EVALUATION REPORT
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1 International Workshop on NASH Biomarkers May 2017 Washington, D.C., EVALUATION REPORT
2 EXECUTIVE SUMMARY INTRODUCTION The 2 nd International Workshop on NASH Biomarkers was organized on 5-6 May 2017 in Washington, D.C.,. The meeting attracted 155 highly motivated participants from 12 countries. This high profile conference brought together leading academia, industry and government experts to discuss the latest research and pathways forward in the field of NASH Biomarkers. The program featured plenary sessions and interactive round table discussions; providing a unique opportunity to meet colleagues in a scientific focused setting. MEETING EXPERIENCE The conference was very well received which is reflected by the evaluation results. All of the respondents (100%) rated their general conference experience as very good or good, an excellent result. Also, the opportunity of networking (98%) and the content of the meeting (100%) were excellently rated by the respondents. PROGRAM The program included 19 invited lectures and 4 panel/roundtable discussions. Respondents indicated that ample time was allocated for discussion. 27 abstracts were accepted for oral or poster presentation. The evaluation scores of all presentations can be found on pages FUTURE MEETING The majority of the respondents very much appreciated the conference to such an extent that they would recommend the meeting to their colleagues (94%) and plan to attend the 2017 meeting (92%). The aim of the NASH Biomarkers workshop continues to offer a cross-disciplinary platform to stimulate collaboration accross sectors to stakeholders to facilitate progress along the path to acceptance, validation and qualification of non-invasive biomarkers for NASH. The Organizing Committee is pleased with the evaluation results and is looking forward to organizing the next edition of the workshop in International Workshop on NASH Biomarkers Evaluation report 2
3 TABLE OF CONTENTS Executive summary 2 Meeting description 4 Meeting demographics 6 Committees 8 Participants' feedback 9 Meeting metrics 16 Conclusion 17 Acknowledgements 18 International Workshop on NASH Biomarkers Evaluation report 3
4 MEETING DESCRIPTION INTRODUCTION 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 of the inaugural workshop in 2016, the second NASH Biomarkers workshop is 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 Meeting Co-Chair 2017 Arun Sanyal Meeting Co-Chair 2017 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. ORGANIZERS The International NASH Biomarkers Workshop is co-organized by Expert Medical Events and the Liver Forum. 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 International Workshop on NASH Biomarkers Evaluation report 4
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 is being 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. Members recently rated the development of a new working group on Biomarkers as their top priority, further indicating the high level of interest in this area. 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 Evaluation report 5
6 MEETING DEMOGRAPHICS NUMBER OF REGISTRATIONS # registrations # countries NUMBER OF PARTICIPANTS # delegates # countries NUMBER OF ABSTRACTS GEOGRAPHICAL DISTRIBUTION OF REGISTRANTS The majority of participants came from the US (81%) United States France Denmark United Kingdom Sweden Germany China Spain Puerto Rico Netherlands Is rael Belgium RETURNING PARTICIPANTS Returning N=39; 25% New N=116; 75% International Workshop on NASH Biomarkers Evaluation report 6
7 MEETING DEMOGRAPHICS PARTICIPANT DEMOGRAPHICS N=155 Prescriber status Area of expertise Multiple answer are possible. Total # values=289 Other; N=45; 15% Prescriber; N=34; 22% Pediatrics; N=11; 4% HIV; N=14; 5% Liver Disease; 65; 22% Non Prescriber; N=121; 78% Oncology; N=15; 5% Pharmacology; N=17; 6% Diabetology; N=21; 7% Immunology; N=22; 8% Hepatology; N=57; 20% Hepatitis; N=22; 8% Employed by Professional specification (University) Hospital; N=10; 7% Laboratory; N=10; 6% University; N=14; 9% esearch Institute; N=14; 9% Other; N=6; 4% NGO; N=2; 1% Industry; N=83; 54% Health Administrator; N=1; 1% Pharmacologist; N=2; 1% Medical Marketing Expert; N=2; 1% Pharmacist (PharmD); N=4; 2% Nurse; N=3; 2% Governmental Official or Representative; N=8; 5% Student; N=1; 1% Other; N=14; 9% Research Fellow; N=1; 1% Researcher (PhD); N=45; 29% Corporate Professional N=35 23% Medical doctor (MD); N=39; 25% Government Agency; N=16; 10% International Workshop on NASH Biomarkers Evaluation report 7
