.7 months (95% CI 1.6-1.8), while 21 (78.0% [95% CI 59.2-89.4]) patients had a decrease in target lesions at the first tumor scan assessment. With a median follow-up of 12.5 months (range, 3.2-20.6), the median duration of response (DOR) and progression-free survival (PFS) were not reached. Censored at 1-year, the DOR and PFS was 80.0% (95% CI 55.1-92·0) and 59·0% (95% CI 38·3-74·9), respectively. Sixteen of 20 (80%) responders, including all 15 patients achieving complete response, had an ongoing response at data cutoff. The addition of Camrelizumab to the GVD regimen did not appear to exacerbate treatment-related adverse events. Any-grade and grade 3 treatment-related adverse events was occurred in 25 (93%) and 9 (33%) patients, respectively. No grade 4 or 5 adverse events were reported. The most common treatment-related adverse events were neutropenia (70%), leukocytopenia (52%), pruritus (30%) and anaemia (26%). An exploratory analysis undertaken to identify potential biomarkers of response indicated a role for serum levels of IFN-γ, IL-10 and sFas to predict the clinical outcome. Conclusions Patients with rrPMBCL represent a particularly challenging population to treat, with few effective treatment options in the context of a dismal prognosis. Aside from palliation, new salvage therapeutic strategies are urgently needed. Camrelizumab plus GVD chemotherapy should be considered as a compelling new standard of salvage therapy with promising efficacy and manageable safety profile for patients with rrPMBCL. Figure Disclosures Rasko: Cure The Future Foundation: Membership on an entity's Board of Directors or advisory committees; Genea: Equity Ownership; Takeda: Honoraria; Rarecyte: Consultancy, Equity Ownership; Gene Technology Technical Advisory, Australian Government: Other: Advisory committee; GSK: Honoraria.

Introduction Understanding the economic impact of managing allogeneic hematopoietic stem cell transplant (HSCT) recipients with cytomegalovirus (CMV) is important for future planning within institutional transplant programs. CMV remains the most frequent viral infection following HSCT of which the clinical impact on transplant outcomes has been well described. However, much less is known about the impact of CMV on health resource utilisation, re-admissions and hospital costs. In addition to antiviral therapy, there are nursing, medical and pharmacy costs to consider. We therefore undertook a study to evaluate the clinical and economic burden of CMV infection following HSCT in a large Australian transplant centre operating under a universal health care system. Methods A retrospective single centre study at the Royal Melbourne Hospital, Melbourne, Australia was performed on all consecutive allogeneic HSCT recipients between January 2015 to December 2017. CMV pre-emptive monitoring using quantitative CMV plasma viral load was performed twice weekly from time of transplant to 100 days or longer in the presence of graft versus host disease. Clinically significant CMV (csCMV) was defined as patients receiving anti-CMV treatment, often with a plasma CMV viral load &gt;400 IU/ml. Throughout the study period, the first line anti-CMV therapy was ganciclovir; either as oral valganciclovir for outpatient management in asymptomatic patients or IV ganciclovir as an inpatient for patients with concerns about oral absorption. Second-line therapy was IV foscarnet. Hospital costing data for the first and subsequent re-admissions for the first 12 months were obtained from the business intelligence unit. Financial year costing was available for FY2015/2016 to FY2017/2018. Ethics was approved by the Melbourne Health Human Ethics Review Committee (HREC 2017.368). Results A total of 255 patients underwent alloHSCT with a median age of 51 years (IQR 40-59) with the most common underlying diagnoses being AML (41%), ALL (11%) and MDS (11%) (Table 1). Thirty-one percent of transplants used myeloablative conditioning, 54% had unrelated donors and 3% had an umbilical cord source. Pre-transplant recipient CMV seropositivity was 62% (n=158), of whom 139 had detectable CMV viremia and 104 (40.8%) experienced clinically significant CMV (csCMV). The median duration of CMV treatment was 33 days (IQR 21-63). Re-admission to hospital within the first 12 months of HSCT occurred in 78.4%. There was a greater number of admissions observed in csCMV patients compared to no csCMV (median 3 vs 2 admissions, p=0.001) with the duration of admitted days within the first 12 months being significantly greater in csCMV patients compared to no csCMV (median 65 vs 36 days, p&lt;0.00001). The mean total cost of treating patients with csCMV for the first 12 months compared to the total cost for patients not requiring CMV treatment was A$196,822 (US$147,616) and A$114503 (US $85,877) (p&lt;0.0001), respectively. Therefore the crude attributable mean cost of treating csCMV was A$82,319 (US$61,739) per patient for the first 12 months of HSCT. The greatest significant contributory costs were from pharmacy A$17,807 (US$13,355), nursing A$16,944 (US$12,708) and medical A$5,898 (US$4,423). Conclusions The health care cost and resource utilisation of treating CMV infection following an allogeneic HSCT is substantial and places a heavy burden on limited health resources. In this study, patients experiencing csCMV had an increased number and longer total duration of admissions days compared to patients who did not require CMV treatment. Interventions aimed at reducing the burden of CMV in alloHSCT recipients are required. Disclosures Yong: Merck Ltd: Honoraria. Bajel:AbbVie: Membership on an entity's Board of Directors or advisory committees, Other: travel funding. Ritchie:Sanofi: Honoraria; Novartis: Honoraria; Imago: Research Funding; Beigene: Research Funding; Takeda: Research Funding; BMS: Research Funding; Pfizer: Consultancy; Amgen: Consultancy, Honoraria, Research Funding. Slavin:Merck Ltd: Honoraria, Research Funding.

Education in Oceania continues to reflect the embedded implicit and explicit colonial practices and processes from the past. This paper conceptualises a cultural approach to education and leadership appropriate and relevant to the Republic of the Marshall Islands. As elementary school leaders, we highlight Kanne Lobal, a traditional Marshallese navigation practice based on indigenous language, values and practices. We conceptualise and develop Kanne Lobal in this paper as a framework for understanding the usefulness of our indigenous knowledge in leadership and educational practices within formal education. Through bwebwenato, a method of talk story, our key learnings and reflexivities were captured. We argue that realising the value of Marshallese indigenous knowledge and practices for school leaders requires purposeful training of the ways in which our knowledge can be made useful in our professional educational responsibilities. Drawing from our Marshallese knowledge is an intentional effort to inspire, empower and express what education and leadership partnership means for Marshallese people, as articulated by Marshallese themselves. Introduction As noted in the call for papers within the Waikato Journal of Education (WJE) for this special issue, bodies of knowledge and histories in Oceania have long sustained generations across geographic boundaries to ensure cultural survival. For Marshallese people, we cannot really know ourselves “until we know how we came to be where we are today” (Walsh, Heine, Bigler & Stege, 2012). Jitdam Kapeel is a popular Marshallese concept and ideal associated with inquiring into relationships within the family and community. In a similar way, the practice of relating is about connecting the present and future to the past. Education and leadership partnerships are linked and we look back to the past, our history, to make sense and feel inspired to transform practices that will benefit our people. In this paper and in light of our next generation, we reconnect with our navigation stories to inspire and empower education and leadership. Kanne lobal is part of our navigation stories, a conceptual framework centred on cultural practices, values, and concepts that embrace collective partnerships. Our link to this talanoa vā with others in the special issue is to attempt to make sense of connections given the global COVID-19 context by providing a Marshallese approach to address the physical and relational “distance” between education and leadership partnerships in Oceania. Like the majority of developing small island nations in Oceania, the Republic of the Marshall Islands (RMI) has had its share of educational challenges through colonial legacies of the past which continues to drive education systems in the region (Heine, 2002). The historical administration and education in the RMI is one of colonisation. Successive administrations by the Spanish, German, Japanese, and now the US, has resulted in education and learning that privileges western knowledge and forms of learning. This paper foregrounds understandings of education and learning as told by the voices of elementary school leaders from the RMI. The move to re-think education and leadership from Marshallese perspectives is an act of shifting the focus of bwebwenato or conversations that centres on Marshallese language and worldviews. The concept of jelalokjen was conceptualised as traditional education framed mainly within the community context. In the past, jelalokjen was practiced and transmitted to the younger generation for cultural continuity. During the arrival of colonial administrations into the RMI, jelalokjen was likened to the western notions of education and schooling (Kupferman, 2004). Today, the primary function of jelalokjen, as traditional and formal education, it is for “survival in a hostile [and challenging] environment” (Kupferman, 2004, p. 43). Because western approaches to learning in the RMI have not always resulted in positive outcomes for those engaged within the education system, as school leaders who value our cultural knowledge and practices, and aspire to maintain our language with the next generation, we turn to Kanne Lobal, a practice embedded in our navigation stories, collective aspirations, and leadership. The significance in the development of Kanne Lobal, as an appropriate framework for education and leadership, resulted in us coming together and working together. Not only were we able to share our leadership concerns, however, the engagement strengthened our connections with each other as school leaders, our communities, and the Public Schooling System (PSS). Prior to that, many of us were in competition for resources. Educational Leadership: IQBE and GCSL Leadership is a valued practice in the RMI. Before the IQBE programme started in 2018, the majority of the school leaders on the main island of Majuro had not engaged in collaborative partnerships with each other before. Our main educational purpose was to achieve accreditation from the Western Association of Schools and Colleges (WASC), an accreditation commission for schools in the United States. The WASC accreditation dictated our work and relationships and many school leaders on Majuro felt the pressure of competition against each other. We, the authors in this paper, share our collective bwebwenato, highlighting our school leadership experiences and how we gained strength from our own ancestral knowledge to empower “us”, to collaborate with each other, our teachers, communities, as well as with PSS; a collaborative partnership we had not realised in the past. The paucity of literature that captures Kajin Majol (Marshallese language) and education in general in the RMI is what we intend to fill by sharing our reflections and experiences. To move our educational practices forward we highlight Kanne Lobal, a cultural approach that focuses on our strengths, collective social responsibilities and wellbeing. For a long time, there was no formal training in place for elementary school leaders. School principals and vice principals were appointed primarily on their academic merit through having an undergraduate qualification. As part of the first cohort of fifteen school leaders, we engaged in the professional training programme, the Graduate Certificate in School Leadership (GCSL), refitted to our context after its initial development in the Solomon Islands. GCSL was coordinated by the Institute of Education (IOE) at the University of the South Pacific (USP). GCSL was seen as a relevant and appropriate training programme for school leaders in the RMI as part of an Asia Development Bank (ADB) funded programme which aimed at “Improving Quality Basic Education” (IQBE) in parts of the northern Pacific. GCSL was managed on Majuro, RMI’s main island, by the director at the time Dr Irene Taafaki, coordinator Yolanda McKay, and administrators at the University of the South Pacific’s (USP) RMI campus. Through the provision of GCSL, as school leaders we were encouraged to re-think and draw-from our own cultural repository and connect to our ancestral knowledge that have always provided strength for us. This kind of thinking and practice was encouraged by our educational leaders (Heine, 2002). We argue that a culturally-affirming and culturally-contextual framework that reflects the lived experiences of Marshallese people is much needed and enables the disruption of inherent colonial processes left behind by Western and Eastern administrations which have influenced our education system in the RMI (Heine, 2002). Kanne Lobal, an approach utilising a traditional navigation has warranted its need to provide solutions for today’s educational challenges for us in the RMI. Education in the Pacific Education in the Pacific cannot be understood without contextualising it in its history and culture. It is the same for us in the RMI (Heine, 2002; Walsh et al., 2012). The RMI is located in the Pacific Ocean and is part of Micronesia. It was named after a British captain, John Marshall in the 1700s. The atolls in the RMI were explored by the Spanish in the 16th century. Germany unsuccessfully attempted to colonize the islands in 1885. Japan took control in 1914, but after several battles during World War II, the US seized the RMI from them. In 1947, the United Nations made the island group, along with the Mariana and Caroline archipelagos, a U.S. trust territory (Walsh et al, 2012). Education in the RMI reflects the colonial administrations of Germany, Japan, and now the US. Before the turn of the century, formal education in the Pacific reflected western values, practices, and standards. Prior to that, education was informal and not binded to formal learning institutions (Thaman, 1997) and oral traditions was used as the medium for transmitting learning about customs and practices living with parents, grandparents, great grandparents. As alluded to by Jiba B. Kabua (2004), any “discussion about education is necessarily a discussion of culture, and any policy on education is also a policy of culture” (p. 181). It is impossible to promote one without the other, and it is not logical to understand one without the other. Re-thinking how education should look like, the pedagogical strategies that are relevant in our classrooms, the ways to engage with our parents and communities - such re-thinking sits within our cultural approaches and frameworks. Our collective attempts to provide a cultural framework that is relevant and appropriate for education in our context, sits within the political endeavour to decolonize. This means that what we are providing will not only be useful, but it can be used as a tool to question and identify whether things in place restrict and prevent our culture or whether