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


Date: Wednesday, November 1, 2017

Time: 11am EDT (NA) / 3pm GMT (UK) / 4pm CET (EU-Central)

Duration: 60 minutes

Featured Speakers:

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 EDT, 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!



          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 and Gentiae Clinical Research. 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.

          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 Cardiology for Clinical Trials, 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. After this post, Dr. Goodman worked closely with the BioTelemetry Research medical team as a senior scientific consultant for several years before becoming the medical director in 2012. Dr. Goodman is an international thought leader in cardiac safety testing, developing protocols, producing scientific reports, conferring with regulators and publishing extensively.


          This webinar will benefit medical and non-medical professionals in the biopharmaceutical industry, especially those supporting oncology drug development with roles in:

          • Clinical Research
          • Clinical Development
          • Medical Affairs
          • Clinical Operations
          • Project Management
          • Regulatory Affairs


          As leaders in clinical trials services for many years, experts from Cardiocore and VirtualScopics are now the Research division of BioTelemetry, the world's largest mobile health information company. As BioTelemetry Research, we provide expert cardiac core lab and imaging services, while monitoring hundreds of thousands of patients and subjects per year, and servicing 20,000 sites and 30,000 devices a month. We offer global operational support for cardiovascular monitoring in all therapeutic areas, and advanced imaging services in oncology, cardiovascular, neurologic, metabolic, musculoskeletal, and medical device studies. Our accessible and experienced research team is comprised of key opinion leaders, board-certified cardiologists and radiologists, sub-specialty scientists, and highly trained technicians — who acquire, evaluate, and report high-quality data through an efficient, cloud-based infrastructure. At BioTelemetry Research, it is our job to support your clinical trial with the most accessible and experienced team and the most advanced technologies available... through personal service on a global scale.

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