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For Consumers

Exploring Scientific Opportunities for Facilitating Development of Vaccines, Blood and Blood Products, and Cellular, Tissue, and Gene Therapies

The Food and Drug Administration (FDA) is announcing a public workshop entitled " From Concept to Consumer: Center for Biologics Evaluation and Research (CBER) Working with Stakeholders on Scientific Opportunities for Facilitating Development of Vaccines, Blood and Blood Products, and Cellular, Tissue, and Gene Therapies."

The goal of the public workshop is to provide stakeholders a forum for the development of innovative scientific knowledge and tools to facilitate the development and availability of new biological products including vaccines, blood and blood products, and cellular, tissue, and gene therapies. The Center for Biologics Evaluation and Research (CBER) is seeking input from government and nongovernment research organizations, medical professional organizations, health care practitioners, patients, disease interest groups, pharmaceutical and biological product manufacturers and their industry organizations, and others with interests in facilitating development of the biological products that CBER regulates. The workshop will cover delineation of opportunities in key technologies and medical science knowledge needed to contribute to science based evaluation of the safety and efficacy of those biological products, and innovative development processes to manufacture them. FDA will discuss and welcomes input concerning all applicable areas of science including, but not limited to, bench laboratory investigations, clinical research and clinical trial design and execution, facility and manufacturing process research, statistical and epidemiological research, and computer science and computer modeling research. The workshop will not cover discussions of biological product discovery and invention, or regulatory policies. The workshop will include presentations by FDA speakers and breakout sessions with panels composed of both FDA staff and non-FDA stakeholders, with an opportunity for public questions and comments.

The workshop will be held on October 7, 2004 from 8:30 a.m. to 5:00 p.m., at the The Gaithersburg Marriott Washingtonian Center, 9751 Washingtonian Boulevard, Gaithersburg, MD 20878

If you are interested in attending this workshop, please register by contacting:
Melanie Whelan
Center for Biologics Evaluation and Research (HFM-43)
Food and Drug Administration
1401 Rockville Pike, Suite 200N
Rockville, MD 20852-1448
301-827-3841 Fax 301-827-3079
Whelan@cber.fda.gov
by mail, fax or email, and provide your name, title, affiliation, address, telephone and facsimile numbers by September 30, 2004.

There is no registration fee for the workshop. If you need special accommodations due to a disability, please contact Melanie Whelan at least 7 days in advance.

Regardless of attendance at the public workshop, interested persons may submit written or electronic comments through September 23, 2004 to the:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852 .
Submit electronic comments to
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www/fda.gov/dockets/ecomments

Please submit a single copy of electronic comments or two copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket Docket No. 2004N-0366
You can read the Federal Register Notice at http://www.fda.gov/cber/meetings/criticalpath100704fr.htm
__________________________________________________________________________________________

AGENDA

8:30 - 8:40 WELCOME
Kathryn M. Carbone, M.D., Associate Director for Research and Division of Manufacturers Assistance and Training
Office of Communication, Training and Manufacturers Assistance, CBER

8:40 - 9:10 Introduction to Scientific Opportunities for Facilitating the Development of Biological Products
Jesse L. Goodman, M.D., M.P.H.
Director, Center for Biologics Evaluation and Research

CBER Staff Presentations: Overview of Current and Future Scientific Opportunities

9:10 - 9:30 VACCINES Office of Vaccines Research and Review Speaker TBD

9:30 - 9:50 CELL, TISSUE AND GENE THERAPIES,
Office of Cellular, Tissue and Gene Therapies, Joyce Frey Vasconcells, Ph.D., Office Director (Acting),

9:50 - 10:10 BLOOD AND BLOOD PRODUCTS
Office of Blood Research and Review, Jay Epstein, M.D., Office Director

10:10 - 10:40 BREAK

10:40 - 11:00 STATISTICS, RISK MANAGEMENT AND CLINICAL TRIAL DESIGN
Office of Biostatistics and Epidemiology, Susan Ellenberg, Ph.D., Office Director

11:00 - 11:20 MANUFACTURING SCIENCE
Office of Compliance and Biologics Quality, James Cohen, JD, Office Director (Acting)

11:20 - 12:00 Questions for morning speakers

12:00 - 1:00 Lunch (on your own)

1:00 - 3:30 Breakouts: Panel Sessions and Open Discussion
Vaccines (Moderator to be determined)
Panelists: Gary Overturf MD (University of New Mexico), John La Montagne PhD (NIAID, NIH), Alan Shaw PhD (Merck), Robert Reinhard (AVAC), Laurie Norwood (CBER/OCBQ)

Blood and Blood Products (Moderator: Hira Nakhasi, Ph.D., CBER/OBRR)
Mark Brecher MD (UNC-CH), Jonathan Goldsmith MD (IDF), Harvey Klein MD (NIH), Chris Healey (PPTA), Gerald Schochetman PhD (Abbott Laboratories), Kay Gregory (Invited) (AABB), Chiang Syin (CBER/OCBQ)

Cell/Gene Therapies (Moderator: Eda Bloom, Ph.D., CBER/OCTGT)
Katherine High MD (University of Pennsylvania), Alex Kuta PhD (Genzyme), Patrick Terry (Genetic Alliance), Sonia Skarlatos PhD (NIH), Nick Obiri (CBER/OCBQ)

Tissues and Tissue Engineering (Moderator: Joyce Frey Vasconcells, Ph.D., CBER/OCTGT)
Michael Yaszemski MD PhD (Invited) (Mayo), Angela Hightwalker PhD (NIST), Sharon Kiely MD MPM (West Penn Allegheny Health System), Nancy Parenteau PhD (Amaranth Bio), Thomas Lynch JD PhD (Cryolife), Jerry Davis (CBER/OCBQ), Celia Whitten (CDRH/FDA)

Statistics, Risk Management and Clinical Trial Design (Mary Foulkes, Ph.D., CBER/OBE)
Marie Griffin MD MPH (Vanderbuilt), M. Elizabeth Halloran MD PhD (Emory), June S. Almenoff MD PhD (GSK), Dennis Dixon PhD (NIH), Pat Holobaugh (CBER/OCBQ)

3:30 - 3:45 BREAK

3:45 - 4:45 Reconvene for Panel Reports

4:45 - 5:00 Closing Comments/Summary
Jesse L. Goodman, M.D., M.P.H., Director, Center for Biologics Evaluation and Research

More about The Challenge and Opportunity on the Critical Path to New Medical Products can be found at - www.fda.gov/oc/initiatives/criticalpath/whitepaper.html

Richard Klein
HIV/AIDS Program Director
Food and Drug Administration
 

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