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Sustainable Influenza Vaccine Production Capacity Stakeholders' Workshop: Day 1 Agenda

January 11, 2010 - Washington, D.C.
Agenda: DAY 1 | DAY 2 | DAY 3

7:00 am – 8:30 am
Ballroom Foyer
Continental Breakfast and Workshop Registration
8:30 am – 8:40 am
Ballroom
Opening Remarks

Dr. Nicole Lurie

Assistant Secretary for Preparedness and Response
Rear Admiral, U.S. Public Health Service
U.S. Department of Health and Human Services

Introduction by:
Dr. Michael L. Perdue
Director, Division of Influenza and Emerging Diseases
Biomedical Advanced Research and Development Authority
Office of the Assistant Secretary for Preparedness and Response
U.S. Department of Health and Human Services
8:40 am – 8:50 am
Ballroom
Welcome and Introduction to the Objectives of the Meeting

Workshop Co-Chairs
8:50 am – 9:20 am
Ballroom
Keynote Address: Global Response to the H1N1 Pandemic

Dr. Marie-Paule Kieny
Director, Initiative for Vaccine Research
World Health Organization

Introduction by:
Mr. John T. Monahan
Interim Director, Office of Global Health Affairs and
Counselor to the Secretary
U.S. Department of Health and Human Services
9:20 am – 10:00 am
Ballroom
Overview of Current Vaccine Manufacturing Capacity in Developing Countries: Existing Infrastructure

Moderator

Mr. John T. Monahan

Interim Director, Office of Global Health Affairs and
Counselor to the Secretary
U.S. Department of Health and Human Services

Speakers
 9:20 am – 9:35 amDr. Marie-Paule Kieny
Director, Initiative for Vaccine Research
World Health Organization
 9:35 am – 9:50 amDr. Suresh Jadhav
Ex-President - Developing Countries Vaccine Manufacturers Network
Executive Director – Serum Institute of India Ltd./Pune
 9:50 am – 10:00 amDiscussion
10:00 am – 10:30 amTea Break
10:30 am – 11:25 am
Ballroom
Overview of Existing Efforts to Develop Sustainable Vaccine Manufacturing Capacity in Developing Countries

Moderator

Dr. Samuel Ponce de León

General Director of the Biological and Reactive Laboratories of Mexico

Speakers
 10:30 am –10:45 amMs. Christina M. Hartman
Project Officer for International Cooperative Agreements
Biomedical Advanced Research and Development Authority
Office of the Assistant Secretary for Preparedness and Response
U.S. Department of Health and Human Services
 10:45 am – 11:00 amDr. Laszlo Palkonyay
Project Officer for HHS Cooperative Agreement
World Health Organization
 11:00 am – 11:15 amDr. Rick Bright
Scientific Director, Influenza Vaccine Project
Vaccine Development Global Program
PATH
 11:15 am - 11:25 amDiscussion
11:25 am – 12:45 pm
Ballroom
Technical Considerations: Role of New and Existing Technologies and Adjuvants and Technology
Transfer Models

Moderator

Dr. Mark L. Rohrbaugh

Director, Office of Technology Transfer
Office of Intramural Research
Office of the Director
National Institutes of Health
U.S. Department of Health and Human Services

Speakers
 11:25 am – 11:40 amDr. Robin Robinson
Director, Biomedical Advanced Research and Development Authority
Office of the Assistant Secretary for Preparedness and Response
U .S. Department of Health and Human Services
 11:40 am – 11:55 amDr. Armen Donabedian
Senior Program Manager, Division of Influenza and Emerging Diseases
Biomedical Advanced Research and Development Authority
Office of the Assistant Secretary for Preparedness and Response
U.S. Department of Health and Human Services
 11:55 am – 12:10 pmDr. Douglas Holtzman
Senior Program Officer
Bill & Melinda Gates Foundation
 12:10 pm – 12:25 pmDr. Jan Hendriks
Account Manager, International Support
The Netherlands Vaccine Institute
 12:25 pm – 12:45 pmDiscussion
12:45 pm – 1:45 pm
Solarium
Lunch
1:45 pm – 2:30 pm
Ballroom
Technical Considerations: Defining Manufacturing Standards, Regulatory Needs, and Capacity and Role of Clinical Trials

Moderator

Dr. Jesse Goodman

Chief Scientist and Deputy Commissioner for Science and Public Health (Acting)
U.S. Food and Drug Administration
U.S. Department of Health and Human Services

Speakers
 1:45 pm – 2:00 pmDr. David Wood
Coordinator, Quality Safety and Standards,
Immunizations Vaccines and Biologicals
World Health Organization
 2:00 pm – 2:15 pmDr. Vu Minh Huong
Senior Program Team Leader
PATH Vietnam Office
 2:15 pm – 2:30 pmDiscussion
2:30 pm – 3:00 pm
Ballroom Foyer
Tea Break
3:00 pm – 4:00 pm
Ballroom
Cost Considerations: Ensuring the Best Returns on Investment while Ensuring Sustainability and Diversification

Moderator and Speaker
 3:00 pm – 3:15 pmDr. Barry Bloom
Harvard University Distinguished Service Professor and
Joan L. and Julius H. Jacobson Professor of Public Health
Department of Immunology and Infectious Diseases
Harvard School of Public Health

Speakers
3:15 pm – 3:30 pmDr. Vichai Chokevivat
Chairman of the Board
Thai Government  Pharmaceutical Organization
 3:30 pm – 4:00 pmDiscussion
4:00 pm – 5:00 pm
Ballroom
Discussion and Final Comments from Day 1

Moderators

Workshop Co-Chairs
5:00 pm – 6:30 pm
Solarium
Welcome Reception