10-12 April 2018
Boston, MA, USA

2017 Speakers

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Ajit Dash
Senior Safety Scientist
Genentech

Ajit is an accomplished, goal oriented biotechnology professional with multidisciplinary background in liver biology, molecular toxicology, pharmacology and medicine. Ajit has strong expertise and focus in the areas of target discovery in nonalcoholic steatohepatitis (NASH) and metabolic rare diseases, and in investigative toxicology. He is a proficient scientific team leader, successful in developing novel technology platforms and their discovery/safety applications. Experienced in driving and participating in effective cross-functional team interactions.

Day Two

Thursday April 6, 2017

14.00 | Drug Safety & Nonalcoholic Steatohepatitis

Alice Chen
Associate Director, R&D, Tissue Applications
Organovo

Dr. Chen is currently Associate Director R&D, Tissue Applications at Organovo in San Diego, CA. Dr. Chen received her PhD in Biology, with an emphasis on Developmental Biology from Johns Hopkins University, in association with the Carnegie Institution of Washington, Department of Embryology in 2005, where she studied the role of WNT signaling in mammalian myogenesis. Dr. Chen then went on to a postdoctoral fellowship at the Harvard Stem Cell Institute from 2005-2009, where her work focused on methodologies to improve the efficiency of human embryonic stem (ES) cell derivation, directed differentiation of ES cells toward the pancreatic lineage, as well as cellular reprogramming by somatic cell nuclear transfer. Dr. Chen has since held positions at Stemgent and BioTime, developing research tools and services for stem cell research, with a focus on reprogramming by induced pluripotency, stem cell expansion and maintenance, and cell fate manipulation via messenger RNAs. She joined Organovo in 2015 to lead development of in vitro human tissue models in liver and kidney for toxicology research and disease modeling.

Day One

Wednesday April 5, 2017

12.30 | Modeling Progressive Liver Disease using 3D Bioprinted Human Liver Tissue

Christian Weyer
President & Chief Development Officer
ProSciento

Dr. Christian Weyer is President and Chief Development Officer at ProSciento. Dr. Weyer’s career in metabolic drug development spans more than 20 years, involving clinical studies and regulatory submissions at all stages of product development and across the continuum of diabetes, obesity and NAFLD/NASH. Prior to joining ProSciento, Dr. Weyer was President and Chief Executive Officer of Fate Therapeutics, where he steered the company’s transition into a publicly-traded cellular therapeutics company, advancing new programs and partnerships in immuno-oncology, inherited metabolic disorders and type 1 diabetes. Prior to Fate Therapeutics, Dr. Weyer was Senior Vice President of R&D at Amylin Pharmaceuticals. During his 12 year tenure at Amylin, he contributed to the development and approval of several first-in-class medicines for diabetes and lipodystrophy, while also leading the company’s programs and global strategic partnership in obesity. Before joining Amylin, Dr. Weyer worked at the National Institutes of Health, NIDDK, conducting clinical research on the pathogenesis of obesity and type 2 diabetes. Dr. Weyer received his M.D. and clinical training at the Department of Metabolic Disorders, World Health Organization Collaborating Center for Diabetes Treatment and Prevention, at the University of Düsseldorf, Germany. Dr. Weyer also holds a postdoctoral master’s degree in advanced clinical research from the University of California, San Diego. He has authored numerous original publications, review articles, and book chapters in the field of endocrinology and metabolism, and has served as a reviewer for multiple scientific journals.

Day One

Wednesday April 5, 2017

09.40 | Designing & Implementing Effective Early Development Strategies in NASH: Challenges & Opportunities

David Lomb
Associate Principal
Defined Health

As an Associate Principal Consultant with Defined Health, David participates in and leads opportunity assessments as well as indication prioritization/sequencing, search, and strategy projects. David regularly contributes to projects in the oncology, dermatology, CNS, and autoimmune and inflammatory disease spaces. In addition, David leads most projects involving the fibrosis therapeutic area at Defined Health. Prior to joining Defined Health in 2010, David was a postdoctoral fellow in the Paul F. Glenn Laboratories for the Biological Mechanisms of Aging at Harvard Medical School. As a scientist at Harvard, David studied a family of enzymes known as sirtuins which have been implicated in the regulation of aging and age-related diseases. Also while at Harvard, David was a fellow in the Early Technology Assessment Program sponsored by the Office of Technology Development. In this position, David was responsible for performing initial commercial assessments of discoveries made by Harvard faculty members. David earned a PhD in Pharmacology from the University of Rochester, in Rochester, New York, where his thesis work focused on the molecular mechanisms of neuronal programmed cell death. David has also earned Bachelor of Science degrees in both Biochemical Pharmacology and Psychology from the University at Buffalo, in Buffalo, New York. David has published in peer reviewed scientific journals and has presented his work at national scientific meetings.

