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Immunology, Pre-clinical Drug Development, Inflammation, Vaccines, Infection
Expert trained in Immunology at the Universities of Birmingham and Bristol in the UK and became Professor of Immunology in 2005. He has particular expertise in cellular immunology, mucosal immunology and infection. He has worked widely with drug development companies…
Drug Development (Small Molecules, Peptides, Biologics, Parenteral Nanoparticles); Drug Delivery
Expert is an expert in analytical instrumentation and analytical methods development and validation, especially for drug regulatory filings with the FDA and EMEA according to all FDA and ICH guidelines. He established a state-of-art core instrument department at Altus Pharmaceuticals…
Psychopharmacology, Drug Development, Medical Devices
Expert's training in psychiatry has focused on biological psychiatry (the biological basis of psychopathology) and on psychopharmacology. He currently directs the Developmental Biopsychiatry Research Program and the Laboratory of Developmental Psychopharmacology at McLean Hospital/Harvard Medical School. He has a broad…
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…
Pediatrics: Anesthesia, Ambulatory Surgery, Analgesia, Pain Management, Analgesic Drug Development
Expert is the former Chief of the Pediatric Pain Service at the Arkansas Children's Hospital and has written about the subject in professional journals. He has twenty years of experience in the management of pain in adults and children. He…
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.…
Drug Delivery, Drug Development, Business Development, IP Strategy, Medical Nanotechnology,
As a business development exectuive and as CEO of several life sciences companies, he has had the opportunity to be closely involved and lead the identification, negotiation and closing of a number of licensing and R&D agreements with pharmaceutical, biotechnology,…
Pharmaceutical Drug Development, Strategic Executive Management, Biopharma Mergers and Acquisitions
Expert has over 20 years of experience. He is extensively active and has significant experience and expertise in Europe and the US in the areas of drug development and financing throughout Europe and the US. He was responsible for the…
Stroke, Preclinical Drug Development, Translational Research
Expert A. Expert, PhD. FAHA is the Director of Translational Research at Employer in Los Angeles, California. He is directing the preclinical development of new methods to treat acute ischemic stroke. Expert has expertise in developing small molecules, proteins and…
New Drug Development and Approval
Expert has extensive experience in complying with requirements of that part of the Act pertaining to drugs as implemented by the regulations of the FDA The requirements affect the development of drugs from the initial stages of screening to final…