Ninth Annual
New Approaches for Predicting Drug Toxicity
Discovering New Models and Integrating Innovative Strategies
June 15-16, 2016 | Boston, MA
WorldPreclinicalCongress.com/Drug-Safety-Conference
Final Agenda Now Available
Adverse drug events such as cardiotoxicity, hepatotoxicity and other organ toxicities, keep surfacing in the clinic and idiosyncratic drug toxicity continues to haunt the drug development process. So what are scientists and clinicians doing to make sure that compounds fail early and cheaply? New screening technologies such as, in vitro assays and in vivo models continue to be developed, but are the right tools being used at the right time to predict and detect adverse events? Cambridge Healthtech Institute’s ninth annual conference on Models to Approaches, looks at the scientific and technological progress being made to better predict drug related toxicities at the preclinical stage, and avoid unexpected and costly findings in the clinic. What assays and models are being used, how reliable and predictable is the data, and how is this information impacting decisions before compounds are tested in patients? Hear experiences shared by experts and join the interactive sessions and panel discussions on issues related to drug toxicity.
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Agenda-at-a-Glance
Day 1
DRUG TRANSPORTERS AND THEIR ROLE IN DRUG TOXICITY
Transporter-Mediated Drug Interactions with Endobiotics, Toxins and Nutrients
Adrian Ray, Ph.D., Senior Director, Department of Drug Metabolism, Gilead Sciences, Inc.
Combination of Top-Down and Bottom-Up Strategy to Elucidate Mechanistic Roles of Transporters in Organ Toxicity
Yurong Lai, Ph.D., Senior Principal Scientist, Pharmaceutical Candidate Optimization, Bristol-Myers Squibb
In vitro Human Intestinal Tissue Model to Assess and Predict Drug-Induced-GI Damage
Seyoum Ayehunie, Ph.D., Vice President, Immunological Systems, MatTek Corporation
Assessing Off-Target Drug Activities by Transcription Factor Profiling in FACTORIAL™ Assays
Sergei Makarov, Ph.D., CEO, Attagene
UNDERSTANDING TRANSLATIONAL CHALLENGES AND INTERPRETING SAFETY GUIDELINES
The Importance of Reverse Translation for Preclinical Off-Target Mitigation
Laszlo Urban, M.D., Ph.D., Global Head, Preclinical Secondary Pharmacology, Novartis Institutes for BioMedical Research, Inc.
Moving beyond the S6(R1): A Snapshot of Toxicity & Safety Pharmacology Tools to Evaluate Biotherapeutics
Susan M.G. Goody, Ph.D., Senior Principal Scientist, Global Safety Pharmacology, Pfizer, Inc.
Presentation to be Announced
Luncheon Presentation: CiPA: How Comprehensive Does It Have to Be
James Kramer, Ph.D., Principal Scientist, Discovery, Charles River
IN VIVO TECHNIQUES FOR MONITORING DRUG TOXICITY
A Disruption of Autonomic Balance: Use of Heart Rate Variability (HRV) in Cardiovascular Safety Pharmacology
Carrie Northcott, Ph.D., Senior Principal Scientist, Global Safety Pharmacology, Pfizer Inc.
Whole-Body Imaging of Drug-Induced Toxicity
Ming Zhao, Ph.D., Associate Professor, Feinberg School of Medicine, Northwestern University
NEW IN VITRO SCREENING APPROACHES FOR SAFETY TESTING
Combination of Screening Assays for Assessing Drug-Induced Liver Injury in Humans
Christoph Funk, Ph.D., Vice Director, Pharmaceutical Sciences, F. Hoffmann-La Roche
In vitro Approach to Classify Drugs According to Their Idiosyncratic, Drug-Induced Liver Injury Liability
Robert A. Roth, Ph.D., DABT, Professor of Pharmacology and Toxicology and Director, Graduate Program in Environmental and Integrative Toxicological Sciences, Michigan State University
Generation of Complex Disease Phenotypes in 3D Bioprinted Human Liver Tissues for the Assessment of Drug-Induced Injury
Leah Norona, Doctoral Candidate Curriculum in Toxicology, University of North Carolina at Chapel Hill
Drug-Induced Vascular Injury (DIVI)- Historical Review of Non-Clinical DIVI and Development of an Early Screening Strategy
Todd Wisialowski, MS, Associate Research Fellow, Global Safety Pharmacology, Pfizer Inc.
