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


  • 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

  • Pat Shafer Managing Director – Life Sciences Operations, Regulatory & Quality, FTI Consultant


  • 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

  • William Beck Director - Supply Chain, Carisma Therapeutics


  • 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

  • Carlos Candido Vice President - External Manufacturing & Supply Chain, Be Biopharma


  • 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

  • Justin Dunlevy Associate Director - Supply Chain & Logistics, Obsidian Therapeutics
  • Marty Giedlin Senior Vice President & Head Of Technical Operations, Senti Biosciences Inc.
  • William Beck Director - Supply Chain, Carisma Therapeutics
  • Todd Applebaum Managing Director, Converge Consulting


  • 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


  • 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


  • 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


  • 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

  • Brooke Greenley Senior Clinical Trial Manager, ImmunityBio, Inc.
  • Marty Giedlin Senior Vice President & Head Of Technical Operations, Senti Biosciences Inc.


• 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

  • Kellen LaVigne Associate Director of Supply Chain and Logistics, Aurion Biotech


  • 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

  • Sarah Miller Director - Supply Chain Program, Sana Biotechnology


  • 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

4:15 pm Close Day 2