Conference Day One
8:00 am Registration & Coffee Networking
8:50 am Chair’s Opening Remarks
9:00 am Industry Leader’s Fireside Chat: Examining Current Challenges Across Supply Chain & Clinical Operations to Consider the Advantages of Problem Solving Collaboratively
Synopsis
Collaboration is key too success to streamline supply and clinical operations; join this morning round table to meet your colleagues and discuss the biggest challenges to be addressed across the meeting.
- Introducing the key challenges that need to be prioritized across supply chain and clinical operations
- Outlining the advantages of uniting supply chain and clinical operations when discussing challenges
- Preparing the audience to move into tracked sessions.
9:45 am Spotlight on Mustang Bio on the Importance of Collaboration Between Logistics and Clinical Operations Teams
Synopsis
- Describing the role of clinical operations in cell therapy supply chain
- Optimizing collaboration between site, clinical operations and manufacturing/supply chain
- Developing processes and systems that address gaps, pain points and resources
10:15 am Morning Refreshment Break & Networking
TRACK A: Logistics
Improving Standardisation Across the Supply Chain to Ensure Clear Communication
11:15 am Dissecting the Challenge that Lack of Standardization Across the Supply Chain Generates to Pinpoint Key Areas Creating Complication
Synopsis
- Discussing how the lack of standardization creates obstacles in the supply chain
- Acknowledging the urgency and necessity to standardize to bring together a collective voice for future modifications
- Exploring how to begin to approach planning to harmonize the industry to bring about a clearer standard
11:45 am Panel Discussion: Considering a More Standardized Future of Supply Chain & Standardising Communication of Information
Synopsis
- Outlining cost effective methods to standard supply chain
- Utilizing success stories to outline efficient supply chain techniques
- Exploring how to standardise communication methods to pass on information throughout the supply chain
12:15 pm Cell Therapy Supply Chain Data Management Considerations
Synopsis
- Providing an alternate approach of cell orchestration with data management as an inter-organizational capability in the industry ecosystem.
- Learning how to provide a secure yet agile data management infrastructure to allow sponsors, hospitals, logistic firms, academic institutions and manufacturing organizations to collaborate in a frictionless way is needed
- Outlining how each organization in the ecosystem will need to consider how they collaborate and share data to support patient centric activities and the ecosystem must ensure data governance and flexibility for each organization to maintain their internal systems and procedures.
10:16 am
TRACK B: Clinical Operations
Navigating Site Selection to Ensure Cost- Effective Expertise for Cell Therapy Trials
11:15 am Exploring Communications Between Sites and Clinical Operations to Ensure Expertise for Clinical Trials from the Site Perspective
Synopsis
- Exploring levels of expertise required for a site to start a clinical trial
- Improving training of site personnel to increase capability of sites
- Strategizing plans for retention of expert personnel
11:45 am Exploring Communications Between Sites and Clinical Operations to Ensure Expertise for Clinical Trials from the Sponsor Perspective
Synopsis
- Considering methods to train personnel at sites from a sponsor perspective
- Exploring site options and what should be considered when picking sites
- Strategizing to pick the best site to carry out your clinical trial effectively
12:15 pm Roundtable: Discussing the Site- Sponsor Relationship
Synopsis
- Summarizing the information laid out in the previous talks to pull together the site and sponsor perspective on site selection.
- Questioning methods and strategies covered in talks on this topic.
- Considering drivers of cost for sites and how cost factors into site selection
12:45 pm Lunch Break & Networking
Moving Forward in Allogeneic Cell Therapy By Overcoming Donor Selection Challenges
1:45 pm Addressing Allogeneic: Tackling Donor Selection and Other Challenges
Synopsis
- Exploring techniques to find the best donor partnering for successful selection
- Discussing pre-testing to select healthy donors and the impact this has on trials
- Considering logistics in regards to transport, shipping and collection of donor cells
2:15 pm Panel Discussion- Considering How Successes in Autologous Therapies can Provide Solutions for Allogeneic Therapies
Synopsis
- Comparing the similarities in transport and storage conditions for autologous and allogeneic
- Discussing shipping and tracking of autologous and allogeneic therapies to establish common ground Using case studies from more mature autologous trials to inform allogeneic trials
Exploring Privacy Regulations Solutions to Integrate Real Word Data and Stakeholder Feedback
1:45 pm Navigating Privacy Regulations for Cell Therapies to Allow for a Global Approach
Synopsis
- Showcasing case studies highlighting what to look out for when integrating real world data
- Considering the value of using real world data in planning
- Navigating privacy regulations differences over the globe
2:15 pm Panel Discussion- Exploring Patient Engagement to Incorporate Stakeholder Feedback into the Drug Development Plan
Synopsis
- Discussing the importance of stakeholder feedback to inform trial design
- Exploring different approaches to engage with patients to gain insight and feedback
- Exploring case studies of successful patient engagement activities
3:00 pm Afternoon Break & Networking
Creating Digitized Supply Chain for a Seamless End to End Process
4:00 pm Utilizing Automated Systems to Track Chain of Custody & Identity More Accurately and Effectively
Synopsis
- Technology to better track apheresis and manufactured products during shipping, manufacturing and infusion
- Rethinking supply chain from a digital perspective to plan for future changes
- Enhanced processes and systems required for the cell therapy supply chain and global commercialization
4:30 pm Audience Discussion: Highlighting the Impact of a Digital and Automated Supply Chain in Therapies
Synopsis
- Discuss ideal future innovations that could revolutionize the cell therapy supply chain
- Considering how automation has increased the efficiency of the supply chain
- Navigating the steps taken by key players to automate their supply chain