When a new drug or device undergoes “first in human” experience, the primary focus is on participant safety.
How will the drug or device interact with the human body?
And will this interaction be safe?
To answer these two questions, regulatory authorities around the world require medical product manufacturers to conduct Phase I, also known as early phase clinical trials.
To learn more about the complexities in early phase clinical trials, I invited Dr. Oren Cohen, President of Clinical Pharmacology Services and Chief Medical Officer at Labcorp Drug Development on the show.
Dr. Cohen has more than 30 years of healthcare experience which includes his work on clinical development.
Prior to joining Labcorp, Dr. Cohen served as the Chief Medical Officer at Viamet Pharmaceuticals.
He has also held multiple leadership roles at Quintiles Inc. such as Senior Vice President, Global Head of Early Clinical Development and Precision Medicine, Senior Vice President, Clinical Research Strategies, Vice President and Senior Director, Medical and Scientific Services, among others.
Dr. Cohen received his MD from Duke University and completed his internship and residency at The New York Hospital, Cornell Medical Center in New York City.
He completed his infectious diseases fellowship at the National Institute of Allergy and Infectious Diseases (NIAID) and stayed on to become an investigator in the Laboratory of Immunoregulation where he conducted basic and translational research under the supervision of Dr. Anthony Fauci.
He also served on the national antiretroviral guidelines panel and ultimately served as Assistant Director for Medical Affairs for NIAID.
Dr. Cohen has published scientific papers in Science, The New England Journal of Medicine, The Lancet, The Journal of Clinical Investigation and Proceedings of the National Academy of Sciences, among others.
He is a Fellow of the Infectious Diseases Society of America and a Consulting Professor of Medicine at Duke University Medical Center.
Please join me in welcoming Dr. Cohen to the Clinical Trial Podcast.
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