|
July 15-16, 2009
NIH OCCAM WORKSHOP:
BOTANICALS & CANCER RESEARCH: CLINICAL TRIALS
Natcher Conference Center, National Institutes of Health Campus
Conference Chair:
Jeffrey D. White, M.D., Office of Cancer Complementary and Alternative Medicine (OCCAM
National Cancer Institute (NCI)
PLENARY TOPICS & WORKING GROUPS
Targets, Pathways, and Networks in Pre-Clinical Models
Emma Shtivelman, Ph.D., Bionovo, Inc.
James McMahon, Ph.D., Center for Cancer Research (CCR)/NCI
Botanical Drug Product Issues
Ikhlas Khan, Ph.D., University of Mississippi
Trevor Castor, Ph.D., Aphios
Clinical Trial Design and Implementation I
Debu Tripathy, M.D., University of Texas Southwestern Medical Center
Francis Law, Ph.D., Simon Fraser University
Clinical Trial Design and Implementation II
Ed Chu, M.D., Yale University Cancer Center
Tommy Cheng, Ph.D., Yale University Medical Center
Role of Industry in Botanical Drug Development
Freddie Ann Hoffman, M.D., Heterogeneity, LLC
Shaw Chen, MD, PhD, Center for Drug Evaluation and Research, FDA
Obtaining Grant Funding for Botanical Drug Research
Isis Mikhail, M.D., Dr.P.H., M.P.H., OCCAM/NCI
Barbara Sorkin, Ph.D., National Center for Complementary and Alternative Medicine
[See: http://www.cancer.gov/cam/newsletter/2009-fall/fall2009_OCCAM_newsletter_home.html ]
=//=
2008 Sino-American Pharmaceutical Professionals Association
(S.A.P.A)
Workshop on Botanical Drug Development in the US
1:00 pm - 5.30 pm, Saturday, April 12th 2008
NJ Tech Center, 675 US Highway One, North Brunswick, NJ 08902
Chair: Simon Li, MD PhD, Neuromed Pharmaceuticals, Inc.
http://sapaweb.org/
-
SAPA Updates: Dr. Hancheng Zhang, President of SAPA
-
Opportunity and Challenges for Botanical Drug Development in the US. Dr. Simon Li, MD, PhD, --Vice President of Medical Research, Neuromed Pharmaceuticals
REGULATORY SESSION
-
Developing Botanicals & other Complex Natural Products for the US Market: A Regulatory Overview. Freddie Ann Hoffman, MD, CEO - HeteroGeneity, LLC
-
Regulatory Clinical Pharmacological Perspectives of Botanical Drug Development in US. John Duan, PhD - Senior Reviewer, Office of Clinical Pharmacology, OTS/CDER/FDA
-
Regulatory Toxicological Perspectives of Botanical Drug Development in the US. Kuei-Meng Wu, PhD - Senior Expert Pharmacologist, OND/CDER/FDA
INDUSTRIAL SESSION
-
Patent Protection for Botanical Drugs. Weihong Hsing, PhD, Patent Attorney - Panitch Schwarze Belisario & Nadel LLP
-
Development of Global Partnership for Botanical Drugs and Case Studies. Kevin Pan, PhD - President, BroadSources, Inc.
-
Managing Distribution Channel in Pharmaceutical Products in the US. Haishan Xiong, PhD, MBA - Regional Account Manager, Roche
View presentations at the American Society of Pharmacognosy website:
http://www.phcog.org/Botanicals/BotanicalsWorkshop.html
Saturday, August 5, 2006
American Society of Pharmacognosy &
US Food & Drug Administration
are pleased to sponsor
A Workshop on Botanicals as "New" Drugs
Crystal Gateway Marriott - Arlington, Virginia
In Memoriam
This Workshop is dedicated to the memory of
Floyd E. Leaders, Jr., PhD
Pharmacognosist & Regulatory Scientist
December 11, 1931 - February 26, 2006
Why develop botanicals as drugs? What's in it for the Manufacturer?
Freddie Ann Hoffman, MD, HeteroGeneity, LLC
Botanicals as "New" Drugs.
Shaw Chen, MD, PhD, Food and Drug Administration
Selecting the "Product": What to look for in the Plant.
Edward M. Croom, Jr., PhD, Croomia, LLC
Facility Requirements for Pharmaceutical Production.
Barbara Immel, Immel Resources, LLC
Developing Botanical Drugs: The Drug Review Process.
Jinhui Dou, PhD, Food and Drug Administration
Chemistry, Manufacturing, and Controls Information Recommended for a Botanical Drug.
Rajiv Agarwal, PhD, Food and Drug Administration
Pharmacology & Toxicology Requirements for Botanical Drugs.
Kuei-Meng Wu, PhD, Food and Drug Administration
* * *
16 -17 October 2006
Drug Information Association (DIA) NHP SIAC
in conjunction with the
International Scientific Association for Probiotics & Prebiotics
present:
WORKSHOP ON PROBIOTICS AS FOODS & AS DRUGS -
SCIENTIFIC & REGULATORY ISSUES
University of Maryland Conference Center
College Park, Maryland
Program Chairs:
Patricia Hibberd, MD, PhD - Tufts New England Medical Center
James Heimbach, PhD - JHeimbach, LLC
Freddie Ann Hoffman, MD - HeteroGeneity, LLC
[Continuing Education Credits] |  |
