8.00am - 5.30pm
Virtual Event | All Timings: Eastern Time

7:30am Registration Opens

8:00 am Chair’s Opening Remarks

Drafting a “Mission Statement” for the Cell Therapy Supply Chain Community

8:15 am Breakfast Panel: What does the Future Landscape of Cell Therapy Look Like? How Can Supply and Logistics Organizations Prepare to Scale?

Synopsis

  • Discussing the future landscape of cell therapy, the market potential, and drawing a roadmap to ramp up supply in a sustainable and standardized manner
  • Highlighting the key challenges to date in cell therapy supply, and how a culture of co-petition can advance the industry
  • Taking aim at ‘best practice’ in supply chain and logistics, from chain of identity to clinical integration, digital systems, cold chain supply, vendor and partnerships management, and patient operations organizations
  • Balancing the implementation of new technology with existing allogeneic vs. autologous

9:00 am Approaching Cell Therapy Supply Chain from a “Big Pharma” Perspective to Enable Industrial-Scale Delivery of Autologous and Allogeneic Treatments

Synopsis

  • Identifying the differentiating components of cell and GTx supply chains, and how to approach industrial scale readiness
  • Examining synergies with existing infrastructure from other pharmaceutical pipelines to ease integration
  • Discussing the ‘layers’ of a cell therapy supply chain, and the implications of ‘make to order’ and patient centric settings
  • Drawing parallels across clinical and commercial scale supply chains and questioning the need to develop them separately

9:30 am Paving Future Directions for Industry Standards and Sharing Strategies to Integrate Standards Alongside Supply Chain Development

  • Robert Shaw Executive Director, Standards Coordinating Body

Synopsis

  • Sharing insights into future directions and what to anticipate as standards evolve for cell therapy supply chains
  • Identifying where standards can be integrated most effectively in the end-to-end, patient-centric supply chain
  • Mapping standards to processes to build out standardization strategy alongside process planning and development

10:00 am Morning Refreshments & Speed Networking

Managing Risk & Ensuring Robust, Reliable End-to-End Supply

10:30 am Case Study: Implementing Risk-Mitigated Sourcing and Procurement Strategies to Guarantee Robust, Reliable Materials Supply

Synopsis

  • Diversifying the supplier base and discussing the pros and cons of single vs. dual sourcing
  • Carrying out risk assessments in key reagents and materials, and implementing risk-mitigation
  • Highlighting the volatility and competition for supply in the cell therapy niche, and how to deal with lead time instability and backorders
  • Creating robust supply agreements, sharing top tips on managing suppliers to secure projected volumes and negotiate lead times

11:00 am Case Study: Demonstrating Effective Use of Redundancy and Risk- Mitigation Can Ensure Minimal Interruption to Supply in Times of Global Disruption

  • Stephanie Mgebroff Director Research Quality Control, Seattle Children’s Research Institute

Synopsis

  • Outlining the benefits gained from implementing ‘back-up plans’ in sourcing equipment and materials, discussing key areas to implement redundancy in case of disruption
  • Questioning the suitability of ‘just in time’ models for cell therapy supply, and the risk posed when supply chains are disrupted
  • Sharing key takeaways from 2020 such as managing flight disruption, material stability and expiry times, equipment and PPE shortages, competition with vaccine supply chains and testing site availability
  • Charting the patient journey in times of disruption, and discussing routes to minimize the impact on patient experience with good cell collection networks, and platforms for communication

11:30 am Case Study: Establishing Sourcing and Procurement Infrastructure to Guarantee Robust, Reliable Raw Materials Supply

  • Ryan Phillips Strategic Sourcing Manager, Precision BioSciences

Synopsis

  • Diversifying the supplier base and discussing the pros and cons of single vs. dual sourcing
  • Carrying out risk assessments on suppliers of key reagents and materials with digital tools for analysis and decision making
  • Highlighting the volatility and competition for supply in the cell therapy niche, and how to deal with lead time instability and backorders
  • Creating robust supply agreements, sharing top tips on managing suppliers to secure projected volumes and negotiate lead times

