MEETING PROSPECTUS. International Workshop on NASH Biomarkers

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International Workshop on NASH Biomarkers 2018 18-19 May 2018 Washington, D.C.

1 International Workshop on NASH Biomarkers May 2018 Washington, D.C., USA MEETING PROSPECTUS

2 ADVANCING HEALTH GLOBALLY THROUGH INNOVATIVE PROGRAMS DESIGNED FOR THE HEALTHCARE PROFESSIONAL

3 TABLE OF CONTENTS Welcome 4 Meeting description 5 Infographics 2016 edition 7 Conference particiaption grants 8 Enduring materials 8 Committees 9 Acknowledgements 10 Contact information 11 #NASHbiomarkers18 IInternational Workshop on NASH Biomarkers Meeting Prospectus 3

WELCOME Veronica Miller, PhD Meeting Chair Arun Sanyal, MD, MBBS Meeting Chair Dear Delegate, The recognition of non-alcoholic steatohepatitis (NASH) as a significant cause of morbidity and mortality

Histology based assessments requiring liver biopsies remains the NASH diagnostic standard; drug developers and clinical researchers are challenged by the lack of accepted and/or validated

4 WELCOME Veronica Miller, PhD Meeting Chair Arun Sanyal, MD, MBBS Meeting Chair Dear Delegate, The recognition of non-alcoholic steatohepatitis (NASH) as a significant cause of morbidity and mortality around the globe has generated much activity in therapeutic and diagnostic development. Histology based assessments requiring liver biopsies remains the NASH diagnostic standard; drug developers and clinical researchers are challenged by the lack of accepted and/or validated non-invasive diagnostic, prognostic and endpoint biomarkers. Collaboration across sectors and stakeholders will facilitate progress along the path to acceptance, validation and/or qualification of non-invasive biomarkers. Building on the success and momentum of the previous years, the third NASH Biomarker workshop is again co-organized by the Liver Forum, a multi-stakeholder organization whose aim is to facilitate therapeutic and diagnostic development and advance the regulatory path for treatment of NAFLD and NASH. This public, abstract driven workshop will provide the much needed time and space to focus on NASH biomarker development by bringing together all the key individuals and organizations in the field of NASH Biomarkers. During this workshop, we will hear from the leaders in the field as we consider collaborative pathways to accelerate the pace of development by increasing efficiency and productivity. By sharing knowledge, coordinating activities, and working through the complex issues surrounding NASH, the NASH Biomarkers Workshop will continue to impact the advancement of the field. Veronica Miller & Arun Sanyal #NASHbiomarkers18 4 International Workshop on NASH Biomarkers Meeting Prospectus

MEETING DESCRIPTION NEEDS STATEMENT Nonalcoholic fatty liver disease (NAFLD) is a leading cause of chronic liver disease worldwide, and is expected to become the leading indication for liver

5 MEETING DESCRIPTION NEEDS STATEMENT Nonalcoholic fatty liver disease (NAFLD) is a leading cause of chronic liver disease worldwide, and is expected to become the leading indication for liver transplant in the United States. NAFLD covers a range of fatty liver disorders that includes two major subtypes: nonalcoholic fatty liver (NAFL), and nonalcoholic steatohepatitis (NASH). Patients with NAFLD typically have slow, or no histological progression, while patients with NASH are at increased risk for disease progression. Progression of NASH can include increasing fibrosis, cirrhosis, liver failure, and hepatocellular carcinoma (HCC). Currently, the only way to diagnose NAFLD is by liver biopsy. However, there are a number of limitations and risks that accompany liver biopsies, including: invasive and/or painful procedure, risk of medical complications, and the possibility of sampling error. While biopsy will likely remain an integral part of liver disease diagnosis, other non-invasive methods of screening, identifying disease severity, and following disease progression are highly sought after. Several non-invasive methods have been developed and have been proposed for use with NAFLD/NASH, including serum biomarkers, and transient elastography. There is a high level of interest in advancing these methods through regulatory pathways, and there are currently a number of collaborative groups that are working on these issues. The first NASH Biomarkers Workshop was held in 2016, and was initiated by the realization that the field was lacking a focused meeting allowing for in-depth discussion amongst all key experts. The second NASH Biomarkers workshop was co-organized by the Liver Forum, a multistakeholder organization whose aim is to advance the regulatory sciences for the treatment of NASH and liver fibrosis. Participants at the 2017 workshop overwhelmingly voted to continue the workshop annually, owing to the tremendous amount of interest and growth in this field. As a result, the workshop returns for a third iteration in This workshop seeks to bring together all the key individuals and organizations in the field of NASH Biomarkers, specifically regulatory agencies from both the U.S. and Europe, industry organizations, academic and clinical researchers, and research networks. By sharing knowledge, coordinating activities, and working through the complex issues surrounding NASH, the NASH Biomarkers Workshop will continue to impact the advancement of the field. International Workshop on NASH Biomarkers Meeting Prospectus 5

