On October 24-25, 2017 scientific experts gathered at the Cardiac Safety Research Consortium (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, attended the annual meeting and presented a complimentary webinar on November 1, 2017 on Key Takeaways from the New CSRC/FDA Meeting on Cardiac Safety and Cardiovascular Safety Issues in Oncology Drug Development.
The webinar is avalibale to view on-demand. Listen to our medical experts as they discuss specific recommendations regarding the prediction, avoidance and detection of cardiovascular (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 to readily implemented in the clinical development arena.
Our experts address 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 ICH E14 guidance. For oncologics, attention is 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.
View the webinar on-demand to learn more about:
- 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
Download our webinar to stay up to date with the changing role of cardiovascular safety monitoring and its implications for sponsors!