Key Takeaways from the New CSRC/FDA Meeting on Cardiac Safety and Cardiovascular Safety Issues in Oncology Drug Development

On October 24–25, 2017 scientific experts will be gathering at the CSRC/FDA Annual Meeting to discuss cardiac risk management and safety assessment in oncology drug development.. BioTelemetry Research’s Chief Medical Officer, Polina Voloshko, MD, and Vice President and Medical Director, Daniel Goodman, MD, will be attending. As a follow up to this meeting, Drs. Voloshko, and Goodman will be providing a complimentary webinar, broadcasting live on Wednesday, November 1, 2017 at 11:00am EST, on the Key Takeaways from the Annual CSRC/FDA Meeting on Cardiac Safety and the Annual Meeting on Cardiovascular Safety Issues in Oncology Drug Development.

Join BioTelemetry Research’s medical experts as they provide an update on issues in cardiac safety from the CSRC/FDA meetings on October 24/25, and discuss specific recommendations regarding the prediction, avoidance and detection of CV safety events in oncologic drug development. These recommendations will convey current thinking from regulatory, academic and industry perspectives and will be focused on practical solutions which can be readily implemented in the clinical development arena. Areas of controversy surrounding CV safety assessment in general and specifically in oncology drug development will be addressed. Topics will include the status of the CiPA initiative, the realities of exposure-response modeling for determination of definitive QT prolongation, the need for a positive control arm, and practical planning for future developments for meeting the ICH E14 guidance. For oncologics, attention will be directed at the challenges involved in the broad range of patients participating in a clinical trial including children as well as patients with early vs. late stage cancer, multiple comorbidities, and those receiving cancer therapy while taking other drugs.

Key discussion topics include:

• The status of ICH E14 guidance
• Practical issues in planning an early definitive QT study
• Realities of determining the maximum anticipated concentration – the “worst case scenario”
• Whether to include a positive control group
• Regulatory mindset moving forward
• Differences between Phase I and non-Phase I oncology, and impacts on CV safety
• Study design issues for proper detection and management of CV events
• Baseline CV risk assessment of clinical trial patients
• Precise classification of CV toxicities
• Major modalities and proper biomarker selections for the assessment of CV toxicities

Register today to stay up to date with the changing role of cardiovascular safety monitoring and its implications for sponsors!

Speakers

Polina Voloshko, MD, Chief Medical Officer, BioTelemetry Research

Dr. Voloshko provides scientific and medical leadership, direction, training and expertise to the BioTelemetry clinical trial staff, cardiologists, medical and scientific consultants and sponsors. She has over 25 years of experience in clinical cardiology, ECG, ECHO and Holter research. Prior to joining the company, she was VP of Cardiovascular Clinical Services at the Ischemia Research and Education Foundation, Gentiae Clinical Research and Cardiocore. Previously, Dr. Voloshko served as 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. Board-certified in cardiology and internal medicine, Dr. Voloshko received her MD, magna cum laude, at the First St. Petersburg Medical School in Russia.

 

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Daniel Goodman, MD, VP, Medical Director, BioTelemetry Research

Dr. Goodman directs all aspects of protocol planning and development for sponsors, and for analysis of cardiac safety results. He is materially involved in innovations in medical technology and novel analyses, as well as in implementing the latest regulatory initiatives. He has direct interactions with key sponsor personnel and with academic experts to provide expert consulting solutions. Dr. Goodman received his training at Yale University and Cornell University Medical School. In the early 1990s, he founded one of the world’s first cardiac core labs. Dr. Goodman went on to be the medical director for Covance Cardiac Safety Services from 1994 until 2007. Before becoming the medical director of BioTelemtry Research in 2012. Dr. Goodman is an international thought leader in cardiac safety testing, developing protocols, producing scientific reports, and conferring with regulators.

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