Saturday July 22nd
(Subject to change).
9:00 AM - 12:00 PM
AMWS-1 - Botanical Drugs: A Regulatory Approach on how FDA reviews a Botanical Application
(20 min presentation each, followed by panel discussion and Q&A)
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?
AMWS-2 - Biochemical and Biophysical Assay Design for Natural Product Discovery Campaigns
This workshop seeks to engage the ASP scientific community in a dialogue regarding strategies to develop purpose-built biochemical and biophysical assays for the discovery of natural products. This workshop will highlight parameters to consider when developing these types of assays specifically for use in screening both fractionated and crude natural product extract libraries. Commonly encountered natural product derived pan-assay interfering substances (PAINS) and strategies to diminish their impact on a screening assay will be discussed, as well as specific triage strategies that may be deployed to identify and prioritize high value screening leads for follow up. The importance in developing orthogonal assays for lead confirmation and target specificity will be highlighted. For the biochemical assays, multiple types of cell free primary screening assays will be introduced (including fluorescence-based assays and ELISA assays, among others) with an emphasis on those assays requiring enzymatic turnover to generate a signal. In the case of biophysical assays, the workshop will highlight the use of ThermoFluor (DSF) technologies, its utility, and limitations in the context of high throughput screening initiatives with special attention paid to the kind of data analysis required for this type of high content screening. Orthogonal evaluation of lead compounds via circular dichroism, thermophoresis, and calorimetry will also be discussed.
1:30 PM - 4:30 PM
PMWS-1 - Current Topics in Botanical Safety
The growing popularity and interest in botanical products on a global scale has led to an increased focus on appropriate safety evaluation of these complex materials. These include aspects related to the characterization and identification of the material, challenges within the regulatory space, and the approaches and methods that can be effectively used to evaluate safety. Various tools, including new approach methodologies (NAMs) that can help screen for potential toxicity, are being explored and adapted for botanicals. In addition, strategies are being developed to connect the scientific advances in analytical chemistry, substance characterization, toxicology, pharmacognosy, and regulatory science, with the aim of improving overall botanical safety. This session will highlight recent and ongoing developments and challenges related to safety evaluation of botanicals, including updates from the Botanical Safety Consortium.
Michelle Embry (HESI), Josh Kellogg (Penn State), Robin Marles, Barbara Sorkin (NIH), Charles Wu (USFDA)
PMWS-2 - Fungal Identification Using Molecular Tools
This workshop will focus on fungal identification using molecular tools. I will use the 2017 manuscript (Raja, H.A., Miller, A.N., Pearce, C.J., and Oberlies, N.H., 2017. Fungal identification using molecular tools: a primer for the natural products research community. Journal of natural products, 80(3), pp.756-770.), as a guideline to conduct this workshop.
We will talk about several aspects related to the molecular identification of fungi during the workshop, which include:
How to obtain sequence data?
1. What regions of fungal genetic data to focus for fungal identification?
2. How to conduct a BLAST search? How not to use BLAST data alone to identify a fungus. Best practices in fungal taxonomy. Some essential terms include HOLOTYPE, ex-type culture, etc.
3. Phylogenetic analysis tools. We will look at some commonly used free tools that can help with molecular phylogenetic analysis.
4. Finally, if you have your sequence data with you, I can help you through your data analysis or steer you in the right direction.
PMWS-3 - Public Speaking for Scientists
Do you wish to improve your scientific communication skills? Have you ever watched someone presenting their data and wondered how they have gotten this far in their career with such poor communication skills? Do you understand what they are discussing? Does anyone in the room understand what they are discussing? Would they go a lot farther if they simply could connect with the audience better? Have you ever had doubts about your own presenting skills? While it is true that some people simply have a knack for presenting, it is absolutely a skill that can be learned, honed, and perfected (particularly for scientists). This workshop will go through some highlights and tips that scientists can use to help them present their 'scientific story' better.
Nicholas Oberlies (University of North Carolina at Greensboro)