26 – 27 October, 2026 | Embassy of France, Washington, DC, USA
A Multi-Stakeholder Multi-Specialty Trialists Think Tank
Organized By
In Collaboration
Organized By
In Collaboration
A MULTI-STAKEHOLDER
MULTI-SPECIALTY
NASH/MASH TRIALISTS THINK TANK
Metabolic, hepatology, nephrology &
cardiovascular cross-talk
Embassy of France,
Organized by
In collaboration 
Organized By
In Collaboration
A MULTI-STAKEHOLDER MULTI-SPECIALTY
NASH/MASH TRIALISTS THINK TANK
24 – 25 October, 2024
Embassy of France
4101 Reservoir Road, NW – Washington, D.C. – 20007
4101 Reservoir Road, NW – Washington, D.C. – 20007
Organized by
In collaboration
Endorsed by the Stravitz-Sanyal Institute for Liver Disease and Metabolic Health
Monday 26 October, 2026
8.30- 10.00
ARE THE RECENT/CURRENT TRIALS ADDRESSING INTEGRATED CKLM MULTIORGAN ENDPOINTS?
THE CURRENT LANDSCAPE
Chairpersons : Arun Sanyal (Richmond, USA) & Faiez Zannad (Nancy, FRA)
8:30-8:40: The global burden of CKLM disease. An update
Jeffrey Lazarus (New York, Barcelona, The Lancet Global Health)
8:40-8:50: The current landscape of MASH-MASLD trials. How far are we from the MOSAIC agenda?
Arun Sanyal (Richmond, USA)
8:50-9:00: Trials of incretin-based agents with potential multi-organ endpoints.
Rohit Loomba (San Diego, USA)
9:00-9:10: Liver-directed anti-MASH agents with “CV-adjacent” metabolic effects
Faiez Zannad (Nancy, FRA)
9:10-9:20: Cardiorenal drugs tested/positioned for liver benefit.
Arun Sanyal (Richmond, USA)
9:20-9:30: FGF21 analogs likely have CV benefits: a hypothesis pending outcomes.
Philip Newsome (Birmingham, UK)
9:30-9:40: Combination strategies explicitly aiming at “MASH + CKM” endpoints
Naim Alkhouri (San Antonio, USA)
The MOSAIC Multi-Stakeholder Think Tank Moderated debate
9.40-10.10
WHAT DOES IT TAKE FOR HEPATOLOGISTS TO PROGRESS TO A CKLM TRIALS FRAMEWORK?
Chairpersons : Arun Sanyal (Richmond, USA) & Faiez Zannad (Nancy, FRA)
Panelists : All speakers
10.00-10.30
Coffee break & Networking
Monday 26 October, 2026
10.30- 11.40
RISK REDUCTION VS. DISEASE MODIFICATION.
WHAT DO TRIALISTS, SPONSORS, AND REGULATORS ACTUALLY THINK?
Chairpersons : Javed Butler (Dallas, TX, USA) & Jörn Schattenberg (Saarbrücken, Germany)
10:30-10:40: Improving outcomes, not just histology. Is full CKLM disease modification possible?
Faiez Zannad (Nancy, France)
10:40-10:50: Hepatologist’s viewpoint
Jörn Schattenberg (Saarbrücken, Germany)
10:50-11:00: Cardiologist’s viewpoint
Javed Butler (Dallas, TX, USA)
11:00-11:10: Nephrologist’s viewpoint
Chirag Parikh (Baltimore, MD, USA)
11:10-11:20: Endocrinologist’s viewpoint
Jennifer Green (Durham, NC, USA)
11:20-11:40: Industry viewpoint
Salvador Augustin (Boehringer)
Jan Marquard (Merck)
Murielle Véniant-Ellison (Amgen)
Jonathan Stine (AstraZeneca)
11:40-11:45: Patients’ viewpoints
Henry Chang (NYC, USA)
11.45-12.10
REGULATORY FORUM and The MOSAIC Multi-Stakeholder Think Tank Moderated debate
WHAT IS AN ACCEPTABLE DISEASE MODIFICATION DEFINITION?
IS THE MASH REGULATORY FRAMEWORK READY FOR MULTI-ORGAN CKLM TRIALS?