8 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, Gregory Everson MD, FACP Chris Leptak MD, PhD Veronica Miller PhD Arun Sanyal MD, MBBS University of Colorado Denver, Denver, CO, FDA Office of New Drugs, Silver Spring, MD, Forum for Collaborative Research, Washington, DC, Virginia Commonwealth University, Richmond, VA, Elmer Schabel MD Claude Sirlin MD European Medicines Agency, London, UK & BfArM, Bonn, Germany UC San Diego, San Diego, CA, International Workshop on NASH Biomarkers Evaluation report 8
9 PARTICIPANTS' FEEDBACK # OF PARTICIPANTS PER SESSION # OF RESPONDENTS PER DAY AM PM Day 1 Day 2 Session 1: 140 Session 5: 132 Session 2: 138 Session 6: 121 Session 3: 127 Session 7: 102 Session 4: 121 Day 1 Day 2 N= 73 N= 56 BACKGROUND OF RESPONDENTS Returning participants N=126 Total # answers=132 Area of expertise N=122 Total # answers=167 Liver complications; N=12; 7% Returning N=39; 31% New N=87; 69% Other; N=17; 10% Imaging; N=18; 11% Drug development; N=55; 33% Diagnostics; N=22; 13% Biomarkers development; 43; 26% Employed by N=126 Total # answers=132 Professional specification N=126 Total # answers=154 Other; N=4; 3% Laboratory; N=4; 3% Research institute; N=6; 5% Hospital; N= 2; 1% NGO; N=1; 1% Government official; N=4; 3% Pharmacologist; N=7; 4% Pharmacist; N=2; 1% Student; N=1; 1% Other; N=7; 5% Government; N=11; 8% University; N=22; 17% Pharmaceutical Company; N=49; 37% Corporate professional; N=27; 17% Researcher; N=60; 39% Diagnostics/Biotech company; N=33; 25% Medical Docter; N=46; 30% International Workshop on NASH Biomarkers Evaluation report 9
10 PARTICIPANTS' FEEDBACK MEETING OBJECTIVES Review current regulatory landscape & 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 N=56 Strongly Neutral Strongly 68% 26% 6% 0% 0% 9 56% 35% 8% 0% 0% 8 63% 33% 4% 0% 0% 7 57% 33% 8% 2% 0% 7 CONFERENCE ORGANIZATION N=73 Strongly Neutral Strongly Content of EME newsletters 52% 43% 5% 0% 0% 15 Frequency of EME newsletters 50% 41% 7% 2% 0% 17 Information on the conference website 46% 43% 11% 0% 0% 10 Online registration process 58% 31% 11% 0% 0% 9 Online abstract submission process 72% 20% 8% 0% 0% 48 Meeting venue 64% 30% 4% 1% 0% 6 Meeting room 61% 28% 6% 3% 1% 6 Audiovisuals 66% 31% 3% 0% 0% 6 Food & Beverage 56% 38% 5% 2% 0% 7 Onsite logistics 71% 26% 3% 0% 0% 7 Service level of Conference Secretariat 76% 22% 2% 0% 0% 14 GENERAL CONFERENCE EXPERIENCE N=56 Strongly Neutral Strongly Overall event experience 78% 22% 0% 0% 0% 6 Opportunity of networking 82% 16% 2% 0% 0% 6 Content of the educational activity 72% 28% 0% 0% 0% 6 Time allocation for discussion 82% 16% 2% 0% 0% 6 Time allocation per presentation 76% 20% 4% 0% 0% 6 No commercial bias (product selling) perceived 65% 22% 10% 2% 0% 7 I would recommend this event to my peers 80% 14% 4% 2% 0% 6 I plan to attend this event next time 75% 17% 6% 2% 0% 8 International Workshop on NASH Biomarkers Evaluation report 10
11 PARTICIPANTS' FEEDBACK INVITED LECTURES FRIDAY 5 MAY 2017 Session 1: Priorities in biomarker development for NASH A pathologist, a radiologist and a hepatologist walked into a bar Brent Tetri, MD Innovation in histological assessment of NASH Pierre Bedossa, MD, PhD - France Panel discussion: Many perspectives, one goal Neutral Strongly Topic is interesting 70% 23% 6% 1% 0% 3 63% 24% 12% 0% 1% 5 Speaker performance 74% 16% 10% 0% 0% 3 Neutral Strongly Topic is interesting 77% 20% 3% 0% 0% 4 67% 23% 6% 4% 0% 4 Speaker performance 57% 33% 7% 3% 0% 4 Neutral Strongly Topic is interesting 69% 30% 1% 0% 0% 2 62% 35% 3% 0% 0% 2 Session 2: Pathways to biomarker qualification and acceptance View from the Top - Potential impact of 21 st century cures act Peter Stein, MD EU perspective Elmer Schabel, MD Germany Neutral Strongly Topic is interesting 43% 36% 19% 3% 0% 3 49% 26% 19% 6% 0% 4 Speaker performance 45% 36% 16% 3% 0% 4 Neutral Strongly Topic is interesting 39% 34% 22% 4% 0% 6 46% 29% 20% 3% 2% 8 Speaker performance 27% 42% 25% 6% 0% 6 International Workshop on NASH Biomarkers Evaluation report 11
