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Agenda for the Patient-Focused Drug Development Meeting on Hereditary Angioedema

September 25, 2017

Time

Description

8:00 – 9:00 a.m.

Registration

9:00 – 9:10 a.m.

Welcome and Introductions
Larissa Lapteva, M.D.

Associate Director, Division of Clinical Evaluation, Pharmacology and Toxicology (DCEPT)
Office of Tissues and Advanced Therapies (OTAT)

Donna Lipscomb
Director, Division of Manufacturers Assistance and Training (DMAT),                                                    
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research (CBER), FDA

9:10 – 9:20 am

Opening Remarks
Wilson Bryan, M.D.
Director, Office of Tissues and Advanced Therapies (OTAT)
Center for Biologics Evaluation and Research (CBER), FDA
CBER, FDA

9:20 – 9:30 a.m.

Overview of FDA’s Patient-Focused Drug Development Initiative
Theresa Mullin, Ph.D.
Director, Office of Strategic Programs
Center for Drug Evaluation and Research (CDER), FDA

9:30 – 9:50 a.m.

Background on Hereditary Angioedema and Therapeutic Options
L. Ross Pierce, M.D.
Medical Officer, DCEPT, OTAT, CBER, FDA

9:50 – 10:00 a.m.

Overview of Discussion Format
Donna Lipscomb
DMAT, OCOD, CBER, FDA
   

Topic 1: Effects of Hereditary Angioedema that matter most to patients and caregivers

10:00 – 10:30 am

Panel Discussion on Topic 1
A panel of patients and patient representatives will provide comments followed by a facilitated group discussion with participants from the audience.

10:30 – 11:30 a.m.

Facilitated Group Discussion on Topic 1
Patients and patient representatives from the audience will be invited to contribute to the discussion.

11:30 – 12:30 p.m.

Lunch

12:30 – 12:35 p.m.

Afternoon Welcome
Donna Lipscomb
OCOD, CBER, FDA

Topic 2: Patients’ perspectives on current treatments

12:35 – 1:05 p.m.

Panel Discussion on Topic 2
A panel of patients and patient representatives will provide comments followed by a facilitated group discussion with participants from the audience.

1:05 – 1:45 p.m.

Facilitated Group Discussion on Topic 2
Patients and patient representatives from the audience will be invited to contribute to the discussion.

Topic 3: Patients’ perspectives on participation in clinical studies

1:45 – 2:15 p.m.

Facilitated Group Discussion on Topic 3
Patients and patient representatives from the audience will be invited to contribute to the discussion.

2:15 – 2:45 p.m.

Open Public Comment

2:45 – 3:00 p.m.

Closing Remarks
Larissa Lapteva, M.D.
Associate Director, DCEPT, OTAT, CBER

 

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