Senior Scientific Director
Dr. Dohrn is an accomplished business executive with 20 years of experience in the pharmaceutical and medical device industry. In Medical and Scientific Affairs, she has led the development of global scientific strategy across multiple therapeutic areas at Abbott, Takeda, TAP and Baxter. She has also held US & global marketing, as well as sales training roles, which brings a unique perspective to clinical development and scientific affairs. Dr. Dohrn is well-published, including a Chapter in the upcoming publication, Translational Medicine in CNS Drug Development, highlighting challenges to patient recruitment in CNS clinical trials. Dr. Dohrn received her BA, MA, and PhD from the University of Chicago, focusing on Behavioral Science and Pharmacology. After completing a Post-doctoral Fellowship in Neuroanatomy at the University of Minnesota in Minneapolis-St. Paul, she joined the pharmaceutical industry. Over the years, she has used her business experience to mentor new scientists—from her alma mater and within the industry—who are interested in moving their careers beyond the bench.
Division of Gastroenterology & Inborn Errors Products
Wednesday April 24
13.45 | Regulatory Guidance on NASH Drug Development
Senior Vice President & Global NASH Lead
Wednesday April 24
15.15 | Session Reserved for Intercept
Co-Chair NIH Fibrosis Scientific Interest Group
National Institutes of Health
Tuesday April 23
17.00 | Kill two birds with one stone: MRI-1867, hybrid inhibitor of peripheral cannabinoid receptor 1 (CB1R) & inducible nitric oxide synthase (iNOS), for the treatment of NASH & liver fibrosis
Thursday April 25
Stratification of NASH Through Patient Data Sets
President & Chief Scientific Officer
Chief Technology Officer
Kunming Biomed International
Chief Medical Officer
Accelerated Enrollment Solutions (AES)
Dawie Wessels is chief medical officer for Accelerated Enrollment Solutions (AES), a unique member of the PPD Select site network. In his current role, he is responsible for medical and therapeutic strategy and leads a team of 150 physicians in 11 countries. Before joining PPD, Dr. Wessels worked in the pharmaceutical industry for more than 20 years where he gained business and medical expertise serving in various roles. He spent 15 years working in clinical pharmacology roles, including principal investigator and medical director in more than 300 studies that included many respiratory and Hypertension trials. He set up and ran a respiratory laboratory in London and performed many pharmacodynamic and proof-of-principal studies as the principal investigator. Later, he was a global group manager leading a team of project managers focused on Phase II studies. Dr. Wessels achieves results through teamwork and strategic leadership. He continuously interacts with scientific advisory boards in different therapeutic areas to ensure the best strategy is in place. Dr. Wessels completed his medical degree and earned his MBA at the University of the Free State in South Africa and was affiliated with the university’s pharmacology department.
Executive Director, Global Product Development
Louis Griffel serves as PPD’s executive medical director of global product development for the gastroenterology therapeutic area. In this role, he provides medical, scientific and product development expertise to PPD clients and internal operational and business development teams. Dr. Griffel joined PPD in February 2015 with 12 years of pharmaceutical experience, including pivotal work on an NDA submission program and several successful sNDAs and EU type II variations. Dr. Griffel has previously worked at Novartis, Schering-Plough, and Purdue Pharma, where he held global clinical development positions. Dr. Griffel is board-certified in gastroenterology and, prior to joining the pharmaceutical industry, served as full-time faculty at Robert Wood Johnson Medical School in New Brunswick, New Jersey, where he was assistant director of the Crohn’s and Colitis Center of New Jersey. Dr. Griffel continues to hold a volunteer faculty appointment as clinical associate professor of medicine at Robert Wood Johnson. Dr. Griffel completed his bachelor’s degree at The Johns Hopkins University in Baltimore, Maryland, and received his Doctor of Medicine degree from Hahnemann University (now Drexel University) School of Medicine in Philadelphia, Pennsylvania. He completed his internal medicine training at Pennsylvania Hospital in Philadelphia and a gastroenterology fellowship at Robert Wood Johnson. He is a member of the American College of Gastroenterology, the American Gastroenterological Association and the American Association for the Study of Liver Diseases and holds an active license to practice medicine in New Jersey.
Chief Executive Officer
OWL Metabolomics (in Partnership with BARC Lab)
Pablo Ortiz became MD by Universidad Autonoma of Madrid (1972-1978) where he also made his PhD (1984-1990) on liver metabolism. Pablo has over 25 years of experience in R&D projects in drug development & clinical trials at Boehringer Ingelheim. From June 2004 till November 2012, he was the CEO of Digna Biotech, a spin-off of the University of Navarra reaching with 4 products till Phase II in that period. Pablo joined OWL in January 2013 as a senior consultant and in June 2014 serving as CEO to develop the first noninvasive diagnostic of NASH based on metabolomics. He has published over 30 papers in international journals.
Executive Medical Director
President & Chief Executive Officer
Global Liver Institute
Director of Crown Bioscience Louisana (CBLA)
Director, NICE Scientific Advice
National Institute for Health & Care Excellence
Associate Director, Tissue Platform Operations
Tuesday April 23
16.20 | Using 3D Bioprinted Human Liver Tissue to Model NAFLD/NASH in vitro?
