1. The CERTs Model for Stakeholder Engagement Public-Private Partnership Hugh H. Tilson, MD, DrPH Chair, CERTs National Steering Committee September 10, 2008

2. DISCLAIMER(S) Nothing in this presentation reflects the official position of the …. “I appoint Tilson as chair because, as near as I can determine, his conflicts of interest are so many and diverse that they cancel each other out.” (John Eisenberg, 1999)

3. THE CERTs APPROACH TO STAKEHOLDERS MISSION/VISION DRIVE CHOICE AND STRATEGY FOR STAKEHOLDER WORK PUBLIC-PRIVATE MANDATE DRIVES PROJECT STAKEHOLDER PARTNERSHIPS PUBLIC HEALTH MISSION DRIVES NATIONAL STAKEHOLDER PARTNERSHIPS, THE PATHS

4. But first... a word from our sponsors!

5. The Centers for Education & Research on Therapeutics The CERTs!

6. Background on the CERTs Program US Congress authorized in 1997 Administered by AHRQ, in consultation with FDA, as U18 cooperative agreements Funded through public and private sources Four centers 1999; three centers added 2000; four more centers added 2006 (through 2011) 2007: Competition/award of 10 new research centers and a new Coordinating Center = 15 Centers total, including CC

7. CERTs 2008-2011

8. CERTs Mission and Vision Vision: “To be a trusted national resource for people seeking to improve health through the best use of medical therapies.” HENCE our STAKEHOLDERS are all those so seeking! Mission: “To conduct research and provide education that will advance the optimal use of drugs, medical devices, and biological products.” HENCE our STAKEHOLDERS are those who must use these agents optimally and require the fruits of the CERTs labors!

9. A core value of the CERTs program is the belief that collaboration of groups with different perspectives and resources is critical if the results are to be applicable in the "real world.“ HENCE another set of STAKEHOLDERS are those with similar missions/visions/directions

10. CERTs APPROACH TO PROJECT PARTNERSHIPS Public Private Partnerships with these stakeholders are essential, not just for financial support, but also for the remarkable hybrid vigor of the CERTs Over a hundred organizations/institutions have collaborated and continue. Their engagement is carefully measured against agreed standards of public-private- partnerships

11. CERTs PATHS to ENGAGED PROGRAM PARTNERSHIPS INTRODUCING THE NATIONAL PROGRAM FOR STAKEHOLDER ORGANIZATIONALPARTNERSHIPS FOR THE NATIONAL CENTERS FOR EDUCATION AND RESEARCH ON THERAPEUTICS, THE “CERTs”: THE PARTNERSHIPS TO ADVANCE THERAPEUTICS, THE “PATHS”

12. CERTs’ PATHS to ENGAGED PARTNERSHIPS … a short history “… IT ALL STARTED IN 2002 WHEN …” Accountability to Congress Visibility to the Sector Invitatory meeting: “every organization with a stake in improving therapeutics” Meet ‘on the hill’ … a statement in itself!

13. PATHS to ENGAGED PARTNERSHIPS Closing the meeting … closing the deal Spilker, PhRMA (a close paraphrase): “This has been a very valuable meeting of a group which needs to meet regularly. I move that we request that the CERTs act as a convener and we meet annually to keep doing this.” Unanimous!

14. CERTs’ PATHS Partners … WHO? National Level Organizations A major focus on improving health through improved therapeutics (biologics, drugs, devices) Named senior executive “most responsible” for the therapeutics initiatives in your organization” “look around you … who is missing?.. Get them here”!

15. CERTs PATHS STAKEHOLDERS GOVERNMENT (FDA, AHRQ, NIH, CMS, CDC, DOD, VA …) INDUSTRY (DRUGS, BIO, DEVICES) ACADEMIA PROFESSIONS PRACTICE/PRACTICE ORGANIZATIONS CONSUMERS/PATIENTS

16. CERTs’ PATHS PARTNERS HOW? FORMAL LISTED ‘MEMBERSHIP’ INVENTORY MAINTAINED ON THE CERTs WEBSITE PROGRAM DESCRIPTIONS OF MAJOR THERAPEUTICS INITIATIVES IN A ‘REGISTRY’ ANNUAL FACE-TO-FACE MEETING THE SIXTY SECOND INTRODUCTIONS!

17. CERTS’ PATHS PARTNERS WHY? CERTs MANDATE TO BRING THE PUBLIC HEALTH PERSPECTIVE TO FDA THE PUBLIC HEALTH VISION IS ONE OF A COLLABORATIVE SYSTEM PUBLIC HEALTH/CERTs AS CONVENOR IT TAKES A VILLAGE

18. CERTs’ PATHS PARTNERS SO WHAT? A NETWORK: a treasure trove of talent A REGISTRY: for those seeking strategic alliances, consultation, alignment A face-to-face FORUM: communication, coordination, collaboration A VISION: no one agent can do this alone; and there’s plenty of work (and credit) to go around!

19. CERTs STAKEHOLDER INVOLVEMENT Advantages: –Right job done the right way by the right team; MULTIPLE STAKEHOLDERS DIRECTLY ENGAGED –Permits synergies & economies Challenges: –Trust, respect, accountability, transparency & time –To make partnership about MORE THAN MONEY!

20. Peter F. Drucker The best way to predict the future is to CREATE it! THE CERTs: The best way to create it is TOGETHER.

21. STAKEHOLDERS IN THERAPEUTICS THANKS!