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

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

Sharon Hertz, MD

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