Pharmaceutical Research Expert Witnesses

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...

Richmond, California

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...

Washington, District Of Columbia

Pharmacology- Clinical, Pharmaceutical Research - Forensic Pharmacology, Toxicology

I am an Associate Professor and Chair; as well as former Chair of the Medical IRB. As a forensic pharmacologist, my role is to analyze, assess, review, and support the attorney's position. I am recognized as an expert witness in pharmacology and toxicology for deposition and trial testimonies (Criminal, Civil and Military courts; both Plaintiff and Defense). My area of expertise includes a broad range of cases such as blood alcohol level (BAL), DUI, adverse drug reactions to medicines, overdose of medicines, drug interactions, and personal injury resulting from an exposure to medicines, effects from drug abuse or industrial chemicals, and induction of cancer by chemicals. I have provided written reports and in the case of a trial, I have testified to clearly explain the findings in the court. I view my role as a forensic pharmacologist involving helping the attorney in preparing a cross-examination of the expert on the opposite side.

Conyers, Georgia

Chemistry & Chemicals, Pharmaceutical Regulation - Medical devices, pharmaceutical research, patents, drug formulation, quality control, laboratories, manufacturing, drug packaging, cosmetics, food, ISO, International Standards of Harmonization (ISO), environmental conditions, compliance, sterilization, chemical synthesis, fermentation, components

Experienced Chemist with 25+ years of experience in quality control, raw materials, manufacturing, validation, and stability. Experience in pharmaceutical, medical device, cosmetics, and food industries. Former odor panel scientist at Proctor & Gamble as a contractor. Extensive teaching experience. International inspector.

Westmont, Illinois

Toxicology, Pharmaceutical Research - Pharmacology, Neuroscience, Toxicology, Industrial Chemicals, Contract Research Organizations, Academic Research, Drug Development, Human Health Risk Assessment, Diplomate of the American Board of Toxicology, DABT, US FDA, US EPA, Gene Therapy, Biologics, Toxicologist, Pharmacologist

I am toxicologist and pharmacologist with a board certification in toxicology. I have 20 years of experience working with in the biotech, pharmaceutical and chemical industries to address pharmacology/toxicology, regulatory affairs issues and human health risk assessment. I have more than 30 years of research, consulting and regulatory experience. I have worked with law firms for the last 15 years in various capacities to support litigation. I am an active member of the American College of Toxicology, Society of Toxicology, and American Society of Gene and Cell Therapies. I also am a Diplomate of the American Board of Toxicology (DABT) since 2018.

Bethesda, Maryland

DNA, Laboratories & Testing - Forensic Science, Pharmaceutical Research, Bioengineering, Biomedical Engineering, Biochemistry, Chemistry, Bacteria, Infection, DNA, Biological Engineering, Testing and Laboratories, Infectious Disease research, Laboratory, Vaccine, Vaccine development

Dr. Byrd is an scientific executive and former senior military officer with significant civil and criminal legal consulting experience including deposition and trial testimony. He has held multiple scientific lead positions including Director of Biosciences at the Army Research Laboratory and Lead Scientific Advisor to the Chief of Staff of the Army and has extensive expertise in biotechnology, chemistry, and life science research processes. . He has also worked as a professor of chemistry, biochemistry, and biology and has collaborated in research efforts with federal, academic, and industry partners such as DARPA, DHS, FBI, MIT, UCSB, and MedImmune, among others. His areas of expertise include: ➢ Bioengineering ➢ Biochemistry ➢ Forensic Science ➢ Microbiology ➢ DNA and Nucleic Acids ➢ Vaccine Development ➢ Research and Development ➢ Biotechnology ➢ Pharmaceutical Development ➢ Bacteria and infection ➢ Laboratory documentation and research review

Chester, New Jersey

Pharmaceutical Research, Chemistry & Chemicals - Analytical chemistry, Drug delivery systems, Natural products chemistry, Oral cavity health, Chemicals characterization, Hair care, Smoking cessation, Cosmetic products, innovation assessment, Organic chemistry, Dietary supplements, Intellectual property (IP), Over the counter (OTC) medicines

SUMMARY: Dr. Abdel-Malik is an accomplished executive innovation leader with a Ph.D. in Organic/Natural Products Chemistry. His expertise lies in the intersection of R&D and business development in the life sciences, particularly in pharmaceuticals and consumer products. PHARMACEUTICALS AND CONSUMER PRODUCTS: AREAS OF EXPERTISE Dr. Abdel-Malik has developed comprehensive expertise across diverse therapeutic areas within pharmaceuticals and consumer products. This expertise includes organic chemistry; natural products chemistry; rare autoimmune diseases medicines (such as tumor necrosis factor-alpha (TNF-α)); gene delivery systems; and regenerative medicines; over-the-counter (OTC) medicines; analytical chemistry (NMR, MS, HPLC, GC, etc.); carbohydrate chemistry; polysaccharide chemistry; chemicals characterization; consumer self-care products; drug delivery systems; formulation technologies; pain management; nicotine replacement therapies; respiratory health (cough and cold; alle...

Princeton, New Jersey

Obstetrics & Gynecology, Pharmaceutical Research - Women's Health

Certified Physician Executive; Certified Physician Investigator; Fellow of the American College of Obstetrics & Gynecology; Fellow of the American College of Surgeons

Garnet Valley, Pennsylvania

Public Health, Pharmaceutical Research - epidemiology, pharmacoepidemiology, outcomes research, observational research, real world evidence

Eileen E. Ming, MPH, ScD, FISPE, is an epidemiologist, pharmacoepidemiologist, outcomes researcher, and leader in the pharmaceutical industry. She served as an outcomes researcher at Merck, an epidemiologist at AstraZeneca, and the head of global epidemiology and pharmacoepidemiology at Shire Pharmaceuticals. Dr. Ming founded Epi Excellence, an epidemiology consulting practice, in 2014. She has worked across a variety of therapeutic areas, from pre-clinical through post-marketing phases, providing epidemiologic strategic and tactical expertise to commercial, clinical development, market access, medical affairs, regulatory, and pharmacovigilance activities. Dr. Ming is an Adjunct Scholar of the Center for Clinical Epidemiology and Biostatistics, and an Adjunct Investigator of the Center for Pharmacoepidemiology Research and Training, at the Perelman School of Medicine at the University of Pennsylvania. She is a Fellow of the International Society for Pharmacoepidemiology. Dr. Ming r...

Providence, Rhode Island

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...

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...

Port Townsend, Washington

Chemistry & Chemicals, Pharmaceutical Research - drug discovery, natural products chemistry, termite control, organic synthesis, lipid metabolism, sterol metabolism, fatty acid, phospholipid, anti-cancer drug, cholesterol, hyaluronic acid, polymers, insect pheromone, hormone biochemistry, biomaterials, regenerative medicine, intellectual property

Expert witness and consultant for intellectual property cases in the chemical and life sciences. Expert in organic synthesis, natural products chemistry, mechanistic enzymology, pest control agents, termite biology, insect and mammalian pheromone biochemistry, insect hormone biochemistry, mammalian and insect steroid metabolism, and photoaffinity labeling and intracellular visualization. Chemical biology of phosphoinositide and lysophosphatidic acid signaling; the chemistry of hyaluronic acid and development of hyaluronic acid derived biomaterials for wound repair, cell culture, tissue engineering. Discovery of anti-cancer, cholesterol-lowering, and anti-inflammatory drugs.