Vice President Product Development
Vice President, Clinical Development
Senior Scientist, Cardiovascular Renal, Metabolic & Ophthalmic Diseases Division
Professor of Systems Biology
Kings College London
Thursday April 25
Systems Biology in NASH: Approaches & Applications
Harvard Medical School
Dr Anthony Samir is an Assistant Professor at Harvard Medical School, and a Diagnostic and Interventional Radiologist at the Massachusetts General Hospital, where he serves as Service Chief for Body Ultrasound Imaging Services. He trained as a MD general practitioner in South Africa, followed by advanced post-graduate training in Internal Medicine and Surgery in New Zealand and Australia, and a five year-residency in Diagnostic and Interventional Radiology in Australia. He completed additional training in medical informatics, followed by two one year subspecialty fellowships in Abdominal Imaging and Interventional Radiology at the Massachusetts General Hospital. He joined the faculty of MGH Radiology and Harvard Medical School in 2006, and then completed a Masters degree in Public Health at the Harvard School of Public Health, with a concentration in the techniques and methods to measure the effectiveness of technology in healthcare settings. In addition to actively seeing patients, Dr. Samir currently works in several domains: (1) Imaging biomarker development and clinical trials: Dr. Samir is an internationally recognized expert in the field of non-invasive diffuse liver disease staging. His research group pioneered widely-used diagnostic assessments for liver fibrosis, and he currently chairs the 32-member clinical subcommittee of the Radiological Society of North America concerned with ultrasonic liver fibrosis staging. Dr. Samir has led two major prospective clinical trials of ultrasound elastography for liver disease and thyroid disease, and is an author of the Uniform Protocol for Imaging in Clinical Trials for ultrasound elastography. (2) Mentorship and education: Dr. Samir is co-editor of Abdominal imaging, a widely used two-volume subspecialty reference text, and is the author or co-author of more than 20 educational book chapters. He has mentored more than thirty post-doctoral fellows, most of whom have gone on to successful academic and clinical careers. (3) Technology development: Dr. Samir co-founded the MGH Clinical Ultrasound Research Laboratory and the MGH/MIT Center for Ultrasound Research & Translation, a joint center focused on rapid innovation and tight integration of engineering and iterative clinical refinement. In these leadership roles, together with collaborators, he has developed a number of medical imaging and image-guided interventional technologies, and has acquired extensive experience innovating successfully in partnership with other academic groups and industry. He has a strong interest in clinical applications and integration of predictive analytics and machine learning models into medical devices. He has received numerous collaborative foundation and government grants and industry funding and support from almost every major medical device company. His awards include the Far Eastern Economic Review Young Inventors Prize, the Siemens Australia Research prize, and the ABC Television Inventor’s Prize.
Director, Division of Gastroenterology & Hepatology; Professor of Internal Medicine
Saint Louis University School of Medicine
Dr Brent Tetri is a medical graduate of Yale University, who then completed his internal medicine residency at the University of Wisconsin in Madison before going on to do a fellowship in Gastroenterology and Hepatology and the University of California at San Francisco. He came straight from that fellowship to become a junior faculty member at Saint Louis University in 1990 and has risen through the ranks from assistant to associate and now full professor with tenure. Dr Tetri took over from Dr Bruce Bacon as the Director of the Division of Gastroenterology and Hepatology at SLU in 2010. Dr Tetri’s interest in liver disease was nurtured at UCSF under the tutelage of many of the greatest researchers in liver disease as that institution has always been a powerhouse of hepatology and the home base for a number of presidents of the American Association for the Study of Liver Diseases. Some of his early research papers were related to mechanisms of liver damage and then he turned his attention to looking at how this liver damage led to scarring or fibrosis in the liver. His encyclopedic knowledge of how the liver works and its role in metabolism led him naturally to study non-alcoholic fatty liver disease – an emerging serious health problem that now affects more than 1 in 5 Americans. In some individuals fatty liver disease can cause progressive liver damage and scarring of the liver, ultimately resulting in cirrhosis and even liver cancer and it is rapidly taking over from hepatitis C as one of the major diseases dealt with by liver specialists. Dr Tetri has played an important leadership role in a small and select group of researchers funded by the NIH to study fatty liver disease – the NASH Clinical Research Network. Over the course of the last decade, they have come up with now-standard definitions of the disease, and they continue to follow a large number of patients recruited from SLU and other centers around the country to determine the outcomes of having fatty liver disease. In the midst of doing this, these researchers have begun to find new ways of treating fatty liver disease and Dr Tetri has made Saint Louis University into a national center of excellence trying to discover treatments for this potentially fatal disease. In addition to his research excellence, Dr Tetri is an outstanding and compassionate physician who provides excellent care for many patients with liver disease inside and outside of the hospital.
Tuesday April 23
08.30 | Keynote: Many Paths to NASH-Many Targets for Treatment
Head of Pharmacology
Bryan Burkey is Head of Biology at Zafgen. Prior to joining Zafgen in 2014, Bryan was a Senior Research Investigator at Novartis Institute of BioMedical Research after being Director for 11 years from 1991. Bryan received his PhD in Developmental Biology from University of Cincinnati College of Medicine.
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.
