Advanced therapy medicinal products (ATMPs), i.e., cell and gene therapy products, is a rapidly evolving field of therapeutic development. A significant proportion of the products are being developed by academia or small/medium-sized enterprises (SMEs).
The many challenges in translation posed by this class of products include aspects covering: manufacturing, non-clinical development plan as relevant to clinical trial, marketing authorization, and reimbursement. In this context, the term translation refers to the relevance of non-clinical data in relation to how it impacts on appropriate and efficient clinical development. In order to successfully overcome these challenges, a clear
understanding of the requirements and expectations of all the stakeholders is critical. This article aims to cover the potential challenges related to such translation and suggested approaches to find solutions based on experience and learnings from the perspective of European Union.
Cecile F. Rousseau, Director, Romaldas Maciulaitis, Dariusz Sladowski, Gopalan Narayanan, VP Disruptive Biologics
Gopalan Narayanan, Vice President Disruptive Biologics
Within VCLS, Dr Narayanan provides leadership in 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.
Cecile Rousseau, Director
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. Upon completing a Ph.D. program in Medical and Biological Engineering at the University Claude Bernard – Lyon 1 in 2002, Cécile proceeded with postdoctoral research in tissue engineering (including but not limited to cartilage, soft organs), toxicology and pharmacology at the Laboratory of Cartilage Biology and Engineering and at the Laboratory of Molecular Assemby of Biological Interest.