Long-term evidence generation is one of the most pressing challenges in clinical development and one of the least examined. Sponsors invest heavily in trial infrastructure, including tokenization and data linkage, and reasonably assume they have preserved their options for future evidence needs. But the questions that matter most to regulators and payers often emerge after a trial closes, when the trial cohort’s ability to answer them has quietly degraded. This webinar takes an honest look at where current approaches work, where they fall short, and what the implications are for how trials should be designed.
Panelists will examine what tokenization was built to do and where it genuinely delivers value. We’ll look at the specific ways trial cohorts erode over time and why standard tools for evaluating linkage quality often obscure that degradation until it is too late to address. We’ll also discuss what regulators increasingly expect in terms of long-term, high-integrity evidence, and the gap between those expectations and what most current evidence infrastructure can reliably provide.
The conversation will be grounded in real experience: from sponsors who have navigated these challenges firsthand, from a regulatory perspective on what sufficient long-term evidence actually looks like, and from PicnicHealth’s work building infrastructure designed specifically for this problem.
Dan is the Chief Medical Officer at PicnicHealth where he oversees a team of clinicians, data scientists, epidemiologists and biostatisticians, and sets product strategy and vision for the company. He is a board certified internist and infectious disease physician and is passionate about leveraging technology to transform patient outcomes, reduce inefficiencies, and ensure that patients’ voices and stories become a more central part of clinical research.
Dan is the Chief Medical Officer at PicnicHealth where he oversees a team of clinicians, data scientists, epidemiologists and biostatisticians, and sets product strategy and vision for the company. He is a board certified internist and infectious disease physician and is passionate about leveraging technology to transform patient outcomes, reduce inefficiencies, and ensure that patients’ voices and stories become a more central part of clinical research.
Jen Webster has held roles in genomics research, healthcare utilization research, medical home transformation and population health before joining Pfizer in 2021. At Pfizer, Jen established a precision medicine real world evidence group, developed technology supporting observational research and lead the development of Pfizer’s Integrated Evidence Planning (IEP) process. Since early 2026, Jen is VP of RWD Strategy and Activation. This role is responsible for establishing Pfizer’s worldwide RWD strategy and for ensuring that the licensed RWD assets are driving drug development.
Donna Rivera, PharmD., MSc., FISPE is the Executive Vice President of Clinical Evidence Modernization at Canal Row Advisors with expertise in scientifically rigorous strategies for use of real-world data (RWD), real-world evidence (RWE), innovative trial design, and artificial intelligence (AI) from experience across government, industry, and academia. At the FDA, Dr. Rivera was Associate Director for Pharmacoepidemiology in the Oncology Center of Excellence (OCE) and Founding Director of the Oncology Real-World Evidence Program, leading collaborative review across CDER, CBER, and CDRH to advance the appropriate use of RWE in oncology product development to facilitate patient-centered regulatory decision-making. She directed initiatives to modernize evidence generation through regulatory review of all oncology submissions containing RWE, regulatory science research portfolio management, regulatory policy development, and leadership of international partnerships and educational programs. Dr. Rivera contributed to the development of multiple FDA guidances related to RWD and RWE, clinical studies, pragmatic clinical trials, and artificial intelligence (AI). She also formed the FDA Oncology AI Program, leading the Oncology AI Council to guide the use of AI applications in regulatory review, research, and policy. As a pharmacist and pharmacoepidemiologist, she has deep expertise in clinical RWD and leveraging pragmatic clinical trials to strengthen patient-centric evidence generation. In her prior role at the National Cancer Institute, Dr. Rivera led a strategic RWD initiative to facilitate SEER registry data linkages through collaborative public-private partnerships, as well as other data science strategy efforts. She has previous experience in clinical trial design from Stiefel, a GlaxoSmithKline company. Dr. Rivera is a Fellow of the International Society for Pharmacoepidemiology and serves as an Affiliate Associate Professor at the University of Maryland School of Pharmacy.
Jaime Green is a freelance science writer and author. Her work has appeared in The New York Times Magazine, The Atlantic, Aeon, Popular Science, Slate, Astrobites, and elsewhere. She is the series editor of The Best American Science and Nature Writing and author of The Possibility of Life: Science, Imagination, and Our Quest for Kinship in the Cosmos.