23 – 24 October, 2025 | Embassy of France, Washington, D. C., USA
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24 – 25 October, 2024

Embassy of France
4101 Reservoir Road, NW – Washington, D.C. – 20007
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Endorsed by the Stravitz-Sanyal Institute for Liver Disease and Metabolic Health

Thursday 23 October, 2025

8:30 -10:00

INTRODUCTION TO MOSAIC 2025

THE CURRENT LANDSCAPE

Chairpersons : Faiez Zannad (Paris, FRA), Arun Sanyal (Richmond, USA)

8.30 – 8.50: Are We Breaking the Siloes? How The Cardiovascular, Kidney, Liver, Metabolism (CKLM) Paradigm Has Disseminated Since We Last Met At MOSAIC?
Faiez Zannad (Paris, FRA), Arun Sanyal (Richmond, USA) 

Where do we start from? Drugs Currently Approved in One or More MASLD, Cardiovascular, Kidney, or Metabolism indication, With Potential for a Complementary Indication Extension.

8.50 – 9.30: Investigator viewpoints
Ania Jastreboff (New Haven, CT, USA), Sven Francque (Antwerp, BEL), Tom Marjot (London, UK), Faiez Zannad (Paris, FRA)

9.30 – 9.55: Industry viewpoints (5 min each)
Mathijs Bunck (Eli Lilly), Diogo Ferrinho (GSK, USA), Dustin Little (AstraZeneca), Michelle Long (NovoNordisk), Rebecca Taub (Madrigal), Ramy Younes (Boehringer Ingelheim)

9.55 – 10.00: Patient’s viewpoint
Henry Chang (Fatty Liver Foundation, USA)

The MOSAIC Multi-Stakeholder Think Tank Moderated debate

10.00 -10.30

THE CURRENT LANDSCAPE – SWOT ANALYSIS

Chairpersons : Faiez Zannad (Paris, FRA), Arun Sanyal (Richmond, USA)

Panelists : all speakers and Jason Campagna (Inventiva, USA), Samuel Engel (Merck), Scott Harris (Altimmune, USA), Katharine Grimmer (Sagimet Biosciences, USA)

10.30 -11.00

Coffee break & Networking

Thursday 23 October, 2025
11:00 -12:00

NEW DATA AND REMAINING GAPS IN EPIDEMIOLOGY AND PATHOPHYSIOLOGY KNOWLEDGE

Chairpersons : Javed Butler (Dallas, USA), Veronica Miller (Berkeley, USA)

11.00 – 11.20: Global Epidemiology: Are We Capturing Inter-Organ Interplay of the Cardiovascular-Liver-kidney Metabolic (CKLM) Syndemic
Nicholas Chew (Singapore, SIN), Greg Roth (Washington, USA)

11.20 – 12.00: Shared Cardiovascular, Kidney, Liver or Metabolism Pathophysiologic Mechanisms and Inter-Organ Crosstalk
Bart Staels (Paris, FRA), Prakash Ramachandran (Edinburgh, UK), Milton Packer (Dallas, USA), Janani Rangaswami (Washington, USA)

12.00 – 12.10: Adipose tissue – Liver crosstalk
Michael Cooreman (Richmond, USA)

12.10 – 12.15: Patient’s viewpoint
Sharon Jaycox (Global Liver Institute, USA)

The MOSAIC Multi-Stakeholder Think Tank Moderated debate

12.15 -12.45

HOW TO IMPROVE EPIDEMIOLOGY AND PATHOPHYSIOLOGY KNOWLEDGE

Chairpersons : Javed Butler (Dallas, USA), Veronica Miller (Berkeley, USA)

Panelists : all speakers

12.45 -13.30

Lunch Break & Networking

Thursday 23 October, 2025
13.30 – 15.10

NEW DATA AND REMAINING GAPS IN PRECLINICAL AND BIOMARKER KNOWLEDGE

Chairpersons : Jörn Schattenberg (Mainz, GER), Raj Vuppalanchi (Indianapolis, USA)

13.30 – 13.50: What May Be Suitable Preclinical and Translational Integrated Models of CKLM Interplay?
Jörn Schattenberg (Mainz, GER)

13.50 – 14.00: The Liver Investigation: Testing Marker Utility in Steatohepatitis (NIMBLE) experience
Arun Sanyal (Richmond, USA)

14.00 – 14.10: Assessing Multi-Organ Involvement Using Emerging Multi-Omics and system biology.
Aleksander Krag (Odense, DEN) 

14.10 – 14.40: Industry viewpoints (5 min each)
Joe Gogain (Somalogic, USA), Karsten Strauss (Olink, SWE), Michael Feigh (Gubra, DEN), Diana Julie Leeming (Nordic Bioscience)

