Gerald A. Faich, FISPE, Presidential Address - International Society ...

State of the Society
Presidential Address to the
Membership, August 2005
Jerry Faich, MD MPH

ISPE is healthy and
growing
• Our numbers are great and growing
• This Nashville meeting has exceeded
every indicator of success
• Our education efforts are expanding
• We are solvent and
• The environment is driving recognition
of, and demand for, epidemiology
• We have new initiatives

Our mission and program
goals
• Membership and finances
• Mission
– Forum
– Educate
– Advocate
• For PE and Risk Management
• Sharpened our mission statement “advance
the health of the public”

Membership
• We combined meeting registration and payment of
membership fees and put all members on the same
annual cycle. All attending this meeting (excluding
exhibitors and one days) are now members!
• Our membership is drawn from industry and
nonindustry sources in about equal proportions.
• It is important to note we are truly international
with half the membership resident outside the US.

ISPE MEMBERSHIP BY COUNTRY
Japan 2.8%
Australia 2.4% Countries with less
than 10 members 5.4%
Canada 5.6%
United Kingdom 6.0%
2005
Sweden 4.8%
Spain 3.4%
The Netherlands 3.1%
France 2.4%
Denmark 1.9%
United States 57.4%
Switzerland 1.8%
Germany 1.7%
Norway 1.2%
TOTAL MEMBERSHIP = 881

We are solvent
This year has been a transition year -we
shifted the fiscal year- and I am pleased to
report there has not been a mass defection.
Kudos and thanks to:
Frank May
Judy Jones
Development Committee-Nancy Dreyer
Mark Epstein and PAI

ISPE Financial details fy 2004
REVENUE $806,285 EXPENSES $743,535
Miscellaneous
income
$12,633
2%
Donations - general
and conference
related
$104,732
13%
Investment income
$31,970
4%
Membership Dues
$174,225
22%
Management and
General
$188,587
25%
ICPE & Midyear
conference
Exhibitors
$21,150
3%
ICPE & Midyear
conference
registration fees
$461,575
56%
Publication costs
$23,906
3%
ICPE & Midyear
conference costs
$531,042
72%
Assets Dec 31, 2004 = $841,289
Assets June 30, 2005=$1,263,000

2005 ICPE revenue sources-
Development Committee
• 10 Academic centers
• 23 Sponsors $102k
• 21 Exhibitors $31k
• Other sources $26k

Forum-Meetings
• Bordeaux meeting-Nick Moore-largest in
attendance and number of abstracts
• Barcelona-Elena Rivero
Euro databases
• Nashville-Wayne Ray and
Billy Holden

Forum-Nashville
Nashville-exceeded exceeded every
indicator of success-abstracts
(PDS)
• From 1994 to 2003 the highest
number of abstracts was 229.
• In 2004 in Bordeaux, it jumped to 334
abstracts.
• This year the volume has grown to
410 abstracts.

Nashville
• Over 700 registrants
• This is a tribute to the quality of the
past meetings and the growth in the
field as a whole.
• No doubt the heightened attention
given to risk and risk management is a
major contributor attendance at this
meeting.

Education
•This meeting had over 250 registered for courses: Intro to
Epidemiology, Advanced Topics or Risk Management.
•FOR ALL SESSIONS, PLEASE TURN IN EVALUATIONS
•Additionally one off site one course successfully done and
another about to be conducted.
•A A heartfelt thanks goes out to the instructors of our courses.
•We hope these efforts will serve as a
means to raise awareness and membership
Special thanks to Jaques LeLorier

ISPE
PUBLICATIONS
PDS – Medline listed
In 2004, in the top 22% of all
biomedical journals
Citation score has continued to
grow, quality to improve.

