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
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
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
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