Novel Digital Endpoint Solutions for Early and Mid-Phase Development
Session introduction
Leveraging Australia’s Early-Phase Advantages to Set Up Scalable, Late-Phase Global Success
Early and mid-phase trials are where critical development decisions are made, yet many programs still rely on endpoints that are hard to scale, justify or operationalize globally. Using Australia as a practical example, the session shows how early digital strategies can lay a scalable foundation for global Phase III success.
Register for this webinar to learn how a digital endpoint strategy implemented in early and mid-phase development can strengthen evidence generation and support regulatory confidence.
Webinar start times:
Tuesday, March 10
11am AEDT (Australia-Eastern) / 8am CST (China) / 9am JST (Japan) / 9am KST (Korea)
Monday, March 9
8pm EST (North America-East)
Webinar end times:
Tuesday, March 10
12pm AEDT (Australia-Eastern) / 9am CST (China) / 10am JST (Japan) / 10am KST (Korea)
Monday, March 9
9pm EST (North America-East)
Join this webinar to hear Clario’s scientific and operational experts along with Tina Soulis, Founder and Director of Alithia Life Sciences, as they focus on a regional perspective from Australia’s early-phase clinical trial ecosystem. Together, they’ll explore how digital endpoints, including eCOA, medical imaging and cardiac testing, can be implemented early in development to generate stronger evidence, reduce variability and support regulatory engagement.
Attendees will learn how:
- Principles for selecting and validating digital endpoints in early and mid-phase studies: what makes an endpoint scientifically robust, feasible and appropriate for early phase development
- How early-phase studies are used to refine endpoints and assess feasibility: using Phase I/II to test, adjust and de-risk endpoints before late-phase commitment
- Operational considerations for implementing digital endpoints across sites and CROs, including site readiness, training, data quality and managing added complexity
- Designing endpoints for continuity from early development into Phase III: how to minimize rework by building for scalability, reproducibility and regulatory acceptance
- The role of imaging and patient-reported outcomes in early oncology development: when and why these measures add value for dose optimization, safety and early efficacy signaling
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.
Tina Soulis
Founder and Director at Alithia Life Sciences
A/Prof Tina Soulis has over 30 years of working in the healthcare (pharmaceuticals and devices), biotechnology, academic research, clinical research and management sectors in senior roles including: CEO of a Contract Research Organization, Director of a successful ASX200 company, VP of Clinical Strategy and Development with an innovative biotechnology company and now, Founder and Director of her own full-service capability clinical CRO. A dynamic and strategic leader, Tina has an extensive network of stakeholders all over the world and experience in many therapeutic areas across all phases on development.
Passionate about mentoring future industry leaders and advocating for the Australian R&D community, Tina serves on several therapeutic executive advisory boards, as Australian resident director to a portfolio of overseas entities and advisors many US-based biotechnology companies.
Recently, Tina launched Alithia Life Sciences, where her motivation and mission is to work with her clients to deliver efficient accomplishment of their project, add value to their programs and to ultimately enable improvement of human health and wellbeing.
Tina is one of the few Australian clinical development leaders who has successfully taken products from lab to regulatory approval.
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.
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.