Advanced therapy medicinal products (ATMPs) belong to a rapidly developing, state-of-the-art field of science and technology in the EU. Due to the complex nature of ATMPs involving gene and cell therapy products, product development can be challenging. Regulatory approval and the final commercial reimbursement needed for an adequate return on investment can also be difficult to obtain. The ATMP development programme should aim to streamline development and avoid known pitfalls in order to produce a viable product that will fulfil its potential in the real-world setting.
This paper discusses an innovative and collaborative approach that needs to be adopted from discovery through all stages of development for ATMPs.
Cecile F. Rousseau, Associate Director; Carole Jones, Director, Market Access; Valerie Pimpaneau, Vice President, CMC & Quality; Emmanuelle Sabbah-Petrover, Associate Director, Complex Biologics; Gopalan Narayanan, Vice President, Disruptive Biologics; Susan Salako, Regulatory Scientist; François Gianelli, Senior Regulatory Scientist.
June 2017 - Regulatory Rapporteur
With 10+ years in nonclinical and translational research and histotechnology, Dr. Cécile F. Rousseau has considerable expertise in medical devices, engineered cellular therapies and companion diagnostics. Within VCLS, the main projects in which she is involved concern the nonclinical and clinical areas, including but not limited to medical devices, cellular therapy, gene therapy, and in vitro diagnostics.View Profile
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
Valerie Pimpaneau is responsible for the management of projects involving the development of CMC, bio-analytical and quality strategies for Drugs, Biologics, Gene and Cell Therapy. Her experience in the Biopharmaceutical industry allows Valerie to interface efficiently with the technical and regulatory teams and help coordinate CMC activities in line with the product development phases.View Profile
Emmanuelle Sabbah-Petrover is Associate Director, Complex Biologics at VCLS. Emmanuelle manages projects involving Advanced Therapy Medicinal Products (ATMP) especially gene therapy; from Non-Clinical to Clinical development phases, both in Europe & US.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