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Achieving Proof of Concept in Drug Discovery and Development

The Role of Competition Law in Collaborations between Public Research Organizations and Industry Helen Yu, University of Copenhagen, Denmark
One of the major shortcomings of the current drug discovery and development process is the inability to bridge the gap between early stage discoveries and pre-clinical research in order to advance innovations beyond the discovery phase. This book examines a drug discovery and development model, where the respective expertise of academia and industry are brought together to take promising discoveries through to proof of concept, providing a means to de-risk the drug discovery and development process.
Extent: 288 pp
Hardback Price: $135.00 Web: $121.50
Publication Date: 2016
ISBN: 978 1 78536 938 4
Availability: In Stock
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  • Law - Academic
  • Biotechnology and Pharmaceutical Law
  • Competition and Antitrust Law
  • Intellectual Property Law
One of the major shortcomings of the current drug discovery and development process is the inability to bridge the gap between early stage discoveries and pre-clinical research in order to advance innovations beyond the discovery phase. This book examines a drug discovery and development model, where the respective expertise of academia and industry are brought together to take promising discoveries through to proof of concept, providing a means to de-risk the drug discovery and development process.

Expert author Helen Yu explores integrated drug discovery by analyzing the intersection of intellectual property law and competition law and discusses the role of stakeholders in the efficient translation and commercialization of publically funded research. Considering the transactional risks associated with drug discovery and development, this book advocates for a greater emphasis on contractual freedom and economic efficiency when assessing collaborative partnerships between industry and public research organizations. This standout book bridges the gap between theoretical research and legal practice by providing a research-based applied perspective on university–industry collaborations in drug discovery and development.

Achieving Proof of Concept in Drug Discovery and Development has an international appeal, especially in countries actively involved in drug discovery and development. Organizations and associations will also benefit from a research-based applied perspective that advocates for a more nuanced application of the law to the pharmaceutical industry.
‘Drug discovery and development has become a complex and expensive multi-institutional commitment. Making integrated innovation models work requires competition regimes accommodating the highly specific challenges of pharmaceutical research. This original and meticulously researched book forces us to radically rethink the role of competition law in promoting innovation making it essential reading for R&D managers, regulators, practitioners, health economists and legal scholars.’
– Graham Dutfield, University of Leeds, UK

‘This book provides a thoughtful and comprehensive analysis of the role of competition law in collaborative agreements leading to drug discovery and development. It makes an important contribution to the debate and is highly recommended.’
– Duncan Matthews, Queen Mary University of London, UK

Contents: Acknowledgements Table of cases Table of legislation PART I. LANDSCAPE OF DRUG DISCOVERY AND DEVELOPMENT 1. Introduction 2. The Pharmaceutical Industry and Drug Development Models 3. Intellectual Property Rights and Competition Law in Collaborative Drug Development Between Industry and Integrated Drug Discovery Organizations PART II. ANALYSIS AND APPLICATION OF EU COMPETITON LAW TO THE INTEGRATED DRUG DISCOVERY MODEL 4. Application of Competition Law to the Integrated Drug Discovery Model: Research and Development Block Exemption Regulation 5. Application of Competition Law to the Integrated Drug Discovery Model: Technology Transfer Block Exemption Regulation PART III. CASE STUDY: AGREEMENTS BETWEEN INDUSTRY AND INTEGRATED DRUG DISCOVERY ORGANIZATIONS 6. Analysis of Collaboration Agreements between Integrated Drug Discovery Organizations and Industry PART IV. CONCLUSION 7. Conclusion and Implications Bibliography Index