Conference Day Two
8:00 am Registration & Coffee Networking
8:45 am Chair’s Opening Remarks
8:50 am A Case Study Exploring Evolving the Site and Sponsor Relationship
Synopsis
- Considering how Immunity Bio has navigated site relations
- Learning from a detailed case study regarding the site- sponsor relationship
- Outlining how the site- sponsor relationship can develop as trials develop through the pipeline
9:20 am Preparing for the Unknown – Mitigating Risk of Process Disruption as Your Therapy Evolves
Synopsis
- As cell and gene therapies are scaling from early-stage clinical to late-stage clinical or commercial operations, the manufacturer will need to address different types of risks
- Identifying and realizing the existence of these risks should be accomplished through performing regular business risk reviews and assessments
- Being prepared to address the time-criticality of process-steps along the treatment cycle and preparing for operational disruption, will make the patient and treatment center experience more reliable
9:30 am Spotlight on Successes in Overcoming Logistical Bottlenecks in Clinical Phases
Synopsis
- Sharing example challenges faced by Carisma Therapeutics to learn how these challenges were tackled
- Highlighting recent achievements of Carisma Therapeutics supply chain
- Thinking about what problems to expect to arise in clinical phases.
10:00 am Morning Break & Networking
TRACK A: Logistics
Creating a Phase Appropriate Supply Chain to Realistically Solve Challenges
11:00 am Utilizing Success Stories to Decipher Key Tactics Used to Solve Challenges at the Pre- Clinical & Early Clinical Phases
Synopsis
- Examining challenges for pre-clinical/ clinical phase trials and realistic solutions to these challenges
- Considering the impact of cost when trying to solve bottlenecks
- Exploring case studies revealing solutions for companies at early stages
11:30 am Panel Discussion: Approaching Cost Effective Methods to Dismantle Challenges for Phase 1/2 Companies
Synopsis
- Identifying from a mid- phase company perspective specific chaellnge that apply to the supply chain
- Discussing cost effective and realistic solutions to overcome challenges
- Exploring case studies to outline success stories in overcoming logistical challenges during the mid-phase
TRACK B: Clinical Operations
Optimizing Logistics for Trial Participants and Sites to Increase Efficiency and Uptake
11:00 am Improving Uptake for Trials to Increase Time Efficiency
Synopsis
- Discussing strategies to decrease logistics for patients to increase participation and adherence to the protocol
- Exploring site logistics for conducting these complex trials
- Sharing new data in this topic area to become more efficient
11:30 am Panel Discussion: Addressing Site Storage Capacity to Look to the Future Scale of Cell Therapies
Synopsis
- Outlining the trajectory of cell therapies to consider plans for growth
- Examining current bottlenecks creating lack of storage capacity
- Showcasing success in overcoming storage capacity shortages
12:30 pm Lunch Break & Networking
Supporting Scalability of the Supply Chain to Enable Smoother Company Growth
1:30 pm Evolving the Supply Chain to Scale Up from Clinical to Commercial Phase
Synopsis
- Exploring challenges when scaling from clinical to commercial and strategies to solve problems
- What are the plans that must be put into place to grow to commercial phases?
- Focussing on case studies of scaling from clinical to commercial
2:00 pm Panel Discussion: Planning to Develop from Your Current Stage: Scaling Up Throughout the Pipeline
Synopsis
• Discussing scalability throughout different stages of the pipeline
• Considering planning for the future ahead to ease the transition through different phases
• Exploring how clinical operations and logistics leaders need to evolve throughout the pipeline
2:45 pm Afternoon Break
3:15 pm Enhancing Efficiency of Transport to Accommodate for the Specific and Time- Pressured Nature of Cell Therapies
Synopsis
- Putting a spotlight on the challenge that short- shelf life of cells poses for the supply chain
- Considering planning for circumstances outside of our control
- Discussing innovations in cryopreservation and how this may integrate with cell therapy transport
3:45 pm Discussing Collaboration with Manufacturing and How Time Taken for Manufacturing Impacts Logistics and Clinical Operations
Synopsis
- Highlighting the need for close and frequent communication between supply chain and clinical operations to coordinate manufacturing and patient enrolment
- Considering the impact of turnaround time for autologous therapies and manufacturing as well as scheduling lead time has on the efficiency of the trial and effect on the trial participant
- Discussing the challenge that manufacturing time poses for the logistics and execution of clinical trials