Chairpersons : Javed Butler (Dallas, TX, USA) & Jörn Schattenberg (Saarbrücken, Germany)
Panelists:
FDA
DHN – Ruby Mehta
DDLO – Raymond Soccio
Biostatistics – Jialu Zhang and/or Yun Wang
DDT – biomarker qualification – Vanitha Sekar
DCN – Fortunato Senatore, Aliza Thompson, Charu Gandotra, Mitchell Psotka
EU- EMA
EMA/CHMP – Janet König (GER), Elita Poplavska (LAT)
BfArM/EMA SAWP – Elmer Schabel (GER)
EMA CHMP Robert Pórszász (HUN)
& All participants
12.10-13.10
Lunch Break & Networking
Monday 26 October, 2026
13.10- 14.20
MOVING FROM F2–F3 BIOPSY ENDPOINTS with CKM SURROGATES TO HARD LIVER AND CKM OUTCOMES
Chairpersons : Nicolas Girerd (Nancy, France) & Chirag Parikh (Baltimore, MD, USA)
13:10-13:20: What CV surrogates can be embedded in liver biopsy trials?
Nicolas Girerd (Nancy, France)
13:20-13:30: What kidney surrogates can be embedded in liver biopsy trials
Steven Coca (New York, NY, USA)
13:40-13:50: Biomarkers and algorithms : Industry viewpoints
Matthew F. W. Gee (Siemens Healthineers)
Joseph Gogain (Somalogic)
Diana Leeming (Nordic Bioscience – Roche)
Victor de Lédinghen (Echosens)
13:50-14:00: MALO event rates in MASH-MASLD patients and sample size estimations
Arun Sanyal (Richmond, USA)
14:00-14:10: CV event rates in MASH-MASLD patients and sample size estimations
Shahzeb Khan (Dallas, USA)
14:10 – 14:20: What is needed to extend MASH-liver biopsy trials to accrue MACE – MALE events?
Subodh Verma (Toronto, CAN)
14.20-14.40
REGULATORY FORUM and The MOSAIC Multi-Stakeholder Think Tank Moderated debate
ARE ACCELERATED APPROVAL PATHWAYS THE WAY FORWARD?
Chairpersons : Nicolas Girerd (Nancy, France) & Chirag Parikh (Baltimore, MD, USA)
Panelists:
EU- EMA
EMA/CHMP – Janet König (GER), Elita Poplavska (LAT)
BfArM/EMA SAWP – Elmer Schabel (GER)
EMA CHMP Robert Pórszász (HUN)
& All participants
Monday 26 October, 2026
14.40- 15.10
ONGOING TRIALS AND HOW THEY ACCOMMODATE CKLM ENDPOINTS
Chairpersons : Sven Francque (Antwerpen, Belgium) & Veronica Miller (Berkeley, USA)
14:40-14:45: Resmetirom
Rebecca Taub (Madrigal)
14:45-14:50: Semaglutide
Michelle Long (NovoNordisk)
14:50-14:55: Tirzepatide
Axel Haupt (Lilly)
14:55-15:00: Survodutide
Daniel Mazo (Boehringer)
15:00-15:05: Efruxifermin
Meena Jain (Akero)
15:05-15:10: Pegozafermin
Jorge Alfonso Ross Terres (Roche)
15.10-15.30
The MOSAIC Multi-Stakeholder Think Tank Moderated debate
HOW SPONSORS ARE WARMING UP FOR THE ULTIMATE GOAL OF MULTI-ORGAN OUTCOME TRIALS
Chairpersons : Sven Francque (Antwerpen, Belgium) & Veronica Miller (Berkeley, USA)
Panelists : all industry faculty members
15.30-15.50
Coffee Break & Networking
Monday 26 October, 2026
15.50- 17.10
HOW TO DESIGN A SINGLE TRIAL WITH MULTIPLE CKLM ENDPOINTS?
METHODOLOGY AND STATISTICAL TOOLKITS
Chairpersons : Scott Berry (USA) & Janet Wittes (Washington DC, USA)
15.50 – 16.00: Mechanistic trials’ design: how to distinguish between common and distinct organ-specific mechanisms in C. K. L. M.
Sven Francque (Antwerpen, Belgium)
16.00 – 16.10: Multi-organ imaging. The UK Imaging Diabetes Study
Marija Mavar (Perspectum, UK)
16.10 – 16.20: Framing the methodological issues for multiorgan endpoint trials.
Janet Wittes (Washington DC, USA)
16.20 – 16.30: One Drug, Several Organs, One Alpha: Managing Multiplicity in CKLM Outcomes Trials
Scott Emerson (Seattle, WA, USA)
16.30 – 16.40: How can Bayesian help?
