COURSE PROGRAM

The course comprises a mix of didactic lectures and hands-on PKPD data modeling and simulation. The 5 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 2017 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, Swedish University of Agricultural Sciences, Uppsala, 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
  • Eric Stefanich, PhD, Genentech, South San Francisco, CA
  • Stacey Tannenbaum, PhD, Astellas, Northbrook, IL
  • Vijay Upreti, PhD, Amgen, San Francisco, CA

​​