Innovative therapies (such as cell and gene therapies) and precision medicine approaches are both based on the use of complex technologies, and potentially even employ the use of different regulated product types (e.g. biologics & devices or in vitro diagnostics). These areas are experiencing rapid evolution: growing scientific insight and clinical evidence, led to the development of highly effective therapies not only in rare disease but also in development for more prevalent and chronic conditions.

As their development requires integration of complex technologies (either in manufacturing processes or molecular evaluation of disease biology), regulators, policy makers and payers are adapting their approaches to evolve. We have seen many changes globally in their approach - how does Europe compare?

Who is This Track Designed For?

Developers of innovative therapies (such as gene and cell therapies), precision medicines and diagnostics: global biologics and IVD regulators, policy makers, industry leaders, academics, patients, HTA bodies representatives and payers.