Speaker Bios

Ruth Stevens, Ph.D.

Executive Vice President and Chief Scientific Officer, Camargo Pharmaceuticals

Dr. Stevens is a cofounder of Camargo Pharmaceutical Services, an end-to-end drug development consulting company that specializes in the 505(b)(2) drug approval process. Dr. Stevens as the Chief Scientific Officer is responsible for the oversight of the Scientific, Clinical, and Research services of Camargo. Dr. Stevens has had a balanced career working at the FDA and in the pharmaceutical industry. She has over 18 years of experience in the scientific, regulatory and clinical development of new drugs and therapeutic agents. Dr. Stevens continues to attend numerous scheduled FDA regulatory meetings throughout the year.

Prior to co-founding Camargo Dr. Stevens served 3 years at Barr Pharmaceuticals, Inc. (formerly Duramed Pharmaceuticals, Inc.) where she was Senior Director of Clinical Affairs. In this role, she directed scientific and clinical activities (Phases 1-4), focusing on women’s health and hormone replacement therapy products. Prior to joining Duramed she served for 3½ years as the Director of Pharmacokinetics & Pharmacodynamics at Phoenix International Life Sciences, Inc., where she was responsible for the scientific management of Clinical Pharmacology Phase 1 and 2 studies.

Preceding Phoenix International, Dr. Stevens served over six (6) years at the U.S. Food and Drug Administration (FDA) where she held positions 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). Specifically at the FDA, she reviewed and supervised the reviews of anti-infectives, analgesics, anti-inflammatories, drugs of abuse, anesthetics, and nuclear medicine and radiopharmaceutical drug products.

Dr. Stevens’ received her PhD in Biopharmaceutics/Pharmacokinetics from Oregon State University and has expertise in clinical study design, mass balance studies, regulatory affairs, pharmacokinetics, and new drug clinical development programs. Dr. Stevens currently holds a position as an Adjunct Associate Professor of Pharmacokinetics at the University of Cincinnati, College of Pharmacy. She has authored 60 abstracts/publications and has been an invited speaker both nationally and internationally. Dr. Stevens earned her MBA from Xavier University.

E. Steve Woodle, MD

Professor of Surgery, University of Cincinnati College of Medicine

Dr. Woodle is Professor of Surgery and Director of the Division of Transplantation in the Department of Surgery at the University of Cincinnati. He has served as Chairman of the Board of Directors of the Israel Penn International Tumor Transplant Registry for the last decade, and is a founding member of the Paired Donation Network.

He is a member of over 30 scientific and professional societies, including the American Surgical Association. He has chaired several committees in the American Society of Transplantation and has served on the Board of Directors of the American Society of Transplantation.

Dr. Woodle has published over 230 scientific articles and 20 book chapters in the field of transplantation. He has been the recipient of NIH research grants in immunobiology and has received a Clinician Scientist Research Award from the American Heart Association. Dr. Woodle has served on several NIH study sections, and several FDA Committees that regulate immunosuppressive drug approval. He has also served on trial design committees for a number of multicenter studies, and has served as lead investigator in several multicenter trials. Dr. Woodle has made seminal contributions in the areas of immunosuppressive drug development, corticosteroid elimination, paired kidney donation, posttransplant malignancies, and plasma cell targeted immunosuppression.

Lynn M. Fallon

President, CTI Clinical Trial and Consulting Services

Ms. Fallon is co-founder of CTI Clinical Trial and Consulting Services and brings to CTI over 19 years of clinical, academic and industry experience. Ms. Fallon has lead the development and expansion of CTI since its inception and is responsible for all aspects of the Consulting Division, including drug development, educational programs, scientific writing, strategic planning, and licensing and acquisition programs. Ms Fallon also participates in the business development, client management, and clinical trials operations of CTI. Ms. Fallon has held Senior Research, Sales and Marketing positions at Wyeth Pharmaceuticals and Fujisawa Healthcare. Ms. Fallon also held clinical positions at Albert Einstein Medical Center wherein she was a leader of the kidney, liver and pancreas transplant department. Lynn also served on multiple advisory board committees, is a member of multiple medical and nursing societies, and editor of various publications and web sites. Ms. Fallon received her Bachelor of Science degree in Nursing from The University of the State of New York.