8:45 am Registration & Morning Coffee Networking


  • Live Demo in Virtual Exhibition Area
  • 1-1 Meetings

9:00 am Opening Remarks

9:10 am FDA Insight: Utilizing 3D Models to Drive Drug Development & Regulatory Acceptance

  • Suzanne Fitzpatrick Senior Advisor for Toxicology Center for Food Safety and Applied Nutrition , U.S Food and Drug Administration (FDA)


  • Outlining the latest developments to incorporate 3D model data to support translational success
  • Addressing the evidence required to advance drug candidates from preclinical 3D studies into phase I clinical trials
  • The need to adapt guidelines, define context of use across the model continuum and using 3D systems to support in vivo evidence

9:30 am Use of Engineered Cardiac Tissues for Applications in Cardio-Oncology


– Overview of Biowire™ II cardiac tissue engineering platform
– Applications in Cardio-Oncology:

  •  Predicting cardiotoxic responses
  • Strategies for developing cardioprotective drugs

9:50 am Self-Assembled Vascularized Organoids for Safety Assessment

10:10 am Live Q&A – Ask the Speakers Your Burning Questions

10:40 am Speed Networking Break

11:10 am Patient-Derived Scaffolds Uncover Breast Cancer Promoting Properties of the Microenvironment


  • To model and further understand the influence of specific microenvironments we have developed an experimental platform using cell-free patient-derived scaffolds (PDSs) from primary breast cancers infiltrated with standardized breast cancer cell lines
  • Patient-derived scaffolds thus mimics in vivo-like growth conditions and uncovers unique information about the malignancy-inducing properties of tumor microenvironment
  • PDSs can potentially be used in cancer drug design and screening

11:30 am High-throughput Organ-on-a-Chip Platform for Disease Modeling and Therapeutic Screening


  • Unlocking novel biology using physiological relevant tissue environments
  • Improving drug discovery efforts by applying better & faster assays
  • Utilizing deep understanding of complex diseases to discover novel therapeutics

11:50 am Human Blood–Brain Barrier On-a-Chip


  • Building models of the BBB that recapitulate physiological phenotypes and provides translatable outputs
  • Improving drug delivery by assessing candidate drug barrier penetration and brain exposure

12:10 pm Fat-on-a-Chip for Drug Discovery & Preclinical Studies


  • Insight into the context of our unique 3D cell culture capabilities, our fat-on-a-chip products and services, and our portfolio of patent-pending and licensed technologies in this area
  • Highlight studies that we have conducted and where areas of collaboration and partnership may exist for attendees interested in advancing the field and/or conducting drug discovery and preclinical studies

12:30 pm Live Q&A – Ask the Speakers Your Burning Questions

1:00 pm Roundtable Discussion: Recapitulating Intestinal Physiology with Stem Cell-derived Models


• Challenges maintaining relevant culture characteristics in vitro
• Mimicking key intestinal function and physiology in vitro

1:45 pm 3D Bioprinting of Functional Human Tissue & Disease Models for Preclinical Studies

  • MinJae Song Staff Scientist - 3D Bioprinting Core, National Institute of Health Sciences


  • Overview of Tissue Bioprinting Group at NCATS
  • Bioprinting of vascularized tissue platform
    – Ocular tissue (retinal pigment epithelium on “choroid”): modeling wet form age related macular degeneration
    – Skin: modeling atopic dermatitis
    – Omentum: modeling ovarian cancer metastasis
    – Neurovascular Unit: modeling glioblastoma
  • Bioprinting of neural circuit: modeling opioid user disorder
  • Future direction
    – Increasing tissue complexity
    – Developing towards 96 well format for a drug screening platform

2:05 pm Novel Optical Coherence Tomography (OCT) Technology for Non-Invasive 3D Ex Vivo Drug Activity Profiling

  • Sumeer Dhar Global Head Sales & Marketing, SCREEN Holding Group


  • SCREEN has developed a novel OCT based technology for imaging and analysis of complex 3D structures, such as, spheroid /organoid for growth & morphological profiling and quantification of internal cavities
  • This unique technology also allows us to perform large tissue imaging, non-invasive monitoring of macro and sprouted neo-vasculature without the need for fluorescent staining for providing quantitative information about the vascular morphological changes, thereby allowing for the evaluation of anti-angiogenic drugs in real time

2:25 pm Automated Electrical Stimulation & Optical Force Readout of 3D Bioprinted Human Muscle Tissues in Microplates


  • Discussing a novel device for automated functional readouts such as force and fatigue of 3D bioprinted human skeletal muscle models in microplates
  • Using a 3D bioprinting approach, we have developed a new screening platform for the automated fabrication of functional human skeletal muscle tissue models attached between two posts in microwells, which can be electrically stimulated
  • It is a promising new in vitro exercise model to identify drugs regulating muscle force and fatigue

2:45 pm Live Q&A – Ask the Speakers Your Burning Questions

  • Sumeer Dhar Global Head Sales & Marketing, SCREEN Holding Group
  • Hansjoerg Keller Senior Principal Scientist, Novartis
  • MinJae Song Staff Scientist - 3D Bioprinting Core, National Institute of Health Sciences

3:40 pm Aspiration-Assisted Bioprinting


  • Tissue spheroids have been increasingly used as building blocks for fabrication of tissues, but their precise bioprinting has been a major limitation
  • Demonstrated for the first time that by controlling the location and distance between spheroids we can mediate collective capillary sprouting
  • Aspiration-assisted bioprinting has great potential to develop tissues not only for tissue engineering but also for disease modeling and microphysiological systems

4:00 pm Advancements in Human Liver Platforms for ADME Studies

  • Niresh Hariparsad Director - Drug Metabolism & Pharmacokinetics Project Leader, Vertex Pharmaceuticals


  • Advancements in Human Liver Platforms for ADME Studies
  • Currently available liver systems and their representative drug metabolism validation datasets
  • Desired functionality for liver platforms to improve their applicability for practical use in the pharmaceutical industry

4:20 pm A Simple High-Throughput Approach Identifies Actionable Drug Sensitivities in Patient-Derived Tumor Organoids


  • Tumor organoids maintain cell-cell interactions, heterogeneity, microenvironment, and drug response of the sample they originate from. Thus, there is increasing interest in developing tumor organoid models for drug development and personalized medicine applications
  • Here we introduce a miniaturized method that allows high-throughput screenings in a format compatible with automation using patient-derived tumor organoids
  • Requiring few tumor cells, we routinely test combination of chemotherapies or targeted therapies directly on primary tumors from patients’ biopsies or surgical samples with the aim to personalize treatment

4:40 pm Human-on-a-Chip Systems for Use in Therapeutic Index Determination & Systemic Toxicity in Pre-Clinical Drug Discovery Application

  • James J. Hickman Professor NanoScience Technology Center, University Central Florida


  • The utilization of multi-organ human-on-a-chip or body-on-a-chip systems for toxicology and efficacy has been suggested as a solution to the lack of good model systems between the single cell level and animal or human systems
  • Application of these systems for ALS, Alzheimer’s, rare diseases, diabetes and cardiac and skeletal muscle mechanistic toxicity will be reviewed
  • The development of in vitro PDPK models that are being used to predict in vivo results will also be presented

5:00 pm Live Q&A – Ask the Speakers Your Burning Questions

5:15 pm Chair’s Closing Remarks & End of Summit