Conference Day One | Wednesday, March 12 2025
8:10 am Coffee & Registration
8:55 am Chair’s Opening Remarks
Scaling Up to Pivotal Studies & Commercialization Readiness
9:00 am Supporting the Complex Supply Chain Needs of a CGT Start-Up
Synopsis
- What are the essential supply chain needs when developing a CGT product?
- How can you maximize the value chain while ensuring cost effectiveness?
- Sourcing budget-friendly resources to keep supply chains operating smoothly
9:30 am Best Practices for Mock Run-Throughs: Pressure Testing Your Processes & Operations
Synopsis
- Highlighting how to perform mock run-throughs to stress test clinical site, transport, and storage protocols
- Specific considerations ahead of a program reaching the market
- Presenting a case study of clinical site run-through: what was learned and implemented in future handling and delivery?
10:00 am Panel Discussion: Enhancing Communication Between Supply Chain & Clinical Operations Departments
Synopsis
- How can supply chain work with clin ops to smoothly co-ordinate patient enrolment, book manufacturing slots, and tackle new regulations for clinical studies?
- What does good collaboration look like for the planning of patient and material delivery?
- How can the two departments instil effective communication when expanding into new regions and onboarding new sites?
10:40 am Morning Refreshments & Speed Networking
Synopsis
Our speed networking is the ideal opportunity to get face-to-face time with many of the brightest minds working in CGT and introduce yourself to the attendees that you would like to build closer working relationships with. Benchmark against the industry leaders and establish meaningful business relationships to pursue for the rest of the conference and beyond.
11:40 am Mastering the Evolution of Clinical-to-Commercial Supply
Synopsis
- Change management: key considerations for an organization
- Long term forecasting: planning ahead for production needs
- Hand-over activities between clinical and commercial teams
12:10 pm Developing and Sustaining a Commercialization-Ready Supply Chain
Synopsis
- Pinpointing the key focus areas for developing a supply chain from clinical- to commercial- stage
- Lessons learned in digitalization, business planning, and demand management
- Having scaled up processes, what are the practical steps to sustaining and refining a commercial supply chain?
- Principles for implementing operation excellence and gaining efficiencies
12:40 pm Lunch & Networking
Building Resilience & Adaptability into Supply Chains
1:40 pm Change Management in Dynamic Gene Therapy Trials: A Case Study in Surviving Constant Protocol Changes and Supply Chain Issues
Synopsis
- Navigating supply chain, stock out, and protocol change challenges during scale-up from Phase 1 to Pivotal
- Overcoming temperature control challenges at sites
- Mitigating waste at clinical sites through JIT shipping
2:10 pm The Critical Role of Supply Planning in Commercial Scale CGT Manufacturing
Synopsis
- Considerations for long-term strategic planning around CGT manufacturing capacity
- Understanding how supply planning can support a successful capacity ramp-up
- Exploring the future evolvement of the role
2:40 pm A Case Study in Effective Contingency Planning
Synopsis
- Outlining how the complexity and variability of CGT supply chains can impact manufacturing and drug delivery deadlines
- Establishing relationships to ensure consistent, reliable product delivery
- The criticality of contingency planning and emergency preparedness to mitigate risk and minimize disruption to patients
3:10 pm Afternoon Refreshments & Scientific Poster Session
Synopsis
This is your opportunity to present a scientific research poster to your peers and those in attendance at the Summit. To submit a poster for this session please contact info@hansonwade.com.
Improving Clinical Labeling & Packaging Processes
3:55 pm Evolving Labeling & Packaging Solutions from Clinical to Pivotal Studies
Synopsis
- What are some key differences between clinical and pivotal requirements?
- Lessons learned for setting up phase 1 clinical labeling and packaging
- Considerations for packaging and second sourcing
4:25 pm Driving Forward Standards in Labeling Medical Products of Human Origin
Synopsis
- Understanding the need for creating and maintaining a uniform global labeling standard
- Shaping current traceability and biovigilance standards for the field
- Exploring future opportunities to continuously improve labeling standards and best practice for the field