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Nanobiotechnology, Drug Delivery Platforms, Medical Devices, Targeted Therapeutics, Diagnostics
Expert has extensive experience establishing R&D operations in early stage biotechnology companies. He applied his knowledge in nano(bio)technology to develop innovative solutions to drug delivery and drug targeting challenges. His efforts to enhance the use of biomaterials in a variety…
Orphan Drugs: FDA/EU/Canada; FDA Approval; Drug Development: CMC, QA, QC, Manufacturing
12 product approvals from FDA including 6 new chemical entities, a 510k device, and three major pharmaceutical efficacy indication supplemental approvals. All received 5-10 years of regulatory exclusivity (Hatch-Waxman, Orphan Drug). These products are generating over $100 million dollars in…
Biopharmaceutical Development
Expert, PhD, is a consultant in the field of BioPharmaceutical Development. He has over 23 years of biotech industry experience in biotherapeutic and diagnostics development, having held senior positions at several biotech companies, most recently, VP of Biologics Development at…
Drug Discovery & Development Technology and Intellectual Property (Patents, Trade Marks, etc.)
He has had the Drug Discovery Department, as part of his role as Director R & D, at Wockhardt Limited, discover several new NCEs during the tenure of this position, which NCEs are more extensively described in a later section…
In-Process Analytical, cGMP Auditing, Polymer Characterization, Analytical Lab Design and Management
Expert has 32 years of industrial analytical chemistry experience. For the last 24 years of that period, he headed the analytical R&D organization of International Specialty Products, a $1.7B specialty chemical company (as of 2007). In his time heading that…
Chemical Analysis and Quality Assurance
She has expertise on Varian instruments ICP-AES; ICP-OES; AAS; GC-MS; NMR; Pelkin elmer ICP-OES; FT-IR; Schimatdzu HPLC; Elementar CHNSO; LC-MS; JEOL EPR; Bruker NMR operation and interpretation of results of various metal containing complexes and compounds of organic nature such…
Clinical Pharmacology, Toxicology, Drug Development, Product Liability, Regulatory Affairs, Pharmaceutical Patents
Expert worked in pharmacological research concerning opiate analgesics. The objective of the research was to find an anti-diarrheal drug with minimal analgesic and addiction potential. In particular, he led the research team that discovered and developed nufenoxole, an antidiarrheal drug.…
Pharmaceutical & Life Science Research and Manufacturing, New Drug Discovery, Therapeutic Strategy
By using standard analytical tools of cellular and molecular biology he has elucidated the molecular mode of action of an anti-diabetic candidate BMOV on the key components of insulin signaling cascades like IR Kinase (IRK) and IRS complexes including gross…
Analytical Science: Elastomers, Plastics, Pharmaceutical, Medical Devices, and Transformer Oil
Expert has worked the field of analytical chemistry for over 30 years. His PhD thesis was on phosphorus NMR as a trace analytical tool. He joined Goodyear and both developed analytical methods mainly using HPLC and GC and after 6…
Pharmaceutical Development, CMC, Project Management, Intellectual Property
Expert has developed modified release products throughout his career. Most recently he led the development of proprietary oral modified release systems at Phoqus Pharmaceuticals. These included zero-order, increasing-rate, pulsatile, delayed-release, chronotherapeutic and fast-release formulations. Prior to that he was responsible…