December 5 – 6, 2022 | Washington DC, USA

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Metabolic, Hepatology, Nephrology and Cardiovascular Cross Talk
Cardiologist, endocrinologist and hepatologist trialists, industry, regulatory experts, payers, patients representatives and other stakeholders crosstalk summit.
A Multi-stakeholder Multi-specialty NASH Trialists Think Tank

A Multi-stakeholder Multi-specialty NASH Trialists Think Tank

Metabolic, Hepatology, Nephrology and Cardiovascular Cross Talk

Organized by the Translational Medicine Academy

TMA logo

In collaboration with CardioVascular Clinical Trialists Forum 

and Liver forum

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

DISEASE EPIDEMIOLOGY
THE LIVER – METABOLIC AND CARDIOVASCULAR INTERSECTIONS
Monday 5 December 2022
08:00 - 10:30 AM


DISEASE EPIDEMIOLOGY. THE LIVER – METABOLIC AND CARDIOVASCULAR INTERSECTIONS

Chairpersons: Kathleen Corey (Boston, MA, USA) & TBD

8:00 – 10:30

Chairs
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Agenda
  • 09:15 – 09:25
    Prevalence and incidence and cost of care

    Zobair Younossi (Falls Church, VA, USA)

  • 09:25 – 09:35
    Relationship of NAFLD with heart failure

    Husam Salah (Little Rock, AR, USA)

  • 09:35 – 09:45
    Burden of cardiorenal disease in NAFLD patients

    Kathleen Corey (Boston, MA, USA)

  • 09:45 – 09:55
    Burden of liver related comorbidities in cardiovascular disease

    Sven Francque (Antwerp, BEL)

  • 09:55 – 10:00
    Burden of cardiac and liver disease in patients with CKD

    Michelle Long (Novonordisk, USA)

  • 10:00 – 10:05
    Are cardiologists paying attention?

    Barton Duell (Portland, OR, USA)

  • 10:05 – 10:10
    Regulatory perspective

    John Sharretts (FDA, USA), Norman Stockbridge (FDA, USA), Aliza Thompson (FDA, USA), Joe Toerner (FDA, USA)

  • 10:05 – 10:10
    Industry perspective

    Amy Articolo (Novonordisk, USA), Sudha Shankar (AstraZeneca, USA)

  • 10:05 – 10:10
    Patient perspective

    Margaret Padilla (Hearne, USA), Sam Castillo (USA)

THE MOSAIC MODERATED MULTISTAKEHOLDER DEBATE WHAT SHORT- AND LONG-TERM OUTCOMES TO PREVENT IN NASH

Chairpersons: Kathleen Corey (Boston, MA, USA)

  • 09:15 – 09:25
    Panelists

    All speakers and guests

COMMON BIOLOGIC DRIVERS OF NASH AS A MULTIORGAN DISEASE

Chairpersons : Paul Ridker (Boston, MA, USA) & Harriette Van Spall (Hamilton, CAN)

11:00 – 13:00

Chairs
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Agenda
  • 10:30 – 10:40
    Role of the metabolic milieu for liver and cardiac disease

    Gerry Shulman (New Haven, CT, USA)

  • 10:40 – 10:50
    Role of systemic inflammatory state in cardiac, renal and liver involvement in metabolic syndrome

    Paul Ridker (Boston, MA, USA)

  • 10:50 – 11:00
    Inflammatory signals and macrophage biology

    Henry Ginsberg (New York, NY, USA)

  • 11:00 – 11:10
    Systemic drivers of pro-fibrogenic state in Metabolic syndrome

    Anna Mae Diehl (Durham, NC, USA)

  • 11:10 – 11:20
    Mechanisms of myocardial dysfunction in NAFLD

    Ambarish Pandey (Dallas, TX, USA)

  • 11:30 – 11:40
    Regulatory perspective

    John Sharretts (FDA, USA), Norman Stockbridge (FDA, USA), Aliza Thompson (FDA, USA), Joe Toerner (FDA, USA)

  • 11:40 – 11:50
    Industry perspective

    Dean Hum (Genfit, FRA), Michelle Berrey (Intercept, USA)

  • 11:50 – 11:55
    Journal Editor perspective:

    Jennifer Sargent (Nature, USA)

  • 11:55 – 12:00
    Patient perspective

    TBD

The MOSAIC Moderated Multistakeholder Debate – New Druggable Molecular Biotargets In NASH

Chairpersons : Paul Ridker (Boston, MA, USA) & Harriette Van Spall (Hamilton, CAN)

  • 09:15 – 09:25
    Panelists

    All speakers and guests

Multiple Phenotypic Characterisation of Patients Eligible for NASH Trials

Chairpersons : Javed Butler (Jackson, TX, USA) & Manal Abdelmalek (Rochester, MN, USA)