they promote and foreground cultural ideas and concepts, a significant discussion of culture linked to education (Kabua, 2004). Donor funded development aid programmes were provided to support the challenges within education systems. Concerned with the persistent low educational outcomes of Pacific students, despite the prevalence of aid programmes in the region, in 2000 Pacific educators and leaders with support from New Zealand Aid (NZ Aid) decided to intervene (Heine, 2002; Taufe’ulungaki, 2014). In April 2001, a group of Pacific educators and leaders across the region were invited to a colloquium funded by the New Zealand Overseas Development Agency held in Suva Fiji at the University of the South Pacific. The main purpose of the colloquium was to enable “Pacific educators to re-think the values, assumptions and beliefs underlying [formal] schooling in Oceania” (Benson, 2002). Leadership, in general, is a valued practice in the RMI (Heine, 2002). Despite education leadership being identified as a significant factor in school improvement (Sanga & Chu, 2009), the limited formal training opportunities of school principals in the region was a persistent concern. As part of an Asia Development Bank (ADB) funded project, the Improve Quality Basic Education (IQBE) intervention was developed and implemented in the RMI in 2017. Mentoring is a process associated with the continuity and sustainability of leadership knowledge and practices (Sanga & Chu, 2009). It is a key aspect of building capacity and capabilities within human resources in education (ibid). Indigenous knowledges and education research According to Hilda Heine, the relationship between education and leadership is about understanding Marshallese history and culture (cited in Walsh et al., 2012). It is about sharing indigenous knowledge and histories that “details for future generations a story of survival and resilience and the pride we possess as a people” (Heine, cited in Walsh et al., 2012, p. v). This paper is fuelled by postcolonial aspirations yet is grounded in Pacific indigenous research. This means that our intentions are driven by postcolonial pursuits and discourses linked to challenging the colonial systems and schooling in the Pacific region that privileges western knowledge and learning and marginalises the education practices and processes of local people (Thiong’o, 1986). A point of difference and orientation from postcolonialism is a desire to foreground indigenous Pacific language, specifically Majin Majol, through Marshallese concepts. Our collective bwebwenato and conversation honours and values kautiej (respect), jouj eo mour eo (reciprocity), and jouj (kindness) (Taafaki & Fowler, 2019). Pacific leaders developed the Rethinking Pacific Education Initiative for and by Pacific People (RPEIPP) in 2002 to take control of the ways in which education research was conducted by donor funded organisations (Taufe’ulungaki, 2014). Our former president, Dr Hilda Heine was part of the group of leaders who sought to counter the ways in which our educational and leadership stories were controlled and told by non-Marshallese (Heine, 2002). As a former minister of education in the RMI, Hilda Heine continues to inspire and encourage the next generation of educators, school leaders, and researchers to re-think and de-construct the way learning and education is conceptualised for Marshallese people. The conceptualisation of Kanne Lobal acknowledges its origin, grounded in Marshallese navigation knowledge and practice. Our decision to unpack and deconstruct Kanne Lobal within the context of formal education and leadership responds to the need to not only draw from indigenous Marshallese ideas and practice but to consider that the next generation will continue to be educated using western processes and initiatives particularly from the US where we get a lot of our funding from. According to indigenous researchers Dawn Bessarab and Bridget Ng’andu (2010), doing research that considers “culturally appropriate processes to engage with indigenous groups and individuals is particularly pertinent in today’s research environment” (p. 37). Pacific indigenous educators and researchers have turned to their own ancestral knowledge and practices for inspiration and empowerment. Within western research contexts, the often stringent ideals and processes are not always encouraging of indigenous methods and practices. However, many were able to ground and articulate their use of indigenous methods as being relevant and appropriate to capturing the realities of their communities (Nabobo-Baba, 2008; Sualii-Sauni & Fulu-Aiolupotea, 2014; Thaman, 1997). At the same time, utilising Pacific indigenous methods and approaches enabled research engagement with their communities that honoured and respected them and their communities. For example, Tongan, Samoan, and Fijian researchers used the talanoa method as a way to capture the stories, lived realities, and worldviews of their communities within education in the diaspora (Fa’avae, Jones, & Manu’atu, 2016; Nabobo-Baba, 2008; Sualii-Sauni & Aiolupotea, 2014; Vaioleti, 2005). Tok stori was used by Solomon Islander educators and school leaders to highlight the unique circles of conversational practice and storytelling that leads to more positive engagement with their community members, capturing rich and meaningful narratives as a result (Sanga & Houma, 2004). The Indigenous Aborigine in Australia utilise yarning as a “relaxed discussion through which both the researcher and participant journey together visiting places and topics of interest relevant” (Bessarab & Ng’andu, 2010, p. 38). Despite the diverse forms of discussions and storytelling by indigenous peoples, of significance are the cultural protocols, ethics, and language for conducting and guiding the engagement (Bessarab & Ng’andu, 2010; Nabobo-Baba, 2008; Sualii-Sauni & Aiolupotea, 2014). Through the ethics, values, protocols, and language, these are what makes indigenous methods or frameworks unique compared to western methods like in-depth interviews or semi-structured interviews. This is why it is important for us as Marshallese educators to frame, ground, and articulate how our own methods and frameworks of learning could be realised in western education (Heine, 2002; Jetnil-Kijiner, 2014). In this paper, we utilise bwebwenato as an appropriate method linked to “talk story”, capturing our collective stories and experiences during GCSL and how we sought to build partnerships and collaboration with each other, our communities, and the PSS. Bwebwenato and drawing from Kajin Majel Legends and stories that reflect Marshallese society and its cultural values have survived through our oral traditions. The practice of weaving also holds knowledge about our “valuable and earliest sources of knowledge” (Taafaki & Fowler, 2019, p. 2). The skilful navigation of Marshallese wayfarers on the walap (large canoes) in the ocean is testament of their leadership and the value they place on ensuring the survival and continuity of Marshallese people (Taafaki & Fowler, 2019; Walsh et al., 2012). During her graduate study in 2014, Kathy Jetnil-Kijiner conceptualised bwebwenato as being the most “well-known form of Marshallese orality” (p. 38). The Marshallese-English dictionary defined bwebwenato as talk, conversation, story, history, article, episode, lore, myth, or tale (cited in Jetnil Kijiner, 2014). Three years later in 2017, bwebwenato was utilised in a doctoral project by Natalie Nimmer as a research method to gather “talk stories” about the experiences of 10 Marshallese experts in knowledge and skills ranging from sewing to linguistics, canoe-making and business. Our collective bwebwenato in this paper centres on Marshallese ideas and language. The philosophy of Marshallese knowledge is rooted in our “Kajin Majel”, or Marshallese language and is shared and transmitted through our oral traditions. For instance, through our historical stories and myths. Marshallese philosophy, that is, the knowledge systems inherent in our beliefs, values, customs, and practices are shared. They are inherently relational, meaning that knowledge systems and philosophies within our world are connected, in mind, body, and spirit (Jetnil-Kijiner, 2014; Nimmer, 2017). Although some Marshallese believe that our knowledge is disappearing as more and more elders pass away, it is therefore important work together, and learn from each other about the knowledges shared not only by the living but through their lamentations and stories of those who are no longer with us (Jetnil-Kijiner, 2014). As a Marshallese practice, weaving has been passed-down from generation to generation. Although the art of weaving is no longer as common as it used to be, the artefacts such as the “jaki-ed” (clothing mats) continue to embody significant Marshallese values and traditions. For our weavers, the jouj (check spelling) is the centre of the mat and it is where the weaving starts. When the jouj is correct and weaved well, the remainder and every other part of the mat will be right. The jouj is symbolic of the “heart” and if the heart is prepared well, trained well, then life or all other parts of the body will be well (Taafaki & Fowler, 2019). In that light, we have applied the same to this paper. Conceptualising and drawing from cultural practices that are close and dear to our hearts embodies a significant ontological attempt to prioritize our own knowledge and language, a sense of endearment to who we are and what we believe education to be like for us and the next generation. The application of the phrase “Majolizing '' was used by the Ministry of Education when Hilda Heine was minister, to weave cultural ideas and language into the way that teachers understand the curriculum, develop lesson plans and execute them in the classroom. Despite this, there were still concerns with the embedded colonized practices where teachers defaulted to eurocentric methods of doing things, like the strategies provided in the textbooks given to us. In some ways, our education was slow to adjust to the “Majolizing '' intention by our former minister. In this paper, we provide Kanne Lobal as a way to contribute to the “Majolizing intention” and perhaps speed up yet still be collectively responsible to all involved in education. Kajin Wa and Kanne Lobal “Wa” is the Marshallese concept for canoe. Kajin wa, as in canoe language, has a lot of symbolic meaning linked to deeply-held Marshallese values and practices. The canoe was the foundational practice that supported the livelihood of harsh atoll island living which reflects the Marshallese social world. The experts of Kajin wa often refer to “wa” as being the vessel of life, a means and source of sustaining life (Kelen, 2009, cited in Miller, 2010). “Jouj” means kindness and is the lower part of the main hull of the canoe. It is often referred to by some canoe builders in the RMI as the heart of the canoe and is linked to love. The jouj is one of the first parts of the canoe that is built and is “used to do all other measurements, and then the rest of the canoe is built on top of it” (Miller, 2010, p. 67). The significance of the jouj is that when the canoe is in the water, the jouj is the part of the hull that is underwater and ensures that all the cargo and passengers are safe. For Marshallese, jouj or kindness is what living is about and is associated with selflessly carrying the responsibility of keeping the family and community safe. The parts of the canoe reflect Marshallese culture, legend, family, lineage, and kinship. They embody social responsibilities that guide, direct, and sustain Marshallese families’ wellbeing, from atoll to atoll. For example, the rojak (boom), rojak maan (upper boom), rojak kōrā (lower boom), and they support the edges of the ujelā/ujele (sail) (see figure 1). The literal meaning of rojak maan is male boom and rojak kōrā means female boom which together strengthens the sail and ensures the canoe propels forward in a strong yet safe way. Figuratively, the rojak maan and rojak kōrā symbolise the mother and father relationship which when strong, through the jouj (kindness and love), it can strengthen families and sustain them into the future. Figure 1. Parts of the canoe Source: https://www.canoesmarshallislands.com/2014/09/names-of-canoe-parts/ From a socio-cultural, communal, and leadership view, the canoe (wa) provides understanding of the relationships required to inspire and sustain Marshallese peoples’ education and learning. We draw from Kajin wa because they provide cultural ideas and practices that enable understanding of education and leadership necessary for sustaining Marshallese people and realities in Oceania. When building a canoe, the women are tasked with the weaving of the ujelā/ujele (sail) and to ensure that it is strong enough to withstand long journeys and the fierce winds and waters of the ocean. The Kanne Lobal relates to the front part of the ujelā/ujele (sail) where the rojak maan and rojak kōrā meet and connect (see the red lines in figure 1). Kanne Lobal is linked to the strategic use of the ujelā/ujele by navigators, when there is no wind north wind to propel them forward, to find ways to capture the winds so that their journey can continue. As a proverbial saying, Kanne Lobal is used to ignite thinking and inspire and transform practice particularly when the journey is rough and tough. In this paper we draw from Kanne Lobal to ignite, inspire, and transform our educational and leadership practices, a move to explore what has always been meaningful to Marshallese people when we are faced with challenges. The Kanne Lobal utilises our language, and cultural practices and values by sourcing from the concepts of jouj (kindness, love), kautiej (respect), and jouj eo mour eo (reciprocity). A key Marshallese proverb, “Enra bwe jen lale rara”, is the cultural practice where families enact compassion through the sharing of food in all occurrences. The term “enra” is a small basket weaved from the coconut leaves, and often used by Marshallese as a plate to share and distribute food amongst each other. Bwe-jen-lale-rara is about noticing and providing for the needs of others, and “enra” the basket will help support and provide for all that are in need. “Enra-bwe-jen-lale-rara” is symbolic of cultural exchange and reciprocity and the cultural values associated with building and maintaining relationships, and constantly honouring each other. As a Marshallese practice, in this article we share our understanding and knowledge about the challenges as well as possible solutions for education concerns in our nation. In addition, we highlight another proverb, “wa kuk wa jimor”, which relates to having one canoe, and despite its capacity to feed and provide for the individual, but within the canoe all people can benefit from what it can provide. In the same way, we provide in this paper a cultural framework that will enable all educators to benefit from. It is a framework that is far-reaching and relevant to the lived realities of Marshallese people today. Kumit relates to people united to build strength, all co-operating and working together, living in peace, harmony, and good health. Kanne Lobal: conceptual framework for education and leadership An education framework is a conceptual structure that can be used to capture ideas and thinking related to aspects of learning. Kanne Lobal is conceptualised and framed in this paper as an educational framework. Kanne Lobal highlights the significance of education as a collective partnership whereby leadership is an important aspect. Kanne Lobal draws-from indigenous Marshallese concepts like kautiej (respect), jouj