Pharmaceutical Research Expert Witnesses in Texas

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...

Austin, Texas

Oncology, Pharmaceutical Research - Oncology Drug Development, Patent Validity, ICH GCP, Written description, Enablement, Obviousness, Anticipation, Pharmacology, FDA, EMA, NMPA/China, PMDA/Japan, Drug formulation, Medical Safety, Phase 1-3 Clinical Trials, Drug Product Safety/Compliance, Medical Oncology

Frederick (Fred) Hausheer, MD, FACP Physician-scientist with over 35 years of international executive leadership and management experience in US and international (EU, JP, China, others) overseeing commercial oncology pharmaceutical research and development (Phase I-III), drug discovery, preclinical translational and clinical medicine, clinical pharmacology, and commercial development strategy and risk management. Inventor/co-inventor on more than 400 issued United States and international pharmaceutical patents, author/co-author of more than 200 scientific/medical publications. Experienced former CEO and current Chief Medical Officer executive with several biopharma companies. He is a former NCI-Designated Clinical Investigator, NCI-Institutional Review Board voting member, and NCI-Experimental Therapeutics Study Section member, and an ad hoc external expert medical advisor for the US FDA. Some of his major awards include the American Cancer Society Fellowship Awards, the Natio...

El Paso, Texas

Pharmacist, Pharmacology- Clinical - Community Pharmacy, Pharmaceutical Research, Recreational Drugs, Medication Errors, Pharmacy Standards of Care, Drug Interactions, Pharmacy Practice

Scott received his initial training in pharmacy and has worked as a registered pharmacist since 1990. He spent several years as a research scientist in the pharmaceutical industry, receiving a number of patents, grants, and publications. His academic experience includes serving as a professor and administrator at several different pharmacy programs. He has served as an item writer and reviewer for both the Pharmacy College Admissions Test (PCAT) and the North American Pharmacist Licensure Examination (NAPLEX). In addition, he served as a fellow in the American Association of Colleges of Pharmacy (AACP) Academic Leaders Fellowship Program in 2011-12. Dr. Weston attended the University of Mississippi where he received a B.S. degree in Pharmacy in 1990. In 1995, he received a Doctor of Philosophy degree from the University of Mississippi in Pharmaceutical/Medicinal Chemistry and then completed a three-year postdoctoral fellowship at the Northwestern University Medical School in the De...