8:00 - 9:00: Open onsite registration – Oxford Conference Center (OCC) Lobby
9:00 - 10:00: Opening Session - OCC Auditorium
Welcome on behalf of the University of Mississippi and the School of Pharmacy
- Joseph Gladden, Interim Vice Chancellor, Research & Sponsored Programs, University of Mississippi
- David Allen, Dean and Executive Director, School of Pharmacy, University of Mississippi
Welcome and Introductory Remarks from Organizers
Introduction of Special Guest and Keynote Speaker
- Larry Walker, Director Emeritus, National Center for Natural Products Research (NCNPR), University of Mississippi
- Steven Tave, Director, Office of Dietary Supplement Programs; CFSAN/FDA
10:00-10:30 | Break
Session 1: "Update and Future Perspectives from the FDA"
Moderator and Session Chair: Sibyl Swift, Special Assistant, Office of Dietary Supplement Programs; CFSAN/FDA
10:30 - 10:50
Karen Hatwell, Senior Advisor for Chemistry, Senior Science Advisory Staff; CFSAN/FDA
"The CFSAN Strategic Research Plan and Research Objectives" - click for download
Cara Welch, Senior Advisor, Office of Dietary Supplement Programs; CFSAN/FDA
"FDA's Dietary Supplement Program: Overview and Update"
Shontell Wright, Chemist, Office of Dietary Supplements Programs; CFSAN/FDA
"The Secret to Successfully Identifying your Botanical NDI"
Meet at OCC side patio across from Cedar Room Dining Hall
12:00 - 1:00 | Lunch (OCC Cedar)
Session 2a: “The P&T Dilemma: Identifying, assessing and adding natural products to institutional formularies. Probiotics and other case examples.” - OCC Auditorium
Moderator and Session Chair: Rick Kingston, President of Regulatory and Scientific Affairs, SafetyCall & Corey Hilmas, Senior VP of Scientific & Regulatory Affairs, NPA
Carla Peterman Williams, Assistant Director of Pharmacy Clinical Services, University of Maryland Medical Center
Dan Fabricant, President and CEO, Natural Products Association
2:30 - 3:00 | Break (30min)
Session 2b: "Quality Assessment" - OCC Magnolia
Moderator and Session Chair: Amit Chandra, Manager Analytical Sciences-Chromatography Group, Amway Corporation
Kirsten Tripplett, QC Senior Scientist, Traditional Medicinals, Inc.
"Applying Macro-and Microscopic identification methods to multi-ingredient botanical dietary supplement finished products"
Maxleene Sandasi, Post-Doctoral Associate, Tshwane University of Technology
"Hyperspectral imaging: a potential tool for the quality control of herbal products"
2:30 - 3:00 | Break (30min)
Session 3a: "Safety Assessment Of Botanicals: 'Green Tea'" - OCC Auditorium
Moderator and Session Chair: Daniel Marsman, Head of Product Safety, Procter & Gamble Co.
Paolo Morazzoni, Scientific Director, Indena S.p.A.
"Curcuminoid-drug interactions: a first transversal clinical-based investigation"
Bill Gurley, Professor, University of Arkansas for Medical Science
"A preclinical safety assessment of the dietary supplement OxyElite Pro (new formula) using various mouse strains"
Igor Koturbash, Associate Professor, University of Arkansas for Medical Sciences
"Assessment of green tea extract hepatotoxicity in a mouse model"
Hellen Oketch-Rabah, Senior Scientific Liaison, U.S. Pharmacopeia Convention
"Green Tea Extract and Hepatotoxicity- Progress of work by USP GTEH Expert Panel"
Session 3b: "Natural Products Discovery and Development" - OCC Magnolia
Moderator and Session Chair: Xing-Cong Li, Principal Scientist, University of Mississippi
Jeffrey Langland, Chair, CINR, Southwest College of Naturopathic Medicine Center for Integrative Naturopathic Research
"Echinacea purpurea: Deciphering the Controversy behind Its Medicinal Properties"
Mohammad Sarwar Alam, Professor, Jamia Hamdard
"Antidiabetic effect of three new compounds isolated from the active methanolic fraction obtained from the roots of Trapa natans L."
