Case Study

Device Platform Selection

The Situation

Company: Small Pharma

Issue: Lead injectable project being developed in an autoinjector and approaching clinical submission when the autoinjector manufacturer discontinued the platform

Project: Select an alternative autoinjector platform and maintain clinical timeline

Challenges Expressed:

  • Development work to-date completed with a discontinued autoinjector platform
  • New team members/perspectives led to different opinions on considerations for a new autoinjector platform
  • Limited manufacturing options for the final combination product (autoinjector assembly)
  • Cost-sensitivities given company size and product indication
  • Tight timeline to clinical submission and study initiation; critical to company funding
  • Very fast ground-up reassessment needed for the current team to provide inputs

Impact:

  • Redevelopment with new autoinjector required
  • Potentially delayed clinical start, adversely impacting company funding
  • Limited platform and manufacturing options given cost constraints

Discovery:

  • Initial total program costs not accurately assessed
  • Commercial manufacturing scale-up was not fully planned, but there was openness to considering options
  • Initial platform selection was not considered on a cross-functional basis
  • Clinical submission and study start timing were not precisely defined
  • Overall project management deficiencies existed

Solutions Implemented:

  • Led cross-functional team through multi-factorial decision-making process, utilizing SCI expertise in autoinjector platforms and development
  • Facilitated expedited engagements with autoinjector manufacturers to meet desired selection timeline
  • Informed senior management (CEO, board members) of cost and timing considerations, leading to project management reconfiguration to address team effectiveness
  • Crafted staged clinical development strategy to allow for quicker study start with prior autoinjector platform, bridging to new platform for a later study
  • Initiated work with selected autoinjector manufacturer in parallel with contracting to meet desired timeline to the clinic