Добірка наукової літератури з теми "Biotech-based new ventures"

Purpose The purpose of this paper is to identify the business model components and related attributes of biotech spin-offs activity that are key to the implementation of the internationalization strategy. Design/methodology/approach The paper is based on a multiple case study analysis including business models of seven biotechnology spin-offs traded on the Warsaw Stock Exchange. Based on the literature review the authors identify the key attributes of the business model for the commercialization of R&D outcomes. The authors conduct an analysis taking into consideration the determinants of biotech spin-off activity. The authors also measure the internationalization strategy implementation with the use of indicators identified in the empirical research literature review. Findings According to the results, the authors identified that international cooperation in research projects and partnering, as well as international experience in the management board and tacit knowledge, play a facilitating role in the business model for the commercialization of biotech spin-off research findings. The cost advantage on the global market, tax advantages and support of venture capital are the key to the exploitation of profit potential on the global market. An important component of the business model specific to companies conducting R&D activities is to ensure firm survival activities by funding research grants to makes R&D possible prior to commercialization. Research limitations/implications The main limitation of this study is the small magnitude of the sample, particularly as only two of the seven analyzed spin-offs realized their profit potential on the global market. Practical implications The findings are important for the development of business models of new biotech ventures. Research results can be used as recommendations for universities on how to effectively build a business model for the commercialization of biotech spin-offs on the basis of R&D outcomes for the internationalization strategy. Originality/value The paper’s uniqueness results from the synergy of combining three research areas: components of business models for commercialization; attributes of biotech R&D activity; and indicators measuring the internationalization strategy implementation. The results can contribute to the existing body of knowledge on business models for the commercialization of R&D outcomes in the context of internationalization. The value of this paper is an extended knowledge of the internationalization of biotech ventures based on R&D outcomes.

The first-of-its-kind University of Plovdiv transdisciplinary project “Vita Plus” is deemed to adopt some positive international practices to initiate and announce that there are researchers at the University of Plovdiv, interested in realizing tech transfers in the field of biotech innovations. Thus, the goal of the present paper is to explain what factors might be crucial to both characterize technological transfer of biotech innovations as successful from University researchers’ viewpoint, and present them to business ventures for commercial purposes. Research methods of the study include data of the most recent thematic study of the World Bank on Bulgaria and analytical reviews of contemporary scientific literature to establish a modern Bulgarian platform for transfer of biotechnological know-hows to bio-based industries in the forthcoming era of bioeconomy. The results of the research are aimed at formation of comparative-analytical parameters and benchmark indicators for economic valuation of implementation of biotechnological solutions in the emerging Bulgarian circular economy, based on observations at the “Vita Plus” project. Conclusions relate to derivation of a set of recommendations for formation of a new integrated approach for creating a working model for technological transfer of University researches and solutions in real bio-based industrial production through the University platform “Vita Plus”.

Liposomes are considered one of the most successful drug delivery systems (DDS) given their established utility and success in the clinic. In the past 40–50 years, Canadian scientists have made ground-breaking discoveries, many of which were successfully translated to the clinic, leading to the formation of biotech companies, the creation of research tools, such as the Lipex Extruder and the NanoAssemblr™, as well as contributing significantly to the development of pharmaceutical products, such as Abelcet®, MyoCet®, Marqibo®, Vyxeos®, and Onpattro™, which are making positive impacts on patients’ health. This review highlights the Canadian contribution to the development of these and other important liposomal technologies that have touched patients. In this review, we try to address the question of what drives innovation: Is it the individual, the teams, the funding, and/or an entrepreneurial spirit that leads to success? From this perspective, it is possible to define how innovation will translate to meaningful commercial ventures and products with impact in the future. We begin with a brief history followed by descriptions of drug delivery technologies influenced by Canadian researchers. We will discuss recent advances in liposomal technologies, including the Metaplex technology from the author’s lab. The latter exemplifies how a nanotechnology platform can be designed based on multidisciplinary groups with expertise in coordination chemistry, nanomedicines, disease, and business to create new therapeutics that can effect better outcomes in patient populations. We conclude that the team is central to the effort; arguing if the team is entrepreneurial and well positioned, the funds needed will be found, but likely not solely in Canada.

