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,  Director; Carole Jones, Director, Market Access; Valerie Pimpaneau, Vice President, CMC & Quality; Emmanuelle Sabbah-Petrover,  Director, Complex Biologics; Gopalan Narayanan, Vice President, Disruptive Biologics; Susan Salako, Regulatory Scientist; François Gianelli, Senior Regulatory Scientist.

June 2017 - Regulatory Rapporteur

Cécile_Rousseau

Cécile F. 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. 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.

Valérie_Pimpaneau

Valérie Pimpaneau, Vice President CMC & Quality

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.

Emmanuelle_Sabbah-Petrover

Emmanuelle Sabbah-Petrover, Director Complex Biologics

As Associate Director at Voisin Consulting Life Sciences, Emmanuelle manages projects involving cell, gene & tissue-based medicinal products (“ATMPs”); from non-clinical to clinical phases, both in Europe & the US. Emmanuelle has a particular expertise in GMO requirements for experimental drugs in Europe.

Dr Narayanan

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.

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