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Gaëlle Clermont, PharmD, PhD

Principal Strategy Consultant

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Dr. Gaelle Clermont has over 20 years of experience in medical product development and testing, specifically in these therapeutic areas: cardiovascular, orthopedics, wound healing and general surgery, among others. Dr. Clermont has both Doctor of Pharmaceutical Sciences (Pharm.D.) and Doctor of Philosophy (Ph.D.) degrees, and began her career at a University Hospital before joining NAMSA in 2001. During her career at NAMSA, she has progressed from Study Director, Laboratory Scientific Director and now to her current role as Preclinical Specialist within the Global Strategy group. Her expertise in preclinical studies and safety evaluations allows her to work with innovative medical device companies supporting their development and regulatory strategies, looking to accelerate the development of their technology and to also address regulatory agency expectations and responses to those studies.


  • Designs, develops and executes regulatory compliant preclinical strategies for multiple innovative devices for worldwide regulatory submissions
  • Supports the development of complex preclinical models in collaboration with NAMSA worldwide laboratories
  • Assists in the development, design and execution of medical product testing plans for a wide range of medical devices from concept to final product
  • Conducts Gap Analyses of biocompatibility and preclinical data
  • Contributes to interactions with global regulatory agencies
  • Supports multiple U.S. Food and Drug Administration (FDA) pre-submission meetings
  • Supports manufacturers, addressing challenges with regulatory bodies in liaison with preclinical strategies/models
  • Oversees strategy execution in the laboratories and participates in problem solving in case of technical and scientific questions
  • Expert in GLP compliance


  • Developed and executed the biocompatibility and preclinical strategy for U.S. and EU market access of an innovative, degradable hemostatic polymer-based device in multiple indications; successful outcome with ongoing clinical trials in EU and U.S.
  • Developed preclinical protocols for evaluation of safety and performance of several devices for FDA pre-submissions (510K, De novo, PMA) including brain implants, blood filtration systems, glucose monitoring systems, dermal fillers, endovascular devices, bone void fillers , dental devices…; obtained FDA approval of strategy prior to study execution
  • Developed the full biocompatibility and preclinical strategy for evaluation of the safety of a nanoparticle-based blood filtration system; discussions with NB and FDA for initiation of clinical trials
  • Supported CE-marking of an innovative magnesium-based dental device
  • Worked with numerous companies to assist in developing product development testing plans to successfully meet investor, company board, regulatory and marketing goals


