8:15 am Registration & Morning Coffee Networking

8:45 am Chair’s Opening Remarks

Industry Consortium, Regulatory & Funding Progresses in 3D Modelling

9:00 am KEYNOTE: FDA’s Update on Packaging Your 3D Model Data for IND Filing


• Hear an update on the FDA’s Predictive Toxicology Roadmap for 2021 (Alternative Methods Working Group)
• Review success stories of 3D models
• Is 3D model data alone enough for regulatory acceptance?

9:30 am IQ MPS Affiliate Update: A Pharmaceutical Industry Perspective on Advancing MPS Adoption in Drug Discovery

  • Jason Ekert Senior Director & Head of Complex In Vitro Models, GlaxoSmithKline


• Evaluate recent 2.0 survey results benchmarking on how pharmaceutical companies are using MPS models
• Explore the highlights on MPS manuscripts outlining specific industry requirements for MPS platforms for various context of use (COE) studies
• Discuss the engagement with health authorities related to the level of MPS characterization and qualification required for specific COE studies

10:00 am The NIH Microphysiological Systems Program

  • Danilo Tagle Associate Director for Special Initiatives, NIH/ NCATS


• Explore the necessary partnerships to advance MPS use and community adoption
• Examine the use of MPS for disease modeling and safety studies
• Learn how to use MPS to inform clinical trial design and Implementation in precision medicine

10:30 am Panel Discussion: Enhancing 3D Models Adoption in Preclinical & Clinical Studies

  • Annie Moisan Bioengineering Program Director, Wellcome Leap
  • Madhu Lal-Nag Program Lead, Research Governance Council, FDA
  • Jason Ekert Senior Director & Head of Complex In Vitro Models, GlaxoSmithKline
  • Danilo Tagle Associate Director for Special Initiatives, NIH/ NCATS


• What are the hurdles for the adoption of 3D models for drug development from an industry perspective?
• Assessing the route to accelerate clinically validated 3D models to boost confidence
• Costs of technology for better ROI – where are we in the Gartner curve?
• Establishing pre-competitive collaboration for patient sample sourcing and biobanking – from IQ Consortium to EuroPDX – driving a transparent dialogue to facilitate long-term partnership

11:15 am Morning Networking Break

Harnessing the Potential of 3D Models in Oncology to Overcome the Limitations of Animal Models

12:00 pm Utilizing Primary Tumor Explants for the Assessment of the Activity of Cancer Immunotherapy Drugs

  • Shamin Li Senior Scientist, Roche Diagnostics


• Highlight the need of a physiological human model to predict response to cancer immunotherapies
• Illustrate the use of primary tumor explants in T cell bispecific antibodies studies
• Discuss the current limitations of the model and future implementations to improve the tumor explant platform

12:30 pm Patient-Derived Explant Cultures (PDECs) as a Model System for Oncology Studies


• Discover a new method to grow intact tumor pieces in a petri dish
• Learn how PDECs retain the immune contexture of the tumor they were derived from
• Evaluate PDECs as excellent tools for oncology drug development

1:00 pm 3D Printed Microfluidics with Applications in Drug Screening & Oncology Research

  • Ruitao Su Postdoctoral Associate, University of Minnesota


• Explore a new methodology to 3D print microfluidics, utilizing a silicone-based ink, and eliminating the need for sacrificial materials
• Assess how 3D printed microfluidic networks can be readily integrated with microsensors and nonconventional freeform surfaces for high-throughput biomedical assays
• Discuss how the biocompatible vascular structures could facilitate the design and fabrication of more complex tissue and metastasis models in oncology study

Utilizing 3D Models to Accelerate Your Drug Discovery & Development in Chronic & Complex Diseases

12:00 pm Mechanistic Understanding of Clinical Drug Induced Liver Injury (DILI): What Can & Can’t be Done Using 3D Liver Models

  • Phillip Hewitt Global Head of Early Investigative Toxicology, Merck KGaA


• Understand the complex nature of DILI make teasing out very difficult mechanisms
• Overview of the many in vitro tools that exist to study specific (known) mechanisms of DILI
• Discuss the importance of negative results when understanding clinical DILI
• Explore the urgent need for more translatable in vitro models addressing immune-related aspects of DILI

12:30 pm A Multi-Functional MPS Platform: Applications to Modeling the Blood-Brain Barrier & Subcutaneous Delivery


