Dr. Gaelle Clermont has over 20 years of experience in medical product development and testing. Dr. Clermont has both Doctor of Pharmaceutical Sciences (Pharm.D.) and Doctor of Philosophy (Ph.D.) degrees, and began her career at a University Hospital before joining NAMSA in 2001. During her career at NAMSA, she has progressed from Study Director, Laboratory Scientific Director and now to her current role as Preclinical Specialist within the Global Strategy group. Her expertise in preclinical studies and safety evaluations allows her to work with innovative medical device companies supporting their development and regulatory strategies, looking to accelerate the development of their technology and to also address regulatory agency expectations and responses to those studies.

CORE COMPETENCIES

• Designs, develops and executes regulatory compliant preclinical strategiesfor multiple innovative devices for worldwide regulatory submissions
• Supports the development of complex preclinical models in collaboration with NAMSA worldwide laboratories
• Assists in the development, design and execution of medical product testing plans for a wide range of medical devices from concept to final product
• Conducts Gap Analyses of biocompatibility and preclinical data
• Contributes to interactions with global regulatory agencies
• Supports multiple U.S. Food and Drug Administration (FDA) pre-submission meetings
• Supports manufacturers, addressing challenges with regulatory bodies in liaison with preclinical strategies/models
• Oversees strategy execution in the laboratories and participates in problem solving in case of technical and scientific questions
• Expert in GLP compliance

RECENT PROJECTS

• Developed and executed the biocompatibility and preclinical strategy for U.S. and EU market access of an innovative, degradable hemostatic polymer-based device in multiple indications; successful outcome with ongoing clinical trials in EU and U.S.
• Developed preclinical protocols for evaluation of safety and performance of several devices for FDA pre-submissions (510K, De novo, PMA) including brain implants, blood filtration systems, glucose monitoring systems, dermal fillers, endovascular devices, bone void fillers , dental devices…; obtained FDA approval of strategy prior to study execution
• Developed the full biocompatibility and preclinical strategy for evaluation of the safety of a nanoparticle-based blood filtration system; discussions with NB and FDA for initiation of clinical trials
• Supported CE-marking of an innovative magnesium-based dental device
• Worked with numerous companies to assist in developing product development testing plans to successfully meet investor, company board, regulatory and marketing goals