Maximizing Value in Early-Phase Oncology Trials: Innovative Endpoints for Early Insights
Early-phase oncology trials provide a unique opportunity to capture high-value endpoint data that can inform rapid, evidence-based decisions on the future of a drug development program. In this webinar, the featured experts will examine how innovative methodologies and technologies are becoming more practical to deploy, delivering deeper insights than traditional strategies across efficacy, safety and patient-reported endpoints.
Register for this webinar to learn how early-phase oncology trials can use innovative endpoints to generate earlier, decision-ready insights.
Session information:
Time:
- 11:00 a.m. – 12:00 p.m. EST (NA-East)
- 04:00 p.m. – 05:00 p.m. GMT (UK)
- 05:00 p.m. – 06:00 p.m. CET (EU-Central)
Join this webinar to learn how advanced image analysis techniques enable more sensitive and earlier detection of treatment response than conventional methods. The speakers will also explore how early-phase pharmacokinetic data can be leveraged in concentration-effect modeling for cardiac safety, not typically feasible in later development. The role for early patient input on tolerability, symptom burden and symptomatic adverse events in strengthening clinician assessments and supporting dose selection will also be discussed.
In this webinar, attendees will learn how:
- Assessing cardiac safety risks of a new oncologic agent in early-phase clinical trials can be achieved with minimal impact on development cost and complexity. Speakers will also review how the elimination of concerns for drug-induced QT prolongation during early development can simplify and accelerate later-stage development.
- Leveraging AI-powered lesion segmentation during dose escalation can facilitate the generation of additional valuable biomarkers, including total tumor burden, that may inform Phase II dose selection more effectively than RECIST alone. Panelists will also review how advanced analytical tools, such as tumor growth kinetics, may be more sensitive predictors of treatment response and progression than RECIST, during early-phase development.
- Patient-reported outcomes (PROs) in early-phase oncology trials provide critical insights into treatment tolerability and the patient experience, enabling a more comprehensive, patient-centered evaluation of risk-benefit profiles. The speakers will also share key highlights and recommendations from recent literature and regulatory guidances on best practices for incorporating PROs in oncology trials.
Speakers
Todd Rudo, M.D.
EVP, 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.
Anu Bansal, M.D., M.S.
VP Medical Imaging, Oncology at Clario
As Vice President of Imaging in oncology, Dr. Anu Bansal provides leadership and oversight of all aspects of Imaging in Phase I to Phase IV drug and device trials from protocol design through registrational submission and post-approval monitoring. He uses his 20+ years of experience in clinical research and patient care to support Clario’s cross-functional teams and clients in medical, regulatory and scientific affairs.
Dr. Bansal trained and has board certifications in Diagnostic Radiology, Diagnostic and Interventional Neuroradiology and Clinical Informatics. He received his undergraduate degree in Biochemistry from Harvard University, his MD from the Albert Einstein College of Medicine and an MS in Healthcare Management from the Harvard School of Public Health. He completed residency training at Brigham and Women’s Hospital and his fellowships at the Mallinckrodt Institute of Radiology at Washington University.
Robert Kleiman, M.D.
Chief Scientific and Regulatory Officer, Cardiac Safety at Clario
Dr. Robert Kleiman, formerly the Chief Medical Officer of ERT, now serves as Clario’s Chief Scientific and Regulatory Advisor for Cardiac Safety. Dr. Kleiman is a Clinical Cardiologist and Cardiac Electrophysiologist, conducting research in basic cellular electrophysiology as well as clinical electrophysiology. Dr. Kleiman provides cardiac safety consulting services to Clario customers, including assistance with trial design, cardiac safety assessments and data analysis, regulatory strategy and regulatory support and other cardiac safety issues during drug development. Dr. Kleiman also participates with CDISC, the Safety Pharmacology Society and HESI in nonclinical and clinical cardiac safety-related areas.
Kelly Dumais, Ph.D.
Senior Director and Global Head of eCOA Science and Consulting at Clario
Dr. Kelly Dumais is a scientist with over 15 years of experience in behavioral and life science research. She is currently the Senior Director and Global Head of eCOA Science and Consulting at Clario. She has expertise in the implementation of electronic clinical outcome assessments (eCOA) and the development and validation of patient reported outcomes (PROs) to support labeling claims. She is a subject matter expert in the development of custom site rater training and participant training for improving accuracy in COA reporting and improving inter- and intra-rater reliability. Furthermore, she has expertise in PRO strategy for oncology clinical trials and has published and presented strategies and outcomes of oncology trials at over 14 conferences and webinars.