Wednesday April 24
16.15 | An Update of Elafibranor & Use as the Backbone for Combinations
Chief Scientific Officer
Dr. David A. Fraser, a co-founder of NorthSea Therapeutics B.V., formerly worked as Group Lead Discovery R&D at Pronova Biopharma AS, part of BASF. Prior to joining Pronova in 2008, he worked as a post-doctoral fellow at Oslo University Hospital, primarily focused on diabetic microvascular complications. He also held a position as Research Officer at Menzies School of Health Research, Darwin, Australia in addition to posts at Nycomed (Denmark) and Aventis Pharma (Norway). He obtained his Ph.D from the University of Oslo, Norway where he studied immune and endocrine responses to acute starvation in patients with rheumatoid arthritis and holds an MSc (with distinction) in Human Nutrition and Metabolism from the University of Aberdeen, Scotland.
Chief Medical Officer
As Pliant’s chief medical officer, Éric Lefebvre, M.D. is responsible for leading the company’s clinical development strategy and clinical operations for its portfolio of product candidates. Prior to joining Pliant, Dr. Lefebvre was head of clinical research and development for non-alcoholic steatohepatitis (NASH) at Allergan, where he advanced cenicriviroc for the treatment of patients with NASH into Phase 3 trials. Previously, he was chief medical officer at Tobira Therapeutics, whose focus was the development and commercialization of therapies to treat liver disease, inflammation, fibrosis and HIV, prior to the company being acquired by Allergan in 2016. Dr. Lefebvre also led global clinical development, global medical affairs and commercialization of novel treatments for HIV and hepatitis C at Janssen Pharmaceuticals for 10 years prior to starting his pharmaceutical career at GSK Canada. This was preceded by 15 years of providing primary care and conducting clinical research in HIV and hepatitis at Clinique Medicale L’Actuel in Montreal, Canada. Dr. Lefebvre earned a B.S. from Edouard-Montpetit College and an M.D. from the University of Montreal.
Vice Chair for Research, Department of Medicine
University of Massachusetts
NASH Education Corporation
Chief Executive Officer
Dr. Everson is Chief Executive Officer and Managing Member of HepQuant, LLC, a company he founded in 2007 with a small group of investors. Dr. Everson received his MD degree from Cornell Medical College, NY, NY and is currently Past Professor of Medicine and Past Director of Hepatology at the University of Colorado, Denver. He is a distinguished Fellow of several professional societies and has published over 300 original papers, books, and book chapters in peer-reviewed journals that include Hepatology, Clinics in Liver Disease, Gastroenterology, Journal of Hepatology, New England Journal of Medicine, The American Journal of Gastroenterology, Alimentary Pharmacology and Therapeutics, andExpert Reviews in Gastroenterology and Hepatology. He has authored several “self-help” books on a variety of liver diseases: Living with Hepatitis C: A Survivor’s Guide, Curing Hepatitis C, Living with Hepatitis B: A Survivor’s Guide, and Living with Hemochromatosis: Answers to your Questions about Iron Overload. He is an advisor and consultant to foundations and industry. Dr. Everson is a member of the American Association for the Study of Liver Diseases (AASLD), American Gastroenterological Association (AGA), American Society of Transplantation (AST), the International Liver Transplant Society (ILTS). He is past member of the Transplant Hepatology Committees of the American Board of Internal Medicine and Accreditation Council for Graduate Medical Education. After over twenty years of research, Dr. Everson founded HepQuant, LLC in order to commercialize his invention of novel technology for noninvasive assessment of chronic liver disease.
Gregory Tesz Ph.D. is an Associate Research Fellow in the Pfizer Internal Medicine Research Unit. At Pfizer, his work has focused on understanding the underlying metabolic dysfunctions of both Nonalcoholic Fatty Liver Disease and Type 2 diabetes in order to inform and develop novel therapies for these diseases. Understanding how abnormal hepatic carbohydrate and lipid metabolism drive steatosis, insulin resistance, and hepatic inflammation has been a goal of Gregory’s research. At Pfizer, he has led the biology research efforts on a number of pre-clinical and clinical stage programs. Gregory received his Ph.D. from the University of Massachusetts Medical School having studied the interplay of inflammation and metabolic homeostasis. His broad range of experience includes preclinical model expertise, preclinical drug development and novel clinical strategies for assessing target engagement.
Wednesday April 24
09.30 | The Therapeutic Potential of Inhibitors of Steatosis for the Treatment of NASH
H. James Harwood
Adjunct Professor Department of Pathology
Wake Forest University School of Medicine
James Harwood, a biochemist and lipid enzymologist, brings over 40 years of research expertise in studying the physiological and pharmacologic modulation of key enzymes and receptors involved in the regulation of intermediary metabolism and over 30 years of broad based expertise in drug discovery and development in the pharmaceutical industry. Presently, Jim is Founder and CEO of Delphi BioMedical Consultants LLC, a consulting practice servicing the pharmaceutical and biotechnology industries, Adjunct Professor in the Department of Cellular and Molecular Biology at the University of Rhode Island where he teaches Biochemistry and advises pre-health profession students, and Adjunct Professor in the Department of Pathology at the Wake Forest University School of Medicine where he collaborates to study metabolic diseases in non-human primates. Prior to this, Jim was Principal Research Investigator in the Department of Cardiovascular and Metabolic Diseases at Pfizer Global R & D where some of his key projects included discovery and development of cholesterol synthesis inhibitors, cholesterol absorption inhibitors, fatty acid synthesis inhibitors, fat absorption inhibitors, and fat metabolism enhancers. Prior to these activities, he was Assistant Professor in the Departments of Medicine and Pharmacology at the University of Florida where he studied the physiological and pharmacologic regulation of cholesterol metabolism in experimental animals and in humans. Jim earned his Ph.D. in Biochemistry in 1982 from Purdue University and has authored over eighty publications in scientific journals.