12 PARTICIPANTS' FEEDBACK Collaboration in action - Biomarkers Endpoints & other Tools Resource Chris Leptak, MD, PhD Collaboration in action - Foundation for the National Institutes of Health Roberto Calle, MD, FACE, FACP - Collaboration in action - Innovative Medicines Initiative Quentin Anstee, BSc, MB BS, PhD, MRCP(UK), FRCP United Kingdom Panel discussion: Building synergy across the Atlantic Neutral Strongly Topic is interesting 61% 28% 9% 1% 0% 6 58% 24% 14% 2% 3% 7 Speaker performance 64% 24% 12% 0% 0% 7 Neutral Strongly Topic is interesting 62% 29% 9% 0% 0% 4 65% 21% 13% 0% 1% 5 Speaker performance 57% 29% 14% 0% 0% 4 Neutral Strongly Topic is interesting 63% 27% 9% 0% 1% 6 62% 24% 11% 0% 3% 7 Speaker performance 73% 16% 9% 0% 1% 6 Neutral Strongly Topic is interesting 59% 33% 6% 0% 2% 7 58% 31% 8% 0% 3% 8 Session 3: Circulating biomarkers Lipidomics and proteomics Puneet Puri, MD Role of genetic assessments Quentin Anstee, BSc, MB BS, PhD, MRCP(UK), FRCP United Kingdom Neutral Strongly Topic is interesting 64% 25% 7% 1% 1% 6 52% 30% 9% 8% 2% 7 Speaker performance 43% 40% 15% 0% 1% 6 Neutral Strongly Topic is interesting 67% 22% 8% 2% 2% 9 59% 20% 11% 6% 3% 9 Speaker performance 64% 23% 11% 0% 2% 9 International Workshop on NASH Biomarkers Evaluation report 12
13 PARTICIPANTS' FEEDBACK Circulating nucleic acids and combination panels Sven Francque, MD, PhD Belgium Neutral Strongly Topic is interesting 64% 26% 9% 0% 2% 7 60% 17% 14% 8% 2% 8 Speaker performance 56% 36% 6% 0% 2% 7 Session 4: Imaging biomarkers MRI; what can it deliver Claude Sirlin, MD Transient elastography & other techniques Raj Vuppalanchi, MBBS Neutral Strongly Topic is interesting 88% 12% 0% 0% 0% 7 77% 12% 8% 2% 2% 8 Speaker performance 91% 9% 0% 0% 0% 7 Neutral Strongly Topic is interesting 71% 24% 5% 0% 0% 10 55% 23% 19% 2% 2% 11 Speaker performance 41% 44% 11% 3% 0% 10 Panel discussion Neutral Strongly Topic is interesting 70% 23% 5% 2% 0% 17 64% 27% 7% 2% 0% 18 SATURDAY 6 MAY 2017 Session 5: Quantative assessment of hepatic health Breath tests Shadab Siddiqui, MD N=56 Strongly Neutral Strongly Topic is interesting 56% 36% 6% 2% 0% 6 50% 24% 20% 4% 2% 6 Speaker performance 50% 38% 8% 4% 0% 6 International Workshop on NASH Biomarkers Evaluation report 13
14 PARTICIPANTS' FEEDBACK Principles of kinetic measures Greg Everson, MD, FACP Panel discussion: Learning from functional, imaging and circulating biomarkers - Challenges of qualification in absence of highly effective therapy N=56 Strongly Neutral Strongly Topic is interesting 72% 22% 6% 0% 0% 6 56% 28% 8% 8% 0% 6 Speaker performance 63% 31% 4% 2% 0% 7 N=56 Strongly Neutral Strongly Topic is interesting 75% 23% 2% 0% 0% 8 77% 17% 4% 2% 0% 8 Session 6: Challenges & opportunities in integrating 'OMICS Big data vs. the individual liver - regulatory perspective Robert Schuck, PharmD, PhD - Big data vs. the individual liver - developer's perspective José María Mato de la Paz, PhD - Spain Future scenarios of algorithm building Tom Travison, PhD - N=56 Strongly Neutral Strongly Topic is interesting 51% 35% 12% 2% 0% 5 37% 41% 18% 4% 0% 5 Speaker performance 48% 34% 14% 4% 0% 6 N=56 Strongly Neutral Strongly Topic is interesting 65% 27% 4% 4% 0% 7 49% 35% 12% 4% 0% 7 Speaker performance 51% 26% 13% 9% 2% 9 N=56 Strongly Neutral Strongly Topic is interesting 40% 29% 23% 4% 4% 4 33% 29% 22% 12% 4% 5 Speaker performance 43% 25% 18% 10% 4% 5 International Workshop on NASH Biomarkers Evaluation report 14
