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23-25 April 2018 | Boston, MA

56 Expert Speakers  3 Streams  12+ Hours of Networking



Jeremy Caldwell
Executive Vice President & Chief Scientific Officer

Jeremy has served as Ardelyx’s chief scientific officer since December 2014. He brings significant experience leading science-driven research organizations within large pharmaceutical companies, research institutes and biotechnology companies. He has spent the last 20 years bringing innovative therapies to the clinic and developing novel drug discovery platforms. Prior to Ardelyx, Jeremy was an entrepreneur-in-residence at Third Rock Ventures, where he focused on the formation and development of life science companies. Before Third Rock, Jeremy served as vice president, head of RNA therapeutics, lead discovery and protein sciences for Merck Research Laboratories, where he oversaw all aspects of the discovery and development of RNA-based therapeutics, as well as small molecule lead generation. Before that, he led the integration of legacy Merck and Schering-Plough discovery and preclinical functions as the founding head of strategic operations. Prior to joining Merck in 2008, Jeremy was the executive director of molecular and cellular biology, lead discovery and genomics at the Genomics Institute of the Novartis Research Foundation (GNF), as well as the chairman and head of GNF's Technology and Early Research Committee. Jeremy was one of the first scientists at the biopharmaceutical company Rigel Inc., a company founded on the transformative mammalian genetics technology he developed at Stanford University as part of his Ph.D. thesis. Jeremy has also worked as an independent consultant to several biotechnology companies in the areas of genomics/proteomics, cell biology, RNA therapeutics and drug discovery, and is a co-founder of the biopharmaceutical company Kalypsys Inc. He received a B.S. in molecular and cellular biology from the University of California at Berkeley and a Ph.D. in molecular pharmacology from Stanford University. He has published over 50 peer-reviewed articles and is the lead inventor on over 25 issued and pending patent applications.

Jerry Colca
Executive & Vice President of Research & Development
Cirius Therapeutics

Jerry Colca has a Ph.D. from the University of Houston (Physiology and Biochemistry, 1980) and did a post-doctoral fellowship at Washington University School of Medicine in St. Louis, where his studies focused on stimulus-secretion coupling the pancreatic islets.  In 1984, he joined the Upjohn company and was part of the team the selected and began development of the anti-diabetic compound pioglitazone.  Since that time, he has spent the last 33 years in the pharmaceutical industry and has continued to focus and publish on the interesting class of pharmaceuticals known as “insulin sensitizers.”  In 2006, he co-founded Metabolic Solutions Development Company (MSDC) where his team discovered the mitochondrial target of TZDs and begin development of two modulators of this target as potential treatments for type 2 diabetes.  In 2017, he became Vice President of Research of Cirius Therapeutics, which is developing MSDC-0602K as a potential treatment for NASH.  He will speak to the current state of these studies.

Jesper Gromada
Head of Metabolism, Obesity & Lipid Therapeutic Area
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.

Ji Zhang

Ji Zhang, received her PhD in Pharmacology at Duke University before going on to become a Postdoctoral Fellow at UCSD. She went on to work as an Assistant Project Scientist and following this, an Assistant Adjunct Professor for UCSD Pharmacology Department. Her main areas of research have been as a mitochondrial biologist studying genetic, biochemical, molecular & cellular biology, physiology and pharmacology to study mitochondrial dysfunction in human diseases. Ji is currently a biology program lead within Merck’s Cardiometabolic Drug Discovery, Fibrosis Group. She has several publications in journals including Journal of Biological Chem and Cell Metabolism.

Jonathan Riek
Vice President, Musculoskeletal & Metabolic Imaging
BioTelemetry Research

Jon is the Vice President, Musculoskeletal and Metabolic Imaging at BioTelemetry Research.  Prior to that, he served as the CTO at VirtualScopics until their acquisition by BioTelemetry in 2016.  He has 16 years experience in the imaging clinical trial market and has been working on non-alcoholic fatty liver disease trials since 2009.  Jon holds a BS, MS and PhD in electrical engineering from the University of Rochester and his thesis was on modelling and correction of motion and flow artifacts in MRI.

Day One

Tuesday April 24, 2018

17.15 | Panel Discussion: Non-Invasive Biomarkers – How Near Are We?

Judith Ertle
Clinical Program Leader
Boehringer Ingelheim

Judith Ertle is the Clinical Program Lead for Boehringer Ingelheim working within Hepatology, Internal Medicine and Gastroenterology. Before joining Boehringer Ingelheim Dr Ertle was Medical Director at PRA Health Sciences and Medical Director for Internal Medicine, Gastroenterology at University Hospital Essen in Germany.

Liangsu Wang
Vice President, Head of Biology
Morphic Therapeutics

Dr. Liangsu Wang is currently a VP, Head of Biology at Morphic Therapeutic. In this role, she has built the biology group for the new biotech start-up, and is leading the areas in fibrosis, inflammatory bowel diseases, and immuno-oncology. Prior to Morphic, Liangsu spent 13 years at Merck and worked across multiple therapeutic areas such as diabetes and complications, cardiovascular diseases, infectious diseases. She served as an Executive Director for Diabetes & NASH Discovery, accountable for the drug discovery portfolio across all stages, as well as clinical candidates support. She led the team and established the scientific strategy for NASH research at MRL, and built the NASH discovery platform including in vitro and ex vivo systems, and multiple animal models. Prior to joining Merck, Liangsu spent seven years in biotech companies, Elitra Pharmaceuticals and Digital Gene Technologies, Inc. at the early stage of her industrial career.

