Drug Development Expert Witnesses

Drug development expert witnesses and consultants listed here may be able to form expert opinions, draft expert witness reports, provide expert witness testimony at deposition and/or trial as or serve as consulting (non-testifying) experts on drug development. The drug development expert witness listings on this page are typically from fields/areas of expertise such as: Infectious Diseases, Pharmaceutical Regulation, Pharmaceutical Research, Toxicology, and Warnings & Labels.

Angela Lynch ToxPlus Consulting LLC

California
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.

Angela Lynch ToxPlus Consulting LLC

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.

David B Ross, MD, PhD, MBI

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 ...

Angela Lynch ToxPlus Consulting LLC

Massachusetts
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.

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