Joel HDR's Email Addresses & Phone Numbers

📖 Summary

- 25+ year experience in Pharma / Biotech R&D and manufacturing activities - Numerous Global senior positions (Global Head, VP, . . .) in Pharmaceutical Development for Biotech and Pharma companies of various sizes (up to more than 20,000 employees) - Strong leadership experience of large, multi-site, multi-national organizations (in Ipsen, Merck Serono, Serono, Ethypharm, Rhône-Poulenc) - Successfull entrepreneurial experience: co-founder, member of the Board and COO of the start-up DDS/Biotech Mainelab company - Significant track record of products brought to the market - Strong Intellectual Property and innovation orientation: co-author of 53 patent families in new pharmaceutical formulations, protein formulations, new drug delivery technologies and processes, . . ., and 65 international publications in this field and 100+ communications in international conferences - Strong impact on technology strategy and business of companies through numerous partnership deals and technology platform developments and M&As. Specialties: Pharmaceutical R&D - Pharmaceutical and Biotech Product Development - CMC Development - Drug Delivery Systems - Protein Formulation Development and Manufacturing - Protein and peptide delivery -Senior Vice President, Peptides - Head of CMC Development Dreux Site @ Leading all the pharmaceutical development activities of the Peptides/Small Molecules platform for development of new products in Ipsen, from Pre-Clinical Development until Phase III, Filing and Life Cycle Management - These activities, based on 5 different sites in Europe and the US and involving about 150 co-workers, include drug substance (DS) development, scale-up and manufacturing of clinical batches, early formulation to support Research activities, drug product (DP) development and process development, analytical development for DS and DP, novel delivery technologies and devices, as well as manufacturing and QC testing of clinical supplies. CMC Development Dreux Site Director (110 co-workers), including budget and Capex management, HR, facility management, Operational Excellence. Responsible for the clinical supply chain (packaging, conditioning, shipping) of all Ipsen clinical studies worldwide for all Franchises (Oncology, Endocrinology, Neurology) and types of products (peptides, small molecules and toxins/biologics). From November 2013 to Present (2 years) Paris Area, FranceVice President, Peptides @ Leading all the Pharmaceutical development activities for development of peptides and small molecules in Ipsen, from Pre-Clinical Development until Phase III, Filing and Life Cycle Management - These activities, based on 5 different sites in Europe and the US, include drug substance (DS) development, scale-up and manufacturing of clinical batches, early formulation to support Research activities, drug product (DP) development and process development, analytical development for DS and DP,as well as QC testing of clinical supplies From January 2012 to October 2013 (1 year 10 months) Paris Area, FranceVice President, Drug Product Development @ Leading all the CMC activities of drug product development of the Ipsen company for NCEs, peptides, proteins from Pre-Clinical Development until Phase III, Filing and Life Cycle Management - These activities, based on 4 different sites in Europe and the US, include early formulation activities to support Research activities, formulation and process development, analytical development and QC testing of clinical supplies, as well as delivery device development. From February 2011 to February 2012 (1 year 1 month) Paris Area, FranceSenior Director - Head of Drug Product Development @ Leading all the CMC activities of drug product development of the Ipsen company for NCEs, peptides, proteins from Pre-Clinical Development until Phase III, Filing and Life Cycle Management - These activities include formulation and process development, analytical development and QC testing of clinical supplies, as well as delivery device development. From July 2008 to March 2011 (2 years 9 months) Paris Area, FranceDirector, Head of Pharmaceutical Development - Biotech Products @ Leading the Global Pharmaceutical Development Operations (resources and projects) of the MerckSerono company for therapeutic proteins (hormones, cytokines, fusion proteins, . . .) and monoclonal antibodies, from Pre-Clinical Development (PCD) to Filing and Life Cycle Management From May 2007 to June 2008 (1 year 2 months) Rome Area, ItalyDirector, Head of Pharmaceutical Development @ Leading the Global Pharmaceutical Development Operations and Clinical Production of the Serono company for proteins (hormones, cytokines, fusion proteins, monoclonal antibodies, . . .) and new chemical entities from Pre-Clinical Development (PCD) to Filing & Life Cycle Management From February 2005 to April 2007 (2 years 3 months) Rome Area, ItalyVice-President Research - R&D Director Europe @ Leading the European R&D and Pharmaceutical Development Operations (resources and projects) of the company from the PCD (including animal studies – PK, tox. studies, . . .) to pilot and cGMP production of clinical supplies, including analytical and QC testing, as well as transfer to industrial sites. Management of the Global Research activities (France and Quebec). Oral dosage formes of NCEs and injectable forms of proteins. From January 2001 to August 2004 (3 years 8 months) Paris Area, FranceCOO and co-founder @ General management of the company, including: - Strategic orientations and financial affairs - Business development – Legal affairs and contract management - Scientific affairs and project management, IPR, - Human Resources From January 1999 to December 2000 (2 years) Angers Area, FranceGeneral Manager @ General management of the organization, including: - Strategic orientations and financial affairs - Business development – Legal affairs and contract management - Scientific affairs and project management, IPR, - Human Resources From February 1996 to December 1998 (2 years 11 months) Angers Area, FranceResearch Group Leader @ - Scientific leader and line manager of a Reserach group of up to 20 scientists and senior scientists, in the field of radical polymerization in dispersed media and in solution From January 1991 to January 1996 (5 years 1 month) Paris Area, FranceHabilitation à Diriger les Recherches, Chemistry @ University Bordeaux I From 1994 to 1994 PhD, Materials Science - Colloid & Interface Science @ University Paris VI From 1984 to 1987 Agrégation Sciences Physiques, Physics - Applied Physics & Materials Science @ Ecole Normale Supérieure - Cachan From 1981 to 1985 Master's degree, Applied Physics & Materials Science @ University Paris XI From 1981 to 1983 Classes Préparatoires aux Grandes Ecoles Scientifiques @ Lycée Blaise Pascal - Clermont-Fd From 1979 to 1981 Joel HDR is skilled in: Pharmaceutical R&D..., Pharmaceutical and..., Drug Delivery Systems, Protein Formulation..., Drug Delivery, Pharmaceutics, Pharmaceutical Industry, Biotechnology, Formulation, Clinical Development, CMC, Product Development, Manufacturing, Technology Transfer, Biopharmaceuticals, Drug Development, Regulatory Affairs, IND, GMP, Drug Discovery, Lifesciences, R&D, Protein Chemistry, Commercialization, Clinical Trials, Organic Chemistry, Chemistry, GLP, Monoclonal Antibodies, Regulatory Submissions, Analytical Chemistry, Validation, HPLC, FDA, Process Simulation, CRO, Life Sciences, Oncology, Strategy, Management