8:00 am
TrakCel’s Breakfast Briefing

8:55 am Chair’s Opening Remarks

Defining Compliance & Quality Requirements to Allocate Resources Appropriately

9:00 am Planning Ahead to Navigate Global Trade Compliance Requirements in Smaller Companies

Synopsis

  • Managing resources and tools to manage shipping lanes, compliance, import and export and customer brokerage
  • Understanding requirements in Customs and Border Protections and which permits are needed to manage risk
  • Hiring and training and multi-functional teams to deal with exceptions across the globe

9:30 am Developing a Seamless End-to-End Process for Cryopreservation Media

  • Robert Newman Chief Scientific Officer, FUJIFILM Irvine Scientific

Synopsis

  • Cryopreservation optimization: cryoprotectants, cell selection, formulation, and processing
  • Defining the effect that cryoprotectants have on cell viability and process
  • Discussing quality attributes specific to cryopreservation media when considering testing, quality controls, and raw materials
  • Understanding the importance of making the right decision the first time and partnering with a supplier who can accelerate the delivery of therapies

10:00 am Sharing Quality Considerations to Ensure Supply Chain & Regulatory Processes Work in Parallel to Prevent Unexpected Barriers to Scaling

Synopsis

  • Adjusting quality and supply chain processes to accommodate challenging therapies
  • Discussing how to deal with a need for responsiveness to quality issues
  • Utilizing tools to tightly integrate quality and supply chain processes

10:30 am
Morning Break & Networking

Logistics Track

Detailing the Key Considerations to Set Up A Forward – Thinking Supply Chain

11.30 Defining the Scope of the Supply Chain to Develop Delivery Models which are Accepted by the Market to Drive Down Future Cost of Goods

Synopsis

  • Highlighting the discrepancies between supply chain developments across the cell therapy industry to come up with solutions to standardize across the industry
  • Providing tools to smaller companies lacking in cell therapy experience to build out robust supply chain teams to enable phase appropriate expansion
  • Taking learnings from successes and failures of supply chain development
  • Educating leadership about the supply chain to allocate resources to ensure the product is viable for market

12.00 Choosing External Manufacturing Partners & Fostering Strong Relationships

  • J.D. Mowery Chief Operating Officer, Treadwell Therapeutics

Synopsis

  • Understanding how to navigate and secure necessary capacity
  • Discussing the key aspects of vendor management and the major obstacles to preventing cell therapy delivery
  • Highlighting the key parameters elements that enable efficient turnaround times for patients

12.30 Panel Discussion: Designing The Start of Your Supply Chain With Phase Appropriate Expansion in Mind to Advance Successfully Through the Value Chain

Synopsis

  • Manging ambiguity to Assess and evaluate the signals for product planning
  • Minimizing risk to ensure product viability to bring therapies to patients that need them and avoid financial losses
  • Understanding differences in regulatory systems, tax regimes and entry requirements to enable international expansion

Clinical Delivery Track

Innovating Patient Support Strategies to Improve Response Rates & Patient Experience

11.30 Case Study: Developing a Patient-Centric CAR-T Service Design to Ensure a Standardized Delivery & Enhanced Patient Experience in Clinical & Commercial Programs

Synopsis

  • Ensuring there are dedicated functions for the customer journey from day one of scheduling through to follow up, shipment and transportation to optimize the patient experience
  • Utilizing educational tools to enhance the patient experience and manage the patient/supplier dynamic
  • Educating staff to ensure standardized delivery of therapies when moving from the clinic to commercial practice

12.00 Case Study: Utilizing CAR-T Lessons Learned to Build an Emerging Modalities Infrastructure

Synopsis

Exploring the unique set of complexities presented by CAR-T compounds which require a specific set-up to

manage successfully

Leveraging experiences from the CAR-T journey to establish an infrastructure supported by team members and systems with specific capabilities to apply to emerging and novel modalities

Exploring radiopharm (Radioconjugates) and managing the clinical supply chain using this model to successfully deliver a novel modality to patients

12.30 Panel Discussion How Can We Provide Additional Support Services to Assist Patients Along The Treatment Journey?

Synopsis

  • Understanding the overlap in patient resources provided sponsors and hospitals sites to ensure that resource are consistent and benefit the patient Working together to ensure that resources are useful
  • Sharing learnings from internal programs such as travel assistance, accommodation, mental and physical health support

1:00 pm
Lunch & Networking

Providing a Framework to Simplify & Implement a Fresh Supply Chain Build

2:00 pm Implementing a Strong Supply Chain Infrastructure From Scratch to Efficiently Achieve Proof-of-Concept in a Large Company Scale Up

  • Anuradha Mehta Senior Director - Global Clinical Programs & Early Development, AstraZeneca

2:30 pm Case Study: a Practical Playbook for Successful Tech Transfers to Maintain Visibility Throughout the Supply Chain

  • J.D. Mowery Chief Operating Officer, Treadwell Therapeutics

Synopsis

  • Discussing when to do tech transfer, and how to ensure supply chain and logistics are considered in the tech transfer process, and understanding clinical requirements
  • Qualifying sites, establishing quality agreements, and creating a communications hierarchy for streamlined and efficient communication
  • Planning for demand and considering capacity, scalability, space, and the commercial viability of equipment and materials

3:00 pm Growing Your Tech Software as the Supply Chain Grows to Enable Phase -Appropriate Expansion

  • Justin Dunlevy Manager, Clinical Supply Chain, Precision Biosciences

Synopsis

  • Making incremental changes to the supply chain to enable continuous process improvement
  • Discussing when to make supply agreements in the tech transfer timeline, and how to account for future demand
  • Working in collaboration with vendors, clinical sites and manufacturers to standardize tech development

3:30 pm Closing Remarks & End of Conference