Search for the right Drug Development expert witness for your legal case. Since 1991, ForensisGroup offers trusted experts in Drug Development to render expert opinion on industry specific issues. Our experienced professionals have been assisting legal and insurance professionals in finding the best expert through out the United States. Contact ForensisGroup today to locate the expert that you need.
"The expert referred was key in achieving an excellent result for my client. For many years, ForensisGroup has made locating and selecting well-qualified experts easy and efficient for me."
- Steve Rice, Esq.
CROWELL & MORING, LLP
I have over 15 years experience in Clinical Pharmacology with expertise in drug development, pediatric development, PK/PD approaches for biosimilar products, oncology dose finding strategy, hematology, anticoagulants, and regulatory standards.
I am a pharmaceutical executive and attorney with over 20 years of experience in intellectual property (IP), drug development, vaccine development, licensing, acquisitions, regulatory affairs, and lobbying. I have created and implemented IP strategies, and regulatory affairs and compliance programs in the areas of medical devices, vaccines, and biosimilars.
I have over 25 years experience in Pharmaceuticals with expertise in biologic global commercialization, pricing, reimbursement and market access of pharmaceuticals. I have additional knowledge in risk assessments, business analyses, commercial strategies and plans regarding product launches, lifecycle management, in-licensing and acquisitions for specialty treatments in multiple therapeutic areas, such as: rare diseases, neurology, oncology, neuroscience and kidney diseases. I have prior expert witness experience with consultations, depositions, and courtroom testimony.
My background in the nutraceutical and pharmaceutical industry has spanned over 30 years. My areas of expertise include formulation development and analytical development. I also have a successful track record of managing people, processes, and projects for the pharmaceutical industry by creating, maintaining, and developing products for specialty products and services. I have over 10 years expert witness experience with consultations and depositions.
I have over 25 years experience working in the field of Neurology with expertise in Clinical / Forensic Neurology and Clinical Drug Development research. I have conducted over 1000 Independent Medical Examinations, Fitness for Duty Examinations, Disability Examinations, Peer Reviews, and Medical Record Reviews. I have also been a medical director in the pharmaceutical industry and involved in the development of drugs for neurological disorders, including Alzheimer’s disease, epilepsy, migraine, multiple sclerosis, neuropathic pain, Parkinson’s disease, depression, schizophrenia, and Downs syndrome. I have also spent more than 15 years as a neurology expert witness in Arizona and Florida and have provided numerous clients with consultations, deposition, and courtroom testimony.
For more than 20 years, I have worked in the field of Neurotoxicology and Behavioral Neuroscience with a particular focus in diagnosing neurotoxic effects in humans using clinical neurological, neurophysiological, neuroradiological, and neuropsychological measures of nervous system function. I have also spent time specifically looking at the interactions between neurotoxicants and age at onset of Parkinson's diseases in humans. I have additional experience in how drugs and neurotoxicants modify human behavior and the progression of neurodegenerative disease. I have also spent over 15 years as a neurotoxicology expert witness in Massachusetts by providing clients with courtroom testimony, consultations, and deposition.
With over 15 years experience in Allergy, Immunology, and Pediatrics, I have spent my career specializing in food allergies, urticaria, eczema, sinusitis, and immunodeficiency. I have additional expertise in pediatric and adult asthma and allergic rhinitis. I have also worked with Protocol development and design, Clinical trial implementation, Investigator training, Standard Operating Procedures (SOP) development, Process development and improvement, Audit preparation, Risk management and amelioration, and Medical monitoring. I have spent time providing my services as an immunology expert witness in Southern California.
I have more than 40 years in the Pharmaceutical industry with expertise on health policy, technology transfer, medico-legal, and health economics issues. I have more than 25 years experience as a former official for the Food and Drug Administration (FDA). I have managed multiple drug regulatory activities and large staffs and have extensive experience in outreach to government agencies and organized medicine. I have additional experience with private practice of family medicine and geriatrics. I have prior deposition and testimony experience, and over 10 years as an expert witness.
I have more than 35 years of experience in Immunology, Virology, and Biochemistry, with over 25 years of regulatory affairs and drug development experience (drugs, biologics, devices). This experience includes CMC, clinical, promotion and advertising, cGMP, cGCP, and success interacting and negotiating with FDA and international health authorities. I am a monoclonal antibody expert. I have founded a pharmaceutical and medical device consulting company to assist companies in strategic planning, FDA liaison and negotiation, FDA meetings, regulatory submissions and formation and execution of plans, and to help meet unanticipated needs and challenges. I have over 5 years of expert witness experience with consultations and deposition.
I have more than 35 years in Pharmacology and more than 25 years in senior management within the industry. My expertise is in drug safety, drug and device development, regulatory, clinical and technical sciences associated with drug and device approval, QA/QC of clinical research services, health outcomes research, and health policy. My company has provided regulatory program development and operational management for drugs and devices, as well as safety and efficacy programs in support of drug approval and postmarketing surveillance, label development and warnings, and label comprehension studies. I also have experience with clinical site management, including QA/QC facility audits of clinical sites and CROs and renovation of quality management systems. I have over 10 years of expert witness experience with consultation, deposition, and courtroom testimony.
