Transcript “Introduction to 21st Annual Meeting” – Howard Greenberg, MD, FCP

2010 ACPU Meeting
Welcome to the
20th Annual Meeting
Cincinnati, Ohio
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Acknowledgements
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107 Registrants from 22 CPUs
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ACPU Program Committee
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Charles H. Pierce, MD, PhD
Donna W. Dorozinsky, RN, MSN
Angela Baker, MHA
Darci Helbling, admin support
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Acknowledgements
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Hosts / Sponsors
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Medpace
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Kendle
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Bernard E. Ilson, MD
Robert Wessel
Edward M. Sellers, MD, PhD
William Sietsema, PhD & Bill Wherle
Community Research
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David Mayleben, PhD
Mark Metzner & Adam Roth
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Acknowledgements
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Exhibitors
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Clinical RSVP
IntegReview
Logos Technologies
Mortara
OmniComm
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ACPU Board of Directors
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Officers
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Howard Greenberg, President
Donna Dorozinsky, President-elect
Michael Turik, Past-president
Vivian West, Treasurer
Carole Coleman, Secretary
Trustees
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term expiring
newly elected
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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
Mark Marley (Lilly)
calls Susana deDennis
(Roche) to discuss an
operational issues
project
[8 Dec 1989]
1989
1990
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
7
ACPU Conceived …
69 people
Mark Marley
meet at Wyeth(Lilly) calls
Ayerst CPU
Susana deDennis (#2) hosted by
(Roche) to
Toni Piergies
discuss his
ACPU
project
conceived
[8 Dec 1989]
[11 Sep 1990]
1989
1990
1991
1992
29 people meet at
1st official ACPU
Roche CPU (#1) to
discuss the Lilly Clinical meeting (#3) at
Upjohn’s
Improvement Project
Kalamazoo, MI
dubbed “Lilly Round
CPU hosted by
Table”
Jack Luderer
[30 Jan 1990]
[13 Oct 1991]
2010
8
ACPU is Born …
69 people
Mark Marley
meet at WyethACPU
(Lilly) calls
Ayerst CPU
Susana deDennis hosted by Toni incorporated
President is
(Roche) to
Piergies
Susana deDennis
discuss his
ACPU
President-elect is
project
conceived
Toni Piergies
[8 Dec 1989]
[11 Sep 1990]
1989
1990
1991
1992
1993
29 people meet at
Roche CPU to discuss 1st official ACPU Members
meeting at
from ~12
the Lilly Clinical
Upjohn’s
Pharma
Improvement Project
Kalamazoo, MI
CPUs;
dubbed “Lilly Round
CPU hosted by
ACPU
Table”
Jack Luderer
Bulletin
[30 Jan 1990]
[13 Oct 1991]
2010
9
ACPU Flourishes …
69 people
Mark Marley
meet at WyethACPU
(Lilly) calls
Ayerst CPU
Susana deDennis hosted by Toni incorporated
President is
(Roche) to
Piergies
Susana de Dennis
discuss his
ACPU
Pres-elect is
project
conceived
Toni Piergies
[8 Dec 1989]
[11 Sep 1990]
1989
1990
1991
1992
1993
29 people meet at
Roche CPU to discuss 1st official ACPU Members
meeting at
from 12
the Lilly Clinical
Upjohn’s
Pharma
Improvement Project
Kalamazoo, MI
CPUs;
dubbed “Lilly Round
CPU hosted by
ACPU
Table”
Jack Luderer
Bulletin
[30 Jan 1990]
[13 Oct 1991]
FDA
Guidance
on INDs
1995
1997
2010
Standards
of CPU
Operation
in DIA
Journal
10
And here we are … 2010
69 people
Mark Marley
meet at WyethACPU
(Lilly) calls
Ayerst CPU
Susana deDennis hosted by Toni incorporated
President is
(Roche) to
Piergies
Susana de Dennis
discuss his
ACPU
Pres-elect is
project
conceived
Toni Piergies
[8 Dec 1989]
[11 Sep 1990]
1989
1990
1991
1992
1993
29 people meet at
Roche CPU to discuss 1st official ACPU Members
meeting at
from 12
the Lilly Clinical
Upjohn’s
Pharma
Improvement Project
Kalamazoo, MI
CPUs;
dubbed “Lilly Round
CPU hosted by
ACPU
Table”
Jack Luderer
Bulletin
[30 Jan 1990]
[13 Oct 1991]
You are here
FDA
Guidance
on INDs
1995
1997    2010
Standards 107 attendees
of CPU
22 CPUs
Operation 54 organizations
in DIA
8 exhibitors
Journal
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ACPU Founding Executive Board*
