Welcome and Introduction Katherine Greene
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1 Welcome and Introduction Katherine Greene Forum for Collaborative Research
2 2 Liver Forum 8 Agenda 12:30 PM Welcome Reception and Registration 2:00 PM Session I: Project and Regulatory Updates 2:00 PM Welcome and Introduction Katherine Greene, Forum for Collaborative Research 2:15 PM Champion of Collaboration Award Awardee: Cheronda Cherry-France, U.S. FDA 2:25 PM Core Outcomes in NASH Project Donna Messner, Center for Medical Technology Policy 2:35 PM Regulatory Update Lara Dimick-Santos, U.S. FDA 2:45 PM Regulatory Discussion 3:10 PM Session II: Parallel Breakout Sessions European Payer Perspective NASH Biomarker Overview NASH Cirrhosis Working Group 4:30 PM Break Lara Dimick-Santos, U.S. FDA Elmer Schabel, European Medicines Agency OPEN SESSION: Plenary Room OPEN SESSION: Carlades Room WG MEMBERS: Grand Causses Room
3 3 Liver Forum 8 Agenda 4:30 PM Break 5:00 PM Breakout Session Report 5:40 PM Working Group Updates 6:00 PM Session III: Combination Therapy 6:00 PM EU Requirements for Fixed Dose Combinations and Lessons Learned from Hypertension and Diabetes: Implications for NASH Elmer Schabel, European Medicines Agency 6:20 PM FDA Considerations for Fixed-Dose Drug Combinations and Lessons Learned 6:35 PM Industry Perspectives on Combination Therapy 7:05 PM Discussion 7:30 PM Adjourn and Evening Reception Stephanie Omokaro, U.S. FDA Laurent Fischer, Allergan Eric Hughes, Novartis Pharma AG Rob Myers, Gilead Sciences Steve Rossi, NGM Biopharmaceuticals
4 4 Liver Forum 8 LIVER FORUM REVIEW What: a platform for ongoing multi-stakeholder dialogue to identify barriers, prioritize research and identify solutions to accelerate therapeutic development for NAFLD/NASH Who: regulatory agencies, professional societies, patient representatives, academic and clinical researchers, industry organizations (pharmaceutical, device, diagnostic, biotech) Scientific experts with commitment to advancing the field Not a venue for marketing, investors, journalists Participation in the Liver Forum is by invitation
5 5 Liver Forum 8 LIVER FORUM REVIEW How: provide a neutral, independent, safe space for discussion and deliberation across stakeholder groups working in NAFLD/NASH field Focus on developing consensus, increasing synergy and collaboration, and reducing duplication and uncertainty Process vs. Meeting Ongoing working group activity throughout the year anchored by larger project events Active & engaged participation Entering the room = consent to be called on
6 6 Liver Forum 8 LIVER FORUM REVIEW Why: Once new drug candidates and therapeutic strategies are identified, their efficient, safe development is in the best interest of all stakeholders, most of all, the patients Professional Societies Academic/ Clinical Researchers Regulatory Agencies Liver Forum Industry Patients/ Community Foundation/ Consortia
7 7 Liver Forum 8 RULES OF THE ROOM What s said in the room, stays in the room Comments/questions are not for attribution Social Media: Meeting
8 8 Liver Forum 8 STEERING COMMITTEE Co-Chairs Regulatory Patient Advocates Veronica Miller Forum for Collaborative Research Arun Sanyal, VCU David Shapiro, Intercept Lara Dimick, FDA/CDER/DGIEP Ruby Mehta, FDA/CDER/DGIEP Chris Leptak, FDA/CDER/OND Elmer Schabel, EMA/BfArM William Baldyga University Illinois at Chicago Donna Cryer, Global Liver Institute Academia Society Industry Scott Friedman, Mount Sinai Miriam Vos, Emory University Vlad Ratziu, Hôpital Pitié Salpêtrière Detlef Schuppan, Mainz University Naga Chalasani, AASLD Annalisa Berzigotti, EASL Gary Burgess, Vectura Limited Laurent Fischer, Allergan Sophie Megnien, Genfit Rob Myers, Gilead
