To be announced.

This session coverskey safety updatesfor cellular therapies currently under development or approved for use. When cellular therapies are ready for clinical evaluation, there are significant challenges in managing product safety.

Key Topics Covered:

• Safety Management Challenges:The specific challenges that arise when managing safety of cellular therapy products in clinical settings.
• Latest Developments:How these safety challenges are being managed from the early clinical stage, based on current developments in the field.
• Evolving Expectations:How greater understanding and confidence gained from years of experience with cellular therapies is changing expectations and helping manage safety challenges.

Sponsored by APCER Life Sciences

Patient safety remains the foundation of our work as pharmacovigilance professionals. Tailoring safety monitoring strategies to align with the unique characteristics of treatment types, disease areas, and patient populations is paramount. This session delves into key pharmacovigilance practices in gene therapy, highlighting specific considerations for safety monitoring during clinical trials and their role in shaping product labels. We’ll also briefly explore the nuances of pharmacovigilance in the commercial landscape for gene therapies. Join us for this engaging discussion and share your valuable insights and experiences.

Join Dr. David Chonzi, Dr. John Lee, and Dr. Ricardo Velazquez for an in-depth panel discussion on the evolving landscape of safety in the development of high-risk therapies, with particular emphasis on cardiovascular and rare disease indications. This session will delve into key challenges such as early safety signal detection, rigorous benefit-risk assessment, and the intricacies of clinical trial design—especially in the context of cutting-edge modalities like gene and RNA-based therapies.

Drawing on real-world examples and current regulatory frameworks, the panel will highlight how safety strategies are adapting to match the pace of scientific innovation. Attendees will come away with actionable insights into proactive safety planning across complex, high-stakes clinical development programs.

Sponsored by Clinigen.

To be announced.

Sponsored by Syneos Health.

As emerging biotech companies bring novel therapies to market at record pace, patient safety must remain a core pillar of success. Yet smaller organizations often face unique challenges, including limited resources, evolving infrastructure, and the need to navigate complex global regulatory landscapes. This session will outline practical, scalable strategies to build a robust patient safety framework from early development through commercialization. Topics will include embedding safety considerations into clinical development, leveraging technology and partnerships for efficient pharmacovigilance, aligning safety strategy with evolving regulations, and fostering a proactive safety culture across small teams. Attendees will gain a blueprint for prioritizing patient protection while maintaining innovation and agility, ensuring safety becomes a catalyst—not a barrier—to growth.

As the ACNU framework continues to take shape, its implications across the pharmacovigilance (PV) ecosystem are becoming increasingly significant. Takeaways from this panel include:

• Understanding the ACNU Framework
• Benefits of ACNU to patients
• Impact of ACNU on PV process
• Technology and Innovation Requirements
• Global Regulatory Considerations

A panel on"Navigating Patient Safety: A Comparative Look Across Pharma, Devices, Cosmetics, and Combination Products"would explore the unique and overlapping safety challenges within each sector. Experts would discuss regulatory frameworks, risk management strategies, and post-market surveillance practices tailored to the specific nature of each product type. The conversation would highlight how innovation, globalization, and evolving consumer expectations are reshaping safety protocols. Ultimately, the session would aim to foster a more integrated approach to patient safety across the life sciences spectrum.