Food and Drug Administration
Center for Drug Evaluation and Research
Summary Minutes of the Advisory Committee for Pharmaceutical Science
July 20, 2001
CDER Advisory Committee Conference Room
5630 Fishers Lane
Members Present Executive Secretary
Stephen R. Byrn, Ph.D., Chair Nancy Chamberlin, Pharm.D.
Judy Boehlert, Ph.D.
Joseph Bloom, Ph.D. FDA
John Doull, M.D., Ph.D. Mei-Ling Chen, Ph.D.
Nair Rodriquez-Hornedo, Ph.D. Yuan-yuan Chiu, Ph.D.
William J. Jusko, Ph.D. Kofi A. Kumi, Ph.D.
Vincent H. L. Lee, Ph.D. Lawrence J. Lesko, Ph.D.
Jürgen Venitz, M.D., Ph.D. Arzu Selen, Ph.D.
Arthur B. Shaw, Ph.D.
Gloria L. Anderson, Ph.D.
Invited SGE Consultant NIH Participants
William H. Barr, Pharm.D., Ph.D. Klaus Gawrisch, Ph.D.
Burton J. Litman., Ph.D.
Invited Academic Guests
Patrick J. McNamara, Ph.D.
Shinya Ito, M.D.
M. Peggy Neville, M.D
Marvin C. Meyer, Ph.D.
Invited Industry Guests
Francis J. Martin, Ph.D.
Leon Shargel, Ph.D., R.Ph.
These summary minutes for the July 20, 2001 meeting of the Advisory Committee for Pharmaceutical Sciences were approved on October 2, 2001.
I certify that I attended the July 20, 2001 of the Advisory Committee for Pharmaceutical Sciences and that these minutes accurately reflect what transpired.
Nancy Chamberlin, Pharm.D. Stephen R. Byrn, Ph.D.
Executive Secretary Chair
Summary Minutes of the July 20, 2001 of the Advisory Committee for Pharmaceutical Science
On July 20, 2001, the Advisory Committee for Pharmaceutical Science met in an open public session at the CDER Advisory Committee Conference Room, 5630 Fishers Lane, Rockville, Maryland. Prior to the meeting, the members, consultants and invited guests had reviewed background material from the FDA. There were approximately 100 people in attendance.
At 8: 34 a.m., the meeting was called to order by the Chair, Stephen R. Byrn, Ph.D. This was
followed by the introduction of meeting participants and the reading of the conflict of interest
statement by Nancy Chamberlin, PharmD., Executive Secretary.
Larry Lesko, Ph.D., introduced the topics and FDA’s objectives during his presentation, Drug Transfer into Breast Milk. Arzu Selen, Ph.D., gave an Overview of the Draft Lactation Studies Guidance. Shinya Ito, M.D, presented on Assessing Drug Transfer into Breast Milk. Then Dr. Patrick J. McNamara, Ph.D., presented on Drug Transfer into Milk: Clinical Methods & Issues. The presentations were followed by the committee discussion of methods to determine drug transfer into breast milk and interpretation of data.
Complex Drug Substances-Liposome Drug Products
Mei-Ling Chen, Ph.D., noted during her Liposome Drug Products: Introduction that issues not addressed in the draft Liposome Drug Products Guidance such as "Equivalence Comparison" for chemistry, manufacturing and controls and Bioavailability/ Bioequivalence would be discussed in this meeting.
Francis J. Martin, Ph.D., provided an overview of a proposed Liposome Classification in his presentation of Liposome Drug Products: Product Evolution and Influence of Formulation on Pharmaceutical Properties and Pharmacology.
Then Arthur Shaw, Ph.D., presented Liposome Drug Products: Chemistry Manufacturing and Control Issues. Kofi A. Kumi, Ph.D., described Bioavailability and Bioequivalence Issues for Liposome Drug Products. These presentations were followed by the committee discussion of issues related to "Equivalence Comparison" for chemistry, manufacturing and controls and Bioavailability/ Bioequivalence.
Open Public Hearing Session:
Christine E. Swenson, Ph.D., Elan, presented on Liposomal Drug Products: The Importance of Supramolecular Structure. Then Gerard M. Jensen, Ph.D., Gilead Sciences, Inc., presented on Liposomal Therapeutics: Process vs. Formulation
The meeting adjourned on July 20, 2001 at 12:46 p.m.
For more detailed information see the verbatim transcript of this meeting on the FDA’s Docket Management Branch Website address:
Nancy Chamberlin, PharmD., Executive Secretary
The Advisory Committee for Pharmaceutical Science