The paper revisits the success case of Boston Route 128 in commercializing technology. The study applies the concept of industrial clusters to explain the development of technologically sophisticated region of Boston Route 128. Boston Route 128 has transformed its structure from the minicomputer and microprocessor-based technology industry in the 1980s to biotechnology industry in the late 1990s and 2000s. It is argued that the successful commercialization process of Boston Route 128 is rooted in innovation, entrepreneurial management and the policy towards technology commercialization. To consider the argument, the paper proposes the cluster model to explain the strengths of Boston Route 128 in biotech clusters. It represents a model of the universities working with industries to form a cluster of high technology based firms. The venture capital accelerates the process of technology commercialization, giving rise to a new Boston model of innovation management. Policy makers may use the Boston model as a benchmark to evaluate their performance in supporting Hi-Tech industries.

The valuation of initial public offerings (IPOs) is of considerable interest, given the important role these enterprises play in economic growth and investors' decisions. IPO valuation is particularly challenging due to the meager information available about new enterprises at offering dates. We extend the research on IPO valuation in various directions. First, we penetrate deep beyond the traditional proxies for value drivers, such as R&D expenditures and cash flows, by defining and testing a host of specific product-related and competitive environment value drivers; second, we examine IPO valuations at three distinct phases of the going-public process; third, we employ both the direct valuation and relative valuation approaches; and fourth, we round up the analysis by examining the long-term performance of IPOs. Based on a sample of biotech IPOs from the 1990s, we document the overwhelming importance of product-related and intellectual property fundamentals, as well as the irrelevance of several key signals, such as venture capital backing and the quality of underwriters, which played prominent roles in previous research.

THIS BOOK IS AN INSIGHTFUL and theoretically ambitious anthropological study of the genomics and biotech industries in the United States and India. These and related science-based sectors form part of the bio-economy, a larger complex of manufacturing, service, and research and development (R&D) activities, grounded increasingly in advancements in the biological sciences. In his groundbreaking study, Kaushik Sunder Rajan seeks to explain the intersection between biological knowledge ? the new knowledge of life itself ? and the economic accumulation process in which large pharmaceutical firms are dominant actors. The most striking manifestation of the bio-economy is the emergence of thousands of small biotechnology and other science-intensive start-up firms. These populate areas close to major universities in the developed parts of the world ? in California, Massachusetts, the Cambridge region in the United Kingdom, and elsewhere ? but have emerged also in some centres in developing countries. This is described in Sunder Rajan?s empirical analysis which investigates the global evolution of the bio-economy, with a particular focus on India and California. He explains the interdependencies between giant pharmaceutical companies and small dedicated biotechnology firms, which operate in conjunction with a myriad of intermediaries, such as venture capitalist firms that provide funding for promising science and facilitate interaction between different bio-economic actors.

