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CORPORATE SPONSORS: ORGANIZED BY:

FASTCongress.com

Functional Analysis & Screening Technologies

C O N G R E S S

C A M B R I D G E H E A L T H T E C H I N S T I T U T E ’ S T H I R D A N N U A L

David C. SwinneyCEO, Institute for Rare and Neglected Diseases Drug Discovery (iRND3)

Per Erik StromstedtDirector, Screening Sciences AstraZeneca

Jeffrey MorganProfessor, Medical Science & EngineeringBrown University

Hicham AlaouiDirector, Cellular PharmacologyGenentech

Linda G. GriffithProfessor, Biological EngineeringMIT

David GraingerProfessor, Pharmaceutical ChemistryUniversity of Utah

Sophie A. LelièvreDirector, 3D Cell Culture Core FacilityPurdue University

David TellersPrincipal Scientist, Discovery ChemistryMerck

Anne BangDirector, Cell-Based Disease Modeling and ScreeningSanford-Burnham-Prebys Medical Discovery Institute

Michael ShenProfessor, Medicine, Systems BiologyColumbia University

FEATURED SPEAKERS:NOVEMBER 9-10

NOVEMBER 10-11

Phenotypic Drug Discovery

3D Cell Culture: Organoid, Spheroid, and Organ-on-a-Chip Models

Screening & Functional Analysis of 3D Models

Coverage Includes:• Organoids and Primary Organotypic 3D Culture in Drug Discovery

• New Target and MoA

• Phenotypic Screening Using Primary and Stem Cell-Derived Models

• Case Studies in Phenotypic Drug Discovery

• Engineering Functional Organ-on-a-Chip Models

• 3D Spheroid Models for Drug Screening

• Microengineered 3D Models for Drug Safety Testing

• Phenotypic and High-Content Screening of 3D Models

• Cancer-on-a-Chip: Engineering 3D Models of Tumor Microenvironment

Dinner Short Courses:

Introduction to High-Content Phenotypic Screening

Screening Strategies for Cancer Immunotherapy

Expert ThinkTank: How to Meet the Need for Physiologically Relevant Assays

REGISTER BY SEPTEMBER 11 &

SAVE UP TO $400

NOVEMBER 9-11, 2015 • RENAISSANCE WATERFRONT HOTEL • BOSTON, MA

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CONFERENCE-AT-A-GLANCE

Phenotypic Drug Discovery 3D Cell Culture: Organoid, Spheroid, and Organ-on-a-Chip Models

Sunday, November 8

5:00 pm Conference Pre-Registration

6:00 – 9:00 Dinner Short Course (Separate registration required) SC1: Introduction to High-Content Phenotypic Screening

Monday, November 9

7:00-8:00 am Conference Registration and Morning Coffee

8:00-10:05 Organoids and Primary Organotypic 3D Culture in Drug Discovery

10:05-10:50 Coffee Break in the Exhibit Hall with Poster Viewing

10:50-12:30 pm Organoids and Primary Organotypic 3D Culture in Drug Discovery (cont’d)

12:30-2:00 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

2:00-3:50 Phenotypic Screening for New Target, Pathway and Mechanism-of-Action Discovery Engineering Functional Organ-on-a-Chip Models

3:50-4:45 Refreshment Break in the Exhibit Hall with Poster Viewing

4:45-6:00 Phenotypic Screening for New Target, Pathway and Mechanism-of-Action Discovery (cont’d) Engineering Functional Organ-on-a-Chip Models (cont’d)

6:00-7:00 Welcome Reception in the Exhibit Hall with Poster Viewing

6:45-7:00 Short Course Registration

7:00-9:00 Dinner Short Course (Separate registration required) SC2: Screening Strategies for Cancer Immunotherapy

Tuesday, November 10

7:00-8:00 Conference Registration and Morning Coffee

8:00-9:55 Phenotypic Screening Using Primary and Stem Cell-Derived Models 3D Spheroid Models for Drug Screening

9:55-10:45 Coffee Break in the Exhibit Hall with Poster Viewing

10:45-12:30 pm Case Studies in Phenotypic Drug Discovery 3D Spheroid Models for Drug Screening (cont’d)

12:30-1:55 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

Screening and Functional Analysis of 3D Models

12:30-1:55 Conference Registration

1:55-3:45 Integrated Approach to in vitro Drug Discovery: Tissue Engineering Meets Systems Biology

3:45-4:30 Refreshment Break in the Exhibit Hall with Poster Viewing

4:30-5:45 Microengineered 3D Models for Drug Safety Testing

5:45-6:00 Short Course Registration

6:00-9:00 Dinner Expert ThinkTank (Separate registration required) SC3: How to Meet the Need for Physiologically Relevant Assays

Wednesday, November 11

7:30-8:00 am Conference Registration and Morning Coffee

8:00-9:55 Phenotypic and High-Content Screening of 3D Models

9:55-10:40 Coffee Break in the Exhibit Hall with Poster Viewing

10:40-11:30 Phenotypic and High-Content Screening of 3D Models (cont’d)

11:30-1:00 pm Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

1:00-2:45 Cancer-on-a-Chip: Engineering 3D Models of Tumor Microenvironment

2:45-3:15 Networking Refreshment Break

3:15-4:30 Cancer-on-a-Chip: Engineering 3D Models of Tumor Microenvironment (cont’d)

4:30 Close of Conference

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SPEAKING FACULTY• Hicham Alaoui, Ph.D., Director, Biochemical and

Cellular Pharmacology, Genentech

• Treena Arinzeh, Ph.D., Professor, Biomedical Engineering, New Jersey Institute of Technology

• Anne Bang, Ph.D., Director, Cell-Based Disease Modeling and Screening, Sanford-Burnham-Prebys Medical Discovery Institute

• Andras Bauer, Ph.D., Senior Scientist, Immunology and Respiratory Therapeutic Area, Boehringer-Ingelheim

• Anne E. Carpenter, Ph.D., Director, Imaging Platform, Broad Institute of Harvard and MIT

• Arijit Chakravarty, Ph.D., Director, Modeling and Simulation, Takeda Pharmaceuticals

• Joseph L. Charest, Ph. D., Group Leader, Biomedical Microsystems, Charles Stark Draper Laboratory, Inc.

• Anthony M. Davies, Ph.D., Center Director, Translational Cell Imaging Queensland (TCIQ), Institute of Health Biomedical Innovation, Queensland University of Technology

• Emma Davies, Ph.D., Senior Scientist, AstraZeneca

• Eugen Dhimolea, Ph.D., Instructor, Medicine, Dana-Farber Cancer Institute, Harvard Medical School

• Adam Feinberg, Ph.D., Associate Professor, Materials Science & Biomedical Engineering, Carnegie Mellon University

• Darren Finlay, Ph.D., Research Assistant Professor, Sanford-Burnham-Prebys Medical Discovery Institute

• Simon A. Gayther, Ph.D., Professor, Preventive Medicine, University of Southern California Keck School of Medicine

• Sharon Gerecht, Ph.D., Associate Professor, Chemical & Biomolecular Engineering, Johns Hopkins University

• Adam D. Gracz, Ph.D., Postdoctoral Fellow, Magness Lab, Gastroenterology and Hepatology, University of North Carolina at Chapel Hill

• David Grainger, Ph.D., Distinguished Professor and Chair, Pharmaceutical Chemistry, University of Utah

• Linda G. Griffith, Ph.D., Professor, Biological Engineering, MIT

• Daniel A. Harrington, Ph.D., Assistant Director, Collaborative Research Laboratory; Faculty Fellow, BioSciences, Rice University

• Kimberly Hartwell, Ph.D., Research Scientist, Vertex Pharmaceuticals

• Kevin E. Healy, Ph.D., Professor, Bioengineering, University of California, Berkeley

• Shane Horman, Ph.D., Research Investigator, Genomics Institute of the Novartis Research Foundation

• Dan Dongeun Huh, Ph.D., Wilf Family Term Chair & Assistant Professor, Bioengineering, University of Pennsylvania