I have over than 25 years of experience in drug development, clinical manufacturing and drug delivery systems. I have been Principal of a firm that provides guidance in all aspects of drug product development. These subjects include: sterile product subject matter, peptide and protein formulation, drug delivery, aseptic processing, sustained release parenteral, excipients, inter partes patent review, technology transfer, injection devises, solubilization, and patent infringement and validity. I also have substantial GMP, FDA R&D and manufacturing experience. I have prior expert witness experience with consultation, deposition, and courtroom testimony.
I have more than 15 years of Pharmaceutical experience. My focus is regulatory affairs, of which my experience includes: drafting and filing IDE and IND applications, preparing correspondences and annual reports to FDA and IRBs, as well as responding to FDA audits, attending meetings, monitoring clinical trials, and training interns for regulatory compliance monitoring or auditing. I have developed regulatory strategies for innovative products, including drugs, biologics, devices and dietary supplements. I also have intellectual property experience, having acted as liaison for legal, bioinformatics, cloning, and screening departments regarding updates of existing inventions and the discovery of new genes, as well as participated in patent drafting and prosecution.
I have more than 35 years of experience in Chemistry and Organic Chemistry. As a Professor, I have taught and done research on topics such as: radical reactions of transition metal-complexed unsaturated systems; synthetic methodologies in organic and organometallic chemistry; novel therapeutic agents for a breast cancer treatment; enzymatic chemistry; cancer drug development; aromatase metabolism; hormonal chemistry; food chemistry; antioxidants; supplements; cosmetics; environmental chemistry, consumer product chemistry, environmental laws. As a Consultant, I have provided support to consumer protection groups, and handled cases involving consumer product torts (cosmetics; foods; electronics; petrochemicals); and supported non-profit organizations in the “failure to warn” litigations and the state actions initiated under the California Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). I have over 10 years of expert witness experience with consultations, deposition, and courtroom testimony.
I have more than 25 years of experience in organic chemistry. My academic research culminated in three post-doctoral programs: bio-organic, heterocyclic and energetic, and carbohydrate chemistry. As a senior research scientist with a big pharmaceutical company, my work focused on drug discovery and medicinal chemistry. I also have expertise in synthetic chemistry, how to make advanced chemicals that are difficult to synthesize and which perhaps have not been made before.
I have more than 30 years of experience in Pharmacology with expertise as a Professor of Pharmacology and Neurological Sciences. My career has included pharmacy practice in a variety of settings, and consultations to the pharmaceutical and medical device industries, government, health care, publishing, and legal fields. My experience includes drug injury and causation, pharmacy standard of care; drug product liability, warnings, and design; alcohol toxicology, kinetics, abuse, intoxication and impairment, recreational drug toxicology (cocaine, marijuana), workmen’s compensation drug intoxication, pain management; pain medication, analgesic, and opiates including oxycontin, oxycodone, percocet, vicodin, and hydrocodone, dilaudid, fentanyl, duragesic, and methadone; dietary supplements and nutrition, and drug patents and trademarks. I have consulted and testified in matters involving drug injury, medication errors, alcohol toxicology, and drug injuries. I have over 10 years of expert witness experience with consultation, deposition, and courtroom testimony.
I have more than 10 years of experience in the field of drug delivery and controlled release technology as it pertains to pharmaceutical formulations. I have opined in both deposition and trial testimony in the area of oral and also injectable pharmaceutical formulations, dissolution testing, controlled release, instant release, sustained release, as well as chemical and materials property characterization and biodegradation of active ingredient (API) from pharmaceutical formulations. I have served as expert in numerous roles for firms in pharmaceutical patent infringement cases including claims construction, patent validity contentions, expert discovery, Markman preparation, scientific advising, as well as serving as the lead witness. I have over 10 years of expert witness experience with consultation, deposition, and courtroom testimony.
I have over 25 years experience as a Medicinal Chemist and Pharmaceutical Drug Discovery expert. I have experience in multiple therapeutic areas including oncology, inflammation, women’s health, and diabetes. I have a comprehensive understanding of the drug discovery process, enzyme inhibitors, including high throughput screening, hit to lead development, lead optimization, and late stage discovery / clinical. My expertise includes a thorough understanding of composition of matter and intellectual property law as an inventor on more than 35 pharmaceutical patents and patent applications.
I have over 40 years experience specializing in pharmaceuticals. My expertise includes: drug development, patent disputes, enzyme inhibitors, and pre-clinical / clinical studies for many therapeutic areas. I have additional expertise as a biochemist in chemotherapy, cancer drugs, cancer treatments, treatments for drug side effects, anti-viral agents, AIDS, HIV, Herpes, Shingles, and Cytomegalovirus (C.M.V.) treatments. I have more than 10 years expert witness experience.
