eChalk Talk: Avoid getting "lost in translation" - Increase confidence in translational research usi

When:  Sep 28, 2022 from 13:15 to 13:45 (ET)
Associated with  AAPS Community

One of the pivotal milestones of early drug development is obtaining approval for an investigational new drug application (IND). A proposed first-in-human (FIH) study design is required for every IND application, of which a robust FIH dose rationale is a critical component. Physiologically-based pharmacokinetic (PBPK) modeling is a methodology based upon in-depth mechanistic understanding of the biological and pharmacologic phenomena which determine in vivo PK in animals and humans. Consequently, PBPK models are well-posed to make robust predictions of in vivo PK exposures, even when based on the limited data available during the initial stages of drug development. As such, PBPK approaches are being increasingly employed to strengthen the FIH dose rationale.

Other applications of PBPK in early development include guiding early formulation development and facilitating lead candidate selection. This eChalkTalk will focus on how PBPK modeling can be applied during early drug development with a particular focus on optimal FIH candidate and dose selection, thereby enhancing the odds of a successful IND and subsequent clinical development.

In this webinar you will learn about:

  • Basic PBPK concepts
  • Paradigms for applying PBPK to FIH dose selection
  • Other potential applications for PBPK in the discovery and pre-clinical phases of drug development


Mark has 20+ years of experience in applying modeling and simulation tools and techniques toward optimally informing drug development decision-making. Throughout his career, Mark has led and contributed to numerous consultancy projects involving population PK, PKPD, and model-based meta-analysis. Mark currently leads Certara’s Quantitative Science Services for the United States. His previous work history has been split between biopharmaceutical companies (GSK and UCB) and companies that support the biopharmaceutical industry (Quintiles and Pharsight.).

In addition to modeling pharmacokinetic and pharmacodynamic data across a wide variety of compounds and therapeutic areas, Mark has also taught more than 50 technical training workshops on modeling tools and methodology. His most recent therapeutic area experience has been with therapies for infectious disease, metabolic, and autoimmune disorders.


Online Instructions:
Download to Your Calendar Outlook Google