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Pharmaceutical Research Expert Witnesses

The SEAK Expert Witness Directory contains a comprehensive list of pharmaceutical research expert witnesses who testify, consult and provide litigation support on pharmaceutical research and related issues. Pharmaceutical research expert witnesses and consultants on this page may form expert opinions, draft expert witness reports, and provide expert witness testimony at deposition and trial. The issues and subjects these pharmaceutical research expert witnesses testify regarding may include: Pharmaceutical Research, Drug Development, Bacteria, Biochemistry, Biologics, Biotechnology, Clinical Trials, Dietary Supplements, Drug Discovery, Drug Formulation, Infection, Medical Devices, Molecular Biology, Natural Products Chemistry, and Accidental/Intentional Overdose.

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David A Kitzenberg, MD, PhD

Life Sciences and Medical Consultant

Kitz Consulting LLC

Denver, Colorado

Pharmaceutical Research, Infectious Diseases - Molecular biology, Microbiology, Science, Scientific research, Life Sciences, Drug development, Medicine, Literature review, Bacteria, Fungus, Medical chart review, Data analysis, Scientific advisor, Medical scientist, Biotech, Startup, Biomedical, infection

Education M.D. - University of Colorado School of Medicine Ph.D. - Molecular Biology, University of Colorado Anschutz Medical Campus B.A. - Summa cum laude Integrative Physiology, University of Colorado Boulder Awards Catalyst Awardee, National Academy of Medicine, Healthy Longevity Global Competition Molecular Pathogenesis of Infectious Diseases National Institute of Allergy and Infectious Diseases T32 Awardee Sobel Scholar, American Society for Investigative Pathology Howard Hughes Medical Institute Undergraduate Research Awardee I have spent the past 15 years immersed in science and medicine, building expertise across both research and clinical disciplines. Throughout my training, I developed the ability to analyze complex subjects and translate them into clear, actionable insights for diverse audiences. I take pride in making technical material accessible and useful, helping clients understand and apply complex information with confidence. My consulting career began as a scie...

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Paul Abato, Ph.D.

Medicinal Chemist Pharma Patent & ANDA Expert

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

EXPERT WITNESS CONSULTING Dr Abato has testified in high stakes litigation cases at the International Trade Commission on 2 occasions, the High Court of Malasia on 3 occasions in addition to Federal and State Courts. He has been deposed nine times and has been engaged as an expert in 10 cases pertaining to patent validity and infringement, ANDA/Paragraph IV disputes, trade secret misappropriation and trademark infringement disputes in cases related 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 prest...

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Krista Wager, MD

Pediatric Hospitalist Physician Expert Witness

Washington, District Of Columbia

Pediatric Hospitalist, Pediatrics - Pharmaceutical research

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Edward U Maduh, R.Ph., M.Sc., Ph.D.

Board licensed Clinical pharmacist & toxicologist

Washington, D.C., District Of Columbia

Toxicology, Pharmaceutical Research - Neurotoxicology mechanisms, Neuropharmacology, Pharmacy errors, Pharmacist duty standards, Drugs of abuse, Neuroscience, Chain drug stores, Drug & chemical safety, Clinical Research, Toxic exposures, Molecular toxicity, Envinronment toxicants, Accidental/Intentional overdose, Acute & chronic effects, Industrial tox, Mechanisms

Dr. Edward U. Maduh is a well accomplished toxicologist, pharmacologist, educator, and clinical pharmacist with extensive expertise in research, drug development, and pharmaceutical care. A U.S. citizen based in Washington, D.C., and Silver Spring, Maryland, Dr. Maduh holds a Ph.D. in Toxicology and Pharmacology from Purdue University, with a thesis on the "Mechanisms of Cyanide Neurotoxicity," along with an M.S. in Pharmacy (Pharmacology) from Idaho State University and a B.S. in Pharmacy from the University of Wyoming. His academic background is complemented by specialized certifications in Neuroscience (Purdue University Neuroscience Program) and Regulatory Issues in Biotechnology University of Maryland Baltimore County (UMBC) Baltimore, Maryland. Dr. Maduh's career spans more than four decades and is marked by significant contributions to understanding cyanide toxicity and antidote development. He has held major research positions, including Principal Investigator and Resident ...

