Despite their significant therapeutic potential, ATMPs face specific market access challenges compared to other therapeutic categories. These include high manufacturing costs, incremental benefit claims that extend over an extended time frame, restriction to centres of excellence and disruption of existing service delivery processes, often requiring significant reallocation of healthcare resources. Development, manufacturing and commercialisation are highly co-dependent processes and do not exist in the sequential, standalone systems in which small molecules and biologics function. In order for commercialisation to be successful, a constant feedback loop should be in place early on in development that drives quality, efficiency, scalability and patient-centred treatment management.
Gopalan Narayanan, Vice President Disruptive Biologics
Narayanan provides leadership within the area of complex and disruptive biologics such as Cell and Gene therapies, called Advanced Therapies Medicinal Products (ATMPs) in Europe, including guidance on product development and regulatory strategy. In addition, he participates in the global effort of rationalising the development process, by enabling innovative regulatory mechanisms through which Advanced Therapies and other disruptive biologics can be developed and brought to patients faster and more efficiently.