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

Rockville, Maryland

PARTICIPANTS

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.

Consumer Representative

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.

 

_____|S|________________ _______|S|___________

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

Page 2

 

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.

Clinical Pharmacology

Larry Lesko, Ph.D., introduced the topics and FDAs 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 FDAs Docket Management Branch Website address:

HTTP://www.fda.gov/ohrms/dockets/ac/acmenu.htm

Prepared by:

Nancy Chamberlin, PharmD., Executive Secretary

The Advisory Committee for Pharmaceutical Science