London was the setting last week for the 25th Annual Meeting of the International Society for Cellular Therapy. The huge increase of clinical trials in cell, gene and tissue therapy over the past 25 years, together with several new therapies reaching the patient, has resulted in this rapidly growing annual meeting with 1500 delegates attending this year. Simultaneously, there has been rapid growth in the number of businesses specialising in cell therapies, especially SME’s.

Don’t let talent shortages hold back new medicines

In common with other fast-growing SME’s, building a successful cell therapy company with strong intellectual and financial assets needs talented leadership that evolves over time as the business matures.

Typically, the steps are:

  • Stage 1: Foundation – Passionate scientist, usually the inventor. Funding from universities,charities, trusts, “catapults” and angel investors. Scientific Proof of Concept
  • Stage 2: Operational establishment and pre-clinical proof of concept. Requires different experience in leadership team supporting the CEO. Developing company further. Developing corporate and development strategies
  • Stage 3: First-in-man – Medical and regulatory expertise. Executing translational strategies, including early engagement with Regulators & KOL’s
  • Stage 4: Phases II & III – Project & budget management, dealing with numerous third party stakeholders – filing with authorities
  • Stage 5: Commercialisation and exit

We need to talk about cell therapy companies

To add to the complexity of building the right team, cell therapeutics requires some very specific expertise. Unfortunately, there’s a clear mismatch between the availability of the talent required and the demand for it. For example, cell therapy requires technical know-how for scale-up and building supply chains as well as regulatory expertise. People with these skills are often found in big pharma companies. However, much of the growth in demand for experts comes from SMEs which are acting increasingly like CMOs for big pharma customers. Similarly, people operating at a higher level have valuable networks and contacts that can smooth the path for pioneering new treatments. Their value can’t be over-estimated in enabling the commercialisation of new therapies and once again they’re rarely found in start-ups.

Planning the whole journey

Properly planned with the end in mind, the shape and talents of the management team can be staged to take new medicines to market as soon as is practically possible and to maximise return to investors. Having a plan that clearly anticipates all the skills that are going to be needed is vital to avoid hitting the roadblock you’ll hit without them.

Nick Stephens, Executive Chairman | Nick.Stephens@theRSAgroup.com

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