12:00 pm Lunch & Networking

Managing the Relationship Between Patient, Manufacturing & Supply Chain Organizations

1:00 pm Case Study: To Freeze, Or Not To Freeze? Deciding When and Where to Implement Cryopreservation in Patient-Centric Supply Chains

Synopsis

  • Weighing up where in the supply chain, and at what stage in development, to implement cryopreservation
  • Considering proximity to apheresis and manufacturing sites, and outlining the decision making process for when it makes sense to cryopreserve cells in local vs. larger supply chain distribution networks
  • Sharing case studies to share the rationale on using fresh vs. frozen products for time sensitive, patient-specific therapies

1:30 pm Building the Connection Between Supply Chain and Manufacturing to Ensure Drug Product Supply for Patients

Synopsis

  • Outlining how to partner the manufacturing and supply chain organizations
  • Ensuring effective communication and efficiency in vein-to-vein supply
  • Planning tactical drug product delivery in a cell therapy organization

2:00 pm Managing the Patient Journey Alongside the Manufacturing Supply Chain to Create an Integrated End-to-End Experience

  • Alicia Dixon Senior Director Cell Therapy Patient Services, Gamida Cell

Synopsis

  • Creating real-time platforms to support patient enrolment and forecast manufacturing for accuracy in scheduling
  • Highlighting where the patient and manufacturing journeys align, and how to create a supply chain model that is streamlined and efficient
  • Managing patient scheduling with digital platforms and depot models to support flexibility and reliability
  • Handling the interaction between the patient, the clinic, and the supply chain to create an integrated continuum with clear communication and clear points of contact

2:30 pm Panel Discussion: How Developers are Adjusting Patient Operations Design Post-COVID

Synopsis

  • Sharing experiences and learnings from managing patients and supply chain operations during a pandemic
  • Identifying patient operations and supply chain process improvements which can be implemented in future operations
  • Bringing together viewpoints from small and large developers, and site perspectives

3:00 pm Tech Slam & Afternoon Networking

Building a Supply Chain Organization & Harmonizing the Logistics Ecosystem

4:00 pm Managing the Clinical Supply Chain for Autologous and Allogeneic Cell Therapy Products, and Moving Towards Standardized Processes

  • Lan Bui Director Cell Therapies Supply Chain, Takeda

Synopsis

  • Sharing experience of setting up autologous vs. allogeneic clinical supply chains, highlighting the distinct challenges and requirements of each
  • Managing allogeneic supply chain planning before country-level readiness
  • Understanding clinical site requirements and strategies to ensure cell therapy processes can be integrated universally
  • Outlining challenges and lessons learnt in transferring end-to-end clinical site processes covering apheresis, cryopreservation, and transfusion

4:30 pm Case Study: Building an End-to-End, Vein-to-Vein Supply Chain and Logistics Organization with Scale-Readiness in Mind

  • Delfi Krishna Head of Strategic Operations Cell & GTx, Immatics

Synopsis

  • Providing an overview of good operations management and organizational set up for end-to-end cell therapy supply and logistics
  • Improving turnaround times with minimized delays and identifying components of the supply chain which can be expedited to reduce vein-to-vein time
  • Building the expertise within your organization to meet headcount requirements for manufacturers, hospitals and external partners
  • Weighing up internal vs. out-sourced vs. point-of-care manufacturing and the implications for scale-ready supply chains, and the relationship between sites, academic centres, and external partners

5:00 pm Case Study: Establishing an Allogeneic End-to-End Supply Chain with Digital Capabilities

  • Bob Amareld Head of Supply Chain, Precision Biosciences

Synopsis

  • Outlining the key challenges and learnings from setting up an early phase allogeneic supply chain
  • Implementing digital tools for esourcing, inventory management
  • Identifying areas of unmet need in technology platforms to improve supply chain efficiency and minimize manual processes

5:30 pm Chair’s Closing Remarks

5:45 pm End of Day 1