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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…
Medicine, Especially Pathology (Laboratory Medicine), Women\’s Health, Cervical Cancer, Breast Cancer
Expert has practiced diagnostic surgical pathology for over 20 years, with special interest and experience in gynecologic and gastro-intestinal pathology. She has participated in several clinical trials with pharmaceutical clients in these areas, and has practical knowledge of what is…
Pharmaceutical & Life Science Research and Manufacturing, New Drug Discovery, Therapeutic Strategy
By using standard analytical tools of cellular and molecular biology he has elucidated the molecular mode of action of an anti-diabetic candidate BMOV on the key components of insulin signaling cascades like IR Kinase (IRK) and IRS complexes including gross…
Neuropharmacology, Aging, Brain Injury, Memory Impairments, Imaging, Neurodegenerative Disorders
Expert has worked on several projects involving Alzheimer's disease (AD). In particular, he has used genetically engineered mouse models to test ideas and answer questions related to how biological memory might be affected by AD pathophysiology. In addition, he has…
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,…
FDA Compliance, Project Management, New Product Development, Validation, Cultural Transformation
Expert has audited many cGMP operations. A good audit starts with a good plan. Before starting an on-site audit, he reviews past audits. He notes indications of possible problem areas and items, if any, that were identified for corrective action…
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,…
Personalized Medicine, Genomics, Proteomics, Bioinformatics, Oncology, Biotechnology, IBD
As the director of the Employer Genomics and Proteomics Center and of the Dana Farber/ Harvard Cancer Center Proteomics Core, Expert has ample expertise in bioinformatics, since each of these facilities includes a whole core for bioinformatics. Expert supevises a…
SARS-CoV-2 Coronavirus, COVID-19, Sanitization Procedures, Forensic Science, Toxicology, DNA Analysis, Food Poisoning, and Toxic Torts
Expert is a Full Professor of Toxicology and has received grants from NIH in the area of Applied Toxicology. Expert has received grants from NIH in the area of Biotoxicology. Part of his research entails molecular analysis of toxins. Expert…
Pharmaceutical Manufacturing, Research and Development, Education & Training
Expert’s primary experience in tablet manufacturing covered conventional pharmaceutical tablets for a variety of drugs and chewable tablets of antibiotics, utilizing both dry and wet granulation techniques and a variety of processing and tablet equipment. His experience encompasses all aspects…