Isai Peimer is a Biotech Analyst at Surveyor Capital (Citadel) where he focuses on public/private investments across the biotechnology sector. From 2010 to 2016, Isai was a Managing Director at Medimmune Ventures, Astrazeneca's investment fund. Isai has served as board member of Adheron Therapeutics (Acquired by Roche), Ambit Biosciences (acquired by Daiichi Sankyo), Armaron Bio. Corridor Pharmaceuticals (acquired by Astrazeneca), Xencor (NASDAQ: XNCR) and The Ivy Foundation Biomedical Innovation Review Board at University of Virginia. Isai was also an investment banker at J.P. Morgan and a Specialty Pharmaceuticals analyst at Alliance Bernstein. Prior to Wall Street, Isai was a management consultant in the pharmaceutical and biotech industry; he began his career as a scientist at Merck. Isai is a graduate of Emory University where he earned a B.S. in Chemistry summa cum laude, and earned his M.B.A. from the Tuck School of Business at Dartmouth.
Chief Scientific Officer & Co-Founder
Jeff Gulcher is Chief Scientific Officer and co-founder of WuXi NextCODE. He is also co-founder of Genomics Medicine Ireland which was recently acquired by WuXi NextCODE. Previously he was Chief Scientific Officer and co-founder of deCODE Genetics. Dr. Gulcher was on staff in the Department of Neurology at Beth Israel Hospital and Harvard Medical School from 1996 to 1998. He received his Ph.D. and M.D. from the University of Chicago in 1990, and completed his neurology residency at Brigham and Women’s Hospital and Beth Israel Hospital of Harvard Medical School in 1996. He received a Bachelor’s Degree in Chemistry/Physics from Michigan State University in 1981. He has co-authored 198 peer-reviewed publications on the genetics of common/complex diseases.
Harvard Medical School
Dr. Chhatwal is an assistant professor at Harvard Medical School and a decision scientist at MGH Institute for Technology Assessment (ITA). His research is centered in decision science, data analytics, outcomes research and health economics. He has over 10 years of experience in developing decision-analytic models to evaluate disease outcomes. He currently leads research in multiple disease areas including hepatitis C, liver cancer, liver transplantation, nonalcoholic fatty liver disease, anal cancer, and opioid and alcohol use disorder. Dr. Chhatwal is the Principal Investigator of a grant from the National Science Foundation that supports development of advanced data-analytic models to evaluate screening and treatment policies for hepatitis C in the United States, and a grant from the American Cancer Society to identify cost-effectiveness personalized surveillance strategy for hepatocellular carcinoma. In collaboration with the World Health Organization, Dr. Chhatwal lead development of an online, interactive tool -- Hep C Calculator -- that evaluates the cost-effectiveness of hepatitis C treatment in 28+ countries. Hep C Calculator allows users to interactively enter local cost data of a country and see the cost-effectiveness results in real-time. His research on hepatitis C modeling has made a direct impact on defining hepatitis C screening and treatment policies, in the United States as well as elsewhere. His work on the cost and impact new hepatitis C drugs has been featured by The Wall Street Journal, Forbes, NPR, and CNBC. In addition, Dr. Chhatwal has conducted research on breast cancer diagnosis that showed how machine learning and operations research methods can improve biopsy decision-making after mammography exams. This work won multiple awards including a best junior faculty paper and best student paper from the Institute for Operations Research and Management Science. His research interests also include advancement of decision-analytic methods used for medical decision-making. Dr. Chhatwal regularly teaches methods-oriented workshops at the annual meetings of the Society for Medical Decision Making and International Society for Pharmacoeconomics and Outcomes Research. He serves as a cost-effectiveness and decision analysis editor to the journal Clinical Gastroenterology and Hepatology, and is also an editorial board member of Medical Decision Making. Prior to joining the ITA, Dr. Chhatwal worked as a health economist for Merck Research Laboratories and was a faculty member at the University of Pittsburgh Graduate School of Public Health and MD Anderson Cancer Center. He received a Bachelor's Degree in Industrial Engineering from Thapar Institute of Engineering and Technology, India in 2001. He then pursued a Master's Degree in Industrial Engineering at Iowa State University in 2004, and a PhD in Industrial Engineering, focusing on operations research, at the University of Wisconsin-Madison in 2008. He won 2nd place prize in George Dantzig dissertation award, a prestigious award for the best dissertation in any area of operations research and management science that is innovative and relevant to practice.
Senior Scientist-Translational Bioinformatics
James is currently a Senior Bioinformatics Scientist in the Translation Medicine group at MedImmune, where he works primarily on biomarker research in cardiometabolic disease. Prior to joining MedImmune in 2016, he was a scientist at Merck for 9 years, where his work focused on genomic data analysis and human genetics in cardiometabolic disease. James earned his PhD in Physiology and Biophysics from Case Western Reserve University in 2006 after completing research in atherosclerosis at the Cleveland Clinic Lerner Research Institute.
