Collaborative Innovation in Drug Discovery: Strategies for Public and Private Partnerships

Sets the stage for a new, improved paradigm in drug discovery Despite spending more than $135 billion annually on RD, the pharmaceutical industry faces an innovation crisis. Given the complexities and the expense of RD, this book argues that we can accomplish much morewith greater efficiency and less costwhen private and public sectors collaborate, each focusing on their core strengths. Collaborative Innovation in Drug Discovery focuses on the early stage of drug discovery, the most critical barrier to delivering a steady flow of viable drug candidates into the pipeline. The book assesses the current state of drug discovery in the pharmaceutical industry, government, non–profit, and academia, identifying the areas where each sector excels and areas where gaps exist. Next, the authors explore ways these sectors can establish mutually beneficial partnerships in order to discover, develop, and bring to market improved, safer drugs to treat human diseases. Topics include: Status of healthcare and unmet medical needs Biomedical research environment, drug discovery efforts, and market risks in industry and academia NIH Roadmap and EU–OpenScreen initiatives Trends in academia–pharmaceutical partnerships, including case studies Drug repositioning, open source partnerships, and challenges and practices for conducting clinical trials Editor Rathnam Chaguturu has assembled a panel of expert authors from around the world, representing all the sectors involved in drug discovery. Their contributions are not only based on a thorough review of the current literature, but also their own first–hand experience of what works and what doesnt. Collaborative Innovation in Drug Discovery offers pharmaceutical scientists and managers working in both private and public sectors a new, more productive road map to discover drugs that the world needs.

