Mechanistic Modeling in Clinical Development


John M. Burke, PhD, Co-founder, President and CEO at Applied BioMath


In the final episode of this three-part GENcast series, we discuss the virtues of mechanistic modeling and how it can significantly impact critical decision-making points in the drug discovery process, an especially critical step as drug developers move closer to IND. Dr. John Burke, President, CEO, and Co-founder of Applied BioMath, discusses the specific applications of mechanistic modeling, including decision-making for first human dose numbers.

  • What is the role of mechanistic modeling in determining first-in-human starting doses, and how does it relate to traditional approaches like NOAEL and MABEL?
  • How do you guide customers through the process of selecting a first-in-human starting dose using mechanistic modeling?
  • What happens after a company files its IND (Investigational New Drug application), and how does mechanistic modeling come into play in the clinical trial phase?
  • How does uncertainty and variability impact the design of clinical trials in the context of mechanistic modeling?
  • Is there a situation where companies might opt for a different approach later in the drug development pipeline, rather than mechanistic modeling?

To read a shortened version of this podcast, click here: How Mechanistic Modeling Informs First-in-Human Dose Selection.

View our other podcasts in this GENcast Series

What is Mechanistic Modeling and How Can it be Applied in Drug Discovery?

Applying Mechanistic PK/PD Modeling Approaches in Preclinical Research