This session will provide an update on recent industry initiatives to transform towards a data-centric protocol, demonstrate real use cases leveraging digital protocol information, and share thoughts on how to prepare for the change required.
Learning Objectives
Understand how various digital protocol collaborations are working together including ICH M11, Transcelerate/CDISC Digital Data Flow, and the HL7 Vulcan Unified Digital Protocol; Demonstrate the digital protocol in action from design through regulatory review; Prepare for the implementation and change management required to realize the benefits of a digital protocol.
Chair
Chris Decker, MS
Speaker
Transforming the Study Protocol from a Document-Centric to a Data-Centric World to Enable AI, Drive Automation, and Design Be Chris Decker, MS
Preparing for ICH M11: Am I Prepared? Robert DiCicco, PharmD
President and Chief Executive Officer, CDISC, United States
Chris is recognized industry wide as a leading technology and standards expert for designing, developing, and implementing complex process and technology solutions. He brings years of experience serving in various executive-level positions across software development, clinical research... Read More →
Vice President, Portfolio Management, TransCelerate Biopharma Inc., United States
Rob DiCicco is the Vice President, Portfolio Management at TransCelerate Biopharma, Inc. Rob joined TransCelerate from IBM Watson Health where he was the Deputy Chief Health Officer. At IBM he worked closely with software designers and developers to inform product roadmaps. Rob also... Read More →
Wednesday June 18, 2025 8:30am - 9:30am EDT
TBDWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
Single Arm Trials (SATs) are an important tool for drug development. The session while focusing on EMA and FDA guidance documents on SATs, will discuss how external information can support the needs and expectations of regulators and HTA globally.
Learning Objectives
Identify the appropriate settings and considerations for using external evidence in designing single-arm trials; Discuss strategies for advancing global drug development with single-arm trials, addressing differing perspectives among regulators and between regulators and HTA representatives.
Senior Director, Global Regulatory Affairs & Policy, R&D, Europe, AstraZeneca
Pulmonologist and immuno-allergist by training, Solange joined AstraZeneca R&D in 2004 and is currently Sr. Global Policy Director, with responsibilities in the Respiratory/Infection, Oncology and Vaccine/Immune therapies franchises. Over the past 20 years, moving from the French... Read More →
Wednesday June 18, 2025 10:30am - 11:30am EDT
TBDWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
ICH is advancing a global technology platform for multi-region collaborative review for CMC Post Approval submissions and inspections. Industry and regulators will discuss the platform’s governance, security, financing, and operations and outlook.
Learning Objectives
Explain the drivers, purpose, and plan for the ICH hosted PQKM Collaboration Platform in your organization; Describe the platform operating framework under ICH including goveranance and operation for regulators and industry participants; Discuss the initiative’s lessons learned and expectations by industry and regulators.
As Asia’s post-marketing surveillance evolves with the use of RWD, aligning these changes with US and European frameworks is essential. This session will cover Asia’s regulatory shifts and provide insights for global harmonization efforts.
Learning Objectives
Evaluate how the integration of RWD into post-marketing surveillance has improved safety monitoring and formulate strategies for applying these practices within your own organization's regulatory and safety frameworks; Analyze case studies on PMS in Asia to propose actionable approaches for implementing database-driven RMP systems in your organization, enhancing selective safety measures.
Professor, College of Pharmacy, Sungkyunkwan University, Korea, Republic of
Dr. Ju-Young Shin is the Chair Professor of Biohealth Regulatory Science at the School of Pharmacy, Sungkyunkwan University (SKKU). She serves as an associate editor for SCIE journals such as Pharmacoepidemiology and Drug Safety and Epidemiology and Health. She earned her B.S. in... Read More →
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBDWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
Industry leaders explore how biopharma is leveraging data foundations and technological advancements, including AI/ML, to improve access and representation in clinical trials, moving from DEI planning to tangible progress in clinical research.
Learning Objectives
Identify key areas where tech and analytics facilitate health equity advancement, focusing on achievable, tech-enabled outcomes; Illustrate concrete use cases where tech and data can support equitable clinical research, such as community outreach, recruitment, and measurement against diversity action plans; Discuss non-technical success factors needed to wholly support data-driven tech
Chief Delivery Officer, Data Services, eClinical Solutions, United States
Katrina Rice is an accomplished Chief Delivery Officer with an impressive career that spans over 20 years and includes advancement into increasingly demanding leadership roles. With a solid history of leading business transformations and managing global portfolios, she is as much... Read More →
Wednesday June 18, 2025 1:45pm - 2:45pm EDT
TBDWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
The healthcare industry is rapidly transforming with AI, necessitating new regulations for its use in drug development. This session proposes collaboration between pharma, biotech, and regulators to co-create a framework ensuring AI-driven innovation
Learning Objectives
Understand the key challenges and regulatory considerations in scaling AI-driven solutions for drug development in healthcare. Explore strategies for effective collaboration between pharma, biotech, and regulatory bodies to create a unified AI framework. Identify actionable steps to ensure AI integration in healthcare is safe, transparent, and compliant with evolving regulations.
Chair
Sridevi Nagarajan, PhD, MS, MSc
Wednesday June 18, 2025 2:45pm - 3:45pm EDT
TBDWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
We’ve all heard the hype around emerging technologies and what it means for our industry, but when it comes down to adding value on the ground today, what advancements are actually making a difference in drug discovery, development, and distribution?
Learning Objectives
Describe and explain the advancements in data analytics and emerging technologies that are adding value to biopharma companies today.
Jessica is an investor and board member adept at deploying technology to make meaningful advancements for both business and society. She was one of the first Chief Digital Officers in the pharma industry, leading the digital transformation for Bayer A.G. across the Pharmaceutical... Read More →
Wednesday June 18, 2025 4:00pm - 5:00pm EDT
TBDWalter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
Data privacy has been a long-standing challenge for RWD sharing and evidence generation across geography. This session will discuss privacy-preserving approaches that enable data access, sharing and collaboration in industry, academia and regulatory
Learning Objectives
Outline privacy-preserving approaches for accessing and sharing real-world data (RWD); Share use cases leveraging various applications (e.g., federated learning networks, synthetic data) in industry, academia and regulatory for RWE generation; Examine regulatory perspectives, methodological challenges and identify future development needs.
