A Global Network for Clinical Research— Really?

1. Greg Koski, PhD, MD, CPI (Honorary) Associate Professor of Anesthesia Harvard Medical School Senior Scientist James Mongan Institute for Health Policy Co-Founder, Alliance for Clinical Research Excellence and Safety A Global Network for Clinical Research— Really?

2. Drug development has been entirely proprietary and conducted largely in corporate silos Clinical trials are not “global”—they are international Harmonization is a euphemism for failure to standardize! One cannot keep doing things the same way and expect different results 2

3. “The current approach to drug development is inefficient, ineffective and unsustainable.” DIA Europe 2010

4. Global R&D Expenditure, Development Times, Global Pharmaceutical Sales & New Molecular Entity Output 1999-2009 *The development time data point for 2009 includes data from 2008 and 2009 only Source: CMR International & IMS Health

5. Development Time For New Molecular Entities First Launched Onto The World Market 2000-2009 • The development time data point for 2009 includes data from 2008 and 2007 only • Major companies are defined as those spending ≥US$ 2 billion in 2009 on ethical pharmaceutical R&D.

6. For many, the current approach to drug development has lost its way • At one time, the foundation of pharmaceutical industry was its desire to develop new medicines and devices to treat and prevent disease • That foundation has been undermined by financial motives • The industry has lost public trust and respect as a result • The industry is repeatedly charged with unethical conduct and exploitation

7. The failing silo business model must be reconsidered in light of dwindling pipelines, spiraling costs, growing regulatory burdens and declining productivity. The erosion of public trust in the pharmaceutical industry must be addressed and the practices that have taken us down the current path must be changed. 7

8. The Global Air Transportation System

9. A Global Air Transport “System”

10. IATA - International Air Transport Association www.iata.org

11. International Air Transport Association

12. The Global Air Transportation System

13. A Global Clinical Research System

14. A global network of accredited, sustainable clinical research sites • Trained and certified professional research teams • Standardized operating policies and procedures • Committed to highest standards of performance • Trusted in their communities and by their global partners A global system for drug development? 14

15. A shared infrastructure for clinical research that aligns good business practices with ethical principles to enhance safety and efficiency while reducing the cost and time required to bring new medical products to market. • Supported by a robust information technology platform to ensure safety and continually monitor and improve performance • The network would provide a framework for quality assurance and regulatory reform that would benefit the entire industry A global system for drug development? 15

16. Drives and rewards standardization • Drives regulatory simplification and compliance • Enhances performance • Increases efficiency • Reduces redundancy • Promotes and enhances safety • Reduces costs • Increases transparency and improves public trust • Promotes investment in sustainable, self-supporting professional clinical research capacity in emerging nations and markets Benefits of a Systems Approach 16

17. http://www.acresglobal.net

18. The Alliance for Clinical Research Excellence & Safety (ACRES), modeled after the International Air Transport Association(IATA), would: • positively align ethics, scientific integrity and good business practices • provide appropriate opportunities and incentives to further the mission of drug and device development • in a safer, scientifically sound, socially responsible manner that rewards all participants and stakeholders If we build it, they will come…

19. An independent, non-profit, non-governmental organization Established/incorporated in an appropriate ‘international’ venue Funded through an independent global trust fund supported by grants, donations, and user fees Promote the use of existing tools, policies and processes rather than re-inventing them— Facilitate abs streamline clinical research while improving safety and quality If we build it, they will come…

20. ACRES Network Architecture—The Core

21. ACRES Network Architecture—The Sites Principal Investigators

22. Web-enabled, “cloud-based” integrated information system with central data warehouse and knowledge engines • System support/facilitation of all operations • Point-of-entry EDC, including AE reporting • SOP driven continuous compliance/quality control • Shared data-base for trial initiation and support • Centralized quality assurance and safety monitoring ACRES Network Infrastructure—The Neural Net

23. http://www.acresglobal.net