Food and Drug Administration

Center for Drug Evaluation and Research

    

Advisory Committee for Pharmaceutical Science

Clinical Pharmacology Subcommittee

November 17-18, 2003

CDER Advisors and Consultants Conference Room

5630 Fishers Lane

Rockville, MD 20857

 

Agenda  

Day 1: Monday, November 17, 2003                        

 

8:30             Call to Order and Opening Remarks                                      Jürgen Venitz, M.D., Ph.D.

                                                                                                                  Chair, CPSC                                                                                                                            

                                                                                                                  Associate Professor, Dept. of Pharmaceutics

Virginia Commonwealth University School of Pharmacy

 

                    Introduction of Committee

 

                         Conflict of Interest Statement                                                            Hilda F. Scharen, M.S.

                                                                                                                  Executive Secretary, ACPS

 

8:40             Introduction                                                                           Lawrence Lesko, Ph.D.,

Director, Office of Clinical Pharmacology     and Biopharmaceutics, Office of Pharmaceutical Science, CDER, FDA

               

                Quantitative analysis using exposure-response 

 

9:10             Proposal for End-of-Phase-2A (EOP2A) meetings                  Lawrence Lesko, Ph.D.,

Director, Office of Clinical Pharmacology     and Biopharmaceutics, CDER, FDA

 

9:40             Issues proposed to be discussed at EOP2A and their impact Peter Lee, Ph.D.,

Associate Director, Office of Clinical Pharmacology and Biopharmaceutics, CDER, FDA

 

9:50             Case Studies                                                                           Ameeta Parekh, Ph.D.,

Office of Clinical Pharmacology and Biopharmaceutics, CDER, FDA

 

                                                                                                                  Hae-Young Ahn, Ph.D.,

Office of Clinical Pharmacology and Biopharmaceutics, CDER, FDA

 

                                                                                                                  Joga Gobburu, Ph.D.,

Office of Clinical Pharmacology and Biopharmaceutics, CDER, FDA

 

10:40             Break

                                                                                                                                                                                                                                                                 

                                                                                                                                               

11:00            Committee discussion

 

11:30            Lunch

 

 

 

Food and Drug Administration

Center for Drug Evaluation and Research

Advisory Committee for Pharmaceutical Science

Clinical Pharmacology Subcommittee

November 17-18, 2003

CDER Advisors and Consultants Conference Room

5630 Fishers Lane

Rockville, MD 20857

 

Agenda  

Day 1: Monday, November 17, 2003 (Cont’d)                

 

12:30            Open Public Hearing

 

1:00             PK-PD (QT) study design: points-to-consider                         Peter Lee, Ph.D.,

Associate Director, Office of Clinical Pharmacology and Biopharmaceutics,  CDER, FDA

 

1:10             Use of clinical trial simulation (CTS) for PK-PD QT studies  Peter Bonate, Ph.D., Ilex Oncology

 

1:40             Case Studies                                                                           Leslie Kenna, Ph.D.,

Office of Clinical Pharmacology and Biopharmaceutics, CDER, FDA

 

2:00             Committee discussion

 

 

                Pediatric Bridging: Pediatric decision tree

 

2:30             Introduction                                                                           Lawrence Lesko, Ph.D.,

Director, Office of Clinical Pharmacology     and Biopharmaceutics, CDER, FDA

 

2:40             Case Studies                                                                           Peter Hinderling, M.D.,

Office of Clinical Pharmacology and Biopharmaceutics, CDER, FDA

 

                                                                                                                  Albert Chen, Ph.D.,

Office of Clinical Pharmacology and Biopharmaceutics, CDER, FDA

                             

3:10             Methods for determining similarity of exposure-response      Stella Machado, Ph.D.,

                    between pediatric and adult populations                                Director, Quantitative Methods and Research Staff, Office of Biostatistics, CDER, FDA

 

3:30             Break

                   

 

3:45             Research experience in the use of pediatric decision tree        Gregory Kearns, Pharm D., Ph.D.

                                                                                                              Children's Mercy Hospital

 

4:30             Regulatory experience in using the pediatric decision tree      Bill Rodriguez, M.D.

Office of Counter Terrorism & Pediatric Drug Development, Division of Pediatric Drug Development, CDER, FDA

4:45             Committee Discussion

 

5:15             Concluding Remarks                                                              Jürgen Venitz, M.D., Ph.D.

Chair, ACPS

 

5:30             Adjourn

 

Food and Drug Administration

Center for Drug Evaluation and Research

    

Advisory Committee for Pharmaceutical Science

Clinical Pharmacology Subcommittee

November 17-18, 2003

CDER Advisors and Consultants Conference Room

5630 Fishers Lane

Rockville, MD 20857

 

Agenda

               

Day 2: Tuesday, November 18, 2003 

              

 

8:30             Call to Order                                                                          Jürgen Venitz, M.D., Ph.D.

                                                                                                                  Chair, CPSC

                   

                    Conflict of Interest Statement                                                Hilda F. Scharen, M.S.

                                                                                                                  Executive Secretary, ACPS

 

8:35             Introduction                                                                           Lawrence Lesko, Ph.D.,

Director, Office of Clinical Pharmacology     and Biopharmaceutics, CDER, FDA

 

                Drug Interactions                                                  

8:45             Introduction                                                                           Shiew-Mei Huang, Ph.D.

Deputy Office Director for Science, Office of Clinical Pharmacology and Biopharmaceutics, CDER, FDA

 

9:00             Evaluation of CYP2B6-based interactions                              David Flockhart, M.D., Ph.D.

Professor, Departments of Pharmacology and Medicine, Indiana University School of Medicine

                                                                                                                  

9:15             Evaluation of CYP2C8-based interactions                              Pertti Neuvonen, M.D.

                                                                                                                  Department of Clinical Pharmacology

University of Helsinki

and University Central Hospital

 

 

9:30             Committee Discussion

 

 

                    Pharmacogenetics: Integration into new drug development

 

10:00            Introduction                                                                           Lawrence Lesko, Ph.D.,

                                                                                                            Director, Office of Clinical Pharmacology     and Biopharmaceutics, CDER, FDA

 

 

10:15            Academic perspectives                                                            David Flockhart, M.D., Ph.D.

                                                                                                            Professor, Departments of Pharmacology and Medicine, Indiana University School of Medicine

                                                                                                                

 

 

Food and Drug Administration

Center for Drug Evaluation and Research

    

Advisory Committee for Pharmaceutical Science

Clinical Pharmacology Subcommittee

November 17-18, 2003

CDER Advisors and Consultants Conference Room

5630 Fishers Lane

Rockville, MD 20857

 

Agenda

               

Day 2: Tuesday, November 18, 2003 (Cont’d)

 

                Pharmacogenetics: Integration into new drug development (Cont’d)                  

 

10:30            Industry perspectives                                                              Richard Hockett, M.D.

                                                                                                                  Sr. Clinical Research Physician

                                                                                                                  Eli Lilly and Company

 

10:45            "Practitioner perspectives"                                                    Mary V. Relling, Pharm.D.

                                                                                                                  St. Jude Children's Research Hospital

 

11:00            Committee Discussion

 

                                                                                                           

11:15            Break

 

 

11:30            Committee discussion

 

12:30            Open Public Hearing

 

1:00             Committee Discussion and Concluding Remarks                                                                  Lawrence Lesko, Ph.D.

 

 

1:30             Adjourn