8.00 AM - 18.30 PM

8:00 am Registration & Welcome Coffee

8:50 am Chair’s Opening Remarks

Establishing Standardized Guidelines for 3D Models to Support Pipeline Progression

9:00 am Advancing Alternatives at FDA

Synopsis

  • Delving into what the FDA are working on
  • 2 FDA Alternative Methods WG
  • Outlining FDA partnership with IQ MPS

9:30 am Addressing the Need to Outline Regulatory Guidance & Clarity for 3D Tissue Models

Synopsis

  • Outlining existing guidance and standards that guide best practice
  • Understanding the importance of defining a few greatly needed contexts of use for regulatory acceptance
  • Producing consensus-based guidance for regulatory acceptance following the in vivo model and discussing best practices

10:00 am Session Reserved for Lead Partner – Crown Bioscience

10:30 am The NIH Microphysiological Systems Program for Risk Assessments in Drug Safety & Efficacy Studies

  • Danilo A. Tagle Director, Office of Special Initiatives, National Center for Advancing Translational Sciences National Institutes of Health

Synopsis

  • Overview of the NIH Tissue Chips program for drug screening
  • Partnerships between NIH, FDA, industry, NASA, BARDA, VA and other stakeholders
  • Effort towards commercialization, industry use, regulatory acceptance and community adoption

11:00 am Break & Structured Networking

Synopsis

Grab a morning coffee and network with fellow industry and academic experts

11:45 am Panel Discussion: Creating Predictive 3D Models Using Cell Line

  • Esmaiel Jabbari Professor of Chemical & Biomedical Engineering, University of South Carolina
  • Timothy Spicer Senior Scientific Director-Dept. of Molecular Medicine, Scripps Research
  • Richard Hanna Associate Director Bioscience Immunology, AstraZeneca

Synopsis

  • Learn from experts in discussing utilizing technology to improve knowledge and confidence and make informed decisions earlier

12:15 pm Development of OCT Imaging Technology & Deep Learning Software Tools for Research & Preclinical Applications

  • Sumeer Dhar Global Head Scientific Sales & Marketing Bioscience & Pharmaceuticals, SCREEN GP EUROPE B.V.

Synopsis

  • SCREEN’s OCT (Optical Coherence technology) platform developed by SCREEN enables imaging and true measurement of 3D structure with imaging in X,Y and Z directions
  • This specific feature allows for direct comparison of tumor/spheroid volume cultured under ex vivo conditions to the preclinical models
  • OCT technology is highly useful in regenerative medicine, toxicology, quality control, and across various disease areas including oncology

12:45 pm Networking Lunch

Exploring 3D Models in Drug Discovery

1:45 pm 3D Tissue Model for Screening Drugs Against Cancer Stem Cells

  • Esmaiel Jabbari Professor of Chemical & Biomedical Engineering, University of South Carolina

Synopsis

  • 3D tissue model representing cancer stem cell niche
  • Exploring drug screening with CSC subpopulation of cancer cells
  • Understanding mechanisms of drug resistance using CSC organoid models

2:15 pm 3D Tissue & Disease Models in a High Throughput Platform for Drug Screening

Synopsis

  • Introduction of Tissue Bioprinting Lab at NCATS
  • Exploring 3D vascularized barrier tissue model
  • Understanding 3D assay development for drug screening

2:45 pm Session Reservered

3:00 pm Q&A

3:15 pm Afternoon Break & Poster

3:45 pm GI Disease Model in 3D Application to Simulate GI Disease Progression (Caco2)

Synopsis

  • Function and barrier integrity readouts of disease progression
  • General application and what we can learn from this method
  • Complex cellular models using GI iPSCs and primary spheroids in combination with immune cells

4:15 pm Answering Questions About Adult Modeling Adult Diseases Using iPSCs – Is It Possible?

