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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.

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Biochemistry Expert Witness CT 525682

Expertise Description

I have over 30 years of consulting experience in vaccine and antibody design relevant to virology and oncology. My areas of focus include high affinity monoclonal antibodies against viral targets, onco-immune pathways, gene expression regulators and tumor neoantigens, molecular biology, and genetics. My expertise includes structure and function of enzymes, antibody structure and function, therapeutic antibodies such as Herceptin and Nivolumab, PCR, structure and function of nucleic acids, cloning of human genes, regulation of gene expression, epigenetics, molecular genetics, biosimilars, therapeutic proteins such as Insulin, GMCSF and anticoagulants. I have prior experience providing clients consultations and courtroom testimony as a biochemistry expert witness.

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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.

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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.

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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.

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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.

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neurology Expert 381857 WA

Expertise Description

I have more than 25 years experience in the field of Neurology with expertise in movement disorders, brain disorders, brain damage, neurologic disability, and dementia. I have experience in education and training of medical students, and outpatient Neurology. As a neurologist, I have been doing botulinum toxin injections (Botox, Xeomin, and Myobloc) for over 20 years for patients with cervical dystonia, blepharospasm, writer's cramp, hemifacial spasm, and spasmodic dysphonia. I also have over 20 years expert witness experience with consultation, deposition, and courtroom testimony.

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Infectious Disease Expert 56350 CA(S)

Expertise Description

I have more than 25 years experience in the field of Infectious Diseases with expertise in hygiene, tropical diseases, infection and immunity, trends in parasitology, leptospirosis, brucellosis, infection diagnosis, epidemiology, immunology, genetics, and molecular pathogenesis. I have additional experience with parasite interactions, malaria transmission, plasmodium biology, intracellular bacteria, bacteriology, leptospira genomics, antibody response and signatures, and vaccine development. I have over 10 years expert witness experience with consultations, deposition, and courtroom testimony.

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Infectious Diseases Expert 440179 AZ

Expertise Description

I have more than 40 years experience in the field of Infectious Diseases. My areas of expertise include tropical diseases, hygiene, medical microbiology, epidemiology, and internal medicine. I have over 15 years expert witness experience with consultations, deposition, and courtroom testimony.

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Infectious Disease Expert 434384 CA(S)

Expertise Description

I have more than 20 years experience in the medical field of Infectious Diseases. My scope of practice includes general internal medicine, antibiotics treatment, community-acquired pneumonia, risk factors for penicillin resistance, empiric antibiotic treatment, and gene-mutation. I am highly familiar with azithromycin monotherapy, potassium channels, investigation of cell membrane potassium, and vacuolar protein sorting defects. I have prior expert witness experience.

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Microbiology Expert 350472 NC

Expertise Description

I have more than 25 years experience in the field of Food Science and Microbiology. My expertise includes bacterial genetics and general microbiology. I have over 15 years expert witness experience with consultations, deposition, and courtroom testimony.

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