Speakers: Scott Obach (Pfizer), David Boudet (Theravance), Honghui Zhou (Johnson & Johnson), Xinning Yang (FDA), Bo Feng (Vertex) and Marciej Zamek-Gliszczynski (GSK)
Organizers: Tracy Chen (Jazz) and Snow Ge (QED)
Date: 2021-09-23- 09/24/2021
Time: 8:30-12:30 Pacific Time
Registration fee: (USD):
Location: Online via Zoom
Major Sponsor: (2)BioIVT; Sekisui XenoTech, LLC
Vendor show vendors registered to date:
Registration: http://www.PBSS.org
Registration deadline:2021-09-22  (it will close sooner if the seating cap is reached)

About the Topic

Note: the meeting times are 8:30am - 12:30pm Pacific Time on Sept 23 and 24. 

Drug interaction is an important consideration throughout drug development.  Since each drug candidate has its unique drug interaction profile in the context of the intended indication, there are no universally accepted strategies for evaluating drug interaction potentials; however, but there are generally adopted drug interaction strategies and practices developed by the industry and regulatory authorities such as the US FDA. 

The goal of this meeting is to provide:
1) a basic introduction to drug interactions
2) a detailed discussion on the 2020 FDA drug interaction guidances
3) a series of case studies on drug interactions involving drug transporters and metabolizing enzymes. 

The speakers are leaders in the field of drug interactions from the FDA and the Pharma/Biotech industry and are involved with the IQ Consortium DDI Working Group and/or the International Transporter Consortium.

Symposium Agenda – Day 1

8:30 - 8:45 am (PST) / 11:30 - 11:45 am (EST)            Introductions - Cuiping Chen (Jazz)

8:45 - 9:45 am (PST) / 11:45 - 12:45 am (EST)            In vitro CYP-mediated DDI - Scott Obach (Pfizer)

9:45 - 10:45 am (PST) / 12:45 - 1:45 pm (EST)           Therapeutic protein-drug interactions: mechanisms and clinical relevance - Honghui Zhou (Janssen/JNJ)

10:45 - 10:55 am (PST) / 1:45 - 1:55 pm (EST)           Major Sponsor Presentation - BioIVT

10:55 – 11:10 am (PST) / 1:55 - 2:10 pm (EST)           Break

11:10 - 12:10 am (PST) / 2:10 - 3:10 pm (EST)           FDA’s Perspective on Clinical Drug Interactions Mediated by Enzymes - Xinning Yang (FDA)

12:10 - 12:45 pm (PST) / 3:10 - 3:45 pm (EST)           Panel Discussion Day 1 - All Speakers, moderated by Cuiping Chen (Jazz Pharmaceuticals) 

Symposium Agenda – Day 2

8:30 - 8:45 am (PST) / 11:30 - 11:45 am (EST)            Welcome Remarks - Snow Ge (QED Therapeutics)

8:45 - 9:45 am (PST) / 11:45 - 12:45 am (EST)            Transporter DDI risk assessment – A preclinical perspective - Bo Feng (Vertex)

9:45 - 10:45 am (PST) / 12:45 - 1:45 pm (EST)           In vivo transporter–mediated DDI - Maciej Zamek-Gliszczynski (GSK)

10:45 - 10:55 am (PST) / 1:45 - 1:55 pm (EST)           Major Sponsor Presentation - Sekisui XenoTech

10:55 – 11:10 am (PST) / 1:55 - 2:10 pm (EST)           Break

11:10 - 12:10 am (PST) / 2:10 - 3:10 pm (EST)           FDA’s perspective on the DDI guidance - XinningYang (FDA)

12:10 - 12:45 pm (PST) / 3:10 - 3:45 pm (EST)           Panel Discussion Day 2  - All Speakers, moderated by Snow (QED Therapeutics )