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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
12
ACPU Charter Members*
Zenta Aldins, SKB
Sara Beechler, PD-WL*
Jack Cavanaugh, Abbott
Donna Dorozinsky, SKB**
Jim Eggert, Lilly
Bernie Ilson, SKB**
Diane Kasparek, BMS
Ken Lee, SKB
Sue Lubin, BMS
Mark Marley, Lilly
Frank Novello, Lilly
Cindy Rogers, Roche
Ed Posvar, PD-WL*
Brian Swanson, BMS
Howard Uderman, BMS
Jane Blue, BMS
Tom Cassidy, Upjohn
*Parke-Davis/Warner-Lambert
**Smith Kline Beecham
*1991-92
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Early Sponsors – 1992*
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Hoffman-LaRoche
Pfizer
Upjohn
Warner-Lambert/Parke-Davis
Wyeth-Ayerst
*ACPU Incorporated in 1992
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Additional Sponsors - 1993
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Abbott
BMS
Ciba-Geigy
Genentech
Eli Lilly
Medical Research Institute of Delaware
Searle
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The Growth years…
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21 October 1992 – Warner-Lambert /ParkeDavis 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
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1989
1990
1991
1992
1993
1994
1995
Hoffman-LaRoche
Wyeth-Ayerst
Upjohn
Warner-Lambert / Parke-Davis
SmithKline Beecham
Abbott / Searle / Evanston
Bristol-Myers Squibb
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The ACPU Meeting Hosts
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1996
1997
1998
1999
2000
2002*
2003
E. Lilly
Wyeth
Abbott
Pharmacia / Upjohn
SKB
Pfizer (Ann Arbor, MI)
Sankyo-MDS, Neptune, NJ
*2001 mtg canceled
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The ACPU Meeting Hosts
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2004
2005
2006
2007
2008
2010*
BMS, Princeton, NJ (GSK)
ACPU with support from USUHS
Lilly, Indianapolis, IN
Pfizer, New Haven, CT
Charles River, Tacoma, WA
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
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1991-92
1992-93
1993-94
1994-95
1995-96
1996-97
1997-98
1998-99
1999-00
Susana R. deDennis, MD, Hoffman-LaRoche
Antoni A. Piergies, MD, Wyeth-Ayerst
Jack R. Luderer, MD, Upjohn Clinic Jasper
Gary L. Steinman, Medexetech
Diane Jorkasky, MD, Smith Kline Beecham
Howard Uderman, MD, Bristol-Myers Squibb
Mark Goldberg, MD, E. Lilly
Alan Sedman, MD, Warner-Lambert/Parke-Davis
Mary Unruh, RN, Wyeth
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The ACPU Presidents
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2000-02
2002-03
2003-05
2005-07
2007-09*
2009-11
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2011-13 Donna Dorozinsky, RN, DWD
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Robert O'Dea, MD, Abbott
Lou Cantilena, MD, USUHS
Donna Dorozinsky, RN, GSK
Marion Kaiser, RN, USUHS
Michael Turik, MD, Lilly
Howard Greenberg, MD, Clinilabs
*Presidency became a 2-year term with By-laws amendment 2007
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Early ACPU Accomplishments
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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 1995
Published 1997
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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
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Roche
Pfizer
Upjohn
WarnerLambert/Parke-Davis
Wyeth-Ayerst
SKB
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Abbott
BMS
Ciba-Geigy
Genentech
Eli Lilly
Searle
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CPUs Remaining in 2010
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Roche
Pfizer
Upjohn
WarnerLambert/Parke-Davis
Wyeth-Ayerst
SKB
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Abbott
BMS
Ciba-Geigy
Genentech
Eli Lilly
Searle
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ACPU Meeting Today
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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
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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?
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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
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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
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