• Esmaiel Jabbari, Ph.D., Professor of Chemical and Biomedical Engineering, Chemical Engineering, University of South Carolina

• Lorin Jakubek, Ph.D., Post Doc Associate, Predictive Toxicology, Sanofi

• Edward J. Kelly, Ph.D., Associate Professor, Pharmaceutics, University of Washington, Seattle

• Hilary Kenny, Ph.D., Research Associate (Assistant Professor), Obstetrics & Gynecology, University of Chicago

• Doo Yeon Kim, Ph.D., Assistant Professor, Neurology, Genetics and Aging Research Unit, Massachusetts General Hospital, Harvard Medical School

• Jean-Louis Klein, Ph.D., Target and Pathway Validation, Platform Technology and Science, GlaxoSmithKline

• Ville Kujala, Ph.D., Postdoctoral Fellow, Disease Biophysics Group, Wyss Institute for Biologically Inspired Engineering

• Sophie A. Lelièvre, D.V.M., LLMPH, Ph.D., Professor, Basic Medical Sciences & Cancer Pharmacology; Director, 3D Cell Culture Core Facility (3D3C) in Discovery Park, Purdue University

• Jing Li, Ph.D., Director, Genomics and Phenotypic Screening, Merck Research Laboratories

• Jesse Lugus, Ph.D., Research Investigator, Developmental & Molecular Pathways, Novartis Institutes for BioMedical Research

• Alison McGuigan, Ph.D., Associate Professor, Chemical Engineering and Applied Chemistry, University of Toronto

• Geeta Mehta, Ph.D., Assistant Research Scientist, Biomedical Engineering, University of Michigan

• Lisa Minor, Ph.D., President, In Vitro Strategies, LLC

• Jeffrey Morgan, Ph.D., Professor, Medical Science & Engineering, Brown University

• Cokey Nguyen, Ph.D., Vice President, R&D, Enumeral

• David Nolte, Ph.D., Professor, Physics, Purdue University; President, Animated Dynamics, Inc.

• Biju Parekkadan, Ph.D., Assistant Professor, Bioengineering, Harvard Medical School

• Donna Peehl, Ph.D., Research Professor, Urology, Stanford University

• Kaushal Rege, Ph.D., Associate Professor, Chemical Engineering, Arizona State University, Tempe, AZ

• Imran Rizvi, Ph.D., Instructor, Medicine and Dermatology, Brigham and Women’s Hospital, Harvard Medical School

• Alan Sandercock, Ph.D., Scientist II, Antibody Discovery and Protein Engineering, MedImmune

• Christian Schmees, Ph.D., Head, Tumor Biology, NMI Natural and Medical Sciences Institute at the University of Tübingen

• Michael M. Shen, Ph.D., Professor, Medicine and Genetics and Development, Columbia University

• Serena Silver, Ph.D., Senior Investigator & Group Leader, Molecular Pharmacology, Novartis

• Lena Smirnova, Ph.D., Research Associate, Johns Hopkins Center for Alternatives to Animal Testing, Johns Hopkins University Bloomberg School of Public Health

• Per Erik Stromstedt, Ph.D., Director, Screening Sciences & Sample Management/Reagent & Assay Development, AstraZeneca R&D

• Wei Sun, Ph.D., Scientist, Therapeutics for Rare and Neglected Diseases (TRND), National Center for Advancing Translational Sciences (NCATS)

• David C. Swinney, Ph.D., CEO, Institute for Rare and Neglected Diseases Drug Discovery (iRND3)

• David Tellers, Ph.D., Principal Scientist, Discovery Chemistry, Merck

• O. Berk Usta, Ph.D., Instructor, Surgery, Center for Engineering in Medicine, Massachusetts General Hospital, Harvard Medical School

• Fabien Vincent, Ph.D., Associate Research Fellow, Hit Discovery and Lead Profiling, Pfizer

• Bridget Wagner, Ph.D., Director, Pancreatic Cell Biology and Metabolic Disease, Center for the Science of Therapeutics, The Broad Institute of MIT and Harvard

• Francis Willard, Ph.D., Senior Research Scientist, Quantitative Biology, Lilly Research Labs

• Zining Wu, Ph.D., Group Leader, Molecular Discovery Research, GlaxoSmithKline

• Muhammad H. Zaman, Ph.D., Professor, Howard Hughes Medical Institute; Professor, Biomedical Engineering and International Health, Boston University

Congratulations. It was a great meeting.

— Co-Founder & Chief Scientific Officer,

Nano3D Biosciences

PAST DELEGATE TESTIMONIALS

I had a very good time. … I appreciated the invitation. It was a most worthwhile trip. … I found the audience quite engaged and I made a number of very good contacts!

— Professor of Biomedical Engineering,

Vanderbilt University

That was an intense, fun-filled three days!

— Director, National Institutes of Health

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Sunday, November 8 | 6:00-9:00 PM(SC1) Introduction to High-Content Phenotypic ScreeningThe ever-increasing demand for improved productivity in research through the generation of robust analysis outputs has driven both the development and deployment of automated high-content analysis (HCA) and phenotypic cell-based approaches to drug discovery. In contrast to the more traditional cellular analysis and target-based approaches, here the researcher is able to evaluate the efficacy of potential therapeutics by monitoring the physiological state of cells through the simultaneous analysis of multiple cellular parameters in the context of an intact biological system. This course will cover the key features of HCS/A technologies and the best approaches to using these technologies for phenotypic cell-based screening.

Instructor: Anthony M. Davies, Ph.D., Center Director, Translational Cell Imaging Queensland (TCIQ), Institute of Health Biomedical Innovation, Queensland University of Technology

Who should attend?This course has been developed to introduce and facilitate scientists who are either moving into the field or who are interested in further developing new phenotypic discovery applications and tools for use with these technologies.

Course Structure(i) An introduction to HCA technologies(ii) Advanced cell-based models for use with HCA(iii) Worked examples of the phenotypic screening approach and future directions(iv) Group discussion and Q&A

Learning Outcomes• Develop a familiarity of the basics of HCS/A technologies• Gain an understanding of the capabilities of this technology• Learn of the latest developments in cell-based models for use in this field• Get a better understanding of the key principles of assay design and development for phenotypic screening

Monday, November 9 | 7:00-9:00 PM(SC2) Screening Strategies for Cancer Immunotherapy

Phenotypic Screening for Novel Cancer Immunotherapy TargetsAlan Sandercock, Ph.D., Scientist II, Antibody Discovery and Protein Engineering, MedImmune

Talk Title to be AnnouncedCokey Nguyen, Ph.D., Vice President, R&D, Enumeral

A Patient-Derived 3D Co-Culture System for Efficacy Testing of Immunotherapeutic Approaches in Cancer

Christian Schmees, Ph.D., Head, Tumor Biology, NMI Natural and Medical Sciences Institute at the University of TübingenAt the NMI we have developed a patient-derived model system to allow for pre-selection of cancer immunotherapeutic products with the highest potential for further preclinical and clinical evaluation. Our co-culture platform comprises primary human 3D tumor spheroids and autologous antigen-specific T lymphocytes. The tumor targeting efficacy of T cell populations is assessed using fluorescence-based analysis of T cell infiltration and quantification of the degree of cytotoxicity induced in the spheroid.

Tuesday, November 10 | 6:00-9:00 PM(SC3) Expert ThinkTank: How to Meet the Need for Physiologically Relevant Assays It used to be adequate to build target-specific and robust assays to drive lead optimization. These assays were relatively inexpensive and reliable and could be counted on to provide chemists with usable results. However, with time, it has become apparent that it is not enough to be robust and target specific. To build therapies for patients, we need to have assays that are more predictive of patient outcome. The current buzz words are “physiologically relevant assays.” This session will explore the need for physiologically relevant assays and explore the ways that we can achieve this endpoint.