Professor of Epigenetics, Fibrosis Research Group
I am interested in delineating epigenetic signalling pathways that trigger fibrogenesis and in doing so, discovering molecular control of fibrogenesis and associated signalling pathways that can be targeted with new as well as existing drugs. More recently we have also embarked on studies that test the ability of environmental factors to affect transgenerational inheritance of predisposition to liver fibrosis. Adaptation to environmental insults is critical for ensuring fitness and survival of the species, however it is currently not clear if predisposition to development of fibrosis exists or indeed if existence of disease in previous generations alters such predisposition.
Thursday April 25
Liver Fibrosis: Deliniating & Utilizing the Complexities of Fibrosis Pathology
Jen-Chieh (Jay) Chuang
Nonalcoholic Steatohepatitis, Fibrotic Diseases, Biomarker Sciences & Research Scientist
Jay Chuang is a biomarker scientist with extensive knowledge in the design and execution of biomarker activities in pre-clinical and clinical stage NASH programs. He has a broad knowledge base in the disciplines of metabolism, endocrinology, inflammation, neuroscience, and fibrosis. Past research projects have involved revealing the novel metabolic roles of orphan nuclear receptors (ONRs), GPCRs, and lysosomal transporters/enzymes in key tissues including pancreatic beta-cells, liver, and central nervous system (CNS). Jay’s current work focuses on the discovery and validation of novel NASH non-invasive biomarkers (NNIBs) for diagnosis and monitoring of fibrosis stage and NAS components (steatosis, lobular inflammation, and hepatic ballooning) using samples from NASH clinical trials.
Senior Director, External Collaborations & Scientific Alliances
Dr Julia Brosnan is the Senior Director for External Collaborations and Scientific Alliances in the Internal Medicine Research Unit (IMRU) at Pfizer (Cambridge, MA, USA). She received her D.Phil from the Biochemistry Department at Oxford University and her BSc(Hons) from Newcastle University. Julia completed post-doctoral fellowships on both sides of the Atlantic and was a Senior Lecturer at Glasgow University prior to joining Pfizer. She is the Industry Lead for the LITMUS consortium.
Research Scientist, Department of Radiology
Massachusetts General Hospital
Laura Brattain is a biomedical engineer at MIT Lincoln Laboratory and a research Scientist at the Department of Radiology, Massachusetts General Hospital. She works at the interface of biomedical image processing, machine learning, high performance computing, biorobotics, and healthcare innovation. She leads the machine learning for medical ultrasound effort at MGH Center for Ultrasound Research and Translation (CURT). She received her PhD in Engineering Sciences from Harvard John Paulson School of Engineering and Applied Sciences.
Senior Vice President
Head Liver Therapeutic Area 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.
Tuesday April 23
08.00 | What is the Future of NASH?
07.50 | Chair’s Opening Remarks
Wednesday April 24
08.20 | Chair’s Opening Remarks
Chief Scientific Officer
Dr. Hayardeny joined Galmed in 2016 bringing more than 16 years of experience in drug development as part of Teva Pharmaceuticals’ global R&D Division. Prior to joining Galmed, Dr. Hayardeny served as Teva’s Senior Director and Head of Research Scientific Affairs. In that capacity, Dr. Hayardeny established the scientific positioning of Teva’s innovative compounds. Additionally, Dr. Hayardeny was responsible for the company’s relationship with institutions of higher education; managing Teva’s global research collaborations and publications. Dr. Hayardeny holds a Ph.D. from Sackler School of Medicine and an MBA from Recanati Business School at Tel Aviv University.
Wednesday April 24
15.45 | Aramchol Phase 2b Results & Phase 3 Outlook
Vice President & 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.
Wednesday April 24
08.30 | NASH/NAFLD: Does Genotype Connect to Phenotype?
Vice President, Metabolic Complications
Janssen Research & Development
Maria Chiara Magnone has a Ph.D. in Neuroscience and 15 years of experience in Translational Sciences and Precision medicine across Cardiovascular and Metabolic Diseases and Neuroscience in Pharmaceutical and Biotechnology companies. Prior to joining Janssen Research and Development she was Sr Director/Head of translational Sciences in Cardiovascular and metabolic Diseases in Astrazeneca, and she previously covered roles of increased responsibility across discovery and early development in Serono, Novartis and Roche. In the past years her main scientific focus has been molecular and genomic disease reclassification in CVMD.
European Liver Patients Association
Marko is Master of Business and Economy, international certified NLP Trainer and NLP Coach and president of Slovenian Association for patients with viral hepatitis SLOVENIA HEP. He is closely involved in the development of ELPA strategy plan, ELPA work plan and budget, ELPA Symposium preparation at ILC organized by EASL and ELPA fundraising activities. He works as ELPA representative for dissemination and communication in project LIVERSCREEN for the European Institute for Innovation and Tehnology (EIT Health) and in Horizon2020 projects LIVERHOPE, GALAXY, and MICROB-PREDICT. Marko is a member of the steering committee and trainer at ELPA University. He is a member of European Association for the Study of the Liver (EASL), international NLP trainer association (INLPTA) and International Communication Association (ICA). In 2014 he wrote a book about his fight against hepatitis C with the title "336 days of Hope". He speaks and understands Slovenian, Croatian/Bosnian/Serbian, English and German. In 2017 he was awarded by Economist Research Unit as one of 18 most influential individuals in the world in the field of hepatitis elimination. Marko is a PhD student at Alma Mater Europaea Slovenia in the program Strategic Communication Management with the research focus on Health Communication.
Wednesday April 24
09.00 | NAFLD & NASH from the Patient Perspective - What Are Our Next Steps?
