Florence Bine-Scheck, MD

As a Service Head of Regulatory NC/Clinical activities at VCLS, Florence provides leadership to a multidisciplinary team of Regulatory NC/Clinical scientists/MDs; more specifically, as a VCLS Senior Medical Director since 2014, she is responsible for a clinical team involved in the development and critical review of clinical protocols/development plans, and the provision of advice on regulatory/clinical aspects of regulatory documents and processes in Europe and the US mainly in oncology, infectious diseases, hematology, CNS (neurology/pain), as well as orphan diseases in various therapeutic areas (Duchenne Myopathies, Cystic Fibrosis, etc.). This includes Scientific Advice (National, EMA, EMA/HTA, US pre-INDs, and corresponding INDs), PRIME/Breakthrough Therapy Designations, Orphan Drug Designations, Pediatric Investigation Plans (PIP/PSPs), and clinical modules of Marketing Authorization Applications (MAAs, NDA/BLAs).

Florence brings to the role more than 30 years of experience gained from working both as a Regulator, and within the pharma industry and her area of expertise includes mainly oncology, cardiovascular, and thrombosis.

Prior to joining VCLS, Florence spent 12 years working at the French Regulatory Agency, evaluating European submissions submitted primarily through the Centralized procedure initially in cardiovascular and thrombosis and then in oncology. This involved the clinical evaluation of initial MAAs and variations, and assessment of clinical trial applications and Compassionate Use Programs, which has given her a solid background in the development and evaluation of New Chemical Entities and Biologics. Whilst at the Agency, she also made several presentations to the CHMP, participated in meetings of the Scientific Advisory Group (SAG), and the Committee for Advanced Therapies (CAT) and collaborated with other European Regulatory Agencies. In addition, she was also involved in the development of national and European guidelines and recommendations.

Prior to that, Florence spent 15 years working in clinical development for JANSSEN, UPSA-BMS group, and IRIS/SERVIER, holding senior Clinical / Medical positions. During this time, she was responsible for planning and managing clinical trials and development plans.  She also provided technical support to R&D teams in Europe the USA, Israel, South Africa, Asia, and Japan, and gained experience of working with key opinion leaders (KOLs), and in managing expert panels.

Florence earned a Medical Doctor Degree from the University René Descartes-PARIS V, a post-graduate Degree in Methodology of Clinical Trials from the University PARIS VII, and a post-graduate Master’s Degree in Pharmaco-Economics applied to the Pharmaceutical Industry from the University Lyon I, in France. In addition to her medical training, she gained additional medical experience in hospitals affiliated with UCLA, UCI, and UCSD (Southern California, USA) and in Bonn (Germany).

Florence’s international background allows her to work successfully in multi-cultural and multi-lingual environments.