i. Dedication ii. Poem Barry Bunin iii Foreword Ferid Murad iv. Preface Rathnam Chaguturu v. List of Contributors Section 1: Perspectives on Collaborative Innovation If I have seen further it is by standing on the shoulders of giants — Isaac Newton 1. Productive Relationships in Research and Development between Government, Industry and Universities Rory Hume 2. Divided We Fall William Mattes 3. Innovation: Open Source and Nonprofit Models in Drug Discovery James Shaeffer and Sarah MacDonald 4. The Changing Face of Innovation in Drug Discovery Litao Zhang and Carl Decicco 5. Current Trends in Collaborative Drug Discovery and Strategies to De–risk Open Innovation–based Precompetitive Initiatives Anuradha Roy and Rathnam Chaguturu 6. A Perspective on the Evolution of Collaborative Drug Discovery and Future Challenges Chistopher Lipinski Section 2: Governmental Initiatives Accelerate Pre–competitive Collaboration Governments will always play a huge part in solving big problems.... They also fund basic research, which is a crucial component of the innovation that improves life for everyone — Bill Gates 7. University–Industry Partnerships Matter Anthony Boccanfuso 8. Trends in the Public Sector Adoption of Translational Research Approaches Mark Scheideler 9. Partnerships for Drug Repositioning: Lessons from the CTSA Pharmaceutical Assets Portal Kate Marusina, Dean Welsch, Lynn Rose, Doug Brock, Nathan Bahr, Aaron Cohen, Rafael Gacel–Sinclair, Pakou Vang, Peter Ruminski, Bruce Bloom, Pamela Nagasawa and Betty Guo 10. Drug Development Programs at the U.S. National Cancer Institute: Use of Public–Private Partnerships as a Catalyst to Advance Cancer Therapy Jason Cristofaro 11. Non–Industrial Pharmaceutical Research in the BRIC Countries: Lessons for Drug Discovery Partnerships with Academic and Governmental Institutions John Watson 12. Death of Drugs and Rebirth of Health Care: Indian Response to Discovery Impasse Bhushan Patwardhan Section 3: A Game Changer for Averting Future Pharma Cliff Coming together is a beginning, staying together is progress, and working together is success — Henry Ford 13. Accelerating Innovation in the Bioscience Revolution Bernard Munos 14. Value–Driven Drug Development: Unlocking the Value of Your Pipeline Valentina Sartori, Michael Steinmann, Petra Jantzer and Matthias Evers 15. Unlocking the Market Potential of Academic Research Assem el Baghdady and Yasser el Baghdady 16. Collaborative Innovation in Pharmaceutical Industry: Approaches and Requirements Monika Lessl and Asadullah Khusru 17. Close Contact: A Co–location Model for Academic–Industrial Partnerships in Drug Discovery Peter Covitz and Terrence Ruddy 18. Success Factors and Obstacles in Academia–Industry Partnerships: A Case Study of a Graduate Program within the Bayer –University of Cologne "Privileged Partnership" Stefan Herzig, Marion Rozowski and Ingo Flamme 19. Academic, Commercial, and Biodefense Case Studies for Collaborative Drug Discovery: Potential for Disrupting Drug Discovery Barry Bunin and Sean Ekins 20. Access Platform: A Streamlined Integrative Partnering Process at SANOFI to Commercialize University–based Intellectual Property Paul Eynott and Carole Fages 21. Entrepreneurship: Drug Discovery Innovation at Start–Up and Medium–Sized Biotechnology Companies Allen Reitz and Kathleen Czupich 22. Chemical Consulting Lester Mitscher Section 4: Nonprofits Drive Bench to Bedside Innovation Can′t afford to innovate? Open up! — Henry Chesbrough 23. Open Source Drug Discovery for Neglected Diseases Tonny Johnson and Sanchayita Kar 24. The Myelin Repair Foundation Accelerated Research CollaborationTM Model: Innovative Disruption in Biomedical Research Gali Hagel 25. Catalysis to Mass Action: The Evolution of CHDI Foundation, a Drug–Development Organization Devoted to Huntington′s Disease Allan Tobin 26. Lessons from the Past as a Means to the Future: Institut Pasteur as a Model Strategy Spencer Shorte 27. Seeding Open Innovation Drug Discovery and Translational Collaborations to Leverage Government Funding: Case Study Involving Sanford–Burnham and Mayo Clinic Thomas Chung, Sundeep Khosla, Andrew Badley and Michael Jackson Section 5: Academic Screening Centers Come of Age Open access high throughput drug discovery in the public domain is a Mount Everest in the making — Rathnam Chaguturu 28. Finding the Middle Ground: Drug Discovery Technology in the Era of Academic Screening Centers Nathan Blow 29. Open Innovation based Drug Discovery in Europe: Some Examples of National and Transnational European Initiatives Integrating Chemistry, Biology and Technology Platforms Philip Gribbon 30. In Sickness and in Health – A Shotgun Marriage that′s Flourishing Horst Flotow and Alex Matter 31. A Flexible Model for Compound Management Facilities to Stimulate Collaborations in the Life Sciences David Camp Section 6: Intellectual Property and Technology Transfer Everything that can be invented has ben invented — Charles Duell 32. Successful Technology Transfer: Lessons from the Translational Medicine Research Collaboration Assem el Baghdady 33. Challenges and Opportunities in Commercializing Academic Drug Discoveries Christopher Paschall 34. The Pivotal Role of the Academic Entrepreneur and the Entrepreneurial University in Global Life Sciences Donna Marie de Carolis Section 7: Final Frontier No one can whistle a symphony; it takes a whole orchestra to play it — Halford E. Luccock 35. The Core Model: Drug Discovery and Development via Effective Translational Science and Public–Private Collaboration Ibis Sanchez–Serrano 36. Using Market–Driven Collaboration to Accelerate Innovation in Biomedicine Elizabeth Iorns 37. The Cost of Taking Eyes off the True End User–Focus on Patient Needs and Outcomes Deborah Collyar 38. To Leash or Unleash the Power of Public–Private Collaboration: A Personal Perspective Hakim Djaballah

RATHNAM CHAGUTURU, P H D, is the Founder CEO of iDDPartners, a nonprofit think–tank focused on pharmaceutical innovation. He has more than thirty years of experience in executing new lead discovery projects and forging discovery partnerships. He is the Founding President of the International Chemical Biology Society and Editor–in–Chief of Combinatorial Chemistry and High Throughput Screening . He serves on several other editorial and scientific advisory boards along with NIH Study Sections, is the recipient of several awards, and is a much sought–after speaker at major national and international conferences, passionately advocating the virtues of collaborative partnerships in addressing the pharmaceutical innovation crisis.