Dose Design: Bridging Early- and Late-Phase Development

Apr 24, 2018

Register Free: http://www.pharmtech.com/pt_w/design

With mounting pressure on innovators to achieve faster timelines and reduce development costs, clinical dose strategies in Phase 1 and 2 are often different from the final commercialized dose form. As companies transition to late-phase development, they must look beyond establishing proof of concept and consider patient needs, scalability and market variables to be successful. It is increasingly important for companies to understand the strategies they can utilize to streamline early-phase development while simultaneously preparing for commercial success. This webcast will discuss key concepts that should be addressed as a molecule advances through the clinical development phases including:

  • Clinical and commercial dosing strategies and the evolution of the dose form
  • Strategies to avoid long-term pitfalls while still meeting early-phase pressures
  • Transition from phase-appropriate to fully-validated analytical methods
  • Manufacturing scalability and tech transfers
  • Case study, including examples of a product evolution from first-in-human to Phase 3

 

Speakers:

Brent Moody, Principal Scientist, Catalent Pharma Solutions

 

Date and Time:

Live: Tuesday, 24 April, 2018 at 11 am EDT | 8 am PDT | 1600 BST | 1700 CEST

After the final airing of the webcast on 24 April, 2018 it will be available on demand until 24 April, 2019. 

Sponsor: Catalent Pharma Solutions

Register Free: http://www.pharmtech.com/pt_w/design

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