9 9 Liver Forum 8 STEERING COMMITTEE Co-Chairs Regulatory Patient Advocates Veronica Miller Forum for Collaborative Research Arun Sanyal, VCU David Shapiro, Intercept Lara Dimick, FDA/CDER/DGIEP Ruby Mehta, FDA/CDER/DGIEP Chris Leptak, FDA/CDER/OND Elmer Schabel, EMA/BfArM William Baldyga University Illinois at Chicago Donna Cryer, Global Liver Institute Academia Society Industry Scott Friedman, Mount Sinai Miriam Vos, Emory University Vlad Ratziu, Hôpital Pitié Salpêtrière Detlef Schuppan, Mainz University Naga Chalasani, AASLD Annalisa Berzigotti, EASL Gary Burgess, Vectura Limited Laurent Fischer, Allergan Sophie Megnien, Genfit Rob Myers, Gilead
10 10 Liver Forum 8 LIVER FORUM 7 RECAP Attendance by Organization Type Attendance by Geographic Location 4% 2% 1% 7% 1% 16% 8% Industry Academic Government Other 19% North America Europe Community Asia 69% Society 73% Australia & South America
11 11 Liver Forum 8 PARTICIPATION Remote In-Person 50 0 LF 1 LF 2 LF 3 LF 4 LF 5 LF 6 LF 7 LF8
12 12 Liver Forum 8 LIVER FORUM 7 RECAP Based on feedback: Eliminated scheduled activities from lunch reception Added longer discussion time Added new method to ask questions and make comments Added breakouts to allow focused discussions Preserved networking time New working groups Complete the evaluation! (constructive feedback)
13 13 Liver Forum 8 RECENT ACCOMPLISHMENTS Baseline parameters in clinical trials for nonalcoholic steatohepatitis: recommendations from the Liver Forum Yuval A. Patel, Joanne C. Imperial, Andrew J. Muir, Quentin M. Anstee, David DeBrota, Lara Dimick-Santos, Claudia Filozof, Ruby Mehta, Arun J. Sanyal, Elmer Schabel, Brent A. Neuschwander-Tetri, Veronica Miller, on behalf of the Liver Forum Data Standardization Working Group 2017, Gastroenterology, Case definitions for inclusion and analysis of endpoints in clinical trials for nonalcoholic steatohepatitis through the lens of regulatory science Mohammad Shadab Siddiqui Stephen A. Harrison Manal F. Abdelmalek Quentin M. Anstee Pierre Bedossa Laurent Castera Lara Dimick Santos Scott L. Friedman Katherine Greene David E. Kleiner Sophie Megnien Brent A. Neuschwander Tetri Vlad Ratziu Elmer Schabel Veronica Miller Arun J. Sanyal on behalf of the Liver Forum Case Definitions Working Group 2018, Hepatology,
14 14 Liver Forum 8 WORK IN PROGRESS Case Definitions Working Group Defining improvement in NAFLD for treatment trial endpoints: Recommendations from the Liver Forum Pediatric Working Group Regulatory considerations for clinical trials in pediatric nonalcoholic fatty liver disease Standard of Care: Lifestyle Working Group Recommendations on Standardization of Diet and Exercise in Clinical Trials of NAFLD
15 15 Liver Forum 8 ADDITIONAL ACTIVITIES Standard of Care Working Group Lifestyle Management Comorbidity Management NASH Cirrhosis Working Group Compensated NASH Cirrhosis Decompensated NASH Cirrhosis Core Outcomes in NASH Center for Medical Technology Policy
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18 18 Liver Forum 8 SPONSORS
19 19 Liver Forum 8 SPONSORS
20 20 Liver Forum 8 SPONSORS
21 21 Liver Forum 8 SPONSORS
22 22 Liver Forum 8 SPONSORS
23 23 Liver Forum 8 PRACTICE USING SLIDO 1. Go to 2. Enter event #LF8 Should we get started? Like questions Type questions and submit
24 24 Liver Forum 8 THANK YOU! Forum Staff Malene Cobourne Terry Daniels Katherine Greene Pedro Goicochea Luis Javier Hernandez Victoria Mason Veronica Miller Brenda Rodriguez Ken Taymor Jessica Weber Prism Event Management Paula Blay Mairead O Reilly Sarah Matthews Graham Hill George Seaton Jonathan Price James Jones Peter Ward James Lucas
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