Moderator: Lisa Minor, Ph.D., President, In Vitro Strategies, LLCPanelists:• Anthony M. Davies, Ph.D., Center Director, Translational Cell Imaging

Queensland (TCIQ), Institute of Health Biomedical Innovation, Queensland University of Technology

• Shane Horman, Ph.D., Research Investigator, Genomics Institute of the Novartis Research Foundation

• Jesse Lugus, Ph.D., Research Investigator, Developmental & Molecular Pathways, Novartis Institutes for BioMedical Research

• David Nolte, Ph.D., Professor, Physics, Purdue University; President, Animated Dynamics, Inc.

• Serena Silver, Ph.D., Senior Investigator & Group Leader, Molecular Pharmacology, Novartis

• Lena Smirnova, Ph.D., Research Associate, Johns Hopkins Center for Alternatives to Animal Testing, Johns Hopkins University Bloomberg School of Public Health

• Wei Sun, Ph.D., Scientist, Therapeutics for Rare and Neglected Diseases (TRND), National Center for Advancing Translational Sciences (NCATS)

• Fabien Vincent, Ph.D., Associate Research Fellow, Hit Discovery and Lead Profiling, Pfizer

*Separate registration required

DINNER SHORT COURSES*

Present a Poster & Save!Cambridge Healthtech Institute (CHI) encourages attendees to gain further exposure by presenting their work in the poster sessions. To secure a poster board and inclusion in the conference materials, your abstract must be submitted, approved and your registration paid in full by October 9, 2015.

• Your research will be seen by leaders from top pharmaceutical, biotechnology, academic and government institutes• Your poster abstract will be published in the conference materials• Receive $50 off your registration fee

*Separate registration required

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SPONSORSHIP, EXHIBIT & LEAD GENERATION INFORMATIONCHI offers comprehensive packages that can be customized to your budget and objectives. Sponsorship allows you to achieve your goals before, during, and long after the event. Packages may include presentations, exhibit space and branding, as well as the use of delegate lists. Signing on early will maximize your exposure to qualified decision-makers and drive traffic to your website in the coming months.

Podium Presentations — Available within Main Agenda! Showcase your solutions to a guaranteed, targeted audience through a 15- or 30-minute presentation during a specific program, breakfast, lunch, or a pre-conference workshop. Package includes exhibit space, on-site branding, and access to cooperative marketing efforts by CHI. Presentations will sell out quickly! Sign on early to secure your talk.

Invitation-Only VIP Dinner/Hospitality Suite Select specific delegates from the pre-registration list to attend a private function at an upscale restaurant or a reception at the hotel. From extending the invitations, to venue suggestions, CHI will deliver your prospects and help you make the most of this invaluable opportunity.

Focus GroupCHI will gladly provide you the opportunity of running a focus group on-site. This exclusive gathering can be useful to conduct market research, collect feedback on a new product idea, and collect marketing intelligence from industry experts on a specific topic.

User Group Meeting/Custom Event Co-locate your user group meeting or custom event. CHI will help market the event, manage logistical operations, develop the agenda, and more. CHI can handle the entirety of the meeting or select aspects.

Exhibit Exhibitors will enjoy facilitated networking opportunities with qualified delegates, making it the perfect platform to launch a new product, collect feedback, and generate new leads. Exhibit space sells out quickly, so reserve yours today!

Additional branding and promotional opportunities are available, including:

• Hotel Room Keys• Conference Tote Bags• Literature Distribution (Tote Bag Insert or Chair Drop)• Badge Lanyards• Program Guide Advertisement

2014 EXHIBITORS

Biolog

BioMedTech Laboratories, Inc.

CYTOO

DiscoveRx

Essen BioScience

InSphero Inc.

Intellicyt Corporation

KIYATEC

Kuraray Co., Ltd.

MD Biosciences, Inc.

Medicyte GmbH

Mimetas

Nortis, Inc.

ProQinase GmbH

Retrogenix Ltd.

SCIVAX USA Inc.

Shantani Proteome Analytics Pvt Ltd.

Sumitomo Bakelite Co., Ltd.

TTP Labtech

For sponsorship & exhibit information, please contact:

Katelin Fitzgerald — Senior Business Development Manager781-972-5458 | kfitzgerald@healthtech.com

HOTEL & TRAVEL INFORMATIONConference Hotel:Renaissance Waterfront Hotel606 Congress StreetBoston, MA 02210Phone: 617-338-4111

Discounted Room Rate: $289 s/dDiscounted Room Rate Cut-off Date: October 14, 2015

Please visit the travel page of www.fastcongress.com for additional information and to book your hotel.

MEDIA PARTNERSMEDIA SPONSOR

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LEAD SPONSORING PUBLICATIONS:

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Looking for additional ways to drive leads to your sales team? CHI’s Lead Generation Programs will help you obtain more targeted, quality leads throughout the year. We will mine our database of 800,000+ life science professionals to your specific needs. We guarantee a minimum of 100 leads per program!

Opportunities include:

• Whitepapers • Web Symposia• Custom Market Research Surveys• Podcasts

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THIRD ANNUAL

Phenotypic Drug DiscoveryMaximizing Information in Early Drug Discovery for Better Target and Drug Selection

NOVEMBER 9-10, 2015

SUNDAY, NOVEMBER 85:00 pm Short Course Registration and Main Conference Pre-Registration

6:00-9:00 (SC1) Dinner Short Course*: Introduction to High-Content Phenotypic Screening

*Separate registration required. See page 4 for details.

MONDAY, NOVEMBER 97:00 am Conference Registration and Morning Coffee

ORGANOIDS AND PRIMARY ORGANOTYPIC 3D CULTURE IN DRUG DISCOVERY

8:00 Chairperson’s Opening RemarksDavid Grainger, Ph.D., Distinguished Professor, Pharmaceutical Chemistry, University of Utah

8:10 Characterizing Organotypic Tumor Tissue Slice Culture for Use in Drug DiscoveryEmma Davies, Ph.D., Senior Scientist, Oncology iMed, AstraZenecaPreclinical in vitro models that better represent the complexity of an in situ human tumor are being sought as part of the IMI project PREDECT (www.predect.eu). It is hoped that better recapitulation of the clinical situation, preclinically, will greatly improve target validation and ultimately get better drugs to patients. As part of PREDECT we have been investigating the use of organotypic slice culture for cultivation of tumor material ex vivo.

8:35 High-Throughput Screening Using a Primary Human 3D Organotypic CultureHilary Kenny, Ph.D., Research Associate (Assistant Professor), Obstetrics & Gynecology, University of ChicagoA multilayered culture containing primary human fibroblasts, mesothelial cells and extracellular matrix was adapted into a robust and reliable 384- and 1,536-multi-well high-throughput screening assay that reproduces the human ovarian cancer metastatic microenvironment. The identified inhibitors were validated using multiple cells and independent in vitro and in vivo secondary assays. These assays specifically investigated the effect of the compounds on ovarian cancer cell adhesion, invasion, proliferation and metastasis to the peritoneal microenvironment. Collectively, these findings show that a 3D organotypic culture can be adapted for high-throughput screening.

9:00 Analyses of Prostate and Bladder Tumor OrganoidsMichael M. Shen, Ph.D., Professor, Medicine and Genetics and Development, Columbia University

9:25 A 3D Culture Model of Alzheimer’s Disease: Challenges and PerspectivesDoo Yeon Kim, Ph.D., Assistant Professor, Neurology, Genetics and Aging Research Unit, Massachusetts General Hospital, Harvard Medical SchoolWe recently developed a human neural cell culture model of Alzheimer’s disease (AD) based on a three-dimensional (3D) cell culture system. This unique cellular AD model recapitulated key events of the pathogenic cascade of this disease, including β-amyloid plaques and neurofibrillary tangles. In this talk, I will present recent updates on our 3D culture model and discuss challenges and prospects.

9:50 Sponsored Presentation (Opportunity Available)

10:05 Coffee Break in the Exhibit Hall with Poster Viewing

10:50 3D Brain Models to Study Neurotoxicity and NeurodegenerationLena Smirnova, Ph.D., Research Associate, Johns Hopkins Center for Alternatives to Animal Testing, Johns Hopkins University Bloomberg School of Public Health

The increasing incidence of neurodevelopmental disorders and lack of cure for neurodegenerative diseases such as Parkinson’s require new human-relevant models. iPSCs allow addressing gene-environment interactions. Therefore, we developed two 3D human neuronal models: (1) human iPSC-derived 3D mini-brains to recapitulate neurodevelopment and after maturation to selectively damage dopaminergic neurons by Parkinson agents, and (2) a homogeneous LUHMES 3D dopaminergic neuronal model, to study their molecular signatures and pathways.

