December 5 – 6, 2022 | French Embassy: Reservoir Road, Washington, DC, USA & LIVE Streamed

A Multi-stakeholder Multi-specialty
NASH Trialists Think Tank

Metabolic, hepatology, nephrology & cardiovascular cross-talk

December 5th & 6th December 2022

French Embassy, Reservoir Road, Washington, DC, USA and Live Streamed
Organized by
In collaboration CVCT Logo
Endorsed by the Stravitz-Sanyal Institute for
Liver Disease and Metabolic Health

A Multi-stakeholder Multi-specialty
NASH Trialists Think Tank

Metabolic, hepatology, nephrology & cardiovascular cross-talk

December 5th & 6th December 2022

French Embassy,Reservoir Road, Wasington, DC, USA and Live Streamed
French Embassy,Reservoir Road,
Wasington, DC, USA and Live Streamed
Organized by
In collaboration
Endorsed by the Stravitz-Sanyal Institute for
Liver Disease and Metabolic Health

A Multi-stakeholder Multi-specialty
NASH Trialists Think Tank

Metabolic, hepatology, nephrology & cardiovascular cross talk

French Embassy, Reservoir Road, Washington, DC, USA and LIVE Streamed

A Multi-stakeholder
Multi-specialty
NASH Trialists Think Tank

Metabolic, hepatology, nephrology & cardiovascular cross talk

Times are in Eastern Standard Time (EST), UTC -5

Monday 5 December 2022

08:00 AM - 06:30 PM

Chairpersons: Kathleen Corey (Boston, MA, USA) & Faiez Zannad (Paris, FRA)

08:00 AM – 10:30 AM

Agenda

  • 08.00 AM – 08.10 AM
    Prevalence and incidence and cost of care
    Zobair Younossi (Falls Church, VA, USA)
  • 08.10 AM – 08.20 AM
    Relationship of NAFLD with heart failure
    Ambarish Pandey (Dallas, TX, USA)
  • 08.20 AM – 08.30 AM
    Burden of cardiorenal disease in NAFLD patients
    Kathleen Corey (Boston, MA, USA)
  • 08.30 AM – 08.40 AM
    Burden of liver related comorbidities in cardiovascular disease
    Sven Francque (Antwerp, BEL)
  • 08.40 AM – 08.50 AM
    Burden of cardiac and liver disease in patients with CKD
    Michelle Long (Novo Nordisk, USA)
  • 08.50 AM – 09.00 AM
    Are cardiologists paying attention?
    Barton Duell (Portland, OR, USA)
  • 09.00 AM – 09.10 AM
    Regulatory viewpoints
    Norman Stockbridge (FDA, USA), Aliza Thompson (FDA, USA)
  • 09.10 – 09.20 AM
    Industry viewpoints
    Amy Articolo (Novo Nordisk, USA), Sudha Shankar (AstraZeneca, USA)
  • 09.20 AM – 09.30 AM
    Patient viewpoints
    Sam Castillo (USA), Margaret Padilla (Hearne, TX, USA)

09.30 AM – 10.30 AM
THE MOSAIC MODERATED MULTISTAKEHOLDER DEBATE – WHAT SHORT- AND LONG-TERM OUTCOMES TO PREVENT IN NASH

Kathleen Corey (Boston, MA, USA) & Faiez Zannad (Paris, FRA)

  • 09:15 – 09:25
    Panelists

    Amy Articolo (Novo Nordisk, USA), Sam Castillo (USA), Kathleen Corey (Boston, MA, USA), Barton Duell (Portland, OR, USA), Sven Francque (Antwerp, BEL), Michelle Long (Novo Nordisk, USA), Margaret Padilla (Hearne, TX, USA), Ambarish Pandey (Dallas, TX, USA), Sudha Shankar (AstraZeneca, USA), John Sharretts (FDA, USA), Ray Soccio (FDA, USA), Norman Stockbridge (FDA, USA), Aliza Thompson (FDA, USA), Zobair Younossi (Falls Church, VA, USA), Faiez Zannad (Paris, FRA) and guests

Chairpersons : Peter Libby (Boston, MA, USA) & Harriette Van Spall (Hamilton, CAN)

