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.
Carole has specialized in the field of Market Access and has an extensive track record of working directly with NICE and NIHR on Health Technology Assessments and policy development in the UK. Carole has close working relationships with several Clinical Commissioning Groups in England, G-BA, HAS and the Centers for Medicare & Medicaid Services in the U.S. which provides an intimate perspective of the changing customer and the future implications for the commissioning of pharmaceutical products. Carole works closely with our clients to ensure an aligned and integrated clinical program and commercialization strategy.View Profile
Gopalan Narayanan is Vice-President, Disruptive Biologics at VCLS. He provides advice and guidance on the global development and regulatory strategy for ATMPs and complex disruptive biologics based on substantial experience in the field as previous medicines regulator in Europe.View Profile