Find an Expert
FDA Regulations, GMP/GLP/GCP Compliance; IND, NDA, BLA, PMA and Product Regulation; Toxicology
Experienced in all aspects of validation and compliance including, GMP/GLP/GCP and part 11. Expert worked for over five years as a reviewer of investigational new drug applications, marketing applications, developing guidance and government policy and supporting approval process. In addition,…
Clinical Trial, Biomarker, Clinical Development, Drug Safety, Medical Affairs, Commercialization
As a prescribing physician and a physician in drug development for many years, Expert has expertise in drug mechanism of action and clinical data, and clinical use. Expert is an expert in drug clinical development from planning to protocol design,…
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…
Analytical Chemistry, Analytical Technology Development and Application
Expert is a Ph.D. Pharmaceutical Analytical Chemist with extensive experience in separations (LC, GC, Prep GC), dissolution, automation (robotics, computers) and general analytical technologies. He has familiarity with NDA programs and marketed product support, including analytical method development, process support,…
Medicine, Pharmacy, Pharmacology/Toxicology with Emphasis on Cannabanoids and Opioids
Expert is a practicing physician and pharmacist, who also holds a Master's of Science degree in Pharmacology and Toxicology. He has performed research in the field of Pharmacology with particular focus on drugs of abuse, cannabinoids and opioids. He has…
Intellectual Property Law, Patent Law; Industries: Biotech, Pharmaceutical, Life Sciences
Expert's Ph.D. thesis research concerned the plasma proteins, especially fetuin. He completed postdoctoral research fellowships at Harvard Medical School / NIH (Alzheimer’s disease, tau gene, genomic cloning), Johnson & Johnson (skin diseases, homeobox transcription factors), and Memorial Sloan-Kettering Cancer Center…
Medical Device, Diagnostic, and Pharmaceutical Clinical Trial Design and Strategy
Expert has over 25 years experience in commercializing medical products. Her experience includes management at Abbott Labs in clinical research and regulatory affairs and as a CEO of a venture capital backed medical diagnotic company. Expert has raised venture money…
EU GMP and Quality Systems
Educated to bachelors degree and masters level in biochemistry with many years experience in this field educated to bachelors degree level with many years experience in the field The Client retained Expert of Employer to help and guide it towards…
Virology, Anti-infectives, Gene Therapy, Bioterrorism Research
He has extensive experience in the development and use of viral vectors for gene transfer and in particular has worked with both adenovirus and AAV vector delivery systems. His work with adenovirus vectors included some of the earliest research focused…