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Translational Clinical Pharmacology
Symposia

Symposium 5: FDA Modernization Act 2.0: How do we Fully Leverage this Unique Opportunity to Transform Drug Development?

Monday, September 9, 2024
8:00 AM – 9:30 AM ET
Location:Grand Ballroom A-C
CE: 1.5

    Co-Chair & Faculty(s)

  • Navin Goyal, PhD

    Senior Director & Group Lead
    Clinical Pharmacology & Pharmacometrics
    Janssen Research & Development, LLC, a Johnson & Johnson Co

    Slides

  • Gwendolyn Pais, PhD

    Research Assistant Professor
    Pharmacy Practice
    Midwestern Univ Chicago Coll of Pharmacy

    • Faculty(s)

  • Rodrigo Cristofoletti, PhD (he/him/his)

    Assistant Professor, Ctr for Pharmacometrics & Systems Pharmacology
    Pharmaceutics, Lake Nona
    Univ of Florida Coll of Pharmacy

  • Daniel Levner, MS, PhD

    Chief Technology Officer
    Emulate Inc

  • Wendy Wu, PhD

    Chemist
    Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Ctr for Drug Evaluation & Review
    US Food & Drug Administration

Target Audience:

This Symposium presents valid content that matches the scope of practice of an interprofessional target audience including research scientists and healthcare professionals in industry, regulatory and academia.



Description:

This Symposium is designed to clarify the US Food & Drug Administration’s (FDA) position on acceptable alternative methods for regulatory submission, the requirement of human as well as animal organ or organoids-on-a-chip and the need for microphysiological systems. In addition, the target audience will gain a better insight into the rigors of testing involved and a better appreciation of the cost-benefit analysis of the new technology.

Goals & Objectives:

Following the completion of this activity, the learner will be able to:
  • Restate the New Alternative Methods acceptable by the US FDA;
  • Explain the requirement of human, as well as animal, organ or organoids-on-a-chip and the need for microphysiological systems;
  • Identify the performance validation needed and the cost-benefit of implementing this new technology.

Presentations:

  • Introduction & Motivation

    Co-Chair & Faculty: Navin S. Goyal, PhD – Janssen Research & Development, LLC, a Johnson & Johnson Co

  • Evolving Drug Development Landscape: Challenges as We Move Away From the Traditional Paradigm

    Co-Chair & Faculty: Gwendolyn Pais, PhD – Midwestern Univ Chicago Coll of Pharmacy

  • Opportunity to Innovate & Push Frontiers: Regulatory Science

    Faculty: Wendy Wu, PhD – US Food & Drug Administration

  • Performance Assessment & Economic Analysis of a Human Liver-Chip for Predictive Toxicology

    Faculty: Daniel Levner, MS, PhD – Emulate Inc

  • Microfluidics & Organ-on-a-chip: Exploiting Potential to the Fullest

    Faculty: Rodrigo Cristofoletti, PhD (he/him/his) – Univ of Florida Coll of Pharmacy

  • Discussion, Questions & Answers, Learner Feedback & Evaluations