Principal, Program Director, Sofinnova Partners MD Start Strategy
Cécile joined our MD Start team in 2019. She is currently CEO of HEPTA Medical, and brings her operational and strategic expertise to Endoron to accelerate the development of the company's highly disruptive technology. Prior to that, she was COO of Gradient Denervation Technologies, and director of clinical, regulatory and market access at SafeHeal, the first company created by MD Start II, where she managed the execution of the first-in-human study and regulatory approvals in the EU and US.
Unofficially, she is MD Start’s regulatory expert.
“We need to make sure we start with the right strategy from the get-go because the regulatory strategy is one of the key drivers of the entire project,” she says. “It will drive the clinical strategy, but also the R&D strategy. This is really a key entry point for the project.”
Prior to joining MD Start, Cécile held various clinical, marketing and regulatory positions in both mature and start-up medical device organizations in the fields of endoscopy, pulmonology, dermatology, surgery and diabetes care; for single and multi-use disposable products and capital equipment.
Cécile holds a bachelor’s degree in biomedical engineering from UTC (Université de Technologies de Compiègne) in France, Dalarna University (Sweden) and Favoloro University (Buenos Aires) in Argentina. She also has a degree in corporate finance from HEC in Paris.
"The regulatory strategy is one of the key drivers of the entire project. It will drive the clinical strategy, but also the R&D strategy."