Kendra Bence
Senior Director, Metabolism

Kendra Bence, PhD, is Senior Director of Metabolism, leading research and discovery efforts in the Non-Alcoholic Fatty Liver Disease/Non-alcoholic steatohepatitis therapeutic area for the Pfizer Internal Medicine Research Unit.  Dr. Bence leads a talented team of scientists focused on developing a deep understanding of the intricate biological mechanisms underlying metabolic syndrome and fatty liver disease, with the goal of identifying novel ways to treat and eventually prevent these metabolic diseases.  She is also the Internal Medicine representative to the Pfizer Worldwide Research & Development Post-Doctoral Program.”

Matthew Coghlan
Senior Director
Novo Nordisk

Matthew has 20 years of experience in cardiovascular and metabolic disease R&D at SmithKline Beecham and AstraZeneca. During this period Matthew led both small and large molecule projects to candidate nomination. Additionally, Matthew was responsible for building the first biologics portfolio for the AstraZeneca cardio-metabolic therapy area. Between 2013 and 2017 Matthew recruited and led the metabolic disease research group at MedImmune.  Recently Matthew moved to Novo Nordisk where he is responsible for leading the external sourcing of opportunities in NASH, obesity and CKD.  

Michal Ayalon
Project Champion
Teva Pharmaceuticals

Dr Michal Ayalon gained her PhD in cell biology and biochemistry from Tel Aviv University and has since gained over 15 years of experience in drug discovery and drug development including non clinical and clinical development, manufacturing and control, regulatory and high level of project management. Dr Ayalon has been Vice President of R&D Operations at IMMUNE Pharmaceuticals, Vice President, Research & Development at Galmed Pharmaceuticals Ltd and is not Project Champion at Teva Pharmaceuticals. She is specialised within development of biologics including recombinant proteins, monoclonal antibodies and fusion proteins in Oncology, Autoimmune diseases, inflammation and metabolic diseases.

Michael Crackower
Executive Director, Immunology and Inflammation Discovery

Dr. Michael Crackower is a Senior Director in the Immunology and Inflammation TCoE at Celgene. He has more than 15 years of experience in drug development conducting and leading research activities from target discovery and validation to advancing programs to clinical trials. In his current role at Celgene, Dr. Crackower leads fibrosis research and drug discovery. His responsibilities include defining strategic direction, progressing the fibrosis pipeline and identifying new industry and academic collaborations to pursue cutting edge projects and capabilities in fibrosis. Prior to joining Celgene, Dr. Crackower worked at Biogen where he built and lead research and drug discovery activities in Tissue Injury and Fibrosis.   Prior to Biogen he spent 9 years at Merck and Co. in Respiratory and Immunology Drug Discovery. At Merck, Dr. Crackower lead numerous aspects of drug discovery and oversaw the discovery of 5 clinical candidate compounds including the first de novo inhaled compound developed at Merck. Prior to joining Merck, he was the head of mouse genetics for 3 years at Amgen Inc, in Thousand Oaks, California. Dr. Crackower received his B.Sc. in Biochemistry from the University of Western Ontario.  He received his PhD in Molecular and Medical Genetics from the University of Toronto in the lab of Dr. Lap-Chee Tsui. His Ph.D training focused on positional cloning/genomics and mouse developmental biology. He conducted his postdoctoral training at The Amgen Research Institute in Toronto in the lab of Dr. Josef Penninger. During this period Dr. Crackower made discoveries in the area of Cardiovascular research, demonstrating a role for ACE2 and PI3K in regulating cardiovascular physiology.  

Day Two

Wednesday April 25, 2018

09.15 | Panel Discussion: Combinational Therapies in the Treatment of NASH

Michael Fuchs
Professor of Medicine
Virginia Commonwealth University

Dr. Michael Fuchs, MD, PhD, is Professor of Medicine at Virginia Commonwealth University School of Medicine and Chief of Hepatology at the Hunter Holmes McGuire VA Medical Center in Richmond, Virginia. He serves as the director of the viral hepatitis and metabolic liver disease program at Hunter Holmes and is a member of the National Veterans Affairs liver transplant board. Dr. Fuchs earned his MD and PhD degrees from the Albert-Einstein University School of Medicine in Ulm, Germany and completed his gastroenterology fellowship at Albert-Einstein University in Ulm where he became Chief of Hepatology in 2003. In 2006, Dr. Fuchs joined the Division of Gastroenterology, Hepatology and Nutrition at Virginia Commonwealth University. Dr. Fuchs has been involved in bench research into regulation of bile acid synthesis and biliary lipid secretion/transport since the late 1980’s. He received postdoctoral fellowship training at Brigham and Women’s Hospital/Harvard Digestive Disease Center in Boston from 1991-1993 and grant funding by the German Science Foundation for two decades. Dr. Fuchs is actively involved in research in the area of the non-alcoholic fatty liver disease. Collectively he has authored and co-authored more than 120 publications. Dr. Fuchs is active in professional organizations such as the European Association for the Study of the Liver (EASL), American Association for the Study of Liver Disease (AASLD), the American Gastroenterological Association (AGA) and the American Heart Association (AHA), respectively. He served on AHA study sections and research committees, the Education and Workforce Committee of AASLD and organized in 2014 the AASLD Career Development Workshop. Dr. Fuchs is currently Associate Editor of Digestive Diseases and Sciences and serves on the Editorial Board of several journals including HEPATOLOGY. He was the guest editor for the 2016 Digestive Diseases and Sciences Emmet B. Keeffe special edition on NAFLD and NASH.

