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April 3-5, 2019 | Boston, MA

56 Expert Speakers  3 Streams  12+ Hours of Networking

Discovery Stream - Workshop A
Monday, April 23 2018

10.00 - 13.00
Comprehensively Evaluate the Predictions & Understanding of the Microbiome in Nonalcoholic Steatohepatitis
Workshop Leader: Jasmohan Bajaj, Associate Professor, Division of Gastroenterology, Virginia Commonwealth University Workshop Leader: Philip Hylemon, Professor of Microbiology & Medicine, Virginia Commonwealth University Workshop Leader: Shirly Pinto, Head of Biology & Drug Discovery, Kallyope

With evidence increasingly suggesting a contribution from gut microbiome as an environmental factor contributing to NAFLD and NASH progression, the potential for the discovery of new therapeutic targets for the treatment and prevention of NASH within the gut-microbiota is becoming an increasingly probable outcome.

Attend this workshop to:
• Understand the involvement of endogenously synthesized antibiotics and secondary bile acids in the regulation of the structure of the gut microbiome
• Objectively assess associations, mechanisms and clinical implications of the gut microbiota to fatty liver pathogenesis, including whether a shift in gut microbiome influences the progression from NAFLD to NASH to Cirrhosis to Hepatocellular Carcinoma
• Explore the current understanding of the gut-brain axis in NASH
• Evaluate the potential for microbiome-targeting NASH therapeutics as a preventative and targeted treatment and prevention of NAFLD and NASH
• Impartially hypothesize the potential for a microbiome diagnostic biomarker as preventative intervention against fatty liver disease

Workshop Leaders:
Shirly Pinto, Head of Biology & Drug Discovery, Kallyope
Phillip Hylemon, Professor of Microbiology & Medicine, Virginia Commonwealth University
Jasmohan Bajaj, Associate Professor, Division of Gastroenterology, Virginia Commonwealth University

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’.

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.

Shirly Pinto, Head of Biology & Drug Discovery, Kallyope

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.

Development Stream - Workshop A
Monday, April 23 2018

10.00 - 13.00
Reviewing Preclinical Models In-Depth as a Comparison of Traditional & Next Generation Advantages & Disadvantages
Workshop Leader: Bryan Fuchs, Assistant Professor of Surgery, Harvard Medical School

Despite a plethora of animal models in the NASH drug development landscape, preclinical representation of the extent of NASH fibrosis alongside a physiology that accurately replicates human clinical NASH features remains a challenge restricting translation into the clinic.

Join your peers at this workshop to:
• Objectively review advantages and disadvantages of traditional to next-generation rodent models including diet, genetic and chemical models
• Evaluate progression towards animal models that most accurately reflect human NASH fibrosis
• Explore opportunities in non-human primate animals to better recapitulate human clinical features
• Learn of advancements in manipulating animal models to provide more context to preclinical findings

Workshop Leader:
Bryan Fuchs, Assistant Professor of Surgery, Harvard Medical School

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.

 

Clinical Stream - Workshop A
Monday, April 23 2018

10.00 - 13.00
Harnessing all Available Opportunities to Improve NASH Patient Recruitment & Evaluating the Poential for NASH Public Health Interventions
Workshop Leader: Ravi Ravinuthala, Director, Liver Clinic, Ohio GI

Although NASH is very common, recruitment into clinical studies is difficult with high screen fail rate. The opportunity to diagnose and monitor patients non-invasively in combination with an increased awareness of NASH as a sequel of other metabolic disease provides opportunity to overcome this challenge.

Attend this workshop to:
• Examine and overcome barriers in patient recruitment
• Discuss the use of multiple/different endpoints in clinical studies to improve patient recruitment and completion
• Recognise NAFLD/NASH as a public health problem and address potential population interventions

Workshop Leader:
Ravi Ravinuthala, Director, Liver Clinic, Ohio GI

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.

