Drug Expert Witnesses in Rhode Island

This expert has over 30 years of experience in law enforcement with 20 of those years in the Drug Enforcement Administration. At the DEA, he worked in various positions including Resident Agent in Charge and Inspector. He currently owns a consulting & investigative services firm and works as a Private Investigator specializing in Consulting and Private and Executive Securities.

This expert is currently working through her consulting company, within the Pharmaceutical Industry as a consultant, providing guidance and service for all aspects of Regulatory Affairs for the entire product lifecycle of drugs and biologics from discovery to approval/launch and post-marketing. In addition, providing expertise in business development pertaining to regulatory intelligence and regulatory due diligence. Her experience includes serving as a member of the Management Team (SVP RA) for three small companies developing novel drugs and biologics, and building and leading a product compliance organization (RA, QA and CQA) for a small biotech company, including approval of their first monoclonal antibody product, while serving in a leadership role on the Management Team. Prior to that, have led regulatory activities for several NDAs (leading to marketed products), INDs and post-marketing regulatory activities in 3 large pharmaceutical companies. She has 5 years experience in small molecule API process development and a PhD in medicinal chemistry and is a frequent contributor to various Industry programs. Specialties: All aspects of Regulatory Affairs for entire product lifecycles for small molecules and biologics, including: -IND/NDA/BLA submission management, prosecution and strategy -FDA meetings -Regulatory Liaison activities -Ad/Promo review and advising -CMC

This expert is a well respected and established Professor of Law specializing in ethics of the healthcare industry. He has testified before Congress and state legislatures and served on government commissions and advisory boards, including the Food and Drug Administration. He has provided training on conflicts of interest related to pharmaceutical good governance for various nations under the aegis of the World Health Organization. He has participated in meetings of the National Academy of Sciences, Institute of Medicine and worked for the World Health Organization. He has extensive experience in the fields of health law and policy, pharmaceutical policy, biomedical law, medical ethics, and more.

This expert is highly qualified in the field of internal medicine. He received his BA from Yale University, his MD from New York University, and his JD from Quinnipiac University. He completed his internship at Cincinnati General Hospital. He then completed three residency programs: a residency in internal medicine at Beth Israel Hospital, a secondary internal medicine residency at Bellevue Hospital in NY, and a non-invasive cardiovascular disease residency at the Veteran's Administration Hospital in the Bronx. He is board-certified in internal medicine, with a specialty in cardiovascular disease. He also holds a Connecticut law license. He is certified in basic life support, advanced cardiac life support, and as a federal, state, and town first responder. He is a member of several associations, including the American College of Legal Medicine, the Connecticut Bar Association, and the American College of Chest Physicians. He was formerly the medical director of the drug addiction program at Hallbrooke Hospital in Connecticut, the senior attending physician for internal medicine and clinical cardiology at Norwalk Hospital, and the chief of medicine for the United States Air Force Medical Corps. This expert has been published several times in medical journals and law journals, and has authored several books. He has also given interviews on medical issues on televised programs, such as the Larry King Show and Good Morning America.

This highly-qualified expert has 14 years of experience in the field of biopharmaceutical development, having earned her BS in biology from the University of North Carolina and her PhD in genetics from the University of California at San Francisco. Her work focuses on drug development with a particular focus on gene and cell therapies, including those with the following elements: AAV, Adenovirus, CRISPR, Zfn, Endonuclease, CAR-T, mRNA, LNP, Lentivirus, HSPC. She has worked in positions such as principal consultant for Halloran Consulting Group, the founder and CEO of Tremont Therapeutics, the senior director of Shire PLC, and the executive director of CRISPR Therapeutics. She is also involved in research in her field as an author of several scientific articles. This expert currently works as the principal at a drug development consulting company in Massachusetts.