11:00 AM – 01:00 PM

Agenda

  • 11.00 AM – 11.10 AM
    Role of the metabolic milieu for liver and cardiac disease
    Gerry Shulman (New Haven, CT, USA)
  • 11.10 – 11.20 AM
    Role of systemic inflammatory state in cardiac, renal and liver involvement in metabolic syndrome
    Peter Libby (Boston, MA, USA)
  • 11.20 AM – 11.30 AM
    Systemic drivers of pro-fibrogenic state in Metabolic syndrome
    Anna Mae Diehl (Durham, NC, USA)
  • 11.30 AM – 11.40 AM
    Mechanisms of myocardial dysfunction in NAFLD
    Ambarish Pandey (Dallas, TX, USA)
  • 11.40 AM – 11.50 PM
    Regulatory viewpoints
    Norman Stockbridge (FDA, USA), Aliza Thompson (FDA, USA),
  • 11.50 PM – 12.00 PM
    Industry viewpoints
    Carol Addy (Genfit, FRA), Michelle Berrey (Intercept, USA)
  • 12.00 AM – 12.05 AM
    Patient viewpoints
    Henry Chang (Fatty Liver Foundation, USA)

12.05 AM – 01.00 PM
THE MOSAIC MODERATED MULTISTAKEHOLDER DEBATE – NEW DRUGGABLE MOLECULAR BIOTARGETS IN NASH
Chairpersons : Peter Libby (Boston, MA, USA) & Harriette Van Spall (Hamilton, CAN)
  • 11:40 AM – 01.00 PM
    Panelists

    Carol Addy (Genfit, FRA), Michelle Berrey (Intercept, USA), Anna Mae Diehl (Durham, NC, USA), Henry Chang (Fatty Liver Foundation, USA), Peter Libby (Boston, MA, USA), Ambarish Pandey (Dallas, TX, USA), Jennifer Sargent (Nature, USA), John Sharretts (FDA, USA), Gerry Shulman (New Haven, CT, USA), Ray Soccio (FDA, USA), Norman Stockbridge (FDA, USA), Aliza Thompson (FDA, USA), Harriette Van Spall (Hamilton, CAN) and guests

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

02:00 PM – 04:00 PM

Agenda

  • 02.00 PM – 02.10 PM
    Cardiac characterization in NAFLD trials
    Faiez Zannad (Paris, FRA)
  • 02.10 PM – 02.20 PM
    Renal disease characterization in NAFLD trials
    Javed Butler (Dallas, TX, USA)
  • 02.20 PM – 02.30 PM
    NAFLD characterization in cardiovascular trials
    Manal Abdelmalek (Rochester, MN, USA)
  • 02.30 PM – 02.40 PM
    Regulatory viewpoints
    Norman Stockbridge (FDA, USA), Aliza Thompson (FDA, USA)
  • 02.40 PM – 02.45 PM
    Industry viewpoints
    Christian Marsolais (Theratechnologies Inc., USA)
  • 02.45 PM – 02.50 PM
    Patient viewpoints
    Henry Chang (Fatty Liver Foundation, USA)

02.50 PM – 04.00 PM

THE MOSAIC MODERATED MULTISTAKEHOLDER DEBATE – PATIENTS ELIGIBLE IN NASH TRIALS, CLINICAL CHARACTERISATION BEYOND LIVER CRITERIA

Chairpersons : Manal Abdelmalek (Rochester, MN, USA) & Javed Butler (Dallas, TX, USA)
  • Panelists

    Manal Abdelmalek (Rochester, MN, USA), Javed Butler (Dallas, TX, USA), Henry Chang (Fatty Liver Foundation, USA), Christian Marsolais (Theratechnologies Inc., USA), Ray Soccio (FDA, USA), Norman Stockbridge (FDA, USA), Aliza Thompson (FDA, USA), Faiez Zannad (Paris, FRA) and guests

Chairpersons: Vlad Ratziu (Paris, FRA) & Harriette Van Spall (Hamilton, CAN)

04:30 PM – 06:30 PM

Agenda

  • 04.30 PM – 04.40 PM
    Cardiac endpoints in NAFLD outcome trials
    Faiez Zannad (Paris, FRA)
  • 04.40 PM – 04.50 PM
    Potential renal endpoints in NAFLD outcome trials
    Faiez Zannad (Paris, FRA)
  • 04.50 PM – 05.00 PM
    Liver endpoints in cardio-renal trials
    Vlad Ratziu (Paris, FRA)
  • 05.00 PM – 05.10 PM
    Use of hierarchical endpoints
    Janet Wittes (Wittes LLC, USA)
  • 05.10 PM – 05.20 PM
    Regulatory viewpoints
    Norman Stockbridge (FDA, USA), Aliza Thompson (FDA, USA)
  • 05.20 PM – 05.30 PM
    Industry viewpoints
    Jerry Colca (Cirius, USA), Rebecca Taub (Madrigal, USA)

