Rosario has over 20+ years of experience in driving R&D, commercial, and operational excellence through business acumen and scientific leadership with roles of increasing responsibility in development, scale-up, transfer, and launch preparation of generic, complex generic and branded products as well as products following a 505b2 regulatory pathway at Merck, Novartis, TEVA and Sandoz. This includes development of active pharmaceutical ingredients and drug products including small molecules, synthetic polypeptides and proteins in various dosage forms (Parenterals, solid oral dosage forms, transdermals, films, etc) and drug-device combination products for a wide gamut of therapeutic areas.
Currently at Sandoz Rosario is Head of Scientific Affairs based in Princeton, NJ responsible for external partnership product development with speed-to-market philosophy leading to timely product submissions (NDAs, 505(b)(2)s, and ANDAs), approvals and on-time launches. Rosario oversees technical due diligence evaluating CMC and bio-analytical aspects of new product opportunities amenable to co-development, in-licensing or acquisition. Moreover, he advances pipeline strategy and leads team for identification, evaluation and prioritization of internal/external robust tuneable technology platforms.
Prior to joining Sandoz, Rosario worked at TEVA Pharmaceuticals as Site Head / Head of Development for Sterile Products in Pomona, New York. He also worked at Novartis as global project leader for API/drug product, Global Quality by Design Network Leader, and led various global teams: QbD training, Specification Setting Strategy and Regulatory CMC team focused on streamlining CMC processes for small molecules/ biologics development projects. In addition, he worked at Merck Research Laboratories API Division supporting the development of synthetic pathways and scale-up of chemical processes for early- to late-stage drug candidates.
Recognized for scientific innovation: 35 research publications, 100+ presentations, and book contributions on formulation, analytical and physical chemistry, process analytical technology (PAT), Quality by Design (QbD), and other topics. Co-Editor (Book): HPLC for Pharmaceutical Scientists.
Antibody Discovery and Protein Engineering
Dr. Philippe Lienard
CMC Pre-Development Science Leader
Philippe Lienard obtained his PhD in organic chemistry at the CNRS, French National Research Center, in Pr Husson’s team, in 1991. After having performed a post-doc in the prestigious Pr Oppolzer’s laboratory in Switzerland, he joined SYNTHELABO in 1993 in chemical development. He occupied several positions including Head of Pilot Plant for 12 years. In 2003, He was expatriated in the USA for 3 years for SANOFI, as Chemical Development Director. Back to France in 2006, he has been working within early Pharmaceutical Sciences Department for 10 years and he’s currently Pre Development Science leader for several programs at the interface of Research and Development.
In the past 21 years Istvan J Enyedy has been involved in new target evaluation, in hit finding, in structure- and ligand-based hit-to-lead optimization, and in building machine learning models for predicting ADMET properties of compounds. He is coauthor on more than 50 publications and 14 patents/applications. He received his PhD in 1998 at Catholic University of America, Washington DC, and did postdoctoral training in Dr. Shaomeng Wang’s group at Georgetown University Medical Center, Washington DC. Between 2001 and 2008 he worked at Bayer Pharmaceuticals, West Haven CT and Novartis Institutes for Biomedical Research in Cambridge MA. Since August 2008 he has been working at Biogen Idec, in Cambridge MA