Day 2
INTERACTIVE BREAKOUT DISCUSSION GROUPS
TOPIC: Safety Assessments for Biologics
Moderator: Susan M.G. Goody, Ph.D., Senior PrincipalScientist, Global Safety Pharmacology, Pfizer, Inc.
TOPIC: Translation of Preclinical Findings to Clinic
Moderators: Carrie Northcott, Ph.D., Senior Principal Scientist, Global Safety Pharmacology, Pfizer Inc. Ming Zhao, Ph.D., Associate Professor, Feinberg School of Medicine, Northwestern University
TOPIC: Using iPSC for Drug Safety Screening
Moderators: Paul W. Burridge, Ph.D., Assistant Professor, Department of Pharmacology, Center for Pharmacogenomics, Northwestern University Feinberg School ofMedicine Xi Yang, Ph.D., DABT, Principal Investigator, Division of Systems Biology, National Center for Toxicological Research (NCTR), U.S. FDA
TOPIC: Key Issues Related to Drug Transporters in a Pharma R&D Setting
Moderator: Christoph Funk, Ph.D., Vice Director, Pharmaceutical Sciences, F. Hoffmann La-Roche
USE OF iPS CELLS FOR DRUG TOXICITY SCREENING
Utilization of iPSCs in Developing Human-on-a-Chip Systems for Phenotypic Screening Applications
James J. Hickman, Ph.D., Founding Director, NanoScience Technology Center; Professor, Nanoscience Technology, Chemistry, Biomolecular Science, Material Science and Electrical Engineering, University of Central Florida
Human-Induced Pluripotent Stem Cells Recapitulate Breast Cancer Patients’ Predilection to Doxorubicin-Induced Cardiotoxicity
Paul W. Burridge, Ph.D., Assistant Professor, Department of Pharmacology, Center for Pharmacogenomics, Northwestern University Feinberg School of Medicine
Utilization of Induced Pluripotent Stem Cells to Understand Tyrosine Kinase Inhibitors (TKIs)-Induced Hepatotoxicity
Qiang Shi, Ph.D., Principal Investigator, Division of Systems Biology, National Center for Toxicological Research (NCTR), U.S. FDA
UNDERSTANDING MECHANISMS TO BETTER PREDICT DRUG TOXICITY
Predict Tyrosine Kinase Inhibitors (TKIs)-Induced Cardiotoxicity Using Induced Pluripotent Stem Cell-Derived Cardiomyocytes
Xi Yang, Ph.D., DABT, Principal Investigator, Division of Systems Biology, National Center for Toxicological Research (NCTR), U.S. FDA
Prediction of Transporter-Related Drug-Induced Liver Injury (DILI) Using Integrated Approaches
Mingxiang Liao, Ph.D., Senior Scientist I, DMPK, Takeda Pharmaceutical Intl. Company
Bridging Luncheon Presentation: Case Studies in Cardiac and Neuro Safety / Toxicity Assessment Using Human iPSC-Derived Cell Systems
Greg Luerman, Ph.D., Head, Applications Development, Axiogenesis Inc.
Plenary Sessions
June 16, 1:45-2:45 pm
PLENARY KEYNOTE PRESENTATIONS:
This year’s Plenary Keynote Presentations feature two prominent thought-leaders who are playing an important role in innovating drug discovery. They share their experiences and their perspectives on what has changed and what can be changed to improve preclinical research, help translate preclinical findings to the clinic, and to foster effective communication and collaboration. Attendees will have an opportunity to ask questions and gain valuable insights from their learnings.
Keynote Speakers:
Anthony J. Coyle Ph.D., Chief Scientific Officer and Senior Vice President, Centers for Therapeutic Innovation, Pfizer Inc.
James Wilson, M.D., Ph.D., Professor, Department of Pathology and Laboratory Medicine, Perelman School of Medicine; Director, Orphan Disease Center and Director, Gene Therapy Program, University of Pennsylvania
June 16, 2:45-3:30 pm
PLENARY KEYNOTE PANEL:
This year’s Plenary Keynote Panel features a group of technical experts from life science technology and service companies, who share their perspectives on various trends and tools that will likely change the way in which we traditionally approach preclinical drug discovery and development. Attendees will have an opportunity to ask questions and understand the impact of recent technical advances.