  • Clermont, S. Lecour, J.J. Lahet, P. Siohan, C. Vergely, D. Chevet, G. Rifle, L. Rochette. Alteration In Plasma Antioxidant Capacity in Chronic Renal Failure and Hemodialysis Patients : a Possible Explanation for the Increased Cardiovascular Risk in These Patients. Cardiovascular Research 2000, 47: 618-23.
  • Clermont, S. Lecour, D. Chevet, C. Guilland, P. D’athis, J.F. Cabanne, J.M. Rebibou, L. Rochette. Vitamin E-Coated Dialyzer Reduces Oxidative Stress in Hemodialysis Patients. Free Radical Biology And Medicine 2001, 31: 233-241.
  • Clermont, C. Vergely, J.J. Lahet, S. Lecour, S. Jazayeri, V. Maupoil, C. Girard, L. Rochette. Systemic Free Radical Activation is a Major Event Involved in Myocardial Oxidative Stress Related to Cardiopulmonary Bypass. Anesthesiology 2002, 96: 80-7.
  • Clermont, C. Vergely, C. Girard, L. Rochette. Atteintes Cellulaires Associées à une Circulation Extracorporelle. Annales De Cardiologie Et D’angéiologie 2002, 52 : 38-43.
  • Vergely, C. Perrin-Sarrado, G. Clermont, L. Rochette. Postischemic Recovery and Oxidative Stress are Independent of Nitric-Oxide Synthases Modulation in Isolated Rat Heart. J Pharmacol Exp Ther. 2002, 303: 149-57.
  • Clermont, S. Lecour, C. Vergely, M. Zeller, C. Perrin, V. Maupoil, O. Bouchot, L. Rochette. Direct Demonstration of Nitric Oxide Formation in Organs of Rabbits Treated by Transdermal Glyceryl Trinitrate using an In-vivo Spin Trapping Technique. Fundamental & Clinical Pharmacology 2003, 17(6): 709-715.
  • Vergely, V. Maupoil, G. Clermont, A. Bril, L. Rochette. Identification and Quantification of Free Radicals during Myocardial Ischemia and Reperfusion using Electron Paramagnetic Resonance Spectroscopy. Archives Of Biochemistry And Biophysics  2003, 420: 209-216.
  • Lecour, G. Clermont, E. Dutoit, L. Gilson, V. Maupoil, S. Lowe, P. Dupuy, C. Girard, L. Rochette. Evidence for the Extra-Pulmonary Localization of Inhaled Nitric Oxide. Heart Disease 2003, 5: 372-377.
  • Hansen T, Clermont G, Alves A, Eloy R, Brochhausen C, Boutrand Jp, Gatti Am, Kirkpatrick Cj. Biological Tolerance of Different Materials in Bulk and Nanoparticulate Form in a Rat Model: Sarcoma Development by Nanoparticles. J R Soc Interface. 2006 Dec 22;3(11): 767-75
  • Goudeau Jj, Clermont G, Guillery O, Lemaire-Ewing S, Musat A, Vernet M, Vergely C, Guiguet M, Rochette L, Girard C. In High-Risk Patients, Combination of Anti-Inflammatory Procedures during Cardiopulmonary Bypass Can Reduce Incidences of Inflammation and Oxidative Stress. J Cardiovasc Pharmacol. 2007 Jan;49(1): 39-45.
  • Gatti Am, Kirkpatrick J, Gambarelli A, Capitani F, Hansen T, Eloy R, Clermont G. ESEM Evaluations of Muscle/Nanoparticles Interface in a Rat Model. J Mater Sci Mater Med. 2008 Apr;19(4): 1515-22.
  • Huber Fx, Mcarthur N, Heimann L, Dingeldein E, Cavey H, Palazzi X, Clermont G, Boutrand Jp. Evaluation of a Novel Nanocrystalline Hydroxyapatite Paste Ostim in Comparison to Alpha-Bsm – More Bone Ingrowth Inside The Implanted Material with Ostim Compared to Alpha Bsm. BMC Musculoskelet Disord. 2009, 10: 164.
  • Clermont G., Alves A., Palazzi X., Boutrand JP.: Preclinical Testing of Combinations Products – A. Lewis (Ed.), Whoodhead Publishing in Materials : Drug Device Combination Products – Delivery Technologies and Applications – 2009: 369-394.
  • Hjort H, Mathisen T, Alves A, Clermont G, Boutrand JP. Three-Year Results from a Preclinical Implantation Study of a Long-Term Resorbable Surgical Mesh With Time-Dependent Mechanical Characteristics. Hernia. 2012, 16: 191-197.
  • Clermont G.: Non-Clinical Functional Evaluation of Medical Devices: General Recommendations and Examples for Soft Tissue Implants – JP. Boutrand (Ed), Whoodhead Publishing in Materials: Biocompatibility and Performance of Medical Devices 2012: 345-361.
  • Bayon Y, Vertès AA, Ronfard V, Egloff M, Snykers S, Salinas GF, Thomas R, Girling A, Lilford R, Clermont G, Kemp P. Translating Cell-based Regenerative Medicines from Research to Successful Products: Challenges and Solutions. Tissue Eng Part B Rev. 2014 Aug;20(4):246-56.
  • Alves A, Gritsch K, Sirieix C, Drevon-Gaillot E, Bayon Y, Clermont G, Boutrand JP, Grosgogeat B. Computerized Histomorphometric Study of the Splenic Collagen Polymorphism: A Control-Tissue for Polarization Microscopy. Microsc Res Tech. 2015 Oct;78(10):900-7.
  • Alves A, Attik N, Bayon Y, Royet E, Wirth C, Bourges X, Piat A, Dolmazon G, Clermont G, Boutrand JP, Grosgogeat B, Gritsch K. DevisingTtissue Ingrowth Metrics: a Contribution to the Computational Characterization of Engineered Soft Tissue Healing. Biomed Mater. 2018 Mar 14;13(3)