Pediatric Care Expert Witness New York 522298

Expertise Description

I am a skilled pediatric care expert witness with more than 15 years in the medical field. My areas of expertise include general pediatrics, osteopathic medicine, asthma, quality assurance, patient centered medical home, and FQHC. I am offering my services as a pediatrics care expert witness.

Sleep Disorders Expert Witness Culver City 529689

Expertise Description

I have over 25 years of consulting experience in the medical field with an emphasis in pulmonology, internal medicine, critical care and sleep disorders. My expertise includes: sleep studies, pulmonary function tests, pulmonary alveolar epithelial cell homeostasis, regulation and effects of intracellular pH in alveolar epithelial cells, mechanisms of alveolar epithelial salt and water transport, development of membrane polarity in alveolar epithelial cells, alveolar epithelial cell growth and differentiation. I also have experience in addressing medicolegal issues within my specialties, both in the worker's compensation system, as well as civil cases. I have provided courtroom testimony, deposition, and consultations for more than 5 years as a sleep disorders expert witness.

Healthcare Management Expert Witness Philadelphia 533276

Expertise Description

I am an experienced healthcare management expert witness with over three decades in the medical field. I specialize in healthcare strategy, strategic change, strategic implementation, organization and management, managed care, and integrated delivery networks for companies dealing with pharmaceuticals, biotechnology, medical devices, and information technology. I have provided consultations, deposition, and courtroom testimony for more than 15 years as a healthcare management expert witness.

Clinical Pharmacology Expert Witness WA 500882

Expertise Description

My experience in academic and industrial clinical research on development of anticancer agents, both classical cytotoxic drugs and targeted agents such as monoclonal antibodies, extends more than 40 years. My work has involved Phase 1 through 4 clinical trials of single agents and combinations, as well as supportive studies such as pharmacokinetic investigations and a clinical QTc study in cancer patients. I have written and supervised the execution of comprehensive clinical development plans that summarized complete development activities leading to NDA and post-marketing development. I have collaborated with investigators at many centers in the US, Canada, and Europe. I have been self-employed as a consultant to industry. I have prior experience providing courtroom testimony, deposition, and consultations as a clinical pharmacology expert witness.

Marketing Expert Witness CA 523546

Expertise Description

With over 5 years experience in the field of Marketing, my expertise is in consumer behavior with a focus on pharmaceutical marketing, health decision-making, and sustainable consumption. I am offering my services as a marketing expert witness.

Dentistry/Acupuncture Expert Witness Thousand Oaks 532553

Expertise Description

I am a knowledgeable and highly skilled dentistry expert witness. I specialize in treating jaw disorders, facial, cephalic and cervical pain, and sleep disordered breathing (OSA) with Oral Appliance therapy with or without PAP, for adults and children. My expertise also includes orthodontics, TMJ disorders, headaches, neuralgias, sleep disordered breathing, Craniofacial Pain, Dental Sleep Medicine, and acupuncture. I have worked for over 35 years in the field and have spent more than 5 years providing consultations and deposition as a dentistry expert witness.

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.

Graphic Design Expert Witness NJ 532082

Expertise Description

I have expertise in graphic design with over 35 years in the field. I am experienced with illustration, web design, book covers, children's books, greeting cards, entertainment, pharmaceutical advertising, logo development, copyright, and corporate identity. I have also worked with brochure design, promotional design, advertising design, website design, and development. I have prior experience offering my services as a graphic design expert witness.

Pharmaceutical Expert Witness NC 531962

Expertise Description

My career in pharmaceuticals has spanned over 30 years. My expertise includes validation, managing QC laboratories, field auditing, and compliance including interactions with the FDA; solid dosage and sterile equipment validation, process validation, cleaning validation, and computer validation; and auditing, compliance/validation program building (including change control), and the writing/execution of validation protocols. I have prior experience offering consultations and deposition as a pharmaceuticals expert witness.

