The course comprises a mix of didactic lectures and discussions, enriched with homework based exercises. The 5 days of the course will be devoted to the following topics:
- Day 4: Developmental Aspects
For details on the course program, please review the preliminary schedule for the 2021 virtual course.
- To provide a basic understanding for the unique pharmacokinetic (PK) and pharmacodynamic (PD) properties of drug products that are based on peptides and proteins
- To facilitate an in-depth understanding of the molecular processes and determinants that govern the PK and PKPD behavior of protein therapeutics
- To introduce applied modeling and simulation as a tool to interpret and predict PK and PKPD behavior of protein therapeutics
- To highlight challenges frequently encountered during the development of protein therapeutics
Pharmaceutical scientists from industry, academia and regulatory agencies with basic knowledge in PK and PKPD that had only limited exposure to the challenges associated with developing protein therapeutics and that would like to receive a comprehensive first overview or refresher on the PK and PKPD of this class of compounds.
- The virtual course will be delivered using the Zoom platform, and will consist of a combination of streaming webcasts, live demonstrations, video-conference style discussions, and some homework assignments.
- All participants are required to attend the course via a computer with camera and microphone, and during discussion sessions, cameras are requested to be switched on for productive interactions.
- The number of course participants will be limited to 40 to allow for interactive discussions.
- The course will be held on April 12 to 16, 2021, from 9:00 am to 2:00 pm US Central Daylight Saving Time (CDT, UTC/GMT -5 hours). Please take time differences to your location into account.
- Johan Gabrielsson, PhD, Biopharmacon, Gothenburg, Sweden
- Bernd Meibohm, PhD, University of Tennessee Health Science Center, Memphis, TN
- Douglas Leipold, PhD, Genentech, South San Francisco, CA
- Gopi Shankar, PhD, Janssen, Spring House, PA
- Siddharth Sukumaran, PhD, Janssen, Spring House PA
- Stacey Tannenbaum, PhD, Astellas, Northbrook, IL
- Vijay Upreti, PhD, Amgen, San Francisco, CA
- Rajbharan Yadav, PhD, Genentech, South San Francisco, CA