15 PARTICIPANTS' FEEDBACK Session 7: The liver in context Integrated assessment of diabetes, cardiovascular & liver risks and its potential application in the clinical management of NAFLD Arun Sanyal, MD, MBBS - Navigating NASH biomarkers: From discovery to clinical practice John Sninsky, PhD - Round table discussion: The way forward N=56 Strongly Neutral Strongly Topic is interesting 93% 5% 0% 2% 0% 12 84% 12% 2% 2% 0% 13 Speaker performance 89% 7% 2% 2% 0% 12 N=56 Strongly Neutral Strongly Topic is interesting 89% 11% 0% 0% 0% 21 85% 9% 6% 0% 0% 22 Speaker performance 89% 9% 3% 0% 0% 21 N=56 Strongly Neutral Strongly Topic is interesting 92% 8% 0% 0% 0% 30 96% 4% 0% 0% 0% 30 OTHER PROGRAM ELEMENTS Oral abstract presentations Data represents the average scores for all oral abstract presentations N=538 Strongly Neutral Strongly Topic is interesting 59% 35% 6% 0% 0% 57% 27% 13% 2% 0% Poster viewing N=56 Strongly Valuable element in the program. Combination of poster session and break was well scheduled. Neutral Strongly 64% 28% 8% 0% 0% 6 62% 30% 6% 2% 0% 6 Conference app (N=56) I downloaded the app: Yes: 43% No: 57% : 7 The app was a valuable addition to the workshop The content of the app was informative The interactive features in the app were useful The app was friendly / intuitive to use Strongly Neutral Strongly 36% 50% 11% 0% 4% 28 24% 48% 29% 0% 0% 35 33% 27% 20% 20% 0% 41 48% 38% 10% 5% 0% 35 International Workshop on NASH Biomarkers Evaluation report 15
16 MEETING METRICS HOW DID YOU LEARN ABOUT THIS EVENT? Multiple answers were allowed N=71 Total # answers=96 0% 5% 10% 15% 20% 25% 30% 35% 40% Website / Newsletter 35% Word-of-mouth 26% Flyer at the other EME/LF meetings Flyer at other meetings Invitation from Faculty 8% 9% 10% Invitation from Industry Societies 4% 5% Other 1% I WAS MOTIVATED TO ATTEND THIS MEETING BY Multiple answers were allowed N=71 Total # answers=96 0% 5% 10% 15% 20% 25% 30% 35% Scientific program 32% Networking Faculty / speakers of the program Meeting objectives 18% 18% 18% Experience from previous meeting 7% Location 4% Other 2% International Workshop on NASH Biomarkers Evaluation report 16
17 CONCLUSION The very succesful 2 nd International Workshop on NASH Biomarkers took place on 5-6 May 2017 in Washington, D.C.,, and was attended by 155 delegates from 12 countries. DEMOGRAPHICS The workshop managed to reach a wide variety of leading experts with different backgrounds. A good mix from academia and industry was reached. Though the attendance of regulatory agency experts was increased compared to last year, a higher attendance of regulatory experts remains a focus for future editions. Lastly, the majority of attendants were from the US, indicating more focus should be put to attracting a larger European audience for future editions. IMPACT Participants indicated that the meeting objectives were mostly met, indicating the program was aligned well with the aim of the meeting. Most of the participants were impressed by the quality of the scientific content and the time allocation for the discussions. The majority also reported that they were satisfied with the overall meeting arrangements and the program allowed plenty of opportunity to network. NEXT EDITION Both the evaluation results and the participants feedback proved the success and the importance of this conference. The Organizing Secretariat will invite the Organizing Committee to further discuss the preparation and the development of the scientific program for next year's edition, scheduled to take place in Washington, D.C. on May International Workshop on NASH Biomarkers Evaluation report 17
18 ACKNOWLEDGEMENTS SPONSORS GOLD LEVEL SUPPORTERS CONTRIBUTORS ENDORSERS EPoS Elucidating Pathways of Steatohepatitis ORGANIZERS International Workshop on NASH Biomarkers Evaluation report 18
19 SAVE THE DATE MAY 2017 International Workshop on NASH Biomarkers 2018 Washington, D.C., WORKSHOP CHAIRS 2018 Stimulating collaboration across sectors and stakeholders to facilitate progress along the path to acceptance, validation and/or qualification of non-invasive biomarkers for NASH. Veronica Miller PhD Forum for Collaborative Research, Washington, DC, Arun Sanyal MD, MBBS Virginia Commonwealth University, Richmond, VA, International Workshop on NASH Biomarkers Evaluation report 19
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