8:15 - 17:30 EST | 5:15 - 14:30 PST

8:15 am Registration & Morning Coffee Networking

Industry Consortium, Regulatory & Funding Progresses in 3D Modelling

8:50 am Chair’s Opening Remarks

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

Synopsis

• 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 Human-First Drug Discovery: Using iPSC-Derived 3D Neurospheroids to Model Diseases & Drive the Discovery of New Targets & Compounds

  • Blake Anson Vice President Scientific Affairs & Partnering, StemoniX

Synopsis

  • Highlight the use of a complex, uniform iPSC-derived neurospheroids in highthroughput
    functional screening platforms to identify new targets and hits for
    neurodevelopmental disorders.
  • Explore how complex human induced pluripotent stem cell (hiPSC)-derived neural
    spheroid platforms enable greater physiological relevance to advance traditional
    drug discovery by bringing human biology to the forefront of the discovery pipeline.
  • Learn how hiPSC-based platforms created from patient and control tissues allow for
    comparisons of the safety and efficacy of new compounds to facilitate clinical translation

10:00 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

Synopsis

• 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

10:30 am The NIH Microphysiological Systems Program

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

Synopsis

• 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

11:00 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

Synopsis

• 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


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

Synopsis

• 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

Synopsis

• 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

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

Synopsis

• 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 3D Engineered Muscle Tissues as Models of Disease & Discovery

Synopsis

  • Learn how iPSC cardiomyocytes and skeletal muscle cells can provide in vitro models of healthy and diseased muscle 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 iPSC cardiomyocytes and skeletal muscle cells can better stratify disease phenotypes and enable enhanced prediction of compound toxicity

12:50 pm A Multi-Functional MPS Platform: Applications to Modeling the Blood-Brain Barrier & Subcutaneous Delivery

Synopsis

• 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

11:35 am Morning Networking Break

1:20 pm Networking Lunch Break


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

2:20 pm Bioprinting the Tumor Microenvironment

  • Madhuri Dey Doctoral Candidate, Pennsylvania State University

Synopsis

• 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

2:50 pm 3D Printed Microfluidics with Applications in Drug Screening & Oncology Research

  • Ruitao Su Postdoctoral Associate, University of Minnesota

Synopsis

• 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

2:20 pm Using Human iPSC-Derived Cardiac Organoids & Bioinformatics to Predict COVID-19-Associated Patient Pathology

Synopsis

• 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

2:50 pm Leveraging In Vitro Kidney Models to Predict Drug Safety & Mechanisms of Action

Synopsis

• 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

3:20 pm Re-Evaluating Immune Modulation for Stem-Cell Derived Therapies Using 3D In Vitro Tissue Models of Immune Attack

Synopsis

• 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

3:50 pm Afternoon Networking Break & Scientific Poster Session

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

4:20 pm iPSC-Derived Models of Human Retina for Drug Discovery

Synopsis

• Discover iPSC-derived in vitro models of the human retina
• Explore the utility of retinal organoids for various applications, including
toxicology and gene therapy

4:50 pm Deciphering Immune Responses to Viruses & Vaccines Using Human Tonsil Organoids

  • Lisa Wagar Assistant Professor, University of California Irvine

Synopsis

• 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

5:20 pm Chair’s Closing Remarks

5:30 pm End of Day One