I have over 30 years experience in pharmaceuticals and am currently a pharmaceutical executive, with extensive knowledge of all phases of drug development, including product approval, manufacturing, labeling, marketing, and distributing. My areas of pharmaceutical expertise include: biotechnology; clinical development; compound evaluation; dosage forms; drug regulatory affairs; facility compliance; FDA approval process; laboratory and manufacturing audits; licensing; medical devices; medicine in the media; microbiological development; microbiology; national and international pharmaceutical projects; patent infringement; pre-clinical / clinical studies; production monitoring; quality control; and regulatory parameters. I have additional expertise in budgeting, financial controls, and strategic planning. I have more than 20 years expert witness experience with consultations, deposition, and courtroom testimony.
I have more than 40 years in the field of Chemistry. My areas of expertise encompass water, food, and drug analysis; organic and inorganic chemical testing on water and wastewater; coliform bacteria analysis in water; and compliance testing for water utilities. My consultations further include qualitative and quantitative chemical analysis on diverse matrices for a variety of other cosmetic and hazardous substances. I have extensive experience in various spectrophotometric and chromatographic techniques. I have over 20 years expert witness experience with consultations, deposition, and courtroom testimony.
I have more than 35 years experience in the field of cGMP pharmaceuticals with expertise in dietary supplement supplier auditing, chemical/pharmaceutical process improvement, and cost reduction through on-line analysis and analytical problem solving. I have experience in research services and quality assurance departments. I have significant expertise in the areas of analytical and polymer chemistry, quality systems and regulatory affairs, with a strong reputation for excellence in analytical problem solving and materials characterization, quality improvement programs and building and motivating technical staffs to be highly productive. I have developed IP, constructed new laboratories and coordinated global organizations. I have consulted in the areas of analytical in process / laboratory problem resolution and cGMP auditing / compliance gap analysis of pharmaceutical and dietary supplement suppliers, cost reduction respectively. I have over 5 years expert witness experience.
I have more than 10 years experience in the areas of pharmacokinetics, neuropharmacology, drug-drug interactions, adverse drug effects, and drug delivery to the brain. This expertise encompasses pharmacology of both prescription drugs and drugs of abuse. I obtained my bachelor's of science degree in Pharmacology and my doctoral degree in Pharmaceutical Sciences, both from the University of Toronto, Canada. I then undertook postdoctoral training with a specific focus on neuropharmacology including drug uptake and effectiveness in the brain in both health and disease. I have worked as an Associate Professor in the Department of Pharmacology at the University of Arizona College of Medicine. My laboratory is funded by grants from the National Institutes of Health and the Arizona Biomedical Research Commission to undertake studies aimed at understanding changes in pharmacokinetics and drug response due to pathologies such as ischemic stroke, cerebral hypoxia, and acute/chronic pain. In addition to research, I teach principles of clinical pharmacology to medical students and molecular pharmacology to graduate students. I have over 5 years experience as a pharmacology expert witness with deposition, consultations, and courtroom testimony.
I have more than 15 years experience in Pediatric Infectious Diseases, particularly HIV, other viral, and fungal infections. I have experience with therapeutic drug monitoring and adherence to long-term anti-infective therapy. I have additional experience with Clinical pharmacometrics (the application of population pharmacokinetic and pharmacodynamic modeling and simulation to the optimization of dosing in individual patients), pharmacology, and pediatrics drug development and infectious diseases. I have over 10 years expert witness experience.
I have more than 30 years experience in Pharmaceutical Economics. My areas of expertise include health economics, pharmaceutical economics, government health care programs (e.g., Medicare, Medicaid, Affordable Care Act), health care market organization, drug legalization policy, cost effectiveness & cost/benefit analysis, comparative effectiveness and outcomes research, hospital costs, treatment selection bias, microeconometrics, health care demand estimation, vaccine policy, HIV/AIDS medical costs and epidemiology, health insurance reform and consulting, evidence-based disease management, and economic assessment of medical technology.
I have more than 25 years experience in the fields of Biotechnology and Pharmaceuticals with expertise in life sciences industries and academics. I have experience with patent/intellectual property review, R&D, product development/evaluation, applications development, marketing, business development, manufacturing, national/international sales, customer support, strategic partnership, licensing, OEM, acquisition and joint ventures. I have over 5 years expert witness experience with consultations, deposition, and courtroom testimony.
I have more than 45 years experience in the field of Pharmaceuticals with expertise in Pharmacy practice, health planning and budgeting, Pharmacy administration, Pharmacoeconomics, Drug Insurance, contraceptives, chronic disease, and cost effectiveness analysis. I have over 15 years expert witness experience.
I have more than 35 years of experience in the field of Pharmacology and Drug Regulation. My extensive experience includes tracking, controlling, summarizing and reporting submissions to the FDA, drug reviews, clinical studies, drug activity in humans, human risk assessment, regulatory affairs, dispensing, and clinical pharmacy. I have over 30 years expert witness experience with consultations, deposition and courtroom testimony.
I have more than 35 years experience in the Pharmaceutical and Pharmaceutical Packaging industries. I have extensive experience in the areas of Laboratory Management and Food and Drug Administration Regulations. My experience also includes various technical management positions in Quality Control, Technical Service, Labeling, and as a Director of Research and Development in Pharmaceutical Packaging. I have over 10 years expert witness experience.
