Drug Development Expert Witnesses

Westmont, Illinois

Toxicology, Pharmaceutical Research - Pharmacology, Neuroscience, Toxicology, Industrial Chemicals, Contract Research Organizations, Academic Research, Drug Development, Human Health Risk Assessment, Diplomate of the American Board of Toxicology, DABT, US FDA, US EPA, Gene Therapy, Biologics, Toxicologist, Pharmacologist

I am toxicologist and pharmacologist with a board certification in toxicology. I have 20 years of experience working with in the biotech, pharmaceutical and chemical industries to address pharmacology/toxicology, regulatory affairs issues and human health risk assessment. I have more than 30 years of research, consulting and regulatory experience. I have worked with law firms for the last 15 years in various capacities to support litigation. I am an active member of the American College of Toxicology, Society of Toxicology, and American Society of Gene and Cell Therapies. I also am a Diplomate of the American Board of Toxicology (DABT) since 2018.

Baltimore, Maryland

Pharmaceutical Regulation, Infectious Diseases - Food and Drug Administration (FDA), drug/biologics safety/labeling/post-marketing surveillance, FDA drug/biologics regulations/procedures/applications (INDs/NDAs/BLAs), clinical trials, drug development, pharmacy compounding, HIV, MRSA, antibiotics, hepatitis, osteomyelitis, influenza, C. difficile

Dr. Ross is a Yale fellowship-trained, board-certified infectious disease physician. An active clinician in practice for over 25 years, he provides patient care in the areas of infectious disease and primary care. Dr. Ross holds a medical degree from New York University School of Medicine, and an undergraduate degree in Molecular Biophysics and Biochemistry from Yale University. He completed his internal medicine residency training at NYU Medical Center, and infectious disease fellowship training at Yale University. Dr. Ross also holds a M.S. and Ph.D. in Biochemistry from NYU, and a Master’s Degree in Biomedical Informatics from Oregon Health and Sciences University. Dr. Ross spent 10 years with the FDA’s Center of Drug Evaluation and Review (CDER) as a medical officer, senior medical reviewer, medical team leader, and new drug review office management official. He has extremely broad experience with FDA regulatory submissions (INDs, NDAs, BLAs, post-marketing safety, labeling ...

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?” Provide leadership in support of label development for new applications, supplemental appl...

Lovettsville, Virginia

Pharmaceutical Research, Infectious Diseases - pharmaceutical regulation, FDA, drug development, antimicrobials, antiseptics, disinfectants, clinical trials, post-marketing surveillance, drug labels, biologics, medical devices, microbiology, biochemistry, molecular biology, food poisoning, data fraud, biological defense, dairy micro, IP

25 years of experience in infectious disease including food microbiology, chemical/ biological defense and regulatory science. Initial employment in the Federal Government was with the Agricultural Research Service (ARS) performing genetic engineering of dairy bacteria. From there, he went to the Department of Defense, specifically Naval Surface Warfare Center (NSWC), working in chemical and biological warfare defense. Spent 12 years as a Clinical Microbiology reviewer in the Center of Drug Evaluation and Review (CDER) at FDA. He has extensive experience with FDA submissions including: pre-IND, IND, NDA, labeling supplements, and post-marketing for antibiotics, topical antiseptics, biologics and generic drugs. As an independent consultant, provided guidance on microbiology and regulatory affairs for clients developing antimicrobials, medical devices and biologics allowing clients to navigate through the FDA regulatory process. This guidance included providing advice for deve...