14.40 – 14.45: Patient’s viewpoint
Michael Betel (Fatty Liver Alliance, CAN)

The MOSAIC Multi-Stakeholder Think Tank Moderated debate

14.45 -15.15

HOW TO IMPROVE PRECLINICAL AND BIOMARKER KNOWLEDGE

Chairpersons : Jörn Schattenberg (Mainz, GER), Raj Vuppalanchi (Indianapolis, USA)

Panelists : all speakers

15.15 -15.40

Coffee Break & Networking

Thursday 23 October, 2025
15.40 – 16.30

CHANGING PARADIGM NEW DATA AND REMAINING GAPS IN IMAGING KNOWLEDGE

Chairpersons : Charlotte Manisty (London, UK), Louise Thomas (London, UK)

Assessing Multi-Organ Involvement Using Emerging Multi-Modality Imaging.

15.40 – 16.00: Investigator viewpoint
Charlotte Manisty (London, UK), Louise Thomas (London, UK)

16.00 – 16.10: Industry viewpoints (5 min each)
Lars Johansson (Antaros, SWE), Andrea Dennis (Perspectum, UK)

16.10 – 16.20: The Role of Machine Learning and Artificial Intelligence. Combining Biomarkers, Bioimaging and Clinical Phenotypes to Assess Multi-Organ Involvement in CKLM States
Mamatha Bhat (Toronto, CA)

16.20 -16.40

The MOSAIC Multi-Stakeholder Think Tank Moderated debate

HOW TO IMPROVE IMAGING KNOWLEDGE

Chairpersons : Charlotte Manisty (London, UK), Louise Thomas (London, UK)

Panelists : all speakers

Thursday 23 October, 2025
16.40 – 17.20

ENDPOINTS IN MULTI-ORGAN CKLM CLINICAL TRIALS

Chairpersons : Carolyn Lam (Singapore, SIN), Harriette Van Spall (Toronto, CAN)

16.40 – 16.50: NITs, Elastography and Other Liver-Related Endpoints to Be Incorporated in Cardiovascular, Kidney Metabolism Clinical Trials
Raj Vuppalanchi (Indianapolis, USA)

16.50 – 17.00: What Metabolic Endpoint May Be Incorporated in MASLD Trials
Javed Butler (Dallas, USA)

17.00 – 17.10: What Kidney Endpoints May Be Incorporated in MASLD Trials
Lesley Inker (Boston, USA)

17.10 – 17.20: What Cardiovascular Endpoints May Be Incorporated in MASLD Trials
Carolyn Lam (Singapore, SIN)

17.20 -18.10

The MOSAIC Multi-Stakeholder Think Tank Moderated debate

ENDPOINTS IN MULTI-ORGAN CKLM CLINICAL TRIALS

Chairpersons : Carolyn Lam (Singapore, SIN), Harriette Van Spall (Toronto, CAN)

Panelists : all speakers

Cocktail Reception and Networking

18.10 -19.30

Friday 24 October, 2025
8.00 – 9.00

HOW TO DESIGN MULTI-ORGAN INTEGRATED CKLM CLINICAL TRIALS DESIGN & STATISTICAL SOLUTIONS

Chairpersons : Jan Tijssen (Brussels, BEL), Janet Wittes (Wittes LLLC, USA)

8.00 – 8.10: Ongoing trials with concurrent evaluation of Cardiovascular, Kidney, Metabolism or MASLD endpoints.
Harriette Van Spall (Toronto, CAN)

8.10 – 8.30: Innovative Design for Integrated Multi-Organ Clinical Trials. The Potential Of Platform, Basket, Umbrella, and other designs
Janet Wittes (Wittes LLLC, USA), Jan Tijssen (Brussels, BEL)

8.30 – 8.40: Interim Analyses and Bayesian Methods.
Scott Berry (Berry Consultants, Austin, USA)

8.40 – 8.50: The “Flexible Augmented Clinical Trial for Improved Evidence Generation” (FACTIVE)
Chris Holmes (Oxford, UK)

8.50 – 9.00: In Silico Modelling.
François-Henri Boissel (Lyon, FRA)

9.00-9.30

The MOSAIC Multi-Stakeholder Think Tank Moderated debate

HOW TO DESIGN MULTI-ORGAN INTEGRATED CKLM CLINICAL TRIALS DESIGN & STATISTICAL SOLUTIONS

Chairpersons : Jan Tijssen (Brussels, BEL), Janet Wittes (Wittes LLLC, USA)

Panelists : all speakers

09.30 -10.00

Coffee Break & Networking

Friday 24 October, 2025
10.00-11:30

SELECTING THE APPROPRIATE TRIAL POPULATION FOR MULTI-ORGAN CLINICAL TRIALS

Chairpersons : Lesley Inker (Boston, MA, USA), Milton Packer (Dallas, USA)

