ConV2X Releases Final Agenda Focused on AI, Clinical Development, FDA Regulation and Pharmaceutical Data Integrity

ConV2X announced the final agenda and expanded speaker roster for its September 24–25 multidisciplinary executive summit at The Foundry in Cambridge, Massachusetts. The program brings together leaders from pharmaceutical development, regulatory science, clinical research, healthcare, artificial intelligence, cybersecurity and decentralized infrastructure to address how emerging technologies can be implemented across life sciences with greater integrity, accountability and measurable value. The 2 Day program places particular emphasis on challenges confronting pharmaceutical and biotechnology organizations: validating generative and agentic AI in global clinical development; producing regulatory grade evidence; protecting clinical trial data integrity; strengthening drug traceability and auditability; navigating divergent FDA, EMA and international requirements; and building cyber resilient data infrastructure. REGULATORY AND OPERATIONAL USE The agenda examines where AI and decentralized technologies are delivering practical value across drug development and where adoption continues to outpace evidence, validation and governance. Sessions include: Beyond Prediction: Orchestrating Generative & Agentic AI in Global Clinical Development The Cost of Getting Data Integrity Wrong Decentralized Technology for Life Sciences: Smart Contracts, Pharma Traceability & Clinical Data Integrity Multi-Agentic AI & Decentralized Architectures Across Pharma and Health Ecosystems From Policy to Practice: Implementing AI at Scale in a Health System Regulatory Divergence & Market Landscape: North America, Europe & Asia in Safe AI, Decentralized Data & Health Innovation Governing at the Speed of Deployment: AI, Standards & the Global Health Data Stack Quantum & Cyber Readiness in Health Systems Discussions will address the evidentiary standards required for predictive, generative and agentic AI; global validation strategies aligned with FDA, EMA and ICH expectations; auditability for continuously learning models; oversight of third party foundation models; trusted data provenance; and the technical and contractual controls sponsors need to preserve scientific and regulatory credibility. The program will also examine continuous pharmaceutical manufacturing and the barriers that can prevent established regulatory frameworks and advanced manufacturing technologies from translating into broader operational acceptance. LEADERS ACROSS PHARMA, REGULATORY SCIENCE AND CLINICAL INNOVATION Featured participants include: Ajaz S. Hussain, PhD — Independent Advisor; former Deputy Director, Office of Pharmaceutical Science, CDER, U.S. FDA; former President, National Institute for Pharmaceutical Technology and Education — Independent Advisor; former Deputy Director, Office of Pharmaceutical Science, CDER, U.S. FDA; former President, National Institute for Pharmaceutical Technology and Education Kelly H. Zou, PhD — CEO, AI4Purpose; Expert in Residence, ARPA-H — CEO, AI4Purpose; Expert in Residence, ARPA-H Charles Iheagwara — Global Head, AI Cybersecurity Delivery, AstraZeneca — Global Head, AI Cybersecurity Delivery, AstraZeneca Edward John Allera — Of Counsel, Life Sciences / FDA & Biotechnology, Buchanan Ingersoll & Rooney — Of Counsel, Life Sciences / FDA & Biotechnology, Buchanan Ingersoll & Rooney Dr. Arsh Arora — Lead, AI & Cyber IR Operations, McKesson — Lead, AI & Cyber IR Operations, McKesson Rama Rao — CEO, BloqCube; former pharmaceutical finance and operations executive — CEO, BloqCube; former pharmaceutical finance and operations executive Deepak Mittal — CEO, NextGen Invent Corporation — CEO, NextGen Invent Corporation Himanshu Jain — Technology, AI Strategy and Innovation Leader — Technology, AI Strategy and Innovation Leader Ingrid Vasiliu-Feltes, MD, EMBA — University of Miami Business School, Department of Healthcare Management and Policy — University of Miami Business School, Department of Healthcare Management and Policy Leo Anthony Celi, MD — Associate Professor, Bioethics, Harvard Medical School — Associate Professor, Bioethics, Harvard Medical School Anjum Khurshid, MD, PhD — Chief Data Scientist, Sentinel Operations Center, Harvard Pilgrim Health Care Institute — Chief Data Scientist, Sentinel Operations Center, Harvard Pilgrim Health Care Institute Honorable John Norris, JD — Executive Chairman, Safely2Prosperity; former Principal Deputy Commissioner, U.S. FDA Additional speakers represent healthcare delivery, AI architecture, clinical research, cybersecurity, standards, public policy, investment and decentralized technology. CLINICAL DATA INTEGRITY AT THE SOURCE A featured clinical trials case study will examine the operational and financial consequences of unreliable data and delayed review. The session will demonstrate an approach designed to establish integrity at the point of data creation, rather than relying solely on retrospective verification, and will consider how AI enabled monitoring may affect oversight, database lock and clinical study reporting. Other life sciences sessions will explore smart contracts, pharmaceutical traceability, drug provenance, consent, immutable audit trails, wearables, decentralized trial models and the role of blockchain in supporting trustworthy evidence across fragmented clinical systems. A CURATED EXECUTIVE ENVIRONMENT ConV2X is designed for candid, multidisciplinary exchange. Attendance is limited to 150 participants, with no exhibit hall or vendor sales presentations. The program is conducted under the Chatham House Rule to support direct discussion of implementation barriers, regulatory uncertainty, unsuccessful approaches and lessons from deployment. ConV2X Decentralized Health 2026 September 24–25, 2026 The Foundry 101 Rogers Street Cambridge, Massachusetts Final agenda: https://conv2xsymposium.com/agenda/ Registration: https://conv2xsymposium.com/shop/ ABOUT CONV2X ConV2X is an in person multidisciplinary executive summit produced by Partners in Digital Health. It convenes leaders across healthcare, life sciences, research, regulation, investment and emerging technology to examine the infrastructure, governance and implementation strategies required to build trusted, scalable health systems. Learn more at https://conv2xsymposium.com/.