Why Phase 3 Trials Fail: Oncology Case Studies and Lessons Learned

Peter Langecker, MD, PhD, Executive Medical Director, Global Oncology, Clinipace Worldwide

Peter provides medical expertise within Clinipace, and externally, acting as Chief Medical Officer or Medical Monitor for sponsor medical projects. He provides clinical development strategy advice, feasibility assessments, and monitoring oversight for select clients. He has more than 25 years of experience in clinical oncology and oncology drug development, specializing in the planning and implementation of clinical Phase I-IV studies, regulatory strategy, and FDA and EMA interactions and submissions. Following his early career as Medical Monitor at Ciba-Geigy and Schering-Plough, he has served in senior roles in several pharmaceutical and biotechnology companies including Coutler, SUGEN, Intarcia, DURECT, and OXiGENE.

Peter received his MD and PhD in medical sciences from the Ludwig-Maximilians University.

Ron Marks, PhD, Chief Scientific Officer, Director of Biostatistics, Co-Founder, Clinipace Worldwide

Ron co-founded Clinipace Worldwide to bring to market an eClinical trial solution that he helped develop at the University of Florida. Ron and his team in the Division of Biostatistics developed a web-based electronic clinical trial system beginning in 1996 that was used to support a 22,000 patient Phase 4 cardiology clinical trial that ran at 870 primary physician sites in 10 countries for 5 years. Theuniversity received a patent on multiple aspects of the eClinical system.

Ron was trained as a Biostatistician. He received his MS and PhD in Statistics at the University of Florida and joined the Division of Biostatistics faculty at the J Hillis Miller Health Center at the University of Florida upon graduation. He served on the faculty for 30 years and as Director for 18 years.

 Since joining Clinipace Worldwide, Ron has served as Chief Scientific Officer and Global Director of Biostatistics.

Barbara Geiger, BSN, RN, Executive Vice President, Oncology, Clinipace Worldwide

Barb has more than 25 years of experience in the conduct and management of Phase I-IV clinical trials and project teams. She has global expertise having run trials in more than 30 countries on six continents, and is still waiting for that trial in Antarctica!

Prior to founding Worldwide Clinical Research (WWCR) in 2000, she spent 10 years in leadership roles at global CROs. Additionally, Barb spent eight years at a major pharmaceutical company and began her career in clinical research in a Phase I/II Private research unit. She is a clinical operations professional and serves our clients as an executive liaison to project teams. An oncology nurse by training, she has extensive experience in oncology and CNS drug development.