Nikolai Naoumov
Executive Director, Hepatology Science & Innovation

Nikolai Naoumov works at Novartis Global Drug Development as Executive Director for Hepatology Science and Innovation, based in Basel, Switzerland. His focus is on developing new therapies for patients with liver diseases especially NASH, autoimmune diseases, liver fibrosis and complications of cirrhosis.  In addition to his work at Novartis Global, Nikolai is also Honorary Scientific Advisor to the Foundation for Liver Research in the UK and Board member of the Liver Foundation in Switzerland. Before joining Novartis in 2007, Nikolai was a tenured Professor of Hepatology at University College London and Consultant Hepatologist at University College London Hospitals. Nikolai has been involved in the development and evaluation of many of the new treatments for patients with liver diseases, initially at the Institute of Liver Studies, King’s College Hospital in London and subsequently at the Institute of Hepatology, University College London. Nikolai has more than 200 publications in the fields of liver immunology, treatment of viral hepatitis and liver transplantation. He is Fellow of both the Royal College of Physicians (London) and the Royal College of Pathologists in the UK, and member of the Association of Physicians of Great Britain and Northern Ireland. He joined EASL in 1987, served as member of the EASL Scientific Committee (1991-1994), and was elected as a Fellow of the American Association for the Study of Liver Diseases (AASLD)

Day Two

Wednesday April 25, 2018

09.15 | Panel Discussion: Combinational Therapies in the Treatment of NASH

08.15 | Targeting Multiple Pathways in NASH – Clinical Perspectives for Combination Therapies

Paul Grayson
President & Chief Executive Officer
Bird Rock Bio

Founder and CEO of RuiYi Bio (Shanghai based GPCR discovery company), merged with Anaphore Inc. to become Bird Rock Bio, La Jolla, CA.  Previously founding CEO of Fate Therapeutics, Managing Director Sanderling Ventures, founding CEO Senomyx Inc.

Kari Wong
Senior Study Director

Kari Wong is a Senior Study Director at Metabolon where she works with clients across the pharmaceutical and biotechnology landscape. Kari received her PhD from The University of Chicago in Molecular Metabolism and Nutrition where she published manuscripts investigating the impact of the vitamin D receptor in global metabolism.  She then went on to do her postdoctoral fellowship at Duke University where she utilized metabolomics to understand muscle metabolism.  Kari joined Metabolon in 2016 where she has analyzed metabolomic data from both pre-clinical and clinical studies crossing a variety of disease states.  One of her focuses is on understanding the metabolic changes associated with NASH.

  • A diverse set of disease drivers including genetics, environmental cues, microbiota metabolism and lifestyle influences come together resulting in an uncertain natural history of NAFLD/NASH and a remarkable array of targets.
  • The development of noninvasive diagnostic markers is necessary to effectively track and treat NASH.
  • Metabolon’s Precision MetabolomicsTM technology is a mass spectrometry-based method that allows for the identification of over 1000 small molecule compounds in a single sample. This technology provides a holistic assessment of NAFLD/NASH complexity.
  • Examples of how this approach has been used in both pre-clinical and clinical areas will be discussed.

Peter Traber
Director of The Board, President, Chief Executive Officer & Chief Medical Officer
Galectin Therapeutics

Dr. Traber is president emeritus of Baylor College of Medicine, where he was chief executive officer from 2003 to 2008. From 2000 to 2003, he was senior vice president of clinical development and medical affairs and chief medical officer of GlaxoSmithKline plc. Dr. Traber served as chief executive officer of the University of Pennsylvania Health System and was chair of the Department of Internal Medicine and chief of gastroenterology for the University of Pennsylvania School of Medicine. Dr. Traber has also managed a molecular biology research laboratory and published over 100 articles of original research, reviews and book chapters. Dr. Traber received his M.D. from Wayne State School of Medicine, a B.S. in chemical engineering from the University of Michigan, and a certificate in medical leadership from Wharton Business School.

Day One

Tuesday April 24, 2018

17.15 | Panel Discussion: Non-Invasive Biomarkers – How Near Are We?

Day Two

Wednesday April 25, 2018

15.30 | Keynote: Clinical Trials & Endpoints in NASH Cirrhosis

Philip Hylemon
Professor of Microbiology & Medicine
Virginia Commonwealth University

Dr. Phillip Hylemon is Professor of Microbiology and Medicine at Virginia Commonwealth University. His laboratory has studied the metabolism of bile acids by gut bacteria since the 1970’s. He has also studied bile acid cell signaling in the liver since the 1990’s. His laboratory discovered the biochemical pathway of bile acid 7-dehydroxylation by gut bacteria and characterized a number of enzymes involved in secondary bile acid synthesis. His laboratory also reported that the sphingosine-1-phosphate receptor 2 is activated by conjugated bile acids and is the main receptor for bile acid activated cell signaling in hepatocytes. He is the co-author on over 239 papers.

Aimo Kannt
Cluster Head Comorbidites & Complications of Diabetes

Day Two

Wednesday April 25, 2018

16.00 | Keynote: Overview on NASH Heterogeneity & Relationships as a Sequel of CVM Disease

Puneet Arora
Senior Medical Director

Dr Arora is a physician-scientist and drug developer, licensed and board certified endocrinologist, with over 10 years of experience in all phases of clinical trials, regulatory filings, development strategy and due diligence in multiple therapeutic areas. In his current early clinical development role, Dr Arora works on Diabetes and Metabolism including Obesity, NASH and Hyperlipidemia, in addition to Wound Healing and Immunology-Inflammation. He has held faculty teaching positions with the University of Minnesota and the Health Partners Medical Group and its affiliated Institute for Education in St. Paul MN. Dr. Arora trained in Advanced Diabetes and Clinical Research at the Mayo Clinic and Graduate School of Medicine in Rochester MN.

