TransCelerate executives and member organizations to present eight sessions focused on the future of global clinical development
PHILADELPHIA, June 10, 2025 -- TransCelerate BioPharma (TransCelerate), a nonprofit organization dedicated to improving the health of people around the world by accelerating and simplifying the clinical research process, today announced its participation in numerous sessions at the DIA 2025 Global Annual Meeting in Washington, D.C. from June 15–19.
As the industry navigates evolving regulatory landscapes, emerging technologies, and new frontiers in patient-centric trials, TransCelerate plays a unique role in fostering industry-wide collaboration to accelerate practical solutions across the R&D ecosystem.
TransCelerate executives, including Allison Cuff Shimooka, Chief Operating Officer, and Rob DiCicco, Vice President of Portfolio Management, along with leaders from its member organizations, such as AstraZeneca, Roche, and Novo Nordisk, will contribute to eight sessions at the conference, addressing essential topics such as clinical trial modernization, patient safety, and the convergence of clinical research and care. Many of these sessions feature diverse, multi-stakeholder panels that bring together not only TransCelerate and its member companies, but also leaders from regulatory agencies, academic institutions, and other industry groups, demonstrating the collaboration and cross-ecosystem alignment needed to advance clinical research.
"No single stakeholder can accelerate transformative progress in clinical research alone. Meaningful collaboration is imperative, especially as we work to further normalize clinical research for patients," said Allison Cuff Shimooka, Chief Operating Officer at TransCelerate. "At this year's DIA Global Annual Meeting, we're excited to share practical perspectives and solutions to help bring new treatments to patients faster, safer, and more efficiently."
Sessions featuring TransCelerate and its member companies include:
Models of Collaborations to Advance Regulatory Science: Lessons Learned
- Date & Time: June 16, 2025 at 2:15 p.m. EDT
- Speakers: Huong Huynh (Session Chair), Critical Path Institute; Meghana Chalasani, FDA Center for Drug Evaluation and Research; Carla Rodriguez-Watson, Reagan-Udall Foundation for the FDA; Allison Cuff Shimooka, TransCelerate; Liang Zhao, University of California San Francisco
- Description: This session will discuss collaborative models in drug development and highlight lessons learned and factors for effective collaborations in advancing regulatory science.
Integrating Clinical Trials and Clinical Care: The Who, What, When, Where, Why and How
- Date & Time: June 16, 2025 at 3:45 p.m. EDT
- Speakers: Emily Gebbia (Session Chair), FDA Center for Drug Evaluation and Research; Rob DiCicco, TransCelerate; Grant Huang, VA Cooperative Studies Program; Jason Wakelin-Smith, Medicines and Healthcare Products Regulatory Agency (MHRA)
- Description: This session will explore approaches to operationalizing clinical trials within clinical care settings, balancing innovation with good clinical practice.
The Need for a Multi-Stakeholder Collaboration to Modernize ICSR Management: How? Why? What?
- Date & Time: June 17, 2025 at 10:30 a.m. EDT
- Speakers: Mayur A Patel (Session Chair), AstraZeneca; Andrew Bate, GlaxoSmithKline; Suranjan De, FDA; Phil Tregunno, MHRA
- Description: This session will highlight the challenges and solutions for modernizing Individual Case Safety Report (ICSR) management through cross-sector collaboration.
Embracing ICH E6(R3) with Risk-Based Quality Management and Data Governance
- Date & Time: June 17, 2025 at 1:45 p.m. EDT
- Speakers: Madeleine Whitehead (Session Chair), Roche; Abigail Dirks, Tufts CSDD; Nicole Stansbury, Premier Research
- Description: This session will focus on integrating risk-based quality management and data governance principles into clinical research operations.
Transforming the Protocol from a Document-Centric to a Data-Centric World Enabling Study Execution Automation and Regulatory Review
- Date & Time: June 18, 2025 at 8:30 a.m. EDT
- Speakers: Chris Decker (Session Chair), CDISC; Rob DiCicco, TransCelerate; William Illis, Novartis
- Description: This session will explore digital protocol initiatives, such as Digital Data Flow (DDF), and how structured data can unlock AI-driven innovation in study execution and regulatory review.
From Bedside to Bench to Bedside: How Adverse Events Converge Clinical Research and Clinical Care
- Date & Time: June 18, 2025 at 8:30 a.m. EDT
- Speakers: Allison Cuff Shimooka (Session Chair), TransCelerate; Jeremy Jokinen, Bristol-Myers Squibb Company; Narayan Nair, FDA; Rebecca Noss, Noss Research Consulting
- Description: This session will look at how adverse event reporting connects clinical research and patient care and explore opportunities for greater stakeholder collaboration across the continuum.
From Guidelines to Real-World Impact: Considerations for the Practical Implementation of ICH M14
- Date & Time: June 18, 2025 at 10:30 a.m. EDT
- Speakers: William Blumentals (Session Chair), Sanofi; Alice Hsu, Amgen; Jie Li, FDA; Susan Oliveria, Thermo Fisher Scientific
- Description: This session will provide a forum for exploring the operational and stakeholder impacts of ICH M14 and practical pathways to implementation.
How AI is Transforming the Area of Data Standards and Access to Source Data
- Date & Time: June 19, 2025 at 9:00 a.m. EDT
- Speakers: Jesper Kjær (Session Chair), Novo Nordisk; Chris Decker, CDISC; Rob DiCicco, TransCelerate; Charles Jaffe, HL7; Patrick Ryan, Janssen
- Description: This session will examine how AI is being used to accelerate the development and adoption of data standards, transforming access to real-world evidence and electronic health data.
Meet with TransCelerate at DIA Global
Media interested in meeting with TransCelerate at the DIA 2025 Global Annual Meeting are welcome to contact Hannah Davis at tcb@0to5.com to schedule a meeting.
About TransCelerate BioPharma Inc.
TransCelerate BioPharma (TransCelerate) is a nonprofit organization that fosters collaboration across the global biopharmaceutical research and development community to simplify clinical trials and help bring new treatments to patients faster, safer, and more efficiently.
Headquartered in the Philadelphia area, TransCelerate has 20 member companies and a robust portfolio of initiatives focused on transforming connectivity, enabling information sharing and reuse, and driving innovative trial designs. For more information, please visit transceleratebiopharmainc.com.
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