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U.S. Department of Health and Human Services


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Drug-Induced Liver Injury: A National and Global Problem, February 2001


Final Program


Dates: February 12 and 13, 2001

Location: Westfields Conference Center, Chantilly VA


Sunday February 11, 2001

4:00 – 6:00 PM Registration


Day 1 – Monday February 12, 2001

7:00 – 8:00 AM Registration

Session 1: Overview


Chairperson: John R. Senior, M.D. (FDA)

8:00 AM Welcome, Program Structure, Goals of the Conference and Workshop

Speaker: John R. Senior, M.D.

8:15 AM Impacts on the Food and Drug Administration

Speaker: Bob Temple, M.D. (FDA)

8:30 AM Impact of Hepatotoxicity on the Pharmaceutical Industry

Speaker: Bert Spilker, M.D., Ph.D. (PhRMA)

8:45 AM Impact on Hepatology and the Practice of Medicine

Speaker: William M. Lee, M.D. (AASLD)

9:00 AM Panel Discussion:

John Senior, Bob Temple, Bert Spilker, Will Lee


Session 2: Framework


Chairperson: Will Lee

Introduction to Preclinical, Clinical, Postmarketing Sessions

9:30 AM Pre-Clinical Issues in Drug Development

Speaker: Francois Ballet, M.D., Ph.D. (PhRMA)

10:15 AM Coffee Break

10:40 AM Clinical Picture and Issues in the Clinical Phases of Drug Development

Speaker: Neil Kaplowitz, M.D. (AASLD)

11:25 AM Post Marketing: State of the Art and Issues Defined

Speaker: Peter K. Honig, M.D., M.P.H. (FDA)

12:10 PM Panel Discussion:

Will Lee, Francois Ballet, Neil Kaplowitz, Peter Honig

12:30 PM Breakout Instructions and Lunch


Session 3: Breakout Sessions

1:30 PM Breakout Sessions

Pre-Clinical (3 sessions):

Group I

Moderator: Vince Meador, Ph.D. (PhRMA)

Discussants: Jack Dean, Ph.D.; Debra Laskin, Ph.D.

Group II

Moderator: Jim MacGregor, Ph.D. (FDA)

Discussants: F.Peter Guengerich, Ph.D.; Sid Nelson

Group III

Moderator: Jim Sanders (PhRMA)

Discussant: Glenn Sipes, Ph.D.

 Clinical (2 sessions):

Group I

Moderator: Bob Temple

Group II

Moderator: Bob Zerbe (PhRMA)

Post Marketing (2 sessions):

Group I

Moderator: Harry Guess (PhRMA)

Group II

Moderator: Hugh Tilson (PhRMA)

3:00 PM Break


Session 4: Breakout Reports


Chairperson: Bob Temple

3:30 PM Breakout Group Reports


Session 5: Panel Discussion

4:30 PM Moderator: Bob Temple

Panel Members:

FDA: Julie Beitz, John Senior, Jim MacGregor

AASLD: Paul Watkins, Gene Schiff, Jim Freston

PhRMA: Jim Kotsanos, Steve Ryder, Vince Meador

5:30 PM Reception


Day 2 - Tuesday February 13, 2001

Session 6: Current Topics in Hepatotoxicity


Chairperson: Bert Spilker (PhRMA)

8:00 AM How Are These Problems Being Addressed in Europe?

Speaker: Roger Williams, M.D.

8:25 AM Looking for Hepatotoxicity, Working Up Patients, and Assessing


Speaker: James W. Freston, M.D., Ph.D.

8:55 AM Emerging Trends in Acute Liver Failure in the United States

Speaker: William M. Lee, M.D. (AASLD)

9:20 AM Pharmacogenomics: Dangerous Drug or Susceptible Patient?

Speaker: Paul B. Watkins, M.D.

9:45 AM Final Q and A, discussion of issues

10:00 AM Breakout Instructions and Break


Session 7: Breakout Sessions

10:30 AM Breakout Sessions:

Pre-clinical (1 session)

Moderators: Jim Sanders; Joe DeGeorge

Discussants: Roger Ulrich; Harry Olson

Clinical (2 sessions)

Moderators: Bob Temple; Bob Zerbe (same as Day 1)

Post Marketing (2 sessions):

Moderators: Harry Guess; Hugh Tilson (same as Day 1)

12:00 NOON Lunch


Session 8: Breakout Reports


Chairperson: Tim Franson (PhRMA)

1:00 PM Breakout Group Reports


Session 9: Panel Discussion

2:00 PM Moderator: Tim Franson

Panel Members:

FDA: Peter Honig, Joe DeGeorge, Bob Temple

AASLD: Neil Kaplowitz, Will Lee, Willis Maddrey

PhRMA: Harry Guess, Jim Sanders, Bob Zerbe

4:00 PM Adjourn