• Explore how a flexible, easy-to-use chip design is introduced for tissue- or organ-on-chip models
• Understand how one application is a blood-brain barrier model that recapitulates both the function (permeability) and morphology of the human BBB
• Review how a second application is a model for subcutaneous delivery of mAbs for prediction of bioavailability

1:00 pm Engineered 3D Heart Tissues as Models of Disease & Discovery


• Learn how iPSC cardiomyocytes can provide in vitro models of healthy and diseased cardiac function
• Explore the restorative effects of compounds with respect to contractility, calcium handling, and various other phenotypes can be assayed on these systems
• Discover how advancing the maturation of iPSCcardiomyocytes can better stratify disease phenotypes and enable enhanced prediction of compound toxicity

1:30 pm Networking Lunch Break

Harnessing the Potential of 3D Models in Oncology to Overcome the Limitations of Animal Models

2:30 pm Bioprinting the Tumor Microenvironment

  • Madhuri Dey Doctoral Candidate, Pennsylvania State University


• Learn the importance of relevant 3D tumor models for understanding important hallmarks of cancer
• Study immune-cancer cell interaction in 3D models
• Employ 3D bioprinting modalities in developing perfusable tumor models

3:00 pm Case Study: Using Patient Derived 3D Models to Test Combinatorial Therapy Approaches for the Treatment of Glioblastoma (GBM)

  • Timothy Spicer Senior Director- Molecular Medicine & Scientific, The Scripps Research Institute


• Hear how large scale screening for in vitro efficacy and drug-gene network analysis has guided the industry toward novel combination therapies, that have shown exceptional synergy in autologous tumors from patients with GBM
• Understand the gap in knowledge about how results play out in vivo, by implementing in vivo models of GBM using validated autologous tumors
• Evaluate the outcomes from the most recent research efficacy study and how it translates into potential clinical trials

3:30 pm Roundtable Discussion: Connecting & Combining Organ Systems Tumor/Non-Tumor


• Uncover how to connect healthy and diseased tissues for efficacy and safety
• Learn how 3D Models can be enhanced to understand cancer biology
• Examine how this benefit drug development and reduce the risk of clinical failure

Utilizing 3D Models to Accelerate Your Drug Discovery & Development in Chronic & Complex Diseases

2:30 pm Using Human iPSC-Derived Cardiac Organoids & Bioinformatics to Predict COVID-19-Associated Patient Pathology


• Learn how to derive cardiac organoids in 3D with high throughput using suspension bioreactors
• Explore the use of hiPSC-derived cardiomyocytes to study in vitro cytopathic effects and viral tropism of SARS-CoV-2
• Evaluate hiPSC models revealing new pathological effects in myocardial tissue of patients who died from COVID-19
• Hear how to leverage 2D imaging, bioinformatics, and the correlation with clinical samples to further support understanding of fundamental virology and pathology
• Asses how cardiac organoids can equip our drug development studies on toxicity, and improve efficacy through better recapitulation

3:00 pm Leveraging Various In Vitro Kidney Models to Predict Drug Safety & Mechanisms of Action


• Overview of micro physiological systems that incorporate kidney compartments (proximal tubule,
distal tubule, etc)
• Gain insights about kidney organoids as an emerging model for safety assessment
• Discover how renal organoid-on-chip systems enhance cellular phenotypes and can be used for safety and MOA studies

3:30 pm Re-Evaluating Immune Modulation for Stem-Cell Derived Therapies Using 3D In Vitro Tissue Models of Immune Attack


• Address the challenges in T1D based on pathology
• Discuss how to choose and compare preclinical/translational data between animal, in vitro and genetics models for immune modulation for stem cell-derived therapies
• Explore the future direction of leveraging 3D in vitro tissue models for immune attack from your lessons learned

4:00 pm Afternoon Networking Break & Scientific Poster Session

Application of Patient- Derived 3D Models for Drug Development & Disease Modelling

4:40 pm Deciphering Immune Responses to Viruses & Vaccines Using Human Tonsil Organoids

  • Lisa Wagar Assistant Professor, University of California Irvine


• Learn how to use primary human lymphoid tissues to grow immune organoids
• Examine how tonsil organoids can be produced in high throughput and respond to vaccine-relevant antigens
• Comprehend inter-individual variation in the adaptive immune response can be quantified

5:10 pm DEBATE – Battle of the 3D Models: PDO vs PDX vs Complex 3D Models


Enjoy this special session dedicated to debating and evaluating the issues around scalability, reproducibility, and validation of each of the different types of models.

5:55 pm Chair’s Closing Remarks

5:55 pm End of Day One