14:00 – 16:00

Chairs
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Agenda
  • 13:15 – 13:25
    Cardiac characterization in NAFLD trials

    Faiez Zannad (Paris, FRA)

  • 13:25 – 13:35
    Renal disease characterization in NAFLD trials

    Javed Butler (Jackson, MS, USA)

  • 13:35 – 13:45
    NAFLD characterization in cardiovascular trials

    Manal Abdelmalek (Rochester, MN, USA)

  • 13:45 – 13:50
    Regulatory perspective

    John Sharretts (FDA, USA), Norman Stockbridge (FDA, USA), Aliza Thompson (FDA, USA), Joe Toerner (FDA, USA)

  • 13:50 – 13:55
    Industry perspective

    Marilyn de Chantal (Theratech, IRE)

  • 13:55 – 14:00
    Patient perspective

    TBD

The MOSAIC Moderated Multistakeholder Debate – Patients Eligible in NASH Trials, Clincial Characterisation Beyond Liver Criteria.

Chairpersons : Javed Butler (Jackson, MS, USA) & Manal Abdelmalek (Rochester, MN, USA)

  • 09:15 – 09:25
    Panelists

    All speakers and guests

Liver, Cardiac and Renal Outcome Endpoints in NASH Trials

Chairpersons: Vlad Ratziu (Paris, FRA) & TBD

16:30 – 18:30

Chairs
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Agenda
  • 14:00 – 14:10
    Cardiac endpoints in NAFLD outcome trials

  • 14:10 – 14:20
    Potential renal endpoints in NAFLD outcome trials

  • 14:20 – 14:30
    Liver endpoints in cardio-renal trials

    Vlad Ratziu (Paris, FRA)

  • 14:30 – 14:35
    Use of hierarchical endpoints

    Janet Wittes (Wittes LLC, USA)

  • 14:35 – 14:40
    Regulatory perspective

    John Sharretts (FDA, USA), Norman Stockbridge (FDA, USA), Aliza Thompson (FDA, USA), Joe Toerner (FDA, USA)

  • 14:40 – 14:45
    Industry perspective

    Jerry Colca (Cirius, USA), Rebecca Taub (Madrigal, USA)

The MOSAIC Moderated Multistakeholder Debate – How to Progress Beyond Liver Endpoints?

Chairpersons: Vlad Ratziu (Paris, FRA) & TBD

  • 09:15 – 09:25
    Panelists

    All speakers and guests

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MOSAIC FORUM
Tuesday 6 December 2022
08:00 - 10:30 AM


Design and Execution Issues of Outcome Trials in NASH

Chairpersons: Scott Evans (Washington DC, USA) & Veronica Miller (CA, USA)

8:00 – 10:30

Chairs
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Agenda
  • 14:45 – 14:55
    Design and statistical innovations
    • Seamless design, pragmatic trials, and how they can help?

      Janet Wittes (Wittes LLC, USA)

    • How to tackle intercurrent events? Estimands in Clinical Trials

      Mouna Akacha (Novartis, USA)

    • Benefit:risk evaluation using a Desirability of Outcome Ranking (DOOR) endpoint

      Scott Evans (Washington DC, USA)

  • 14:55 – 15:05
    Best practices to keep patients in the long term outcome trials

    Sophie Jeannin (Summit Clinical Research, USA)

  • 15:05 – 15:15
    Minorities in CVD, CKD and NASH trials

    Harriette Van Spall (Hamilton, CAN)

  • 15:15 – 15:20
    How to synergize and bridge multiple discipline investigators

    Claudia Filozof (LabCorp, USA), Marcus Hompesch (Prosciento, USA)

  • 15:15 – 15:20
    Regulatory perspective

    John Sharretts (FDA, USA), Norman Stockbridge (FDA, USA), Aliza Thompson (FDA, USA), Joe Toerner (FDA, USA)

  • 15:20 – 15:25
    Industry perspective

    Roberto Calle (Regeneron, USA), Michael Cooreman (Inventiva, FRA)

  • 15:25 – 15:30
    Patient perspective

    Donna Cryer (Global Liver, USA)

The MOSAIC Moderated Multistakeholder Debate – Design And Execution Issues of NASH Outcome Trials

Chairpersons: Scott Evans (Washington DC, USA) & Veronica Miller (CA, USA)

  • 09:15 – 09:25
    Panelists

    All speakers and guests

Use of Noninvasive Tests (NITs) for Efficacy and Safety Assessment- Circulating Biomarkers

Chairpersons: Faiez Zannad (Paris, FRA) & TBD

11:00 – 13:00

Chairs
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Agenda
  • 09:45 – 09:55
    Cardiac biomarkers and NITs

