Case Study

Partnership Assessment

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:

  • Project timeline delays
  • Significant cost overruns
  • Receipt of CRL from FDA

Project: Multilevel review of the company’s combination products program with remediation recommendation for:

Leadership Level

  • Platform strategy
  • Organizational structure\

Program Level

  • Experience
  • Decision-making
  • Cross-functional alignment
  • Regulatory submission documents

Challenges Expressed:

 

  • Lack of combination product at the leadership level 
  • Multiple regulatory failures
  • Inexperience managing the complex web of functional internal and external relationships required to successfully develop and launch a combination product (see below example diagram)

Impact:

  • Delayed launch anticipated
  • Budget overages
  • Nervous investors 

Discovery:

    • The CMC department was crossing swim lanes, doing Device work
    • Client’s team was not well-versed in Risk Management
    • Regulatory strategy was set by previous project standards instead of current regulations and project requirements
    • The client incorrectly assumed that the Device OEM would supply submission-ready and complete documentation
    • Poor budget and contingency planning 
    • The client and their Device Vendor were not aligned on clinically relevant parameters
    • Misaligned Quality Management Systems and expectations of each party’s role
    • Poor information sharing / Groups making independent decisions

    Solutions Implemented:

    • Delivered a detailed analysis of discoveries and their impact on the project’s budget, timeline, and ultimate success
    • Created a strategic plan for necessary activities for alleviating project roadblocks.
    • Provided roadmaps for aligning regulatory and quality management strategies between client and their device partners.
    • Developed a communication system and aligned/socialized roles and responsibilities of each involved party.
    • Shared insights to support the updating to a realistic go-forward budget and timeline.
    • Provided cross-functional combination product development trainings based on discovered educational needs at both the executive/leadership and execution levels.