6 MEETING DESCRIPTION MEETING OBJECTIVES Review the current regulatory landscape and gaps in regulatory science related to biomarker development for NAFLD Review the gaps in evidence needed to qualify specific biomarkers for NAFLD Stimulate collaborative science to accelerate biomarker development for NAFLD Promote innovation in design and analytic approaches to biomarker development for NAFLD TARGET AUDIENCE The target audience of this meeting consists clinical, basic and translational researchers from academia and industry, physicians, pharmacologists, drug development experts, government representatives, young investigators and other experts involved in drug development for NASH. UNIQUE MEETING FEATURES This workshop provides a unique international translational platform for interchange between healthcare professionals involved in NASH. By bringing expert in the field of NASH biomarkerstogether the workshop stimulates international collaborations and networks. ASSESSMENT METHOD To assess the meeting, each delegate will be provided with a detailed feedback form where they can assess the speakers, whether or not the meeting objectives were met, the rationale behind their motivation to attend, the general logistics of the meeting, and much more. All the questions are then fully analyzed and a comprehensive report is created and shared with the committee members. These reports help us better understand our delegates and how to make the next meeting better. For a maximum response rate, we invite the chairs of each session to encourage the participants to take a few minutes and complete the feedback forms. We are also introducing a web-based application to allow participants access to the feedback forms electronically. ORGANIZERS The International NASH Biomarkers Workshop is co-organized by Expert Medical Events and the Liver Forum, a multi-stakeholder organization whose aim is to facilitate therapeutic and diagnostic development and advance the regulatory path for treatment of NAFLD and NASH. ACCREDITATION This workshop will not be a CME accredited activity. 6 International Workshop on NASH Biomarkers Meeting Prospectus

INFOGRAPHICS 2017 OCCUPATION COUNTRIES The majority of the 155 delegates attending the NASH Biomarkers Workshop 2017 worked as researcher,

80% Researcher Medical doctor (MD) Corporate professional Other Government official 28% 26% 23% 18% 5% 80% of the participants (n=129) were

WORKPLACE TYPE The majority of the 160 delegates attending the NASH Biomarkers workshop worked for an Industry organization (54%).

(University) Hospital 7% University 8% Laboratory 6% Other 5% NGO 1% Industry 54% RETURNING PARTICIPANTS 25% of participants (n=40) attended

is indicated to what extent participants indicated that the meeting objectives were met. 1.

7 INFOGRAPHICS 2017 OCCUPATION COUNTRIES The majority of the 155 delegates attending the NASH Biomarkers Workshop 2017 worked as researcher, medical doctor, or corporate professional. 80% Researcher Medical doctor (MD) Corporate professional Other Government official 28% 26% 23% 18% 5% 80% of the participants (n=129) were from the US, 16% came from a EU country. WORKPLACE TYPE The majority of the 160 delegates attending the NASH Biomarkers workshop worked for an Industry organization (54%). Others were employed by a government agency (10%), research institute (9%), or others. (University) Hospital 7% University 8% Laboratory 6% Other 5% NGO 1% Industry 54% RETURNING PARTICIPANTS 25% of participants (n=40) attended both the first and second edition of the NASH Biomarkers workshop 2017 Research Institute 9% Government Agency 10% MEETING OBJECTIVES Below is indicated to what extent participants indicated that the meeting objectives were met. 1. Review the current regulatory landscape & gaps in regulatory science related to biomarker development for NAFLD 2. Review the gaps in evidence needed to qualify specific biomarkers for NAFLD 3. Stimulate collaborative science to accelerate biomarker development for NAFLD 4. Promote innovation in design and analytic approaches to biomarker development for NAFLD 94% 91% 96% 90% International Workshop on NASH Biomarkers Meeting Prospectus 7