Ravi Ravinuthala
Director, Liver Clinic
Ohio GI

Dr. Ravi Ravinuthala completed his initial postgraduate medical training at the Postgraduate Institute of Medical Education and Research (PGIMER) in Chandigarh, India. He later trained in England and was elected a Member of the Royal College of Physicians of United Kingdom (MRCP). In the United States, Dr. Ravinuthala completed his Internal Medicine Residency and Gastroenterology Fellowship at Henry Ford Hospital, Detroit, Michigan. He did a Transplant Hepatology Fellowship at the Henry Ford Transplant Institute and is approved by United Network of Organ Sharing (UNOS) as a Transplant Hepatologist. Dr. Ravinuthala is one of two Board Certified Gastroenterologists in Transplant Hepatology in the Greater Cincinnati area. He is simultaneously an Associate Professor of Medicine in the Division of Gastroenterology at the University of Kentucky, Lexington and University of Cincinnati, Cincinnati. He also is the Medical Director of the Mercy Health Liver and Pancreas Center at Jewish Hospital and is actively involved there in the development of a Center of Excellence for liver diseases. He is the Director of Ohio GI’s Liver Clinic which includes NASH, Cirrhosis and Viral Hepatitis programs. Dr. Ravinuthala has been awarded “Fellow of American Association for Study of Liver Diseases” designation in 2015. He is a past President of the Association of Indian Physicians. He is a keenly involved member of the American Association for the Study of Liver Diseases, American Society of Transplantation, and Asia Pacific Association for the Study of Liver Disease. Dr. Ravinuthala is Board Certified in Gastroenterology and Transplant Hepatology.

Ray Chung
Vice Chief of Gastrointestinal Division, Director of Hepatology & Liver Centre
Massachusetts General Hospital

Raymond Chung, MD is the Director of Hepatology and Liver Center at Massachusetts General Hospital and a Associate Professor of Medicine at Harvard Medical School. Dr. Chung completed his B.A. at Harvard College and his MD from Yale University School of Medicine. He completed a residency in Internal Medicine and a fellowship in Gastroenterology and Hepatology at the Massachusetts General Hospital. Dr. Chung’s focus has been fundamental and translational research in HCV infection.  Major focus of his research has been elucidating the basis for the observed accelerated liver disease pathogenesis in HCV-HIV coinfection.  In this regard his research has made important contributions to the current understanding of hepatic pathogenesis of coinfection.  

Rebecca Taub
Found, Director & Chief Medical Officer, Executive Vice President, Research & Development
Madrigal Pharmaceuticals

Rebecca Taub, M.D. has served as Chief Medical Officer and Executive Vice President, Research & Development, and as a member of our Board of Directors, since July 2016. Previously, Dr. Taub served as Chief Executive Officer and as a member of the Board of Directors of privately-held Madrigal Pharmaceuticals, Inc. from inception through its merger with Synta Pharmaceuticals Corp. Prior to joining Madrigal, Dr. Taub served as Senior Vice President, Research and Development of VIA Pharmaceuticals from 2008 to 2011 and as Vice President, Research, Metabolic Diseases at Hoffmann-La Roche from 2004 to 2008. In those positions, Dr. Taub oversaw clinical development and drug discovery programs in cardiovascular and metabolic diseases including the conduct of a series of Phase I and II proof of conduct clinical trials. Dr. Taub led drug discovery including target identification, lead optimization and advancement of preclinical candidates into clinical development. From 2000 through 2003, Dr. Taub worked at Bristol-Myers Squibb Co. and DuPont Pharmaceutical Company, in a variety of positions, including Executive Director of CNS and metabolic diseases research. Before becoming a pharmaceutical executive, Dr. Taub was a tenured Professor of Genetics and Medicine at the University of Pennsylvania. Dr. Taub is the author of more than 120 research articles. Before joining the faculty of the University of Pennsylvania, Dr. Taub served as an Assistant Professor at the Joslin Diabetes Center of Harvard Medical School, Harvard University and an associate investigator with the Howard Hughes Medical Institute. Dr. Taub received her M.D. from Yale University School of Medicine and B.A. from Yale College

Ryan Feaver
NASH Program Leader
HemoShear Therapeutics

Ryan Feaver, PhD, is a Senior Director and the Program Leader for HemoShear Therapeutics’ nonalcoholic steatohepatitis (NASH) drug discovery program.  Dr. Feaver is a biomedical engineer with expertise in hemodynamics and the impact of the imparted shear stresses on the endothelium and their role in disease development, such as in atherosclerosis.  He has been instrumental in pioneering the development of in vitro human disease surrogate systems for drug discovery and development.  These patented in vitro systems recapitulate in vivo complexities of native tissue by incorporating tissue-specific primary human cells, 3D architecture, physiologically-relevant risk factors, and hemodynamic and transport conditions. Such models include vascular systems for studying atherosclerosis and species-dependent drug-induced vascular injury, and liver systems for studying pediatric rare diseases and NASH.  The NASH platform has been recognized by four Presidential Awards at the 2016-2018 “Liver Meeting” of the American Association for the Study of Liver Diseases (AASLD). HemoShear’s liver models are instrumental to its ongoing pre-clinical drug discovery programs in inborn errors of metabolism and NASH.  Dr. Feaver is a graduate of Duke University and received his PhD in biomedical engineering at the University of Virginia.