eo mour eo (reciprocity), and jouj (kindness, heart). The role of a leader, including an education leader, is to prioritise collective learning and partnerships that benefits Marshallese people and the continuity and survival of the next generation (Heine, 2002; Thaman, 1995). As described by Ejnar Aerōk, an expert canoe builder in the RMI, he stated: “jerbal ippān doon bwe en maron maan wa e” (cited in Miller, 2010, p. 69). His description emphasises the significance of partnerships and working together when navigating and journeying together in order to move the canoe forward. The kubaak, the outrigger of the wa (canoe) is about “partnerships”. For us as elementary school leaders on Majuro, kubaak encourages us to value collaborative partnerships with each other as well as our communities, PSS, and other stakeholders. Partnerships is an important part of the Kanne Lobal education and leadership framework. It requires ongoing bwebwenato – the inspiring as well as confronting and challenging conversations that should be mediated and negotiated if we and our education stakeholders are to journey together to ensure that the educational services we provide benefits our next generation of young people in the RMI. Navigating ahead the partnerships, mediation, and negotiation are the core values of jouj (kindness, love), kautiej (respect), and jouj eo mour eo (reciprocity). As an organic conceptual framework grounded in indigenous values, inspired through our lived experiences, Kanne Lobal provides ideas and concepts for re-thinking education and leadership practices that are conducive to learning and teaching in the schooling context in the RMI. By no means does it provide the solution to the education ills in our nation. However, we argue that Kanne Lobal is a more relevant approach which is much needed for the negatively stigmatised system as a consequence of the various colonial administrations that have and continue to shape and reframe our ideas about what education should be like for us in the RMI. Moreover, Kannel Lobal is our attempt to decolonize the framing of education and leadership, moving our bwebwenato to re-framing conversations of teaching and learning so that our cultural knowledge and values are foregrounded, appreciated, and realised within our education system. Bwebwenato: sharing our stories In this section, we use bwebwenato as a method of gathering and capturing our stories as data. Below we capture our stories and ongoing conversations about the richness in Marshallese cultural knowledge in the outer islands and on Majuro and the potentialities in Kanne Lobal. Danny Jim When I was in third grade (9-10 years of age), during my grandfather’s speech in Arno, an atoll near Majuro, during a time when a wa (canoe) was being blessed and ready to put the canoe into the ocean. My grandfather told me the canoe was a blessing for the family. “Without a canoe, a family cannot provide for them”, he said. The canoe allows for travelling between places to gather food and other sources to provide for the family. My grandfather’s stories about people’s roles within the canoe reminded me that everyone within the family has a responsibility to each other. Our women, mothers and daughters too have a significant responsibility in the journey, in fact, they hold us, care for us, and given strength to their husbands, brothers, and sons. The wise man or elder sits in the middle of the canoe, directing the young man who help to steer. The young man, he does all the work, directed by the older man. They take advice and seek the wisdom of the elder. In front of the canoe, a young boy is placed there and because of his strong and youthful vision, he is able to help the elder as well as the young man on the canoe. The story can be linked to the roles that school leaders, teachers, and students have in schooling. Without each person knowing intricately their role and responsibility, the sight and vision ahead for the collective aspirations of the school and the community is difficult to comprehend. For me, the canoe is symbolic of our educational journey within our education system. As the school leader, a central, trusted, and respected figure in the school, they provide support for teachers who are at the helm, pedagogically striving to provide for their students. For without strong direction from the school leaders and teachers at the helm, the students, like the young boy, cannot foresee their futures, or envisage how education can benefit them. This is why Kanne Lobal is a significant framework for us in the Marshall Islands because within the practice we are able to take heed and empower each other so that all benefit from the process. Kanne Lobal is linked to our culture, an essential part of who we are. We must rely on our own local approaches, rather than relying on others that are not relevant to what we know and how we live in today’s society. One of the things I can tell is that in Majuro, compared to the outer islands, it’s different. In the outer islands, parents bring children together and tell them legends and stories. The elders tell them about the legends and stories – the bwebwenato. Children from outer islands know a lot more about Marshallese legends compared to children from the Majuro atoll. They usually stay close to their parents, observe how to prepare food and all types of Marshallese skills. Loretta Joseph Case There is little Western influence in the outer islands. They grow up learning their own culture with their parents, not having tv. They are closely knit, making their own food, learning to weave. They use fire for cooking food. They are more connected because there are few of them, doing their own culture. For example, if they’re building a house, the ladies will come together and make food to take to the males that are building the house, encouraging them to keep on working - “jemjem maal” (sharpening tools i.e. axe, like encouraging workers to empower them). It’s when they bring food and entertainment. Rubon Rubon Togetherness, work together, sharing of food, these are important practices as a school leader. Jemjem maal – the whole village works together, men working and the women encourage them with food and entertainment. All the young children are involved in all of the cultural practices, cultural transmission is consistently part of their everyday life. These are stronger in the outer islands. Kanne Lobal has the potential to provide solutions using our own knowledge and practices. Connie Joel When new teachers become a teacher, they learn more about their culture in teaching. Teaching raises the question, who are we? A popular saying amongst our people, “Aelon kein ad ej aelon in manit”, means that “Our islands are cultural islands”. Therefore, when we are teaching, and managing the school, we must do this culturally. When we live and breathe, we must do this culturally. There is more socialising with family and extended family. Respect the elderly. When they’re doing things the ladies all get together, in groups and do it. Cut the breadfruit, and preserve the breadfruit and pandanus. They come together and do it. Same as fishing, building houses, building canoes. They use and speak the language often spoken by the older people. There are words that people in the outer islands use and understand language regularly applied by the elderly. Respect elderly and leaders more i.e., chiefs (iroj), commoners (alap), and the workers on the land (ri-jerbal) (social layer under the commoners). All the kids, they gather with their families, and go and visit the chiefs and alap, and take gifts from their land, first produce/food from the plantation (eojōk). Tommy Almet The people are more connected to the culture in the outer islands because they help one another. They don’t have to always buy things by themselves, everyone contributes to the occasion. For instance, for birthdays, boys go fishing, others contribute and all share with everyone. Kanne Lobal is a practice that can bring people together – leaders, teachers, stakeholders. We want our colleagues to keep strong and work together to fix problems like students and teachers’ absenteeism which is a big problem for us in schools. Demetria Malachi The culture in the outer islands are more accessible and exposed to children. In Majuro, there is a mixedness of cultures and knowledges, influenced by Western thinking and practices. Kanne Lobal is an idea that can enhance quality educational purposes for the RMI. We, the school leaders who did GCSL, we want to merge and use this idea because it will help benefit students’ learning and teachers’ teaching. Kanne Lobal will help students to learn and teachers to teach though traditional skills and knowledge. We want to revitalize our ways of life through teaching because it is slowly fading away. Also, we want to have our own Marshallese learning process because it is in our own language making it easier to use and understand. Essentially, we want to proudly use our own ways of teaching from our ancestors showing the appreciation and blessings given to us. Way Forward To think of ways forward is about reflecting on the past and current learnings. Instead of a traditional discussion within a research publication, we have opted to continue our bwebwenato by sharing what we have learnt through the Graduate Certificate in School Leadership (GCSL) programme. Our bwebwenato does not end in this article and this opportunity to collaborate and partner together in this piece of writing has been a meaningful experience to conceptualise and unpack the Kanne Lobal framework. Our collaborative bwebwenato has enabled us to dig deep into our own wise knowledges for guidance through mediating and negotiating the challenges in education and leadership (Sanga & Houma, 2004). For example, bwe-jen-lale-rara reminds us to inquire, pay attention, and focus on supporting the needs of others. Through enra-bwe-jen-lale-rara, it reminds us to value cultural exchange and reciprocity which will strengthen the development and maintaining of relationships based on ways we continue to honour each other (Nimmer, 2017). We not only continue to support each other, but also help mentor the next generation of school leaders within our education system (Heine, 2002). Education and leadership are all about collaborative partnerships (Sanga & Chu, 2009; Thaman, 1997). Developing partnerships through the GCSL was useful learning for us. It encouraged us to work together, share knowledge, respect each other, and be kind. The values of jouj (kindness, love), kautiej (respect), and jouj eo mour eo (reciprocity) are meaningful in being and becoming and educational leader in the RMI (Jetnil-Kijiner, 2014; Miller, 2010; Nimmer, 2017). These values are meaningful for us practice particularly given the drive by PSS for schools to become accredited. The workshops and meetings delivered during the GCSL in the RMI from 2018 to 2019 about Kanne Lobal has given us strength to share our stories and experiences from the meeting with the stakeholders. But before we met with the stakeholders, we were encouraged to share and speak in our language within our courses: EDP05 (Professional Development and Learning), EDP06 (School Leadership), EDP07 (School Management), EDP08 (Teaching and Learning), and EDP09 (Community Partnerships). In groups, we shared our presentations with our peers, the 15 school leaders in the GCSL programme. We also invited USP RMI staff. They liked the way we presented Kannel Lobal. They provided us with feedback, for example: how the use of the sail on the canoe, the parts and their functions can be conceptualised in education and how they are related to the way that we teach our own young people. Engaging stakeholders in the conceptualisation and design stages of Kanne Lobal strengthened our understanding of leadership and collaborative partnerships. Based on various meetings with the RMI Pacific Resources for Education and Learning (PREL) team, PSS general assembly, teachers from the outer islands, and the PSS executive committee, we were able to share and receive feedback on the Kanne Lobal framework. The coordinators of the PREL programme in the RMI were excited by the possibilities around using Kanne Lobal, as a way to teach culture in an inspirational way to Marshallese students. Our Marshallese knowledge, particularly through the proverbial meaning of Kanne Lobal provided so much inspiration and insight for the groups during the presentation which gave us hope and confidence to develop the framework. Kanne Lobal is an organic and indigenous approach, grounded in Marshallese ways of doing things (Heine, 2002; Taafaki & Fowler, 2019). Given the persistent presence of colonial processes within the education system and the constant reference to practices and initiatives from the US, Kanne Lobal for us provides a refreshing yet fulfilling experience and makes us feel warm inside because it is something that belongs to all Marshallese people. Conclusion Marshallese indigenous knowledge and practices provide meaningful educational and leadership understanding and learnings. They ignite, inspire, and transform thinking and practice. The Kanne Lobal conceptual framework emphasises key concepts and values necessary for collaborative partnerships within education and leadership practices in the RMI. The bwebwenato or talk stories have been insightful and have highlighted the strengths and benefits that our Marshallese ideas and practices possess when looking for appropriate and relevant ways to understand education and leadership. Acknowledgements We want to acknowledge our GCSL cohort of school leaders who have supported us in the development of Kanne Lobal as a conceptual framework. A huge kommol tata to our friends: Joana, Rosana, Loretta, Jellan, Alvin, Ellice, Rolando, Stephen, and Alan. References Benson, C. (2002). Preface. In F. Pene, A. M. Taufe’ulungaki, & C. Benson (Eds.), Tree of Opportunity: re-thinking Pacific Education (p. iv). Suva, Fiji: University of the South Pacific, Institute of Education. Bessarab, D., Ng’andu, B. (2010). Yarning about yarning as a legitimate method in indigenous research. International Journal of Critical Indigenous Studies, 3(1), 37-50. Fa’avae, D., Jones, A., & Manu’atu, L. (2016). Talanoa’i ‘a e talanoa - talking about talanoa: Some dilemmas of a novice researcher. AlterNative: An Indigenous Journal of Indigenous Peoples,12(2),138-150. Heine, H. C. (2002). A Marshall Islands perspective. In F. Pene, A. M. Taufe’ulungaki, & C. 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School administrators’ “frequent turnover” has been discussed intensively in the Turkish Educational System recently. Currently, principals are selected for 4 years after an interview conducted by a committee of directors of national education. After that period, they either go back to their classes or are chosen for another 4 years for the last time. This frequent turnover can be disruptive for schools. This study was conducted to determine school principals’ views on administration work and this frequent turnover. The study employed a qualitative research design. The participants were 20 principals chosen with maximum sampling method. The data were analyzed with content analysis method. Results revealed that most principals consider administration work as a professional and career profession which requires expertise, leadership qualities and education in educational administration. They also evaluate the selection system as problematic and limiting their work period with 4 years prevents them from realizing long-term projects. Finally, they think that the system works with political considerations clearly.

