Our Team
Our team is composed of 2 Senior R&D Experts and a part-time Junior Data Analyst. Both Senior Experts have a scientific and medical background, with over 20 years of experience each. However, they have developed over time a truly complementary experience in strategy and development and have a complete vision of drug development starting from Research and covering all development phases, areas, and technologies.
This today allows us to cover together a very broad scope of what our partners precisely expect from us, from very early (even virtual) product inception all the way through to the end of a full development or an exit.
Catherine COMBOT-PLETAN
- Senior Biotechnology Consultant in Life Sciences & Health Care
- President and Founder
Training:
Pharm.D, Essec
Experience
- +20 year experience in start-up, Biotech, Pharma, CRO
- Project manager (Pierre Fabre)
- Global Head of Clinical department (Chiltern International)
- Full Research & Development Program – Biotech Strategic Project Director (LFB Biotechnology)
- Head of Projects Development (Gamamabs Pharma – Start-up developing Biologics in Cancer)
- Senior leader of cross-functional multidisciplinary and multicultural expert teams
- Global vision on full developments from Research to Market Launch
- Strong knowledge of NBEs early development (Mabs, Bispecifics, Fusion proteins, plasma proteins, coagulation factors…)
- Expertise in Global Operations & Translational project management (Pre-clinical, CMC, Clinical, Regulatory, Alliance strategy….)
- Value creation of Projects by optimizing costs / timelines and also improving quality
Track record :
- Successful Lead of several key Biotech early strategic programs from Research up to First In
- Human/Start of phase II
- Value creation and contribution to funds raising for a start-up (15 M€)
- Value creation leading to a license with a US Partner for an international Mabs program
- Preparation of several complex development plans and due diligences (EU and US files)
- Successful regulatory submissions (IMPD/IND, Orphan designations, Scientific Advices, ATU / Compassionate use…)
- Successful international clinical trials management (high recruitment, positive audit…)
- Building strong positive international partnerships (academic and private)
- Development of a reliable network of CMO, CRO and experts
Yannick PLETAN
- Senior Medical and Clinical Consultant in Life Sciences & Health Care
- General Manager
- Board Member of several listed and private biotech companies
Training:
MD, MSc, FFPM, Harvard Business School, HEC
Experience
- Physician – Pulmonologist – Immunologist – University of Paris
- Master Degree in Clinical Pharmacology and Pharmacokinetics
- Post-Doc at INSERM, Former Head of a Hospital Respiratory Medicine Department, Visiting Professor, Immuno-Pharmacology -University of California Davis
- Global Head, Immunology, Rhône Poulenc-Rorer (SANOFI)
- Global Head Clinical Development, Chief Medical Officer, Head of R&D Strategy, Pierre Fabre Group
- Vice-president Medical & Scientific Division, Pfizer SAS
- Country Medical Director, Roche France
- Author, co-author of several international guidelines (WHO, ICH)
- Co-Founder of the European Diploma of Pharmaceutical Medicine (EUDIPHARM)
OUR PARTNERS
We have a full network of international partners, experts and we collaborate with external consultants for highly technical areas:
- CMC experts (all areas: new chemical and biological entities, cell therapy)
- Non-clinical experts
- Medical, Clinical Therapeutic or diagnostic area experts in various fields (oncology, CNS, cardio-vascular, anti-infectives, rare diseases etc…)
- Methodologists, epidemiologists and statisticians
- Data Scientists, Machine Learning and AI experts
- Medical writers
- Safety and pharmacovigilance professionals
- Regulatory experts (EU, US)
- Medical and Scientific Communication specialists
- Legal and IP experts
- Vendors : CMOs, CROs….
