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Pharmaceutical Sciences (Small Molecules and Peptide Delivery), Novel Drug Delivery (Micelles, Liposomes, and Insitu Forming Gel), and Conventional Dosage Forms (Solid, Semisolid, and Liquid)
Expert is an experienced pharmacist with a demonstrated history of working in the pharmaceuticals industry. A skilled researcher, she is knowledgeable of R&D development in Pharmaceutics (small molecules), cosmetics and OTC (herbal products). Expert is experienced in industry and academic…
PAEK Process Development and Manufacturing
Expert has over 10 years' PAEK experience. During this time, he served as new product development chemist, project leader, and manufacturing manager for PEKK commercialization. As a new product development chemist, he assumed hands-on responsibility for laboratory process and product…
Pharmaceutical Manufacturing, Combination Products, Medical Devices, and Good Clinical Practices
Expert is a retired Public Health Service (PHS) Officer with 16 years of FDA experience in Pharmaceuticals, Medical Devices, Biologics, and Bioresearch Monitoring. She has held the positions of Investigator, Pre-Approval Manager, Supervisory Investigator, and Foreign Inspection Cadre Member. She…
Pharmaceutical Development
Expert has over 28 years experience as a pharmaceutical executive managing various aspects of drug product development, including outsourced pharmaceutical manufacturing and broad aspects of the CDMO industry. Previously, Expert was the President of Pharmaceutical Development Services and the Chief…
Molecular Psychiatry and Neuroscience, Neuropharmacology, Cancer Immunotherapy
Expert has combined his extensive expertise in molecular biology, immunology, molecular neuroscience and psychiatry, and cancer biology to develop a new avenue in the discovery of suitable molecular targets for complex treatment of neurodevelopmental disorders (e.g. ADHD). The new treatment…
Specialty Chemicals,Pharmaceuticals, Nutrition, Composites,Synthetic Resins, Engineering Plastics
Expert has over 10 years of operational, business, strategic and executive leadership experience in this area having run DSM's pharmaceutical businesses in this area; he also led the Ant-Infectives business in the Asia Pacific, Middle East and Africa and was…
Pharmaceuticals & Healthcare in Brazil: Entry Strategy, Market Evaluation & BD
Expert has ran 6 pharma & healthcare businesses as General Manager/CEO/President in his 40 years in Brazil ranging from subsidiaries of US, German, UK & Latin American labs to local start ups. Businesses covered Rx & hospital products, OTCs &…
Transdermal Development Including INDs, ANDAs, NDAs, MAAs, CMC, Preclinical, Clinical, Bioequivalence
I have been involved in transdermal product development for 15 years and have spearheaded the development of quality control, quality assurance, regulatory affairs and clinical research departments. Among my activities are: 1. Designing preclinical, clinical and bioequivalence studies. 2. Filing…
Clinical Development, Regulatory Development
Following more than 25 years in the pharmaceutical industry (Big Pharma, Contract Research Organizations, Small Pharma), Expert has accumulated experience from several hundred clinical studies, primarily in Phase I/Phase II ("First-in-Human", "proof-of-concept") across most therapeutic areas (Metabolic, Infectious, Oncology, Urology,…
GMP Compliance EPCMV of BioPharmaceutical Process, Clean Utilities, Systems, Facilities Engineering
He is a Health Canada Expert (in 2007) and a Senior BioProcess Engineer & Project Manager Consultant; He acquired more than 21 years’ experience with various BioPharma Industries & Consulting companies (SNC Lavalin Pharma), where more than 50 projects were…