Development Plan for a combined tissue-engineered product (ATMP)

The Project

Small biotech company (SME) developing an allogenic tissue-engineered product (TEP) for the treatment of heart failure that lacked the internal expertise for early-stage drug development plan.

The Challenge

The Challenge

Define an overall drug development plan at an early stage:

  • Regulatory strategy and recommended activities
  • Define milestones for manufacturing, nonclinical, clinical development
  • Time points for interaction with competent authorities (national and EMA)
  • Timelines
  • Cost (including fees and possible external support)
The Solution

The Solution

Client benefitted from Biopharma Excellence brain tank i.e., extensive ATMP, CMC and Strategy  experience.

  • Biopharma Excellence strategic expert provides development plan including:
    • Early development up to MAA
    • Timelines and costs
    • Advice on do‘s and don’ts
  • F-2-F-meeting to illustrate key elements and provision of further details
  • Supported client with experts for ATMP, Strategy, CMC, Nonclinical and Clinical Strategy
The Outcome

The Outcome

Reliable development plan for strategic decisions covering early development up to MAA.

  • Received reliable estimates for resources and timelines to achieve a central MA in a highly innovative field
  • Basis for strategic decision of Company’s management
  • Basis for Company’s management for budget negotiations with Investors
  • Regulatory support right from the start involving a strong partner that is able to support all steps from drug development to MA, and beyond

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