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 also spent more than a decade as a pharmaceuticals expert witness in FL by providing consultations, as well as courtroom testimony and deposition.

Expert 512825 - AZ FL

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.

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.

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 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.

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.

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 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.

Expert 512999 - AL AK AZ AR BC 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 QC RI SC SD TN TX UT VT VA WA WV WY WI

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.

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 502783 - AL AZ AR CA(N) CA(S) CO CT DE DC FL GA 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 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.

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.

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 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.

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.

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.

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.

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.

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.

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 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).

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.

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.

Expert 460317 - CA(N) CA(S)

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.

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 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.

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 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.

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.

Expert 163951 - VA

Expertise Description

I have over 10 years experience in the field of Drug Enforcement and Pharmaceuticals. My experience includes drug policies, pharmaceutical diversion, drug diversion investigations, and criminal / civil / administrative actions. I have prior expert witness experience.

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.

Expert 358474 - MA

Expertise Description

I have over 30 years experience in Oncology & Pharmacotherapy. My experience includes outpatient oncology clinic, research pharmacy, inpatient bone marrow transplant pharmacy, and inpatient hematology and oncology pharmacy. My expertise consists of bloodstain patterns, pharmacotherapeutic treatment of various oncologic and hematologic disease states, chemotherapeutic agents, supportive care medications, needed lab values, and medication side effects.

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.