Explore the Agenda
Cell Therapy Fundamentals Bootcamp
Tuesday, September 15
In Vivo Bootcamp
Tuesday, September 15
Automated Manufacturing, Regulations & Partnering Bootcamp
Tuesday, September 15
8:00 am Check-In & Coffee
Welcome to the 11th CAR-TCR Summit. Settle in with refreshments as you spark early conversations with peers focused on the same priorities as you.
Automated Manufacturing, Regulations & Partnering Bootcamp
Explore the latest innovations and practical strategies to automate across development phases, overcoming integration challenges and ensuring consistent outcomes to strengthen commercial viability.
For manufacturing experts across all stages of development, looking to the future.
Workshop A
9:00 am Leveraging Automated Manufacturing to Reduce COGs & Enhance Commercial Scale Readiness While Aligning with GMP Expectations
Automated manufacturing is emerging as the industry’s clearest path to lower COGs, broader patient access and sustainable commercial success.
In this focused session, evaluate where automation delivers the greatest value in your manufacturing process, how to integrate it into your existing framework and how to align with regulations. Through case studies and in-depth discussions, combining industry leaders involved in automated manufacturing and key regulatory experts, gain insight into the decisions, trade-offs and lessons shaping automated manufacturing programmes to de-risk execution and ensure a smooth and economical road to market.
- Analyzing the impact of automation on cost of goods to optimize resource allocation and support sustainable clinical and commercial manufacturing
- Integrating automated platforms within GMP manufacturing and quality systems while maintaining data integrity and oversight
- Interpreting updated cell therapy GMP and advanced manufacturing technology expectations to leverage regulatory flexibility without compromising compliance
Morning Break & Networking
Take a moment to pause with tea, coffee and refreshments, continue initial conversations and exchange fresh perspectives ahead of returning to the bootcamp session.
Building Strong Regulatory & Commercial Strategies to Smooth the Path to Commercialization
11:30 am Analyzing Acquisition Case Studies to Understand Deal Drivers & Strategic Characteristics
- Examining recent acquisitions to identify common characteristics of companies and technologies that attract big pharma interest
- Highlighting deal structures, valuation trends, and strategic priorities to optimize deal readiness and enhance attractiveness for future partnerships or acquisitions
12:00 pm Bridging Regulatory & Commercial Expectations to Restructure the Pathway to Commercialization & Long-Term Follow Ups
- Clarifying CAR-T FDA regulations within existing biologics frameworks to understand current expectations for CMC, preclinical, and clinical development
- Interpreting evolving regulatory frameworks to enable adaptive decisions that balance patient safety, operational feasibility and commercial sustainability
- Adapting development and regulatory strategies to align with evolving FDA guidance, to advance novel cell therapy programs
Lunch Break & Networking
Recharge over lunch while reflecting on the morning’s insights and uncovering new perspectives with your peers before heading into the afternoon session.
1:30 pm Workshop B: Aligning Partnership Expectations & Facilitating Face-to-Face to Encourage Successful Collaborations
Take your seat across the table from pharma and VC leaders actively evaluating emerging platforms in this interactive roundtable setting. Understand their therapeutic interests and investment considerations, then showcase your pipeline and align on partnership expectations through rare face-to-face interactions to ignite interest in your pipeline and cultivate collaborative, strategic partnerships.
- Understand pharma and VC therapies of interest, considering in vivo and beyond to identify high-value opportunities
- For pharma and investors, engage with senior leaders from pioneering biotech and academics early to uncover opportunities for collaboration. • For biotech, gain actionable insights by hearing what your peers are developing and understanding first-hand the direction of pharma and biotech innovation
- Leave with new connections, strategic alignment opportunities, and practical knowledge to advance your projects
End of Bootcamp Day
3:30 pm C-Level Think Tank
Scale Readiness Across Modalities
This invitation-only think tank designed exclusively for C-suite executives offers a rare opportunity to connect with cell therapy leaders across modalities and indications. Exchange perspectives, engage in depth discussions on the most pressing challenges, influence the direction of the field and gain strategic insights that extend beyond the summit.