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2010 ACPU Meeting

Welcome to the20th Annual Meeting

Cincinnati, Ohio

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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

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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

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Acknowledgements

Exhibitors Clinical RSVP IntegReview Logos Technologies Mortara OmniComm

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ACPU Board of Directors

Officers Howard Greenberg, President Donna Dorozinsky, President-

elect Michael Turik, Past-president Vivian West, Treasurer Carole Coleman, Secretary

term expiringnewly elected

Trustees Colleen Hoke Cathy Lavin Charles Pierce Adel Nada Angela Baker Royce Morrison William Smith Walter Kraft

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A Blast from the Past …

20th Annual Meeting is Historical*

* Special thanks to Gary Steinman and Donna Dorozinsky

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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

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ACPU Conceived …

1990 1991 19921989

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 PiergiesACPU

conceived[11 Sep 1990]

1st official ACPU meeting (#3) at Upjohn’s Kalamazoo, MI CPU hosted by Jack Luderer

[13 Oct 1991]

2010

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ACPU is Born …

1990 1991 19921989

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 PiergiesACPU

conceived[11 Sep 1990]

1st official ACPU meeting

at Upjohn’s Kalamazoo, MI CPU hosted by Jack Luderer

[13 Oct 1991]

ACPU incorporatedPresident is

Susana deDennisPresident-elect is

Toni Piergies

20101993

Members from ~12 Pharma CPUs;ACPU

Bulletin

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ACPU Flourishes …

1990 1991 19921989

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 PiergiesACPU

conceived[11 Sep 1990]

1st official ACPU meeting

at Upjohn’s Kalamazoo, MI CPU hosted by Jack Luderer

[13 Oct 1991]

ACPU incorporatedPresident is

Susana de DennisPres-elect isToni Piergies

20101993 1995 1997

Members from 12 Pharma CPUs; ACPU

Bulletin

FDA Guidance on INDs

Standards of CPU Operation in DIA Journal

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And here we are … 2010

1990 1991 19921989

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 PiergiesACPU

conceived[11 Sep 1990]

1st official ACPU meeting

at Upjohn’s Kalamazoo, MI CPU hosted by Jack Luderer

[13 Oct 1991]

ACPU incorporatedPresident is

Susana de DennisPres-elect isToni Piergies

2010

You are here

1993 1995 1997

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

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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

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ACPU Charter Members*Zenta Aldins, SKB Sue Lubin, BMSSara Beechler, PD-WL* Mark Marley, LillyJack Cavanaugh, Abbott Frank Novello, LillyDonna Dorozinsky, SKB** Cindy Rogers, RocheJim Eggert, Lilly Ed Posvar, PD-WL*Bernie Ilson, SKB** Brian Swanson, BMSDiane Kasparek, BMS Howard Uderman, BMSKen Lee, SKB Jane Blue, BMS

Tom Cassidy, Upjohn*Parke-Davis/Warner-Lambert

**Smith Kline Beecham

*1991-92

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Early Sponsors – 1992*

Hoffman-LaRoche Pfizer Upjohn Warner-Lambert/Parke-Davis Wyeth-Ayerst

*ACPU Incorporated in 1992

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Additional Sponsors - 1993

Abbott BMS Ciba-Geigy Genentech Eli Lilly Medical Research Institute of

Delaware Searle

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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

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The ACPU Meeting Hosts

1989 Hoffman-LaRoche 1990 Wyeth-Ayerst 1991 Upjohn 1992 Warner-Lambert / Parke-

Davis 1993 SmithKline Beecham 1994 Abbott / Searle / Evanston 1995 Bristol-Myers Squibb

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

*2001 mtg canceled

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The ACPU Meeting Hosts

2004 BMS, Princeton, NJ (GSK) 2005 ACPU with support from USUHS 2006 Lilly, Indianapolis, IN 2007 Pfizer, New Haven, CT 2008 Charles River, Tacoma, WA 2010* Medpace / Community

Research / Kendle, Cincinnati, OH*2009 mtg canceled

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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

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The ACPU Presidents

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

Davis 1999-00 Mary Unruh, RN, Wyeth

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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

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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

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ACPU Bulletin

Volume 1 No 1

July 1993

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ACPU Early Contributions

Published 1997Published 1995

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ACPU Recent Contributions

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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

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CPUs of Members 1992-3 Roche Pfizer Upjohn Warner-Lambert/

Parke-Davis Wyeth-Ayerst SKB

Abbott BMS Ciba-Geigy Genentech Eli Lilly Searle

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CPUs Remaining in 2010 Roche Pfizer Upjohn Warner-Lambert/

Parke-Davis Wyeth-Ayerst SKB

Abbott BMS Ciba-Geigy Genentech Eli Lilly Searle

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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

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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)

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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!

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ACPU: In the Beginning

ACPU 1990

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ACPU: Then and Now …

ACPU 1990

ACPU 2010