• The Regulatory Review of Pro-Arrhythmic Risk for Oncology Drugs
  • The regulatory environment in the U.S. and Europe
  • Review ICH E14 in relation to target population studies, such as many oncology programs
  • The timing of ECG studies in oncology programs
• The FDA QTc Interdisciplinary Review Team
  • Describes the operational structure and function
  • Discusses the impact on cardiac safety assessment for oncology compounds
  • Shares clinical lessons learned from review processes
• Current Principles of the Statistical Analysis of Cardiac Safety Studies
  • Central tendency-based analysis
  • Exposure response modeling of QTc and plasma concentration data
• Cardiac Safety in Oncology Drug Development Programs
  • Detailed examples of several case studies
• Echocardiographic Cardiac Safety Assessment for Oncology Drugs
  • Analyze potential to cause congestive heart failure or cardiomyopathy
  • Echocardiography protocol design
  • Echocardiocraphic procedures

— About Your Workshop Leaders —

Christopher H. Cabell, M.D., MHS FAAC is Director, Cardiac Safety at Duke Clinical Research Institute. Dr. Cabell is anAssistant Professor of Medicine and Cardiology at Duke UniversitySchool of Medicine and serves as CEO of COResearch, a clinicaltrials core laboratory services company. In addition, Dr. Cabellserves as the associate director of the Duke Clinical Research Institute ECG Core Laboratory. He earned his medical degreefrom Duke University, where he also served as a medical resident, Chief Resident, and as a cardiology fellow. Dr. Cabell has developed specific expertise in the study of drug safety with specific attention to safety surveillance and cardiac safety in therapeutic drug development programs. He has over 50 original articles, reviews, editorials, book chapters and electronic publications. His research has been published in several prestigious journals including NEJM, JAMA, Circulation, American Heart Journal, Archives of Internal Medicine, American Journal of Medicine, American Journal of Cardiology and Clinical Infectious Diseases. Dr. Cabell has received numerous awards and recognition including induction into AOA, Greenfield Scholar in Cardiology Award, Four School Physician/Scientist Training Program and he was a Howard Hughes Medical Institute Medical Student Research Training Fellow. In addition, he is a member of a number of professional organizations and committees including the American Heart Association Clinical Cardiology Council where he has served on both the Young Investigators Committee and the Imaging Committee.

Kamal Shah, M.D. is Therapeutic Area Lead for Oncology, Safety Risk Management at
Pfizer Inc. Dr. Shah received his M.D. andD.A. (Anesthesiology) in 1984. After a few years of private practice, he joined the clinical research in 1992. He has worked at a couple of CROs, a 140 physician multispecialty clinic in NC as a Director, Clinical Research & IRB. He has also worked at a couple of pharmaceuticals companies as a Director, pre and post marketing Pharmacovigilance before joining Pfizer Inc.

Cynthia L. Green, Ph.D. is an Assistant Professor of Biostatistics and Bioinformatics at Duke University School of Medicine and serves as Director of Data Management and Biostatistics of COResearch, a clinical trials core laboratory services company. In addition, she serves as a biostatistics faculty member of the Duke Clinical Research Institute. She earned her B.S. degree in mathematics from Duke University and her M.S. and Ph.D. in statistics from North Carolina State University. Dr. Green has over fifteen years of experience in the design and analysis of clinical trials. For seven years, she was the Co-Director of the DCRI Ischemia Monitoring Core Laboratory. Under her guidance, the lab conducted clinical trials research for treatment regimens using continuous ECG monitoring technology. She has published extensively as both primary and co-author in medical and statistical literature. Dr. Green has expertise in survival analysis with missing data, clinical trials and biomarker analyses. Dr. Green has also applied novel statistical methodology for missing data in survival analysis to actual ECG data analysis situations. In addition, she is a member of a number of professional organizations and committees including the American Statistical Association and the Society for Clinical Trials.

Polina Voloshko, MD is Vice President of Medical Operations at Cardiocore. As Cardiocore's Vice President, Medical Operations, Dr. Voloshko manages Cardiocore's centralized echocardiography and electrocardiography teams. During her 22 years experience as a cardiologist, Dr. Voloshko has overseen hundreds of cardiac safety trials including Thorough QT studies and over 60 oncology clinical trials. Prior to coming to Cardiocore, she served as the Vice President of Cardiovascular Clinical Services for Gentiae and the non-profit Ischemia Research and Education Foundation, where she designed and conducted oncology and echocardiography protocols. Earlier in her career, Dr. Voloshko was a research fellow at the University of California San Francisco (UCSF) and Chief of Cardiology at Riga City Hospital in Riga, Latvia, an affiliate of the Latvian Medical University. She also practiced invasive and non-invasive clinical cardiology at the Republican Institute of Cardiology in Riga and served as a primary care physician at Riga City Hospital. Board certified in cardiology and internal medicine, Dr. Voloshko received her M.D., Magna Cum Laude, at the First St. Petersburg Medical School in Russia.

— Who Should Attend —

You will benefit from this event if you are a Vice President or Director/Manager at a Pharmaceutical or Biotech Company with responsibilities in the areas of:

Media Partner

Sponsors and Exhibitors

Media Partners

Visit our website at www.cbinet.com/clinicaloncology