Conference Day Two | Thursday, March 13 2025
8:10 am Coffee & Registration
8:25 am Chair’s Opening Remarks
Establishing Effective Cross-Collaboration Between Supply Chain Stakeholders
8:30 am Implementing Integrated Digital Solutions into Supply Chains
Synopsis
- How and when should I digitalize?
- Finding phase- and stage- appropriate solutions that encompass both product and patient journeys
- Co-ordinating system choice and implementation with what’s best for the hospital site
9:00 am IWG Risk-Based Center Qualification & Autolus’ Implementation
Synopsis
- Outline of the IWG risk-based center qualification process
- Benefits to Treatment Centers and Industry
- Autolus case-study: implementation in the real-world
9:30 am Mastering the CDMO Selection, Negotiation & Relationship Building Process
Synopsis
- Designing an efficient evaluation process
- Ensuring that the CDMO has the required capabilities
- Negotiating terms and costs for tech transfer and clinical batch manufacturing
10:30 am Morning Refreshments & Speed Networking
10:40 am Cell Therapy Patient Operations: Creating a Positive Customer Experience
Synopsis
- How can a Patient Operations role support cell therapy sites, and why is it critical to provide this level of support to sites?
- With multiple teams touching the cell therapy vein-to-vein process, it is critical that manufacturers provide support from apheresis to infusion
- A Cell Therapy Patient Operations team provides white glove service that differentiates from other manufacturers
11:10 am Panel Discussion: Simplifying Processes Between Different Partners to Create an Integrated Supply Chain
Synopsis
- How to work with partners to deliver full-service levels during unpredictable demand and constrained capacity
- Considerations for ensuring partners implement new technology systems
- Simplification of clinical activities to make logistics work in practice
Developing & Implementing Industry Standards
11:50 am Overcoming Interoperability Challenges through Standardization
Synopsis
- Describing problem areas that hinder full traceability of medical products of human origin (MPHO)
- Discussing HL7® FHIR® and USCDI standards
- Expanding interoperability solutions to enhance MPHO traceability
12:20 pm Lunch & Networking
1:20 pm Differences in Apheresis Collection Requirements Between Different CAR-T Cell Manufacturers
Synopsis
- Describing the mechanism and general approach for mononuclear cells collections by apheresis
- Presenting current differences in collection protocols required by manufacturers
- Proposing possible solutions to deal with the current situation and ways to achieve industry-wide standardization
1:50 pm Audience Discussion: Brainstorming Solutions to the Lack of Industry Standardization
Synopsis
- Across drug sponsors, hospitals and vendors – where are standardized protocols most in need of defining and implementing?
- Generating actionable ideas to standardise packaging, labelling, shipping, and collection requirements for CGTs
- How could these be implemented tomorrow to secure a faster end-to-end supply chain?
2:45 pm Afternoon Refreshments & Networking
Navigating Different Requirements & Ensuring Global Compliance
3:15 pm Considerations for Raw Material Selection and Testing to Support a Commercial Product
Synopsis
- Understanding the nuances of defining raw materials as ancillary or excipient
- Clarifying USP, EP, BP and JP raw material grade requirements: what grade of material should I be selecting?
- Ensuring security of supply and quality of materials for CGTs
3:45 pm Panel Discussion: Highlighting Key Differences in Global Supply Chain Regulations Between Different Bodies
Synopsis
- What are some key US vs EU regional differences that impact critical and/or raw material sourcing, and supply chain continuity for drug sponsors?
- How do expectations and benchmarks differ between the FDA and EMA?
- Practical advice for CGT developers working in both regions