Saurabh Gupta
Director, Translational Research & Early Clinical

Saurabh Gupta is a translational medicine expert with more than 10 years of experience in drug development and clinical biomarker strategies across multiple therapeutic areas specifically fibrosis, cardiovascular-metabolics, CNS, rare diseases and Endocrinology. Presently he is the Director of Translational Research and Early Clinical at Takeda Pharmaceuticals International Co., Boston, USA, leading translational medicine and biomarker strategies in GI, CNS and number of rare disease programs. He has successfully identified and implemented target engagement, MOA, disease, safety, patient stratification biomarkers for in different phases of clinical trials. His research experience expands both in industry and academics across continents in diverse working environments. He has more than 40 peer-reviewed publications, numerous invited talks and presentations in international congresses. He has been reviewer/guest editor for number international journals including Nature Reviews Neuroscience, British Journal of Pharmacology, Cephalalgia, Headache, Journal of Cardiovascular Pharmacology and Vascular Pharmacology.

Scott Q Siler
Chief Scientific Officer
DILIsym Services, Inc.

Scott Q Siler, Ph.D., is the Chief Scientific Officer 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 quantitative systems pharmacology (QSP) models to pharmaceutical drug development with the company Entelos. As a Principal Scientist at Entelos, 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 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.  Combining these experiences, Dr. Siler has a unique combination of expertise in metabolic diseases, liver physiology and hepatocyte health, bioenegertics, and quantitative systems pharmacology that lends itself to the study of non-alcoholic fatty liver disease (NAFLD), drug-induced liver disease (DILI), and metabolic diseases like type 2 diabetes.

Sean Muthian
Executive Director, External Science Innovations

Entrepreneurial life scientist with broad therapeutic area background and expertise in Inflammation/Immunology, Pain, Oncology and Neural Diseases. More than 13 years of drug discovery/development experience with 16 (NCE & NBE) programs across early, preclinical and clinical stages including, focus on patient segmentation for proof of mechanism and proof of concept endpoints. Commercial experience of greater than 2 years in leading scientific sales & marketing. Leadership of up to 7 direct reports and 30 indirect reports including multi-disciplinary matrixed teams dedicated to delivering clinical candidates, early clinical read-outs, portfolio/pipeline, external R&D and marketing.

Day Two

Wednesday April 25, 2018

09.15 | Panel Discussion: Combinational Therapies in the Treatment of NASH

Shirly Pinto
Head of Biology & Drug Discovery

Shirly Pinto received her Ph.D., from Weil Cornell Graduate School of Medical Sciences [NYC] where she worked with Tim Tully at Cold Spring Harbor Labs and determined the genetic role for latheo, a Drosophila gene associated with learning defects. Shirly was awarded with the Rachele Prize for graduating Ph.D student with best published work. Shirly joined Merck in 2005 after a postdoctoral appointment with Jeff Friedman at the Rockefeller University, which culminated in a breakthrough Science publication on neuronal plasticity and rapid hypothalamic rewiring in response to leptin. At Merck, Shirly gained in-depth knowledge of drug discovery from target validation to lead optimization spanning 12 years in the pharmaceutical industry in multiple therapeutic areas related to cardio-metabolism and tissue injury. Recognized for leadership with a strong track record of delivering on drug discovery milestones. Known for successfully building new areas of research. Noted ability to build strong collaboration internally and externally. Currently Shirly is Vice President and Head of Biology at Kallyope, a biotechnology company headquartered in New York City focused on the development of an industry-leading platform to harness the gut- brain axis.

Sophie Mégnien
Chief Medical Officer

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

Tuesday April 24, 2018

08.45 | Exploring the Latest Regulatory Requirements for Developing NASH Therapeutics

Sudha Shankar
Head of Cardiometabolic Translational Medicine & Early Clinical Development
NGM Biopharmaceuticals

Dr Sudha Shankar is a physician scientist with subspecialty training in endocrinology, cardiology and clinical pharmacology. Her academic work focused heavily on human in vivo and cardiometabolic disease. Dr Shankar lead the Cardiometabolic Translational group at Merck for nearly 7 years before moving to lead the Cardiometabolic Research group at Eli Lilly for 3 years including leading their NASH program. Throughout her 10 years at both Merck and Eli Lilly, Dr Shankar focused extensively on clinical biomarkers, leading to her becoming the FNIH Industry Co-Chair for the NIMBLE Consortium. Now at NGM Biopharmaceuticals she is the Head of Cardiometabolic Translational Medicine & Early Clinical Development.

Day One

Tuesday April 24, 2018

17.15 | Panel Discussion: Non-Invasive Biomarkers – How Near Are We?

Thomas Hughes
President & Chief Scientific Officer

Dr. Hughes has more than 25 years of industry experience in the development and commercialization of pharmaceutical products and an extensive knowledge of the obesity and metabolic disease industry. Leading Zafgen since 2008 as CEO, Dr. Hughes currently serves as President, Chief Scientific Officer and a member of the company’s Board of Directors. From 1987 to 2008, Dr. Hughes held several positions at Novartis AG (and formerly Sandoz Pharmaceuticals) including Vice President and Global Head of the Cardiovascular and Metabolic Diseases Therapeutic area at the Novartis Institutes for BioMedical Research in Cambridge, MA. In these roles, he oversaw many drug discovery and development projects targeting obesity, diabetes and heart disease. As a scientist, Dr. Hughes led Novartis’ efforts to discover and develop its dipeptidyl peptidase IV inhibitor vildagliptin (Galvus®/Eucreas®), a drug used for the treatment of type 2 diabetes, currently approved in 70 countries.