11:15 In vitro Hydrogel-Based Culture of Patient-Derived Xenografts for Cancer StudiesDaniel A. Harrington, Ph.D., Assistant Director, Collaborative Research Laboratory; Faculty Fellow, BioSciences, Rice UniversityMany primary cell types, including PDX models, are not readily grown on conventional 2D tissue culture substrates. We describe our ongoing efforts using customizable, biocompatible hydrogels to enable the extended laboratory culture of cancer PDXs and other primary cells in 3D. This platform permits the use of these desirable cell lines for laboratory manipulation and drug testing in miniaturizable formats.

11:40 Addressing Challenges in Organoid Culture Using a High-Throughput Microraft Array PlatformAdam D. Gracz, Ph.D., Postdoctoral Fellow, Magness Lab, Gastroenterology and Hepatology, University of North Carolina, Chapel HillOrganoid cultures have emerged as a powerful tool for understanding adult stem cell biology in a wide range of tissues. However, conventional organoid methodology presents unique challenges in terms of accurate quantification and retrieval of samples. Bioengineered microraft arrays address these challenges by providing a high-throughput platform for long-term clonal tracking and retrieval of organoids. As proof of concept, we use microraft arrays to study stem cell-niche interaction and probe the molecular characteristics of organoid phenotypes.

12:05 pm Comparing 2D Kidney Cell and 3D Kidney Organoid Cultures for in vitro Drug Toxicity Assays David Grainger, Ph.D., Distinguished Professor, Pharmaceutical Chemistry, University of UtahMany new 3-D cell culture models seek to preserve in vivo-like organization within tissue-like or organoid constructs to elicit more relevant pharmacological toxicity and toxicity marker up-regulation. We report our development of a kidney proximal tubule (PT) 3D gel-based organoid culture comparison against conventional 2D kidney cell cultures to assess nephrotoxicity markers from common model drugs and select nanoparticles.

12:30 Luncheon Presentation: Profiling of Sponsored by 1,600 Novel Natural Product-Based Compounds across 13 Human Primary Cell-Based Phenotypic AssaysJamil Aarbiou, Team Leader, Biology BioFocus, a Charles River company, Leiden, The NetherlandsTo support our partners’ drug discovery programs, we developed >100 phenotypic human primary cell assays. One of our clients, Janssen Incubator, developed a natural product drug discovery platform using natural product scaffold-based chemical entities. We used 13 human primary cell-based assays, from RA, IPF, T2D or healthy donors, to screen 1,600 compounds. Data from these screens provided valuable starting points for further compound optimization and highlighted which assays could help identify unique, disease-relevant mechanisms of action.

PHENOTYPIC SCREENING FOR NEW TARGET, PATHWAY AND MECHANISM-OF-ACTION DISCOVERY

2:00 Chairperson’s RemarksDavid C. Swinney, Ph.D., CEO, Institute for Rare and Neglected Diseases Drug Discovery (iRND3)

2:05 Phenotypic Screening Identifies New, Diverse Molecular Mechanisms of Action (MMOAs)David C. Swinney, Ph.D., CEO, Institute for Rare and Neglected Diseases Drug Discovery (iRND3)

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There is a great need for new medicines with novel mechanisms that provide increased efficacy and improved safety. Recently approved medicines work in many different ways and phenotypic assays contributed to the identification of the many, different MMOAs. It is clear that phenotypic assays are an important tool to identify novel MMOAs and the corresponding medicines.

2:30 Small-Molecule Discovery for Diabetes: The Importance of Combining a Phenotypic Approach and Mechanism-of-Action StudiesBridget Wagner, Ph.D., Director, Pancreatic Cell Biology and Metabolic Disease, CSofT, Broad Institute of MIT and HarvardIdentifying small molecules that impact on pancreatic beta-cell survival and function could have a great impact on developing new diabetes therapies. Taking a phenotypic cell-based approach can help speed this process. However, a major bottleneck in the process is determining the mechanism of action of novel compounds. Here, I will discuss our approaches to small-molecule discovery in the beta cell, as well as current efforts to streamline the process of understanding mechanistic activity.

2:55 Targeting Tumor Recurrence through Physiologically Relevant ScreensKimberly Hartwell, Ph.D., Research Scientist, Vertex PharmaceuticalsEfforts to develop more effective cancer therapies may benefit from high-throughput screening systems that reflect the complex physiology of the disease, including cancer stem cells and supportive interactions with the malignant microenvironment. Primary cancer cells were cultured with stromal cells, as were primary normal cells, revealing cancer-specific stem-cell dependencies by small-molecule screening.

3:20 Sponsored Presentation (Opportunity Available)

3:50 Refreshment Break in the Exhibit Hall with Poster Viewing

4:45 Information in Biological Images: Targeting Diseases and Characterizing CompoundsAnne E. Carpenter, Ph.D., Director, Imaging Platform, Broad Institute of Harvard and MITMicroscopy images contain rich information about the state of cells, tissues and organisms. Our laboratory extracts patterns of morphological perturbations (“signatures”) from images to identify similarities and differences between chemical or genetic treatments, with the ultimate goal to identify the causes and potential cures of disease. Using model systems that are more and more physiologically relevant, we are developing assays and accompanying algorithms to extract multi-parametric morphological fingerprints of cell populations.

5:10 Target Hypothesis Generation and Validation for PTS Hits Using Target Space AnnotationsAndras Bauer, Ph.D., Senior Scientist, Immunology and Respiratory Therapeutic Area, Boehringer IngelheimBinding of a small molecule to its target domain is a prerequisite of biological activity. By interrogating existing target-ligand pairs covering the known ligandable proteome, we can predict candidate target-ligand pairs for phenotypic screening hits. An alternative to this method is using purified protein libraries representing ligandable domains to screen for protein-target domain interactions in a label-free format. This talk will focus on implementation of both technologies for generating and validating target-ligand hypotheses for bioactive compounds emerging from phenotypic screens.

5:35 Repurposing Drug Screens to Elucidate New Drug Targets and Pathways for Infectious Disease and CancerWei Sun, Ph.D., Scientist, Therapeutics for Rare and Neglected Diseases (TRND), National Center for Advancing Translational Sciences (NCATS)NCATS has established a unique approved drug collection containing 4,265 compounds. Using this library, we have screened against several disease models, including malaria gametocytes, antibiotic-resistant bacteria and drug-resistant ovarian cancer. Compared to target-based screens, these phenotypic-based screens are more disease relevant, offering additional biological complexity. Not only were potent candidates for further drug development identified, but these screens also revealed novel molecular targets and pathways that increased insight into these disease processes.

6:00-7:00 Welcome Reception in the Exhibit Hall with Poster Viewing6:45 Short Course Registration

7:00-9:00 (SC2) Dinner Short Course*: Screening Strategies for Cancer Immunotherapy

*Separate registration required. See page 4 for details.

TUESDAY, NOVEMBER 107:00 am Conference Registration and Morning Coffee

PHENOTYPIC SCREENING USING PRIMARY AND STEM CELL-DERIVED MODELS

8:00 Chairperson’s Opening RemarksJing Li, Ph.D., Director, Genomics and Phenotypic Screening, Merck Research Laboratories

8:10 Phenotypic Discovery Approaches to Generative Medicine in AstraZenecaPer Erik Stromstedt, Ph.D., Director, Screening Sciences & Sample Management/Reagent & Assay Development, AstraZeneca R&DNative cell types with relevance to drug discovery in cardiac regeneration and islet health are being used by AstraZeneca to develop assays with improved physiological relevance over traditional approaches. Development and application of phenotypic assays using cellular systems utilizing the iPS technology, precise genome editing (PGE) technologies and primary human cells will be discussed. The presentation will use case studies to demonstrate both the advantages and hurdles of these approaches to identify novel targets, pathways or mode of action.

