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.

Expert 518552 - NJ NY

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.

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.

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.

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.

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.

Expert 505785 - AL AK AZ AR CA(N) CA(S) CO CT DE DC FL GA HI IA ID IL IN KS KY LA ME MD MA MI MN MS MO MT NE NV NH NJ NM NY NC ND OH OK OR PA RI SC SD TN TX UT VT VA WA WV WY WI

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.

Expert 512307 - IL

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.

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.

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.

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.

Expert 503284 - CA(N)

Expertise Description

I have more than 30 years experience in the Retail Pharmacy field. My expertise includes store operations, corporate compliance, government relations, finance, marketing, and enabling technology solutions. I have consulting experience in working with manufacturers, wholesalers, retailers, and others as a subject matter expert in retail pharmacy, workflow insight, and practice evaluations. I formerly served on various advisory boards for manufacturers, academia, and pharmacy practitioners. I have prior expert witness experience with consultations and deposition.

Expert 40535 - CA(S)

Expertise Description

I have more than 45 years experience in pharmacology and pharmacy with the industry. My expertise includes side effects of drugs, drug abuse by the elderly, elderly care, respiratory pharmacology, respiratory and inhalation therapy, respiratory therapy drugs, cardiovascular drugs, and malpractice. I have prior expert witness experience.

Expert 414596 - AZ

Expertise Description

I have more than 5 years experience in Pharmacology and Physiological Science. I have experience in the areas of blood-brain barrier/neurovascular unit biology, drug transport, drug delivery approaches/technologies and neuroscience. My additional expertise includes in vivo disease models, Drug Transporter Biology, CNS Pharmacology, Molecular Pharmacology, and Neuroscience. I have prior expert witness experience with consultations, deposition, and courtroom testimony.

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.

Expert 97168 - MD

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.

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.

Expert 440376 - IL

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.

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.

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.