Thomas Murphy
Director, Scientific Applications

Dr. Thomas Murphy is a cell biologist with 20 years’ experience in molecular cell biology and target identification and validation. His specific research interests have spanned biological imaging, cell signaling, and angiogenesis.  Prior to joining Organovo, Dr. Murphy was based in Singapore where he was involved with the scientific direction of a leading SE Asian life science distribution and genomics service business (Research Instruments Pte Ltd). Previously, Dr. Murphy worked as an Applications Scientist at Thermo Scientific (Dharmacon RNAi Technologies), where he functioned as a subject matter expert in the field of RNA interference and provided specialist knowledge for fellow scientists using RNAi technology. During his post-doctoral fellowship, he worked at the Novartis Institute for Functional Genomics (GNF) in San Diego, where he was responsible for conceiving and implementing genome-wide siRNA-based screens against inflammatory and oncology pathways. He received his B.A. in Biology from Occidental College, followed by his Ph.D. from the Molecular Biology Institute at University of California, Los Angeles. He has also held research positions at UC San Francisco and Amgen Inc. As Director of Scientific Applications at Organovo, Dr. Murphy oversees the scientific support and applications development for the company’s 3D bioprinted liver and kidney tissues and associated testing services

Day One

Tuesday April 24, 2018

16.30 | Modelling Progressive Liver Disease Using 3D Bioprinted Human Liver Tissue

Ajit dash
Senior Safety Scientist

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.

Arie Regev
Chair, Liver & GI Safety Committee, Global Patient Safety
Eli Lilly & Company

Dr. Regev heads the Safety Advisory Hub and chairs the Liver Safety Committee at Eli Lilly and Company. He serves as the co-chair of the CIOMS DILI Working Group and the co-chair the IQ DILI Initiative. He is also an Associate Professor of Medicine at the Division of Gastroenterology and Hepatology of Indiana University School of Medicine. Dr. Regev received his M.D. degree from the Hebrew University in Jerusalem, Israel. He completed residency in Medicine and fellowship in Gastroenterology at Rabin Medical Center and Tel Aviv University, and subsequently completed clinical fellowship in Hepatology and Transplant Hepatology at the Division of Hepatology of the University of Miami, in Miami, Florida. He worked at the Division of Hepatology of UM as an Associate Professor of Medicine and Director of the Hepatology Fellowship Program. Dr. Regev has conducted numerous clinical trials in the field of viral hepatitis, liver transplantation, and drug induced liver injury. He was the principal investigator of a number of NIH funded clinical trials and served as principal investigator on several investigator initiated and industry supported clinical trials in the area of viral hepatitis, nonalcoholic fatty liver disease, drug induced liver injury, and liver transplantation. He is the author of numerous publications in major medical Journals including Gastroenterology, Hepatology, American Journal of Gastroenterology, Clinical Gastroenterology and Hepatology, Journal of Hepatology, Liver Transplantation, Gut, Transplantation, Proceedings in Transplantation, Digestive Diseases and Sciences, and Drug Safety. He authored several chapters in major medical textbooks including Schiff’s Diseases of the Liver, The Clinician’s Guide to Liver Disease, Viral Hepatitis, Requisites in Gastroenterology and Advances in Internal Medicine. Dr. Regev received Teaching and Research Awards at the University of Miami and Tel Aviv University. In January 2007 he joined the Global Patient Safety organization of Eli-Lilly and company, and joined the faculty of Indiana University School of Medicine as Associate Professor of Medicine.

Andy Nichols
Chief Scientific Officer
Catabasis Pharmaceuticals

Andy Nichols is Chief Scientific Officer at Catabasis Pharmaceuticals, a biotechnology company in Cambridge Massachusetts, where he is responsible for scientific strategy, leading research and non-clinical development and delivering a pipeline of innovative product candidates based on its proprietary SMART Linker drug discovery platform for the treatment of rare diseases through a network of internal expertise and external partnerships.  Prior to Catabasis, Andy was Associate Vice President, Cardiometabolic Diseases at Merck Research Labs where he led drug discovery and early clinical development programs. Prior to Merck, Andy was Vice President of Preclinical Research at Zafgen, Vice President of Research at Alinea, Vice President of Drug Discovery Project Leadership at Millennium and Director of the Alliance Management Group at SmithKline Beecham. He holds an M. Phil. and Ph.D. in Cardiovascular Pharmacology from the University of Cambridge, England and a B.Sc. in Pharmacology from the University of Leeds, in England.

Bill Esler
Principal Scientist

Dr William Esler studied at Harvard University between 1993 and 1998 and has since been researching into Pfizer’s work on Acetyl-CoA-Carboxylase Inhibitor in NASH in his role as Principal Scientist.

Brian Wamhoff
Head of Innovation
HemoShear Therapeutics

Dr. Wamhoff serves as HemoShear Therapeutics' Head of Innovation and is a company founder.  He is responsible for development and management of strategic team initiatives to ensure a robust pipeline of disease models to advance our drug discovery platform and early stage therapeutic programs.  Dr. Wamhoff has led teams to oversee the successful development of human vascular and liver disease models, as well as ongoing development of a tumor microenvironment system.  These advancements have been built in part by his role in securing >$19 million in NIH Small Business Innovation Research funding from five different NIH institutes. Additional activities include scientific publication strategy and activities, thought leader development and engagement activities, and intellectual property and patent strategy. Dr. Wamhoff, former Associate Professor at the University of Virginia, has co-founded multiple medical device and therapeutics companies.  He obtained a B.S. in biology with a minor in business administration from Rhodes College, where he was the 2011 Distinguished Alumnus; he received his Ph.D. in medical physiology from the University of Missouri.  

Bryan Fuchs
Assistant Professor of Surgery
Harvard Medical School

Dr. Fuchs received his PhD in Biology from Saint Louis University examining the role of glutamine transporters in hepatocellular carcinoma (HCC) growth and survival. He completed a postdoctoral fellowship in the Division of Surgical Oncology at the Massachusetts General Hospital Cancer Center studying the role of epidermal growth factor (EGF) in the development of liver fibrosis and HCC. He is currently an Assistant Professor of Surgery at Harvard Medical School where his lab focuses on the identification of molecular pathways involved in liver fibrosis, and the analysis of anti-fibrotic therapies. More recent work has focused on the development of novel molecular imaging strategies to quantify collagen and lysyl oxidase-mediated collagen cross-linking as non-invasive means to monitor fibrosis progression, prognosticate outcomes, and measure response to therapy.  