8:35 Opportunities and Challenges with Phenotypic Screening Using Human iPS-Derived NeuronsHicham Alaoui, Ph.D., Director, Biochemical and Cellular Pharmacology, Genentech

9:00 Utilizing hiPSC-Derived Differentiated Cells for High-Throughput Drug ScreeningAnne Bang, Ph.D., Director, Cell-Based Disease Modeling and Screening, Sanford-Burnham-Prebys Medical Discovery InstituteDevelopment of technology platforms that can be used to perform compound screens against patient-specific human induced pluripotent stem cell (hiPSC)-derived cell types with relatively high throughput will be essential to realize the potential that these cells hold for disease modeling and drug discovery. Towards this goal, we have been working to develop a standardized battery of assays against which hiPSC-derived neurons can be screened for specific phenotypes. Our results demonstrate the feasibility of performing higher throughput drug screens on hiPSC-derived neurons and establish platforms for future screens using patient specific cells.

9:25 Sponsored Presentation (Opportunity Available)9:55 Coffee Break in the Exhibit Hall with Poster Viewing

CASE STUDIES IN PHENOTYPIC DRUG DISCOVERY10:45 Lessons Learned in Phenotypic Drug DiscoveryFabien Vincent, Ph.D., Associate Research Fellow, Hit Discovery and Lead Profiling, PfizerThis presentation will cover a collection of scientific vignettes (i.e., lessons) based on in-house experience with phenotypic drug discovery and touching on a broad range of topics including designing the best phenotypic assays, primary cells and donor-to-donor variability analysis, hit triage and validation, use and misuse of chemogenomics libraries, toxicity and safety derisking of PDD hits.

11:10 Identification of HIV Latency Reactivation Agents through Phenotypic Screening: A Case StudyDavid Tellers, Ph.D., Principal Scientist, Discovery Chemistry, MerckRecent advances in the fields of biology, chemistry, proteomics and screening technology have greatly improved our chances of identifying underlying protein targets. We will highlight progress on all these fronts as they relate to the discovery of mechanisms and chemical matter, derived from an ultra-high throughput phenotypic screen, which induces latent HIV expression in infected cells.

11:35 A Case Study of Applying Annotated Chemical Libraries and Chemical Biology Strategy in Phenotypic ScreensZining Wu, Ph.D., Investigator, Molecular Discovery Research, GlaxoSmithKline

12:00 pm Phenotypic Screening for Anti-Diabetes AgentsFrancis Willard, Ph.D., Senior Research Scientist, Quantitative Biology, Lilly Research Labs

12:30 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own1:10 Close of Conference

8

INAUGURAL

3D Cell Culture: Organoid, Spheroid, and Organ-on-a-Chip ModelsPhysiologically-Relevant 3D Models for Drug Discovery and Toxicity Assessment

NOVEMBER 9-10, 2015

SUNDAY, NOVEMBER 85:00 pm Short Course Registration and Main Conference Pre-Registration

6:00-9:00 (SC1) Dinner Short Course*: Introduction to High-Content Phenotypic Screening

*Separate registration required. See page 4 for details.

MONDAY, NOVEMBER 97:00 am Conference Registration and Morning Coffee

ORGANOIDS AND PRIMARY ORGANOTYPIC 3D CULTURE IN DRUG DISCOVERY

8:00 Chairperson’s Opening RemarksDavid Grainger, Ph.D., Distinguished Professor, Pharmaceutical Chemistry, University of Utah

8:10 Characterizing Organotypic Tumor Tissue Slice Culture for Use in Drug DiscoveryEmma Davies, Ph.D., Senior Scientist, Oncology iMed, AstraZenecaPreclinical in vitro models that better represent the complexity of an in situ human tumor are being sought as part of the IMI project PREDECT (www.predect.eu). It is hoped that better recapitulation of the clinical situation, preclinically, will greatly improve target validation and ultimately get better drugs to patients. As part of PREDECT we have been investigating the use of organotypic slice culture for cultivation of tumor material ex vivo.

8:35 High-Throughput Screening Using a Primary Human 3D Organotypic CultureHilary Kenny, Ph.D., Research Associate (Assistant Professor), Obstetrics & Gynecology, University of ChicagoA multilayered culture containing primary human fibroblasts, mesothelial cells and extracellular matrix was adapted into a robust and reliable 384- and 1,536-multi-well high-throughput screening assay that reproduces the human ovarian cancer metastatic microenvironment. The identified inhibitors were validated using multiple cells and independent in vitro and in vivo secondary assays. These assays specifically investigated the effect of the compounds on ovarian cancer cell adhesion, invasion, proliferation and metastasis to the peritoneal microenvironment. Collectively, these findings show that a 3D organotypic culture can be adapted for high-throughput screening.

9:00 Analyses of Prostate and Bladder Tumor OrganoidsMichael M. Shen, Ph.D., Professor, Medicine and Genetics and Development, Columbia University

9:25 A 3D Culture Model of Alzheimer’s Disease: Challenges and PerspectivesDoo Yeon Kim, Ph.D., Assistant Professor, Neurology, Genetics and Aging Research Unit, Massachusetts General Hospital, Harvard Medical SchoolWe recently developed a human neural cell culture model of Alzheimer’s disease (AD) based on a three-dimensional (3D) cell culture system. This unique cellular AD model recapitulated key events of the pathogenic cascade of this disease, including β-amyloid plaques and neurofibrillary tangles. In this talk, I will present recent updates on our 3D culture model and discuss challenges and prospects.

9:50 Sponsored Presentation (Opportunity Available)

10:05 Coffee Break in the Exhibit Hall with Poster Viewing

10:50 3D Brain Models to Study Neurotoxicity and NeurodegenerationLena Smirnova, Ph.D., Research Associate, Johns Hopkins Center for Alternatives to Animal Testing, Johns Hopkins University Bloomberg School of Public HealthThe increasing incidence of neurodevelopmental disorders and lack of cure for neurodegenerative diseases such as Parkinson’s require new human-relevant models. iPSCs allow addressing gene-environment interactions. Therefore, we developed two 3D human neuronal models: (1) human iPSC-derived 3D mini-brains to recapitulate neurodevelopment and after maturation to selectively damage dopaminergic neurons by Parkinson agents, and (2) a homogeneous LUHMES 3D dopaminergic neuronal model, to study their molecular signatures and pathways.

11:15 In vitro Hydrogel-Based Culture of Patient-Derived Xenografts for Cancer StudiesDaniel A. Harrington, Ph.D., Assistant Director, Collaborative Research Laboratory; Faculty Fellow, BioSciences, Rice UniversityMany primary cell types, including PDX models, are not readily grown on conventional 2D tissue culture substrates. We describe our ongoing efforts using customizable, biocompatible hydrogels to enable the extended laboratory culture of cancer PDXs and other primary cells in 3D. This platform permits the use of these desirable cell lines for laboratory manipulation and drug testing in miniaturizable formats.

11:40 Addressing Challenges in Organoid Culture Using a High-Throughput Microraft Array PlatformAdam D. Gracz, Ph.D., Postdoctoral Fellow, Magness Lab, Gastroenterology and Hepatology, University of North Carolina, Chapel HillOrganoid cultures have emerged as a powerful tool for understanding adult stem cell biology in a wide range of tissues. However, conventional organoid methodology presents unique challenges in terms of accurate quantification and retrieval of samples. Bioengineered microraft arrays address these challenges by providing a high-throughput platform for long-term clonal tracking and retrieval of organoids. As proof of concept, we use microraft arrays to study stem cell-niche interaction and probe the molecular characteristics of organoid phenotypes.

12:05 pm Comparing 2D Kidney Cell and 3D Kidney Organoid Cultures for in vitro Drug Toxicity Assays David Grainger, Ph.D., Distinguished Professor, Pharmaceutical Chemistry, University of UtahMany new 3-D cell culture models seek to preserve in vivo-like organization within tissue-like or organoid constructs to elicit more relevant pharmacological toxicity and toxicity marker up-regulation. We report our development of a kidney proximal tubule (PT) 3D gel-based organoid culture comparison against conventional 2D kidney cell cultures to assess nephrotoxicity markers from common model drugs and select nanoparticles.

