Microbiome science has grown over the past years with high potential to provide innovative, efficient, and targeted solutions to various health issues. Innovative technologies and health products based on and/or targeting microbiome have emerged, raising unprecedented questions as part of their development. Navigating this emerging field, developers and regulators have to develop adapted approaches and regulatory frameworks for the development of microbiome health products.
In this session, we aim to guide you through the global development of your microbiome product, by answering questions such as:
- How are microbiome therapeutics regulated under the EU and US frameworks?
- What challenges will you need overcome to reach the clinic?
- How to leverage interactions with regulators in the EU and in the US to de-risk and accelerate your development?
- What recent evolutions occurred in the EU and US frameworks and guidance for Microbiome products? What can we expect for the future?
- Strategic considerations for selecting the location of initial clinical studies?
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Featured Speakers
Clara Desvignes, M.Sc.
Director, Drugs, Medical Devices & Microbiome-based Products
As Director in Regulatory Science at VCLS, Clara supports companies in the development and implementation of global regulatory strategies for the development, evaluation and marketing of drugs & medical devices, as well as combination products. She leads the Microbiome products regulatory expertise in both the medical (drugs incl. biologics and Live Biotherapeutic Products, medical devices, combination products) and food arenas. She is specifically in charge of projects involving microbiome-related technologies such as prebiotics, probiotics and postbiotics, for which she coordinates the regulatory, nonclinical, clinical and CMC related activities. Clara participates to the development of regulatory science in that domain by building alternative regulatory paths for emerging products, supporting development plans toward regulatory agencies, and promoting awareness through expertise associations and working groups.
Pauline Lestringant, Ph.D.
Associate Director, Regulatory Science
Pauline is the Associate Director in Regulatory Science at VCLS. Her expertise lies in the design and implementation of global regulatory strategies for the development of innovative drugs. In particular, in cell and gene therapies and microbiome products.
Pauline has a strong scientific background and hands-on experience with FDA interactions in early development and throughout clinical stages until registration. She also provides mentorship to start-ups and actively engages with the microbiome industry at conferences globally.
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