Pharmaceutical Research Expert Witnesses in Virginia

Pharmaceutical Research, Chemistry & Chemicals - API process development, API manufacturing, Solid state and physicochemical characterization, enabled formulation development, drug product development, drug product manufacturing, stereochemistry, process impurity identification, control, synthetic route selection, preformulation, polymorphism

HIGHLIGHTS • Twenty-eight years of industrial experience in all aspects of chemical development • Twenty-four years of experience in oversight of external vendors performing chemical development, custom starting material production and API manufacturing, preformulation, formulation development, drug product manufacturing, and all associated CMC activities • Eighteen years of experience in devising and executing integrated CMC development programs • Hands-on, results-oriented leadership of CMC development and multidisciplinary teams • Innovation in the conception of practical synthetic routes to pharmaceuticals, development and implementation of chemical processes for the manufacture of APIs and chemical process troubleshooting. • Expertise in technology transfer and oversight of chemistry from the research laboratory to kilo labs, pilot plants and multipurpose plants at contract development and manufacturing organizations • Experience in the development and manufacture o...

Pharmaceutical Research, Chemistry & Chemicals - Drug Formulation, Biotechnology, liquid formulation, formulation, medicinal chemist, organic chemist, pharmacokinetics, stability studies, dietary supplements, tetracyclines, synthetic biology, drug tests

EXPERT WITNESS CONSULTING Dr Abato has been involved in 8 cases, been deposed 5 times and has testified at trial in 4 cases. Dr Abato has testified in high stakes litigation cases at the International Trade Commission and federal courts for major players in the pharmaceutical industry. He has experience with ANDA, trade secret, trademark infringement, patent infringement and contract law cases relating to pharmaceuticals. Upload Dr Abato’s CV, which includes a complete list of case numbers and Law Firms that he has represented. PHARMACEUTICAL EXPERIENCE Dr. Abato is a Medicinal Chemist. His expertise includes drug research, medicinal chemistry, organic chemistry, drug formulation for; IT, IV, IP, ICV, IN, IM and oral dosing routs, stability studies, extensive structure-activity relationships, efficacy, pharmacokinetics, as well as all pre-clinical testing required for IND submission to the FDA. Dr Abato was awarded the prestigious “Heroes of Chemistry Award” by the Amer...

Lovettsville, Virginia

Pharmaceutical Research, Infectious Diseases - pharmaceutical regulation, FDA, drug development, antimicrobials, antiseptics, disinfectants, clinical trials, post-marketing surveillance, drug labels, biologics, medical devices, microbiology, biochemistry, molecular biology, food poisoning, data fraud, biological defense, dairy micro, IP

25 years of experience in infectious disease including food microbiology, chemical/ biological defense and regulatory science. Initial employment in the Federal Government was with the Agricultural Research Service (ARS) performing genetic engineering of dairy bacteria. From there, he went to the Department of Defense, specifically Naval Surface Warfare Center (NSWC), working in chemical and biological warfare defense. Spent 12 years as a Clinical Microbiology reviewer in the Center of Drug Evaluation and Review (CDER) at FDA. He has extensive experience with FDA submissions including: pre-IND, IND, NDA, labeling supplements, and post-marketing for antibiotics, topical antiseptics, biologics and generic drugs. As an independent consultant, provided guidance on microbiology and regulatory affairs for clients developing antimicrobials, medical devices and biologics allowing clients to navigate through the FDA regulatory process. This guidance included providing advice for deve...