Find an Expert
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…
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.…
Technical Commercial Development Support, Technology Transfer Food Non-Food Ingredients, Obesity
Expert K. Expert is the Principal of a consulting firm and has over 35 years experience in R & D., marketing, operations, process development and quality assurance. Expert engaged and managed a consulting business with network of experts that range…
Facilitating Business Growth Through Commercialization of New Medical and Biotechnology Products
Expert has extensive experience supporting clients in pharmaceutical, medical and industrial markets. An electrical engineer by training, and the principal of his own consultancy for more than 12 years, he brings strong market, business development and technical skills to his…
Immunology, Vaccine Research
Expert is an internationally recognized expert in mucosal immunology. He has published more than 70 papers and reviews in several prestigious scientific journals. He is best known for experimentally establishing (with continuing research) the concept of a common mucosal immunologic…
Parenteral and Enteral Nutrition
PARENTERAL & ENTERAL NUTRITION. Expert has a solid background in nutrient utilization and metabolic adaptation during nutritional support by total parenteral or enteral nutrition. Applications of these nutritional support techniques include studies of tumor growth and metastasis in mice; immune…
Animal Models, Preclinical Testing, GLPs, Protocols, Data Capture Forms, Veterinary Medicine
Expert has a significant amount of experience with developing animal models through discussions with cross-functional groups and considerable expertise in veterinary surgery and biomechanics. He has experience with animal models for the cardiovascular, peritoneal, gastrointestinal, cutaneous, reproductive, urinary, and skeletal…
Gastroenterology, Medical Use of Voice Recognition
A leading expert on the evaluation of medical lexicons, Expert is the American representative to the international group developing the minimal standard terminology to digestive endoscopy and has a major grant to test it in the U.S. The National Library…
Cough Medicine, Smoke Effects on the Lungs, Vivo Assessment of Airway Clearance, etc.
Expert has expertise in mucus rheology, coughing and cough clearance. His research in mucology involves the study of airway surface fluid (ASF) and how it contributes to lung defense. ASF, the secretory product of the respiratory tract, is composed of…