#RBQMLive
RBQMLive 2026 On-Demand
Keynote—RBQM at a Turning Point: From Adoption to Operational Maturity—E8 and E11 Potential Expansion
Speakers: Ken Getz, Executive Director & Professor, Tufts CSDD and Ken McFarlane, VP, Strategic Consulting, CluePoints
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For this session, we will explore how RBQM has achieved widespread adoption and how companies are organizations are operationalizing risk-based approaches. The keynote will examine where the industry stands today, why expectations and practices have shifted, and how regulatory tailwinds (e.g., ICH E6(R3)) and the rapid emergence of AI and real-world oversight, are redefining the RBQM landscape. Attendees will gain a clear perspective on the next phases of RBQM and the organizational capabilities needed to succeed.
Panel—Beyond Adoption: Proving the Value of a Mature RBQM Program
Participants: Featuring Demi You, Sanofi; Jamie O’Neill, RBQM Contributor; Miguel Valenzuela, Alnylam; and Kyle Given, CluePoints
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Organizations have largely implemented RBQM, but achieving measurable value requires moving beyond compliance toward operational excellence. This discussion explores how leading sponsors are advancing their RBQM programs, overcoming common barriers, and building mature, scalable risk management practices. Panelists will share lessons learned around governance, organizational change, cross-functional collaboration, and, critically, how they build and defend the business case: the metrics that convince finance and quality leadership that RBQM delivers a measurable return.
Trusted AI in Clinical Operations: From Automation to Decision Intelligence
Speakers: Cris McDavid, Parexel; Brian Barnes, BioNTech; and Sas Maheswaran, CluePoints
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AI is rapidly moving from experimentation to practical application across clinical development. This session explores how organizations are implementing AI responsibly while improving efficiency, consistency, and decision-making. Speakers will discuss governance, validation, transparency, auditability, continuous monitoring, and what sponsors need from AI vendors to confidently integrate AI into regulated clinical processes.
Designing Quality: From Inspection Readiness to Predicting Risk Before First Patient
Speakers: Kris Luypaert, Merck KGaA, and Tom Whitman, Biogen
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Inspection readiness is no longer about preparing for an audit. It is about continuously understanding and managing quality risk throughout a study. This session explores how organizations are shifting from reactive compliance to predictive quality management, using historical study data and protocol intelligence to identify emerging risk before they affect execution, and increasingly to design risk out at the protocol stage. As protocols become more complex, panelists will discuss how early risk visibility improves planning, oversight, and regulatory confidence.