During 1990s, traditional senior high school education encountered challenges of social transitions, information explosion while entering a learning-oriented society. Educational reforms and policies were conducted and enforced nation-wide. School libraries was situated in a turning edge to cope with the education reforms. Two major projects have impacted heavily on the development of high school (including vocational high schools) librarianship. One was the subsidy for collection development from the Ministry of Education that enriched the high schools’ library holdings, the other one was the establishment of “The Senior High School Library Guidance Committee (SHSLGC)”. SHSLGC consists of scholars of Library and Information Science Education, educational administrators, and selected high school library directors. The SHSGC Team started consulting jobs by selecting high school libraries as demonstrative models in different regions of the Island, conducting library symposiums, having published “The Handbook for Senior High School Libraries”, hosting forums for high school principals and chief librarians, establishing professional courses for chief librarians, and paying on-site visits to high school libraries around the Island. The on-site visits created inter-library cooperation and exchange of professional experiences among high schools and vocational high schools. Efforts continued and when the “ Library Law” was effected in year of 2002, SHSLGC gained its legal stands and became a regular organization to officially provide its services to senior school libraries. In addition to its original services 2 during the years, SHSLGC expanded its services to conduct researches on current-status of senior school libraries, posting e-Paper on the Internet, composing a high school e-learning data bank, helping high school libraries to delivery services to communities. This paper addresses the development of SHSLGC, the history, milestones, the implementation, and its impact as well.

In light of an ongoing debate over the authorship of the Redfern address (was it then Prime Minister Paul Keating or his speechwriter, Don Watson, who was responsible for this historic piece?), the authors of this article consider notions of ownership, authorship, and acknowledgement as they relate to the crafting, delivery, and reception of historical political speeches. There is focus, too, on the often-remarkable partnership that evolves between speechwriters and those who deliver the work. We argue that by drawing on the expertise of an artist or—in the case of the article at hand—speechwriter, collaboration facilitates the ‘translation’ of the politician’s or patron’s vision into a delivered reality. The article therefore proposes that while a speech, perhaps like a commissioned painting or sculpture, may be understood as the product of a highly synergistic collaboration between patron and producer, the power-bearer nonetheless retains essential ‘ownership’ of the material. This, we argue, is something other than the process of authorship adumbrated above. Leaving aside, for the present, the question of ownership, the context in which a speech is written and given may well intensify questions of authorship: the more politically significant or charged the context, the greater the potential impact of a speech and the more at stake in terms of its authorship. In addition to its focus on the latter, this article therefore also reflects on the considerable cultural resonance of the speech in question and, in so doing, assesses its significant impact on Australian reconciliation discourse. In arriving at our conclusions, we employ a method assemblage approach including analogy, comparison, historical reference, and interview. Comprising a range of investigative modalities such as those employed by us, John Law argues that a “method assemblage” is essentially a triangulated form of primary and secondary research facilitating the interrogation of social phenomena that do not easily yield to more traditional modes of research (Law 7). The approach is all the more relevant to this article since through it an assessment of the speech’s historical significance may be made. In particular, this article extensively compares the collaboration between Keating and Watson to that of United States President John F. Kennedy and Special Counsel and speechwriter Ted Sorensen. As the article reveals, this collaboration produced a number of Kennedy’s historic speeches and was mutually acknowledged as a particularly important relationship. Moreover, because both Sorensen and Watson were also key advisers to the leaders of their respective nations, the comparison is doubly fertile.On 10 December 1992 then Prime Minister Paul Keating launched the International Year of the World’s Indigenous People by delivering an address now recognised as a landmark in Australian, and even global, oratory. Alan Whiticker, for instance, includes the address in his Speeches That Shaped the Modern World. Following brief instruction from Keating (who was scheduled to give two orations on 10 December), the Prime Minister’s speechwriter and adviser, Don Watson, crafted the speech over the course of one evening. The oration that ensued was history-making: Keating became the first of all who held his office to declare that non-Indigenous Australians had dispossessed Aboriginal people; an unequivocal admission in which the Prime Minister confessed: “we committed the murders” (qtd. in Whiticker 331). The impact of this cannot be overstated. A personal interview with Jennifer Beale, an Indigenous Australian who was among the audience on that historic day, reveals the enormous significance of the address:I felt the mood of the crowd changed … when Keating said “we took the traditional lands” … . “we committed [the murders]” … [pauses] … I was so amazed to be standing there hearing a Prime Minister saying that… And I felt this sort of wave go over the crowd and they started actually paying attention… I’d never in my life heard … anyone say it like that: we did this, to you… (personal communication, 15 Dec. 2016)Later in the interview, when recalling a conversation in the Channel Seven newsroom where she formerly worked, Beale recalls a senior reporter saying that, with respect to Aboriginal history, there had been a ‘conservative cover up.’ Given the broader context (her being interviewed by the present authors about the Redfern Address) Beale’s response to that exchange is particularly poignant: “…it’s very rare that I have had these experiences in my life where I have been … [pauses at length] validated… by non-Aboriginal people” (op. cit.).The speech, then, is a crucial bookend in Australian reconciliation discourse, particularly as an admission of egregious wrongdoing to be addressed (Foye). The responding historical bookend is, of course, Kevin Rudd’s 2008 ‘Apology to the Stolen Generations’. Forming the focal point of the article at hand, the Redfern Address is significant for another reason: that is, as the source of a now historical controversy and very public (and very bitter) falling out between politician and speechwriter.Following the publication of Watson’s memoir Recollections of a Bleeding Heart, Keating denounced the former as having broken an unwritten contract that stipulates the speechwriter has the honour of ‘participating in the endeavour and the power in return for anonymity and confidentiality’ (Keating). In an opinion piece appearing in the Sydney Morning Herald, Keating argued that this implied contract is central to the speech-writing process:This is how political speeches are written, when the rapid business of government demands mass writing. A frequency of speeches that cannot be individually scripted by the political figure or leader giving them… After a pre-draft conference on a speech—canvassing the kind of things I thought we should say and include—unless the actual writing was off the beam, I would give the speech more or less off the printer… All of this only becomes an issue when the speechwriter steps from anonymity to claim particular speeches or words given to a leader or prime minister in the privacy of the workspace. Watson has done this. (Keating)Upon the release of After Words, a collection of Keating’s post-Prime Ministerial speeches, senior writer for The Australian, George Megalogenis opined that the book served to further Keating’s argument: “Take note, Don Watson; Keating is saying, ‘I can write’” (30). According to Phillip Adams, Keating once bluntly declared “I was in public life for twenty years without Don Watson and did pretty well” (154). On the subject of the partnership’s best-known speech, Keating claims that while Watson no doubt shared the sentiments invoked in the Redfern Address, “in the end, the vector force of the power and what to do with it could only come from me” (Keating).For his part, Watson has challenged Keating’s claim to being the rightfully acknowledged author of the Redfern Address. In an appearance on the ABC’s Q&A he asserted authorship of the material, listing other famous historical exponents of his profession who had taken credit for their place at the wheel of government: “I suppose I could say that while I was there, really I was responsible for the window boxes in Parliament House but, actually, I was writing speeches as speechwriters do; as Peggy Noonan did for Ronald Reagan; as Graham Freudenberg did for three or four Prime Ministers, and so on…” (Watson). Moreover, as Watson has suggested, a number of prominent speechwriters have gone on to take credit for their work in written memoirs. In an opinion piece in The Australian, Denis Glover observes that: “great speechwriters always write such books and have the good sense to wait until the theatre has closed, as Watson did.” A notable example of this after-the-era approach is Ted Sorensen’s Counselor in which the author nonetheless remains extraordinarily humble—observing that reticence, or ‘a passion for anonymity’, should characterise the posture of the Presidential speechwriter (131).In Counselor, Sorensen discusses his role as collaborator with Kennedy—likening the relationship between political actor and speechwriter to that between master and apprentice (130). He further observes that, like an apprentice, a speechwriter eventually learns to “[imitate] the style of the master, ultimately assisting him in the execution of the final work of art” (op. cit., 130-131). Unlike Watson’s claim to be the ‘speechwriter’—a ‘master’, of sorts—Sorensen more modestly declares that: “for eleven years, I was an apprentice” (op. cit., 131). At some length Sorensen focuses on this matter of anonymity, and the need to “minimize” his role (op. cit.). Reminiscent of the “unwritten contract” (see above) that Keating declares broken by Watson, Sorensen argues that his “reticence was [and is] the result of an implicit promise that [he] vowed never to break…” (op. cit.). In implying that the ownership of the speeches to which he contributed properly belongs to his President, Sorensen goes on to state that “Kennedy did deeply believe everything I helped write for him, because my writing came from my knowledge of his beliefs” (op. cit. 132). As Herbert Goldhamer observes in The Adviser, this knowing of a leader’s mind is central to the advisory function: “At times the adviser may facilitate the leader’s inner dialogue…” (15). The point is made again in Sorensen’s discussion of his role in the writing of Kennedy’s Profiles in Courage. In response to a charge that he [Sorensen] had ghost-written the book, Sorensen confessed that he might have privately boasted of having written much of it. (op. cit., 150) But he then goes on to observe that “the book’s concept was his [Kennedy’s], and that the selection of stories was his.” (op. cit.). “Like JFK’s speeches”, Sorensen continues, “Profiles in Courage was a collaboration…” (op. cit.).Later in Counselor, when discussing Kennedy’s inaugural address, it is interesting to note that Sorensen is somewhat less modest about the question of authorship. While the speech was and is ‘owned’ by Kennedy (the President requested its crafting, received it, edited the final product many times, and—with considerable aplomb—delivered it in the cold midday air of 20 January 1961), when discussing the authorship of the text Sorensen refers to the work of Thurston Clarke and Dick Tofel who independently conclude that the speech was a collaborative effort (op. cit. 227). Sorensen notes that while Clarke emphasised the President’s role and Tofel emphasised his own, the matter of who was principal craftsman will—and indeed should—remain forever clouded. To ensure that it will permanently remain so, following a discussion with Kennedy’s widow in 1965, Sorensen destroyed the preliminary manuscript. And, when pressed about the similarities between it and the final product (which he insists was revised many times by the President), he claims not to recall (op. cit. 227). Interestingly, Robert Dallek argues that while ‘suggestions of what to say came from many sources’, ‘the final version [of the speech] came from Kennedy’s hand’ (324). What history does confirm is that both Kennedy and Sorensen saw their work as fundamentally collaborative. Arthur Schlesinger Jr. records Kennedy’s words: “Ted is indispensable to me” (63). In the same volume, Schlesinger observes that the relationship between Sorensen and Kennedy was ‘special’ and that Sorensen felt himself to have a unique facility to know [Kennedy’s] mind and to ‘reproduce his idiom’ (op.cit.). Sorensen himself makes the point that his close friendship with the President made possible the success of the collaboration, and that this “could not later be replicated with someone else with whom [he] did not have that same relationship” (131). He refers, of course, to Lyndon Johnson. Kennedy’s choice of advisers (including Sorensen as Special Counsel) was, then, crucial—although he never ceded to Sorensen sole responsibility for all speechwriting. Indeed, as we shortly discuss, at critical junctures the President involved others (including Schlesinger, Richard Goodwin, and Myer Feldman) in the process of speech-craft and, on delivery day, sometimes departed from the scripts proffered.As was the case with Keating’s, creative tension characterised Kennedy’s administration. Schlesinger Jr. notes that it was an approach practiced early, in Kennedy’s strategy of keeping separate his groups of friends (71). During his Presidency, this fostering of creative tension extended to the drafting of speeches. In a special issue of Time, David von Drehle notes that the ‘Peace’ speech given 10 June 1963 was “prepared by a tight circle of advisers” (97). Still, even here, Sorensen’s role remained pivotal. One of those who worked on that speech (commonly regarded as Kennedy’s finest) was William Forster, Director of the Arms Control and Disarmament Agency. As indicated by the conditional “I think” in “Ted Sorensen, I think, sat up all night…”, Forster somewhat reluctantly concedes that while a group was involved, Sorensen’s contribution was central: “[Sorensen], with his remarkable ability to polish and write, was able to send each of us and the President the final draft about six or seven in the morning…” (op. cit.).In most cases, however, it fell on