For full session details and more insights into the summit, explore the full 2025 event guide:
Conference Day One
Wednesday 15th October 2025
8:45 am Chair’s Opening Remarks
Developing Unique Models for Target Identification to Encourage Aspirational Drug Discovery
9:00 am Analyzing Simultaneous Targeting of PD-1 & FcγRIIb to Discover Challenges & Mitigations in the Absence of Double Humanized Mouse Models
Synopsis
- Demonstrating the biological relevance of simultaneously targeting PD-1 and FcγRIIb to modulate autoimmune disease pathways for enhanced therapeutic efficacy
- Overcoming the lack of double-humanized PD-1/FcγRIIb models by developing alternative approaches to enable thorough drug evaluation
- Optimizing mouse model development for PD-1 agonist screening by balancing biological relevance with technical constraints to improve preclinical predictability
9:30 am Utilizing Organ-on-a-Chip Models in Rheumatoid Arthritis to Validate Innovative Targets
Synopsis
- Recapitulating the architecture of a joint using micro physiological systems to improve the translatability of human pathophysiology
- Capturing the immune and non-immune complexity in a synovium micro-environment to increase therapeutic relevance to Rheumatoid Arthritis
- Validating novel targets, using synovium-on-a-chip models to ensure drug effect for potential Rheumatoid Arthritis patients
10:00 am Bridging In Vitro and In Vivo Data with a Targeted Approach to De-Risking Cell Therapy Safety in Autoimmunity
Synopsis
- Leveraging focused in vitro binding data to select clinically relevant in vivo models for cell therapy safety assessment
- Using biochemical profiling to guide predictive model selection for autoimmune cell therapies
- Leveraging pan-autoimmunity insights to streamline model development
10:30 am Morning Refreshment Break & Speed Networking
Utilizing Unique Modeling Techniques to Optimize Drug Safety Prediction & IND Approvals
11:00 am Roundtable Discussion: Navigating the FDA’s Shift from Animal Models to Standardized Ex Vivo Approaches for IND Success
Synopsis
- Implementing ex vivo models to align with the FDA’s reduced-animal-testing upcoming mandate
- Streamlining IND workflows to address preclinical submission challenges, increasing approval efficiency and reducing development delays
- Leveraging successful case studies to demonstrate alternative model viability, providing clear benchmarks for inflammatory drug pipelines
12:00 pm Lunch Break & Networking
Predicting the Efficacy of Novel Drugs to Increase Therapeutic Reliability
1:30 pm Leveraging Humanized & Syngeneic Models for Autoimmune Therapies to Advance Drug Efficacy
Synopsis
- Utilizing humanized models with research-grade drug equivalents to enhance clinical relevance, accelerating IND approval
- Comparing syngeneic vs. humanized Lupus models to optimize efficacy studies, streamlining autoimmune drug development
- Integrating hypoimmune “cloaking” technology to prevent cell rejection expanding potential for Inflammatory Bowel Disease/ Type 1 Diabetes
2:00 pm Interactive Workshop: Leveraging Oncology Learnings From Organ-on-a- Chip Models to Optimize Safety & Efficacy for Faster IND Submissions in Autoimmunity
Synopsis
- Enabling human-relevant safety/efficacy data using an Organ-on-a-Chip Model to accelerate autoimmune drug development and reduce animal testing
- Highlighting oncology-derived engager strategies to streamline inflammatory drug efficacy testing and combinatorial therapy design
- Adopting FDA-compliant in vitro platforms for standardizing preclinical workflows to improve IND approval rates and align with regulatory shifts
3:30 pm Afternoon Break & Refreshments
3:45 pm Utilizing Preclinical Models to Predict Efficacy of Regenerative Stem Cell Therapies
Synopsis
- Developing preclinical stem cell models to validate efficacy and safety to accelerate IND approvals
- Bridging in vitro and large animal data for human-relevant insights to improve clinical translation
- Leveraging biomarker strategies through academics and CRO partnerships to de-risk therapy development
4:15 pm Understanding the Response Variability of a Drug Among Patient Populations
Synopsis
- Testing Capstan’s targeted LNPs on autoimmune patient samples to generate human relevant efficacy data
- Validating models with known therapies vs failed candidates to refine predictive power
- Incorporating clinical data for fine tuning models to reduce the patient variability to treatments