12:30 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

ENGINEERING FUNCTIONAL ORGAN-ON-A-CHIP MODELS2:00 Chairperson’s RemarksDan Dongeun Huh, Ph.D., Wilf Family Term Chair & Assistant Professor, Bioengineering, University of Pennsylvania

2:05 Microengineered Physiological Bio-Mimicry: Human Organs-on-ChipsDan Dongeun Huh, Ph.D., Wilf Family Term Chair & Assistant Professor, Bioengineering, University of PennsylvaniaThis talk will present interdisciplinary research efforts focused on leveraging unique capabilities of microfluidics and microfabrication to develop microengineered biomimetic models that reconstitute complex structures, dynamic

FASTCongress.com 9

microenvironments, and physiological functionality of human organs. Specifically, I will talk about: i) a bioinspired microsystem that mimics the structural and functional complexity of the alveolar-capillary interface in the living human lung, ii) a specialized in vitro human disease model that simulates pulmonary edema, and iii) a microengineered model of the ocular surface in the human eye.

2:30 Replicating Organ and Tissue Function Using MicrofabricationJoseph L. Charest, Ph.D., Group Leader, Biomedical Microsystems, Charles Stark Draper Laboratory, Inc.Microfabricated systems can mimic components of native tissue resulting in realistic in vitro models. Specifically, micro/nano-topography, microfluidically-controlled fluid flow, and small scale structures can guide cells to form tissue with organ- or tissue-specific function. The microfabrication approach yields models representing kidney and tumor as well as other tissues, with the potential to include unique features and new metrics to evaluate and predict efficacy of new therapies.

2:55 3D Cell Culture for Quantitatively Identifying Form and Function of Cancer Stem CellsMuhammad H. Zaman, Ph.D., Professor, Howard Hughes Medical Institute; Professor, Biomedical Engineering and International Health, Boston UniversityUnderstanding how cells respond to mechanical, chemical and structural cues in 3D environments is not only important from a fundamental perspective, but also needed for designing better therapeutics. Our work, combining multi-scale simulations, novel biomechanical tools and biomimetic hydrogels will analyze cancer cell response to chemotherapeutics, and optimization of 3D culture to analyze cellular form and function during various stages of disease.

3:20 Sponsored Presentation (Opportunity Available)

3:50 Refreshment Break in the Exhibit Hall with Poster Viewing

4:45 3D Printed and Nanofabricated Scaffolds for Engineering Contractile Cardiac MuscleAdam Feinberg, Ph.D., Associate Professor, Materials Science & Biomedical Engineering, Carnegie Mellon UniversityWe are developing tissue engineering technologies to build the extracellular matrix (ECM) from the bottom-up just like cells do during embryogenesis and wound healing. To do this, we have developed a biomimetic, surface-initiated assembly process that recapitulates how cells naturally build the ECM in tissues at the nanoscale as well as 3D bioprinting techniques to create larger structures that incorporate more intricate anatomy. Together, these approaches provide a reductionist system where complexity can be engineered back into the matrix system, which we are exploiting as a 3D cardiac tissue engineering platform and basic science tool.

5:10 Heart-on-a-Chip Platforms for Drug Toxicity TestingVille Kujala, Ph.D., Postdoctoral Fellow, Disease Biophysics Group, Wyss Institute for Biologically Inspired Engineering, John A. Paulson School of Engineering and Applied Sciences, Harvard UniversityThe Disease Biophysics Group at Harvard University has developed heart-on-a-chip platforms for cardiac contractility and electrophysiology measurements. Here, we will cover the latest advancements and their applications in drug toxicity testing.

5:35 Talk Title to be AnnouncedKevin E. Healy, Ph.D., Professor, Bioengineering, University of California Berkeley

6:00-7:00 Welcome Reception in the Exhibit Hall with Poster Viewing

6:45 Short Course Registration

7:00-9:00 (SC2) Dinner Short Course*: Screening Strategies for Cancer Immunotherapy

*Separate registration required. See page 4 for details. TUESDAY, NOVEMBER 107:00 am Conference Registration and Morning Coffee

3D SPHEROID MODELS FOR DRUG SCREENING8:00 Chairperson’s Opening RemarksJeffrey Morgan, Ph.D., Professor, Medical Science & Engineering, Brown University

8:10 Designer 3D Spheroids for Testing Drugs and Drug UptakeJeffrey Morgan, Ph.D., Professor, Medical Science & Engineering, Brown UniversityThis talk will focus on the use of our micro-mold technology to form designer 3D spheroids of mixed cell types. We are quantifying drug transport and drug elimination and the role of efflux pumps.

8:35 Drug Response in the Context of the 3D Tumor MicroenvironmentEugen Dhimolea, Ph.D., Instructor, Medicine, Dana-Farber Cancer Institute, Harvard Medical SchoolIn vitro 3D cultures of malignant cell lines and patient-derived samples mimic the architecture and pathophysiology of human tumors more faithfully than conventional 2D cultures. In addition, 3D cultures often reassume the molecular profile and drug-resistant phenotype observed in the clinic. The development of appropriate tissue-engineered tumor models and their adaptation for scalable drug testing will contribute significantly to understanding cancer biology, discovering new therapeutics and designing personalized cancer treatments.

9:00 3D Spheroids for Anti-Cancer Drug ScreeningDarren Finlay, Ph.D., Research Assistant Professor, Sanford-Burnham-Prebys Medical Discovery Institute3D spheroid cultures better recapitulate true tumor architecture and nutrient gradients than do traditional 2D monolayers. Here we demonstrate how 3D cancer spheroids show differential sensitivity to relevant anti-cancer agents and how co-culture with various stromal, or non-tumor, factors can greatly modulate chemosensitivity. Furthermore, we show how patient tumor-derived 3D spheroid samples can be used for precision medicine profiling.

9:25 Sponsored Presentation (Opportunity Available)

9:55 Coffee Break in the Exhibit Hall with Poster Viewing

10:45 Reaching Physiological Relevance with 3D Cell CultureSophie A. Lelièvre, D.V.M., LLMPH, Ph.D., Professor, Basic Medical Sciences & Cancer Pharmacology; Director, 3D Cell Culture Core Facility (3D3C) in Discovery Park, Purdue UniversityRelevance to physiological parameters of real tissues is a requirement for any 3D cell culture model to bring useful information and findings. Using the example of the mammary gland, I will discuss the criteria that inform the choice of the 3D culture system, including spheroid-like culture, cultures favoring the interaction of different tissues, and organ-on-a-chip culture in order to provide a reproducible model for basic and translational research.

11:10 High-Throughput 3-D Small Cell Number Spheroids for Ovarian Cancer Drug Screening for Individualized TherapiesGeeta Mehta, Ph.D., Assistant Research Scientist, Biomedical Engineering, University of MichiganWe have recently established a high-throughput platform for stable formation of uniform-sized ovarian cancer spheroids using very low cell numbers (ranging from 10 cells to 100 cells). We assess the utility of spheroids generated in this platform by performing a chemosensitivity assay. We believe that this platform can be applied to the use of rare cancer stem-like cell populations found in primary patient samples and ascites. The stable incorporation of low cell numbers ensures that these samples can be handled prudently in order to study novel and emerging drugs that target rare cancer initiating cells and chemoresistant populations.

11:35 Developing Spheroid Preclinical Models of Advanced Prostate Cancer for High-Throughput ScreensDonna Peehl, Ph.D., Research Professor, Urology, Stanford UniversityProstate cancer (PCa) is under-represented in large cell line panels used to screen drugs, and the most predictive preclinical model of 3D culture has never been widely applied to screen PCa cells. New methodologies to culture spheroids from patient tissues and xenografts will provide models that encompass the genetic heterogeneity of advanced PCa, and facilitate high-throughput assays to identify new therapeutic leads and correlate drug response with genetic phenotype.