Sorensen alone to craft the President’s speeches. While Sorenson’s mind surely ‘rolled in unison’ with Kennedy’s (Schlesinger Jr. 597), and while Sorensen’s words dominated the texts, the President would nonetheless annotate scripts, excising redundant material and adding sentences. In the case of less formal orations, the President was capable of all but abandoning the script (a notable example was his October 1961 oration to mark the publication of the first four volumes of the John Quincy Adams papers) but for orations of national or international significance there remained a sense of careful collaboration between Kennedy and Sorensen. Yet, even in such cases, the President’s sense of occasion sometimes encouraged him to set aside his notes. As Arthur Schlesinger Jr. observes, Kennedy had an instinctive feel for language and often “spoke extemporaneously” (op. cit.). The most memorable example, of course, is the 1961 speech in Berlin where Kennedy (appalled by the erection of the Berlin Wall, and angry over the East’s churlish covering of the Brandenburg Gate) went “off-script and into dangerous diplomatic waters” (Tubridy 85). But the risky departure paid off in the form of a TKO against Chairman Khrushchev. In late 1960, following two independent phone calls concerning the incarceration of Martin Luther King, Kennedy had remarked to John Galbraith that “the best strategies are always accidental”—an approach that appears to have found its way into his formal rhetoric (Schlesinger Jr. 67).Ryan Tubridy, author of JFK in Ireland, observes that “while the original draft of the Berlin Wall speech had been geared to a sense of appeasement that acknowledged the Wall’s presence as something the West might have to accept, the ad libs suggested otherwise” (85). Referencing Arthur Schlesinger Jr.’s account of the delivery, Tubridy notes that the President’s aides observed the orator’s rising emotion—especially when departing from the script as written:There are some who say that Communism is the way of the future. Let them come to Berlin. And there are some who say in Europe and elsewhere we can work with the Communists. Let them come to Berlin … Freedom has many difficulties and democracy is not perfect, but we have never had to put up a wall to keep our people in.That the speech defined Kennedy’s presidency even more than did his inaugural address is widely agreed, and the President’s assertion “Ich bin ein Berliner” is one that has lived on now for over fifty years. The phrase was not part of the original script, but an addition included at the President’s request by Kennedy’s translator Robert Lochner.While this phrase and the various additional departures from the original script ‘make’ the speech, they are nonetheless part of a collaborative whole the nature of which we adumbrate above. Furthermore, it is a mark of the collaboration between speechwriter and speech-giver that on Air Force One, as they flew from West Germany to Ireland, Kennedy told Sorensen: “We’ll never have another day like this as long as we live” (op. cit. 88; Dallek 625). The speech, then, was a remarkable joint enterprise—and (at least privately) was acknowledged as such.It seems unlikely that Keating will ever (even semi-publicly) acknowledge the tremendous importance of Watson to his Prime Ministership. There seems not to have been a ‘Don is indispensable to me’ moment, but according to the latter the former Prime Minister did offer such sentiment in private. In an unguarded moment, Keating allegedly said that Watson would “be able to say that [he, Watson, was] the puppet master for the biggest puppet in the land” (Watson 290). If this comment was indeed offered, then Keating, much like Kennedy, (at least once) privately acknowledged the significant role that his speechwriter played in his administration. Watson, for his part, was less reticent. On the ABC’s Q&A of 29 August 2011 he assessed the relationship as being akin to a [then] “requited” love. Of course, above and beyond private or public acknowledgement of collaboration is tangible evidence of such: minuted meetings between speechwriter and speech-giver and instructions to the speechwriter that appear, for example, in a politician’s own hand. Perhaps more importantly, the stamp of ownership on a speech can be signalled by marginalia concerning delivery and in the context of the delivery itself: the engagement of emphases, pause, and the various paralinguistic phenomena that can add so much character to—and very much define—a written text. By way of example we reference again the unique and impassioned delivery of the Berlin speech, above. And beyond this again, as also suggested, are the non-written departures from a script that further put the stamp of ownership on an oration. In the case of Kennedy, it is easy to trace such marginalia and resultant departures from scripted material but there is little evidence that Keating either extensively annotated or extemporaneously departed from the script in question. However, as Tom Clark points out, while there are very few changes to Watson’s words there are fairly numerous “annotations that mark up timing, emphasis, and phrase coherence.” Clark points out that Keating had a relatively systematic notational schema “to guide him in the speech performance” (op. cit.). In engaging a musical analogy (an assemblage device that we ourselves employ), he opines that these scorings, “suggest a powerful sense of fidelity to the manuscript as authoritative composition” (op. cit.). While this is so, we argue—and one can easily conceive Keating arguing—that they are also marks of textual ownership; the former Prime Minister’s ‘signature’ on the piece. This is a point to which we return. For now, we note that matters of stress, rhythm, intonation, gesture, and body language are crucial to the delivery of a speech and reaffirm the point that it is in its delivery that an adroitly rendered text might come to life. As Sorensen (2008) reflects:I do not dismiss the potential of the right speech on the right topic delivered by the right speaker in the right way at the right moment. It can ignite a fire, change men’s minds, open their eyes, alter their votes, bring hope to their lives, and, in all these ways, change the world. I know. I saw it happen. (143)We argue that it is in its delivery to (and acceptance by) the patron and in its subsequent delivery by the patron to an audience that a previously written speech (co-authored, or not) may be ‘owned’. As we have seen, with respect to questions of authorship or craftsmanship, analogies (another device of method assemblage) with the visual and musical arts are not uncommon—and we here offer another: a reference to the architectural arts. When a client briefs an architect, the architect must interpret the client’s vision. Once the blueprints are passed to the client and are approved, the client takes ownership of work that has been, in a sense, co-authored. Ownership and authorship are not the same, then, and we suggest that it is the interstices that the tensions between Keating and Watson truly lie.In crafting the Redfern address, there is little doubt that Watson’s mind rolled in unison with the Prime Minister’s: invisible, intuited ‘evidence’ of a fruitful collaboration. As the former Prime Minister puts it: “Watson and I actually write in very similar ways. He is a prettier writer than I am, but not a more pungent one. So, after a pre-draft conference on a speech—canvassing the kind of things I thought we should say and include—unless the actual writing was off the beam, I would give the speech more or less off the printer” (Keating). As one of the present authors has elsewhere observed, “Watson sensed the Prime Minister’s mood and anticipated his language and even the pattern of his voice” (Foye 19). Here, there are shades of the Kennedy/Sorensen partnership. As Schlesinger Jr. observes, Kennedy and Sorensen worked so closely together that it became impossible to know which of them “originated the device of staccato phrases … or the use of balanced sentences … their styles had fused into one” (598). Moreover, in responding to a Sunday Herald poll asking readers to name Australia’s great orators, Denise Davies remarked, “Watson wrote the way Keating thought and spoke” (qtd. in Dale 46). Despite an uncompromising, pungent, title—‘On that historic day in Redfern, the words I spoke were mine’—Keating’s SMH op-ed of 26 August 2010 nonetheless offers a number of insights vis-a-vis the collaboration between speechwriter and speech-giver. To Keating’s mind (and here we might reflect on Sorensen’s observation about knowing the beliefs of the patron), the inspiration for the Prime Minister’s Redfern Address came from conversations between he and Watson.Keating relates an instance when, on a flight crossing outback Western Australia, he told Watson that “we will never really get Australia right until we come to terms with them (Keating).” “Them”, Keating explains, refers to Aborigines. Keating goes on to suggest that by “come to terms”, he meant “owning up to dispossession” (op. cit.)—which is precisely what he did, to everyone’s great surprise, in the speech itself. Keating observes: I remember well talking to Watson a number of times about stories told to me through families [he] knew, of putting “dampers” out for Aborigines. The dampers were hampers of poisoned food provided only to murder them. I used to say to Watson that this stuff had to be owned up to. And it was me who established the inquiry into the Stolen Generation that Kevin Rudd apologised to. The generation who were taken from their mothers.So, the sentiments that “we did the dispossessing … we brought the diseases, the alcohol, that we committed the murders and took the children from their mothers” were my sentiments. P.J. Keating’s sentiments. They may have been Watson’s sentiments also. But they were sentiments provided to a speechwriter as a remit, as an instruction, as guidance as to how this subject should be dealt with in a literary way. (op. cit.)While such conversations might not accurately be called “guidance” (something more consciously offered as such) or “instruction” (as Keating declares), they nonetheless offer to the speechwriter a sense of the trajectory of a leader’s thoughts and sentiments. As Keating puts it, “the sentiments of the speech, that is, the core of its authority and authorship, were mine” (op. cit.). As does Sorensen, Keating argues that that such revelation is a source of “power to the speechwriter” (op. cit.). This he buttresses with more down to earth language: conversations of this nature are “meat and drink”, “the guidance from which the authority and authorship of the speech ultimately derives” (op. cit.). Here, Keating gets close to what may be concluded: while authorship might, to a significant extent, be contingent on the kind of interaction described, ownership is absolutely contingent on authority. As Keating asserts, “in the end, the vector force of the power and what to do with it could only come from me” (op. cit.). In other words, no Prime Minister with the right sentiments and the courage to deliver them publicly (i.e. Keating), no speech.On the other hand, we also argue that Watson’s part in crafting the Redfern Address should not be downplayed, requiring (as the speech did) his unique writing style—called “prettier” by the former Prime Minister. More importantly, we argue that the speech contains a point of view that may be attributed to Watson more than Keating’s description of the speechwriting process might suggest. In particular, the Redfern Address invoked a particular interpretation of Australian history that can be attributed to Watson, whose manuscript Keating accepted. Historian Manning Clark had an undeniable impact on Watson’s thinking and thus the development of the Redfern address. Per Keating’s claim that he himself had “only read bits and pieces of Manning’s histories” (Curran 285), the basis for this link is actual and direct: Keating hired Clark devotee Watson as a major speech writer on the same day that Clark died in 1991 (McKenna 71). McKenna’s examination of Clark’s history reveals striking similarities with the rhetoric at the heart of the Redfern address. For example, in his 1988 essay The Beginning of Wisdom, Clark (in McKenna) announces:Now we are beginning to take the blinkers off our eyes. Now we are ready to face the truth about our past, to acknowledge that the coming of the British was the occasion of three great evils: the violence against the original inhabitants of the of the country, the Aborigines, the violence against the first European labour force in Australia, the convicts and the violence done to the land itself. (71)As the above quote demonstrates, echoes of Clark’s denouncement of Australia’s past are evident in the Redfern Address’ rhetoric. While Keating is correct to suggest that Watson and he shared the sentiments behind the Address, it may be said that it took Watson—steeped as he was in Clark’s understanding of history and operating closely as he did with the Prime Minister—to craft the Redfern Address. Notwithstanding the concept of ownership, Keating’s claim that the “vector force” for the speech could only come from him unreasonably diminishes Watson’s role.ConclusionThis article has considered the question of authorship surrounding the 1992 Redfern Address, particularly in view of the collaborative nature of speechwriting. The article has also drawn on the analogous relationship between President Kennedy and his Counsel, Ted Sorensen—an association that produced historic speeches. Here, the process of speechwriting has been demonstrated to be a synergistic collaboration between speechwriter and speech-giver; a working partnership in which the former translates the vision of the latter into words that, if delivered appropriately, capture audience attention and sympathy. At its best, this collaborative relationship sees the emergence of a synergy so complete that it is impossible to discern who wrote what (exactly). While the speech carries the imprimatur and original vision of the patron/public actor, this originator nonetheless requires the expertise of one (or more) who might give shape, clarity, and colour to what might amount to mere instructive gesture—informed, in the cases of Sorensen and Watson, by years of conversation. While ‘ownership’ of a speech then ultimately rests with the power-bearer (Keating requested, received, lightly edited, ‘scored’, and delivered—with some minor ad libbing, toward the end—the Redfern text), the authors of this article consider neither Keating nor Watson to be the major scribe of the Redfern Address. Indeed, it was a distinguished collaboration between these figures that produced the speech: a cooperative undertaking similar to the process of writing this article itself. Moreover, because an Australian Prime Minister brought the plight of Indigenous Australians to the attention of their non-Indigenous counterparts, the address is seminal in Australian history. It is, furthermore, an exquisitely crafted document. And it was also delivered with style. As such, the Redfern Address is memorable in ways similar to Kennedy’s inaugural, Berlin, and Peace speeches: all products of exquisite collaboration and, with respect to ownership, emblems of rare leadership.ReferencesAdams, Phillip. Backstage Politics: Fifty Years of Political Memories. London: Viking, 2010.Beale, Jennifer. Personal interview. 