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Medicinal Chemistry and Pharmaceuticals
Expert's services have been retained in a high-profile ANDA case against Pfizer. Expert was deposed and participated in pretrial preparation. He has recently provided expert witness consulting services in a case for a nutraceutical company, where he was deposed and…
Medicated Aerosol and Inhalers
Expert has been in the field of Medicated aerosol (MDI, DPI and nebulizers) since 2004. His PhD was in this field and most of his 77 published paper and 48 conferences presentations are in this field. Expert has a respiratory…
BioStatistics, Pharmaceutical Devices, Biotechnology, and FDA and EMA Submissions
Expert holds a Ph.D in Statistics and has 25 years' applicable industry experience. He currently serves as a biostatistical expert witness in high-stakes pharmaceutical and medical device litigations. He has expertise in pre- and non-clinical, Phases I-IV in biostatistics, data…
Inhalation Toxicology
At Harvard University, I am a Staff Scientist at the Center for Nanotechnology and Nanotoxicology. Much of my research centers on inhalation toxicology, nanomedicine and biomedical applications of functional nanomaterials, especially nanoparticles for targeted drug delivery. I publish my work…
Pharmaceutical Discovery and Preclinical Development
SPECIFIC PRODUCTS IVIG (Gammar-P IV ) Rhone Poulenc Rorer Marketed AMP – 579 Rhone Poulenc Rorer Phase II Fenofibrate (TriCor) Abbott in-licensed from Fournier. Over $1 Billion in annual sales. ABT-538/ABT-378 (Kaletra) Abbott over $1 Billion in peak annual sales…
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,…
Life Science, Biotech, Pharmaceuticals: Research and Development, Smart Manufacturing/ Supply Chain, and Market Launch/ Commercialization
Expert has over 20 years of experience in strategic innovation, system building, and delivering value solutions for global markets. His focus is on building infrastructure synergies between science, technology, and finance. As a Strategic Advisor, he has experience with: •…
Mycotoxic Nephropathy, Pathology, Mycotoxins
Expert demonstrates expertise in veterinary pathology and diagnostics in areas of morbid anatomy, necropsy, histopathology, toxicologic pathology, toxicology and diagnostic services. Expertise in relation to designing of experiments and reading various macroscopic, microscopic and ultrastructural changes in animal tissues samples.…
Rapid Development of Controlled Release Drug and Drug-Device Combination Products
Expert, Ph.D., is an independent consultant with 15+ years experience in developing controlled release implantable and injectable products for proteins/peptides and small molecule drugs, spanning from chronic/systemic delivery to acute/local delivery, with special focus on drug delivery platforms and drug-device…
Neuropharmacology, Intoxication, Drug Abuse, Disability, Poisoning, Pharmacological Pain Management
This Expert comes from a background in behavioral pharmacology of opiate and non-opiate analgesic drug development, and cognition-related drug effects in both university and pharmaceutical industry, basic and clinical research. Expert has thirty post-doctoral years of consulting experience. Particular interests…