meeting prospectus - virology...

www.expertmedicalevents.com

MEETING PROSPECTUS

www.expertmedicaleducation.com

International Workshop on NASH Biomarkers 201818 - 19 May 2018 Washington, D.C., USA

ADVANCING HEALTH

GLOBALLY THROUGH

INNOVATIVE PROGRAMS

DESIGNED FOR THE

HEALTHCARE PROFESSIONAL

IInternational Workshop on NASH Biomarkers 2018- Meeting Prospectus 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

International Workshop on NASH Biomarkers 2018- Meeting Prospectus4

WELCOME

Veronica Miller, PhD 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

Arun Sanyal, MD, MBBS Meeting Chair

International Workshop on NASH Biomarkers 2018- Meeting Prospectus 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 multi-stakeholder 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 2018.

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.


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.

MEETING DESCRIPTION


INFOGRAPHICS 2017

RETURNING PARTICIPANTS

MEETING OBJECTIVES

COUNTRIESOCCUPATION

WORKPLACE TYPE

The majority of the 155 delegates attending the NASH Biomarkers Workshop 2017 worked as researcher, medical doctor, or corporate professional.

28%

Researcher Medical doctor (MD)

Corporate professional

Other Government official

26% 23% 18% 5%

25% of participants (n=40) attended both the first and second edition of the NASH Biomarkers workshop 2017

80% of the participants (n=129) were from the US, 16% came from a EU country.

The majority of the 160 delegates attending the NASH Biomarkers workshop worked for an In-dustry organization (54%). Others were employed by a government agency (10%), research institute (9%), or others.

80%

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%

Industry54%

Government Agency

10%

Research Institute

9%

University8%

(University) Hospital

7%

Laboratory6%

Other5%

NGO1%


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 MATERIALSINFECTIOUS DISEASES ONLINEEnduring 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.

IInternational Workshop on NASH Biomarkers 2018- Meeting Prospectus 9

COMMITTEES

ORGANIZING COMMITTEE

Quentin Anstee BSc, MBBS, PhD, MRCP(UK), FRCP

Newcastle University, Newcastle, UK

Gregory Everson MD, FACP

University of Colorado Denver, Denver, CO,

USA

Arun Sanyal MD, MBBS

Virginia Commonwealth University, Richmond, VA,

USA

Charles Boucher MD, PhD

Erasmus Medical Center, Rotterdam,

the Netherlands

Pierre Bedossa MD, PhD

University of Paris-Diderot, Paris, France

Chris Leptak MD, PhD

FDA Office of New Drugs, Silver Spring, MD,

USA

Elmer Schabel MD

European Medicines Agency, London, UK & BfArM, Bonn, Germany

Roberto Calle MD, FACE, FACP

Foundation for the National Institutes of Health, Bethesda, MD, USA

Veronica Miller PhD

Forum for Collaborative Research, Washington, DC,

USA

Claude Sirlin MD

UC San Diego, San Diego, CA,

USA


ACKNOWLEDGEMENTS

SPONSORS

ENDORSERS

Elucidating Pathways of SteatohepatitisEPoS

GOLD LEVEL

SUPPORTERS

CONTRIBUTORS


FOR MORE INFORMATION, PLEASE CONTACT US AT:

EXPERT MEDICAL EVENTS

Biltstraat 106

3572 BJ Utrecht

the Netherlands

www.expertmedicalevents.com

[email protected]

+31 30 230 7146

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