Pharmaceutical Research Expert Witnesses

Psychiatry, Pharmaceutical Research - Psychiatric Adverse Reactions, Side Effects, Suicide, Homicide, Involuntary Intoxication

Dr. Josef Witt-Doerring is board-certified psychiatrist who specializes in the accurate identification of psychiatric adverse drug reactions. Previously, Dr. Witt-Doerring served as a Medical Officer within the Division of Psychiatry at the Food and Drug Administration, where he analyzed emergent safety issues for psychiatric drugs and proposed strategies to mitigate risk such as writing safety sections in psychiatric drug labels. Dr. Witt-Doerring has worked in three different pharmaceutical companies (Two for psychiatric medications, and one for oncology) in clinical research and drug safety positions. With respect to clinical experience, Dr. Witt-Doerring is the supervising Medical Director for telepsychiatric services for emergency room and consult-liaison psychiatry for HCA Healthcare's TriStar Division in Tennessee. Within this role, he oversees the quality of psychiatric care for 24 psychiatrists working in a division comprised of 20 hospitals and emergency rooms. Dr. W...

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

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 American Chemical Society in 2019 for his contribution to NUZYRA, the latest antibiotic that works on antibacterial resistant bacteria. Additionally, he has developed qualified clinical candidates for Spinal Muscular Atrophy (SMA) and Multiple Sclerosis. As a Medicinal Chemist, Dr Abato has also conducted research in the areas of Malaria, Tuberculosis and Cancer. PHARMACEUTICAL CONSULTING Dr Abato provides consulting services for medicinal chemistry, drug formulation, chemistry manufacturing and controls, literature search/summary and manag...

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.

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.

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.

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.

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

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.

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...

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

Chemistry & Chemicals, Toxicology - Chemist, Chemist Medicinal, Pharmacology, Pharmaceutical Research, Pain Medicine, Cannabis, Explosives, Forensic Sciences, Laboratories, Testing, Analysis, Patents, Chemistry Litigation

Pharmaceutical Research, Warnings & Labels - Pharmaceutical Industry, Drug Development, Product Labeling, Regulatory Labeling, Prescribing Information, Indications, Dosage, Contraindications, Warnings, Precautions, Adverse Experiences, Regulatory Strategy, Regulatory Compliance, Safety, FDA, Review of Promotional Materials

Medical License, Residency in Internal Medicine, PhD in Molecular Biology, NIH Biotechnology Fellowship, Tufts University Center for Study of Drug Development (Clinical Pharmacology, Drug Development, and Regulation), Drug Information Association (Global Perspective on Medical Writing and Document Preparation for the Pharma Industry and Regulatory Agencies), Maintain Medical License Continuing Medical Education Requirements.

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...

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

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 American Chemical Society in 2019 for his contribution to NUZYRA, the latest antibiotic that works on antibacterial resistant bacteria. Additionally, he has developed qualified clinical candidates for Spinal Muscular Atrophy (SMA) and Multiple Sclerosis. As a Medicinal Chemist, Dr Abato has also conducted research in the areas of Malaria, Tuberculosis and Cancer. PHARMACEUTICAL CONSULTING Dr Abato provides consulting services for medicinal chemistry, drug formulation, chemistry manufacturing and controls, literature search/summary and manag...

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...

Psychiatry, Pharmaceutical Research - Psychiatric Adverse Reactions, Side Effects, Suicide, Homicide, Involuntary Intoxication

Dr. Josef Witt-Doerring is board-certified psychiatrist who specializes in the accurate identification of psychiatric adverse drug reactions. Previously, Dr. Witt-Doerring served as a Medical Officer within the Division of Psychiatry at the Food and Drug Administration, where he analyzed emergent safety issues for psychiatric drugs and proposed strategies to mitigate risk such as writing safety sections in psychiatric drug labels. Dr. Witt-Doerring has worked in three different pharmaceutical companies (Two for psychiatric medications, and one for oncology) in clinical research and drug safety positions. With respect to clinical experience, Dr. Witt-Doerring is the supervising Medical Director for telepsychiatric services for emergency room and consult-liaison psychiatry for HCA Healthcare's TriStar Division in Tennessee. Within this role, he oversees the quality of psychiatric care for 24 psychiatrists working in a division comprised of 20 hospitals and emergency rooms. Dr. W...

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.