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Accidental Drugs: A Historical Look at How Certain Drugs Came to Market and Policy Pathway Opportunities
Session Chair(s)
Kimberly Belsky, MS
Reg Policy & Intell and AdPromo, Regulatory Affairs
Independent, United States
For drug history buffs and those interested in life cycle management, this session will review how drugs have been repurposed or found to have an unintentional off-target effect, the incentives for R&D that led to FDA approval and even blockbuster status and how collaboration can shape future opportunities.
Learning Objective : Identify the benefit to the patient and industry of drug repurposing for new indications and life cycle management through a historical review of accidental drugs; Explain how precompetitive collaborations and policy pathways can accelerate drug development; Identify how standardized methods can facilitate repurposing and address the needs of special populations through shared resources and modified regulatory pathways.
Speaker(s)
Accidental Drugs: A Historical Look at How Certain Drugs Came to Market and Policy Pathways
Kimberly Belsky, MS
Independent, United States
Reg Policy & Intell and AdPromo, Regulatory Affairs
Regulatory Innovation Incentives: Do They Work?
Andrew Robertson, JD, PhD
Takeda, United States
Vice President, Head of Global Regulatory Policy and Innovation
Upgrading the Paths to Approval for Neonatal Therapies
Lynn Diane Hudson, PhD
Critical Path Institute, United States
Chief Science Officer
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Ways to register
Registration override should work.