1. 1 2010 ACPU Meeting Welcome to the 20 th Annual Meeting Cincinnati, Ohio

2. 2 Acknowledgements 107 Registrants from 22 CPUs ACPU Program Committee Charles H. Pierce, MD, PhD Donna W. Dorozinsky, RN, MSN Angela Baker, MHA Darci Helbling, admin support

3. 3 Acknowledgements Hosts / Sponsors Medpace Bernard E. Ilson, MD Robert Wessel Kendle Edward M. Sellers, MD, PhD William Sietsema, PhD & Bill Wherle Community Research David Mayleben, PhD Mark Metzner & Adam Roth

4. 4 Acknowledgements Exhibitors Clinical RSVP IntegReview Logos Technologies Mortara OmniComm

5. 5 ACPU Board of Directors Officers Howard Greenberg, President Donna Dorozinsky, President-elect Michael Turik, Past-president Vivian West, Treasurer Carole Coleman, Secretary term expiring newly elected Trustees Colleen Hoke Cathy Lavin Charles Pierce Adel Nada Angela Baker Royce Morrison William Smith Walter Kraft

6. 6 A Blast from the Past … 20 th Annual Meeting is Historical* * Special thanks to Gary Steinman and Donna Dorozinsky

7. 7 In the Beginning … an idea 19901989 Mark Marley (Lilly) calls Susana deDennis (Roche) to discuss an operational issues project [8 Dec 1989] 29 people meet at Roche CPU (#1) hosted by Susana deDennis to discuss the Lilly Clinical Improvement Project dubbed “Lilly Round Table” [30 Jan 1990] 2010

8. 8 ACPU Conceived … 1990199119921989 Mark Marley (Lilly) calls Susana deDennis (Roche) to discuss his project [8 Dec 1989] 29 people meet at Roche CPU (#1) to discuss the Lilly Clinical Improvement Project dubbed “Lilly Round Table” [30 Jan 1990] 69 people meet at Wyeth- Ayerst CPU (#2) hosted by Toni Piergies ACPU conceived [11 Sep 1990] 1st official ACPU meeting (#3) at Upjohn’s Kalamazoo, MI CPU hosted by Jack Luderer [13 Oct 1991] 2010

9. 9 ACPU is Born … 1990199119921989 Mark Marley (Lilly) calls Susana deDennis (Roche) to discuss his project [8 Dec 1989] 29 people meet at Roche CPU to discuss the Lilly Clinical Improvement Project dubbed “Lilly Round Table” [30 Jan 1990] 69 people meet at Wyeth- Ayerst CPU hosted by Toni Piergies ACPU conceived [11 Sep 1990] 1st official ACPU meeting at Upjohn’s Kalamazoo, MI CPU hosted by Jack Luderer [13 Oct 1991] ACPU incorporated President is Susana deDennis President-elect is Toni Piergies 20101993 Members from ~12 Pharma CPUs; ACPU Bulletin

10. 10 ACPU Flourishes … 1990199119921989 Mark Marley (Lilly) calls Susana deDennis (Roche) to discuss his project [8 Dec 1989] 29 people meet at Roche CPU to discuss the Lilly Clinical Improvement Project dubbed “Lilly Round Table” [30 Jan 1990] 69 people meet at Wyeth- Ayerst CPU hosted by Toni Piergies ACPU conceived [11 Sep 1990] 1st official ACPU meeting at Upjohn’s Kalamazoo, MI CPU hosted by Jack Luderer [13 Oct 1991] ACPU incorporated President is Susana de Dennis Pres-elect is Toni Piergies 2010199319951997 Members from 12 Pharma CPUs; ACPU Bulletin FDA Guidance on INDs Standards of CPU Operation in DIA Journal