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Robert L Copeland, MS, PhD

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.

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Sidney Spector

Sidney A. Spector, MD, PhD

Tampa, Florida

Neurology, Pharmaceutical Research - Neurology, Pharmaceutical, Concussion, peripheral, stroke, Neuorologist, Research, musculoskeletal, sclerosis, nerve injury, Spine, Kinesiological, migraine, lumbar, neurodegenerative, Carpal Tunnel, spinal, headaches, cervical, seizures

Dr. Sidney A. Spector, MD, PhD, is a Board Certified Neurologist with a post doctorate degree in Kinesiological Sciences, currently actively practicing Neurology. Dr. Spector has performed independent medical evaluations over the past 13 years in the areas of worker's compensation, no-fault and personal injury, and has provided expert testimony in depositions and arbitrations. With active medical licenses in New York, Florida, Arizona, Oregon and Washington, Dr. Spector provides expert medical opinion to defense and plaintiffs' attorneys, insurers and state worker's compensation departments in the context of IMEs, Fitness for Duty and Short and Long Term Disability Insurance examinations throughout the United States. In addition, Dr. Spector lectures on related topics including work- and sports-related concussion, carpal tunnel syndrome, spinal cord injury, musculoskeletal disorders of the neck and lower back, traumatic peripheral nerve injury, migraine, seizures, stroke, multiple...

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Willa L Carter

CQG

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.

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Per Lindell, Sc.D.

Expert on biopharmaceutical industry, MIT Sc.D.

Novadigm Consulting Group

Bethesda, Maryland

Pharmaceutical Research, DNA - Drug development, Gene therapy, Oligonucleotide, Drug manufacturing, Bioprocessing, Biologics, Biopharmaceuticals, Monoclonal antibodies, Peptides, Drug discovery, Biotechnology, Business valuation, Due diligence, Drug regulation, Therapeutics, Cell therapy, Drug research, Research and development, RNA therapeutics, Drug research

Management consultant and fractional management services to biopharma companies providing a broad set of services. Hands on management experience from Big Pharma, biotech companies, and as consultant COO for biotech companies. Consulting experience from Boston Consulting Group. Large industry network. Over 25 years broad experience in US, EU, Japan and Australia. Doctor of Science from MIT in Biochemical Engineering with minor in Management. Master of Science in Chemical Engineering from Royal Institute of Technology, Sweden. Consulting Experience from Boston Consulting Group, Arthur D. Little and IBM. Biopharma experience from Pharmacia, BASF Pharma and several biotech companies. Fulbright scholar. Member of the Umbrex, BiotechExcec and Alacrita consultant networks. Uniquely broad and deep experience both as a hands-on manager and consultant, in drug discovery, preclinical and clinical development (including IND filings and clinical trial management), biologics and gene thera...

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Christopher M Byrd, PhD

Extensive Laboratory and Forensic DNA Experience

BSquared Consulting, LLC

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, Military, Department of Defense, DNA transfer

Dr. Byrd is an scientific executive and former senior military officer with 23+ years pf 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

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Magdy M. Abdel-Malik, Ph.D.

Expert Witness I R&D Executive I Life Science

Quaestio Global Partners LLC

Chester, New Jersey

Pharmaceutical Research, Chemistry & Chemicals - Organic Chemistry, Drug Delivery Systems, Formulation Technologies, Chemicals Characterization, Natural Products Chemistry, Scientific Claims Substantiation, Regulatory Compliance Assessment, Dietary Supplements, Analytical Chemistry, Over the Counter (OTC), Ingredients Evaluation, Intellectual Property (IP)

Dr. Abdel-Malik is a strategic innovation leader with extensive R&D and business development experience across the life sciences — encompassing pharmaceuticals, consumer health, cosmetics, dietary supplements, personal care, and medical devices. As Founder of Quaestio Global Partners (QGP), he has applied that expertise across leading global organizations — and today extends it as an Expert Witness in life sciences litigation. He is an Executive in Residence at Princeton University and a Grant Reviewer at Rutgers University. PHARMACEUTICALS AND CONSUMER PRODUCTS: AREAS OF EXPERTISE Dr. Abdel-Malik's scientific expertise is grounded in organic chemistry, natural products chemistry, carbohydrate & polysaccharide chemistry, analytical chemistry, chemical characterization & structure elucidation, drug delivery systems & formulation technologies, consumer insights knowledge, scientific claims substantiation, regulatory compliance assessment, innovation assessment, product characterizat...