15 Dec. 2016.Clark, Tom. “Paul Keating’s Redfern Park Speech and Its Rhetorical Legacy.” Overland 213 (Summer 2013). <https://overland.org.au/previous-issues/issue-213/feature-tom-clarke/ Accessed 16 January 2017>.Curran, James. The Power of Speech: Australian Prime Ministers Defining the National Image. Melbourne: Melbourne UP, 2004.Dale, Denise. “Speech Therapy – How Do You Rate the Orators.” Sun Herald, 9 Mar.2008: 48.Dallek, Robert. An Unfinished Life: John F. Kennedy 1917-1963. New York: Little Brown, 2003.Foye, Jonathan. Visions and Revisions: A Media Analysis of Reconciliation Discourse, 1992-2008. Honours Thesis. Sydney: Western Sydney University, 2009.Glover, Denis. “Redfern Speech Flatters Writer as Well as Orator.” The Australian 27 Aug. 2010. 15 Jan. 2017 <http://www.theaustralian.com.au/national-affairs/opinion/redfern-speech-flatters-writer-as-well-as-orator/news-story/b1f22d73f67c29f33231ac9c8c21439b?nk=33a002f4d3de55f3508954382de2c923-1489964982>.Goldhamer, Herbert. The Adviser. Amsterdam: Elsevier, 1978.Keating, Paul. “On That Historic Day in Redfern the Words I Spoke Were Mine.” Sydney Morning Herald 26 Aug. 2010. 15 Jan. 2017 <http://www.smh.com.au/federal-politics/political-opinion/on-that-historic-day-in-redfern-the-words-i-spoke-were-mine-20100825-13s5w.html>.———. “Redfern Address.” Address to mark the International Year of the World's Indigenous People. Sydney: Redfern Park, 10 Dec. 1992. Law, John. After Method: Mess in Social Science Research. New York: Routledge, 2004. McKenna, Mark. “Metaphors of Light and Darkness: The Politics of ‘Black Armband’ History.” Melbourne Journal of Politics 25.1 (1998): 67-84.Megalogenis, George. “The Book of Paul: Lessons in Leadership.” The Monthly, Nov. 2011: 28-34.Schlesinger Jr., Arthur M. A Thousand Days: John F. Kennedy in the White House. Andre Deutsch, 1967.Sorensen, Ted. Counselor: A Life at the Edge of History. New York: Harper Collins, 2008.Tubridy, Ryan. JFK in Ireland. New York: Harper Collins, 2010.Watson, Don. Recollections of a Bleeding Heart: A Portrait of Paul Keating PM. Milsons Point: Knopf, 2002.———. Q&A. ABC TV, 29 Aug. 2011.Whiticker, Alan. J. Speeches That Shaped the Modern World. New York: New Holland, 2005.Von Drehle, David. JFK: His Enduring Legacy. Time Inc Specials, 2013.

Area Studies and Study Abroad in the 21st Century The future now belongs to societies that organize themselves for learning. - Ray Marshall and Marc Tucker, Thinking for a Living, xiii Few today would argue with the conviction that nearly every phase of our daily lives is shaped and informed by global societies, corporations, events and ideas. More than ever before, it is possible to claim that we are increasingly aware of the dynamic power and penetrating effects of global flows on information, technology, the sciences, the arts, the humanities, and languages. Borderless, spaceless and timeless, such sources of knowledge, it appears, are effortlessly digested and disseminated without clocks, calendars, or physical limitations. It is, of course, a mistake to believe that packages of “instant” knowledge that appear to wing their way at megahertz speeds in and through our earthly lives account for all or nearly all that there is to know—or, more importantly, to learn—about our communities, regions and the globe itself. On the contrary: the “knowing” about how to live, to work, to prosper, or to understand ourselves and those around us is not what educators mean when they speak of intellectual achievement and practical understanding. It is the “learning” about us, our societies and our global knowledge that lies at the heart of the international educator’s life work, and it is the learning that is the most controversial aspect of education. The act of “learning,” in fact, is less objective and more subjective, is less passive and more active, and is less superficial and more profound in each of our lives. By definition, a responsible learner is one who takes on the intellectual challenge and the social and personal obligation to leave this globe a better place for those who follow, who assumes the life work of influencing the lives of others, and who is committed to making the best of every opportunity both within the reach and beyond the vision of the mind’s eye. Study abroad has traditionally been viewed as a time of seeing and viewing, however passively, the differences and similarities of other peoples, societies and cultures. The period of knowing about what others do or say can occur at any time during one’s life; however, the “knowing” of studying abroad is accomplished in the college years prior to the accumulated knowledge about practical learning and living. In this respect, study abroad has been seen as an experience which may or may not invest the students in greater or lesser insights about the peoples, societies or cultures around them. Further, when study abroad is bound up with travel or movement from place to place, it can become a passive act, so much so that travel rather than learning becomes the goal of the study abroad experience. Simply put, the more that one travels, the more, it is argued, one learns. Furthermore, while seen as desirable for “classroom learning,” some would say that no amount of academic preparation appears to be useful in the enterprise of the travel experience, since so many experiences are unpredictable, individualized and, in some cases, arbitrary. From the perspective of study abroad, it might be said that the gods of area studies no longer completely fulfill our students’ needs, while the gods of global studies have not yet fulfilled their promises. Janus-like, international educators look in one direction at a still highly intense and valued picture of local cultures and identities, and in another direction toward an increasingly common culture, economy and society. The former appears to celebrate the differences and “uncommonness” of the human experience while the latter smoothes over the differences to underscore the commonalities and sameness of our contemporary world. The choice appears to be between the particular and the universal, the local and the global. Academic preparations, such as area studies programs, appear to be unnecessary for the individualized forms of learning, such as study abroad. Indeed, since an area studies preparation may raise or strengthen stereotypical perceptions of the overseas peoples, societies and cultures, it has been argued that it best be left aside. In this context, students are viewed as a tabula rasa on which new discoveries from living and studying overseas leave an imprint or impression. It seems that sending as many students as possible in as many directions as possible has become the dominant study abroad objective. Thus, “whole world” presentations and documentation often rely on the “other” as the learning objective with little or no attempt to discriminate or distinguish the levels of learning that such “whole world” immersion entails. In recent times, additional concerns about liability, health, safety and comfort levels have been added to the “pre-departure” orientations and training programs. The “student as self-learner” continues to be viewed and treated as a “customer knowledge-consumer” within both U.S. private and public colleges and universities. In the age of “globalization,” it is the conviction of the editors of Frontiers that knowledge consumption is only a small aspect of the 21st century international educators’ arsenal. More importantly, it will be argued in this special issue on area studies and Study Abroad that the intellectual development of the U.S. undergraduate needs to be enhanced with skills of self-learning and transdisciplinary perspectives on local and regional cultures and languages. The authors contributing to this special thematic issue of Frontiers have been asked to bring their state-of-the-art thinking on area studies to bear on the key question confronting study abroad: How does specialized understanding of geographical and cultural areas of the world enhance and strengthen undergraduate learning on and beyond our campuses? In other words, in what ways do area studies inform overseas learning through the activity of study abroad? The variety of responses demonstrates two principal ways in which area studies has begun to reformulate its goals and strategies. First, area studies reaffirms a commitment to local and regional comprehensive research and teaching, and redefines its mission in terms of the need to come to grips with local knowledge and specific social and cultural practices within a globalized world. Second, area studies specialists question long-held definitions of concepts, including those of “geographical area” and “globalization,” in order to maximize contributions to U.S. undergraduate learning. David Ludden begins our issue with a review of the Social Science Research Council and the Ford Foundation’s understanding of the transition in area studies from the Sputnik era to the globalization era. Ludden notes the faculty dilemma in working in an “area.” He points out the political interests of the Cold War for public funding of such specialized academic skills, skills which, whether funded by the government or not, were and continue to be defined by the scholar first and then by finances. Drawing on his own experience at the South Asia Institute at the University of Pennsylvania, Ludden takes the reader through the intellectual rationale for area studies, and how that rationale is being redefined in favor of stronger area studies in the present globalization era. Gregory Kulacki’s study of China and the Chinese experience points accurately to one approach to defining area studies; that is, in terms of the peoples and cultures studied. In a sense, Kulacki makes it clear that Chinese studies is “legitimate” and has authority as long as it reflects the Chinese themselves, their experiences and lives. Ann Curthoys, on the other hand, notes the growing importance of defining Australians and Australian studies not only in terms of the changing experiences of contemporary Australia, but also in terms of the demands of non-Australians, who ask for more precision in defining Australians, their history, society and cultures. Richard Beach and George Sherman take on a more difficult matter, at least from the viewpoint of U.S. faculty and students. Canada is rarely seen as a study abroad site for U.S. students, not only because of its geographical position but also for its cultural and historical proximity. The overall U.S. view, albeit unflattering, is that Canada and Canadians are very much like the U.S. and Americans, so why study in Canada? Beach and Sherman argue that history, languages, and borders do make a difference, both physically as well as culturally. Using the argument of the previous area studies specialists, they are interested in the ways that Canadians have shaped and informed their cultural and social identities in the teeth of U.S. economic and political domination in the region. The implications of globalization are, perhaps, more immediately evident in the Canadian case than in any other world region. U.S. students would do well to observe the processes of adaptation and acculturation first-hand by studying and living in Canada. James Petras gives us a broader vista of regional adaptation to the economic and political forces of globalization with his essay on Latin America. Indeed, Latin America has a dynamic similar to that of Canada due to its physical, cultural and historical proximity to the U.S. It would be a mistake to see Latin America only in terms of the north-south regional dynamics, since Europe, Asia and Africa have also shaped both past and present structures and institutions within that region in ways far more dramatic than has the United States. Study abroad, Petras reminds us, is an excellent way of learning directly about Latin American societies, cultures and politics from Latin Americans themselves, a learning that may be widely different from the official U.S. diplomatic and corporate perspectives. Finally, the very familiar world regions, such as England, offer in some cases more challenges to the U.S. undergraduate than might be expected. Jane Edwards looks at Britain and all that U.S. students may or may not know about that culture and society. The study of Britain lends itself, Edwards argues, to more than the usual challenges, due to the preconceived notions that U.S. students bring with them to, say, London. Understanding the “European-ness” of Britain and its historic relationship with continental Western Europe will justify the need to see Britain as less familiar and more complex, thus necessitating the need to study, visit and live in parts of Britain and Western Europe. In this case, the area does define the country, its identity and culture in a historical interplay of social, cultural and economic forces. David Lloyd, Philip Khoury and Russell Bova invite the reader to return to large regional perspectives through African, Middle Eastern and Russian area studies. David Lloyd presents an analysis of the broad and immediate contexts of African studies. While recognizing the difficulty of establishing consistently causal links between African studies and study abroad in Africa, he delineates the significance of local, experience-based study for the development of collaborative African studies research. Lloyd argues that the benefits of study abroad in Africa to African studies belie the relatively small number of students involved. Further, assessment for funding and other purposes needs to utilize criteria that take into account the challenges of on-site study in Africa and the depth of post-study abroad participation not just in African studies per se, but in other related areas as well. Considering the recent past of Middle East studies, Philip Khoury charts its response to post-Cold War criticism. He illustrates new directions the field is taking towards including different geographic areas, and new emphasis in organizational priorities, noting the importance of funding for providing first-hand contact for students in Middle Eastern studies with scholars from the Middle East. Khoury assesses the impact of recent historical and political events in the area on Middle Eastern studies, and looks toward more inclusive research efforts. Russell Bova examines another region that has undergone considerable political, social and economic change in the 20th century. Having moved from empire to soviet socialist states and now to a confederation of nation states, Russia and, naturally, Russian area studies, offer an excellent example of local and regional complexities both in the nomenclature of the region and in the changes in Russian studies programs. Bova illustrates the need to understand the specific dynamics of local communities in their relationship to larger administrative units such as provinces, states and national capitals. In referring to the “double transition” of contemporary Russia, Bova reminds us that globalization is both a grass roots and elite process with many unlikely “bedfellows” that is also changing more rapidly