Chief Medical Officer & Senior Vice President
Manu Chakravarthy, M.D., Ph.D., is the Chief Medical Officer and Senior Vice President, Clinical Development for Axcella Health. In this position, he provides strategic direction and oversight for Axcella’s clinical research and development activities, including the execution of a variety of clinical trials across several indications. Manu brings a deep commitment to innovation and translational medicine with an unwavering focus to address serious unmet medical needs by translating breakthrough discoveries into the clinic, and meaningfully improve human health. Prior to assuming his current role, Dr. Chakravarthy served as the Global Head of External R&D in diabetes and cardiovascular research at Eli Lilly & Co where he was responsible for external innovation efforts, including the identification/evaluation of novel therapeutics, platforms, and technologies for in/out-licensing, establishing academic collaborations, and consortia management across the value chain to complement and enhance Lilly’s internal R&D portfolio. He also served as the industry co-leader of the Innovative Medicine Initiative’s LITMUS project, one of the largest public-private consortia efforts to elucidate noninvasive biomarkers for NAFLD. Before his global leadership role at Lilly, Dr. Chakravarthy spent more than 7 years at Merck & Co., where he began his industry career in Experimental Medicine as an associate director and progressively gained increasing experience across the R&D spectrum from discovery, clinical pharmacology, biomarker development and late-stage drug development in endocrine, metabolic, neuroscience and anti-viral therapeutic areas. During this time, he assumed positions of increasing responsibility and leadership within the company, ultimately serving as a Distinguished Scientist and led the clinical pharmacology groups in Discovery Medicine for groups in diabetes and cardiometabolic diseases within Translational Medicine. Dr. Chakravarthy received his medical degree from the University of Texas Houston Medical School, his doctorate in cell biology & physiology from the University of Texas Graduate School of Biomedical Sciences and the MD Anderson Cancer Center, and his bachelor’s degree in Liberal Arts from St. John’s University. He completed a residency in Internal Medicine at the Hospital of the University of Pennsylvania and clinical Fellowship in Endocrinology, Diabetes & Metabolism at the Barnes-Jewish Hospital in St Louis. Dr. Chakravarthy undertook postdoctoral research training as an American Diabetes Association Postdoctoral Fellow at Washington University School of Medicine in St. Louis with Professor Clay Semenkovich focusing on lipid metabolism. His research elucidated the role of de novo lipogenesis via fatty acid synthase in hepatic steatosis, including the discovery of an endogenous ligand for the nutritionally regulated transcription factor, PPARalpha. Following his clinical and postdoctoral research training, Dr. Chakravarthy was appointed as Instructor of Medicine in the Department of Endocrinology & Metabolism at Washington University School of Medicine. Dr. Chakravarthy is Board-certified in Endocrinology, Diabetes & Metabolism and continues to serve patients as an Adjunct Clinical Assistant Professor of Medicine at the Rutgers School of Medicine, NJ.
Founder, Chairman, President & Chief Technical Officer
Dr. Bradley has held key positions within the pharmaceutical industry for over 25 years and has extensive expertise in drug discovery and strategic drug development with a focus on target selection, drug proof of concept, preclinical pharmacology/toxicology, and IND/Phase I/II/III/NDA preparation in numerous therapeutic areas. Prior to forming SAJE Pharma, Dr. Bradley ran his own consulting firm, working with small and mid-sized bio and pharmaceutical companies. He concentrated on developing strategic research and development plans for clients and on carrying out those plans using an extensive network of high quality, cost-efficient CROs. Dr. Bradley has been the founder or co-founder of five previous biopharmaceutical companies where he has served in various executive R&D and board functions. Those companies include: Genetic MediSyn, Protarga, Replicon, Apothec, and Index Therapeutics. His work in those companies resulted in in-licenses, out-licenses, 18 patents, and numerous drugs discovered and developed through regulatory submissions. Previously to these companies, Dr. Bradley worked for 12 years at Merck and Co., where he was Director of Safety Assessment and Biological Research. Before joining Merck, Dr. Bradley was a Senior Staff Fellow at the National Cancer Institute of the National Institutes of Health where he worked on cancer drug development. He has been involved in several worldwide regulatory submissions in the areas of allergy, neurology, infectious disease, cardiovascular disease, and oncology. Dr. Bradley received a B.A. in Biology from The University of Pennsylvania and a Ph.D. in Biological Sciences from Stanford University. He was a Leukemia Society Postdoctoral Fellow at Stanford in the laboratory of Dr. Robert Schimke, where he studied molecular and cellular biology applied to mechanisms of aging and carcinogenesis. Dr. Bradley has authored 11 issued patents and 68 peer-reviewed scientific publications and numerous abstracts, book chapters, reviews, and published symposium conferences.
Director, Head of Fibrosis
Min received his MD degree in China and his PhD in vascular biology at the University of California, Riverside. He then researched on insulin resistance and obesity in Jerrold Olefsky’s lab at the University of California, San Diego, during his post-doctoral training. In the meantime, Min passed all three steps of the United States Medical Licensing Examination to obtain his ECFMG certificate. Prior to joining Morphic Therapeutic, Min worked at Pfizer, Takeda, and Merck on target ID, target validation, and in vivo pharmacology. Currently at Morphic, Min leads a discovery team and manages research activities on pre-clinical and translational research to target integrin proteins for fibrosis indications.