Workshop A - Please note that the venue has changed. See below

Tuesday April 4, 2017

10.00 | The Next Big Global Epidemic: Review of Nonalcoholic Steatohepatitis & the New Liver Disease Landscape

David Q.-H. Wang
Professor
Saint Louis University School of Medicine

Dr. Wang is a Professor of Internal Medicine, member of Saint Louis University Liver Center & Member of Saint Louis University Center for Cardiovascular Research. Dr. Wang received his MD and PhD from Shanghai Second Medical University and then went on to do postdoctoral training at Harvard Medical School and Brigham and Women’s Hospital. He has an active research interest in the molecular and genetic mechanisms of cholesterol homeostasis and the pathophysiology of cholesterol-related diseases. His current research focuses on the pathophysiology of cholesterol gallstone disease and genetic analysis of gallstone (Lith) genes, the molecular physiology and genetics of the intestinal cholesterol and fatty acid absorption, the biochemistry of bile formation, and the physical-chemistry of cholesterol crystallization in bile. Also, his research is directed principally at a specific area that appears to be fundamental to understanding nonalcoholic fatty liver disease, insulin resistance, and the metabolic syndrome.

Workshop B - Please note that the venue has changed. See below

Tuesday April 4, 2017

14.00 | Preclinical Models of Nonalcoholic Steatohepatitis

Dean Hum
Chief Scientific Officer
Genfit

Dean HUM earned a Ph.D. in Biochemistry from McGill University in Montreal in 1990. An expert in the modulation of transcription factors and nuclear receptors associated with endocrine and cardiometabolic diseases, he held a research position at the University of California in San Francisco before becoming a Professor at Laval University in Quebec. He joined GENFIT in 2000 as Chief Scientific Officer. Dean Hum is today a key person in the organization of GENFIT. In particular, he is responsible for defining, implementing, employing and coordinating short-, medium- and long-term strategies relating to R&D programs and portfolio. He coordinates all R&D activities with the CEO and in close collaboration with scientific officers and project managers.

Day Two

Thursday April 6, 2017

16.00 | Unmet Needs for Comprehensive Clinical Management of NASH Patients

Emil Chuang
Vice President & Head, Translational Research & Early Clinical in Gastroenterology
Takeda

Currently the VP and Head of Translational Research and Early Clinical in Gastroenterology at Takeda Pharmaceuticals Has been in Pharmaceutical industry for over 15 years, with a focus on developing novel therapies and diagnostics of GI disorders Completed medical School at University of Sydney, and by training is a Pediatric Gastroenterologist and previously on faculty at Duke University and U. of Pennsylvania.  

Day One

Wednesday April 5, 2017

14.00 | Capture Learnings to Enhance Preclinical Development of NASH Targeting Therapies

James Trevaskis
Principal Scientist, Cardiovascular & Metabolic Diseases
MedImmune

James is an experienced scientist with strong in vivo pharmacology background, with emphasis on identification and validation of novel targets for the potential treatment of metabolic diseases, particularly obesity, diabetes and NASH. Strategically leverage target candidates, as a single agent or in combination, to maximize therapeutic potential. Cross-functional project team leadership for discovery and drug development targets, and nomination of clinical development candidates.

Day One

Wednesday April 5, 2017

12.00 | Preclinical In Vivo Pharmacology Assessments of NASH Therapeutics: Are We There Yet?

Jesper Gromada
Head, Metabolism, Obesity & Lipid Therapeutics
Regeneron Pharmaceuticals

Jesper Gromada is the Head of Metabolism, Obesity and Lipid Therapeutic Area at Regeneron Pharmaceuticals. Prior to joining Regeneron in 2012 Jesper was responsible for diabetes and metabolism research and drug discovery at Novartis. Jesper has also held positions of responsibility at Eli Lilly and Novo Nordisk. Jesper received his PhD in cell biology from University of Copenhagen in 1995.

Day Two

Thursday April 6, 2017

12.00 | Looking Beyond the Literature: Optimize Validation of Novel NASH Targets

Keld Fosgerau
CSO
Gubra Aps, Hørsholm, Dennmark

Keld Fosgerau is CSO at Gubra Aps, Hørsholm, Dennmark and holds a Master’s of Science in biological chemistry and an industrial PhD in hepatic glycogen metabolism. The past 16+ years he has been deeply involved in metabolic research, most of the time focusing on diabetes and obesity and related disorders such as NASH. Keld has been covering the full spectrum from large pharma corporation to small biotech start-up and has a long history of scientific leadership, alliance management and people management. Functionally his focus has primarily been on target biology, pharmacology and drug discovery. Keld has published more than 75 articles and communications on metabolic research.

