Meeting of the Anesthetic and Life Support Drugs Advisory Committee

May 16, 2002

 

Agenda

 

8:00 8:15

Welcome and Introductions

Cynthia McCormick, MD

8:15 8:20

Conflict of Interest Statement

Advisors and Consultant Staff

8:20 9:20

Open Public Hearing

Public Comments

9:20 9:30

 

General Clinical/Regulatory Issues in Development of Drugs Intended for Treatment of a Chronic Illness

Sharon Hertz, MD

9:30 9:40

 

Specific Clinical/Regulatory Issues in Development of Drugs for Peripheral Neuropathy and Neuropathic Pain

Gerald Dal Pan, MD, MHS

9:40 10:10

Scales Used in the Evaluation of Peripheral Neuropathy

Eva Feldman, MD

10:10 10:15

Questions

 

10:15 10:30

Break

 

10:30 11:00 

Electrophysiologic Tests Used in the Evaluation of Peripheral Neuropathy and Neuropathic Pain

David Cornblath, MD

11:00 11:05

Questions

 

11:05 11:35 

Skin Biopsy in the Evaluation of Peripheral Neuropathy and Neuropathic Pain

Justin McArthur, MB, BS, MPH

11:35 11:40

Questions

 

11:40 12:55

Lunch Break

 

12:55 1:25 

Discussion of Entry Criteria for Clincial Triasl for Diabetic Peripheral Neuropathy

 

1::25 1:55 

Discussion of Clinical Efficacy Outcomes in Peripheral Neuropathy Trials (for disease modification and/or non-pain symptom redcution)

 

1:55 2:25

Discussion of Duration of Clinical Trials for Peripheral Neuropathy Trials

  

2:25 2:40

Break

 

2:40 3:10 

Point-Counterpoint: Exrapolation of Findings from One Type of Neuropathic Pain to Another Neuropathic Pain Condition

Michael Rowbotham, MD and Robert Dworkin, MD

3:10 3:20

Questions

 

3:20 3:50

Discussion of Clinical Efficacy Outcomes in Neuropathic Pain Trials

 

3:50 4:20 

Discussion of Exrapolation of Findings from One Type of Neuropathic Pain to Another

 

4:20 4:50

Discussion of Duration of Clinical Trials for Peripheral Neuropathy Trials

 

4:50 5:05

Wrap-up

 

5:05

Adjourn