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David J Augeri, PhD

Pharmaceutical IP Litigation Expert Witness

DJ AUGERI PHARMA CONSULTING, LLC

Princeton, New Jersey

Chemistry & Chemicals, Pharmaceutical Research - Synthetic Organic/Medicinal Chemistry, ANDA Expert Witness, DPP4 SGLT2 ANDA, HatchWaxman, Obviousness, Enablement, Infringement, Invalidity, Paragraph IV, Patent IP and Litigation, Osimertinib EGFR, GLP-1 agonists, Sitagliptin, drug discov. and development, Dapagliflozin, venclexta bcl2, btk Ibutinib, Adagrasib KRASG12C, FLT3, POSITA

With over 10 years of experience as an expert witness at DJ Augeri Pharma Consulting LLC, I specialize in pharmaceutical patent litigation, specifically in the areas of synthetic organic and medicinal chemistry, drug discovery, and CMC/API process development. I provide critical support for legal clients, offering expert reports, prior art review, claims interpretation, and testimony in U.S. and Canadian courts. My work spans patent infringement, validity, obviousness, and enablement analyses, as well as consulting on ANDA/Hatch-Waxman litigation, with a focus on diabetes and oncology drugs. I am committed to advancing pharmaceutical innovation by combining my expertise in medicinal chemistry, structure–activity relationships, and drug development, from preclinical research to IND submissions. My technical contributions include designing alternative compounds, optimizing drug properties, and overseeing CMC facets of clinical development. I strive to provide high-quality, data-dri...

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Eileen E. Ming, MPH, ScD, FISPE

Epidemiologist

Epi Excellence LLC

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 Real-World Effectiveness and Safety of Therapeutics, at the Perelman School of Medicine at the University of Pennsylvania. She is a Fellow of the International Society for Pharmacoepidemiology. D...

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Paul Abato, Ph.D.

Medicinal Chemist Pharma Patent & ANDA Expert

Providence, Rhode Island

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Bruce Rodda, Ph.D., M.B.A., PStat

Ph.D. Biostatistician, Clinical Trials Expert

Strategic Statistical Consulting LLC

Spicewood, Texas

Statistics, Pharmaceutical Research - Biostatistics, Clinical Trials, Statistical Analysis, Design of Clinical Trials, Expert Reports, Clinical Reports, Regulatory Review, Due Diligence for M & A, Clinical Literature, Expert Testimony, Protocol Evaluation, Evaluation of Clinical Trials

Dr. Rodda is an experienced biostatistician specializing in the clinical and regulatory objectives of pharmaceutical and biotechnology companies. He has held senior positions in research and development at several major pharmaceutical companies. In those positions his responsibilities included directing the strategy, design, implementation, evaluation, and reporting of all phases of multinational clinical development programs. These positions included directing (V.P. level) biostatistics, data management, clinical operations, medical development strategy, protocol review, medical writing, project management, and scientific systems. His organizations have been instrumental in the approval of more than 30 new medical entities in 11 therapeutic areas, both in the U.S. and abroad. Following a career as an executive in the pharmaceutical industry, he established Strategic Statistical Consulting LLC and has provided statistical consulting to approximately 70 firms focussing on clinic...

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G. Scott Weston, RPh, MBA, PhD

LionSong Enterprises, LLC

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...

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Peter Coderre, PhD

Antimicrobial Regulatory Consulting

Lovettsville, Virginia

Pharmaceutical Research, Infectious Diseases - pharmaceutical regulation, FDA, drug development, antimicrobials, antiseptics, disinfectants, clinical trials, post-marketing surveillance, drug labels, biologics, medical devices, medical 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...

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Glenn D Prestwich, PhD

Life science IP Expert - Caltech/Stanford

Clear Solutions Biomedical

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.

You can also find Pharmaceutical Research Expert Witnesses in:

Colorado, District Of Columbia, Florida, Georgia, Maryland, New Jersey, Pennsylvania, Rhode Island, Texas, Virginia, and Washington