Day One

Wednesday April 5, 2017

11.30 | Characterization of Diet-Induced Rodent Models Of NASH

Gregory Tesz
Principal Scientist
Pfizer

     

Day One

Wednesday April 5, 2017

11.00 | Overview of Preclinical Rodent Models for NAFLD/NASH: From Metabolic Dysfunction to Fibrosis

Laurent Fischer
Senior Vice President & Liver Therapeutics Area Head
Allergan

Laurent Fischer is the Senior Vice President and Liver Therapeutic Head at Allergan. Laurent was the CEO of Tobira Therapeutics, which was recently acquired by Allergan. Laurent has also held postions of responsibility at Jennerex Biotherapeutics, Ocera Therapeutics, Telomedix, Auxeris Therapeutics, MedVantX, DuPont Pharmaceuticals and Roche.

Day Two

Thursday April 6, 2017

15.00 | Improve Clinical Trial Design by Hearing Lessons Learned from Phase II Clinical Trial

Manal Abdelmalek
Associate Professor
Duke University

Workshop A - Please note that the venue has changed. See below

Tuesday April 4, 2017

10.00 | The Next Big Global Epidemic: Review of Nonalcoholic Steatohepatitis & the New Liver Disease Landscape

Manu Chakravarthy
Vice President & Global Head, External R&D, Diabetes & Cardiometabolic Diseases
Eli Lilly & Co.

Day One

Wednesday April 5, 2017

16.30 | Chair’s Closing Remarks

08.30 | Chair’s Opening Remarks

Day Two

Thursday April 6, 2017

17.00 | Chair’s Closing Remarks

09.10 | Industry & Academia: Crossing the Divide to Move the Needle in Non-Invasive Biomarkers for NASH

09.00 | Chair’s Opening Remarks

Melissa Palmer
Global Clinical Development Lead, Hepatology
Shire Pharmaceuticals

Melissa Palmer, MD has been a hepatologist since 1988. She was in a solo practice devoted to treating and evaluating patients with liver disease until 2009 at which time she became Director of Hepatology at NYU Plainview. Dr. Palmer left this position to become Senior Vice President of Clinical Research and Head of Hepatology at Kadmon Corporation. After 1 year Dr. Palmer was promoted to Global Head of Hepatology, and became Senior Vice President of Pharmacovigilance in addition to SVP of Clinical Research. She remains a Clinical Professor of Medicine at NYU.

Day One

Wednesday April 5, 2017

16.00 | Non-Invasive Technologies: Critical Review of Current Approaches to Identify Respondent Patient Populations & Determine Drug Efficacy During Clinical Trials

Paul McCracken
Vice President, Medical Imaging
ICON

Dr. Paul McCracken has over 20 years’ experience in imaging and pharmaceuticals, with a strong track record of applying imaging and biomarkers to drug discovery and development across a range of therapeutic areas. Dr. McCracken joined ICON from Eisai, where he led the Imaging Centre of Excellence, which drives novel approaches for discovery targets and translational biomarkers, primarily through the introduction of imaging genetics and the acceleration of novel PET approaches. Prior to Eisai, Paul worked at Merck Research Laboratories, where he developed preclinical and translational imaging biomarkers and strategies to assess new molecular and biologic entities. Dr. McCracken holds a Bachelor of Science in Physics from The College of New Jersey, a Master of Science in Physics/Medical Physics from Wright State University and received his Ph.D. in Biomedical Engineering – Imaging from the Mayo Clinic College of Medicine.

Day Two

Thursday April 6, 2017

09.40 | Optimizing Trial Design with Key Biomarkers & Imaging Endpoints

Raffi Werner
Chief Executive Officer
Exalenz

With over 25 years of experience in the medical device arena, Raffi Werner joined Exalenz Bioscience in 2010 and has served as Chief Executive Officer since 2015. As CEO, Raffi is leading the company in expanding its clinical research and broadening its pipeline of liver function diagnostic and prognostic applications. Raffi Werner holds a B.Sc. in Industrial Engineering from Tel Aviv University, and a joint MBA from Northwestern University and Tel Aviv University.

Day One

Wednesday April 5, 2017

15.30 | The Use of the 13C Methacetin Breath Test as a Function Test in Patients with NASH: A Novel, Noninvasive Diagnostic & Prognostic Tool

Reshma Shringarpure
Senior Director, Clinical Research
Intercept Pharmaceuticals

Reshma is the Senior Director of Clinical Research at Intercept Pharmaceuticals. Prior to joining Intercept Pharmaceuticals in 2014 Reshma was at Santarus. She has also held positions at Prometheus Laboratories, Amylin Pharmaceuticals, Scientific Connexions and Havard Medical School.  In 2002, Reshma received her PhD from University of Southern California in Molecular biology.

Day Two

Thursday April 6, 2017

14.30 | Challenges in the Clinical Development of NASH

Stephen Bravo
Medical Director
Sand Lake Imaging

Day Two

Thursday April 6, 2017

11.00 | Hub & Spoke: The New Paradigm for NASH Study Subject Recruitment

Scott Q Siler
President
DILIsym Services, Inc.

