Process Validation & Regulatory Strategies for Fast-track and Breakthrough Therapies

BioTechLogic’s Tracy TreDenick delivered a very well-received presentation at BPI West 2018 discussing process validation and regulatory strategies for expedited approval drugs.

BioTechLogic has done numerous projects supporting clients working to bring therapeutics with accelerated approval status to market. Given the complexity and the challenge of these programs, it’s little surprise that the talk was of such great interest.

Highlights of the presentation included discussion of:

  • Overview of FDA’s Expedited Pathway Designations
  • Look at 2012-2017 Breakthrough Therapy (BT) designation by therapy
  • Expedited vs traditional development program timelines
  • Common challenges for Breakthrough Therapy products
  • Regulatory
  • Common process development challenges for BT Products
  • Common analytical challenges for BT products
  • Common manufacturing challenges for BT products
  • Keys to a successful regulatory strategy
  • Understanding scientifically complete CMC sections
  • Process validation
  • Keys for successful validation

Review full presentation deck below: