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Lise Merlay Barbin, PhD, Eng

As a Director, Regulatory Science, Lise manages projects from early stages of development to late clinical development phases and up to preparation of MAA/BLA/NDA, both in Europe & the US. She works in close collaboration with international life sciences companies to help in the preparation, coordination and submission of centralised Marketing Authorisation Applications (MAAs), as well as New Drug Applications (NDAs), and Biologics License Applications (BLA), of innovative drugs and biologics. This includes strategic input and regulatory writing services of CTD Modules, managing the team of experts involved, as well as coordinating the preparation of written and oral answers as part of the assessment procedures. Lise is also involved in European scientific advice procedures including the authoring of Briefing documents, in orphan drug designation (ODD) applications, as well as in the preparation of Paediatric Investigation Plans (PIP). She also provides recommendations on the feasibility of these applications and on the strategy to develop to meet Agencies’ expectations.

Lise has more than 10 years of experience, having worked in academia, the pharmaceutical industry, and consultancy, where she gained an in-depth knowledge of various therapeutic areas (including oncology, neurology, ophthalmology, metabolic diseases and ENT).

Lise started her career as a medical and regulatory writer for a French pharmaceutical company where she was responsible for authoring a wide spectrum of regulatory documents. She also gained experience of the centralized procedure and in responding to regulatory agency questions.

Then, as a principal regulatory scientific and medical writer, Lise led a team of medical writers, working in close collaboration with cross-functional internal and external teams and experts, and acting as a key liaison person for regulatory activities.

More recently, Lise moved into the provision of consultancy services to support international drug development programmes. In this role she was responsible for authoring and reviewing non-clinical and clinical modules of the CTD; the assessment, utilisation and positioning of available data; writing of meeting requests, briefing packages and responses to questions from agencies; as well as ODD requests and PIPs.

Lise graduated in 2005 with a chemical engineering degree from both the European Engineering School in Chemistry, Polymers & Materials, ECPM in Strasbourg (France), and from the University of Stuttgart (Germany). She was awarded her PhD in biochemistry from the Biochemistry Institute of the University of Stuttgart and conducted post-doctoral research at the Pasteur Institute in Paris.

In addition to French, her mother tongue, Lise speaks English and German, and has a basic knowledge of Spanish.

Lise is based in our Boulogne office in France.

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