Pascale Clment, Ph.D.

Home: 33 3 68 28 00 07 Souffelweyersheim 67460 FRANCE Cell: 33 6 51 51 88 95 Email: orangepascale@gmail.com

SUMMARY Efficient scientific project leader, Ph.D., with over 15 years of industry experience in drug development and product evaluation. Proven success in project management with a thorough understanding of CMC, GMP, ICH and Health Canada / FDA guidelines along with a good knowledge of regulatory affairs. Superior problem solving, decision-making and analytical skills as well as a strong ability to cultivate optimal cross-functional collaborations. An excellent communicator known for her rigorous scientific approach, organizational skills and team leadership. Languages: French, English and German (B1 Zertificat Deutsch, basic German). Expert use of Microsoft Office, Microsoft Project, SharePoint, Mac and PC PROFESSIONAL EXPERIENCE 2010 2011 PHARMASCIENCE, Montreal, Canada SENIOR PROJECT LEADER INNOVATIVE PORTFOLIO Global strategic leadership of project teams, overseeing all development activities aiming at IND\NDA and CTA\NDS\PLA filing for innovator products. Act as a CMC expert for the Clinical and Regulatory department of innovative products. Liaise with Scientific Affairs, Marketing and Business Development departments to get alignment and successful project completion within timelines and budget. Achievements: Developed the scientific Due Diligence process to support Business Development in product selection for acquisition / in licensing of innovative products for the North American market Developed a process for the project management of Natural Health Product submissions of non-traditional products in Canada. Several products were approved in 2010-2011. Manage the first Rx to OTC switch project at Pharmascience (first one done by a generic company in Canada). The NDS was submitted in 2009 and the NOC received in 2011 2006 2010 ROYALMOUNT PHARMA / PHARMASCIENCE, Montreal, Canada PROJECT MANAGER, PHARMACEUTICAL DEVELOPMENT In charge of all pharmaceutical development activities for active pharmaceutical ingredients and finished products for the Innovative Products Division in collaboration with research contract organizations and internal R&D teams. Lead cross-functional pharmaceutical development project teams up to regulatory approval. Achievements:

 Pharmaceutical development of 3 topical formulations and several oral products for clinical trials in Canada, USA and UK Developed a strategy to perform a pilot clinical trial in a short timeline with a tight budget using an innovative formulation Implemented Project Management concept and tools (Project Charter, Project Plan/Schedule, Status Report) for innovative drug products Lead Scientific Due Diligence teams for product evaluation (Rx, OTC, Medical Device Class 1 and II) 2004-2006 AXCAN PHARMA, Mont-St-Hilaire, Canada PROJECT MANAGER, PHARMACEUTICAL DEVELOPMENT Manufacturing of Phase I-II clinical batches, preparation of CMC section of regulatory submissions (INDs, CTAs), technology transfer, formulation optimization, project coordination with partners/contractors in charge of API and finished product development/manufacturing. Achievements: Pharmaceutical development of 3 oral products (1 pancrelipase, 2 ursodiol derivatives) and one injectable (amino acids) for Phase I and II clinical trials Implementation of Project Management in the Pharmaceutical Development department 2001-2003 SKYEPHARMA (RTP-PHARMA), Montreal, Canada SENIOR FORMULATION SCIENTIST Developed formulations of insoluble drugs (oral and injectable) using Skyepharmas patented technologies. Experienced with Microfluidizer operation, formulation characterization (microscopy, particle size analysis, and stability), sterilization and drying by lyophilization. 2000- 2011 EVALULAB, Montreal, Canada Ethics committee member as a scientific expert 1996-2000 YVES ROCHER, France FORMULATION SCIENTIST Studied the properties of concentrated emulsions in-vitro diffusion of an active using Franz cells. Scientific articles published and one patent deposited. 1995 CLARINS, France Technician, Safety and efficacy testing of cosmetics PARFUMS CHRISTIAN DIOR, France Formulation Scientist

EDUCATION 2005-2006 1997-2000 1994-1995 1992-1994 1989-1992 Project Management Excellence, Canadian Management Center, Canada Ph.D., Pharmaceutical Sciences, Universit Paris XI, France DESS (Master), Cosmetic Sciences, Universit Paris XI, France M.Sc., Pharmaceutical Sciences, Universit de Montral, Canada B.Sc., Biochemistry, McGill University, Canada

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ACTIVITIES AND INTERESTS Member of various swimming teams since 1987 Hiking, cross-country skiing

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