Providing expert regulatory, gene therapy and manufacturing advice

Challenge

A new GMP facility for the production of investigational therapies needed regulatory, gene therapy and manufacturing advice.

Solution

Our client was a European leader in the GMP production of cell therapeutics and viral vectors for gene therapy, and consequently had an extensive pipeline of prospective developmental products for both academic and commercial customers.

With the expectation that market demand for clinical trials supply of cellular and gene therapies was due to increase dramatically over the coming years, driven by rapid growth in gene therapy, CAR T- cell immunotherapy and other cellular therapeutics, our client wanted to develop plans to expand capacity and refine their manufacturing facilities. They also wanted to look at options for bringing in external capital.

We conducted a reality check and high-level due diligence exercise by interviewing key members of the client team to understand their customer base, capabilities and capacity, financials (actual and projected), development plans, any underpinning assumptions and projections, the context and status of any discussions with prospective investors, and the nature of any proposed transaction.

Our consultants reviewed the technical plans to ensure there were no red flags, and conducted an independent reality check of the development plans, based on a review of the materials provided, our knowledge of the market, and competition in supply of GMP cellular and gene therapy therapeutics, focusing on:

  • the opportunity for our client and the sustainability of market demand
  • the solidity of the development plans and the associated funding requirement
  • the arguments for creating a commercial entity and involvement of external capital
  • the prospective valuation of the entity and funding mechanisms
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