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
Rajiv Agarwal (CMC of Botanicals), Donna Christner (DNDAPI, ONDP/OPQ/CDER/FDA), Margaret M. Kober (Food and Drug Administration), Mark Hirsch (DUOG/ORPURM/OND/CDER/FDA), Charles Wu (ONDP IO, ONDP/ OPQ/CDER/FDA)
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.
Presenters - TBD
PMWS-2 - Fungal Taxonomy
Presenters - TBD