11. 11 And here we are … 2010 1990199119921989 Mark Marley (Lilly) calls Susana deDennis (Roche) to discuss his project [8 Dec 1989] 29 people meet at Roche CPU to discuss the Lilly Clinical Improvement Project dubbed “Lilly Round Table” [30 Jan 1990] 69 people meet at Wyeth- Ayerst CPU hosted by Toni Piergies ACPU conceived [11 Sep 1990] 1st official ACPU meeting at Upjohn’s Kalamazoo, MI CPU hosted by Jack Luderer [13 Oct 1991] ACPU incorporated President is Susana de Dennis Pres-elect is Toni Piergies 2010 You are here 199319951997      Members from 12 Pharma CPUs; ACPU Bulletin FDA Guidance on INDs Standards of CPU Operation in DIA Journal 107 attendees 22 CPUs 54 organizations 8 exhibitors

12. 12 ACPU Founding Executive Board* Susana deDennis, Roche, President Toni Piergies, Wyeth, President-elect Gary Steinman, UCSF, Treasurer Mary Unruh, Wyeth, Secretary Trustees: Jane Blue, Tom Cassidy, Sara Bechler *1991-92

13. 13 ACPU Charter Members* Zenta Aldins, SKBSue Lubin, BMS Sara Beechler, PD-WL*Mark Marley, Lilly Jack Cavanaugh, AbbottFrank Novello, Lilly Donna Dorozinsky, SKB**Cindy Rogers, Roche Jim Eggert, LillyEd Posvar, PD-WL* Bernie Ilson, SKB**Brian Swanson, BMS Diane Kasparek, BMSHoward Uderman, BMS Ken Lee, SKBJane Blue, BMS Tom Cassidy, Upjohn *Parke-Davis/Warner-Lambert **Smith Kline Beecham *1991-92

14. 14 Early Sponsors – 1992* Hoffman-LaRoche Pfizer Upjohn Warner-Lambert/Parke-Davis Wyeth-Ayerst *ACPU Incorporated in 1992

15. 15 Additional Sponsors - 1993 Abbott BMS Ciba-Geigy Genentech Eli Lilly Medical Research Institute of Delaware Searle

16. 16 The Growth years… 21 October 1992 – Warner-Lambert /Parke- Davis hosted mtg #4 in Ann Arbor, Michigan by Allen Sedman 7 October 1993 – SKB hosted mtg #5 in Philadelphia, PA by Diane Jorkasky October 1994 – Abbott and Searle hosted mtg #6 in Deerfield, IL by Toni Piergies & Jack Cavannaugh 11 October 1995 – BMS hosted mtg #7 in Princeton, NJ by Les Soyka

17. 17 The ACPU Meeting Hosts 1989Hoffman-LaRoche 1990Wyeth-Ayerst 1991Upjohn 1992Warner-Lambert / Parke-Davis 1993SmithKline Beecham 1994Abbott / Searle / Evanston 1995 Bristol-Myers Squibb

18. 18 The ACPU Meeting Hosts 1996E. Lilly 1997Wyeth 1998Abbott 1999Pharmacia / Upjohn 2000SKB 2002*Pfizer (Ann Arbor, MI) 2003Sankyo-MDS, Neptune, NJ *2001 mtg canceled

19. 19 The ACPU Meeting Hosts 2004BMS, Princeton, NJ (GSK) 2005ACPU with support from USUHS 2006Lilly, Indianapolis, IN 2007Pfizer, New Haven, CT 2008Charles River, Tacoma, WA 2010*Medpace / Community Research / Kendle, Cincinnati, OH *2009 mtg canceled

20. 20 ACPU Challenges “Fully 2/3 of the CPUs represented in ACPU membership have experienced substantial change. There have been corporate mergers and reorganizations, consolidations, changes in leadership and revised missions. CPUs have closed. ACPU’s leaders have found it difficult to find time to devote to ACPU. It has been even more difficult to find members willing to help” September 1995

