|
Agenda
| 8:00
a.m. |
Welcome,
Goals of the Colloquium |
|
Linda
Engel, Special
Assistant to the Director for Program Development, NCCAM, Colloquium
Organizer
Myron
S. Weinberg, Chairman,
The Weinberg Group, Inc., Colloquium Chair
|
| 8:10
a.m. |
NCCAM's
Legislative Mandate |
|
Peter
Reineke, Legislative Director,
on behalf of The Honorable Tom Harkin |
| 8:25
a.m. |
The
NCCAM Perspective |
|
Stephen
E. Straus, Director, NCCAM
"Challenges and Opportunities
for Collaboration with Industry" [
Text-Only Version
] |
| 9:25
a.m. |
The
Industrial Perspective--Raw Materials, Manufacturing, and Marketing |
|
Moderator:
Robert Hoerr, President,
Research-Based Dietary Ingredients Association; Chairman and
Chief Technology Officer, GalaGen, Inc.
Freddie
Ann Hoffman, Senior Director,
Medical and Clinical Development, Consumer Health Care, Pfizer,
Inc.
"Needs
of the Industry in Developing Complementary and Alternative
Medicine (CAM) Therapeutics"
[ PDF
(*)
| Text-Only
Version ]
James
Lassiter, President, The
Lassiter Group
"Toward
an Evidence Base for CAM Therapeutics"
[ Text-Only
Version ]
Audience
Discussion
|
| 11:00
a.m. |
The
Industrial Perspective--Quality Assessment |
|
Moderator:
Marilyn Barrett, President,
Pharmacognosy Consulting Services
Joseph
M. Betz, Vice President
for Scientific and Technical Affairs, American Herbal Products
Association
"Pros
and Cons of Current Certification Programs"
[ Text-Only Version
]
Steven
J. Dentali, Scientific
Director for Botanical Sciences, Nutricia/Rexall Sundown
"Current
Concepts of Product Standardization and Quality Control"
[ Text-Only
Version ]
John
Cardellina, President,
American Society of Pharmacognosy, and Vice President, Botanical
Science and Regulatory Affairs, Council for Responsible Nutrition
"The
Need for a Unified Approach To Developing Standards"
[ Text-Only
Version ]
Audience
Discussion
|
| 12:15
p.m. |
Luncheon |
| 1:15
p.m. |
The
Regulatory Framework: An Overview of Food, Drug, and Dietary
Supplement Law
|
|
I.
Scott Bass, Partner, Sidley
& Austin
"Federal Law and Complementary
Medical Products"
[
Text-Only Version
]
Audience
Discussion
|
| 1:45
p.m. |
The
Existing Models for NIH-Industry Collaboration |
|
Carole
A. Heilman,
Director, Division of Microbiology and Infectious Diseases,
National Institute of Allergy and Infectious Diseases, NIH
"Existing
Models for NIH-Industry Collaboration"
[
Text-Only
Version ]
Audience
Discussion
|
| 2:15
p.m. |
Exploring
Opportunities for Collaboration |
|
Co-Moderators:
Paul
M. Coates, Director, Office
of Dietary Supplements, Office of the Director, NIH
Edward
M. Croom, Jr., Scientific
and Regulatory Affairs Manager, Indena USA East, Inc.
|
| 2:20
p.m. |
Panel
I: How Can We Work Together to Generate Information on Efficacy
and Safety of CAM Therapeutics? |
|
Daniel
O. Clegg, Professor of Medicine,
Chief, Division of Rheumatology, University of Utah School of
Medicine
Christine
Lewis, Director, Office
of Nutritional Products, Labeling, and Dietary Supplements,
Center for Food Safety and Applied Nutrition, Food and Drug
Administration (FDA)
David
Schardt, Associate Nutritionist,
Center for Science in the Public Interest
R.
William Soller, Senior
Vice President and Director of Science & Technology, Consumer
HealthCare Products Association
Robert
Temple, Director, Office
of Medical Policy, Center for Drug Evaluation and Research,
FDA
Connie
M. Weaver, Distinguished
Professor and Department Head, Department of Foods and Nutrition,
Purdue University
|
| 3:30
p.m. |
Coffee
Break |
| 4:00
p.m. |
Panel
II: How Can We Work Together to Address Issues of Quality of
CAM Therapeutics? |
|
Jonathan
Davidson, Professor, Department
of Psychiatry & Behavioral Sciences, Duke University, School
of Medicine
Beth
Lambert, CEO, Herbalist
& Alchemist, Inc.
Eugene
I. Lambert, Partner, Covington
& Burling
Jerry
L. Newman, Vice President,
Research and Development, Kemin Foods, L.C.
William
R. Obermeyer, Vice President
for Research, ConsumerLab.com, L.L.C.
Kathleen
J. Pompliano, Manager,
Business Development, NSF International
David
Seckman, Executive Director/Chief
Executive Officer, National Nutritional Foods Association
Roger
L. Williams, Executive
Vice President and Chief Executive Officer, U.S. Pharmacopeia
|
| 5:15
p.m. |
Summary
and Next Steps |
|
Myron
S. Weinberg |
| 5:45
p.m. |
Adjourn |
*
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|
