Moving the Needle in Vaccine Trials: Optimizing Digital Endpoint and Operational Strategies to Enable Study Success
Register for this webinar to discover how advanced eCOA, cardiac monitoring and digital endpoints can ensure your vaccine trials meet the highest standards of quality, safety and regulatory readiness.
Session information:
Time:
- 11:00 a.m. – 12:00 p.m. EDT (NA-East)
- 16:00 – 17:00 BST (UK)
- 17:00 – 18:00 CEST (EU-Central)
Vaccine studies often rely on rapid and efficient execution across global, multi-center populations. However, strategies for accelerating trials must never compromise data integrity or regulatory compliance.
In this vaccine-focused webinar, Clario’s experts will discuss the evolving standards for safety and toxicity grading within vaccine trials, along with best practices for designing reactogenicity diaries that capture local and systemic symptoms accurately. The session will explore why Bring Your Own Device (BYOD) is often the preferred modality for modern vaccine trials when considering participant burden, data integrity and speed. It will also examine how electronic diaries (eDiaries) can improve accuracy and provide regulatory-ready data for faster and accurate decision-making. The unique challenges and considerations for assessing cardiac safety in vaccine development will also be discussed.
Register for this webinar to discover how advanced eCOA, cardiac monitoring and digital endpoints can ensure your vaccine trials meet the highest standards of quality, safety and regulatory readiness.
Speakers
Todd Rudo, M.D.
EVP and Chief Medical Officer at Clario
Dr. Todd Rudo is EVP and Chief Medical Officer at Clario, providing medical and scientific leadership across the organization. He has nearly 20 years of clinical cardiology and pharmaceutical research experience, with a career predominantly focused on drug safety.
Dr. Rudo has board certifications in cardiology, cardiac electrophysiology, nuclear cardiology, adult echocardiography and internal medicine. His team provides expert consulting to clients on scientific and regulatory strategy, and ensures Clario’s product portfolio is scientifically robust, generating high-quality clinical trial endpoint data. Dr. Rudo has a particular interest in applying innovative technologies to improve the scientific rigor of clinical trials, while maintaining focus on the customer experience, including minimizing patient and site burden.
Saima Khakwani
Scientific Advisor, eCOA Science and Consulting at Clario
Saima is a Scientific Advisor at Clario and the internal subject matter expert for vaccines. She specializes in eCOA design, with a focus on reducing patient burden and improving data quality through best practices in diary design, including the use of paper and free text.
With over six years of experience supporting Phase II and III trials across multiple therapeutic areas, Saima has led scientific contributions in oncology, respiratory, pain, diabetes, cardiac disorders and vaccines.
Saima continues to contribute to internal research aimed at improving the quality of clinical trial delivery and has authored and co-authored numerous scientific publications.
Fabian Chen, M.D., Ph.D.
VP and Deputy CMO, Cardiology at Clario
Dr. Fabian Chen is Deputy Chief Medical Officer – Cardiology and Vice President at Clario. In addition to providing leadership for Clario’s Cardiac Safety department, Dr. Chen offers expert consultation to clients on scientific and regulatory strategy. Dr. Chen has nearly 20 years of clinical cardiology and pharmaceutical research experience. Recent positions include Chief Medical Officer at the University of Pennsylvania Gene Therapy Program and Vice President of Clinical Development at Rocket Pharmaceuticals. Dr. Chen also has over 10 years of experience in both early and late-stage clinical development, working at Merck and Novartis Pharmaceuticals.
Fabian received his undergraduate degree from Harvard College and his M.D. and Ph.D. from Yale University. He completed his internal medicine and cardiology training at the University of Pennsylvania School of Medicine. Prior to entering the pharmaceutical industry, Fabian was a faculty member of the departments of Medicine, Pediatrics and Molecular & Cellular Physiology at the University of California, Los Angeles.