Can't-miss conference covers botanical science, regulation

Can't-miss conference covers botanical science, regulation

Check out the final agenda for the 13th Annual Oxford International Conference on the Science & Regulation of Botanicals on April 15 to 17. Register today!


8 to 9 a.m. Open onsite registration – Oxford Conference Center (OCC) Lobby

9 to 10 a.m. Welcome and introductory remarks (OCC) Auditorium

  • Larry A. Walker, PhD, Director, NCNPR
  • David D. Allen, RPh, PhD, Dean of the School of Pharmacy, Executive Director of the Research Institute of Pharmaceutical Sciences and Professor of Pharmacology
  • Alice M. Clark, PhD, Vice-Chancellor for Research and Sponsored Programs, Frederick A.P. Barnard Distinguished Professor
  • Ikhlas Khan, PhD, Director UM-FDA Center of Excellence

Inaugural Address

  • Daniel Fabricant, PhD, Director, Division of Dietary Supplement Programs, ONLDS/CFSAN/FDA

10 to 10:30 a.m. Break

10:30 a.m. to 12 p.m. SESSION 1: Two Perspectives on the Safety, Science & Quality of Botanicals 20 Years after DSHEA. Moderator and session chair: Mark Blumenthal

  • Loren D. Israelsen, President, United Natural Products Alliance
  • Daniel Fabricant, PhD, Director, Division of Dietary Supplement Programs, ONLDS/CFSAN/FDA

12 to 12:15 p.m. Conference photograph (Meet at OCC side patio across from Cedar Room Dining Hall)

12:15 to 1 p.m. Lunch – OCC Cedar Room Dining Hall

1 to 2:30 p.m. SESSION 2: Update and Future Perspectives from the Regulator. Moderator and session chair: Daniel Fabricant, PhD

  • Angela F. Pope, PhD, Consumer Safety Officer, GMP Team, FDA: “Top GMP Inspection Observations and Concerns: Why Do These Problems Persist?”
  • Cara Welch, PhD, Regulatory Special Assistant, Division of Dietary Supplement Programs, ONLDS/CFSAN/FDA: “AERs, Ingredient Safety, and Labeling: An Update”
  • Charles Wu, PhD, Pharmacologist, FDA: “Development of botanical new drugs - US FDA's regulatory perspectives”

2:30 to 3 p.m. Panel Discussion

3 to 3:30 p.m. Break

3:30 to 5 p.m. SESSION 3: Standards, Methods and Key PrioritiesModerator and session chair: De-an Guo, PhD

  • Joseph M. Betz, PhD, Director, Dietary Supplement Methods and Reference Materials Program, Office of Dietary Supplements, National Institutes of Health: “The NIH Office of Dietary Supplements: A Twenty-year retrospective”
  • Hai-nan Wang, MD, Director, Division of Traditional Chinese Medicine, Department of Drug and Cosmetic Registration, China Food and Drug Administration: “Current Regulatory Status of TCM and Natural Medicinal Products of China”
  • Zhong-zhi Qian, PhD, Department of Administrative Affairs, Chinese Pharmacopoeia Commission: “Development of Pharmocopoeial standards in China”

5:30 p.m. Reception/Dinner for faculty and all attendees



8:30 to 10 a.m. SESSION 4: Creating a Corporate Culture of Compliance. Moderator and Session Chair: Rick Kingston, PharmD.

  • Dan Marsman, DVM, PhD, Section Head, Product Safety and Regulatory Affairs, Procter & Gamble Company: “Dietary Supplement Product Stewardship and Regulatory Compliance – a Corporate View”
  • Frank Jaksch, CEO, ChromaDex, Inc., Irvine, CA, USA: “Testing to a Standard: How to Stop Lab Shopping”
  • Jay Udani, MD, CEO and Medical Director, Medicus Research: “How Will New FDA Guidelines Regarding INDs for Research Studies on Functional Foods and Dietary Supplements Affect Claims Substantiation, for the Natural Products Industry?”