Duan-Fang Liao, Professor, Hunan University of Chinese Medicine
"Nortriterpenoids and triterpenoids from stem of Kadsura heteroclite"
Wei Wang, Professor, Institute of Chinese Herbal Medicine
"Diverse Phytochemicals from Chinese Medicine and Hunan Ethnomedicine"
Sayeed Ahmad, Professor, Jamia Hamdard
Hypoglycemic potential of aqueous extract of Butea monsperma flower: A medicinal plant from Indian System of Medicine
6:00 - 8:00pm | Opening Reception
Reception/Mixer at the Lyric Oxford & Presentation of the Award for Outstanding Contribution in Natural Product Science
Session 4: "Clinical Toxicology Investigations Impacting Supplement Safety Surveillance" - OCC AuditoriumModerator and Session Chair: Larry Walker, Director Emeritus, NCNPR, University of Mississippi
Victor Navarro, Professor of Medicine, Jefferson Medical College
"Dietary Supplement Related Liver Injury"
Rick Kingston, President, SafteyCall
"Poison control incident data; dietary supplement AERs and safety signals"
9:45 - 10:15 | Break
Session 5a: "Prospects for Naturally Derived Cannabinoids as FDA Regulated Therapeutics" - OCC AuditoriumModerator and Session Chair: Mahmoud ElSohly, Research Professor, University of Mississippi
Ethan Russo, Director of Research and Development, International Cannabis and Cannabinoids Institute
"History of Cannabis as Medicine: Correlations to Modern Research"
Eric Marsh, Doctor, Children's Hospital of Philadelphia
"Clinical and Preclinical Data for Cannabidiol in Epilepsy: Real Signal through the Noise"
Larry Walker, Director Emeritus, University of Mississippi
"States' initiatives on Cannabis-derived products in the treatment of resistant childhood epilepsy: challenges and updates"
Session 5b: "Critical Uses of Reference Materials in Natural Products Science" - OCC MagnoliaModerators and Session Chairs: Joseph Betz, National Institutes of Health, Office of Dietary Supplements (NIH ODS) & Catherine Rimmer, Chemical Sciences Division, National Institute of Standards and Technology (NIST)
Adam Kuszak, Health Policy Analyst, Office of Dietary Supplements/National Institutes of Health
"The NIH ODS Analytical Methods and Reference Materials Program: recent activities and the road ahead"
Paula Brown, Director of Applied Research, Natural Health & Food Products, British Columbia Institute of Tech
"The critical role of reference materials in metabolomic approaches to natural products research"
Rahul Pawar, Research Chemist, Office of Regulatory Science/DBC/BMB FDA/Center for Food Safety and Applied Nutrition
"Sensitive and Rapid Quantitation of Three Ginkgolic Acids in Dietary Supplements of Ginkgo"
Catherine Rimmer, Research Chemist, National Institute of Standards and Technology
"ODS/NIST certified reference materials and Quality Assurance Programs for the botanical and natural products communities"
12:00 - 1:00 | Lunch
Session 5b (continued): "Critical Uses of Reference Materials in Natural Products Science" - OCC Magnolia
Holly Johnson, Chief Science Officer, American Herbal Products Association AHPA
"Reference Materials in Botanical Authentication"
Uma Sreenivasan, Head of Reference Materials R&D, Cerillant Millipore Sigma
"Reference materials, primary standards, and compendial standards: when and how each are used in quality control and basic research"
Cynthia Rider, Toxicologist, National Toxicology Program/National Institute of Environmental Health Sciences
"Reference materials as research reagents for 'biologic similarity' studies"
2:30 - 3:00 | Break (30min)
Session 6: "Big Data For Botanicals – Outlook And Recommendations" - OCC AuditoriumModerator and Session Chair: Amy Roe, Product Safety & Regulatory Affairs, The Procter & Gamble Company
Tim Baker, Research Fellow, The Procter & Gamble Company
"Analytical Characterization Platform for Chemical Constituents in Botanicals"
Donna McMillan, Research Fellow, Central Product Safety, The Procter & Gamble Company
"Large scale botanical and phytochemical data to assist in rapid analysis for safety assessment"