    Joao Ferreira (Porto, POR)

  • 09:55 – 10:05
    Liver biomarkers and NITs

    Arun Sanyal (Richmond, VA, USA)

  • 10:05 – 10:15
    Renal biomarkers and NITs

    Chirag Parikh (Baltimore, USA)

  • 10:15 – 10:20
    Proteomic biomarkers in NASH

    Martin Cornillet (Stockholm, SWE)

  • 10:15 – 10:20
    Regulatory perspective

    John Sharretts (FDA, USA), Norman Stockbridge (FDA, USA), Aliza Thompson (FDA, USA), Joe Toerner (FDA, USA)

  • 10:20 – 10:25
    Industry perspective

    Clifford Brass (Novartis, USA), Clare Paterson (Somalogic, USA), Sara Sadi (Olink, SWE) Steve Williams ( Somalogic, USA), Joseph Gogain (Somalogic, USA)

  • 10:25 – 10:30
    Patient perspective

    TBD

The MOSAIC Moderated Multistakeholder Debate – What Surrogate Biomarkers are Acceptable for Approval?

Chairpersons: Faiez Zannad (Paris, FRA) & TBD

  • 09:15 – 09:25
    Panelists

    All speakers and guests

Imaging Tests in NASH Trials

Chairpersons: Rohit Loomba (San Diego, USA) & David Yankelevitz (New York, NY, USA)

14:00 – 16:00

Chairs
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Agenda
  • 10:30 – 10:40
    Cardiac Imaging based assessment of NAFLD

    Zahi Fayad (NY, USA)

  • 10:40 – 10:50
    Imaging based assessment of NAFLD

    Scott Reeder (Washington, WA, USA)

  • 10:50 – 11:00
    Integrated clinical imaging of heart, liver and kidneys

    Lars Johansson (Antaros, SWE)

  • 11:00 – 11:10
    Regulatory perspective

    John Sharretts (FDA, USA), Norman Stockbridge (FDA, USA), Aliza Thompson (FDA, USA), Joe Toerner (FDA, USA)

  • 11:10 – 11:15
    Industry perspective

    TBD, Richard Ehman (Resoundant, USA), Laurent Sandrin (Echosense, USA)

  • 11:15 – 11:20
    Patient perspective

    TBD

The MOSAIC Moderated Multistakeholder Debate – What Imaging Tests are Acceptable for Approval?

Chairpersons: Rohit Loomba (San Diego, USA) & David Yankelevitz (New York, NY, USA)

  • 09:15 – 09:25
    Panelists

    All speakers and guests

Recent and Ongoing Cardiorenal, Metabolic And NAFLD Trials Succes Stories and Lessons from Failures

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

16:30 – 19:00

Chairs
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Agenda
  • 10:30 – 10:40
    Reviewing the therapeutic landscape for CV disease

    Faiez Zannad (Paris, FRA)

  • 10:40 – 10:50
    Reviewing the therapeutic landscape for CKD

  • 10:50 – 11:00
    Reviewing the therapeutic landscape for type 2 diabetes

  • 11:00 – 11:10
    Reviewing the therapeutic landscape for obesity

    Stephen Wiviott (Boston, MA, USA)

  • 11:10 – 11:15
    Reviewing the therapeutic landscape in NAFLD

    Stephen Harrison (San Antonio, TX, USA)

  • 11:15 – 11:20
    Regulatory perspective

    John Sharretts (FDA, USA), Norman Stockbridge (FDA, USA), Aliza Thompson (FDA, USA), Joe Toerner (FDA, USA)

  • 11:15 – 11:20
    Industry perspective

    Mark Hartman (Eli Lilly, USA), Rami Younes (Boehringer, GER)

  • 11:15 – 11:20
    Journal Editor perspective

    Stuart Spencer (The Lancet, GBR), Jane Leopold (NEJM, USA)

  • 11:15 – 11:20
    Patient perspective

    Gamal Shiha (London, GBR)

The MOSAIC Moderated Multistakeholder Debate – Are the Current Trials Addressing the Multi-organ Multi-system Dimensions of NASH ?

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

  • 09:15 – 09:25
    Panelists

    All speakers and guests

Networking Dinner – The Future of MOSAIC Clinical Trialists Meetings

Chairpersons : Stephen Harrison (TX, USA), Veronica Miller (CA, USA), Arun Sanyal (Richmond, VA, USA), Faiez Zannad (Paris, FRA)

  • 09:15 – 09:25
    The MOSAIC group is committed to draft a position paper summarizing the recommendations of the forum
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  • Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry's standard
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Sponsors
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In collaboration with the Liver forum of the
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In collaboration with the Liver forum of the
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