Ruth E. Stevens

About Ruth E. Stevens

About Camargo Pharmaceutical Services Camargo Pharmaceutical Services is an…

Experience

1. Senior Advisor

   Premier Research

   Sep 2021 — Present · WA, US

   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 20••••21. She served as Board Member of Camargo Pharmaceutical Services from 20••••21. 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.

Skills

• Medical Devices
• Clinical Development
• Pharmaceutical Industry
• Pharmacodynamics
• Drug Development
• Drug Discovery
• Pharmacokinetics
• Regulatory Affairs
• Ind
• Fda
• Clinical Research
• Oncology
• Clinical Pharmacology
• Commercialization
• Regulatory Submissions
• Biotechnology