Expert Witness Profile · Expert T616L
This expert is a Ph.D. medicinal chemist and veteran pharmaceutical research and development executive with more than 18 years of supervisory experience, specializing in chemistry, manufacturing and controls (CMC) regulatory strategy and FDA submissions.
Expertise spans drug formulation and delivery (oral, ophthalmic, parenteral, and nanoparticle and microparticle systems), IND, NDA, ANDA, and BLA regulatory submissions, drug-device combination products, radiopharmaceutical CMC, polymorph screening, process development and scale-up, and cGMP and cGLP quality systems, across small molecules and biologics.
Attorneys retain this expert for pharmaceutical patent matters turning on formulation and manufacturing, ANDA and Hatch-Waxman disputes, regulatory compliance questions, and combination product cases.
Credentials
Formal Education
- Ph.D. in Organic Medicinal Chemistry from the Philadelphia College of Pharmacy and Science
- M.S. in Organic Chemistry from the University of Bombay
- B.S. in Chemistry and Microbiology from the University of Bombay
Why Attorneys Retain This Expert
Expert Qualifications
- More than 18 years of supervisory pharmaceutical research and development experience
- CMC regulatory strategy across small molecules, biologics, and combination products
- Experience with IND, NDA, ANDA, and BLA submissions to the FDA and international regulators
- Prior service as an expert witness on pharmaceutical patent matters