10.00 – 10.40: What Are the Unmet Needs and What is the Clinically Relevant Patient Population?
Arun Sanyal (Richmond, USA), Javed Butler (Dallas, USA)

10.40 – 10.50: Avoiding Routine Exclusion in CKM Trials of Participants with Liver Dysfunction.
Naga Chalasani (Indianapolis, USA)

10.50 -11.10: Avoiding Routine Exclusion in MASLD Trials of Participants with Cardiovascular and/or Kidney Exclusion Citeria
Naim Alkouri (Houston, USA)

11.10 – 11.20: Screening for concomitant Heart Failure/CVD and MASLD
Carolyn Lam (Singapore, SIN)

11.20 – 11.30: How to enroll patients with CKD in MASLD trials
Lesley Inker (Boston, MA, USA)

11.30 – 11.35: Patient’s viewpoint
Margaret Padilla (San Antonio, TX, USA)

11.35 -12.00

The MOSAIC Multi-Stakeholder Think Tank Moderated debate

SELECTING THE APPROPRIATE TRIAL POPULATION FOR MULTI-ORGAN CLINICAL TRIALS

Chairpersons : Lesley Inker (Boston, MA, USA), Milton Packer (Dallas, USA)

Panelists : all speakers

12.00 -13.00

Lunch Break & Networking

Friday 24 October, 2025
13.00-13.30

EVENT ENRICHMENT POWER AND SIZE FOR MULTI-ORGAN TRIALS

Chairpersons : Charu Gandotra (FDA, USA), Sven Franque (Antwerp, BEL)

Enriching CKM Trials For MALO In Multi-Organ Outcome trials and How To Power a Trial for Major Adverse Liver Outcomes (MALO)
Sven Franque (Antwerp, BEL)

Enriching MASLD Trials For Major Adverse Cardiac Events (MACE) In Multi-Organ Outcome trials and how to power a trial for For MACE
Nicolas Girerd (Nancy, FRA)

13.30-14.50

The MOSAIC Multi-Stakeholder Think Tank Moderated debate

REGULATORY REQUIREMENTS TO FIT A CHANGING PARADIGM

Chairpersons : Charu Gandotra (FDA, USA), Sven Franque (Antwerp, BEL)

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
bbas 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

Friday 24 October, 2025
15.10 -16.30

HOLISTIC APPROACH TO CKLM TRIALS AND CARE DISSEMINATING AND IMPLEMENTING THE MOSAIC AGENDA

Chairpersons : Ben Abbott (The Lancet), Shahzeb Khan (Dallas, TX, USA)

15.10 – 15.20: Raising public awareness. The Liver Forum viewpoint
Veronica Miller (Berkeley, USA)

15.20 – 15.40: Overcoming The Siloed Clinical Practice. How To Promote a Holistic Management Of MASLD/MASH In the Context of the CKLM Construct.
Shahzeb Khan (Dallas, TX, USA), Jörn Schattenberg (Homburg, GER)

15.40 – 15.55: Accelerating the Science of MultiOrgan Clinical Trials (5 min each). PCORI viewpoint
Tracy Wang (Durham, USA) 

The role of Public Funding Agencies
Tania Kamphaus (FNIH, USA)

The role of NIH-FNIH
Tania Kamphaus (FNIH, USA), Vandana Sachdev (NHLBI, USA)

15.55 – 16.10: How To Popularize the CKLM Concept in the Medical Community? The Role of Medical Journals. Journal Editors’ Viewpoints (5 min each)
Ben Abbott (The Lancet), Jennifer Sargent (Metabologia, EASD), Jane Leopold (NEJM)

16.10 – 16.30: How To Promote Multiorgan Approach Advocacy. Patients’ viewpoints (5 min each)
Michael Betel (Fatty Liver Alliance, CAN), Magdalena Daccord (FH Europe Foundation), Wayne Eskridge (Fatty Liver Foundation, USA), Henry Chang (Fatty Liver Foundation, USA), Patrick Gee (iAdvocate, USA) Sharon Jaycox (Global Liver Institute, USA), Margaret Padilla (San Antonio, TX, USA)

16.30-17.00

The MOSAIC Multi-Stakeholder Think Tank Moderated debate

HOW TO DISSEMINATE AND IMPLEMENT THE MOSAIC AGENDA

Chairpersons: Ben Abbott (The Lancet), Shahzeb Khan (Dallas, TX, USA)

17.00

CONCLUDING REMARKS

Faiez Zannad (Paris, FRA), Arun Sanyal (Richmond, USA)

17.30

ADJOURN