Clinical Toxicology Expert 519610 AL

Expertise Description

I am a toxicologist with over 20 years experience in the field of clinical toxicology. After a nearly 20 year career leading the Poison Control Center at a children's hospital of Philadelphia, which included consulting on toxicology cases from 21 counties in Pennsylvania and Delaware, I have worked as an independent consultant specializing in medical communications and providing consultation and expert witness testimony on cases such as: medication errors, medication adverse events, poisonings (accidental and intentional), pharmaceutical product liability, alcohol or drug-related motor vehicle accidents, carbon monoxide exposures, chemical exposures (including occupational-related exposures), and environmental issues.

Drug Therapy/Pharmacy Expert 531712 OR

Expertise Description

I am an experienced pharmacy expert witness. I have specialized for over 35 years in drug therapy, geriatric care, pharmacy practice with nursing home and assisted living residents, adverse drug reactions, drug interactions between prescription and nonprescription medications, fatal events associated with inappropriate prescribing, standards of care, and toxicity. I have provided consultations, deposition, and courtroom testimony as a drug therapy and pharmacy expert witness for more than 35 years.

Pharmaceutical Patent Expert Witness PA 531216

Expertise Description

I have worked in the pharmaceutical industry for more than 45 years. My areas of expertise include pharmaceutical patents, drug discovery, biochemistry and pharmacology, biotechnology, drug design, and Hatch-Waxman Patent Litigation. I have provided consultations, deposition, and courtroom testimony for over 15 years as a pharmaceutical patent expert witness.

Plastics Patent Expert 513273 CA(S)

Expertise Description

I have over 30 years' consulting experience as a surface and advanced materials scientist with an emphasis in research, development, intellectual property, outreach, and training. I have worked with polymer, advanced materials, personal care products, and the pharmaceutical separations industries. My expertise includes strategic planning, patent enforcement, budgeting & control, international partnerships, due diligence, patent strategy, research & development, board presentations, patent & trademarks, technology start-ups, and business plans. I have provided solutions, technical direction and legal assistance in the fields of polymer and surface science addressing applications in consumer products, textiles, biomedical devices, and material testing. I have provided consultations, courtroom testimony, and deposition for more than 10 years as a plastics patent expert witness.

Pharmaceuticals Expert Witness PA 531269

Expertise Description

My experience in the pharmaceutical industry spans over 55 years. I specialize in research & development, preclinical chemistry, preformulation, formulation development, intellectual property, patent defense, regulatory affairs, drug development and commercial manufacture of drug substance and drug product. I have spent more than two decades years offering consultations, deposition, and courtroom testimony as a pharmaceutical industry expert witness.

Medical Billing & Coding Expert 501916 NJ

Expertise Description

With over 15 years experience in medical billing and coding, I have worked with Eclaims, Zyantus, Accuchecker, Medisoft, Billflash, Crystal Reports, Navinet and Emdeon for a variety of medical practices and specialties. I am offering my services as a medical billing and coding expert witness.

Pharmaceutical Expert 525774 RI

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.

Pharmaceutical Expert 529155 AL

Expertise Description

I have over 35 years of experience in pharmaceuticals with an expertise in the formulation, manufacturing, and regulation of cosmetics, drugs, medical devices and nutritional supplements. I also have experience in research and development, including formulation, stability and analytical chemistry, clinical trials and manufacturing of pharmaceuticals. I have prior experience offering consultations and deposition as a pharmaceuticals expert witness.

Regulatory Pharmacist Expert 529118 CA(S)

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.

Clinical Pharmacology Expert 529071 MD

Expertise Description

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.

Pharmaceutical Executive & Attorney Expert 528814 NY

Expertise Description

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 am offering my services as a pharmaceutical expert witness.

Nutrition Expert 522564 CA(S)

Expertise Description

I have over 30 years of experience working with nutrition trend-tracking, market assessment, and creating business-building ideas. My areas of expertise include beauty/cosmetics; food; over-the-counter drugs; personal and home care; appliances; nutrition, diet and fitness; engineering/home improvement and market research. I am offering my services as a nutrition expert witness.

Neuro-Oncology Expert 520350 TX

Expertise Description

I have over 20 years experience in Neuro-Oncology with expertise in brain tumors, brain cancer, and the evaluation and treatment of patients with primary malignant gliomas, particularly glioblastomas. I have spent more than 5 years providing my services as a neuro-oncology expert witness.

