Ruth E. Stevens Email & Phone Number

Washington, United States

Dr. Stevens is an internationally recognized regulatory scientist, regulatory strategist, speaker, and advisor with more than 30 years of involvement in all aspects of new drug development, with deep insights into the processes and approaches of the United States Food and Drug Administration (FDA). Currently, she is a Senior Advisor to Premier Research, a clinical research and development company, and is a member of Vincerx Board of Directors, a publicly traded clinical-stage biopharmaceutical company that is advancing new therapies intended to address unmet medical needs for the treatment of cancer. Dr. Stevens was a co-founder of Camargo Pharmaceutical Services and its Chief Scientific Officer & Executive Vice President from 2003-2021. She served as Board Member of Camargo Pharmaceutical Services from 2017-2021. Dr Stevens is a former FDA team leader and technical discipline reviewer. She has been a pioneer in the 505(b)(2) regulatory domain and has a virtually unparalleled track record of success. Dr. Stevens was a Recipient of 2019 Oregon State University, Icon of Pharmacy award, and induction into the Pharmacy Hall of Fame.Dr. Stevens has played a leading role as both chief strategist and executive program manager in virtually all aspects of drug development, including multiple product approvals to her credit. She has been a consultant to both FDA, including as an Advisory Committee Member and invited speaker, and Industry throughout her career. Dr. Stevens has led over 180 FDA meetings, including pre-Investigational New Drug Application (PIND); End-of-Phase-2 (EOP2), pre-New Drug Application (PNDA), End-of-Review (EOR); Type A, B, and C meetings, including speaking at an FDA Advisory Committee Meeting on a Sponsor’s behalf. Dr. Stevens obtained her Ph.D. in Biopharmaceutics/Pharmacokinetics from Oregon State University and earned her MBA from Xavier University. She is a guest lecturer at the College of Pharmacy, Oregon State University.

Cincinnati, Ohio, United States

Dr. Stevens has over 30 years of experience in the development of new drugs and therapeutic agents. In addition to her work for Camargo, Dr. Stevens is an adjunct associate professor of pharmacokinetics at the University of Cincinnati, College of Pharmacy. She has authored 44 abstracts/publications and has been an invited speaker both nationally and internationally. Prior to joining Camargo, Dr. Stevens was senior director of clinical affairs at Duramed Pharmaceuticals, Inc. (now Barr Pharmaceuticals) overseeing Phase I-IV scientific and clinical activities, with emphasis on women's health and HRT products. She also served as director of pharmacokinetics and pharmacodynamics at Phoenix International Life Sciences, Inc. (now MDS Pharma Services), where she was responsible for scientific management of Clinical Pharmacology Phase I and II studies. Dr. Stevens began her career at the U.S. Food and Drug Administration (FDA) as a pharmacokinetic reviewer and a team leader in the Office of Clinical Pharmacology and Biopharmaceutics in the Center for Drug Evaluation and Research (CDER).