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)
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
In collaboration with the Liver forum of the
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