Suramya Waidyanatha, Discipline leader for chemistry, National Institute of Environmental Health Sciences, National Institute of Health
"Naturally Complex: The National Toxicology Program Strategy for Phytochemical Characterization of Botanical Dietary Supplements for Use in Safety Assessment"
2:30 - 3:00 | Break (30min)
Session 7a: "Natural Products and Cosmetics" - OCC Auditorium
Moderator and Session Chair: Shabana Khan, Principal Research Scientist, University of Mississippi
Stanislav Vukmanovic, General Health Scientist, DHHS/FDA/CFSAN/OFVM/CFSAN/OCAC/COS
"Hapten-Independent Mechanisms of Skin Sensitation"
Linda Loretz, Director, Safety and Regulatory Toxicology, Personal Care Product Council
"A Decision Tree Approach to Assess the Safety of Botanicals in Cosmetics"
Baatile Komane-Mofokeng, Graduate Student, Tshwane University of Technology
"Cosmetic applications of African seed oils: Clinical observations"
Session 7b: "Quality Assessment of Traditional Chinese Medicine" - OCC MagnoliaModerator and Session Chair: Jimmy Yuk, Senior Business Development Manager, Waters Corporation
Jinghui Wang, Chief Pharmacist, Beijing Institute of Drug Control
"Fingerprint Study in TCM Quality Control on scientific and regulatory basis"
Binbin Song, Technology Consultant, Chinese Pharmacopoeia
"Build up effective quality control of herbal medicine through improving Fingerprint similarity evaluation system - Fingerprint similarity evaluation system development and design for improvement"
Jinle Cheng, Chinese Pharmacist Director & Doctoral Supervisor, Guangzhou University of Chinese Medicine
"Development and quality control of Ultrafine Granular Power of TCM"
Zhong-Zhi Qian, Professor, Chinese Pharmacopoeia
"TCM Volume of Chinese Pharmacopoeia 2020 Edition"
Jimmy Yuk, Senior Business Development Manager, Waters Corporation
"Direct Visualization Of Botanicals Using Mass Spectrometry For Discovery And Quality Control"
Poster Session- OCC Oak
Session Chair: Amar Chittiboyina, University of MississippiA special session featuring poster presentations and a reception.
Session 8: "Natural Product Research and Regulation in the Americas: Work Underway Across the Region" - OCC AuditoriumModerator and Session Chair: Michael Smith, Consultant, MJS Consulting
Mathew Bown, Senior Policy Advisor, Health Canada
"Modernizing the Regulation of Self-Care Products in Canada"
Rosa Amelia Villar Lopez, Country Representative, Health Ministry
"Research and Regulation Of Natural Products In Peru" - click to download
Veronica Margarita Lopez Moreno, Country Representative, Health Ministry; Daniel Gallego-Perez, PAHO/WHO
"Natural Products Regulation in Nicaragua And Way Forward, A Brief Case Study" - click for download
Lucrecia Pérez de Batres, Pharmacist, Universidad de San Carlos de Guatemala
"The Central American Regulation of Medicinal Natural Products" - click for download
Session 9a: "Natural Products Research On TCM" - OCC AuditoriumModerator and Session Chair: De-An Guo, Professor, Shanghai Institute of Materia Medica
Rong-Rong He, Professor, Jinan University
"Pharmacological evaluation of Chinese patent herbal medicine: a hard nut to crack"
Quan-bin Han, Professor, Hong Kong Baptist University
"The discovery, chemistry, and immunomodulating effects of a unique polysaccharide of Dendrobii Officinalis Caulis"
De-An Guo, Professor, Shanghai Institute of Materia Medica
"Discovery of effective combination in the exact of Ginkgo biloba"
Session 9b: "Future Initiatives on Dietary Supplements" - OCC Magnolia
Moderator and Session Chair: Loren Isrealsen, President, UNPA
Gloria Zhang, Director, Herbridge Media
"Regulatory and Environmental Trends in China : Clean, Land, Air and Water"
Mark Blumenthal, Founder/CEO, American Botanical Council
"Proposed BAPP Best Practices SOP for the Disposal/Destruction of Irreparably Defective Materials"
12:00 - 1:00 | Lunch (OCC Cedar)
Session 10a: "Town Hall Meeting" - OCC Auditorium
Moderators and Session Chairs:
President of Regulatory and Scientific Affairs, SafetyCall; Corey Hilmas, Senior VP of Scientific & Regulatory Affairs, NPA.