21. 21 The ACPU Presidents 1991-92Susana R. deDennis, MD, Hoffman-LaRoche 1992-93 Antoni A. Piergies, MD, Wyeth-Ayerst 1993-94Jack R. Luderer, MD, Upjohn Clinic Jasper 1994-95Gary L. Steinman, Medexetech 1995-96Diane Jorkasky, MD, Smith Kline Beecham 1996-97Howard Uderman, MD, Bristol-Myers Squibb 1997-98Mark Goldberg, MD, E. Lilly 1998-99 Alan Sedman, MD, Warner-Lambert/Parke-Davis 1999-00 Mary Unruh, RN, Wyeth

22. 22 The ACPU Presidents 2000-02 Robert O'Dea, MD, Abbott 2002-03 Lou Cantilena, MD, USUHS 2003-05 Donna Dorozinsky, RN, GSK 2005-07 Marion Kaiser, RN, USUHS 2007-09* Michael Turik, MD, Lilly 2009-11 Howard Greenberg, MD, Clinilabs 2011-13 Donna Dorozinsky, RN, DWD *Presidency became a 2-year term with By-laws amendment 2007

23. 23 Early ACPU Accomplishments ACPU contribution to FDA IND Guidance: DIA Annual Meeting, June 26, 1995 “Expedited IND Filing Strategies: A proposal to FDA from the ACPU” Minimum Standards of Operation of CPUs presented 1993 & published in DIA Journal 1997 Committee formation (Membership, Nominations, Publications, Standards, Education, management, Regulatory Affairs) The ACPU Bulletin

24. 24 ACPU Bulletin Volume 1 No 1 July 1993

25. 25 ACPU Early Contributions Published 1997 Published 1995

26. 26 ACPU Recent Contributions

27. 27 ACPU Challenges “Fully 2/3 of the CPUs represented in ACPU membership have experienced substantial change. There have been corporate mergers and reorganizations, consolidations, changes in leadership and revised missions. CPUs have closed. ACPU’s leaders have found it difficult to find time to devote to ACPU. It has been even more difficult to find members willing to help” September 1995

28. 28 CPUs of Members 1992-3 Roche Pfizer Upjohn Warner- Lambert/Parke-Davis Wyeth-Ayerst SKB Abbott BMS Ciba-Geigy Genentech Eli Lilly Searle

29. 29 CPUs Remaining in 2010 Roche Pfizer Upjohn Warner- Lambert/Parke-Davis Wyeth-Ayerst SKB Abbott BMS Ciba-Geigy Genentech Eli Lilly Searle

30. 30 ACPU Meeting Today Abbott Laboratories ACCP Biogen Camargo Central Kentucky Research Charles River Clinilabs Clinical RSVP ClinPharm Network Columbus Clinical Commonwealth Biomedical Community Research Comprehensive Phase One Covance CTI Clinical Daiichi Sankyo DMI Duke DWD & Associates E Lilly East Carolina University ERT Galleon Pharmaceutical ICON Independent IRB IntegReview Kansas City University Kendle LMC Logos Technologies Medpace Midwest Institute Mortara New Orleans Center NIH OmniComm Oregon Health & Science University Pfizer Pierce One Proctor & Gamble Profile Research Progressive Medical Ready Clinical Rimax research SciCom Pro Schulman IRB SNBL Thievon-Wright Tufts University Velesco Pharmaceutical University of Cincinnati Western IRB WIL Research Worldwide Clinical Trials

31. 31 What Can ACPU Offer You? Share your issues & best practices Break-out discussions Networking (membership guide) Opportunity to publish and present Leadership (trustee/officer) Hosting (sponsor future ACPU meeting)

32. 32 Current ACPU Agenda Member Needs & Future Vision Project Improved Website Publish ACPU Guidance Recommendations Expand Membership ACPU Collaborations We need active involvement of members It’s Y/our ACPU!

33. 33 ACPU: In the Beginning ACPU 1990

34. 34 ACPU: Then and Now … ACPU 1990ACPU 2010