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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…
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…
Engineering Systems, R&D, Infrastructure, Governance, Projects and Program Management, Risk Management
Expert began research in computational mechanics of fibre-reinforced composite materials through which he obtained his PhD. With this background, he explored other advanced materials like piezoelectrics. Piezoelectric materials are essential for the development of SAW sensors. Surface Acoustic Wave (SAW)…
Patent & Copyright Infringement, Depositions & Testify, Cell Phone Tracking, GPS, Cell Tower Records
Expert has consulted for law firms in California in connection with helping them write claims that provide the best patent coverage. He helps them in avoiding infringement by devising different technical approaches and novel ways to patent ideas and designs.…
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…
Baby Diapers, Non-Woven, Absorbent Products, Films, Wipes, and Consumer Tissue & Towel
Has extensive experience in the development and evaluation of absorbent materials of all types for the management of all types of human exudates. This includes cellulose absorbent cores, superabsorbent materials, foams, fibers and non-woven absorbent materials. Has commercialized over a…
Thin Film Deposition, Chemical Mechanical Polishing, Semiconductor Process Integration
Expert has 10 years of experience developing consumable products and processes for application in chemical mechanical polishing. He holds approximately ten patents and patent applications on consumables and processes for chemical mechanical polishing. The expert has intimate knowledge of chemical…
Patent Law, Law, Medical Device Design, Drug & Perishable Material Stability, 510(k) Approvals
Expert's legal practice focuses on intellectual property and patents. He is registered to practice both in California for general legal issues, and nationally for patent issues through the USPTO. In addition to filing and prosecuting patents, he also has experience…
Intellectual Property: Analysis and Strategy Development
Twenty plus years with ExxonMobil Chemical Company where Expert worked on numerous organic chemicals and their commercial applications. Inventor on 70 US patents many of which deal with said organic chemicals including chemical intermediates and polymers. Did extensive work on…
Surface Science, Polymers, Textiles, Testing Materials, Plastics, Physical Chemistry, Pharmaceutical
Expert worked for three years as the Director of RD&E for the chemical products division of Waters Inc. In addition to the direction of the research in chromatographic media he was co-inventor of 7 patents for water-wettable extraction media and…