 |
Scientific Considerations Related to Developing
Follow-On Protein
Products
Public Workshop
September 14-15, 2004
AGENDA
Day 1 - September 14, 2004
8:30 Introduction Ajaz Hussain, Ph.D., Deputy Director,
Office of Pharmaceutical Science, CDER
8:40 Opening Remarks Janet Woodcock, M.D., Acting Deputy Commissioner for Operations, FDA
8:50 Opening Remarks Jesse Goodman, M.D., Director, CBER
9:00 Terminology Keith Webber, Ph.D., Acting Director, Office of Biotechnology Products, OPS/CDER
Speakers: (20 minutes)
Gordon Johnston, Vice President Regulatory Affairs, Generic Pharmaceutical Assoc.
Joseph Carrado, M.Sc.., R.Ph., Sr. Director Regulatory Affairs, Duramed Research
Inc.
9:45 General Panel
Panel Members:
Keith Webber, Ph.D., CDER
Barry Cherney, Ph.D., CDER
Janice Brown, M.S, CDER
Amy Rosenberg, M.D. CDER
Steven Kozlowski, M.D. CDER
Chris Joneckis, Ph.D. CBER
Speakers: (65 minutes)
Yafit Stark, Ph.D., Senior Director Global Clinical Research, TEVA Pharmaceutical Industries,
Caroline Loew, Ph.D., Vice President Scientific and Regulatory Affairs, Pharmaceutical Research and Manufacturers
of America (20 minutes)
Doron Shinar, Ph.D., Director, Non Clinical Safety, TEVA Pharmaceutical Industries, Ltd.
Carole Ben-Maimon, M.D., President and COO, Duramed Research Inc. (15 minutes)
Sara Radcliffe, MPH, Managing Director, Scientific and Regulatory Affairs, Biotechnology Industry Organization
10:45 Break
11:00 Panel #1 - Manufacturing Issues
Panel Lead: Keith Webber, Ph.D.
Panel Members:
Frank Holcombe, Ph.D., CDER
Barry Cherney, Ph.D., CDER
Blair Fraser, Ph.D., CDER
Chris Joneckis, Ph.D., CBER
Speakers: (60 minutes)
Art LeBlanc, MS, President, SICOR Pharmaceuticals, Inc
Robert L. Garnick, Ph.D., Senior Vice President, Regulatory Affairs, Quality, and Compliance, Genentech, Inc.
John Dingerdissen., Vice President, Worldwide Manufacturing, Global Biologics Supply Chain, Centocor, Inc.
Suzanne Sensabaugh, MS, MBA., VP, Regulatory Affairs and Quality, SICOR, Inc., Biotechnology Division
Mathias Hukkelhoven, Ph.D., Senior Vice President, Global Head of Drug Regulatory Affairs, Novartis
Pharmaceuticals Corp.
Robert Adamson, Ph.D., Vice President, BioPharmaceutical Process Development, Wyeth BioPharma
12:30 Lunch (on your own) 1:30
Panel # 2 - Characterization Issues
Panel Lead: Barry Cherney, Ph.D., CDER
Panel Members:
Lawrence Yu, Ph.D., CDER
Steven Moore, Ph.D., CDER
Andrew Chang, Ph.D., CBER
William Egan, Ph.D., CBER
Speakers: (90 minutes)
Robert Zeid , Principal Consultant, TLI Development
Arnon Chait, Ph.D., President, ANALIZA, Inc.
Christopher J. Holloway, Ph.D., Dr.rer.hum.biol.habil., Group Director of Regulatory Affairs and CSO, ERA
Consulting Group
Andy Jones, Ph.D., Staff Scientist, Formulation and Analytical Development, Genentech, Inc.
Vytautas Naktinis, Ph.D., Principal Consultant, PROBIOS p.e (20 minutes)
Walter W. Hauck, Ph.D., Statistical Consultant, USP, Professor, Thomas Jefferson University
Jacob R. Hartman, Ph.D., Director, Development, BioTechnology General (Israel)Ltd.
Charles Diliberti, Vice President, Scientific Affairs, Barr Laboratories Inc.
3:30 Break
3:45 Panel # 3 - Potency and Surrogates for Efficacy and Safety
Panel Lead: Janice Brown, M.S, CDER
Panel Members:
David Orloff, M.D., CDER
David Green, Ph.D., CDER
Patrick Swann, Ph.D., CDER
Drusilla Burns, Ph.D., CBER
Speakers: (40 minutes)
Linda Fryklund, Ph.D., Director, Medical and Scientific Affairs, Pfizer AB Sweden (30 minutes)
Patricia C. Weber, Ph.D., Chief Scientific Officer, ExSAR Corp.
4:55 Closing Remarks Ajaz Hussain, Ph.D., Deputy Director,
Office of Pharmaceutical Science, CDER
5:00 End of first day
Day 2 - September 15, 2004
8:00 Introduction to Day 2 Ajaz Hussain, Ph.D., Deputy Director,
Office of Pharmaceutical Science, CDER
8:15 Panel # 4 - Immunogenicity Issues
Panel Lead: Amy Rosenberg, M.D., CDER
Panel Members:
Dena Hixon, M.D., CDER
Elizabeth Shores, Ph.D., CDER
Basil Golding, M.D., CBER
Marjorie Shapiro, Ph.D., CDER
Alexandra Worobec, M.D., CDER
Speakers: (40 minutes)
Johanna Griffin, Ph.D., President, Procognia Inc.
Fredric G. Bader, Ph.D., Vice President, Process Sciences, Global Biologics Supply Chain, Centocor, Inc.
Terry Gerrard, Ph.D., President, TLG Consulting Inc.
Kenneth B. Seamon, Ph.D., Vice President, Global Regulatory Affairs, Amgen Inc.
9:15 Break
9:30 Panel # 5 - Preclinical and Clinical Issues
Panel Lead: Steven Kozlowski, M.D., CDER
Panel Members:
Marc Walton, M.D., CDER
Jeri El Hage, Ph.D., CDER
Dorothy Scott, M.D., CBER
David Green, Ph.D. CDER
Mercedes Serabian, M.S., DABT, CBER Speakers: (50 minutes)
James D. Green, Ph.D., DABT, Senior Vice President, Preclinical and Clinical Development Sciences, Biogen Idec,
Hal Barron, M.D. F.A.C.C., Senior Vice President, Development, Genentech, Inc.
Don Baker, Ph.D., Vice President, Post Market Quality Management, Baxter BioSciencer
Murray P. Ducharme, PharmD, FCCP, FCP, Vice President, PK/PD, MDS Pharma Services
John Greenwood, Director of Regulatory Affairs, GeneMedix plc
11:30 Ajaz Hussain, Ph.D., Deputy Director,
Office of Pharmaceutical Science, CDER 12:00 End of Day 2
Back to Top 
Back to Follow-On Protein Products
Date created: September 16, 2004; updated June 6, 2006 |
|
