8.00am - 5.30pm
Virtual Event | All Timings: Eastern Time
Virtual Event | All Timings: Eastern Time
7:30am Coffee Room Opens
8:15 am Chair’s Opening Remarks
Managing the Chain of Identity for Safer, More Reliable Patient-to-Patient Supply Chains
8:30 am Proposing Standardization to Create Industry-Wide Consensus with Minimal Complexity and Risk
Synopsis
- Providing guidance on the ISBT 128 standard and their application in personalized cell therapy
- Considering future developments and areas of standardization for the chain of identity and patient identifiers
- Setting out the current requirements to employ ISBT 128, and progress in global implementation in line with WHO’s recommendation for globally consistent coding systems for human cells
9:00 am Sharing Experience of Setting up and Scaling Chain of Identity Platforms, Highlighting Key Learnings and Future Improvements
Synopsis
- Outlining the key features and requirements of the chain of identity for autologous cell therapies
- Sharing experience of setting up a chain of identity and discussing the allowable identifiers for patients, and where they should be derived from
- Managing and maintaining the chain of identity and the chain of custody during scale and digitization
- Discussing what personal information manufacturers should handle, the legal considerations, and how these might change across territories
9:30 am Case Study: Creating a Digital Ecosystem to Enable Real-Time Tracking, Scheduling and Follow-Up to Enhance Clinician, Patient, and Manufacturer Experience
Synopsis
- Managing and maintaining overall supply processes enabled by digital systems for vein-to-vein optimization and end-to-end visibility
- Creating a user-friendly, standardized interface with necessary blinding capability for the patient, clinician, external partners, and sponsors
- Discussing the potential of a digital ecosystem to inform quality operations, gather transit and excursion data, and to track patients before, during, and after treatment
- Understanding the requirements of a digital ecosystem for clinical vs. commercial distribution to ensure commercial suitability and enable global patient scheduling
10:00 am Morning refreshments & Speed Networking
Optimizing Cold Chain Logistics for Fast, Affordable, Temperature-Controlled Transport
11:00 am Developing Orchestration Platforms to Enable Industrial-Scale Maturity for Cell and Gene Delivery
Synopsis
- Sharing strategies for digital transformation to enable cell therapy industrialization in clinical and commercial settings
- Discussing the characteristics, strategy, and principles of clinical vs. commercial scale supply chains and questioning the need to develop systems separately
- Achieving condition management by tracking and correcting deviations on the cold chain
- Building end-to-end quality into cell therapy supply chain IT systems from donation to infusion and beyond
- Echoing clinician requirements in digital ecosystems to ensure platforms are appropriate and user-friendly in the context of a treatment center
11:30 am A Chilling Impact: Process Control in Cold Chain Management
Synopsis
- Current scientific thought, demonstrating the path to improved quality
- Planning for downstream cold chain compatibility from the start
- Pathways and considerations for scaling cold chain distribution
- Perspectives from the Point of Care centers – steps to ensure success
12:00 pm Case Study: Designing a Cold Chain with Real-Time Feedback to Gather Tracking Data and Ensure Fast Response to Deviations
Synopsis
- Implementing innovative technologies to manage inventory, and track products in real time and enable fast response to deviations
- Ensuring ultra-low temperature storage and temperature control during transit and at the site to minimize deviations and temperature excursions
- Managing digital transformation from paper-based to digital chain of custody and maximizing the end-user experience
12:30 pm Designing the Complementary GS1 and ISBT 128 Guidelines for Shipping Medical Products of Human Origin
Synopsis
- Discussing end-to-end traceability via ISBT 128 labeling
- Describing shipment identified by GS1 SSCC
- Sharing data via GS1 Despatch Advice message
12:45pm Lunch & Networking
Mastermind Session
1:30 pm Next Steps to Advance the Field and Implement Standardized Practice for Cell Therapy Supply Chain and Logistics
Synopsis
- Reflecting on the key takeaways from the summit to hold guided discussion on next steps to advance the industry and progress standards and harmonization in cell therapy supply chain and logistics
- Discussing how to standardize the chain of custody and chain of identity for efficient patient and product tracking
- Creating standards at the cell collection site which are efficient, affordable, and realistic for clinicians and manufacturers
- Establishing standards for labelling and packaging, with global distribution in mind
- Setting up IT systems with a standardized interface for clinicians, patients, external partners, and sponsors
3:00.pm Afternoon Refreshments
Preparing the Supply Chain & Logistics Ecosystem for Scale & Commercial Viability
3:30 pm Discussing Why Cell and Gene Companies Need to Invest in Supply Chain Organizational Setup Earlier Than Ever
Synopsis
- Building base processes across supply chain functions to grow the entire organization towards launch
- Making more risk-based decisions in supply chain and logistics organizations
- Outlining the phases of supply chain growth for cell and GTx, and planning out the personnel demands through development
4:00 pm Sharing Experience to Establish a Commercial Supply Chain and Logistics Organization as a Framework for Industry-Wide Harmonization and Scale-Readiness
Synopsis
- Forecasting resources, capability planning, and manufacturing capacity and distribution to secure supply and ensure ease of scale-up and scale-out
- Thinking long-term about scale and guidelines, and setting up organization structure early to account for projections
- Launching a cell therapy product globally and operating a commercial supply chain, proviing a high-level overview of what to expect and how to plan
- Identifying potential partners and establishing relationships with CMOs and logistics partners
4:30 pm Managing the Growing Momentum of Cell Therapy Clinical Development and Discussing the Barriers to Scale for Hospitals
Synopsis
- Sharing insights into how clinical sites can prepare for the scaled delivery of ATMPs
- Managing expectations of clinical trial sponsors and communicating capacity, site requirements, and best practices for tech transfer and onboarding
- Building the expertise in the clinic with bespoke training programs and subject matter experts to lead cell therapy product delivery in a sustainable manner to ensure consistent delivery and alignment with SOPs
- Sharing a clinical perspective on the future industry growth, and how trial centres are preparing
- Considering the challenges and requirements of moving to a decentralized model in the future, and the clinical infrastructure that may be required for the on-boarding of non-specialist and community centers