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Evaluation ViewAttendees 17

Pharmaceuticals (includes Biologics & Drugs)

Challenges in Precision Medicine Product Development

Wednesday, October 8, 2025
1:00 PM - 2:00 PM EST
Location/Room: 304
Advances in precision medicine have been met with significant regulatory, development and business challenges, including:
• The need for adaptive regulatory frameworks to accommodate the evolving landscape of precision medicine
• Managing and interpreting large volumes of diverse patient data to identify meaningful patterns and actionable insights.
• Ensuring accuracy of biomarkers
• Effective co-development strategies between therapeutic drug and companion diagnostic sponsors

While the FDA has committed to working with industry to expedite efforts for demonstrating he safety and efficacy of precision medicine products, it is critical for drug and companion diagnostic sponsors to understand the current obstacles affecting commercialization of these products.

Participants will be able to use this knowledge to understand what FDA expects and how to integrate FDA expectations into the product development plans.

Learning Objectives:

  • Understand challenges with designing analytical and clinical validation studies when co-developing companion diagnostics for precision medicine solutions targeting small patient subpopulations, and how to overcome these challenges
  • Recognize assay hurdles lending difficulty with identifying the appropriate patients eligible for clinical trial enrollment as well as eligibility for the right therapy after commercialization
  • Identify key considerations when selecting a diagnostic partner for a co-development program and the critical decisions impacting a successful commercialization