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Conference Agenda
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Day 1 (August 21st) |
| 3:00 - 4:00 |
On Site Registration – Oxford Conference Center Lobby |
| 4:00 - 5:00 |
Introductory Remarks:
- Ikhlas Khan, Ph.D. Assistant Director, NCNPR.
- G. N. Qazi, Ph.D., Director, Regional Research Laboratory (CSIR) Jammu.
- K. K. Dwivedi, Ph.D., Counselor (Science and Technology), Embassy of India.
- Larry A Walker, Ph.D., Director, NCNPR.
- Alice M. Clark, Ph.D., Vice-Chancellor for Research and Sponsored Programs.
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| 5:00 - 6:00 |
Opening Address: Robert Brackett, Ph.D., Director, CFSAN. The Role of Science in Effective Regulation of Botanical Dietary Supplements. |
| 6:00 - 8:30 |
Dinner – Memory House
(Shuttles will take people from OCC to Hotels and Memory House) |
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Day 2 (August 22nd) |
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Session 1: Authentication, Identification, Processing of Botanicals
Session Chair: Christine Swanson, Ph.D., Office of Dietary Supplements of NIH |
| 8:10 - 8:15 |
Welcome from Barbara Wells, Pharm. D. Dean of the School of Pharmacy. |
| 8:15 - 8:55 |
Michael McGuffin, President - American Herbal Products Association. Starting at the Ground: Good Agricultural and Collection Practice for Herbal Raw Materials. |
| 8:55 - 9:35 |
De-an Guo, Ph.D., Deputy Director of Modern TCM Research Center, Peking University. Quality control and in vivo process of traditional Chinese medicine. |
| 9:35 - 9:55 |
Break |
| 9:55 - 10:35 |
Roy Upton, Executive Director, American Herbal Pharmacopoeia. Pharmacopoeial Standards: Needs, Current Status, Future Needs. |
| 10:35 - 11:15 |
G. N. Qazi, Ph.D., Director, Regional Research Laboratory (CSIR) Jammu. Golden Triangle Partnership (GTP): A New Initiative in India. |
| 11:15 - 11:55 |
Reinhard Länger, Ph.D., Institute of Pharmacognosy, University of Vienna. Science and practice in authentication of botanicals: Are classical methods still needed? |
| 11:55 - 12:40 |
Lunch – Oxford Conference Center Dining Hall |
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Session 2: Cultivation and Supply of Raw Material
Session Chair: Mark Blumenthal, Executive Director, American Botanical Council. |
| 12:40 - 1:20 |
Ed Fletcher, Chief Operating Officer, Botanicals Division of SSI. Good Agricultural and Collection Practice for Herbal Raw Materials: How to Apply Them in the Field. |
| 1:20 - 2:00 |
Y. S. Bedi, Ph.D., Scientist Regional Research Laboratory (CSIR), Jammu. Cultivation for Sustainable Supply of Raw Material. |
| 2:00 - 2:20 |
Break |
| 2:20 - 3:00 |
Josef Brinckmann, V.P. R&D, Traditional Medicinals. Sourcing of Pharmacopoeial Grade Botanical Raw Materials from Controlled Cultivation and Sustainable Wild Collection: An Herbal Product Manufacturer’s Experience. |
| 3:00 - 3:40 |
Steve Carr, Coordinator of the Succulent Cultivation Project, Namibia. Hoodia in Namibia: Cultivation and Supply of Raw Materials. |
| 3:40 - 4:25 |
Discussion Group |
| 4:25 - 5:00 |
Shuttles will take people from OCC to Hotels. |
| 5:00 - 6:30 |
Busses Depart from the Hotels for Memphis at 5:00 sharp! |
| 6:30 - 9:00 |
Dinner and Excursion to B.B. Kings, Memphis Tennessee. Busses will depart from Memphis at 9:00 sharp and will arrive in Oxford at 10:30 P.M. |
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Day 3 (August 23rd) |
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Session 3: Analytical Approaches for Quality and Safety Assessment of Botanicals
Session Chair: Joseph M. Betz, Ph.D., Office of Dietary Supplements of NIH |
| 8:15 - 8:55 |
Ikhlas Khan, Ph.D., Assistant Director, NCNPR. Authentication of Botanicals: A Comprehensive Approach. |
| 8:55 - 9:35 |
Kerri L. LeVanseler, Ph.D., Tech. Manager-Chemistry Laboratory NSF Int. Dietary Supplement Analytical Efforts at NSF International. |
| 9:35 - 9:55 |
Break |
| 9:55 - 10:35 |
Eike Reich, Ph.D., Head of Laboratory, CAMAG. Standardized HPTLC Methods for Identification of Botanicals and Detection of Adulteration. |
| 10:35 - 11:15 |
J. S. Yadav, Ph.D., Director Indian Institute of Chemical Technology (CSIR), Hyderabad. Quality Issues relating to Traditional systems of Medicine-An Indian perspective. |
| 11:15 - 11:55 |
Richard B. van Breemen, Ph.D., University of Illinois at Chicago. Analytical Approaches for the Authentication and Evaluation of the Safety of Botanical Dietary Supplements. |
| 11:55 - 12:40 |
Lunch – Oxford Conference Center Dining Hall |
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Session 4: Assessing the Safety of Botanicals