Scott Berry (USA) (5min)
16.40 – 16:55: Trial execution, cost, and feasibility issues – Industry viewpoint
Axel Haupt (Lilly)
Fady Tanios (Regeneron)
David Soergel (Madrigal)
16:55-17:10: ARO/CRO viewpoints
Adrian Hernandez (DCRI, Durham, NC, USA)
Alessandra Vignola (Wordlwide Leadership)
17.10-17.40
The MOSAIC Multi-Stakeholder Think Tank Moderated debate
FEASIBILITY AND ACCEPTABILITY OF SINGLE TRIALS WITH MULTIPLE CKLM ENDPOINTS
ENDPOINTS IN MULTI-ORGAN CKLM CLINICAL TRIALS
Chairpersons : Scott Berry (USA) & Janet Wittes (Washington DC, USA)
Panelists : all speakers
ADJOURN DAY ONE
TRANSFER AND OFF-SITE DINNER
18.10 -19.30
Cocktail Reception and Networking
18.10 -19.30
Tuesday 27 October, 2026
8.30-9.20
MULTIPLE DRUG COMBINATIONS FOR MULTIPLE ORGAN INDICATIONS
Chairpersons : Mazen Noureddin (Houston, USA) & Harriette Van Spall (Hamilton, Canada)
8.30 – 8.40: Ongoing and newly released MASH/MASLD combination drugs.
Mazen Noureddin (Houston, USA)
8.40 – 8.50: Ongoing and newly released Cardio/Kidney/Metabolism combination drugs
Harriette Van Spall (Hamilton, Canada)
8.50 – 9.00: Phase II trials of combination therapies in CKLM trials
Zobair Younossi (Washington DC, USA)
9.00 – 9.10: Phase III trials of combination therapies in CKLM trials
Ming Hua Zheng (Wenzhou, China)
9.10 – 9.20: Industry viewpoints
Jason Campagna (Inventiva)
MeeJ Kim (GSK)
Salvador Augustin (Boehringer)
9.20-9.55
The MOSAIC Multi-Stakeholder Think Tank Moderated debate
OPPORTUNITIES AND CHALLENGES OF DRUG COMBINATION TRIALS IN THE CKLM FRAMEWORK
Chairpersons : Mazen Noureddin (Houston, USA) & Harriette Van Spall (Hamilton, Canada)
Panelists :
EMA
EMA/CHMP – Janet König (GER), Elita Poplavska (LAT)
BfArM/EMA SAWP – Elmer Schabel (GER)
EMA CHMP Robert Pórszász (HUN)
& All participants
9.55-10.15
Coffee Break & Networking
Tuesday 27 October, 2026
10.15- 11.05
THE ROLE OF REAL WORLD EVIDENCE RWE IN CKLM
Chairpersons : Nancy Dreyer (Dreyer LLC, USA) & Shahzeb Khan (Dallas, TX, USA)
10.15 – 10.25: How do modern learning health systems evaluate therapies after approval?
Harlan Krumholz (New Haven, CT, USA)
10.25 – 10.35: What outcomes actually matter post approval?
Javed Butler (Dallas, TX, USA)
10.35 – 10.45: How can RWE data complement the conditional approval of MASLD drugs
Nancy Dreyer (Dreyer LLC, USA)
10.45 – 10.55: Opportunities and challenges for building a CKLM registry
Ian Neeland (Cleveland, OH, USA)
10.55 – 11.05: How to deal with RWE: quality metrics needed in the regulatory process
Adrian Hernandez (DCRI, Durham, NC, USA)
11.05-11.40
The MOSAIC Multi-Stakeholder Think Tank Moderated debate
Impact of RWE in CKLM
Chairpersons : Nancy Dreyer (Dreyer LLC, USA) & Shahzeb Khan (Dallas, TX, USA)
Panelists : all speakers
Tuesday 27 October, 2026
11.40- 12.20
REDUCING TOTAL LIFETIME COST ACROSS CKLM
PAYER VALUATION OF MULTIPLE ORGAN INDICATIONS
Chairpersons: Javed Butler (Dallas, TX, USA) & Arun Sanyal (Richmond, USA)
11.40 – 11.50: How do payers treat multi-indication drugs? Are liver-only agents at risk?