10 to 10:30 a.m. Break

10:30 a.m. to 12 p.m. SESSION 5: Collaborations for Safety, Postmarket Surveillance and Regulatory Reporting. Moderator and session chair: Rick Kingston, PharmD.

  • Rick Kingston, PharmD, President, Regulatory and Scientific Affairs, Safety Call International, and Clinical Professor of Pharmacy, University of Minnesota: “Postmarket Surveillance: Integrating the Needs of Industry, Academia, Government and Consumers”
  • Victor Navarro, MD, Chairman, Division of Hepatology; Medical Director, Liver Transplantation, Einstein Medical Center, Philadelphia: “Challenges in Investigating Potential Cases of Botanical Induced Liver Damage: A Clinician’s View”
  • Pieter Cohen, MD, General Internist, Cambridge Health Alliance; Assistant Professor of Medicine, Harvard Medical School: “Detecting dangerous supplements: is Med Watch enough?”

12 to 1 p.m. Lunch – OCC Cedar Room Dining Hall

1 to 2:30 p.m. SESSION 6: Communicating Safety to Consumers. Moderator and session chair: Bill Gurley, PhD

  • Andrew Shao, PhD, VP, Global Product Science & Safety, Herbalife: “Communications to the end-user: Informing decisions for notice, advisory and warning statements on dietary supplements”
  • Mark Blumenthal, Executive Director, American Botanical Council: “Quality Considerations in the Global Herb Market: Accidental and Intentional Adulteration of Botanical Raw Materials & Extracts”
  • Chris Xing, PhD, Associate Professor, Department of Medicinal Chemistry, College of Pharmacy, University of Minnesota: “Kava’s cancer prevention potential and hepatotoxic risk – what do we know and what shall we do?”

2:30 to 3:30 p.m. Break

3:30 to 5 p.m. Lawn Games and BBQ



8:30 to 10:10 a.m. SESSION 7: International Perspective on the Development of Botanicals. Moderator and Session Chair: Larry Walker, PhD

  • De-an Guo, PhD, Shanghai Research Center for TCM Modernization, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai 201203, P.R. China: “Progress made in development of Chinese traditional Medicine”
  • Yuan Shiun Chang, PhD, Professor, China Medical University, Taiwan, Republic of China: “Regulation and Quality Control of Chinese Medicines in Taiwan”
  • Ed Fletcher, Chief Operating Officer, Strategic Sourcing, Inc.: “Looking at the Industry DSHEA Built”
  • Ghulam Nabi Qazi, PhD, Vice Chancellor, Jamia Hamdard (Hamdard University): “Current Status of Indian Systems of Medicine”

10:10 to 10:30 a.m. Break

10:30 a.m. to 12:10 p.m. SESSION 8: Modern Analytical Techniques. Moderator and Session Chair: Joseph M. Betz, PhD

  • Fabien Scorza, Sales & Marketing Manager, CAMAG Scientific Inc.
  • Kate Yu, Senior Manager of Business Operations, QC & Manufacture, Pharmaceutical Life Science, Waters Corporation
  • Steven M.  Royce, Americas Food Segment Manager, Agilent Technologies, Life Sciences & Chemical Analysis.

12:10 to 1 p.m. Lunch – OCC Cedar Room Dining Hall

1 to 2:30 p.m. SESSION 9: The Media’s Role in Educating Industry and the Public. Moderator and Session Chair: Frank Lampe

  • Malcom Spicer, Managing Editor, The Tan Sheet
  • Marc Brush, Editor in Chief, Nutrition Business Journal
  • Mike O'Keeffe, New York Daily News

2:30 to 3 p.m. Break

3 to 4 p.m. Industry Reaction Panel. Moderator and session chair: Loren D. Israelsen, JD

  • Maged Sharaf,  Chief Science Officer, American Herbal Products Association
  • Steve Mister, President and CEO, Council for Responsible Nutrition
  • Andrew T. O’Hare (Andy), CAE, Sr. VP Government Affairs/COO, Natural Products Association

4 to 5 p.m. Afternoon tour of NCNPR facilities

6 p.m. Banquet for all faculty and attendees




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