Explore the Agenda
8:00 am Check-In & Morning Coffee
8:50 am Chair’s Opening Remarks
Advancing Standardization Across Processes, Systems, & Technologies to Enable Efficiency, Interoperability, & Scalable Operations
9:00 am From Clinical to Commercial: How Immatics prepared for Product Launch with a Landmark Digital Transformation
- Why Immatics prioritized digital enablement before launch and what risks this eliminated downstream
- How inspection‑ready, patient‑centric processes and systems were built ahead of BLA submission without slowing clinical innovation
- Key learnings for scaling confidently into commercial delivery without need for costly rework
9:30 am Maximizing Impact by Balancing Innovation, Budget, & Technology for Sustainable Growth
- Prioritizing therapeutic innovation while allocating resources effectively to support digital and operational needs
- Managing technology and software adoption costs to ensure optimal performance and return on investment
- Guiding emerging biotechs to stretch limited funds effectively while fostering innovation
10:00 am Morning Break & Speed Networking Session
Streamlining Fragmented Digital Workflows & Portals to Enhance Communication, Reduce Administrative Burden, & Improve End-to-End Coordination
11:00 am Embedding Standards Early in the Process for Optimal Compliance
- Explore emerging scenarios for extending chain of identity (CoI) beyond autologous therapies to support commercial and off-the-shelf models and streamline end-to-end services
- Examine how accrediting bodies evolve requirements from “should” to “shall”, and what that shift means for sustained compliance over time
- Identify future proofing strategies for applying chain of identity identifiers across systems
11:30 am Enabling Interoperability at Scale to Facilitate Standardization Without Uniformity
- Enabling interoperability while preserving internal agility and innovation to maintain competitive differentiation and accelerate growth
- Standardizing data structures and communication to eliminate silos, streamline operations, and reduce costs
- Reducing complexity from inconsistent packing, documentation, and checklists to improve efficiency, reliability, and scalability
12:00 pm Cleanroom Packaging & Sterility Solutions for Cell & Gene Therapy
- Outsourced cleanroom packaging and kitting solutions for cell and gene therapy manufacturers
- Integrated cGMP warehousing, disinfection, sterile packaging, and final kit assembly
- Steam and vaporized hydrogen peroxide sterilization services and RTU products for high-value biologics
- FDA registered and ISO 13485 certified partner focused on sterility assurance compliance
12:10 pm Lunch Break & Networking
Streamlining Workflows & Global Distribution to Manufacture Allogeneic Therapies at Scale
1:15 pm Reducing Operational Complexity at Sites & Treatment Centres for High- Quality, Reliable Care
- Minimizing variability in packing, documentation, and procedures to lower training burdens, reduce liability, and decrease error risk
- Standardizing chain of identity and chain of custody practices to improve interoperability across sponsors, logistics providers, and clinical sites
- Designing processes around patient and site realities with clearer, more consistent expectations for storage, transportation, and digital workflows
1:45 pm Panel: Confronting Portal Fragmentation to Accelerate Workflows & Enable Faster, More Connected Care
- Adopting hub or network-based models to reduce portal fatigue whilst accommodating site-specific operations
- Providing shared visibility across logistics, manufacturing, and clinics to support compressed vein-to-vein timelines (<14 days) and accelerate therapy delivery
- Leveraging commercially available digital tools for adoption in new and community-based sites
2:30 pm Afternoon Break & Networking
Optimizing Collaboration Across the Supply Chain for Reliable, Cost-Effective, & Scalable Performance
3:00 pm Panel Discussion: Cross-Collaboration Across the CGT Supply Chain for Improved Connectivity
- Navigating last mile logistics to support coordination between providers, couriers, and healthcare providers and ensure timely therapy delivery
- Optimizing packaging, labelling, and cold-chain procedures to enhance efficiency, maintain safety, and ensure regulatory compliance
- Engaging regulators, CROs, CDMOs, and logistics partners to align expectations, reduce delays, and strengthen end-toend connectivity
4:00 pm Supporting Early-Stage CGT Companies to Accelerate Global Growth & Market Readiness
- Facilitating technology transfer, platform standardization, and manufacturing scale-up to attain clinical and commercial readiness and enable faster market entry
- Building strategic partnerships and networks to reduce risk, shorten timelines, and improve access to global markets
- Guiding small biotech teams through the complex regulatory landscape to ensure compliance and progression toward commercialization