Edgar Charles
Director, Exploratory Clinical & Translational Research
Bristol-Myers Squibb

Edgar D. Charles, M.D., M.Sc., is the clinical lead for PEG-FGF21 at Bristol-Myers Squibb. In this position, he provides strategic direction and oversight for BMS’ PEG-FGF21 clinical research and development activities, including the execution of clinical trials. Prior to assuming his current role at BMS, Edgar was at Merck & Co., where he led efforts across the R&D spectrum from discovery, clinical pharmacology and late-stage drug development across several therapeutic areas. Edgar received his M.D. from the University of Alabama at Birmingham, his M.Sc. in Clinical Investigation from Rockefeller University, and his B.A. in Economics from the University of Chicago. He completed a residency in internal medicine and a fellowship in infectious diseases at New York University. Edgar undertook postdoctoral research training as a Clinical Scholar at Rockefeller University in New York City in the laboratory of Charles M. Rice, Ph.D., where he researched hepatitis C virus pathogenesis. Edgar rose through the ranks at Rockefeller, later serving as Chief Clinical Scholar and an Assistant Professor leading basic and translational research programs investigating the mechanisms of virus-induced autoimmunity.

Dean Hum
Senior Executive Vice President & Chief Scientific Officer

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 One

Tuesday April 24, 2018

16.45 | Identification of Biomarkers for the Diagnosis of NASH

Donna Cryer
Global Liver Institute

Donna R. Cryer, JD, has channeled her personal experience as an IBD and liver transplant patient into professional advocacy as president and chief executive officer of the Global Liver Institute, the innovation and collaboration platform for the liver community. For almost a decade Mrs. Cryer led CryerHealth, a healthcare consulting firm she founded, providing strategic counsel to top biopharmaceutical companies, patient advocacy organizations, and emerging technology firms on patient engagement in health information technology, drug discovery, and clinical decision making. She is a frequent speaker on the topic of patient-centeredness and patient engagement in healthcare transformation. Mrs. Cryer serves on the Executive Committee of the People-Centered Research Foundation, the Boards of Directors of the Society for Participatory Medicine and the Personalized Medicine Coalition, as a patient representative to the U.S. Food and Drug Administration and the ABIM Gastroenterology Specialty Board. Mrs. Cryer’s community service also includes roles on the Boards of Trustees of Sibley Memorial Hospital/Johns Hopkins Medicine and The Taft School.

Gyongyi Szabo
Professor & Vice Chair of Medicine
University of Massachusetts Medical School

Gyongyi Szabo, MD, PhD is the Worcester Foundation for Biomedical Sciences Endowed Chair, Associate Vice Provost for Interprofessional Education, Professor and Vice Chair of Medicine at the University of Massachusetts Medical School. Dr. Szabo is an internationally recognized leader in the field of liver immunology and inflammation. Her translational research and clinical investigations focus on alcoholic hepatitis, non-alcoholic fatty liver disease and viral hepatitis. She is the lead investigator on an NIH-supported multicenter clinical trial on alcoholic hepatitis. Her laboratory studies molecular mechanisms of inflammation and innate immunity to identify therapeutic targets and to explore translation of bench to bedside opportunities in liver diseases. Her recent research focuses on the role of Toll-like receptor and Nod-like receptor signaling pathways in alcoholic and non-alcoholic fatty liver diseases and the importance of micro-RNAs as biomarkers. In recognition of her contributions to medical research she was recently elected to become member of the Hungarian Academy of Sciences. She serves on the Editorial Board of Hepatology, and on the Advisory Board of several agencies including the NIH ExRNA Consortium. She has the honor of serving as President of the American Association for the Study of Liver Diseases in 2015.  

Hani Jouihan
Scientist, Cardiovascular & Metabolic Disease

Hani is an innovative drug discovery researcher at the Cardiovascular & metabolic Disease (CVMD) discovery unit at Medimmune/AstraZeneca with multidisciplinary background in metabolic diseases particularly liver disease (NASH/NAFLD), obesity, diabetes, nuclear receptors, and cross-talk between the immune system and overall metabolism.  Hani has strong expertise and focus on identification of novel targets for the potential treatment of metabolic diseases. Prior to joining Medimmune, Hani was a postdoctoral fellow in Ajay Chawla’s laboratory at Stanford University where he participated in unravelling novel roles of the immune pathway IL4/STAT6 and eosinophils in regulating insulin sensitivity and enhancing glucose homeostasis, respectively. Hani earned a PhD in Biochemistry from the University of Utah where his work at Donald McClain’s lab established a novel role for manganese in enhancing insulin secretory capacity of pancreatic b-cells in a mouse model of Hemochromatosis. Hani has published in peer reviewed scientific journals and has presented his work at national scientific meetings.

James Swaney
Director of Biology
Inception Sciences

James Swaney is the director of Biology and the scientific lead in fibrosis at Inception Sciences in San Diego CA. He received his PhD in Molecular Pathology at UC San Diego with an emphasis in Molecular Pharmacology, related to fibrotic cardiac remodeling. He has over 12 years of experience in Biotech/Pharma, working in both in vitro and in vivo Pharmacology. His primary expertise is in fibrotic tissue remodeling and inflammation and he has successfully advanced programs from early preclinical development to IND filing and early stage clinical trials.