Director of the Metabolic Health Center
Texas Liver Institute
Dr. Alkhouri is Associate Professor of Medicine and Pediatrics at the University of Texas (UT) Health in San Antonio and he is the director of the Metabolic Health Center at the Texas Liver Institute. He was most recently Assistant Professor of Medicine at the Cleveland Clinic Digestive Disease and Surgery Institute and Director of the Metabolic Liver Disease Clinic Dr. Alkhouri received the American College of Gastroenterology Junior Faculty Development Award to study the analysis of breath volatile organic compounds to diagnose nonalcoholic fatty liver disease He has over 100 peer-reviewed publications and presents his work at both national and international medical conferences
Executive Director, Hepatology Sciences & 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).
Tuesday April 23
17.30 | Critically Reviewing Which Mechanisms of Action to Combine to Address NASH
Chief Medical Officer
Patrick Horn is Chief Medical Officer at Albireo. He has extensive drug development experience in both large and small companies. His work in the Biotech industry includes planning and leading successful development programs for therapeutics targeting orphan diseases ranging from Phase 1 through regulatory approval and product launch. He has formal training and extensive experience in clinical pharmacology. Pat received both his MD and PhD from the University of Chicago and completed a Pediatric Residency at Boston Children’s Hospital. Prior to transitioning to industry, Pat was a practicing pediatrician at a major academic institution in Chicago for almost 20 years.
Executive Vice President, Commercial
Pascal Prigent has a rich experience of more than 20 years in the pharmaceutical industry (Eli Lilly, GSK), on 3 continents (Europe, North America, Latin America). Prior to joining GENFIT, he was Vice President Marketing for the Vaccines division of GSK US where he led the commercial strategy for a multi-billion dollar vaccine portfolio. Pascal Prigent holds a Master of Business Administration from INSEAD (1995) and is a graduate of Reims Business School (1989).
Cofounder & Chief Executive Officer
Peter Guzzo, Ph.D. has over 20 years of drug discovery and development experience and is the Cofounder and CEO of ConSynance Therapeutics, a clinical stage drug development company. He has broad knowledge in multiple therapeutic indications, intellectual property creation and management, building entrepreneurial teams as well as business development experience with pharma, biotech and academic institutions. Pete holds a PhD in Organic Chemistry from University of Notre Dame and conducted postdoctoral training at Rensselaer Polytechnic Institute.
Director of the Institute for Innovation in Imaging
Massachusetts General Hospital
Dr. Caravan is the Director of the Institute for Innovation in Imaging at Massachusetts General Hospital and Associate Professor of Radiology at Harvard Medical School. He leads a multidisciplinary and translational molecular imaging lab focused on the invention of novel molecular probes and their broad applications in cardiovascular, pulmonary, renal, and hepatic diseases as well as in cancers. His research spans novel chemistry technologies to advanced MRI and PET imaging in animal models to applications in patient populations. Dr. Caravan received a PhD in Inorganic Chemistry from the University of British Columbia. Following post-doctoral work at the EPFL (Switzerland) he worked in industry developing targeted MR probes. He joined the faculty of Harvard Medical School in 2007 and has been a continuously funded NIH researcher. He has published over 100 original peer reviewed papers and holds over 25 issued or pending patents.
Peter has had a distinguished career in drug development, research, management, and governance, with demonstrated success in large matrix and small entrepreneurial organizations, including those in the pharmaceutical industry, biotechnology, academia, and healthcare. He is adept at strategic planning, designing and leading complex scientific and drug development programs, recruiting and leading effective executive teams, effecting and managing change efforts, building value, and effective communication. Prior to joining Alacrita, Peter was CEO and CMO of Galectin Therapeutics where he brought a galectin-3 inhibitor, a putative anti-fibrotic drug, from a research compound through development to a phase 3-ready program in NASH cirrhosis and built a pipeline of other indications. Before that in the pharmaceutical industry, he was Senior Vice President and CMO at GlaxoSmithKline where he had responsibility for a broad range of therapeutic areas. In academic medicine, Peter ran a basic science laboratory program that made fundamental discoveries in liver and intestinal biology, and he served as Chief of Gastroenterology, Chairman of Medicine and CEO of the University of Pennsylvania School of Medicine and Health System. He also was President and CEO of Baylor College of Medicine. Peter has a BS degree in chemical engineering from the University of Michigan, an MD degree from Wayne State University School of Medicine, and a certificate in business leadership for physicians from The Wharton School.
Chief Medical Officer
Dr Scalfaro is in charge of strategy and operational management of early-stage clinical drug development at Enyo Pharmaceuticals. He brings to this a wide range experience in the healthcare sector, working notably in infectious diseases (HCV, via the development of Alisporivir), septicaemia, oncology, Alzheimer’s disease and cardio-respiratory diseases. He has been previously involved in setting up a Personalised Medicine Business Unit at Debiopharm Group and is involved in Swiss eHealth start-up companies
Chief Executive Officer
Prof. Fishman is the scientific founder of the company and was previously a professor of Life Sciences and headed the Laboratory of Clinical and Tumor Immunology at the Felsenstein Medical Research Institute, Rabin Medical Center. Prof. Fishman is a very accomplished scientist and has authored or co-authored over 150 publications and presented the findings of her research at many major scientific meetings. Her scientific work was the foundation on which Can-Fite was built. This scientific work has gained recognition as one of the leading approaches for new generation therapies for cancer and other diseases. Her past managerial experience included seven years as CEO of Mor Research Application (MRA), a company that was in charge of the commercialization of intellectual property from all hospitals and research centers of Clalit Health Services, the largest healthcare provider in Israel, and was also the first clinical CRO in Israel. She was also involved in the establishment and served on the Board of Directors of several life sciences technology start-ups.
