Catherine Pletan

Background

About Catherine Pletan

Our concept :"Speeding up operations" and "Running the projects to success" Experience 1- Expertise in technical scientific R&D operations 2- Global vision from Research & Pre-clinical stage to CMC and end of clinic 2- Very good knowledge of products full development, implementation of program strategies and all technical operations, 3- Scientific background to build, lead and challenge cross-functional multidisciplinary and multicultural expert team, 4- Senior expertise in Project management to structure, drive projects and propose solutions CEO support and Translational strategic and operational oversight of novel therapeutics development to improve the value of the R&D projects, reach the milestones on time, match the board expectations and facilitate/contribute to funds raising Track record : 25 years+ of experience in Biotech/Medtech, Start-up, Pharma, CRO and Consulting - Successful lead of key Biotech early strategic programs from Discovery up the phase II POC (some currently on the market in EU and US). Less than 12 Months development from Lead candidate to FIH on 2 projects- Contributed to positive regulatory achievements by EMEA and FDA: Type B&C meetings, Scientific Advices, Orphan Designations, IMPD/IND, CTA/EC, ATU / Compassionate use, pre-BLA under fast-track status - Value creation of key programs leading either to funds raising (up to 30 M€ for early stage) and to US/EU Partner licensing- Preparation of several complex strategies and development plans - Many international clinical trials management in variety of indications (high recruitment, positive audit…)- Building of a reliable network of CMO, CRO partners and experts in Europe and US Specialities - International multicultural environments - Strategy, road map and development plan conception / strategic planning / budget - Drive translational sciences and drug’s development by managing the whole global R&D Operations (IP, research, pre-clinical, CMC, clinical, regulatory, QA, business, alliance strategy, Market access…)- Due diligence (in and out), project evaluation - Portfolio management - Strategic budgeting & planning implementation - CRO/CMO selection, negotiation and management - Development of partnerships Values : Entrepreneurship, real leader, strong personal values, passion for sport, highly energetic with a positive “can-do” attitude, willpower, a real team spirit and a strong commitment to problem-solving solutions and delivering results. Flexible and easily adaptive to change.