Session Chair: Jason Woo, MD, MPH, FACOG Division of Dietary Supplement Program, ONPLDS, CFSAN, FDA. |
| 12:40 - 1:20 |
Christine Haller, MD, Assistant Professor of Medicine, Clinical Pharmacology, University of California, San Francisco. Monitoring Dietary Supplement Adverse Events – An FDA/ Poison Control Center Collaboration. |
| 1:20 - 2:00 |
John Markowitz, PharmD, BCPP, South Carolina College of Pharmacy. Botanical-Drug Interactions: Assessing Clinical Significance. |
| 2:00 - 2:20 |
Break |
| 2:20 - 2:35 |
D. Y. Rao, Ph.D., Head, TNBD, Council of Scientific & Industrial Research, New Delhi. Overview of the New Millennium Indian Technology Leadership Initiative (NIMITLI). |
| 2:35 - 3:05 |
Bhushan Patwardhan, Ph.D., Professor & Director, Interdisciplinary School of Health Sciences, University of Pune, Pune. Overview of the New Millennium Indian Technology Leadership Initiative (NIMITLI). |
| 3:05 - 3:35 |
Arvind Chopra, MD, Director and Chief Rheumatologist, Center for Rheumatic Diseases, Pune. Clinical Study - Osteo- and Rheumatic Arthritis. |
| 3:35 - 4:15 |
Somesh Sharma, Ph.D., Chief Scientific Officer, Nicholas Piramal India Ltd., Mumbai. Development of Phytopharmaceutical in an Industrial Setting with Major Emphasis on Efficacy and Safety. |
| 4:15 - 5:00 |
Discussion Group |
| 5:00 - 6:30 |
Shuttles will run to and from the Hotels. Additional poster setup time. |
| 6:30 - 7:00 |
Dinner - Oxford Conference Center Dining Hall |
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Session 5: Poster Session - Oxford Conference Center Dining Hall (7:00 – 9:00)
Session Chair: Leila G Saldanha, Ph.D., RD, Scientific Consultant, NIH. |
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Day 4 (August 24th) |
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Session 6: Development Considerations for Botanicals that Impact Quality, Research and Regulation
Session Chair: Steven Musser, Ph.D., Chief, Instrumentation and Biophysics Branch, CFSAN, FDA |
| 8:15 - 8:55 |
Freddie Ann Hoffman, MD, CEO, HeteroGeneity, LLC. The Fork in the Road: How the Development Path Impacts the Regulatory Destination. |
| 8:55 - 9:35 |
Ranjit Puranik, CEO, Shree. Dhootpapeshwar Ltd., Mumbai. Good Manufacturing Practices for ISM drugs.
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| 9:35 - 9:55 |
Break |
| 9:55 - 10:35 |
Marguerite Klein, Program Officer, Division of Extramural Research and Training, NCCAM. Botanical Quality: NCCAM Policy and Guidance for Research. |
| 10:35 - 11:15 |
Mary L. Hardy, MD, UCLA Geffen School of Medicine. Herbal Interventions in Clinical Trials and Case Reports: Implications for Research & Regulation. |
| 11:15 - 11:55 |
Narendra Bhatt, B.Sc; M.D. (Ayu.), CEO, Zandu Pharmaceuticals, Mumbai, India. A Matrix Model Approach to Quality, Research and Regulation of 'CAM' Products - An Ayurvedic Perspective to Approach to Standardization of 'Cam' Products - An Ayurvedic Perspective |
| 11:55 - 12:40 |
Lunch – Oxford Conference Center Dining Hall |
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Session 7: Regulatory Aspects of Botanicals
Session Chair: Jeanne Rader, Ph.D., Director, Division of Research and Applied Technology, ONPLDS, CFSAN, FDA |
| 12:40 - 1:20 |
Jinhui Dou, Ph.D., Botanical Review Team, ODE-I, CDER, FDA. Assessment of the Current Standing of Botanical New Drug Development from Botanical Drug Review Experience.
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| 1:20 - 2:00 |
Nandini Kumar, MBBS, DCP & MHSc., Deputy Director General, Indian Council of Medical Research, Ansari Nagar, New Delhi, India. Indian Herbal Drugs - Regulatory Aspects. |
| 2:00 - 2:20 |
Break |
| 2:20 - 3:00 |
Vasilios (Bill) Frankos, Ph.D., Acting Director, Division of Dietary Supplement Programs, ONPLDS, CFSAN, FDA. FDA Update on Dietary Supplement Regulation and Safety.
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| 3:00 - 3:40 |
Luis G. Valerio, Jr., Ph.D., OFAS/CFSAN/US FDA. Predicting Rodent Carcinogenic Potential of Natural Chemicals Occurring in the Human Diet Using In Silico Quantitative Structure-Activity Relationship Modeling. |
| 3:40 - 4:30 |
Discussion Group - Closing Remarks - Comments |
| 4:30 - 6:00 |
Shuttles will take people to Hotels |
| 6:00 - 9:00 |
Dinner – Oxford University Club (Walking distance from Downtown Inn. Shuttles will take individuals to and from The Inn at Ole Miss). |
For additional information, please contact:
Ikhlas Khan, Ph.D.
Assistant Director
National Center for Natural Products Research
School of Pharmacy
Thad Cochran Research Center
The University of Mississippi
University, MS 38677
Phone: (662) 915-7821
Fax: (662) 915-7989
E-mail: ikhan@olemiss.edu
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