Events of 2004-5 5 are driving recognition
of, and demand for, epidemiology
• Vioxx
• FDA guidelines finalized March 2005
• EMEA/ICH/CIOMS guidances
• US Congressional and IOM inquiries
• Tysabri, Bextra

Statement on Regulatory Systems to
Improve Pharmaceutical Safety
Three OF Eight
Eight ISPE SUGGESTED ACTIONS, Feb 2005
• MORE STUDIES- Rapid conduct of
pharmacoepidemiologic studies should be done whenever
an important safety concern arises for a marketed
product
• MORE REGULATORY AUTHORITY- In some countries
there should be increased regulatory authority to require
the conduct of postmarketing studies in a timely manner.
• LIMITED PROMOTION- Cautious promotion of products
during the initial marketing phase should be done

In Memoriam
Bengt Eric (Beye(
Beye) ) Wiholm MD

Leadership
• Executive Committee-Sean Hennessey,
Frank May, Susanna Perez
• Board
• Committees
• Program Chairs
• Executive Secretary and staff

Our (wonderful) Staff
• Executive Secretary, Mark
H. Epstein
• Account Coordinator,
Angela Charles
• Staff Accountant
(Membership/ Meeting
Registration), Barry Gimble
• Controller, Thomas O'Hora,
CPA
• PAI Management, Norman
Wallis,
President/Consultant

ISPE Committees-1
Bylaws & Policy
Development
Education
Fellowship & Awards
Finance
Global Development
Hugh Tilson, Keith Beard,
Michael Lewis
Nancy Dreyer, Cees Schep,
Krishna Bahadursingh
Jacques LeLorier, Tom
MacDonald, Sebastian
Schneeweiss, , James Lewis
Susana Perez-Gutthann,
Jerry Faich
Frank May,
Corinne de Vries
Stan Edlavitch,
Byung-Joo Park, Songlin Xue

ISPE Committees-2
Strategic Planning
Membership
Public Policy &
Ethics
Public Relations
Publications
Scientific Program
Sean Hennessy,
Allen Mitchell
Annette Stemhagen
Elizabeth Andrews,
Gottfried Kreutz, Susan
Sacks
Yola Moride
Dan Fife, David Lilienfeld,
Syed Rizwanuddin
Ahmad, Harry Seifert
Wayne Ray, Bert

Academic Council
Stephen Evans
Industry Council
Alejandro Arana Navarro &
Nancy Santanello
Government Council
Syed Rizwanuddin Ahmad &
Kirsten Myhr
Student Council
Kevin Haynes

How does the future
look? Initiatives

2005 Elections
• You elected to the Board as officers and
directors the following members:
– Allen Mitchell, President Elect;
– Corinne de Vries, Vice President Finance – Elect
– Ken Rothman; Alec Walker; Lynn Bosco;
Nicholas Moore; and Alejandro Arana- Board
Members
• Sincere appreciation to all of the members
who agreed to stand for election this year

Challenges ahead
• Membership-regulators,
regulators, EURODurg
• Risk management learnings,
education, participation and
assessment
• Greater visibility and impact eg joining
CIOMS
• More member involvement

Special Interest Groups
• Effective forum for major special interests
within PE
– Drug Utilization
– Registries
– Databases
– Biologics
– Devices
– Vaccines
• Petition board, elect own leaders, program
suggestions, education, advocacy
suggestions

• In my twenty years of involvement with pharmacoepidemiology I have never
witnessed anything approaching the current level of interest, concern and
commitment to the field. Epidemiology is being used to gather better
evidence for medical product effectiveness, safety and value. Device failures,
drug withdrawals, heightened provider and patient concern are fueling the
demand for ways to better understand and measure product performance in
the real world. Add to this requirements to intervene to minimize e risk, new
regulatory guidance and conditions at time of approval of products and we
see a veritable “perfect storm” effect. The challenge for us individually ividually and as
a Society is to develop methods to obtain and use evidence to impact i
on
clinical practice and patient behaviors. We need to continue to advocate for
the expanded use of epidemiology in these critical areas.
• I thank you for allowing me this year to serve you and I hope to see you in
Nashville.
•