Michael Sherman (Ex CMS, Sherman Healthcare Solutions, LLC)
11.50 – 12.00: National & commercial payers’ viewpoints
Helen Knight (NICE, UK)(5min)
Adrian Towse (Office of Health Economics, London, UK)
12.00 – 12.10: Reimbursement behavior: Population-level contracts vs. Outcomes-based agreements
Sarah Emond (ICER, Boston, MA, USA)
12.10 – 12.20: Bundled chronic-disease pathways: How are sponsors shaping up their programs?
Jyothis George (NodThera)
Jerry Colca (Cirius)
12.20-12.40
The MOSAIC Multi-Stakeholder Think Tank Moderated debate
A CKLM THERAPY COSTS $X ANNUALLY, REDUCES WEIGHT AND MASH PROGRESSION IMMEDIATELY,
KIDNEY AND HEART-FAILURE EVENTS WITHIN THREE YEARS, AND MACE ONLY AFTER SIX YEARS.
WHO SHOULD PAY, HOW MUCH, AND ON WHAT EVIDENCE?
Chairpersons: Javed Butler (Dallas, TX, USA) & Arun Sanyal (Richmond, USA)
12.40-13.40
Lunch Break & Networking
Tuesday 27 October, 2026
13.40- 14.10
The MOSAIC Multi-Stakeholder Think Tank Moderated debate
PATIENTS TRIAL PARTICIPANTS AND PATIENTS’ ADVOCATES FORUM
Chairpersons: Henry Chang (Fatty Liver Foundation, USA) & Elsie Evans (FH Europe Foundation)
Michael Betel (Fatty Liver Alliance, CAN)
Elsie Evans (FH Europe Foundation)
Wayne Eskridge (Fatty Liver Foundation, USA)
Henry Chang (Fatty Liver Foundation, USA)
Patrick Gee (iAdvocate, USA)
Marko Korenjak (European Liver Patients’ Association)
Margaret Padilla (San Antonio, TX, USA)
Template For an Innovative MOSAIC Trial Protocol With Multi-Organ Composite Endpoint Seeking Approval of Multiple Indications For A Combinatorial Agent Use-case (5min)
Robert Beardsley (Cirius, USA)
Template protocol (15 min)
Faiez Zannad (Paris, FRA)
Issues to be debated (60 min)
1. What Can Be a Regulatory Approvable Multi-Organ Composite Endpoint.
2. Regulatory Requirements to Have More Than One Organ System Outcomes Approved in One Trial?
3. “Cardiovascular Safety Should Be Adequately Monitored”. How To Assess CV Safety in Non-CV Trials? Safety Endpoints, Trial Design and Trial Size?
FDA relevant divisions viewpoints
Abbas Bandukwala, Charu Gandotra, William Sanders, Fred Senatore, John Sharretts, Raymond Soccio, Aliza Thompson, Yun Wang, Jialu Zhang, Norman Stockbridge (Stockbridge, LLC)
14.50-15.10
Coffee Break & Networking
Tuesday 27 October, 2026
14.10-15.10
DISSEMINATION AND IMPLEMENTATION OF THE CKLM AGENDA
Chairpersons: Harlan Krumholz (JACC) & Philip Newsome (Birmingham, UK)
14.10 – 14.20: AHA Cardiovascular- Kidney-Metabolic Health Initiative
Chiadi Ndumele (Baltimore, MD, USA)
14.30 – 14.40: Conceptual framework of Cardio–Vascular–Kidney–Liver–Metabolic (CVKLM) Multiorgan Staging
Guillaume Baudry (Nancy, FRA)
14.40 – 14.50: The AHA created the CKM taxonomy. May Europe become the place where CKM evolves into true CKLM integration?
Philip Newsome (Birmingham, UK)
14.50 – 15.10: Journal Editors viewpoints.
Ben Abbott (The Lancet), Harlan Krumholz (JACC), Jane Leopold (NEJM), Ashley Castellanos-Jankiewicz (Nature
Medicine), Jennifer Sargent (Metabologia, EASD)
15.10-15.30
The MOSAIC Multi-Stakeholder Think Tank Moderated debate
HOW TO BUILD THE ROADMAP FOR DISSEMINATION AND IMPLEMENTATION OF THE CKLM AGENDA?
Chairpersons: Harlan Krumholz (JACC) & Philip Newsome (Birmingham, UK)
15.30-15.40
CONCLUDING REMARKS
Faiez Zannad (Paris, FRA), Arun Sanyal (Richmond, USA)
17.30
ADJOURN
In collaboration with the Liver forum of the
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