12:00 pm 3D in vitro Modeling of Epithelial Ovarian Cancer for Biomarker DiscoverySimon A. Gayther, Ph.D., Professor, Preventive Medicine, University of Southern California Keck School of MedicineWe have established multiple ovarian cancer cell lines and normal ovarian epithelial cells as 3D multicellular spheroid models following cell culture using polyHEMA-coated tissue culture plastics. 3D EOC cell cultures display many of the histological features of primary tumors not present in 2D monolayer cultures. Complex cell/cell and cell/matrix adhesions can be seen throughout the surface of the cell membrane of each cell. Cells within spheroids typically cycle more slowly, and upregulate expression of tumor-associated proteins that are highly expressed in primary ovarian cancer specimens. We have also shown that the 3D models are typically more resistant to chemotherapeutic agents and small molecule therapies than 2D models.

12:30 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

1:10 Close of Conference

10

THIRD ANNUAL

Screening & Functional Analysis of 3D ModelsComplex Cellular Models Predictive of Human Response to Improve Early Decision Making

NOVEMBER 10-11 , 2015

TUESDAY, NOVEMBER 1012:30 pm Conference Registration

INTEGRATED APPROACH TO IN VITRO DRUG DISCOVERY: TISSUE ENGINEERING MEETS SYSTEMS BIOLOGY

1:55 Chairperson’s Opening Remarks2:00 Integration of Microdevices, Systems Biology and Tissue Engineering for Drug DevelopmentLinda G. Griffith, Ph.D., Professor, Biological Engineering, MIT

2:25 Talk Title to be AnnouncedJean-Louis Klein, Ph.D., Target and Pathway Validation, Platform Technology and Science, GlaxoSmithKline

2:50 Exploring Pancreatic Neogenesis with LWM CompoundsJesse Lugus, Ph.D., Research Investigator, Developmental & Molecular Pathways, Novartis Institutes for BioMedical ResearchTo determine whether the ductular epithelial cells of the adult pancreas possess the capacity to differentiate into beta cells, we developed a 3D culture of “miniducts” and screened them with a LWM compound library to look for expression of insulin.

3:15 Sponsored Presentation (Opportunity Available)3:45 Refreshment Break in the Exhibit Hall with Poster Viewing

MICROENGINEERED 3D MODELS FOR DRUG SAFETY TESTING

4:30 Microengineered Cell and Tissue Systems: Evolution of in vitro Liver TechnologiesO. Berk Usta, Ph.D., Instructor, Surgery, Center for Engineering in Medicine, Massachusetts General Hospital, Harvard Medical SchoolThe liver performs many key functions such as serving as the metabolic hub of the body. For this reason, the liver is the focal point of many investigations aimed at understanding an organism’s toxicological response to endogenous and exogenous challenges. We will present a survey and critical comparison of in vitro liver technologies along a broad spectrum, but focus on the current renewed push to develop “organs-on-a-chip” in our laboratory and elsewhere.

4:55 A 3D Human Kidney Microphysiological System for Drug Safety TestingEdward J. Kelly, Ph.D., Associate Professor, Pharmaceutics, University of Washington, SeattleThe kidney proximal tubule is a primary target of drug-induced nephrotoxicity. In this talk, I will describe the development and functional characterization of a 3-dimensional human kidney proximal tubule microphysiological system or MPS. The MPS anatomically replicates the polarity of the proximal tubule, expresses appropriate marker proteins, and exhibits biochemical and synthetic activities, as well as secretory and reabsorptive processes associated with in vivo proximal tubule function. Current studies with the MPS are focused on response mechanisms to prototypical nephrotoxins as well as new chemical entities.

5:20 Development of a Rat Primary Hepatocyte Spheroid Model for Toxicity ScreeningLorin Jakubek, Ph.D., Postdoctoral Researcher, Predictive and Investigative Toxicology, SanofiCommon methods used to produce spheroids are often limited in their application to toxicity screening due to cell loss, cell number or feasibility of the culturing method to existing assays. The objective of this work is to develop spheroids of primary hepatocytes in a format amenable to assays currently in use in the pharmaceutical industry. Here we show a characterization of the

model for viability, morphology and functionality of primary hepatic spheroids. Examples of preliminary toxicity data will be presented as part of the ongoing model validation. While still in the validation phase, this model shows promise for predictive toxicity screens.

5:45 Short Course Registration

6:00-9:00 Dinner Expert ThinkTank* (SC3) How to Meet the Need for Physiologically Relevant Assays

*Separate registration required. See page 4 for details.

WEDNESDAY, NOVEMBER 117:00 am Conference Registration and Morning Coffee

PHENOTYPIC AND HIGH-CONTENT SCREENING OF 3D MODELS

8:00 Chairperson’s Opening RemarksDavid Nolte, Ph.D., Professor, Physics, Purdue University; President, Animated Dynamics, Inc.

8:10 Next-Generation Assays for Next-Generation Oncology TargetsSerena Silver, Ph.D., Senior Investigator & Group Leader, Molecular Pharmacology, NovartisGrowth of cancer cells in 2D format has been a workhorse of the cancer research world, enabling high-throughput biology endeavors to identify new targets and new drugs. However, it is clear that we are sampling only a subset of cancer complexity in these models, for example by comparison of genomic characterization between primary tumors, xenografts, and cell lines grown in 2D. I will discuss our efforts to use methods such as co-culture and high-content imaging of cells grown in 3D systems to assess if these can indeed “fill the gap” and advance oncology drug discovery.

8:35 A Perspective on the Current State of 3-Dimensional and Complex Phenotypic Screening in Contemporary Drug DiscoveryShane Horman, Ph.D., Research Investigator, Genomics Institute of the Novartis Research Foundation The initiation of a drug discovery project which involves a complex or 3-dimensional phenotypic screening platform requires grappling with logistical challenges that influence every step of the process. Primarily, can the disease or tissue be accurately mimicked in an in vitro microtiter plate environment? But beyond that, careful consideration must be given to the cell type(s), growth matrix, assay and readout methods as well as the downstream data analyses. Collectively, these factors can make or break a drug discovery effort. Herein I discuss the benefits and potential pitfalls of complex and multi-culture 3D cell models currently used in the pharmaceutical industry.

9:00 Heterogeneity on a Plate: A Soft Agar-Based Assay System for Studying Tumor EvolutionArijit Chakravarty, Ph.D., Director, Modeling and Simulation, Takeda PharmaceuticalsTumor evolution is well accepted as a feature of clinical cancer etiology and response to treatment. Evidence for evolutionary processes can also be found in the preclinical in vitro and in vivo settings. Tumor evolution has clear implications for drug discovery and development, but in order to understand those implications, we have to be able to study the process first. In my talk, I will present an in vitro tumor evolution assay, developed from a soft agar culture using automated microscopy and high-content analysis. I will then discuss the analysis of this data, using methods derived from population biology and evolutionary theory.

FASTCongress.com 11

9:25 Sponsored Presentation (Opportunity Available)

9:55 Coffee Break in the Exhibit Hall with Poster Viewing

10:40 The Challenges of Identifying Cellular Phenotypes in 3D in vitro Cellular Assay SystemsAnthony M. Davies, Ph.D., Center Director, Translational Cell Imaging Queensland (TCIQ), Institute of Health Biomedical Innovation, Queensland University of TechnologyCurrently, one the biggest drivers in the field of translational research is the need to improve the relevance of cell-based assays. To achieve this goal many investigators are turning their attention to high-content analysis used in conjunction with primary cells and/or 3D cell assay models. Despite the potential benefits that these new experimental approaches may offer, their use has not been without both technical and practical difficulties. In this presentation we will discuss the challenges we have encountered here at TCIQ and the solutions that we have arrived at to meet our research objectives.

11:05 Biodynamic Imaging of 3D Tissue Models and ex vivo BiopsiesDavid Nolte, Ph.D., Professor, Physics, Purdue University; President, Animated Dynamics, Inc.The challenge to extract high-content information from inside three-dimensional tissue is met by biodynamic imaging that probes a wide range of intracellular dynamics up to 1 mm deep inside living tissue. Biodynamic imaging is compatible with virtually all three-dimensional tissue culture, such as multicellular tumor spheroids grown either in bioreactors, by the hanging drop method, or in multi-well spheroid plates, as well as ex vivo biopsies of living tissue.

