Commercializing the Stem Cell Sciences

Summary

This book offers a comparative analysis of the commercial models adopted in the global stem cell industries, focusing on case-studies of publicly available information about different companies around the world working on adapting stem cell technologies to market. The case-studies are used to highlight the different possible pipelines for developing stem cell technologies and the issues faced by companies in the competitive global market.

Promising new developments in biomedical technology like stem cell science are widely endorsed by governments keen to reduce spiralling healthcare costs, clinicians focused on patient care and patients demanding revolutionary new treatments. The intersections between governments, healthcare settings and community demand are the environment in which companies are operating to secure a profit in a global marketplace. The key questions posed by this book include: a) is there an optimum commercial model? and b) what can emerging companies learn from their predecessors?

Extant research on the global stem cell bioeconomy has highlighted the ways that culture, ethics and national politics have influenced and shaped the commercial possibilities for companies entering into the stem cell market and what possibilities exist for negotiating these barriers. Key issues for commercialization in particular include raising money to conduct research, dealing with regulatory frameworks, developing an intellectual property portfolio, testing technologies in animals and patients, and securing market share. This book explores these issues in examining the future commercial development of the stem cell sciences.

Key Features

• Each chapter includes in-depth discussion of case-studies of products undergoing development and the pathways to market that are being adopted.
• Explicitly focused on the question of commercial optimization, this project is the first of its kind move beyond concerns about ethics and regulation to examine how products are actually being developed for market.
• The analysis is considered within a global context, with case-studies being drawn from a diverse range of countries that are commercialising stem cell products.
• This book features a strong comparative element in order to facilitate a focus on best practice within varied national contexts.
• Unlike other projects in the field that are focused on human applications only, this book includes discussion of non-human applications of stem cell therapies because this is one of the fastest growing commercial markets to date, and translation of successful products from animal uses to human uses is currently an revolutionary growth area.

Content

• Stem cell science, biotechnology and the problem of commercialization - modelling the most successful biotech business in the world: entrepreneurialism as the cornerstone of US biotech; Negotiating the valley of death. Where does stem cell science fit in with biotechnology commercialization? Reagents, Disease models, Technology systems, Off the shelf products and Non-human applications. The limits of commercialization in the stem cell sciences: The market; The relationship between risk and return. What are the most lucrative commercial models to adopt?
• Stem cell treatments in a global marketplace - patients drive the market: Patient activists, Stem cell tourism, and Anti-ageing medicine. Health-care providers and the consumption of stem cell technologies: The politics of healthcare, Inequalities in healthcare and The future of lifestyle medicines. Scepticism and fraud? Or worthwhile endeavour? Drs Shroff and Varma and The Dominican Republic. The lucrative potential of animal applications of stem cell products and techniques. Genetic Savings and Clone; The horse-racing industry; Greater efficiency in livestock production. Shoring up market-share?
• How do innovation systems help biotechnology commercialize? - the international context of stem cell science. Innovating for enhanced competitiveness. The principle of competitive advantage and why it matters. The key components of national innovation systems: Funding, Regulation, People, Education, Taxation, Business rules, Patenting, Consumer protection. The intersections between commercialization and innovation.The constraints of working in-country; Global flows of labour and capital; Globalisation and innovation systems?
• Low-risk, low value strategies: Adult stem cells - a brief history of adult stem cell technologies: Bone marrow transplants, Cord blood banking. Adult stem cell science in the 21st Centuryeg 1 Mesoblast/Angioblast eg 2 Regeneuseg 3 breast enhancement surgery (Tokyo Team) eg 4 Vision repair (Sydney Eye Hospital) So where are the commercial opportunities?
• High-risk, high-value: Embryonic Stem cells - the global debate, US politics and hESC research. Patenting issues in the EU and the US global regulatory disparity. Current clinical trials: Geron. Other FDA approvals? The future of hESC research?
• Low-risk, low-value: iPS cells - autonomous solutions. Imagined scenarios� ownership of centralized production facilities - outpatient clinics - training delivery - supplementary products and processes. The iPS cell industry?
• What will happen next? - what we will see in the next 2-5 years is the incremental development of scientific knowledge, and some very simple yet highly effective clinical applications emerging from adult stem cell products.

Readership

Key stakeholders in the stem cell industries: investors, entrepreneurs, product-transfer specialists, biotech industry associations, scientists, clinicians, particular in Australia, the US, Europe and South East Asia. Academics interested in developing bioeconomies, policy-makers, lawyers, politicians, prospective patients.

Author

Dr Olivia Harvey is a Postdoctoral Research Fellow at the University of New South Wales, Sydney. Previously she held a Postdoctoral Fellowship at the Centre for Biomedicine and Society at King's College London. Since 2007, Dr Harvey's research has focused on the comparative politics of the stem cell industries in a global context, paying specific attention to the conditions of innovation that enhance the commercial opportunities to be obtained and the commercial strategies that might be adapted to profit from these conditions. Olivia was recently awarded a prize for the Best Article in the 2009 volume of Politics and Policy for a paper on stem cell research in the US.