Case Study

Vendor Relationship Management

The Situation

Company:Medium-sized Pharma developer with “some” combination product experience

Issue: Partnered with a Device OEM to develop/launch a new combination product and experiencing roadblocks that were delaying launch and increasing costs 

Project: Perform a multilevel review of the company’s combination products program at the leadership level (platform strategy, organizational structure) and at the program level (knowledge-base, decision-making, cross-functional alignment, regulatory submission documents/processes). After discovery, perform remediation and propose a path forward.

Challenges Expressed:

  • Under-resourced staff overloaded with work that often fell outside of their area of expertise
  • Lack of understanding of combination product development processes at the management level
  • Lack of practical knowledge of Risk Management
  • Investors getting “antsy”
  • Frustrations with vendors inability to provide needed deliverables and project oversight

Impact:

  • Project timeline delays
  • Significant cost overruns
  • Receipt of CRL from FDA
  • Potential future loss of funding

Discovery:

  • Management was not experienced in combination products, creating misguidance in executive decision-making related to these programs
  • Regulatory strategy was set based on previous projects, despite client having multiple previous regulatory failures
  • The CMC team was doing Device work
  • There was insufficient in-house talent that was well-versed enough in Risk Management
  • False assumptions that the device OEM would supply submission-ready and complete regulatory documentation
  • Client and device vendor were not aligned on clinically relevant parameters or quality management systems and expectations of each party’s role
  • Lack of effective communications systems and decision-making collaboration/roles

Solutions Implemented:

  • Created and taught education/training modules to address executive team knowledge gaps
  • Provided roadmap for necessary cross-functional collaboration and inputs and set up role-appropriate communication and decision-making processes
  • Embedded regulatory subject matter experts to perform remediation and set up processes for client to monitor and apply evolving regulations
  • Provided interpretation, preparation, and in-meeting support for FDA Q&As
  • Performed DHF remediation
  • Embedded device development subject matter experts, including Risk Management consultants, to provide functional expertise and relieve CMC team so they could focus on their role more effectively
  • Aligned expectations and systems between client and device OEM for regulatory, clinical, and quality efficiency and completeness