Explore the Agenda
8:00 am Check-In & Morning Coffee
8:50 am Chair’s Opening Remarks
From Lab to Market: Controlling Costs, Improving Efficiency, & Ensuring Sustainable Growth in Emerging Therapies
9:00 am Scaling Smart: Transitioning from R&D to Commercial Operations for Broader Patient Access
- Building operational efficiency to reduce costs while maintaining speed, reliability, and quality in therapy delivery
- Prioritizing commercial capabilities alongside scientific expertise to support larger patient populations and sustainable growth
- Re-evaluating processes for scalability, reliability, and strong unit economics to ensure cost-effective operations without compromising therapy integrity
9:30 am Roundtable: Navigating the Unknown: Overcoming Market Uncertainty & Funding Gaps to Build a Resilient Supply Chain
- Responding to shifting industry investments and corporate pullbacks to maintain supply chain continuity and avoid disruption
- Securing sustainable funding for continued therapy development to support reliable sourcing, manufacturing, and distribution
- Aligning strategic planning with evolving market landscapes to ensure compliant, scalable, and cost-effective supply chain operations
10:30 am Morning Break & Networking
Optimizing Storage Solutions for Reliable Delivery of Cell & Gene Therapies
11:30 am Managing Clinical Cell Journey Challenges to Minimize Risk & Improve Patient Access
- Proactive planning with logistics service providers for anticipated issues such as inclement weather and government shutdowns
- Working through customs delays
- Temperature excursion management
12:00 pm Integrating Supply Chain, Manufacturing, & Storage Strategies for Product Excellence
- Collaborating across CDMOs, logistics partners, and clinical teams to anticipate storage bottlenecks, optimize capacity, and maintain therapy flow
- Mitigating risks associated with cryopreserved product handling, inventory backlogs, and inconsistent container designs to reduce operational disruptions
- Planning scalable storage solutions that ensure rapid patient access and facilitate growth strategies
12:30 pm Navigating Equipment & Material Transitions in CGT Manufacturing to Maintain High-Quality Treatment
- Managing operational complexity in a mixed ecosystem of bags and vials to maintain workflow, optimize storage, and manage inventory adjustments
- Utilizing equipment and materials for scale-up to ensure each stage of cell culture and therapy differentiation is reliably supported
- Mitigating risks during technology or material transitions to protect product integrity, prevent contamination, and maintain regulatory compliance
1:00 pm Lunch Break & Networking
Ensuring Safe & Timely Transportation of Cell & Gene Therapies for Reliable Global Supply
2:00 pm Roundtable: Driving Integration to Reduce Fragmentation & Build a Resilient CGT Supply Chain Network
- Exploring integration as a solution to improve industry standards, consistency, and operational reliability
- Reviewing the relationship between increased integration and standardization to identify efficiencies and reduce errors across the CGT supply chain
- Imagining the CGT industry 5 years from now to define what a fully integrated, patient-centric ecosystem could look like
- Generating practical actionable insights to help stakeholders implement deeper integration and strengthen supply chain resilience
2:30 pm Effective Treatment Center Support: Enabling Just-In-Time Delivery to Minimize Delay & Maximize Patient Access
- Aligning delivery schedules with hospitals and providing robust training to ensure appropriate procedures are met on arrival, improving workflow efficiency and site experience
- Designing processes around patient and site realities with clearer, more consistent expectations for storage and product preparation
- Compressing timelines between manufacturing, transport, and patient administration to reduce the risk of delay and ensure timely treatment
- Facilitating communication between sponsors, logistics providers, and clinical staff to enable seamless last-mile delivery and maintain product integrity
3:00 pm Afternoon Break & Networking
3:30 pm Panel: Establishing Reliable Shipping Channels & International Lanes to Ensure Consistent Global Delivery of Patient-Specific Therapies
- Reviewing standardized shipping lanes and customs protocols to ensure timely and predictable delivery of patient-specific therapies
- Coordinating with regulatory agencies, transport services, and logistics providers to maintain safety and integrity of live-cell products in transit
- Navigating regional transport differences and compliance requirements to reduce delays, prevent product loss, and minimize risk of expiration
4:15 pm Integrating Community Hospitals into Cell & Gene Therapy Supply Chains
- Discussing key challenges and mitigation strategies
- Enabling decentralized and mobile collection models to support community hospitals without on-site collection or processing facilities
- Implementing just-in-time delivery and alternative storage strategies to address limited ln2 infrastructure and ensure day-of-infusion readiness
- Aligning sponsors, manufacturers, logistics providers, and community hospitals with emerging FACT and BSR/PDA standards to support compliant transport, storage, and administration