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.

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 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 517114 - 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 experience in opthalmology. My areas of expertise include all areas of general ophthalmology but most specifically cataract and intraocular lens surgery, YAG laser surgery, laser refractive surgery (LASIK, PRK), corneal surgery (transplants, collagen crosslinking, pterygium, intracorneal inlays, intracorneal ring segments/lntacs), phakic intraocular lenses, refractive lensectomy, and glaucoma medical/surgical management. I have over 15 years expert witness experience with consultations, deposition, and courtroom testimony.

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 150060 - CA(N)

Expertise Description

I have over 25 years experience as a practicing physician specializing in rheumatology and internal. My expertise includes: internal medicine, rheumatology, chronic pain, and pharmaceutical product liability. I am experienced in all phases of clinical care, clinical decision-making, clinical research, and medical education. I am knowledgeable and proficient in disability evaluations and expert witness report writing. I have 20 years expert witness experience with consultations, deposition, and courtroom testimony.

Expert 96567 - CA(N)

Expertise Description

I have 35 years experience in neurology with expertise in Clinical / Forensic Neurology and Pain Management. My specialties include Independent Medical Examinations, Fitness for Duty Examinations, and Disability Insurance Examinations; medical records review; written reports; and expert testimony. My areas of expertise include: Post-traumatic Headache, Traumatic Brain Injury and Post-concussion Syndrome, Post-traumatic seizures or Epilepsy, Cervical Whiplash, Discogenic Disease in the neck and lower back, peripheral nerve injury, soft tissue musculoskeletal injury, Post-traumatic Fibromyalgia Syndrome, traumatic spinal cord injury, toxic exposure / neurotoxicity, catastrophic injury, electrical injury / electrocution, Thoracic Outlet Syndrome (TOS), Reflex Sympathetic Dystrophy (RSD), carbon monoxide poisoning, and product liability issues injurious to the nervous system. I have more than 15 years expert witness experience with consultations, deposition, and courtroom testimony.

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 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 398560 - CA(S)

Expertise Description

I have more than 50 years experience in the field of Toxicology with expertise in pharmacological and biochemical medicine. I have experience with cause-and-effect relationships, as well as, medical malpractice (prescribing errors), pharmaceutical product liability, drugs of abuse, chemical exposures and consumer product exposures and liability. I have over 20 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 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.

Expert 175384 - CA(S)

Expertise Description

I have more than 35 years experience as a pediatrician. My expertise includes childhood physical / sexual abuse; Shaken Baby Syndrome (SBS); Munchausen’s Syndrome by Proxy (MSBP); Fetal Alcohol Spectrum Disorder (FASD); lead poisoning; standards of pediatric care; childhood injury and product liability; child and adolescent growth and development; autism and other developmental disabilities; and child custody evaluation. I have over 10 years expert witness experience with consultations, deposition, and courtroom testimony.

Expert 323381 - NY

Expertise Description

I have more than 35 years experience in product liability/warnings. My experience includes evaluation, design, and implementation of product warnings for major US companies such as Playtex, Rheem, Otis Elevator, S.C. Johnson, and Dr. Pepper Seven Up. I have over 35 years expert witness experience with consultations, deposition, and courtroom testimony.


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