Discovery Stream - Workshop B
Monday, April 23 2018

14.00 - 17.00
Enhance the Understanding of Liver Cell-to-Cell Interactions in the Pathogenesis of NASH & Evaluate the Opportunity for Next Generation Therapeutic Targets
Workshop Leader: Adil Mardinoglu, Assistant Professor of Systems Biology , Royal Institute of Technology, Sweden Workshop Leader: Ray Chung, Vice Chief of Gastrointestinal Division, Director of Hepatology & Liver Centre, Massachusetts General Hospital Workshop Leader: Alan Mullen, Principal Investigator , Massachusetts General Hospital Workshop Leader: George Lauer, Associate Professor of Medicine , Massachusetts General Hospital

Despite significant progression of established NASH candidates into the clinic, the intricacies of cell-to-cell interactions driving NASH clinical features remains a consistently evolving topic of interest for de novo target identification and disease interventions in the future disease interventions in the future.

Join the in-depth discussion at this workshop to:
• Review of known cell-to-cell interactions implicated in NASH pathogenesis including cross-talk between liver immune cell populations and assess the potential for of newly understood cellular interactions as therapeutic targets
• Understand the involvement of cell-to-cell interactions in subset NASH populations to influence stratifying patients for specific NASH treatments

• Comprehensively analyse the biological functions in healthy and NASH diseased states using biological network models as an integration of multiomics data

• Learn how to successfully employ systems biology into hepatology to identify biomarkers and drug targets

• Understand how to use systems biology for simulation of liver tissue functions and its crosstalk with other tissues for prediction of therapeutics and side effects

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

Adil Mardinoglu, Assistant Professor of Systems Biology, Royal Instsitute of Technology 

Adil Mardinoglu, Assistant Professor of Systems Biology , Royal Institute of Technology, Sweden

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.

 

Alan Mullen, Principal Investigator , Massachusetts General Hospital

George Lauer, Associate Professor of Medicine , Massachusetts General Hospital

Development Stream - Workshop B
Monday, April 23 2018

14.00 - 17.00
Exploring the Translatability of Non-Invasive Biomarkers in NASH
Workshop Leader: Banumathi Cole, Scientific Director, NASH Program, HemoShear Therapeutics Workshop Leader: Saurabh Gupta, Director, Translational Research & Early Clinical, Takeda

With NASH affecting an estimated 16-30 million adults in the US there is urgent clinical need for reliable methods to diagnose and stage liver pathology using non-invasive biomarkers.

Be part of the conversation at this workshops to:
• Objectively assess the current preclinical non-invasive biomarker landscape and validation of biomarkers
• Evaluate translatable fibrotic endpoints in animal models
• Review the potential of current biomarkers and their data in NASH cohorts
• Discuss biomarkers as a tool in patient diagnosis, stratification and longitudinal monitoring in clinical trials

Workshop Leader:
Saurabh Gupta, Director, Translational Research & Early Clinical, Takeda
Banumathi Cole , Scientific Director, NASH Program, HemoShear Therapeutics

Banumathi Cole, Scientific Director, NASH Program, HemoShear Therapeutics

Saurabh Gupta, Director, Translational Research & Early Clinical, Takeda

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.

Clinical Stream - Workshop B
Monday, April 23 2018

14.00 - 17.00
Evaluating the Key Challenges to the Successful Commercialization of Drugs for NASH
Workshop Leader: Amama Sadiq, Medical Director , Clarion Healthcare

Analysts predict that the market for NASH drugs could reach $35-40 Billion by 2025. However, analysts and drug developers alike appear to have largely overlooked at least two factors that could prevent the industry from realizing the full potential of this market:

  • The size of the addressable patient population may be much smaller than population-based studies suggest
  • Pushback from payers may limit access

Join this workshop to learn more about the key commercial challenges facing developers as they bring drugs for NASH to market:

  • What will a label indication for NASH look like?
  • How will clinicians determine which NASH patients to treat?
  • How will clinicians identify these patients in clinical practice?
  • What criteria will payers use to determine eligibility for reimbursement?
  • How will the pricing of drugs for NASH influence market access and reimbursement?
  • Once multiple drugs are approved, how will payers manage access to combination therapy?

Workshop Leader:
Amama Sadiq, Medical Director , Clarion Healthcare 

Amama Sadiq, Medical Director , Clarion Healthcare