INTRODUCTION Anti-CD19 CAR T-cell immunotherapy is promising for patients with relapsed/refractory CLL. Hypogammaglobinemia can result from normal CD19+ B-cell depletion by CAR-T cells. CLL patients are already at risk for infections due to impaired immune function, lymphodepletion prior to CAR-T cells infusion, and immunosuppressive therapies. Intravenous immunoglobulin (IVIG) is used to manage hypogammaglobulinemia, although standard criteria for IVIG administration in this setting has not been established. We studied the incidence of hypogammaglobinemia and report infectious complications, risk factors, IVIG use, and clinical outcomes for CLL patients treated with anti-CD19 CAR-T cells. METHODS Adult CLL patients who received CD19-directed CAR-T therapy in 3 clinical trials (NCT01029366, NCT01747486, NCT02640209) from July 2010 to February 2020 were included. We reviewed demographics, available IgG levels, IVIG use, and clinical outcomes with a particular focus on infectious complications. Hypogammaglobulinemia was defined as IgG <4.5 g/L. Infections during the first 28 days after CAR-T were excluded to account for chemotherapy-induced neutropenia. CLL response was based on the 2008 International Workshop Group on CLL as per study protocols. The use of IVIG for hypogammaglobulinemia was at the discretion of investigator or treating physician. Fisher's test, Wilcoxon test and logrank were used for data analysis. RESULTS Records of 71 adult patients with CLL were reviewed; 4 were excluded from further analysis as they did not have IgG levels after CAR-T. The median age at time of CAR-T was 63 years (range 43-78 years). 31 patients (46%) were alive, 31 (46%) were deceased, and 5 (7%) were lost to follow up at time of review. Median follow up for all patients was 33 months (range 2-114 months). Of the 55 patients with an IgG level prior to CAR-T infusion, 24 (44%) had hypogammaglobulinemia at baseline After CAR-T infusion, 54 of 67 patients (81%) developed new or persistent hypogammaglobulinemia, and 40 of these patients (74%) received IVIG (Table 1). Forty-eight patients (72%) received at least one infusion of IVIG after CAR-T. Median time to initiation of IVIG after CAR-T infusion was 2.8 months (range 0.1-71.2 months). IVIG was used in 29 of 35 (83%) responders (defined as PR or CR) vs 19 of 32 (59%) in non-responders (defined as NR or PD) (p=0.056). There was no difference in survival observed based on whether or not patients had hypogammaglobulinemia (Figure). 42 patients (63%) had documented infections not related to chemotherapy-induced neutropenia. Fifteen (22%) had one documented infection, and 27 (40%) had more than one documented infection. There were 13 infections documented in patients who did not have hypogammaglobulinemia; the most common were ENT/sinus infections (5), bacteremia (2), URI (2), and other (2). There were 94 infections documented in patients who developed or had persistent hypogammaglobulinemia; the most common were lower respiratory tract infection/pneumonia (21), URI (20), and ENT/sinus infections (13). Complete and partial responders had more infections compared to non-responders or those who progressed (p = 0.01). Patients with hypogammaglobulinemia after CAR-T had an average of 1.74 (range 0-15) infections vs 1 (range 0-3) in patients without hypogammaglobulinemia. Patients who received IVIG had more infections (p=0.003); without IVIG the average number of infections was 0.58 (range 0-3), and with IVIG, the average number of infections was 2.00 (range 0-15). CONCLUSION Evaluating clinical outcomes with infections after CAR-T and potential strategies to minimize infection risk may improve morbidity and mortality in CLL patients. Use of IVIG was driven by individual practice, with heterogeneity regarding indication, frequency, and duration of treatment, though there was no difference in patient characteristics or response in patients who did or did not develop hypogammaglobulinemia. Patients who responded to CAR-T had more frequent infections, as might be expected in the setting of transient or persistent B- cell aplasia or hypoplasia. Patients who had more infections were more likely to receive IVIG. Further studies to define criteria for IVIG repletion in CLL patients treated with CD19-directed CAR-T cells may be incorporated in a standard clinical management algorithm. Table 1 Disclosures Frey: Amgen: Consultancy, Honoraria; Syntax: Consultancy, Honoraria; Kite Pharma: Consultancy, Honoraria. Davis:Tmunity Therapeutics, Inc.: Consultancy, Patents & Royalties, Research Funding; Cellares Corporation: Membership on an entity's Board of Directors or advisory committees; Novartis Institutes for Biomedical Research: Patents & Royalties. Hexner:Blueprint Medicines Corporation: Other: serves on a data safety monitoring committee, Research Funding; Novartis: Research Funding; Samus Therapeutics: Research Funding; American Board of Internal Medicine: Other: member of the hematology exam committee. Schuster:Novartis, Genentech, Inc./ F. Hoffmann-La Roche: Research Funding; AlloGene, AstraZeneca, BeiGene, Genentech, Inc./ F. Hoffmann-La Roche, Juno/Celgene, Loxo Oncology, Nordic Nanovector, Novartis, Tessa Therapeutics: Consultancy, Honoraria. Gill:Fate: Consultancy; Sensei: Consultancy; Aileron: Consultancy; Tmunity Therapeutics: Research Funding; Carisma Therapeutics: Patents & Royalties, Research Funding; Novartis: Research Funding. Grupp:Servier: Research Funding; Kite/Gilead: Research Funding; Roche: Consultancy; GlaxoSmithKline: Consultancy; Humanigen: Consultancy; CBMG: Consultancy; Jazz: Other: SSC; Adaptimmune: Other: SAB; TCR2: Other: SAB; Cellectis: Other; Juno/BMS: Other; Janssen/JnJ: Consultancy; CRISPR Therapeutics/Vertex Pharmaceuticals: Other; Allogene: Other; Novartis: Consultancy, Other: SSC, Research Funding. Melenhorst:Johnson & Johnson: Consultancy, Other: Speaker; Novartis: Other: Speaker, Research Funding; Kite Pharma: Research Funding; IASO Biotherapeutics: Membership on an entity's Board of Directors or advisory committees, Research Funding; Poseida Therapeutics: Consultancy; Simcere of America: Consultancy. Lacey:Novartis: Patents & Royalties: CAR T cells, Research Funding; Tmunity: Research Funding; Cabaletta: Research Funding; Carisma: Research Funding. Fraietta:Tmunity: Research Funding. Hwang:Novartis: Research Funding; Tmunity Therapeutics: Research Funding. Siegel:Novartis: Patents & Royalties; Tmunity: Patents & Royalties; Poseida: Membership on an entity's Board of Directors or advisory committees; Vetigenics: Current equity holder in private company, Membership on an entity's Board of Directors or advisory committees. Levine:Terumo: Consultancy; Novartis: Consultancy, Patents & Royalties: Dr. Levine has a patent Methods for treatment of cancer (US 8906682) (US 8916381)(US 9101584) with royalties paid to University of Pennsylvania, a patent Compositions for treatment of cancer (US 8911993) (US 9102761) (US 9102760) with royalties paid to U; Lilly Asia Ventures: Consultancy; Avectas: Membership on an entity's Board of Directors or advisory committees; Patheon: Membership on an entity's Board of Directors or advisory committees; Immuneel: Membership on an entity's Board of Directors or advisory committees; Incysus: Membership on an entity's Board of Directors or advisory committees; Ori Biotech: Membership on an entity's Board of Directors or advisory committees; Vycellix: Membership on an entity's Board of Directors or advisory committees; Tmunity Therapeutics: Current equity holder in private company, Research Funding. June:Bluesphere Bio: Membership on an entity's Board of Directors or advisory committees; Cabaletta Bio: Current equity holder in private company, Membership on an entity's Board of Directors or advisory committees; Carisma Therapeutics: Membership on an entity's Board of Directors or advisory committees; Cellares: Membership on an entity's Board of Directors or advisory committees; Celldex: Consultancy, Membership on an entity's Board of Directors or advisory committees; DeCART Therapeutics: Membership on an entity's Board of Directors or advisory committees; Immune Design: Membership on an entity's Board of Directors or advisory committees; Kiadis Pharma: Current equity holder in private company; Novartis: Patents & Royalties, Research Funding; Tmunity Therapeutics: Current equity holder in private company, Membership on an entity's Board of Directors or advisory committees, Patents & Royalties, Research Funding; Ziopharm Oncology: Current equity holder in private company, Membership on an entity's Board of Directors or advisory committees. Porter:Tmunity: Patents & Royalties; Novartis: Honoraria, Other: Advisory board, Patents & Royalties: CAR T cells for CD19+ malignancies, Research Funding; American Board of Internal Medicine: Other: Member, exam writing committee (end date Oct 2019); National Marrow Donor Program: Membership on an entity's Board of Directors or advisory committees; Janssen: Other: Advisory board; Genentech/Roche: Current equity holder in publicly-traded company, Other: Spouse employment (ended Sept 2020); her salary includes stock/options; Glenmark: Other: Advisory board; Adicet bio: Other: Advisory board; Incyte: Other: Advisory board; Kite/Gilead: Other: Advisory board. OffLabel Disclosure: CAR T cells for CLL