Pharmacy Expert 525125 PA

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 454715 VA

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 521681 CA(S)

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 523372 PA

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 514225 FL

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 512825 AZ

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.

Immunology Expert 500905 CA(S)

Expertise Description

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.

Pharmaceutical Expert 518694 MD

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.

FDA Drug Development Expert 518552 NJ

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 CA(S)

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.

Internal Medicine Expert 518113 MD

Expertise Description

I have more than 45 years of experience in Internal Medicine. Scientific highlights from my clinical research include developing orphan drugs for sickle cell disease and thalassemia, documenting that hemoglobin A1c could be used as a measure of longer term “control” in diabetes mellitus, the observation that patient self monitored glucose values along with HBA1c values could be used as two independent means of quantifying “control,” documentation that improved glucose levels improve outcome of pregnancy in women with diabetes and reverse several pathologies associated with the disease, discovery of an assay that could be used to document levels of alcohol consumption over time, and the first use of atomic force microscopy to visualize cells. I also have experience with telemedicine, and hold 15 U.S. patents, have sponsored 7 INDs to the FDA. I have published over 400 peer reviewed primary articles, chapters, editorials, reviews and 21 books and monographs. I have over 30 years expert witness experience with consultations, deposition, and expert testimony.

Drug Safety Expert 518266 TX

Expertise Description

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.

Drug Development Expert 518320 NJ

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 CA(S)

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.

Pharmaceutical Expert 515811 CA(S)

Expertise Description

I have more than 40 years of experience in the Pharmaceutical industry with expertise as a Registered Pharmacist. I have served on a pharmacy board for over 8 years and through this experience I have been part of committee panel that is presented with pharmacists’ defense of their disciplinary cases, and as a committee we enforced disciplinary actions, and if accusations should be dismissed. This has provided a broad perspective for me and has helped me to be fair and objective.

Pharmaceutical Business Expert 379288

Expertise Description

I have been an active participant in both the brand and generic pharmaceutical industries for over 45 years. I have managed virtually every product in the branded pharmaceutical line and generics as a Vice President of Marketing and Sales. I have also started and managed 3 specialty pharmaceutical advertising agencies as well as a consulting firm. My consulting specializes on the interaction and relationship of the brand and generic pharmaceutical industries, companies, and products. I have worked on legal cases related to: patents, damages, commercial success, as well as contractual issues with over 20 years of expert witness experience with consultations, deposition, and courtroom testimony.

Organic Chemistry Expert 512999 AL

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 505785 AL

Expertise Description

I have more than 15 years of experience as professional Pharmacist and 6 years as an expert witness in: drug injury causation, pharmacy standards of practice and malpractice, drug-related medical malpractice, medication error event reconstruction, drug product liability, and drug-related civil defense. My expert witness experience includes consultations, deposition, and courtroom testimony.

Pharmaceutical Formulations Expert 502783 AL

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.

Chemistry Expert 502254 NC

Expertise Description

I have more than 30 years experience in the field of Chemistry with expertise in Organic Chemistry. As a chemist, I have and extremely broad grasp of chemical knowledge: subject matter expertise includes carbohydrates, peptides, amino acids, proteins, nucleotides, heterocyclic chemistry, catalysis, organic synthesis, chemical handling, chemical purifications, chemical analysis techniques, solid phase organic synthesis, polymer synthesis, chemical nomenclature and medicinal chemistry. I have also provided patent drafting, response drafting, document editing, literature search and science/ IP advising services to small pharmaceutical companies, chemistry-related businesses, and small biotech firms. I have over 25 years expert witness experience with consultations, depositions, and courtroom testimony.

