Case Study

Design and Development Pivot

The Situation

Company: Big (Fortune 500) Pharma

Issue: Two projects hit time-sensitive design and development roadblocks that required quick strategic focus and execution.

Projects: 

Project 1: Drug delivery system received a complete response letter (CRL)encompassing significant portions of the design and development process. A competitive product was known to be entering the market soon.

Project 2: Drug delivery system was reaching end of life/salability and required urgent replacement and company had limited ability to sell legacy product and replenish stock.

Challenges Expressed:

  • Development work was completed on and unclearly defined system
  • Clear and consistent control and documentation in DHF and submission was lacking
  • Significant supplier quality concerns; Time and cultural differences needed bridging across their single-source supply chain and within client
  • Challenges gaining executive consensus on available options
  • Rapid evaluation of concerns, paths-forward, and updating documentation/testing to reduce regulatory risk was needed

Impact:

  • Potential loss of competitive advantage and market share for both products

Discovery:

  • Totality of testing requirements were not accurately assessed for either project
  • Supplier quality was incorrectly vetted for the legacy product
  • Market landscape for this type of drug delivery device was incompletely assessed at program outset for both products
  • Clinical bridging for the legacy product was inaccurately assessed, given requirement changes, as was device changes over the entire lifetime
  • Competing global requirements/needs were hijacking program resources for both projects

Solutions Implemented:

  • Led cross-functional team to address specific issues preventing approval; clarified previous feedback from the regulator; supported FDA engagements with no further significant/negative Agency feedback
  • Identified key attributes in submissions to clearly and explicitly support based on client’s product and use-case
  • Worked on-site with client’s supplier to bridge gap and facilitate rapid data exchange
  • Advised client on existing and known concerns in supply chain
  • Identified process improvements to support a successful submission of a replacement to their legacy product