8 CONFERENCE PARTICIPATION GRANTS The conference participation grants provide healthcare professionals with the opportunity to attend a conference they would otherwise be unable to attend due to financial restrictions. All applications include a CV, a motivation letter, and potentially an abstract (requirements vary depending on the workshop). These are submitted via an independent CPG portal and are evaluated against the assessment criteria using robust, impartial and independent peer review processes by the Grant Review Committee. This process will ensure that only the highest quality, most relevant and most competitive research is accepted. The grants are supported by the financial contributions allocated by the sponsor, who, has no control, influence, or involvement in the selection process of the attendees whatsoever. Priority is given to applicants who have actively participated in original research or scientific work that is being presented at the meeting and/or those who will profit most from participating in order to improve their daily clinical management. These grants help defray costs for registration, travel and accommodation for delegates and foster their ability to form valuable professional networks and develop vital collaborations. Conference participation grant applications will be solicited, selected and awarded by an expert Grant Review Committee. Please note that the TITANIUM, PLATINUM and GOLD support levels will reduce the costs for conference participation grants. Supporters can indicate a desired number of CPGs to be granted in the response form further below. ENDURING MATERIALS INFECTIOUS DISEASES ONLINE Enduring information presented at the conference will be freely retrievable and widely disseminated to reach thousands of virtual participants beyond the walls of the conference center. Infectious Diseases Online is a premier online platform offering scientific materials in special topical areas and proceedings of conferences. By accessing the website, visitors have full access to: Abstract Books Meeting Reports Workshop Presentations Webcasts All the data on Infectious Diseases Online is organized by workshop and date, making the materials highly organized and easy to find. The meeting proceedings will also be published on the meeting website. 8 International Workshop on NASH Biomarkers Meeting Prospectus

COMMITTEES ORGANIZING COMMITTEE Quentin Anstee

Boucher MD, PhD Roberto Calle MD, FACE, FACP

Newcastle, UK University of Paris-Diderot,

Rotterdam, the Netherlands Foundation for the

USA Gregory Everson MD, FACP Chris Leptak MD,

University of Colorado Denver, Denver, CO, USA

University, Richmond, VA, USA Elmer Schabel MD

London, UK & BfArM, Bonn, Germany UC San

9 COMMITTEES ORGANIZING COMMITTEE Quentin Anstee BSc, MBBS, PhD, Pierre Bedossa MD, PhD Charles Boucher MD, PhD Roberto Calle MD, FACE, FACP MRCP(UK), FRCP Newcastle University, Newcastle, UK University of Paris-Diderot, Paris, France Erasmus Medical Center, Rotterdam, the Netherlands Foundation for the National Institutes of Health, Bethesda, MD, USA Gregory Everson MD, FACP Chris Leptak MD, PhD Veronica Miller PhD Arun Sanyal MD, MBBS University of Colorado Denver, Denver, CO, USA FDA Office of New Drugs, Silver Spring, MD, USA Forum for Collaborative Research, Washington, DC, USA Virginia Commonwealth University, Richmond, VA, USA Elmer Schabel MD Claude Sirlin MD European Medicines Agency, London, UK & BfArM, Bonn, Germany UC San Diego, San Diego, CA, USA IInternational Workshop on NASH Biomarkers Meeting Prospectus 9

10 ACKNOWLEDGEMENTS SPONSORS GOLD LEVEL SUPPORTERS CONTRIBUTORS ENDORSERS EPoS Elucidating Pathways of Steatohepatitis 10 International Workshop on NASH Biomarkers Meeting Prospectus

11 FOR MORE INFORMATION, PLEASE CONTACT US AT: EXPERT MEDICAL EVENTS Biltstraat BJ Utrecht the Netherlands International Workshop on NASH Biomarkers Meeting Prospectus 11

EVALUATION REPORT

International Workshop on NASH Biomarkers 2017 5-6 May 2017 Washington, D.C., EVALUATION REPORT www.expertmedicalevents.com/nashbiomarkers EXECUTIVE SUMMARY INTRODUCTION The 2 nd International Workshop