Panelists:
Matt Gevaert, Ph.D., CEO and Co-founder, KIYATEC
Amit Vasanji, Ph.D., CTO & CSO, ImageIQ
Biographies:
Dr. Anthony Coyle is the founding CSO of the Centers for Therapeutic Innovation (CTI) and is responsible for CTI’s strategy and scientific direction. Before leading CTI, Dr. Coyle was the Vice President and Global Head of Respiratory, Inflammation, and Autoimmunity Research at MedImmune Biologics, a Division of AstraZeneca. At MedImmune, Dr. Coyle advanced a biologic portfolio from discovery to Phase II in the areas of respiratory and autoimmune diseases, specifically targeting lupus, asthma and COPD. Prior to his work at MedImmune, Dr. Coyle was Director of Research at Millennium Pharmaceuticals, where he led a group responsible for the identification of novel target genes, as well as for late stage lead optimization and delivery of both small-molecule and biologic development candidates. Dr. Coyle has been Associate Professor in the Department of Pathology and Experimental Therapeutics at McMaster University in Ontario since 1992. He has authored more than 200 manuscripts. Dr. Coyle holds a BSc (with honors) and a Ph.D. from Kings College, University of London. Dr. Coyle is a member of the scientific board for the Alliance for Lupus Research, the C4 NCATS consortium and the Boston Children’s Hospital Technology Fund Advisory Board.
Dr. James M. Wilson is a Professor in the Perelman School of Medicine at the University of Pennsylvania where he has led an effort to develop the field of gene therapy. Dr. Wilson began his work in gene therapy during his graduate studies at the University of Michigan over 30 years ago. He then moved to Boston to do a residency in Internal Medicine at the Massachusetts General Hospital and continued his work in gene therapy at MIT. He created the first and largest academic-based program in gene therapy after being recruited to University of Pennsylvania in 1993. He initially focused on the clinical translation of existing gene transfer technologies but soon redirected his efforts to the development of second and third generation gene transfer platforms; the first of which was licensed to a biotechnology company he founded that resulted in the first, and only, commercially approved gene therapy in the western hemisphere. More recently, his laboratory discovered a family of viruses from primates that could be engineered to be very effective gene transfer vehicles. These so called “vectors” have become the technology platform of choice and have set the stage for the recent resurgence of the field of gene therapy. Dr. Wilson has also been active in facilitating the commercial development of these new gene therapy platforms through the establishment of several biotechnology companies. Throughout his career, the focus of Dr. Wilson’s research has been rare inherited diseases, ranging from cystic fibrosis to dyslipidemias to a variety of metabolic disorders. Dr. Wilson has published over 550 papers, reviews, commentaries and editorials in the peer-reviewed literature and is an inventor on over 117 patents.
Dr. Matthew (Matt) Gevaert is the CEO of KIYATEC Inc., a life sciences company in Greenville, SC. KIYATEC specializes in ex vivo 3D cell culture and tissue systems that more accurately replicate in vivo human biology and function, with a focus on methods to accurately predict individual cancer patients’response to drugs by culturing and treating live patient derived primary cells. Dr. Gevaert co-founded the company and has served as CEO since 2007. Possessing a background which combines both business and technology, before his role at KIYATEC Dr. Gevaert led the commercialization of Clemson University’s biomedical and biotechnology intellectual property portfolio for nearly 5 years, working with both entrepreneurial start-ups and large, industry leading corporations. He has previous experience with Merck, 3M and Dow Chemica l, and has been published in Science magazine and the journal of the US National Academy of Engineering. Currently he serves as a board member of SCBIO, the state of South Carolina’s life science industry organization, and a board member of NEXT, which provides entrepreneur services and infrastructure to high-growth ventures in Greenville and Upstate South Carolina. Dr. Gevaert grew up the fifth of six children on a farm in Ontario, Canada and graduated from the University of Waterloo with a bachelor’s degree in Applied Chemistry. He also holds a master’s degree and a doctorate in Bioengineering from Clemson University. He maintains current appointments as adjunct professor in the Clemson University Department of Bioengineering and as a lecturer in the Clemson MBA in Entrepreneurship & Innovation.
Dr. Amit Vasanji has over 17 years of experience with basic and clinical research image acquisition, processing, analysis, visualization and biomedical software engineering. He was the founder of Cleveland Clinic’s Biomedical Imaging and Analysis Center, and served as its Executive Director. During his tenure at the Cleveland Clinic, he authored over 50 publications — many in high impact journals, participated in the writing of numerous federally funded grants, served as a consultant and/or co-investigator on many federal, state, corporate, and institutional grants, presented at national scientific meetings, and won various awards for innovation and service. Dr. Vasanji received a BS in Biomedical Engineering from the University of Miami, and a Ph.D. in biomedical engineering from Case Western Reserve University
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