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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 & Device Clinical Development, Regulatory Approval, Adverse Reactions, Expert Witness
Clinical Pharmacology is the scientific discipline that brings science to the process of drug development, particularly at the key stage where a molecule of interest becomes a drug candidate. From this point, through the rest of Development, the science of…
Nursing, Medical Literature, Healthcare
Expert started her career as a medical/surgical and hematology/oncology nurse working at Children's Hospital. She received her master's degree in (clinical nurse specialist and nurse practitioner) pediatrics from the University of Delaware. Expert went on to take a position at…
Clinical Anesthesiology, Surgical Recovery Room, Critical Care, Pain Medicine, Abused Drug
Current Practicing Anesthesiologist responsible for caring for individuals that use abused drugs on a regular basis. These individuals have both medical and psychological problems resulting from both recent and long term abuse of drugs. Treats individuals who receive care at…
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…
Computer Science: Embedded-Computer Systems, Statistical Analysis, Data Recovery, Languages
He carries out forensic consulting, writes specialized computer programs both for others and for his own amusement, edits technical books, tutors in English for speakers of other languages, serves as treasurer for not only the local Emergency Squad but also…
Chemical Process Safety Management, Plant Protection, Risk Management, Chemical Plants
He has hands on 25 years experience in design, project execution, commissioning and operation in chemical process industries which includes fertiliser, petrochemical, bulk drugs, fine chemicals, petroleum, oil & gas plants. He was recognised by international technology suppliers such as…
Clinical Development Processes and Clinical Trial Technologies
Expert has worked extensively in bringing technology solutions to solve inherent problems of clinical trial processes. The software products he has worked on ranges from 'electronic data collection' to 'document centric' solutions to reduce overall time it takes to bring…