I provide expert witness services in connection with Hatch-Waxman type ANDA and patent infringement litigation in the area of pharmaceutical technology. I have been deposed twice, sat in and advised counsel on two other depositions, was involved with one pretrial preparation and I have testified at trial.
My services have been retained a major Generic Pharmaceutical Company, I was deposed and participated in pretrial preparation. I have also provided testimony at trial in in a patent infringement case.
I also consult for the Biotechnology industry and am currently working with H3-Biomedicine where I oversee radio-labled syntheses of active pharmaceutical agents standards for pharmacokinetic studies in support of for clinical trials for their cancer drug cantidates.
A Ph. D. Medicinal Chemist with over 25 years experience in the discovery and development of novel human therapeutics in the areas of anti-infective, anti-inflammatory and neurodegenerative diseases. I contributed to the development of NUZYRUA (Omadacycline), a new antibiotic approved by the FDA in October of 2018.
I have been involved in all aspects of drug research and development from formulation development, synthesis/purification, in-vitro, in-vivo (efficacy and pharmacokinetics), dosing routs, and the management of CROs to support pre-clinical testing.
Established in 1981, System Engineering And Laboratories (SEAL) specializes in providing multi-disciplined engineering and scientific consulting, product testing, safety and… Read more…