Analysis Group Managing Principals Mei Sheng Duh and Michael Holland Join Panel on Risks and Rewards of Accelerated FDA Pathways 

Event:Risks and Rewards of Accelerated FDA Pathways
Date: March 29, 2018
Host:Mintz Levin
Location:Mintz Levin, One Financial Center, Room 38A,, Boston, MA
Times:1:30–4:00 p.m. (PT) / 4:30–7:00 p.m. (ET)

Recently, the options for accelerated FDA pathways have increased – for devices, drugs, and biologics. The political dialogue over drug pricing has increased scrutiny of expedited approvals. Analysis Group Managing Principals Mei Sheng Duh and Michael Holland will join Peter Stebbins of J&J Innovation and Aoife Brennan of Synlogic in a panel discussion moderated by Bethany Hills, chair of Mintz Levin's FDA practice, on the risks and rewards of utilizing accelerated FDA pathways. The discussion will bring a variety of perspectives to the topic of pursuing an accelerated FDA pathway, focusing on whether the shorter time to market carries risks, and delving into its rewards. 

Discussion points will include:

  • When to consider an alternative pathway to approval
  • Risks, including clinical and data risks, and the chance of FDA denial
  • Clinical and data risks
  • Market perceptions (increased value, rising stock prices)
  • Realities of the pathways
  • Pairing exclusivity and accelerated pathways
  • Finance theory on risk and stock pricing

 

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