Advanced Therapy Medicinal Products (ATMPs) are an innovative type of medicines for human use, based on genes, cells or tissues. The multiplicity of clinical studies involving ATMPs and more especially GMO products has brought us to focus on the specific requirements for these type of clinical trials.
The aim of this article is to synthesize the European regulation of the ATMPs and particularly to discuss some of the European national specific procedures for clinical trials with Genetically Modified Organisms (GMOs). Because the use of GMOs in clinical trials falls under two directives in Europe, national implementation has led to a lot of differences between the European countries regarding regulatory framework, and administrative requirements for clinical trials with GMOs.
Key learning objectives :
Define the GMO frameworks “contained use” and “deliberate release” and understand the specific requirements resulting from it.
Provide an overview of the national regulatory framework in France, Germany, Italy and United Kingdom.
Emphasize the differences to open the discussion on the harmonization of the ATMP’s regulation among EU countries.
Marie MIchel, Senior Regulatory Scientist
Submission and maintenance of the clinical trial application package to European competent authorities and ethics committees, for small molecules and GMOs. Coordination of a project team to ensure that all national/local requirements for the concerned countries are checked and necessary documents are drafted and reviewed in accordance with local requirements.
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.
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.