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
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.
Carole Jones, Director Market Access
Carole leads the development of a Market Access service, working closely with the Regulatory and Clinical functions to ensure clients follow an aligned and integrated development program and commercialisation strategy. Responsibilities span protocol review, health economics, Health Technology Assessment submission and value communication services.