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Bioanalytics
Keynote

Keynote: Effective Drug Development Requires Rationales, Not Rules – Rethinking Guidance for Industry

Wednesday, October 23, 2024
1:30 PM – 2:30 PM MT
Location:151 ABCG

Bioanalytics

The increasing complexity of new and emerging modalities requires recognition that existing guidance was crafted to address simpler therapeutics and more limited contexts. To date, there has been an almost universal tendency to try to force-fit to existing guidance, rather than approaching new challenges (and rethinking old ones!) from first principles (i.e. think like a scientist). This presentation will highlight how reasoning by analogy has led to propagation of erroneous approaches in drug development with bioanalysis practices rooted in superstition rather than science. Such approaches cost time, money and resource and negatively impact our ability to efficiently deliver life changing therapies to patients. Lessons learned from the last 2 decades of data will demonstrate the pressing need for rationales, not rules when crafting guidance for industry.

Learning Objectives:

  • Re-evalaute current practices and apply scientific principles to drive method development and validation
  • Understand the common pitfalls associated with reasoning by analogy that can hinder drug development decision making
  • Apply first principles thinking to improve scientific approaches and build confidence in drug development decision making
  • Recognize where efforts are adding value vs not and focus on ROI to improve direction and course of drug development