each decade than had been the case fifty years ago. Finally, Richard Falk and Nancy Kanach collaborate to discuss the ways in which globalization and study abroad are emerging in the post-Cold War period. The sudden shifts of economic and political power make our world more fragile and more difficult to comprehend without considering the “computer gap” that is rapidly leaving whole communities and even nations in a more uneven relationship with the power brokers than ever before. The need to reflect with care and precision through area studies is complemented by the additional pressing need to study, see and learn outside of the U.S. Globalization means promoting study abroad and reaffirming the strengths of local and regional studies. Taken together, these essays invite international educators to reconsider notions of learning before, during and after study abroad. The writers view study abroad as an opportunity for social and intellectual engagement with other peoples and with oneself. The essays point to a variety of ways of intellectually preparing our students for their initial encounters with sets of real-life global experiences. Reflecting on such engagement and encounters allows students to begin to formulate, with increasing sophistication, specific and general concepts about individual differences, local and regional commonalities, and the global transformations of our present era. In light of the current area studies debates, we might also reconsider approaches to pre-departure preparations, create onsite projects, and reorganize the overseas curricula of study abroad programs themselves. In particular, students can continue to benefit from area and global studies programs back on the home campus upon their return, where they can enter effectively into scholarly debates and continue the learning and personal growth that began while they were abroad. Frontiers welcomes comments and suggestions for future special issues. We see ourselves and our field of international education in greater need of close cooperation with our faculty colleagues both in terms of defining the work of international learning, and in terms of formulating and designing international or global programs. We thus invite our readers to see Frontiers as a forum for such academic exchanges, and promise that Frontiers will respond to articles, essays, book reviews and reviews of resources for study abroad with collegial interest and enthusiasm. We wish to thank especially Brian Whalen, Rhoda Borcherding and our other colleagues on the Editorial Board for their support, encouragement and assistance in completing this special issue. We are particularly pleased with the authors and their willingness to listen to our requests and comments. Thomas Ricks, Villanova University Katharine Krebs, SUNY Binghamton Michael Monahan, Macalester College Suggestions for Further Reading Altbach, Philip G. and Patti McGill Peterson, eds. Higher Education in the 21st Century: Global Challenge and National Response. IIE Research Report Number 29. Annapolis, MD: IIE Books, 1999. This slim volume focuses on principal topics for colleges and universities to consider both locally and globally. Philip Altbach and Todd Davis set the tone of the volume with their “notes for an international dialogue on higher education.” Stressing the need for practical education, the authors also raise issues about the role of technology, the increase in “internationally mobile students,” the global role of graduate education, privatization of higher education, committed faculty and the threats of “managerialized” universities. The eight responses to the opening themes address specific issues for China, India, Africa and South Africa, Latin America, Japan and Europe. The work is a very good discussion text for international educators and their area studies faculty colleagues, and also provides a theoretical basis for the design and development of overseas programs. Stephen R. Graubard, ed. “Education Yesterday, Education Tomorrow.” Daedalus. Vol. 127, No. 4 (Fall, 1998). The eleven authors of this issue of the Journal of the American Academy of Arts and Sciences build off the Fall 1995 issue of Daedalus and its topic of “American Education: Still Separate, Still Unequal.” While neither accepting nor rejecting the thrust of A Nation at Risk, the authors look both at what has occurred over the past three decades, and at what is on the horizon for the next decade. In stressing reforms of systems and innovative ways of learning, the authors’ discussions invite the international educator to address a variety of ways in which students learn and to challenge the system in which they thrive. WWW. NAFSA.ORG/SECUSSA.WHYSTUDY In 1989, NAFSA and COUNCIL created the Whole World Committee (WWC). Initially chaired by John Sommers and now chaired by Mick Vandenberg, the WWC set out to find ways by which U.S. students could and would choose non-European overseas sites for a semester of study and learning. One of the tasks that the WWC accomplished was the creation of four area study essays on Africa, Asia, South America and the Middle East. Each essay, entitled “Why Study in …,” addresses basic fears and stereotyping of the non-European world regions. The essays then focus on benefits, health and safety, “getting started,” housing, and practical learning in each of these regions. In newly-attached longer versions, the essays also have a bibliography and more informative texts. The shorter versions were published serially in Transitions Abroad. NAFSA has added two additional important essays to this website, on “Class and Study Abroad” and “An African-American in South Africa.” Overall, the readers of Frontiers will be well-advised to access the articles at the website and consider using all the essays in their pre-departure orientation training, faculty area studies discussion groups, and in welcome-back sessions for returning students. Richard Falk. Predatory Globalization: A Critique. Cambridge, UK: Polity Press, 1999. The thesis of Richard Falk’s critique is that “predatory globalization’ has eroded, if not altogether broken, the former social contract that was forged between state and society during the last century or so” (p. 3). The breaking of that contract resulted from the state’s “deference to the discipline of global capital” and the neglect of the common good. Falk argues that only the “massing of strong transnational social pressures on the states of the world could alter the political equation to the point where the state could sufficiently recover its autonomy in relation to the world economy.” He demonstrates the emergence of a new kind of transnational politics referred to as “globalization-from-below.” In restoring “global civil society,” this new politics will need to move forward with the project of cosmopolitan democracy, including the protection of human rights. For the international educator, creating overseas programs that allow for a better understanding of the interconnectedness of regional and global levels is an admirable goal. More important, however, are those programs that offer U.S. undergraduates insights into “world order priorities” such as global poverty, protection of the planet, the sources of transnational violence, and “responsible sovereignty” in ways rarely found in traditional classroom learning on our campuses. Mark Tessler, Jodi Nachtwey and Anne Banda. Eds. Area Studies and Social Science: Strategies for Understanding Middle East Politics. Bloomington and Indianapolis, IN: Indiana University Press, 1999. This edited work addresses a wide range of issues involved in the “rational choice” versus area studies debate that is so well elucidated by David Ludden in the opening article of our special issue. Looking at the “area studies controversy” from the perspective of political scientists, the editors’ Introduction underscores questions that we international educators need to address ourselves. It is valuable to wonder about the “uses and abuses” of area studies in planning our overseas programs, or discussing the “internationalization” of our curricula. It is also critical to understand the Eurocentric and overly-simplistic approaches of the social science “rational choice” models. While agreeing that both area studies and the social science theories and methodologies are necessary for a global understanding, the present work places such questions within the context of the Middle East as a stimulus and a model for increasing the value of research about any country or region.

Phillip Noyce is one of Australia’s most prominent film makers—a successful feature film director with both iconic Australian narratives and many a Hollywood blockbuster under his belt. Still, his beginnings were quite humble and far from his role today when he grew up in the midst of the counterculture of the late sixties. Millions of young people his age joined the various ‘movements’ of the day after experiences that changed their lives—mostly music but also drugs or fashion. The counterculture was a turbulent time in Sydney artistic circles as elsewhere. Everything looked possible, you simply had to “Do It!”—and Noyce did. He dived head-on into these times and with a voracious appetite for its many aspects—film, theatre, rallies, music, art and politics in general. In fact he often was the driving force behind such activities. Noyce described his personal epiphany occurring in 1968: A few months before I was due to graduate from high school, […] I saw a poster on a telegraph pole advertising American 'underground' movies. There was a mesmerising, beautiful blue-coloured drawing on the poster that I later discovered had been designed by an Australian filmmaker called David Perry. The word 'underground' conjured up all sorts of delights to an eighteen-year-old in the late Sixties: in an era of censorship it promised erotica, perhaps; in an era of drug-taking it promised some clandestine place where marijuana, or even something stronger, might be consumed; in an era of confrontation between conservative parents and their affluent post-war baby-boomer children, it promised a place where one could get together with other like-minded youth and plan to undermine the establishment, which at that time seemed to be the aim of just about everyone aged under 30. (Petzke 8) What the poster referred to was a new, highly different type of film. In the US these films were usually called “underground”. This term originates from film critic Manny Farber who used it in his 1957 essay Underground Films. Farber used the label for films whose directors today would be associated with independent and art house feature films. More directly, film historian Lewis Jacobs referred to experimental films when he used the words “film which for most of its life has led an underground existence” (8). The term is used interchangeably with New American Cinema. It was based on a New York group—the Film-Makers’ Co-operative—that started in 1960 with mostly low-budget filmmakers under the guidance of Jonas Mekas. When in 1962 the group was formally organised as a means for new, improved ways of distributing their works, experimental filmmakers were the dominant faction. They were filmmakers working in a more artistic vein, slightly influenced by the European Avant-garde of the 1920s and by attempts in the late 1940s and early 1950s. In film history, this era is also known as the Third Avant-garde. In their First Statement of the New American Cinema Group, the group drew connections to both the British Free Cinema and the French Nouvelle Vague. They also claimed that contemporary cinema was “morally corrupt, aesthetically obsolete, thematically superficial, temperamentally boring” (80). An all-encompassing definition of Underground Film never was available. Sheldon Renan lists some of the problems: There are underground films in which there is no movement and films in which there is nothing but movement. There are films about people and films about light. There are short, short underground films and long, long underground films. There are some that have been banned, and there is one that was nominated for an Academy Award. There are sexy films and sexless films, political films and poetical films, film epigrams and film epics … underground film is nothing less than an explosion of cinematic styles, forms and directions. (Renan 17) No wonder that propelled by frequent serious articles in the press—notably Jonas Mekas in the Village Voice—and regular screenings at other venues like the Film-makers’ Cinemathèque and the Gallery of Modern Art in New York, these films proved increasingly popular in the United States and almost immediately spread like bush fires around the world. So in early September 1968 Noyce joined a sold-out crowd at the Union Theatre in Sydney, watching 17 shorts assembled by Ubu Films, the premier experimental and underground film collective in 1960s Australia (Milesago). And on that night his whole attitude to art, his whole attitude to movies—in fact, his whole life—changed. He remembered: I left the cinema that night thinking, "I’m gonna make movies like that. I can do it." Here was a style of cinema that seemed to speak to me. It was immediate, it was direct, it was personal, and it wasn’t industrial. It was executed for personal expression, not for profit; it was individual as opposed to corporate, it was stylistically free; it seemed to require very little expenditure, innovation being the key note. It was a completely un-Hollywood-like aesthetic; it was operating on a visceral level that was often non-linear and was akin to the psychedelic images that were in vogue at the time—whether it was in music, in art or just in the patterns on your multi-coloured shirt. These movies spoke to me. (Petzke 9) Generally speaking, therefore, these films were the equivalent of counterculture in the area of film. Theodore Roszak railed against “technocracy” and underground films were just the opposite, often almost do-it-yourself in production and distribution. They were objecting to middle-class culture and values. And like counterculture they aimed at doing away with repression and to depict a utopian lifestyle feeling at ease with each imaginable form of liberality (Doggett 469). Underground films transgressed any Hollywood rule and convention in content, form and technique. Mobile hand-held cameras, narrow-gauge or outright home movies, shaky and wobbly, rapid cutting, out of focus, non-narrative, disparate continuity—you name it. This type of experimental film was used to express the individual consciousness of the “maker”—no longer calling themselves directors—a cinematic equivalent of the first person in literature. Just as in modern visual art, both the material and the process of making became part of these artworks. Music often was a dominant factor, particularly Eastern influences or the new Beat Music that was virtually non-existent in feature films. Drug experiences were reflected in imagery and structure. Some of the first comings-out of gay men can be found as well as films that were shown at the appropriately named “Wet Dreams Festival” in Amsterdam. Noyce commented: I worked out that the leading lights in this Ubu Films seemed to be three guys — Aggy Read, Albie Thoms and David Perry […They] all had beards