Saturday July 22, 2023 - Check Back for additional program details

**Program Subject to Change**


Executive Committee Meeting

Time: 9:00 am - 4:00 pm
Location: Lindon Oak Room

(Invitation Only)


Time: 9:00 am - 12:00 pm

Botanical Drugs: A Regulatory Approach on how FDA Reviews a Botanical Application

Moderator: Nandakumara Sarma, Ph.D., United States Pharmacopeia


Rajiv Agarwal, Ph.D, Ph.D, Expert Regulatory Review Scientist (CMC of Botanicals), NDPB1, DNDP1/ONDP/OPQ/CDER/FDA – Botanicals as Drugs: CMC and Regulatory Challenges

Donna Christner, Ph.D, Branch Chief, DNDAPI, ONDP/OPQ/CDER/FDA – Drug Master Files for Botanical Drugs:  What are They and How Does FDA Review Them?

Margaret M. Kober, R.Ph., M.P.A,  Chief, Project Management Staff Division of Regulatory Operations for Urology, Obstetric, and Gynecology, DRORDPURM/ORO/OND/CDER/FDA – Understanding the FDA Application Process

Mark Hirsch, MD, Medical Team Leader, DUOG/ORPURM/OND/CDER/FDA – Clinical Considerations

Charles Wu, Ph.D, Pharmacognosist, Botanical Team/ONDP IO/ONDP/OPQ/CDER/FDA – Botanical Review Considerations

Sang Ki Park, PhD, DABT; Toxicologist; DPT-ID/OND/CDER/FDA – Non-Clinical Aspects of a Botanical Drug Review:  What is Needed?


Time: 9:00 am - 12:00 pm

Biochemical and Biophysical Assay Design for Natural Product Discovery Campaigns

Presenters: Shilpa Shenoy Kurian (National Cancer Institute, National Institutes of Health) and Brice A. P. Wilson (National Cancer Institute, National Institutes of Health)


Time: 1:30 pm - 4:30 pm

 Current Topics in Botanical Safety

Presenters – Michelle Embry (HESI), Josh Kellogg (Penn State), Robin MarlesBarbara Sorkin (NIH), Charles Wu (USFDA)


Time: 1:30 pm - 4:30 pm

Fungal Identification Using Molecular Tools

Presenters: Huzefa Raja (University of North Carolina at Greensboro)


Time: 1:30 pm - 4:30 pm

Public Speaking for Scientists

Presenter: Nicholas Oberlies (University of North Carolina at Greensboro)

Opening Reception

Time: 6:00 pm - 9:00 pm
Location: Salon E-H


Sunday July 23, 2023

Monday July 24, 2023

Tuesday July 25, 2023

Wednesday July 26, 2023