Synopsis

  • How can we use iPSCs to understand adult disease?
  • What can we learn from iPSC-derived models that are not phenotypically / functionally mature – the fetal gene signature
  • Discuss the use of iPSCs to develop 3D tissue models
  • How can we meet the challenge of statistical power in the face of remarkable differences between patient-derived

Exploring 3D Models in Drug Development

1:45 pm Advanced Intestinal Models for Preclinical Safety: Validation of An Organ-on-a-chip System for Early Screening

  • Philip Hewitt Global Head of Early Investigative Toxicology, Merck Healthcare KGaA

Synopsis

  • Comparison of 2D, 3D and OOAC cell models: which context of use is each fit for
  • Assessment of iPSC derived colon organoids
  • Pre-validation and implementation of OOAC small intestine model (CaCo2)
  • Future perspectives and more complex intestinal models

2:15 pm Application of 3D Small Intestinal & Colonic Organoids to Assess Clinical Diarrhoea Risk

  • Kenneth Pryde Senior Scientist, Oncology Safety Sciences, AstraZeneca

Synopsis

  • What are intestinal organoids and why we are using them during development to assess clinical diarrhoea risk for novel oncology medications?
  • Briefly outline limitations of preclinical animals models to assess human diarrhea risk
  • Outlining our experimental approach/capabilities/strategy for intestinal organoid application to support safer drug discovery – include cross-modality and crossspecies data examples
  • Introducing novel predictive models we are developing in AZ to better quantify human diarrhoea risk

2:45 pm MPS Models in Investigative Toxicology

Synopsis

  • Application of Human Lung Alveolus MPS model in mechanistic understanding of ADC induced Lung toxicity
  • Comparison to traditional 2D models
  • Discussion on additional gaps and challenges

3:15 pm Afternoon Break & Poster

3:45 pm Translational Framework for Oral Prodrugs with an Intestine on a Chip Model

  • Abhinav Sharma Abhinav Sharma Postdoctoral Research Scientist, AbbVie

Synopsis

  • A microfluidic organ-on-chip model using human intestine-derived primary cells were established
  • Prodrug-specific enzyme expression was confirmed, and the localization was consistent with the intestinal expression in vivo
  • Human in vitro to in vivo correlations (IVIVC) was established for commercially available prodrugs using cells from multiple human donors

4:15 pm Evaluating Immune Modulators in a Lung Tumor Microphysiological System with 3D Endothelium

  • Katrina Wisdom Investigator, Bioengineer in Complex In Vitro Models, GSK

Synopsis

  • Understanding that complex features of the tumor microenvironment are not always recapitulated in standard in vitro models
  • Discussing how to develop, characterize, and validate 3D, complex in vitro models to address these gaps
  • Exploring how combined efficacy and safety readouts can be integrated earlier into drug discovery

4:45 pm Afternoon Break & Poster

Applications & Comparison of 2D, 3D & In Vivo

5:15 pm Should we be Utilizing or Moving Away from Animal Models?

Synopsis

  • Hear industry leaders discuss the topic of the use of animal models with 3D tissue models. Can we show that these 3D models really do predict and reflect what is happening in vivo in relation to the patient? Should we be using this to move away from animal models or use in conjunction with?
  • Discuss the different uses for animal versus 3D models when it comes to screening, tox and efficacy

5:45 pm Building a Bridge between 2D iPSC Cardiomyocyte Assays & Engineered Cardiac Tissue – Case Study: Impact of Activin A

  • Scott MacDonnell Associate Director Cardiovascular, Fibrosis & Renal Research, Regeneron Pharmaceuticals

Synopsis

  • Activin A has been linked to the development of cardiac dysfunction in aging and disease. The underlying mechanism by which Activin A-mediated signaling modifies human cardiomyocyte functions are currently lacking
  • Using an activin A overexpression animal model, two-dimensional human iPSCcardiomyocytes, and three-dimensional Human engineered cardiac tissues, we investigated whether activin A signaling impacts cardiomyocyte excitation–contraction coupling mechanisms required to maintain heart function

6:15 pm Chair’s Closing Remarks, End of Day One

6:30 pm Drinks Reception Hosted by Crown Bioscience