Session 10b: "CENAPT Workshop - Practical Implementation of Metabolomics for the Study of Botanicals"- OCC Magnolia
Moderator and Session Chair: Charlotte Simmler, Research Assistant Professor, Center for Natural Product Technologies (CENAPT), University of Illinois at Chicago
Paula Brown, Director of Applied Research, Natural Health & Food Products, British Columbia Institute of Technology
"Metabolomics Analysis as a Tool for Understanding Plant Secondary Metabolite Production and Improved Quality of Botanical-Based Products"
Joshua J. Kellogg, Post-Doctoral Associate, The University of North Carolina Greensboro
"Approaches to Evaluate Botanicals via Mass Spectrometry Metabolomics"
2:00 - 3:00 | Afternoon tour of NCNPR facilities or Medicinal Plant Garden
3:00 - 9:00pm | ICSB Picnic at the Jefferson
Located at The Jefferson, 365 Highway 6 East, Oxford, MS 38655
Join us for Food, Fun, Music and Outdoor Games
The shuttle leaves from the Conference Center at 3:00pm!
Session 11: "International Perspectives on Botanical Research" - OCC AuditoriumModerator and Session Chair: Stefan Gafner, Chief Science Officer, American Botanical Council
10:00 - 10:30 | Break
Session 12a: "Regulatory Aspects of Botanicals" - OCC Auditorium
Moderator and Session Chair: Jinhui Dou, Vice Dean, Yiling Pharmaceutical, Inc.
Charles Wu, Botanical Review Team Lead (Acting), FDA/CDER/OPQ-IO
"Challenge and Opportunity of Botanical Drug Product Approval in the U.S. -the FDA’s Perspective"
Yue Hua Zhou, Deputy Office Director, Office of Traditional Chinese Medicines, CDE, CFDA
Session 12b: "DNA Authentications" - OCC Magnolia
Moderator and Session Chair: Sarah Handy, Research Biologist, Center for Food Safety and Applied Nutrition
Pang-Chui Shaw, Professor, Chinese University of Hong Kong
"Authentication and quality control of concentrated herbal medicine granules by molecular technology"
David Erickson, Founder & CEO, DNA4 Technologies LLC
"Genome2-ID: A bioinformatic tool for unbiased and rapid species identification using genomic scale Next Generation Sequencing data"
Iffat Parveen, Research Scientist, University of Mississippi
"Family-specific DNA Mini-barcodes for Identification of Botanicals"
Santhosh Kumar J.U., Graduate Student, Kuvempu University
"DNA barcoding of Momordica species and assessment of adulteration in Momordica herbal products, an anti-diabetic drug"
12:10 - 1:10 | Lunch
Session 13: "Tools To Assess The Quality" - OCC Auditorium
Moderator and Session Chair: John Travis, Senior Research Scientist, NSF International
Michael Repka, Director Of The PII Center For Pharmaceutical Technology, University of Mississippi
"Critical Issues in the Development of Tablets and Capsules"
Jack Henion, Scientific Founder, Advion
"LC/MS Analysis of Cannabis-Samples for Cannabinoids and Pesticides Compounds Employing a Compact Mass Spectrometer"
Phil Wylie, Sr. Research Scientist, Agilent Technologies
"The Next Chapter in the Analysis of Pesticide Residues in Cannabis using GC/Q-TOF Instrumentation"
Giorgis Isaac, Principal Scientist, Waters
"Authentication of Botanicals and Herbal Products Using UPLC/Ion Mobility QTof-MS and a Metabolomics Approach"
Maged Sharaf, Chair Advisory Board & Director, CAMAG Scientific Inc.
"The International HPTLC Association"
Shi Qiu, Post-Doctoral Associate, University of Mississippi
"Ultra-high performance liquid chromatography─high resolution mass spectrometry guided characterization of new fusaricidins from Paenibacillus sp. MS 2379"
Mohammad Kamil, Professor, Zayed Complex for Herbal Research & Traditional Medicine
"Good Medicinal Plants Practices (GMPP) -Assuring Safety, Efficacy, and Quality of Botanical Products – From Field to Firm"
Afternoon tour of NCNPR facilities or Medicinal Plant Garden.
6:30pm | Closing Ceremony and Banquet - OCC Cedar
Our closing ceremony, including a wonderful plated dinner, poster awards, and a closing presentation by Dr. Ikhlas Khan.
Registration is required and is available online and onsite.