Jamie Bates
Senior Research Scientist
Gilead Sciences

Jamie received her PhD in Molecular and Cell Biology in the Immunology department from U.C. Berkeley in Mark S. Schlissel's lab where she elucidated the role of cis-elements in regulating V(D)J recombination. Following this, Jamie went on to be a postdoctoral fellow in the lab of Patrick O. Brown at Stanford University where she identified genes that were regulated post-transcriptionally in a murine leukemia model using a novel genome-wide polysome profiling technique. Jamie is currently a Research Scientist at Gilead Sciences supporting development of small molecule inhibitors for NASH.

Jason Campagna
Senior Vice President, Global NASH Lead
Intercept Pharmaceuticals

Jason Campagna is currently Senior Vice President and Global NASH Program Lead at Intercept Pharmaceuticals. Previously, he worked at The Medicines Company where he held numerous positions of increasing responsibility and global scope; ultimately serving as SVP of the Surgery and Perioperative Care Business. He graduated from the combined MD/PhD program at The University of Miami with a Ph.D. in Molecular and Cellular Pharmacology, and then completed his post-doctoral fellowship at the Neural Plasticity Research Group, his Internal Medicine internship, Anesthesia and Critical Care residency and Cardio-Thoracic Anesthesia fellowship all at the Massachusetts General Hospital in Boston. Most recently, he served on the board of directors for Annovation Biopharma from 2012 until its acquisition by The Medicines Company in 2015. He has served on the Board of Directors for the Neuroscience Research Institute in Santa Barbara, CA since 2007, and just completed a term as Scholar in Residence at the Kennedy Institute for Bioethics at Georgetown University.

Day One

Tuesday April 24, 2018

17.45 | Chair’s Closing Remarks

08.15 | Keynote: Review Latest Advancements in NASH Drug Development

08.00 | Chair’s Opening Remarks

Day Two

Wednesday April 25, 2018

16.30 | Chair’s Closing Remarks

08.00 | Chair’s Opening Remarks

Jasmohan Bajaj
Associate Professor, Division of Gastroenterology
Virginia Commonwealth University

Dr Bajaj is an Associate Professor at the Department of Internal Medicine, Division of Gastroenterology at Virginia Commonwealth University. He has worked on projects including Probiotic Host Interactions and Quality of Life in Liver Cirrhosis and has published articles including ‘Microbiota, cirrhosis, and the emerging oral-gut-liver axis’ and ‘Gastric acid suppression promotes alcoholic liver disease by inducing overgrowth of intestinal Enterococcus’.

Linda Morrow
Vice President and Chief Medical Officer

Dr. Linda Morrow is Chief Medical Officer at ProSciento, Inc. Her career in metabolism-focused clinical R&D, spanning more than 25 years, includes contributions to clinical development strategies and early phase research studies for many of the diabetes and related metabolic drugs and devices on the market globally today. Prior to her role as Chief Medical Officer, Dr. Morrow was Vice President and Chief Operating Officer for ProSciento with oversight of the clinical operations, project management and subject recruitment teams for global multi-site CRO studies and ProSciento’s state-of-the-art early phase facility in San Diego. During her role in this leadership position, ProSciento gained an industry-wide reputation as the leading organization for early phase diabetes research and one of only a few CROs with the experience and expertise in designing and conducting NASH first-in-human studies. Dr. Morrow has been the principal investigator on more than 80 clinical research studies for metabolic small and large molecule therapies, biologics, biosimilars and devices. Dr. Morrow previously held faculty member positions at the University of Michigan Division of Geriatric Medicine and Harvard’s Division on Aging where she led investigator-initiated clinical trials in carbohydrate metabolism and aging before moving into the private sector. Dr. Morrow earned a medical degree from the Medical College of Pennsylvania (now Drexel University) and completed her residency in Internal Medicine at the University of Michigan. Dr. Morrow is an author on more than 50 publications, including peer-reviewed journals, textbook chapters, and invited editorials.    

Clayton Dehn
Vice President Clinical Pharmacology Services
High Point Clinical Trials Center

Clayton Dehn is a clinical research physiologist with particular expertise in endocrine disorders, especially those related to fertility and metabolic disturbances. He is a co-inventor of a process and substance for disturbing the inheritance pattern of ion-channelopathic disorders by selectively disabling genetically undesirable sperm cells. He is also the sole author of the first publication cautioning against the risk of SGLT-inhibition inducing ketoacidosis in insulinopenic populations. Clayton brings over 15 years of knowledge and experience as a clinical research professional in the pharmaceutical, device, and CRO industries. His experience spans across global drug development, medical affairs, pharmacovigilance and regulatory affairs.  

Nathalie Belmonte
Senior R&D Director
Promethera Biosciences

Nathalie Belmonte has more than 10 years of experience working in the field of cell therapy from both an academic and biotech position. Specifically, she has extensive experience with the development of mesenchymal stem cells, hematopoietic stem cells and T cells in the fields of regenerative medicine and immunotherapy. Before joining Promethera Biosciences, Nathalie was VP Discovery at TxCell developing Treg cell based therapy for autoimmune diseases. Nathalie was a scientist in a French academic laboratory (INSERM) dedicated to the development of cell therapies for muscular dystrophy. Prior to this, Nathalie was a scientist at the San Raffaele Hospital at the Telethon Institute for Gene Therapy (TIGET) in Milan, working in the field of hematopoietic stem cells and muscle regeneration. She started her career working in a French academic lab in Nice (CNRS) working on embryonic stem cells and stem cells from adipose tissue. Nathalie has a PhD in Cellular and Molecular Biology at the University of Nice Sophia Antipolis.