Explore the Agenda
Regulatory Bootcamp
Understanding Regulatory Landscapes to Navigate Approvals & Accelerate Global Cell Therapy Development
9:30 am Navigating MHRA Guidelines & Clinical Trial Regulations for CAR & TCR Therapies
- Clarify the latest MHRA regulations shaping CAR-T and TCR-T therapy development, including decentralized manufacturing and personalized treatment pathways to accelerate patient access to safe, specialized therapies
- Outline approaches to documentation, engagement, and compliance that support smooth regulatory interactions
- Evaluate the impact of MRHA legislation on CAR and TCR therapy trials
10:00 am Navigating Asia–EMA Regulatory Pathways to Accelerate Global Development
- Compare regulatory frameworks, approval pathways, and clinical trial requirements across key Asian markets and the EMA
- Identify opportunities to streamline global development by leveraging Asia’s evolving regulatory landscape
- Highlight emerging opportunities for biotechs to expand into Asian markets through collaborative or parallel regulatory approaches
Partnerships & Investment Bootcamp
Seizing Opportunities for Funding & Data to Progress in the Current Financial Climate
9:30 am Navigating Ethics Approval for Investigator Initiated Trial Set-Up in China for Early Human Data
- Discuss the step-by-step process for obtaining ethics approval in China’s regulatory environment
- Highlight practical lessons from setting up IITs with local investigators to accelerate trial initiation
- Share how early human data from Chinese IITs can de-risk development and build credibility with global investors and partners
10:00 am Understanding How Clusters Accelerate Grants & Growth in Europe
- Explain how European and national consortia and cluster models connect biotechs with academic and industry partners
- Highlight the advantage of shared infrastructure and credibility in winning non-dilutive strategic national grants
10:30 am Morning Networking Break
Unlocking Market Access with Modernised Regulatory Pathways
11:00 am Panel Discussion: Current Efforts to Spearhead Regulatory Modernisation & Acceptance of Novel CGT Technologies
- Share how regulators in Europe, the US, and Asia are adapting frameworks to keep pace with emerging cell and gene therapy technologies
- Highlight initiatives that foster earlier and more constructive engagement
- Understand how modernisation efforts can accelerate approvals, support broader adoption, and make CGTs more commercially viable
12:00 pm Planning Early for European Market Entry: Navigating Regulatory & Access Differences Between the US & EU
- Highlight the importance of early strategic planning for US biotechs expanding into Europe to avoid rushed launches and regulatory setbacks
- Compare FDA prerequisites and EMA expectations to identify critical divergences that can impact timelines and trial readiness
- Discuss market access procedures and lessons learned from companies like Cabaletta on how to successfully prepare for European entry
Strengthening Biotech, Pharma, & Academic Collaborations to Accelerate Growth & Reduce Risk
11:00 am Panel Discussion: Building Stronger Bridges Between Biotechs, Pharma & Investors
- Share how biotechs can present data and strategy in ways that help investors and pharma make faster, more confident decisions, reducing risk on both sides
- Highlight how pharma and investors can communicate expectations more clearly ensuring companies design studies and pipelines that are partner-ready
12:00 pm A Landscape Overview of CAR & TCR Therapies
- Reviewing recent developments within the CAR and TCR deal landscape
- An overview of recent and potential CAR and TCR regulatory announcements
- Highlighting prevalent platform technologies, armoring strategies and novel in vivo CAR therapies
12:30 pm Lunch & Networking Break
Advancing Cell Therapy Reach via Streamlined Patient Access Frameworks
1:30 pm Leveraging Hospital Exemption & Compassionate Use to Improve Patient Access Under Evolving EU Legislations
- Discuss how hospital exemptions and compassionate use frameworks operate across Europe and their role in bridging access gaps
- Highlight the implications of ongoing legislative reviews on developer responsibilities, regulatory oversight, and safety standards
2:00 pm Roundtable Discussion: Navigating Access & Reimbursement Challenges in Europe
- Discuss the major differences in reimbursement pathways between the US and European markets
- Examine how pricing, evidence generation, and value demonstration impact payer negotiations and long-term sustainability of cell therapies
- Discuss practical steps developers can take early in clinical and regulatory planning to prepare for country-specific reimbursement challenges and accelerate access post-approval
Strengthening Biotech, Pharma, & Investor Collaborations to Accelerate Growth & Reduce Risk
1:30 pm Strategic Matchmaking Roundtable Session: Connecting Innovators with Pharma, Investors, & C-Level Insights to Refine Partnership Readiness
- Rotate through the tables to learn from Pharma and C-level executives with partnership experience, and gain practical insights to shape your future strategy
2:30 pm End of Strategic Bootcamp Days
2:45 pm C-Level Think Tank
A closed door discussion uniting top C-level executives from biotech and senior executives from pharma to discuss the most pressing challenges and advancements shaping the CAR-TCR field in Europe. This year’s Think Tank explores Tregs in autoimmune disease to understand how they can be leveraged as therapies and their significance when other effector cell therapies are used.
Invite Only