August 21-23, 2018

Boston, MA

Day One
Monday, August 28, 2017

Day Two
Tuesday, August 29, 2017

Translatable Discoveries Bridging the In Vitro In Vivo Gap

08.30
Integrating Advanced In Vitro Liver Models with Other New Technologies to Reduce Risks of Drug Induced Liver Injury (DILI) in Pharmaceutical Development

  • Frank Sistare Scientific Associate Vice President, Safety Assessment & Laboratory Animal Resources, Merck and Co. Inc.

Synopsis

  • Demonstrating the increasingly sophisticated in vitro test systems, novel molecular end points, translational biomarkers, and humanized animal models that are being used to more accurately predict DILI
  • Revealing case studies on how higher throughput models can be qualified and integrated to enable earlier and better decisions, reduce costs, prevent wasted resources, and accelerate success
  • Overcoming multiple challenges that are yet to be addressed before fully realizing the promise of more predictive tools

09.00
Scientific Supermodels: Integrating Microphysiological & Mathematical Models to Improve Translation to Clinic

  • Matthew Wagoner Associate Director of Mechanistic and Investigative Toxicology, Takeda

Synopsis

  • Exploring the integration of semi-mechanistic modeling with MPS’s as a way of driving model informed drug development
  • Developing flexible strategies with organoid cultures to maximize predictability and translatability of early discoveries and lower attrition rates
  • Using mathematical and microphysiological models for understanding cross species differences during drug development
  • Addressing the level of complexity required for functional analysis of intended targets

09.30
Translatable Discoveries Bridging the In Vitro In Vivo Gap

Synopsis

  • Assessing the current state of complex 3D cell culture platforms
  • Bridging the translational medicine gap between in vitro assays and in vivo drug response assessments
  • Evaluating clinically relevant ex vivo 3D (EV3D) drug response assays and complex, 3D coculture micro-tumor models using patient matched immune components

09.40
Microphysiological Models Informing Target Assessment to Translational Biomarkers

  • J. Eric McDuffie Scientific Director, Head of Investigative & Mechanistic Toxicology, Janssen Pharmaceuticals

Synopsis

  • Contemporary microphysiological models to generate discovery compound safety profiles.
  • Leveraging imaging technologies and in vitro models to inform target assessment.
  • Case studies: Monitoring for translational safety biomarker changes in vitro

10.10
Morning Refreshments & Networking

The Future of Risk Assessment: Using Microphysiological Systems to Capture More Relevant Investigative Toxicology Data

11:20
A New Comprehensive Translational Paradigm Using Human iPSCDerived Cardiomyocytes for Safety Assessment of Drug-Induced Arrhythmias

  • Armando Lagrutta Director, Cellular Electrophysiology & Pharmacology, Safety Assessment & Laboratory Animal Resources, Merck and Co. Inc.

Synopsis

  • Evaluating the use of human induced pluripotent stem cell-derived cardiomyocytes (hiPSC-CMs) for acute and long-term assessments of drug-induced proarrhythmic effects in fluorescence-and impedance-based platforms
  • Highlighting case studies involving use of the test system for de-risking the CV safety of Hepatitis-C Virus nucleoside inhibitor antiviral agents
  • Understanding the evolving use of nanofiber scaffolds for 3-D modelling with High Content Assay (HCA) imaging endpoints in hiPSC-CMs

11.10
MicroHeart: A Screening-Ready, Physiologically Relevant Human iPSC-Derived Cardiomyocyte Platform.

Synopsis

  • Revealing a High Throughput Screening platform that more closely resembles the tissue architecture of native human heart tissue
  • microHeart induces features of human iPS-derived cardiomyocyte maturity, tackling fundamental challenges in the research applications for these cells
  • Cells are pre-plated in high-density screening formats and ready to use, enabling easier and larger throughput

11.50
iPSC Derived Mature Cardiac Tissue for Drug Development

Synopsis

  • Description of BiowireTM II Platform
  • Characteristics of Cardiac Tissue Maturity
  • Applications for Drug Development

12.00
Lunch & Networking

Non-Traditional Systems Enabling Better Mechanistic & Investigative Toxicology Studies

13:00
Bioprinted 3D Primary Liver Tissues Enabling the Assessment of Organ-Level Responses to Clinical Drug Induced Toxicity In Vitro

  • Adrian Roth Head of Mechanistic Safety, Hoffman La Roche

Synopsis

  • Exploring how to model clinically relevant tissue responses through the generation of a 3D liver model with architecture closely resembling that of in vivo human tissue
  • Confirming viability and functionality over prolonged culture periods as well as recapitulation of clinical liver toxicity not detected in conventional models
  • Demonstrating how 3D bioprinted liver tissues can both effectively model DILI and distinguish between highly related compounds with differential profile
  • Exploring how the bioprinting approach opens up possibilities to recreate aspects of organ structure in vitro and testing of drug induced effects so far not possible

13:30
Hormonal Modulation of Organs-on-Chips to Recapitulate In Vivo ADME Tox Profiles In Vitro

  • John Wikswo Gordon A. Cain University Professor & Director, VIIBRE

Synopsis

  • Addressing the absence of homuncular endocrine regulation in conventional cell culture models
  • Showcasing how Microfluidic MicroFormulators can support temporal control of hormones, nutrients, metabolites and other factors in both well-plate and organs-onchips
  • Exploring research and strategies to include diurnal variation of hormones, nutrients, and metabolites

14:00
Using Microfluidic Technology & a 3D In Vitro Follicle Growth Model to Test Compounds’ Female Reproductive Toxicity

  • Shuo Xiao Assistant Professor Reproductive Health & Toxicology, University of South Carolina

Synopsis

  • Developing a chip based system that can recapitulate the human 28-days menstrual cycle and its hormone secretion profiling on a dish
  • Using the FRT chip to screen and test the compound toxicity, including drugs already in market, compounds under development, as well as environmental contaminants
  • Validating the in vitro data using the in vivo models and exploring the concept of back translation

14:30
Afternoon Refreshments & Networking

Forward Applications for Microphysiological Systems

15:00
The NIH Program on Tissues-on-Chips for Drug Screening, Safety & Efficacy Testing: Progress & Future Plans

  • Lucie Low Tissue Chip Program Manager, NIH/NCATS

Synopsis

  • Assessing the progress made over the last 5 years of the program, and innovativeand collaborative partnerships that have helped drive the development of tissue chip technology
  • Evaluating the progress made in identifying current efforts towards the validation and standardization of tissue chip technology
  • Addressing predictive efficacy testing using tissue chips to better inform the pipeline, and future of NIH funding efforts

15:30
Panel Discussion: Where the Rubber Meets the Road, the Roadmap to Regulatory Acceptance

  • Lucie Low Tissue Chip Program Manager, NIH/NCATS
  • Murat Cirit Director, Translational Systems Pharmacology, MIT
  • J. Eric McDuffie Scientific Director, Head of Investigative & Mechanistic Toxicology, Janssen Pharmaceuticals
  • Frank Sistare Scientific Associate Vice President, Safety Assessment & Laboratory Animal Resources, Merck and Co. Inc.

Synopsis

  • How can we overcome the regulatory hurdles and approval standards for the pre-clinical applications of 3D human tissue models?
  • Addressing the need to translate findings back to animal systems before making the leap to humans in the preclinical setting
  • What are the requirements from regulatory agencies to help facilitate further success?
  • What regulatory conversations need to take place to further advance microengineered tissues development?
  • What key scientific breakthroughs are needed to further accelerate the adoption of microphysiological systems?

16:15
Close of Conference Day Two