Name and Educational Degree: Leblanc, Bernard, DVM, Ph.D Certifications DACVP Education 1973    Certificat d’Etudes de Statistiques Appliquées à la Biologie Médicale - Université Paris 6. 1976    Certificat d’Etudes Supérieures de Biologie et Pathologie des Animaux de Laboratoire -     Faculté de Médecine de Paris. 1977    Docteur Vétérinaire. Prix de Thèse - Faculté de Médecine de Paris, Ecole Vétérinaire d’Alfort, Paris. 1977    Certificat d’Etudes Supérieures d’Immunologie Générale - Faculté de Médecine de Paris. 1978    Certificat d’Etudes Supérieures de Cancérologie Expérimentale - Faculté de Médecine de   Paris. 1979    Attestation d’Etudes Approfondies de Cancérologie Expérimentale - Faculté de Médecine de Paris-Sud 1983    Agrégation d’Histologie Anatomie Pathologique Vétérinaire. - Ecoles Nationales     Vétérinaires. 1985    Doctorat de 3eme Cycle en Cytologie - Faculté des Sciences, Université Paris 6. 1987    Diplomate American College of Veterinary Pathologists (by Examination) 1995    Diplomate European College of Veterinary Pathologists (Charter Member)   Business Address: 6 Cité Lemercier Paris, France 75017 France Contact Information: Telephone: +33 (0)9 75 69 55 11 Mobile Number: +33 (0)6 88 85 44 60 Email Address: bernard.leblanc@novosafe.eu Web Site URL: http://www.novosafe.eu Specialties Design of strategies tailored to drug candidate needs (first entry into human….). Definition of mechanistic investigation programs for risk management. Development of innovative solutions for difficult problems. Analysis, interpretation, presentation of data sets. Characterization of Non-Clinical Safety profile of candidates. Preparation of white papers. Expert panels. Scientific and regulatory review of non-clinical regulatory submission packages(European, Us, Japanese  and Rest of the World). Understanding and responding to Non-Clinical regulatory queries. Due Diligence for licencing opportunities: Thorough Non-Clinical risk assessment.   Experience Twenty five years of experience of drug development with Pfizer as a Toxicology Pathologist, a Clinical Pharmacologist and a Safety Scientist: Extensive experience of drug development at global level (Chemicals and Biologics): Interactions with regulatory agencies, contributions to IND/IMPD/IB, contributions to NDA/IRD/MAA for a dozen of approved drugs and excipients. Acted as an internal expert for global safety issues within the company. Past Co-Chair of the Safety Ad Hoc Group (SAHG) of the European Federation of Pharmaceutical Industry Associations (EFPIA). Member of the ICH Expert Working Group for the revision of the ICH M3 guideline (R2) ”  Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals”. Presentations in meetings on current issues in non-clinical safety: Innovative Strategies for First Entry into Man, Novel Biomarkers of Drug-Induced Toxicity, Hepatotoxicity Testing, Transgenic Mouse Models for Carcinogenicity Testing, Genotoxic Impurities, Metal Impurities. << Back to Index of Consultants