Overview

June 15: Summit

In January 2024 DIA held a multi-stakeholder executive roundtable on this topic, which resulted in a publication with specific recommendations that came out in May 2024. We are excited to continue the important work by inviting the broader community from academia, government, industry and nonprofit organizations to join us in June 2025 – the day before the start of our Global Annual Meeting in Washington DC. Together, we’ll unravel the potential and address the hurdles of this dynamic frontier in regulatory science and come up with an action plan and recommendations for how to most effectively advance the field of cell and gene therapy development in order to increase patient access and ultimately improve health outcomes.

BONUS – Register for the Cell and Gene Summit as well as the Global Annual Meeting kicking off the very next day, you will receive 30% off EACH event!

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Highlights & Features

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Highlights & Features

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Who should attend?

Conference Designed for
- Academia
- Biotechnology
- Clinical Pharmacology
- Clinical Research and Development
- Clinical Operations
- CMC
- CROs/Vendors
- Drug Discovery
- Drug Safety/Pharmacovigilance
- Government Affairs
- Policy and Intelligence
- Preclinical
- Quality Assurance
- Regulatory Agencies
- Regulatory Affairs, Operations, and Strategy
- Research and Development
- Risk Management, including Risk Evaluation and Mitigation Strategies (REMS)
- Strategic Sourcing/Planning

Learning objectives

At the completion of this conference, the participant should be able to:
- Understand the latest advancements in cell and gene therapy, including the journey from translational research to patient access
- Explore challenges in global regulatory harmonization and strategies to align regulatory requirements across different regions
- Hear real-world case studies from leading companies to identify practical lessons and opportunities in oncology (CAR T therapy), Type 1 diabetes and pediatric hematological disorders
- Engage in multi-stakeholder dialogues to craft actionable recommendations for regulatory and clinical advancements in advanced therapies