24 – 25 October, 2024 | Embassy of France, Washington, D. C., USA
Mosaic Nash
Organized by
In collaboration CVCT Logo

24 – 25 October, 2024

Embassy of France
4101 Reservoir Road, NW – Washington, D.C. – 20007
Organized by
In collaboration

Endorsed by the Stravitz-Sanyal Institute for Liver Disease and Metabolic Health

THURSDAY OCTOBER 19th 2023
8.30am-10.30 am

Setting the stage

Multi-Organ/System Accelerated Innovation in MASLD/MASH. What, So What, and Now What?
The conceptual framework and main objectives of MOSAIC

MOSAIC Chairs

MASLD/MASH LIVER – HEART – KIDNEY CLINICAL PRESENTATIONS AND OUTCOMES.

ASSOCIATED OR CONSUBSTANTIAL CONDITIONS?

Chairpersons: Stephen Harrison (San Antonio, TX, USA) & Faiez Zannad (Paris, FRA)

When do patients with liver disease die from CVD complications
Meena Bansal (New York, NY, USA)

Patients with atherosclerotic CVD often have liver and renal related issues associated with poor outcome
William Alazawi (London, UK)

Patients with Heart Failure and preserved ejection fraction, often have liver and renal related issues associated with poor outcome
Javed Butler (Dallas, TX, USA)

Is there a link between CKD and MASLD/MASH?
Meg Jardine (Sydney, AUS)

Patients with lipid disorders are at high risk of MASLD/MASH, CVD and CKD
Robert Rosenson (New York, NY, USA)

T2D obesity , the microbiote, and progression to CVD
Juan P Frias (Velocity Clinical Research, USA)

MASLD/MASH in Non-obese – what is that? How is it different? Should it be approached differently
Mindie Nguyen (Palo Alto , CA , USA)

Industry viewpoints
Phil Ambery (AstraZeneca, SWE), Roberto Calle (Regeneron, USA), Sam Engel (Merck, USA), David Fraser (Northsea, NED), Michelle Long (Novo Nordisk, DK)

Patients’ viewpoints
Henry Chang (Fatty Liver Foundation, USA)

The MOSAIC Multistakeholder Panel Debate

LIVER – CARDIOVASCULAR – KIDNEY INTEGRATIVE VIEWS

Chairpersons: Stephen Harrison (San Antonio, TX, USA) & Faiez Zannad (Paris, FRA)

All speakers and panelists

THURSDAY OCTOBER 19th 2023
10.30-11.00

COFFEE

THURSDAY OCTOBER 19th 2023
11.00 -13.00

HOW MECHANISMS, BIOTARGETS AND DRUGS MAY BE COMMON TO MASLD/MASH AND CARDIORENALMETABOLISM DISORDERS

Chairpersons: Vera Bittner (Birmingham, AL, USA) & Veronica Miller (Berkeley, CA, USA)

Rapid fire: 5 mins presentations. 4 slides each

Lipotoxicity, steatosis, inflammation, and fibrosis – are these serial or independent pathophysiologies
Bart Staels (Lille, FRA)

Alpha, gamma and pan Peroxisome proliferator-activated receptor agonists.
Sven Francque (Antwerp, BEL)

Sodium-glucose transport proteins inhibitors
William Alazawi (London, UK)

Glucagon-Like Peptide 1 Receptor Agonist
Mikhail Kosiborod (Kansas City, MO, USA)

Mineralocorticoid receptor antagonists
Faiez Zannad (Paris, FRA)

Fibroblast growth factor 21
Stephen Harrison (San Antonio, TX, USA)

Triglyceride rich lipoproteins – LP(a)-Cholesterol.
Vera Bittner (Birmingham, AL, USA) 

AMP-activated protein kinase
Vlad Ratziu (Journal of Hepatology, FRA)

Thyroid hormone receptor beta
Paul M Yen (Singapore, SIN)

Fibrogenesis as a systemic biotarget
Meena Bansal (New York, NY, USA)

Targeting hepatic mitochondrial uncoupling to treat MASLD, MASH and Cardiometabolic Disease
Gerald Shulman (New Haven, CT, USA)

pUFAs and eicosanoids
David Fraser (Northsea, NED)

Growth Hormone
Laura Ditchel (Boston, MA, USA) 

Combination therapy
Onno Holleboom (Amsterdam, NED) 

The MOSAIC Multistakeholder Panel Debate

SYSTEMIC – MULTI-ORGAN- PLEIOTROPIC EFFETCS OF DRUGS

Chairpersons: Vera Bittner (Birmingham, AL, USA) & Veronica Miller (Berkeley, CA, USA)

All speakers and panelists

THURSDAY OCTOBER 19th 2023
13.00 -14.00

LUNCH

THURSDAY OCTOBER 19th 2023
14.00 -16.00

NON-INVASIVE NON-LIVER EVALUATIONS IN MASLD/MASH TRIALS. 'MUST HAVE' VS. 'GOOD TO HAVE'?

Chairpersons: Meg Jardine (Sydney AUS) & Arun Sanyal (Richmond, VA, USA)

10 mins presentations

Atherosclerosis endpoints: Imaging
Matt Kelly (Caristo Diagnostics, UK)

Heart Failure endpoints
Javed Butler (Dallas, TX, USA)

CKD endpoints
Meg Jardine (Sydney, AUS)

Malignancies endpoints
Neehar Parikh (Ann Arbor, MI, USA)

Patient reported outcomes
Zobair Younossi (Falls Church, VA, USA)

Non-Liver biomarkers to be assessed in MASLD/MASH biobanks?
Mohammad Siddiqui (Richmond, VA, USA)

Industry viewpoints
DeAunne Denmark (Somalogic, USA), James Min (Cleerly, USA), Karsten Strauss (Olink, SWE)

Patients’ viewpoints
Margaret Padilla (San Antonio, TX, USA), Jeff McIntyre (Global Liver, USA)

The MOSAIC Multistakeholder Panel Debate

SHORTLISTING NON-INVASIVE NON-LIVER EVALUATIONS FOR MASLD/MASH TRIALS.