Pharmacy Expert 502271 MI

Expertise Description

I have more than 50 years experience in the field of Pharmaceuticals with expertise in leading pharmacy and managing care organizations. I have experience with pharmaceutical care and delivery, pricing strategies, audit and recovery of billing and processing discrepancies, and giving counsel to governmental and commercial health plans. I have over 10 years expert witness experience with consultation and deposition.

pharmacotherapy Expert 502117 CA(S)

Expertise Description

I have more than 30 years experience in the Pharmacy field with expertise in Pediatric Pharmacotherapy. I have experience with Pharmacology, usage and regulatory concerns, Toxicology/Adolescence substance abuse, Pediatric Hypertension/Nephrotic Syndrome; as well as, Hyperlipidemia in Children: Pathophysiology and Therapy Neonatal/Pediatric Seizures, Pediatric CNS Infectious Diseases, and Pediatric Pharmacotherapy Case Review. I have over 25 years expert witness experience with consultation, deposition, and courtroom testimony.

pharmacology Expert 502920 CA(S)

Expertise Description

I have more than 25 years experience in the field of Pharmacology with expertise in the facilitation, regulatory, and legislative affairs of pharmacies. I have experience with formulary management, education and training of pharmacists, nurses, physicians and pharmacy support staff, as well as the implementation of cost-effective prescribing practices. I have prior expert witness experience with consultation and deposition.

Pharmaceutical Chemist Expert 321554 NY

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.

Pharmaceuticals Expert 151650 NC

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.

Medical Device And Pharmaceuticals Expert 107522 CA(S)

Expertise Description

I have 25 years of experience in the Pharmaceuticals and Medical Device Industry. My experience as a Laboratory Director includes product development, analytical chemistry, organic chemistry, inorganic chemistry, wet chemistry, laboratory testing, environmental sample testing, materials testing, complaint investigations, FDA investigations, quality assurance, manufacturing, facilities system audits, preventative actions, US-FDA / EMEA issues, warning letters, remediation, Therapeutic Goods Administration (TGA) inspection, Millennium Challenge Corporation (MCC) inspection, analytical method development, method validation, internal and external laboratory audits, optimized equipment usage, use of developmental software, consumer products, extensive knowledge in active pharmaceutical ingredient (API) synthesis, active pharmaceutical ingredient (API) and dosage form analysis, stability programs, non-conformance investigations, quality engineering, process optimization, laboratory training, stability study protocols, and pharmaceutical lawsuits. I have prior expert witness experience.

Pharmaceuticals Expert 59053 FL

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.

Dentist Expert 42788 TX

Expertise Description

I have more than 25 years experience in the field of Dentistry with expertise in Restorative Dentistry, and Pharmacology. I have experience with neurochemical mechanisms, neurotransmitters, dental case management, withdrawal, human physiology, and Orthodontics.

Pharmaceuticals Expert 502013 NJ

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 414596 AL

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.

Pharmaceutical Economics Expert 324124 CA(S)

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.

Nursing Expert 340786 OR

Expertise Description

I have more than 25 years experience in the field of Nursing. My areas of expertise include Infusion Therapy and vascular access devices. I also have experience with Chemotherapy and PICC (peripherally inserted central catheter).

Chemistry Expert 500206 IL

Expertise Description

I have more than 40 years experience in the field of Chemistry with expertise in classical chemistry and biochemistry. I have experience with the separation, purification, characterization and analysis of small molecules, enzyme inhibitors, enzymes and proteins and related processes. I have additional experience with Microbiology and fermentation science, cost reduction, Regulatory compliance (OSHA, EPA, Groundwater, USDA, Homeland Security, etc.), and chemical and biochemical processes, their development, evaluation, optimization, including biocatalysis and applied biotechnology. I have over 10 years expert witness experience with consultations, deposition, and courtroom testimony.

Cosmetics Expert 427826 CA(S)

Expertise Description

I have more than 25 years in the field of Cosmetic Chemistry. My extensive experience includes research and development, product development, business development, operations, sales and marketing for personal care, skin conditions, cosmetic procedures, OTC, Nutraceuticals and pharmaceutical industries.

Biotechnology Expert 460317 CA(N)

Expertise Description

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.

Pharmaceutical Expert 457777 PA

Expertise Description

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.

