SOURCE: Xtalks

Xtalks Webinars

October 16, 2017 07:30 ET

Specific Cardiovascular issues in Oncology Drug Development, New Webinar Hosted by Xtalks

TORONTO, ON--(Marketwired - October 16, 2017) - 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 upcoming CSRC/FDA Annual Meeting on Cardiac Safety and Cardiovascular Safety Issues in Oncology Drug Development.

Join BioTelemetry Research's medical experts as they 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!

For more information about this complimentary event visit: Specific Cardiovascular issues in Oncology Drug Development.


Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

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