COURSE PROGRAM

The course comprises a mix of didactic lectures and hands-on PKPD exercises. The five course days will be devoted to the following topics:

  • Day 1: Basic Concepts
  • Day 2: Drug Disposition
  • Day 3: PK/PD
  • Day 4: Drug Development Aspects
  • Day 5: Immunogenicity

For details on the course program, please review the preliminary 2024 course schedule. 

COURSE OBJECTIVES

  • 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

TARGET AUDIENCE

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.



COURSE FACULTY

  • Johan Gabrielsson, PhD, MedDoor AB, Gothenburg, Sweden​
  • Bernd Meibohm, PhD, University of Tennessee Health Science Center, Memphis, TN​
  • Douglas Leipold, PhD, Genentech, South San Francisco, CA
  • Gopi Shankar, PhD, Larimar Therapeutics, Janssen, Bala Cynwyd, PA
  • Sid Sukumaran, PhD, Janssen, Spring House, PA
  • Stacey Tannenbaum, PhD, Metrum Research Group, Tariffville, CT
  • Vijay Upreti, PhD, Amgen, San Francisco, CA​​


COURSE LOGISTICS

The virtual course will be delivered using the Zoom platform, and will consist of a combination of streaming live lectures, live demonstrations, and video-conference style discussions.

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 from 9:00 am to 2:00 pm US Central Daylight Saving Time. Please take the time difference to your location into account.