Autoimmune & Regulatory Focus Days
Tuesday, 25th February
8:00 am Check-In & Morning Coffee
Autoimmune Focus Day
9:00 am Chair’s Opening Remarks
9:10 am Room Introduction
Synopsis
This is the perfect opportunity to introduce yourself to your peers and make the most of this intimate networking opportunity before diving headfirst into a day focused on developing cell therapies for autoimmune indications
Addressing the Safety Concerns with Autoimmune Indications to Reduce Toxicities & Improve Efficacy
9:30 am Development Progress & Opportunities for CAR-T in Autoimmune Disease
Synopsis
• Immune effectors for autoimmune disease
• Exploring the emerging data landscape for CAR-T in autoimmune indications
• Analysing the development considerations for autoimmune diseases
10:00 am T-Cell Engagers in Autoimmune Diseases: An Alternative Approach for T-Cell Redirecting Therapy
Synopsis
• Emerging data supporting the safety and efficacy of TCEs to treat autoimmune disease
• Practical advantages of TCE vs CAR-T for T-cell redirecting therapy for autoimmune diseases
• Evolving TCE landscape: CD19 and beyond
Regulatory Focus Day
9:00 am Chair’s Opening Remarks
9:10 am Room Introduction
Synopsis
This is the perfect opportunity to introduce yourself to your peers and make the most of this intimate networking opportunity before diving headfirst into a day focused on understanding and meeting regulatory expectations
Understanding How to Get Regulatory Approval to Carry out Trials & Conduct Testing of Your Cell Therapy Product
9:30 am Case Study: Hearing from a Successful IND Filing to Hone Regulatory Considerations & Get Approval to Conduct Clinical Trials
Synopsis
• Exploring regulatory guidelines and how to meet them
• Understanding the data required to get IND approval
• Reviewing steps taken to ensure successful IND filing
10:00 am Assessing Assays & Manufacturing Capabilities Required to Characterise Your Product to Gain Regulatory Approval
Synopsis
• Evaluating what key assays are required to show safety
• Benchmarking manufacturing conditions required for consistent batch production
• Translating preclinical data to show potential impact on humans
10:30 am Morning Networking Break
Navigating Through Multiple Autoimmune Indications to Select the Disease with Highest Durability & Efficacy Data to Move the Needle Forward in Treating All Autoimmune Diseases
11:00 am Developing TCR & CAR Targeted Engineered Treg Cells for Autoimmune Diseases
Synopsis
• Developing TCR targeted EngTreg GNTI-122 for Type 1 Diabetes
• CAR discovery for EngTreg therapy
• CAR EngTregs for other autoimmune diseases
12:00 pm Panel Discussion: Assessing Autoimmune Disease Indications to Understand Which One to Select & How it Might Benefit from Cell Therapy
Synopsis
• Reviewing how to select the “correct” autoimmune indication
• Identifying what makes the “correct” autoimmune indication
• Exploring the true benefit of cell therapy on said indication
Gaining Regulatory Support to Understand the Way Forward & What Guidelines Need to be Met to Continue Progress in the Field
11:00 am Breaking Down Barriers: An Effective Regulatory Engagement to Accelerate Innovation for ATMPs
Synopsis
• Proactive engagement and CMC leadership
• Risk management and education
• Tailored guidelines and timeline management
12:00 pm Panel Discussion: Navigating the Regulatory Perspective on Novel & Different Approaches to Cell Therapy to Understand the Way Forward
Synopsis
• Understanding the regulatory perspective on cell engineering and armouring
• Exploring regulatory perspective on different cell types to make the smart choice
• Examining regulatory perspective on autologous therapy vs allogeneic therapy and how that affects your manufacturing processes
12:30 pm Networking Lunch
1:30 pm Audience Discussion: Analysing How to Show Durability of Response for Non-Life- Threatening Diseases to Convince Physicians to Dose Patients
Synopsis
• Exploring the hesitancy behind dosing patients and how to convince them
• Reviewing the best way to showcase strong durability of response
• Showcasing durability of response for off-the-shelf approaches
Use this time to discuss and collaborate with your peers the best way to convince physicians to use cell therapy for autoimmune indications
1:30 pm Audience Discussion: Discussing the Inclusion Criteria for Current & Novel Therapies to Confidently Conduct Clinical Trials
Synopsis
• Exploring how inclusion criteria affect patient recruitment
• Understanding how safety profile feeds into the inclusion criteria
• Overcoming narrow inclusion criteria to ensure accurate clinical trials
Use this time to discuss and collaborate with your peers on patient recruitment and inclusion criteria to ensure success in clinical trials
2:30 pm End of Autoimmune & Regulatory Focus Days & Start of Driving Diversity in CAR-TCR & C-Level Think Tank
3:00 pm Panel Discussion: Women in the Workplace
Synopsis
Understanding the challenges faced by women in the workplace, the workplace experience as a woman and a woman in power and most importantly, how to ensure equal opportunities for women.
FREE TO ATTEND
5:00 pm End of Diversity Session
3:00 pm C-level Think Tank
Synopsis
An exclusive opportunity for top C-level executives from biotech and senior executives from pharma to collaborate and discuss the most pressing challenges the CAR-TCR community are facing in Europe. Run by experienced leaders Gwendolyn Binder and Raphaël Ognar, there will be no stone left unturned: join this discussion to share thought leadership on how to drive efficacies, boost safety, improve cost efficiency and unlock accessibility of cell therapies, to ultimately deliver durable CAR and TCR therapies to patients.
FREE TO ATTEND
INVITE ONLY
5:00 pm End of C-level Think Tank
