Key People

KEY PEOPLE

Key People

Leadership Team

Karine Bertrand, PhD

Chief Technical Officer

Karine Bertrand graduated from ESPCI ParisTech (École Supérieure de Physique et Chimie Industrielles) and holds a PhD in Medicinal and Organic Chemistry from the University of Lille. Karine started her career at UCB Pharma and then joined Genfit (Euronext: GNFT) where she held several senior positions (Director of Pharmaceutical and Analytical Chemistry and Development, Director of Strategic Planning and Program Management, and Executive Vice President of Corporate Development).
With more than 20 years of experience in R&D and pharmaceutical project management, she has a broad range of expertise covering the design and operational and technical management of pharmaceutical discovery, development, manufacturing and control programs, as well as the definition and implementation of regulatory strategies for products up to the point where they are marketed as drugs and medical devices. She has negotiated agreements with pharmaceutical raw material manufacturers and suppliers from all continents and has overseen the manufacture of several tons of GMP products throughout her career. Director of Product Development at Da Volterra since 2015, Karine Bertrand is responsible for the design, development and manufacturing of the company’s products. In particular, she is the architect of Da Volterra’s strong scale-up of production capabilities and is now preparing the company’s industrial tool for the first commercialization.

Da Volterra

Karine Bertrand, PhD

Chief Technical Officer

Pierre-Alain Bandinelli

Chief Business Strategy Officer

Pierre-Alain Bandinelli graduated from École Polytechnique and MINES ParisTech with a specialization in biology, data analysis and management of innovative companies. He joined Da Volterra at the end of 2009 after working at the Johns Hopkins University (Baltimore, USA) to develop new tissue engineering solutions. He is the author of a dozen publications and posters in pharmaco-economics and medical sciences. Pierre-Alain is also the founder of a company that develops expert software for the aeronautical industry. He is experienced in managing innovative projects and structuring companies. With 10 years of experience in intellectual property, he has coordinated the filing of 14 patent families and has helped obtain about 100 patents in all geographical areas of the world. In charge of partnerships, he has successfully negotiated more than 10 public and private collaborations for a total amount of 30 M€. With a broad knowledge of the development of new high-tech products such as pharmaceuticals, he has played a major role in defining Da Volterra’s orientations and has been at the origin of the creation of the company’s market access, marketing and data mining departments. Under his leadership, the market access strategies for the pipeline products have been clarified and some have already been validated by some of the most demanding authorities. With the other members of the Management team, Pierre-Alain is committed to continuing the transformation of Da Volterra into a pharmaceutical champion in the field of the microbiome and related pathologies.

Da Volterra

Pierre-Alain Bandinelli

Chief Business Strategy Officer

Virginie Coste

Regulatory Affairs & Quality Director, PRRC

Virginie Coste holds a Master Degree in Control and Quality Assurance of Drug Products (Faculty of Pharmacy Paris XI). Virginie first worked at Genfit (Nasdaq & Euronext: GNFT) as Quality and Regulatory Affairs Assistant and then at the CRO Naturalpha where she spent 12 years at a senior position (Quality and Regulatory Affairs Director, senior Consultant). She was in charge of QMS set-up and maintenance, regulatory watch at international level (human and veterinary drugs, medical devices, nutraceuticals), all submission procedures for clinical trials, and conduct of GxP audits and trainings.

Regulatory Affairs & Quality Director at Da Volterra since 2017, Virginie is responsible for implementing the company’s regulatory strategy and quality policy to ensure the application of the regulations and standards for all activities of the company.  She coordinates the regulatory operations related to the development, registration and maintenance of marketing authorization & CE Mark for Da Volterra’s products (as drug or medical device) both in US and EU, and supports the Medical, Clinical, and Product teams on their activities related to regulatory affairs and quality assurance.

Virginie is an expert in coordinating filings and obligations in respect of drug and medical device regulations in the USA with the FDA and in Europe with competent authorities and notified bodies.

She brings to Da Volterra more than 15 years of experience in regulatory affairs and quality system management in both biotech companies and CROs.

Da Volterra

Virginie Coste

Regulatory Affairs & Quality Director, PRRC

 

Board of Directors

Nabil Abadir

Independent Board Member

Nabil Abadir is a Medical Doctor with over 25 years’ experience in the pharmaceutical and biotechnology industry. He graduated from the Alexandria University Faculty of Medicine in 1983 before joining the life science industry.
His experience includes working in small companies (Ferring Pharma, Clementia, Amarin) as well as major pharma companies (Novartis, Sanofi, Abbott, Schering Plough & Merck). He led the local medical department as VP Medical for Schering Plough Canada before heading Merck’s Medical Affairs organization for Europe, Canada, Middle East and Africa region based in Switzerland. Nabil then was nominated as the Executive VP for Clementia Pharma, a Canadian start-up biotech company until its acquisition by Ipsen Pharma. He led the Global Medical Affairs organization for Novartis Gene Therapy. Dr. Abadir is Chief Medical Officer and Head of Global Medical Affairs Amarin since April 2022.

Throughout his career he successfully built and strengthened a number of medical organizations at the local, regional and global level: he created multiple best practices, SOPs, guidelines, asset life cycles, real-life data generation and dissemination plans including Health Economic data to support the pricing and reimbursement of various assets. His extensive experience covers a wide range of therapy areas, including oncology and anti-infectives. He also experienced a number of acquisitions and mergers and participated in multiple business development deals.

Da Volterra

Nabil Abadir

Independent Board Member

 

Scientific and Clinical Advisors & Collaborators