Drug Development Expert Witness 523160

Expertise Description

I have over 35 years experience in the fields of toxicology, pharmacology, pharmacokinetics and drug development. My expertise includes global nonclinical development of small molecule and protein drugs, regulatory toxicology (FDA, EU and Japan), performing due diligence on potential inlicensed programs, conducting inhouse and contract GLP pharmacology/toxicology/ADME/PK studies, in vitro toxicity testing and screening, in vivo disease models, research and investigational toxicology, assessment of immunotoxicologic/host resistance/hematopoietic effects of drugs and chemicals, flow cytometry, pulmonary toxicology/immunology and biosimilars. I am offering my services as a drug development expert witness.

Pharmacology Expert Witness 393555

Expertise Description

I have over 30 years of experience in pharmacology with a focus in developmental pharmacology. My areas of focus include pediatric pharmacotherapy, pediatric pharmacokinetics, blood modifiers, antimicrobial therapy and Rotavirus infection and Rotashield vaccine. I have an additional expertise in medication errors, adverse drug events, medication management, pharmacigenomics, medication safety, and therapeutic drug monitoring. I have provided consultations and deposition for more than 5 years as a pharmacology expert witness.

Advanced Materials/Polymers Expert 531995

Expertise Description

I have over 35 years experience in Advanced Materials & Polymers with expertise in nanotechnology, environmental engineering, polymer membranes for liquid, gas, and vapor separations; controlled drug delivery devices and techniques; barrier plastics for food and specialty packaging; monomer and solvent removal from formed polymers; and water and gas purification. I have over 20 years expert witness experience with consultations, depositions, and courtroom testimony.

Pharmaceutical Expert Witness 525774

Expertise Description

I have over 20 years experience in pharmaceuticals with expertise in drug research and development from synthesis/purification, in-vitro, in-vivo (efficacy and pharmacokinetics) testing, dosing routs, formulation and the management of CROs to support pre-clinical testing. My research covers novel human therapeutics in the areas of anti-infective, anti-inflammatory and neurodegenerative diseases such as multiple sclerosis, arthritis and spinal muscular atrophy. I have prior experience providing consultations and deposition as a pharmaceuticals expert witness.

Regulatory Pharmacist Expert Witness 529118

Expertise Description

I have over 20 years experience as a regulatory pharmacist with an expertise in cosmetic regulations, skin care and hair color formulation, infusion, TPN preparation, laboratory benchwork, cosmetic patents, and clinical pharmacy. I have spent more than 25 years providing numerous clients with deposition, consultations, and courtroom testimony as a regulatory pharmacist expert witness.

Phlebotomy Expert Witness TX 528964

Expertise Description

With over a decade in the field of phlebotomy, my areas of focus include conducting diagnostic tests, monitoring patients, transporting biological and medical materials, drug screening, IV's, disposal of biomedical waste, blood drawing, breath alcohol testing, and kidney screening. I am offering my services as a phlebotomy expert witness.

Pharmacy Expert Witness Pennsylvania 525125

Expertise Description

I have spent 20 years working in the clinical pharmacy practice. My areas of focus include medication safety and medication error prevention in all facets of pharmacy practice. I have additional expertise in clinical microbiology and infections diseases. I have provided consultations, deposition, and courtroom testimony for more than a decade as pharmacy expert witness.

Pharmacology Expert Witness Virginia 454715

Expertise Description

With more than 20 years experience as a Physician & Pharmacist, I have an expertise in Medical, Pharmacy, Pharmacology, and Toxicology cases. My specialties include postmortem pharmacologic analysis, anaphylactic reactions, Baxter-recalled Heparin, cosmetics lasers and medication photosensitivity, overdoses on medication, specifically Fentanyl and Dilaudid, cardiac and respiratory arrest, Pharmacist errors in filling and dispensing medications, standards of care for pharmacies, adverse effects of medications, cognitive impairment, falls related to medications, wrongful death, medical marijuana, positive drug screens, safety in the workplace, and use of medication in relation to workers compensation injury claims. I have provided consultations, deposition, and courtroom testimony for over 5 years as a pharmacology expert witness.

Pharmacology Expert Witness California 521681

Expertise Description

I have over 30 years experience in Pharmacology with expertise in Pediatrics, Regulatory Compliance, Ambulatory Care, and Managed Care services. Additionally, I oversee the ambulatory clinical pharmacy services, which included the anticoagulation service, pediatric hematology/oncology clinic, and pharmacists who practiced in the HIV, Renal, Cholesterol, Hypertension and Investigational Drugs Clinics. I have also spent more than 15 years as a pharmacology expert witness by providing deposition, courtroom testimony, and consultations.

Pharmaceutical Expert Witness 523372

Expertise Description

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 experience offering consultations, deposition, and courtroom testimony as a pharmaceuticals expert witness.

Pharmaceuticals Expert Witness FL 514225

Expertise Description

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.

Neurology Expert Witness AZ FL 512825

Expertise Description

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.

Pharmaceutical Expert 518694

Expertise Description

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.

