Advanced therapy medicinal products (ATMPs) were making headlines long before SARS-CoV-2, the virus that causes COVID-19, emerged onto the scene. The successful development of COVID-19 vaccines, including mRNA vaccines, has brought next-generation therapies into the spotlight and boosted the long-term projections for growth in this sector. Christian K. Schneider at Biopharma Excellence outlines 5 strategies for success while avoiding common pitfalls.

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Bringing Novel Therapies to Market: 5 Strategies for Success

Advanced therapy medicinal products (ATMPs) were making headlines long before SARS-CoV-2, the virus that causes COVID-19, emerged onto the scene. The successful development of COVID-19 vaccines, including mRNA vaccines, has brought next-generation therapies into the spotlight and boosted the long-term projections for growth in this sector.

Nevertheless, although ATMPs hold great promise, exploiting the technology has been challenging. Organisations need to adopt multidisciplinary strategies that begin as early in the development process. Christian K. Schneider, head of Biopharma Excellence and Chief Medical Officer, outlines 5 strategies for success while avoiding common pitfalls.

Novel therapies, known as advanced therapy medicinal products (ATMPs) in Europe and as cell and gene therapy products (CGTPs) in the US, could be game changers for the treatment of severe conditions that today have only limited treatment options. Driven by scientific innovations, impressive clinical outcomes, and a succession of new product approvals, the market for advanced therapies is set to be worth almost $21.2 billion by 2028, according to analysts.

The ATMP sector is now considered to be at an “adolescent stage” by many analysts, which means it holds great promise for making personalised medicine a reality and improving global health through wider accessibility to innovative and personalised medicines and devices.

Promises and Challenges

With promises, however, come challenges. The model for innovative therapies is very different from that for conventional development, and more tailored approaches are needed. ATMPs typically deal with smaller patient populations; special requirements for manufacturing where patients’ lives can depend on the speed with which a therapy can move from bedside to manufacturing and back again; and pricing models that can make the therapy prohibitive for many payers.

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