Scott Q Siler, Ph.D. is the President of DILIsym Services, Inc. and Co-Director of the DILI-sim Initiative. Dr. Siler graduated with a Ph.D. in Nutrition from the University of California, Berkeley and worked for more than 12 years integrating physiology and mathematics and applying (QSP) models to pharmaceutical drug development with the company Entelos. As a Principal Scientist at Entelos, he oversaw and contributed to the development of the Metabolism PhysioLab. Moreover, he led multiple projects with pharmaceutical partners, evaluating potential treatments for type 2 diabetes.  Also during his time with Entelos, Dr. Siler oversaw the early development efforts of what would become the current DILIsym® software. Upon leaving Entelos in 2011, Dr. Siler became Co-Director of the DILI-sim Initiative and later the President of DILIsym Services.  Over this time, he has continued working on advancing the DILIsym® software in both oversight and technical roles. Dr. Siler has also overseen and contributed to the development of two other QSP models for DILIsym Services, MITOsym® and NAFLDsym™.  Dr. Siler has given numerous presentations (public and proprietary) about the QSP efforts in addition to co-authoring numerous publications.

Day Two

Thursday April 6, 2017

12.30 | NAFLDsym™: a new QSP model for accelerating drug development for NAFLD and NASH

Sophie Mégnien
Chief Medical Officer
Genfit

After studying in several countries, including the United States, Sophie Mégnien obtained her degree in Medicine from the University of Paris VI. She is an expert in the clinical development of cardiometabolic diseases (hypercholesterolemia, diabetes) and their vascular (atherosclerosis) and hepatic complications. She completed her internship in the field of clinical trial monitoring. Since then, she has held a number of posts as Project Manager in the R&D departments of various international pharmaceutical companies such as Smithkline Beecham, Glaxo Wellcome and Bayer. After ten years as a Project Manager, Sophie Mégnien became a consultant in Quality Management and Procedures at Sunnikan Consulting before joining Naturalpha, a company specializing in the coordination of clinical projects in the cardiovascular, metabolic and nutrition fields. Sophie Mégnien is currently Chief Medical Officer at GENFIT.

Day One

Wednesday April 5, 2017

09.10 | Keynote: Paradigms in NASH Disease Progression & Drug Discovery

Stephen Previs
Director
Merck & Co

Stephen is a Director at Merck & Co and is heavily involved with NASH drug development. Prior to joining in 2009 Stephen was an Assistant Professor for Nutrition and Medicine at Case Western Reserve University. Stephen was also a Post-Doctoral Fellow at Yale University.

Day One

Wednesday April 5, 2017

14.30 | Preclinical to Clinical Translation: Critically Review Quantification Methods of Liver Fat Oxidation as well as Protein Flux Biomarkers

Steven England
Director & Head of Future Therapeutics & Technologies
AbbVie

Steve is an experienced professional in the early stages of drug discovery and development -from target identification, through project initiation up to proof of concept. This has been gained at Pfizer, AstraZeneca and Abbott/AbbVie. Steve has broad-based scientific expertise, primarily in the neuroscience area and more recently in chronic liver disease and more generally in immunology and oncology. Throughout his career Steve has managed both large and small groups of scientists and established a number of successful external collaborations with both academics and small companies. Currently Steve has two major roles – Firstly, leading the Discovery effort focused on liver disease at AbbVie, aimed at identifying treatments for NASH/NAFLD and also autoimmune diseases of the liver. Secondly, Steve head Future Therapeutics & Technologies - a team tasked with the identification and 'internalisation' of atypical therapeutic modalities.

Day Two

Thursday April 6, 2017

11.30 | New Approaches to Identifying Novel Targets for NASH

Weilin Xie
Senior Principal Scientist, Biotherapeutics
Celgene

Dr. Weilin Xie is Principal Senior Scientist at Celgene Corporation.  He directed Celgene’s fibrosis research unit through 2016.  As a project leader or biology lead, he and his team have advanced multiple fibrosis projects from early discovery to clinic or IND filings.   As a member of Celgene’s due diligence teams, Dr. Xie has been instrumental in several high profile collaborations and acquisitions within Celgene’s fibrosis and inflammation/auto-immunity franchise.  Additionally, as a member of Celgene’s Joint Research Committee,  he oversees many corporate collaborations.  Dr. Xie co-initiated Celgene’s protein homeostasis drug discovery efforts by targeting E2 and E3 ubiqutin ligases and was co-project leader for identifying  the mechanism of action of Celgene’s IMiDs class drugs.

Day One

Wednesday April 5, 2017

08.40 | Dash to Treat NASH: Overview of Nonalcoholic Steatohepatitis Drug Development