5 Pharmaceutical Drug Development Expert Witnesses Found

Results Sorted Below by State

Tim Kamerzell, MD, PhD

Overland Park, Kansas
Hospitalist, Internal Medicine - Hospital Medicine, General Internal Medicine, Telemedicine, Perioperative Medicine, Medical Devices, Pharmaceutical Research and Development, Pharmaceutical Regulation, Chemistry, Biochemistry,
...Kamerzell received a PhD in Pharmaceutical Chemistry from the University of Kansas and has extensive experience working in the pharmaceutical industry as a research scientist at Genentech, Inc. Dr. Kamerzell completed research fellowships at Harvard Medical School and Mount Sinai School of Medicine in the areas of drug discovery and design, cardiovascular disease, and electrophysiological mechanisms of cardiac arrhythmias. He remains active in research and works as a consultant to multiple pharmaceutical and biotechnology companies. Dr. Kamerzell has several patents related to the design of novel therapeutics and has published extensively in peer reviewed chemistry journals. He remains an active adjunct professor of Pharmaceutical Chemistry at The University of Kansas in Lawrence, KS and is a section editor for the journal Protein and Peptide Letters and Scientific Advisor to the Editor of the Journal of Pharmaceutical Sciences. Dr....

Stuart G Levy SGL Chemistry Consulting, LLC

Arlington, Massachusetts
Pharmaceutical Research, Chemistry & Chemicals - API process development, API manufacturing, Solid state and physicochemical characterization, enabled formulation development, drug product development, drug product manufacturing, stereochemistry, process impurity identification, control, synthetic route selection, preformulation, polymorphism
HIGHLIGHTS • Twenty-eight years of industrial experience in all aspects of chemical development • Twenty-four years of experience in oversight of external vendors performing chemical development, custom starting material production and API manufacturing, preformulation, formulation development, drug product manufacturing, and all associated CMC activities • Eighteen years of experience in devising and executing integrated CMC development programs • Hands-on, results-oriented leadership of CMC development and multidisciplinary teams • Innovation in the conception of practical synthetic routes to pharmaceuticals, development and implementation of chemical processes for the manufacture of APIs and chemical process troubleshooting....

Magdy M. Abdel-Malik, Ph.D. Quaestio Global Partners LLC

Chester, New Jersey
Pharmaceutical Research, Chemistry & Chemicals - Analytical chemistry , Drug delivery systems , Natural products chemistry, Oral cavity health, Chemicals characterization, Hair care, Smoking cessation, Cosmetic products, innovation assessment, Organic chemistry, Dietary supplements, Intellectual property (IP) , Over the counter (OTC) medicines
...His expertise lies in the intersection of R&D and business development in the life sciences, particularly in pharmaceuticals and consumer products. PHARMACEUTICALS AND CONSUMER PRODUCTS: AREAS OF EXPERTISE Dr. Abdel-Malik has developed comprehensive expertise across diverse therapeutic areas within pharmaceuticals and consumer products....

Debra Leibold, MD, PhD Consultant

Blue Bell, Pennsylvania
Pharmaceutical Regulation, Warnings & Labels - Pharmaceutical Industry, Drug Development, Product Labeling, Regulatory Labeling, Prescribing Information, Indications, Dosage, Contraindications, Warnings, Precautions, Adverse Experiences, Regulatory Compliance, Safety, FDA, Off-label Use
Ethical Full Lifecycle Labeling/Prescribing Information That Never Cuts Corners For Pharmaceutical Giants Merck, Shire, and J&J: Labeling strategy and leadership that brings product labeling and products to market supporting vaccines and treatments for infections, internal medicine, oncologic, and rare diseases. These include life-saving, ground breaking, and first-of-its-kind products. Bring decision makers across divisions to the table to negotiate resolution of labeling issues - leading to the creation, revision, and maintenance of clear and compliant product labels that educate health care professionals and patients in the US, EU, Japan, and Rest of World. Gain consensus and champion proactive consensus-building across Research, Statistics, Regulatory, Joint Ventures, Legal, and Marketing on labeling - laser-focused on the bottom line: “What do the doctor and patient need to know?”...

Paul Abato, Ph.D.

Providence, Rhode Island
Pharmaceutical Research, Chemistry & Chemicals - Drug Formulation, Biotechnology, liquid formulation, medicinal chemist, organic chemist, pharmcokinetics, stability studies, dietary supplements, tetracyclines, synthetic biology, breathalyzer, drug tests
...Dr Abato has testified in high stakes litigation cases at the International Trade Commission and federal courts for major players in the pharmaceutical industry. He has experience with ANDA, trade secret, trademark infringement, patent infringement and contract law cases relating to pharmaceuticals. Upload Dr Abato’s CV, which includes a complete list of case numbers and Law Firms that he has represented. PHARMACEUTICAL EXPERIENCE Dr. Abato is a Medicinal Chemist. His expertise includes drug research, medicinal chemistry, organic chemistry, drug formulation for; IT, IV, IP, ICV, IN, IM and oral dosing routs, stability studies, extensive structure-activity relationships, efficacy, pharmacokinetics, as well as all pre-clinical testing required for IND submission to the FDA....