and […] seemed to come from the basement of a terrace house in Redfern. Watching those movies that night, picking up all this information, I was immediately seized by three great ambitions. First of all, I wanted to grow a beard; secondly, I wanted to live in a terrace house in the inner city; and thirdly, I wanted to be a filmmaker. (Ubu Films) Noyce soon discovered there were a lot of people like him who wanted to make short films for personal expression, but also as a form of nationalism. They wanted to make Australian movies. Noyce remembered: “Aggy, Albie and David encouraged everyone to go and make a film for themselves” (Petzke 11). This was easy enough to do as these films—not only in Australia—were often made for next to nothing and did not require any prior education or training. And the target audience group existed in a subculture of people willing to pay money even for extreme entertainment as long as it was advertised in an appealing way—which meant: in the way of the rampaging Zeitgeist. Noyce—smitten by the virus—would from then on regularly attend the weekly meetings organised by the young filmmakers. And in line with Jerry Rubin’s contemporary adage “Do it!” he would immediately embark on a string of films with enthusiasm and determination—qualities soon to become his trademark. All his films were experimental in nature, shot on 16mm and were so well received that Albie Thoms was convinced that Noyce had a great career ahead of him as an experimental filmmaker. Truly alternative was Noyce’s way to finally finance Better to Reign in Hell, his first film, made at age 18 and with a total budget of $600. Noyce said on reflection: I had approached some friends and told them that if they invested in my film, they could have an acting role. Unfortunately, the guy whose dad had the most money — he was a doctor’s son — was also maybe the worst actor that was ever put in front of a camera. But he had invested four hundred dollars, so I had to give him the lead. (Petzke 13) The title was taken from Milton’s poem Paradise Lost (“better to reign in hell than serve in heaven”). It was a film very much inspired by the images, montage and narrative techniques of the underground movies watched at Ubu. Essentially the film is about a young man’s obsession with a woman he sees repeatedly in advertising and the hallucinogenic dreams he has about her. Despite its later reputation, the film was relatively mundane. Being shot in black and white, it lacks the typical psychedelic ingredients of the time and is more reminiscent of the surrealistic precursors to underground film. Some contempt for the prevailing consumer society is thrown in for good measure. In the film, “A youth is persecuted by the haunting reappearance of a girl’s image in various commercial outlets. He finds escape from this commercial brainwashing only in his own confused sexual hallucinations” (Sydney Filmmakers Co-operative). But despite this advertising, so convincingly capturing the “hint! hint!” mood of the time, Noyce’s first film isn’t really outstanding even in terms of experimental film. Noyce continued to make short experimental films. There was not even the pretence of a story in any of them. He was just experimenting with his gear and finding his own way to use the techniques of the underground cinema. Megan was made at Sydney University Law School to be projected as part of the law students’ revue. It was a three-minute silent film that featured a woman called Megan, who he had a crush on. Intersection was 2 minutes 44 seconds in length and shot in the middle of a five-way or four-way intersection in North Sydney. The camera was walked into the intersection and spun around in a continuous circle from the beginning of the roll of film to the end. It was an experiment with disorientation and possibly a comment about urban development. Memories was a seven-minute short in colour about childhood and the bush, accompanied by a smell-track created in the cinema by burning eucalyptus leaves. Sun lasted 90 seconds in colour and examined the pulsating winter sun by way of 100 single frame shots. And finally, Home was a one-and-a-half-minute single frame camera exploration of the filmmaker’s home, inside and out, including its inhabitants and pets. As a true experimental filmmaker, Noyce had a deep interest in technical aspects. It was recommended that Sun “be projected through a special five image lens”, Memories and Intersection with “an anamorphic lens” (Sydney Filmmakers Co-operative). The double projection for Better to Reign in Hell and the two screens required for Good Afternoon, as well as the addition of the smell of burning leaves in Memories, were inroads into the subgenre of so-called Expanded Cinema. As filmmaking in those days was not an isolated enterprise but an integral part of the all-encompassing Counterculture, Noyce followed suit and became more and more involved and politiced. He started becoming a driving force of the movement. Besides selling Ubu News, he organised film screenings. He also wrote film articles for both Honi Soit and National U, the Sydney University and Canberra University newspapers—articles more opinionated than sophisticated. He was also involved in Ubu’s Underground Festival held in August and in other activities of the time, particularly anti-war protests. When Ubu Films went out of business after the lack of audience interest in Thoms’s long Marinetti film in 1969, Aggy Read suggested that Ubu be reinvented as a co-operative for tax reasons and because they might benefit from their stock of 250 Australian and foreign films. On 28 May 1970 the reinvention began at the first general meeting of the Sydney Filmmakers Cooperative where Noyce volunteered and was elected their part-time manager. He transferred the 250 prints to his parents’ home in Wahroonga where he was still living he said he “used to sit there day after day just screening those movies for myself” (Petzke 18). The Sydney University Film Society screened feature films to students at lunchtime. Noyce soon discovered they had money nobody was spending and equipment no one was using, which seemed to be made especially for him. In the university cinema he would often screen his own and other shorts from the Co-op’s library. The entry fee was 50 cents. He remembered: “If I handed out the leaflets in the morning, particularly concentrating on the fact that these films were uncensored and a little risqué, then usually there would be 600 people in the cinema […] One or two screenings per semester would usually give me all the pocket money I needed to live” (Petzke 19). Libertine and risqué films were obviously popular as they were hard to come by. Noyce said: We suffered the worst censorship of almost any Western country in the world, even worse than South Africa. Books would be seized by customs officers at the airports and when ships docked. Customs would be looking for Lady Chatterley’s Lover. We were very censored in literature and films and plays, and my film [Better to Reign in Hell] was banned from export. I tried to send it to a film festival in Holland and it was denied an export permit, but because it had been shot in Australia, until someone in the audience complained it could still be screened locally. (Castaway's Choice) No wonder clashes with the law happened frequently and were worn like medals of honour in those days of fighting the system, proving that one was fighting in the front line against the conservative values of law and order. Noyce encountered three brushes with the law. The first occurred when selling Ubu Films’ alternative culture newspaper Ubu News, Australia’s first underground newspaper (Milesago). One of the issues contained an advertisement—a small drawing—for Levi’s jeans, showing a guy trying to put his Levis on his head, so that his penis was showing. That was judged by the police to be obscene. Noyce was found guilty and given a suspended sentence for publishing an indecent publication. There had been another incident including Phil’s Pill, his own publication of six or eight issues. After one day reprinting some erotic poems from The Penguin Collection of Erotic Poetry he was found guilty and released on a good behaviour bond without a conviction being recorded. For the sake of historical truth it should be remembered, though, that provocation was a genuine part of the game. How else could one seriously advertise Better to Reign in Hell as “a sex-fantasy film which includes a daring rape scene”—and be surprised when the police came in after screening this “pornographic film” (Stratton 202) at the Newcastle Law Students Ball? The Newcastle incident also throws light on the fact that Noyce organised screenings wherever possible, constantly driving prints and projectors around in his Mini Minor. Likewise, he is remembered as having been extremely helpful in trying to encourage other people with their own ideas—anyone could make films and could make them about anything they liked. He helped Jan Chapman, a fellow student who became his (first) wife in December 1971, to shoot and edit Just a Little Note, a documentary about a moratorium march and a guerrilla theatre group run by their friend George Shevtsov. Noyce also helped on I Happened to Be a Girl, a documentary about four women, friends of Chapman. There is no denying that being a filmmaker was a hobby, a full-time job and an obsessive religion for Noyce. He was on the organising committee of the First Australian Filmmakers’ Festival in August 1971. He performed in the agit-prop acting troupe run by George Shevtsov (later depicted in Renegades) that featured prominently at one of Sydney’s rock festival that year. In the latter part of 1971 and early 1972 he worked on Good Afternoon, a documentary about the Combined Universities’ Aquarius Arts Festival in Canberra, which arguably was the first major manifestation of counterculture in Australia. For this the Aquarius Foundation—the cultural arm of the Australian Union of Students—had contracted him. This became a two-screen movie à la Woodstock. Together with Thoms, Read and Ian Stocks, in 1972 he participated in cataloguing the complete set of films in distribution by the Co-op (see Sydney Filmmakers Cooperative). As can be seen, Noyce was at home in many manifestations of the Sydney counterculture. His own films had slowly become more politicised and bent towards documentary. He even started a newsreel that he used to screen at the Filmmakers’ Cooperative Cinema with a live commentary. One in 1971, Springboks Protest, was about the demonstrations at the Sydney Cricket Ground against the South African rugby tour. There were more but Noyce doesn’t remember them and no prints seem to have survived. Renegades was a diary film; a combination of poetic images and reportage on the street demonstrations. Noyce’s experimental films had been met with interest in the—limited—audience and among publications. His more political films and particularly Good Afternoon, however, reached out to a much wider audience, now including even the undogmatic left and hard-core documentarists of the times. In exchange, and for the first time, there were opposing reactions—but as always a great discussion at the Filmmakers’ Cinema, the main venue for independent productions. This cinema began with those initial screenings at Sydney University in the union room next to the Union Theatre. But once the Experimental Film Fund started operating in 1970, more and more films were submitted for the screenings and consequently a new venue was needed. Albie Thoms started a forum in the Yellow House in Kings Cross in May 1970. Next came—at least briefly—a restaurant in Glebe before the Co-op took over a space on the top floor of the socialist Third World Bookshop in Goulburn Street that was a firetrap. Bob Gould, the owner, was convinced that by first passing through his bookshop the audience would buy his books on the way upstairs. Sundays for him were otherwise dead from a commercial point of view. Noyce recollected that: The audience at this Filmmakers’ Cinema were mightily enthusiastic about seeing themselves up on the screen. And there was always a great discussion. So, generally the screenings were a huge success, with many full houses. The screenings grew from once a week, to three times on Sunday, to all weekend, and then seven days a week at several locations. One program could play in three different illegal cinemas around the city. (Petzke 26) A filmmakers’ cinema also started in Melbourne and the groups of filmmakers would visit each other and screen their respective films. But especially after the election of the Whitlam Labor government in December 1972 there was a shift in interest from risqué underground films to the concept of Australian Cinema. The audience started coming now for a dose of Australian culture. Funding of all kind was soon freely available and with such a fund the film co-op was able to set up a really good licensed cinema in St. Peters Lane in Darlinghurst, running seven days a week. But, Noyce said, “the move to St. Peters Lane was sort of the end of an era, because initially the cinema was self-funded, but once it became government sponsored everything changed” (Petzke 29). With money now readily available, egotism set in and the prevailing “we”-feeling rather quickly dissipated. But by the time of this move and the resulting developments, everything for Noyce had already changed again. He had been accepted into the first intake of the Interim Australian Film & TV School, another one of the nation-awareness-building projects of the Whitlam government. He was on his “long march through the institutions”—as this was frequently called throughout Europe—that would bring him to documentaries, TV and eventually even Hollywood (and return). Noyce didn’t linger once the alternative scene started fading away. Everything those few, wild years in the counterculture had taught him also put him right on track to become one of the major players in Hollywood. He never looked back—but he remembers fondly…References Castaway’s Choice. Radio broadcast by KCRW. 1990. Doggett, Peter. There’s a Riot Going On: Revolutionaries, Rock Stars and the Rise and Fall of ’60s Counter-Culture. Edinburgh: Canongate, 2007. Farber, Manny. “Underground Films.” Negative Space: Manny Farber on the Movies. Ed. Manny Farber. New York: Da Capo, 1998. 12–24. Jacobs, Lewis. “Morning for the Experimental Film”. Film Culture 19 (1959): 6–9. Milesago. “Ubu Films”. n.d. 26 Nov. 2014 ‹http://www.milesago.com/visual/ubu.htm›. New American Cinema Group. “First Statement of the New American Cinema Group.” Film Culture Reader. Ed. P. Adams Sitney. New York: Praeger, 1970. 73–75. Petzke, Ingo. Phillip Noyce: Backroads to Hollywood. Sydney: Pan McMillan, 2004. Renan, Sheldon. The Underground Film: An Introduction to Its Development in America. London: Studio Vista, 1968. Roszak, Theodore. The Making of Counter Culture. New York: Anchor, 1969. Stratton, David. The Last New Wave: The Australian Film Revival. Sydney: Angus and Robertson, 1980. Sydney Filmmakers Co-operative. Film Catalogue. Sydney: Sydney Filmmakers Co-operative, 1972. Ubu Films. Unreleased five-minute video for the promotion of Mudie, Peter. Ubu Films: Sydney Underground Movies 1965-1970. Sydney: UNSW Press, 1997.