11:30 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

CANCER-ON-A-CHIP: ENGINEERING 3D MODELS OF TUMOR MICROENVIRONMENT

1:00 pm Chairperson’s Opening RemarksTreena Arinzeh, Ph.D., Professor, Biomedical Engineering, New Jersey Institute of Technology

1:05 Hydrogels as Artificial Extracellular Micro-Environments to Study AngiogenesisSharon Gerecht, Ph.D., Associate Professor, Chemical & Biomolecular Engineering, Johns Hopkins UniversityHydrogel biomaterials provide a highly controlled three-dimensional (3D) environment that is structurally and biomechanically similar to the native extracellular matrix (ECM). These can provide a rich biochemical landscape as well as biophysical cues to influence cell behavior. In this talk I will present our recent efforts to develop hydrogel matrices that activate signaling pathways during 3D vascular assembly.

1:30 Targeted Combinations to Overcome Physical and Stromal Determinants of Treatment Resistance in 3D Tumor ModelsImran Rizvi, Ph.D., Instructor, Medicine and Dermatology, Brigham and Women’s Hospital, Harvard Medical SchoolThe susceptibility of cancers to therapeutic intervention is determined by epithelial mesenchymal transition status as well as a complex milieu of physical and cellular cues in the tumor microenvironment. These cues originate from many sources including the surrounding matrix, diffusible growth factors and cytokines, the architectural and organizational features of the tumor, and heterotypic communications between tumor cells and stromal partners. Among the various microenvironmental factors that warrant investigation, hydrodynamic stress and tumor endothelial cells are emerging as important modulators of biology in many cancers including ovarian cancer. Understanding the therapeutic implications of heterogeneity that result from physical and stromal cues is critical to designing more effective regimens for challenging cancers, including metastatic OvCa.

1:55 Implantable Microenvironments to Capture Stem/Cancer CellsBiju Parekkadan, Ph.D., Assistant Professor, Surgery (Bioengineering), Harvard Medical School, Massachusetts General HospitalBone marrow is an important, yet inaccessible, site to understand stem/cancer cell biology. In this presentation, we will introduce a 3D implant to model human bone marrow in mice and discuss several in vivo case studies that have captured human stem/cancer cells at this localized implant site. We also describe a bone marrow microchip as a bridge platform to capture and implant circulating stem/cancer cells for end-to-end longitudinal research.

2:20 Engineered Culture Systems for Cancer Stem CellsEsmaiel Jabbari, Ph.D., Professor of Chemical and Biomedical Engineering, Chemical Engineering, University of South CarolinaThe 3D in vitro cell culture system has emerged as an attractive approach to bridge the gap between 2D cell culture and in vivo systems. With naturally derived matrices, it is difficult to isolate and study cell response to individual factors in the microenvironment on cancer cells. Therefore, there is a need to develop engineered matrices for selection and enrichment of the most malignant stem cell subpopulation in the cancer cell population to study the role of individual factors in the tumor microenvironment on tumorigenesis.

2:45 Networking Refreshment Break3:15 TRACER: A 3D Engineered Tumor for Quantifying Spatial Metabolic Reprogramming in Hypoxic GradientsAlison McGuigan, Ph.D., Associate Professor, Chemical Engineering and Applied Chemistry, University of TorontoCurrently it is challenging to characterize specific properties of cells and the corresponding microenvironment from where they originated. We have developed a modular approach to assemble 3D engineered tumors by rolling thin (30 micron thick) tumor cell-impregnated scaffolds on an oxygen impermeable core. In our Tumor Roll for Analysis of Cell Response (TRACER), cells at different depths within the roll experience different oxygen and nutrient levels mimicking the variation seen in tumors at progressively further distances from a blood vessel. Our system can be rapidly (<1s) disassembled for analysis by unrolling. The geometry of the system allows the spatial location of the cells along the length of the strip in the disassembled construct to be easily mapped to their location in the 3D construct to facilitate separation of populations of cells from different microenvironments. Furthermore, this cell isolation can be achieved rapidly, enabling acquisition of snap-shot data such as metabolic profiles. Here we will describe use of TRACER to perform a 3D spatial metabolomics analysis of tumor cells in hypoxic gradients.

3:40 Investigating Breast Cancer Dormancy Using Tissue Engineering ModelsTreena Arinzeh, Ph.D., Professor, Biomedical Engineering, New Jersey Institute of TechnologyDespite early detection through the use of mammograms and aggressive intervention, breast cancer remains a clinical dilemma. Breast cancer (BC) can resurge after >10 years of remission. Studies indicate that BC cells (BCCs) with self-renewal and chemoresistance could be involved in dormancy. The majority of studies use in vitro, two-dimensional (2D) monolayer cultures, which do not recapitulate the in vivo microenvironment. Thus, to determine the effect of the three-dimensional (3D) microenvironment on BCCs, we use tissue engineering scaffolds that more closely mimic the extracellular matrix of the tumor and sites of metastasis. We will present findings demonstrating BC dormancy can be supported by specific features of the tissue engineering scaffolds.

4:05 Hydrogel-Facilitated 3D Tumor Microenvironment Models of Cancer Dormancy, Relapse and Micrometastasis: Fundamentals and Synergistic Drug TreatmentsKaushal Rege, Ph.D., Associate Professor, Chemical Engineering, Arizona State UniversityWe describe novel 3D tumor microenvironment models of cancer dormancy, relapse from dormancy and formation of micrometastatic nodules, all on a novel hydrogel platform. This technology facilitates the formation of dormant cancer cell and/or cancer cell-stromal cell co-cultures. These dormant 3D dormant microenvironments are resistant to anti-proliferative drugs including docetaxel and mitoxantrone. New synergistic approaches that include targeting the protein production machinery were effective in complete ablation of dormant cells. Chemo-mechanical modulation of the hydrogel results in escape of cells from dormancy, which can be greatly reduced using docetaxel.

4:30 Close of Conference

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Pricing and Registration Information

NOVEMBER 9-10 NOVEMBER 10-11

Phenotypic Drug Discovery Screening and Functional Analysis of 3D Models

3D Cell Culture: Organoid, Spheroid, and Organ-on-a-Chip Models

CONGRESS PRICING – BEST VALUE!(Includes access to 2 conferences, excludes short courses)

Early Registration Discount until September 11, 2015 $2299 $999Advance Registration Discount until October 9, 2015 $2499 $1099

Registrations after October 9, 2015 and on-site $2599 $1199

SINGLE CONFERENCE PRICING (Includes access to 1 conference, excludes short courses)

Early Registration Discount until September 11, 2015 $1399 $649Advance Registration Discount until October 9, 2015 $1599 $729Registrations after October 9, 2015 and on-site $1799 $799

DINNER SHORT COURSE PRICING(Includes access to short courses only. Add a short course to your conference registration and save $100.)

Single Short Course $595 $295Two Short Courses $895 $495Three Short Courses $1095 $595Add Short Course(s) and Save $100 -$100 -$100

Sunday Evening, November 8 6:00-9:00pm

Monday Evening, November 9 7:00-9:00pm

Tuesday Evening, November 10 6:00-9:00pm

SC1: Introduction to High-Content Phenotypic Screening

SC2: Screening Strategies for Cancer Immunotherapy

SC3: Expert ThinkTank: How to Meet the Need for Physiologically Relevant Assays

CONFERENCE DISCOUNTS

Drug Safety Executive Council (DSEC)- Discount (20% off) Members of the DSEC community will receive a 20% discount off a conference registration. Our records must indicate you are a member.Poster Submission- Discount ($50 off)Poster abstracts are due by October 9, 2015. Once your registration has been fully processed, we will send an email containing a unique link allowing you to submit your poster abstract. If you do not receive your link within 5 business days, please contact jring@healthtech.com. *CHI reserves the right to publish your poster title and abstract in various marketing materials and products.

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