Chairpersons: Meg Jardine (Sydney AUS) & Arun Sanyal (Richmond, VA, USA)

All speakers and panelists

THURSDAY OCTOBER 19th 2023
16.00– 16.30

COFFEE

THURSDAY OCTOBER 19th 2023
16.30– 17.30

NON-INVASIVE LIVER ENDPOINTS IN NON-LIVER TRIALS

Chairpersons: Arun Sanyal (Richmond, VA, USA) & Harriette Van Spall (Hamilton, CAN)

10 mins presentations

Which future CVD and CKD trials should be enriched with liver endpoints?
Harriette Van Spall (Hamilton, CAN)

What liver biomarker substudies to recommend in CV trials
Arun Sanyal (Richmond, VA, USA)

What liver imaging substudies to recommend in CV trials
Mazen Noureddin (Los Angeles, CA, USA)

Industry viewpoints
Lars Johansson (Antaros, USA), Laurent Sandrin (Echosens, USA)

Patients’ viewpoints
Michael Betel (Fatty Liver Alliance, CAN)

Regulatory viewpoints 
FDA: Frank Anania (FDA, USA), John Sharretts (FDA, USA), Raymond Soccio (FDA, USA)

THURSDAY OCTOBER 19th 2023
17.30 -18:15

COCKTAIL RECEPTION

THURSDAY OCTOBER 19th 2023
18.15 – 20.30

SEATED DINNER AT EMBASSY

The MOSAIC Multistakeholder Panel Debate

TRANS-SPECIALTY COLLABORATORY
WHAT LIVER ENDPOINTS MAY BE EXPLORED IN CARDIO-RENAL-METABOLIC TRIALS?

Chairpersons: Arun Sanyal (Richmond, VA, USA) & Harriette Van Spall (Hamilton, CAN)

All speakers and panelists

FRIDAY OCTOBER 20th 2023
8.30- 10.30

MULTIPLE ENDPOINTS IN A SINGLE TRIAL.
HITTING MULTIPLE TARGETS WITH A SINGLE BULLET.
INVESTIGATING MULTIPLE HYPOTHESES THROUGH CONCURRENT SUB-STUDIES.

Chairpersons: Veronica Miller (Berkeley, CA, USA) & Arun Sanyal (Richmond, VA, USA)

How to secure Cardiorenal claims in MASLD/MASH liver trials?
Aliza Thompson (FDA, USA)

How to secure metabolic claims in MASLD/MASH liver trials?
John Sharretts (FDA, USA)

How to seek a liver-MASLD/MASH claim in non-liver Cardio/Renal/Metabolism trials?

Investigator viewpoint
Arun Sanyal (Richmond, VA, USA)

Rationale for multiple outcomes in future MASLD/MASH clinical trials
Juan Pericàs (Barcelona, ESP)

Design and methodological issues with (multi-organ) composite, co-primary, secondary and hierarchical endpoints
Marc Buyse (IDDI, BEL) 

How to statistically construct multiple endpoints in a statistical analysis plan?
Janet Wittes (Wittes LLC, USA)

How artificial intelligence and machine learning may help?
Rohan Khera (New Haven, CT, USA)

Patients’ viewpoints
Margaret Padilla (San Antonio, TX, USA)

The MOSAIC Multistakeholder Panel Debate

TRANS-SPECIALTY COLLABORATORY
HOW TO DESIGN FUTURE MASLD/MASH /CARDIORENAL TRIALS

Chairpersons: Veronica Miller (Berkeley, CA, USA) & Arun Sanyal (Richmond, VA, USA)

All speakers and panelists

FRIDAY OCTOBER 20th 2023
10.30-11.00

COFFEE

FRIDAY OCTOBER 20th 2023
11.00- 12.00

WHAT SHOULD BE THE TARGET PATIENT POPULATION FOR A COMBINED MASLD/MASH/CARDIOMETABOLIC TRIAL?

Chairpersons: Stephen Harrison (San Antonio, TX, USA), Faiez Zannad (Paris, FRA)

Investigator viewpoints
Arun Sanyal (Richmond, VA, USA)
Faiez Zannad (Paris, FRA)

Industry viewpoints
Michael Cooreman (Inventiva, FRA), Michelle Long (Novo Nordisk, DK), Ramy Younes (Boehringer Ingelheim, GER)

Patients’ viewpoints
Jeff McIntyre (Global Liver, USA)

Regulatory viewpoints
FDA: Frank Anania (FDA, USA), John Sharretts (FDA, USA), Charmaine Stewart (FDA, USA),Raymond Soccio (FDA, USA), Aliza Thompson (FDA, USA)

FRIDAY OCTOBER 20th 2023
12.00- 13.00

The MOSAIC Multistakeholder Panel Debate
NEXT STEPS. HOW TO ADVANCE THE MOSAIC AGENDA?

Chairpersons: Stephen Harrison (San Antonio, TX, USA), Faiez Zannad (Paris, FRA)

All speakers and panelists

FRIDAY OCTOBER 20th 2023
13.00- 14.00

LUNCH AND ADJOURN