Biopharmaceutical Tools Expert 433308 MA

Expertise Description

I have more than 25 years experience in the life science research and biopharmaceutical tools industries. I have experience with biochemistry and technology as a development scientist and technology manager. I am knowledgeable in the products used to analyze and purify proteins and nucleic acids, as well as protein analysis and purification technologies. I have a working knowledge of molecular and cellular biology. My technology development and product management expertise includes strategic planning, technology road-mapping, and product positioning. I have additional experience with intellectual property and freedom to practice assessments.

Toxicology Expert 354590 OK

Expertise Description

I have more than 20 years experience in the field of Forensic Toxicology, Chemistry, and Pharmaceutical Sciences. My expertise includes pharmaceutical compounding; polydrug interactions; nutraceuticals and herbal drugs; workplace drug testing; postmortem and human performance toxicology; pharmacogenomics; laboratory instrumentation and analysis; drug potency, sterility, and endotoxin testing; product contamination; pharmaceutical development and deformulation; critical review of laboratory procedures; and other areas of chemical analyses. My other consultations consist of cosmetic product-testing; complaint sample testing; analytical issues surrounding IP for cosmetic and drug products; and various product-testing analyses, such as high pressure liquid chromatography (HPLC), mass spectrometry, gas chromatography (GC), thin layer chromatography (TLC), and ultraviolent (UV) methods. I have over 10 years expert witness experience with consultations, deposition, and courtroom testimony.

Obgyn Obstetrics And Gynecology Expert 428491 CA(S)

Expertise Description

I have more than 25 years experience within the Pharmaceutical and Medical Devices Industry. My expertise also includes areas of Obstetrics and Gynecology, with special interests in abnormal uterine bleeding, minimally invasive uterine interventions, endoscopic applications of radiofrequency (RF) electricity, radiofrequency electrosurgery, surgical endoscopy, laparoscopic access systems, hysteroscopic and other uterine surgery. My other research consists of sterilization services, incisional parameters, various bipolar electrode systems, the electrosurgical loop electrode, resectoscope, and controlled deployment of needles in tissue. I have over 30 years expert witness experience with consultations, deposition, and courtroom testimony.

Pharmacy And Pharmacology Expert 384176 CA(S)

Expertise Description

I have over 20 years experience in the field of Pharmacology and Clinical Pharmacy. My experience includes special research in infections diseases pharmacotherapy, viruses, antimicrobial resistance, and antifungal therapy. I am a principal investigator on a number of research studies on antimicrobial resistance relating to extended-spectrum beta-lactamases and most recently, efflux-mediated resistance in Pseudomonas aeruginosa. I actively investigate the aerosolization potential of antifungal agents. My additional research focuses on host-microbial interactions during acute and chronic infections, bacterial virulence or modulation, and host response.

Pharmacy Expert 40536 CA(S)

Expertise Description

I have more than 35 years experience in pharmacy risk management, pharmacy- and pharmaceuticals-related litigation, third-party drug benefits, and freelance writing for the healthcare communications industry. I have experience as a practicing clinical pharmacist, a hospital pharmacy director, a regional hospital pharmacy administrator, and a consultant in private practice. My expertise includes medical and pharmaceutical writing and editing; drug information; pharmacy practice and operations; risk assessment and management; clinical pharmacy services; standards of care for pharmacy practice; pharmacy law; managed care pharmacy services; long-term care pharmacy services; pharmaceutical care in correctional facilities; and pharmaceutical care in industrial clinics. I have additional experience with community pharmacy practice, community pharmacy law, and business practices pertaining to pharmacies. I have over 20 years expert witness experience with consultations, deposition, and courtroom testimony.

Oncology Expert 358474 CA(S)

Expertise Description

I have more than 30 years of experience in Oncology & Pharmacotherapy. My experience includes outpatient oncology clinics, research pharmacy, inpatient bone marrow transplant pharmacy, and inpatient hematology and oncology pharmacy. My expertise consists of pharmacotherapeutic treatment of various oncologic and hematologic disease states, chemotherapeutic agents, supportive care medications, needed lab values, and medication side effects. I am also a clinical pharmacist in the area of hematology/oncology, and a professor of pharmacy practice where I have taught oncology therapeutics to both pharmacy and medical students.

Pharmaceutical Industry Expert 343607 GA

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.