US-based Alara Expands MetriScan™ Distribution into China. Varsal Sets Up Special Chemical Facility in China. Three Taiwan-based Biotech Firms to Jointly Set Up Vaccine Production Plant. Malaysia's Sirim Comes Up with Latest Ceramic Membrane Filter Technology. Fuzhou Branch of Rocky Mountain Launches New Product. SurroMed Expands Global Efforts with New Singapore Facility. Malaysia's Top Glove Expands into International Market. TNT Offers Bio-logistics Services in Singapore. Malaysia's ITAV Enters into Agreement with Eastgate and Biotech Asia. Thailand to Undertake Bio-diesel Fuel Project. Chugai Sells Business Rights of Medical Device Products to Kobayashi. Sumitomo in Joint Research with RIKEN on Pharmaceutical Development Based on Genome Information. Settlement of Investigation into Takeda Subsidiary's Marketing Practices of Prostate Cancer Drug. Novartis and Korea Yet to Agree on Leukemia Drug Price. VaxGen Receives Funding for Development of AIDS Vaccine in India, China and Africa. Fujisawa Launches Protopic Ointment in Canada. BresaGen and Image Guided Neurologics to Produce and Distribute Proprietary Cell Delivery Device. Progen Industries and BresaGen Sign Manufacturing Agreement. India's Kopran Gets Better Deal for Heart Drug Aten. Reliance Life Sciences to Scale Up Biotech. NZ's Delphic and Japan's Sysmex Announce Joint Venture. Australian Biotech Companies Get Another A$3.6 Million of Funding.