Forensic Pathology Expert 518776

Expertise Description

I am a forensic pathology with expertise in cardiovascular pathology, performing postmortem examinations (both full autopsies and external examinations), determining cause of death, reviewing medicolegal and autopsy cases for attorneys and families, and providing written reports and deposition and trial testimony. I have additional experience in determining causes of death as a result of carbon monoxide toxicity and/or thermal injuries due to fire, and also in drug safety evaluation (global pharmacovigilance), clinical pharmacology (Phase 1 trials), and regulatory strategy. I have more than 15 years of experience as a forensic pathologist.

FDA Drug Development Expert 518552

Expertise Description

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.

Drug Safety Expert 514143

Expertise Description

I have more than 30 years experience in the Pharmaceutical industry. My expertise includes drug development, drug safety, side effects, and regulatory affairs. I have experience with medico-legal matters, such as informed consent, malpractice, negligence, incompetent practice on the part of medical professionals, mental health. My experience with many therapeutic areas include: oncology (hematological and solid tumors), diabetes, obesity, anti-infectives (anti-bacterial and anti-viral), pulmonary (asthma, COPD), influenza, women’s health, bone (Paget’s disease and osteoporosis), lupus, arthritis, transplantation, autoimmune diseases, Anti-malarials, and CNS (psychiatry, Alzheimer’s disease). I have also worked with small and large molecules, including gene therapy, and Biosimilars. My practice has specialized in rare and neglected diseases, with a strong background in drug safety, and how that interfaces with drug information functions. I have over 10 years of expert witness experience.

Drug Development Expert 518320

Expertise Description

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.

Pharmaceuticals Expert 518341

Expertise Description

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.

Organic Chemistry Expert 512999

Expertise Description

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.

Pharmacology Expert 512307

Expertise Description

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.

Pharmaceutical Formulations Expert 502783

Expertise Description

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.

Pharmaceutical Chemist 321554

Expertise Description

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.

Emergency Medicine 107591

Expertise Description

I have over 30 years experience in Neck Fractures, Pulmonary Embolism, Emergency Medicine and Forensic Medicine. I have more than 10 years expert witness experience with consultations, deposition, and courtroom testimony.

Pharmaceuticals 151650

Expertise Description

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.

Pharmaceuticals 59053

Expertise Description

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.

Pharmaceuticals 502013

Expertise Description

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.

Pharmacology Expert Witness 414596

Expertise Description

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.

Pediatrics Infectious Diseases 41691

Expertise Description

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.

Pharmaceutical Economics 324124

Expertise Description

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.

Pharmacology 97168

Expertise Description

I have more than 40 years experience in the fields of Toxicology, Carcinogensis, Pharmacology, and Pharmacy, with expertise in Standard of Care. I have experience with conducting health evaluations and risk assessments; toxic substances and pesticides, cancer causation, cancer screening, cancer studies, chemical testing, pollution prevention, radioactive substances, hazardous wastes, and anti-cancer drugs. I have additional knowledge of experimental therapeutics, toxic effects of chemicals (such as lead, benzene, and sewer gas), acute myelogenous leukemia (AML), nephrogenic systemic fibrosis (NSF), rhabdomyolysis; as well as, drug-to-drug interactions, and pharmacokinetics including absorption, distribution, and elimination of drugs from the body. I have more than 15 years expert witness experience with consultations, deposition, and courtroom testimony.

Pharmacist 440376

Expertise Description

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.

Internal Medicine And Sleep Medicine 432925

Expertise Description

I have over 25 years in the field of Internal Medicine. My extensive experience includes internal and sleep medicine, Gastrointestinal (GI) Randomized Event and Safety Open-Label NSAID Study, and GI Safety Of Study Drug Compared with Non-Selective Nonsteriodal Anti-inflammatory Drugs (NSAIDS) In Osteoarthritis Patients. I have prior expert witness experience with consultations, deposition, and courtroom testimony.

Pediatric Dermatology 426295

Expertise Description

I have more than 20 years experience in the field of Dermatology. My experience includes skin conditions, pediatric dermatology, dermatologic surgery, dermatopharmacology, cutaneous mycology, psoroasis, therapeutics / FDA, clinical pharmacology, dermato-venereologica, dermatologic surgery, and current drug delivery. My teaching experience consists of biology, molecular genetics, diagnosis, and chemistry topics. My dermatologist research interests are directed toward treatment of uncomplicated skin and superficial skin, benefits of concomitant use of mild cleansing bar, facial contact dermatitis, treatment of acne, salicylic acid, ameliorate ashy skin, secondarily-infected dermatoses, acne vulgaris, actinic keratoses, and efficacy of other medications and dermatologic drugs. I have over 10 years expert witness experience with consultations, deposition, and courtroom testimony.

Rheumatology And Allergy 142953

Expertise Description

I have over 40 years experience in Rheumatology / Allergy and Clinical Immunology. I also specialize in internal medicine. My expertise includes environmental health, including food, safety, mold, and allergens. My clinical interests also consist of autoimmunity and nutrition / immunity. I have more than 35 years expert witness experience with consultations, deposition, and courtroom testimony.

Pharmaceutical Industry 343607

Expertise Description

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.