Chief Medical Officer, Executive Vice President Research & Development
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.
Wednesday April 24
14.15 | Showcasing the Clinical Development of MGL3196
Richard Lee is a director in the Cardio/Metabolic/Renal division of the Antisense Drug Discovery Group at Ionis Pharmaceuticals. He received his PhD training in the laboratory of Larry Rudel at Wake Forest University, followed by a postdoctoral fellowship in Peter Edwards laboratory at the University of Los Angeles. Dr. Lee then transitioned to Ionis Pharmaceuticals to work on antisense oligonucleotide (ASO) drug discovery focusing on dyslipidemia therapeutics. Over the last 10 years Dr. Lee has made key contributions to the preclinical characterization of mipomersen, a human apoB ASO approved for treatment of homozygous FH, volanosorsen, a human apoC-III ASO which recently completed a successful phase III trial in familial chylomicronemia syndrome, and Angptl3Rx, which is currently entering phase II trials for dyslipidemia/metabolic syndrome. Recently, Dr. Lee’s focus has shifted from dyslipidemia to metabolic syndrome, including NASH and beta cell dysfunction.
Thursday April 25
Drug Development Strategy & Regulatory Intelligence in NASH
Commercial Development Lead, Internal Medicine
Ritesh Shah has spent 21 years at Pfizer in a variety of roles spanning Commercial, Strategy and Analytics across US, Europe and Asia.
Executive Director; Head, Liver Disease Program
China Novartis Institute for BioMedical Research
Robert Arch is the Executive Director & Head of Liver Disease Program at Novartis Institutes for Biomedical Research (NIBR). Prior to joining NIBR Robert was the Senior Director of Liver Disease Research at Takeda. Robert has also held positions of responsibility at GSK, Pfizer and Washington University School of Medicine. Robert specialises in Immunology, Lymphocytes, T cells, TNFR signal transduction; academic and industry research and management.
Executive Director, Internal Medicine Research Unit
Director – CardioMetabolic Discovery
Saswata Talukdar is Director of CardioMetabolic Drug Discovery at Merck. Prior to joining Merck in 2015 Saswata was a principal scientist at Pfizer in CVMED. Saswata received his Post Doc at the University of California, San Diego and his PhD in Biochemistry and Molecular Pharmacology from West Virginia University School of Medicine.
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.
Executive Vice President- Strategic Development
Suneil Hosmane is the Executive Vice President of Strategy at GENFIT Corp., which he joined at the end of 2017. He has a leadership role on multiple strategic initiatives that span across GENFIT’s therapeutic and diagnostic programs. Suneil also held positions of increasing responsibility at Becton Dickinson Diagnostics, Intercept Pharmaceuticals, and EchoSens. Suneil holds a Ph.D. in Biomedical Engineering from the Johns Hopkins University School of Medicine and a BSc/MSc in Electrical Engineering from the University of Illinois at Urbana-Champaign.
Associate Vice President in Clinical Development
Star Seyedkazemi is the Associate Vice President in Clinical Development at Allergan, primarily responsible for global clinical development of therapeutic agents and combinations for nonalcoholic steatohepatitis. Prior to joining Allergan as part of its acquisition of Tobira Therapeutics, Star served as the medical lead for the phase 2 and 3 trials to evaluate the efficacy and safety of cenicriviroc, a novel CCR2/5 antagonist, for the treatment of liver fibrosis associated with NASH. Star received her Doctor of Pharmacy degree from Nova Southeastern University and completed a HIV specialty residency. Her career includes pharmaceutical industry experience in global clinical development and medical affairs in liver and infectious diseases, preceded by clinical care and research.
Chief Executive Officer
Fatty Liver Foundation
Senior Principal Scientist
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.
Assistant Professor of Medicine
Harvard Medical School
Yury Popov received an M.D. (1997) from Grodno State Medical School, Belarus and PhD in Biochemistry (2004) from Institute of Biochemistry of National Academy of Sciences of Belarus. He was the first scientist from Eastern Europe to win the prestigious Sheila Sherlock EASL fellowship award to pursue postdoctoral training in translational liver fibrosis research at the University of Erlangen-Nuremberg in Germany. In 2005, Dr. Popov relocated to USA to join faculty at Beth Israel Deaconess Medical Center and Harvard Medical School. Dr. Popov is currently directing a Liver Fibrosis Research Lab and Core and holding an appointment of Assistant Professor of Medicine at Beth Israel Deaconess Medical Center and Harvard Medical School. He is also an Associate Editor of American Journal of Physiology-Gastrointestinal and Liver Physiology, and ad hoc reviewer for over 30 scientific journals. Dr. Yury Popov’s laboratory's major research focus is on liver fibrosis/cirrhosis and its life-threatening sequelae. Specifically, his team investigates the basic mechanisms of progression and regression of liver scarring, with the goal of the development of non-invasive diagnostic tools to measure these processes in the clinic, and novel therapies to prevent and reverse cirrhosis and its life-threatening complications such as primary liver cancers.