What are the need-to-know characteristics of regulatory, nonclinical and clinical specific to microbiome products? A translational perspective
- Regulatory environment for microbiome products, Differences between USA and EU regulatory requirements;
- Microbiome products NC evaluation compared to drugs/ biologics NC evaluation: same objectives but different strategies;
- Regulatory NC considerations and approach;
- Take-home messages: integrated approach CMC / nonclinical / clinical.
Clara Desvignes, Senior Regulatory Scientist
As a senior regulatory scientist at VCLS, Clara is involved in the development of microbiome-related health products, both in the medical and food area. Clara earned an engineering degree majoring in Sciences and Technologies of human biology, nutrition and food, at AgroParisTech, France. She also studied specialized food products in the University of Milan, Italy, as part of her engineering’s degree. Prior to joining VCLS, and as part of her engineering degree, Clara worked for 6 months at RNI-Consulting (Angers, France), where she gained particular experience in the areas of for nutritionals and nutraceuticals
Cecile Rousseau, Ph.D, 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 Assembly of Biological Interest.
Peri Aghadiuno, MBBS, MRCOG, Medical Director
Peri is a Medical Director with VCLS, She provides input into the drafting and critical review of clinical development plans including prospective drafting and gap analysis); critical review of clinical parts of EMA Scientific Advice, National Scientific Advice and Joint EMA-HTA bodies Scientific Advice briefing documents; responses to issues raised (by CHMP/National regulators)and corresponding presentations, critical review of clinical parts and significant benefit sections of ODD briefing documents and PIP briefing documents and the rehearsal of client presentations on clinical regulatory perspective for oral explanations when required.