SciClone Pharmaceuticals' Hepatitis B Treatment to Gain Approval in Japan. Prana Biotechnology Partners with Neuroscience Victoria. EGF Approved for Treatment of Diabetic Foot Ulcer. US-based Disease Sciences to Explore Possibility of Mad Cow Disease in China and Australia. US-based GeneMachines Supplies Microarrayers to Genome Institute of Singapore. Beijing Genomics Institute Selected as Sun Microsystems Center of Excellence. US-based Pharmacia Donates Eye Medicine to China. SciClone's ZADAXIN Approved as Cancer Treatment in the Philippines. US-based Trinity Files New Drug Application for HIV Treatment in Thailand. Genemedix to Launch US$28.6 Million Biotech Venture Capital Fund. Germany's Degussa Focussing on Asia. Kirin Brewery to Expand Collaboration with US-based Dendreon. India's Candila Pharma to Increase Sales in Australia and NZ. Australian Biotech Firm among Founders of New Stem Cell Research Facility. Australian Firm, Cerylid Biosciences, Receives A$9.9 Million Investment. Shriram Biotech to Produce Xanthan Gum. Singapore Firm Buys British Drug Company. Marketing of Bayer's Anti-Cholesterol Drug in Taiwan Halted. Taiwan Biowell Produces Biochip to Help Fight Crime. US-based Arena Pharmaceuticals Announces Multi-Receptor Cart Collaboration with Taiwan Taigen Biotechnology. US Tanox to Set up Protein Drug Plant in Taiwan.

By granting universities the rights to assert ownership of intellectual property (IP) resulting from United States (US) federally sponsored research, the Bayh-Dole Act of 1980 has stimulated considerable interest from policymakers around the world. Inspired by the US example, the Australian government has introduced a similar patent policy to encourage the commercialisation of publicly funded research. Research institutions have quickly responded to this policy and established technology transfer offices (TTOs) to manage the identification, protection and exploitation of IP created by their employees. It is often assumed that this IP-based approach accelerates the transfer of new inventions from academia to industry and helps to generate national benefits and social return from public investment in research. This thesis provides a case study of the commercialisation of publicly funded research in the biotechnology sector in Australia. Following mainly a qualitative approach, the study explores the rise of the research commercialisation phenomenon by tracking its historical origins, key turning points and their present ramifications. It also examines the perceptions, motivation and experiences of various participants such as academic scientists, technology transfer managers, entrepreneurs/CEOs and private investors. At the individual level, an important finding of this study was that the term research commercialisation is understood differently by different participants. Two main views were identified which not only differ semantically, but also in their objectives, timescales, assumptions and measures of success. The clarification of these views enables the participants to better understand each other and minimise unproductive debates. At the institutional level, this study revealed that by focusing on the exploitation of IP resulting from publicly funded research, Australia's current TTO-based structural arrangements may interfere with the flow of scientific discoveries from academia to industry and encourage academic inventors and entrepreneurs to bypass the TTOs. Explanations for these unexpected outcomes are given and suggestions for possible improvement are discussed. Although this study is based on the biotechnology sector in Australia, the research findings may have important implications for any other sectors and for other countries with similar structural arrangements.

This chapter analyzes the early years of the first generation of biotechnology companies. The setting is the 1970s, a time when landmark scientific discoveries in molecular biology triggered all manner of perturbations in university science, pharmaceutical research, and venture finance. The result was the creation of a new form—a science-based commercial entity, which emerged from overlapping networks of science, finance, and commerce. This novel collection of organizational practices that coalesced into a dedicated biotech firm (DBF) proved highly disruptive. Using historical analysis of archival materials, supplemented by interviews with DBF founders, this chapter pieces together the “lash-up” process that melded elements from three separate realms—academic science, venture finance, and commercial health care—into an interactively stable pattern.

“But,” some readers might say, “look at Israel, look at San Diego—it is still feasible to become a Silicon-Hyphen.” To which this chapter answers: “And would it be a good idea if it is?” The chapter opens the mind of the reader to new ways of thinking about innovation and growth. Providing a frontal attack on the start-up religion and its most important commandment: using venture capital (VC) as a basis for growth. VCs have attained the paradigmatic status of a “must-have,” institution, when in fact they are just one, not very successful, solution to solving the question of how to finance innovation. The chapter does it by explaining how VCs really work and make money (and for whom), where and when they are successful (rarely and only in ICT and biotech), what does that means to the companies they finance, who is allowed to be part of this party, and what are the impacts on communities in places where the VCs are successful (inequality levels last seen in the Gilded Age). It utilizes research on Israel and Silicon Valley to drive those points home. At the end of the chapter the reader should realize that, YES, they want innovation-based growth, but NO, even if they could make it happen, the last thing they want for their community is to become a Silicon-Valley/Israel look-alike.