05.30 PM – 06.30 PM
THE MOSAIC MODERATED MULTISTAKEHOLDER DEBATE – HOW TO PROGRESS BEYOND LIVER ENDPOINTS?
Chairpersons: Vlad Ratziu (Paris, FRA) & Harriette Van Spall (Hamilton, CAN)
  • Panelists

    Jerry Colca (Cirius, USA), Vlad Ratziu (Paris, FRA), Ray Soccio (FDA, USA), Norman Stockbridge (FDA, USA), Rebecca Taub (Madrigal, USA), Aliza Thompson (FDA, USA), Joe Toerner (FDA, USA), Harriette Van Spall (Hamilton, CAN), Janet Wittes (Wittes LLC, USA), Faiez Zannad (Paris, FRA) and guests

Tuesday 6 December 2022

08:00 AM - 07:00 PM

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

08:00 AM – 10:30 AM

Agenda

  • Design and statistical innovations
    • 08.00 AM – 08.10 AM
      Seamless design, pragmatic trials, and how they can help?
      Janet Wittes (Wittes LLC, USA)
    • 08.10 AM – 08.20 AM
      How to tackle intercurrent events? Estimands in Clinical Trials
      Nicolas Girerd (Nancy, FRA)
    • 08.20 AM – 08.30 AM
      Benefit:risk evaluation using a Desirability of Outcome Ranking (DOOR) endpoint
      Scott Evans (Washington DC, USA)
  • 08.30 AM – 08.40 AM
    Best practices to keep patients in the long term outcome trials
    Sophie Jeannin (Summit Clinical Research, USA)
  • 08.40 AM – 08.50 AM
    Minorities in CVD, CKD and NASH trials
    Harriette Van Spall (Hamilton, CAN)
  • 08.50 AM – 09.10 AM
    How to synergize and bridge multiple discipline investigators
    Claudia Filozof (LabCorp, USA), Marcus Hompesch (Prosciento, USA)
  • 09.10 AM – 09.20 AM
    Regulatory viewpoints
    Norman Stockbridge (FDA, USA), Aliza Thompson (FDA, USA)
  • 09.20 AM – 09.30 AM
    Markers of cardiometabolic health in patients with NASH are improved in most recent clinical results
    Michael Cooreman (Inventiva, FRA)
  • 09.30 AM – 09.35 AM
    Industry viewpoints
    Roberto Calle (Regeneron, USA)
  • 09.35 AM – 09.40 AM
    Patient viewpoints
    Jennifer Berg (USA)

09.40 AM – 10.30 AM
THE MOSAIC MODERATED MULTISTAKEHOLDER DEBATE – DESIGN AND EXECUTION ISSUES OF NASH OUTCOME TRIALS
Chairpersons: Scott Evans (Washington DC, USA) & Veronica Miller (Berkeley, CA, USA)
  • Panelists

    Jennifer Berg (USA), Roberto Calle (Regeneron, USA), Michael Cooreman (Inventiva, FRA), Scott Evans (Washington DC, USA) , Claudia Filozof (LabCorp, USA), Nicolas Girerd (Nancy, FRA), Marcus Hompesch (Prosciento, USA), Sophie Jeannin (Summit Clinical Research, USA), Veronica Miller (Berkeley, CA, USA) , Norman Stockbridge (FDA, USA), Aliza Thompson (FDA, USA), Joe Toerner (FDA, USA), Harriette Van Spall (Hamilton, CAN), Janet Wittes (Wittes LLC, USA) and guests

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

11:00 AM – 01:00 PM

Agenda

  • 11.00 AM – 11.10 AM
    Cardiac biomarkers and NITs
    Joao Ferreira (Porto, POR)
  • 11.10 AM – 11.20 AM
    Liver biomarkers and NITs
    Arun Sanyal (Richmond, VA, USA)
  • 11.20 AM – 11.30 AM
    Renal biomarkers and NITs
    Chirag Parikh (Baltimore, MD, USA)
  • 11.30 AM – 11.40 AM
    Regulatory viewpoints
    Norman Stockbridge (FDA, USA), Aliza Thompson (FDA, USA)
  • 11.40 AM – 11.50 AM
    Industry viewpoints
    Karsten Strauss (Olink, SWE), Jessica Williams ( Somalogic, USA)
  • 11.50 AM – 11.55 AM
    Patient viewpoints
    Henry Chang (Fatty Liver Foundation, USA)

11.55 AM – 01.00 PM

THE MOSAIC MODERATED MULTISTAKEHOLDER DEBATE – WHAT SURROGATE BIOMARKERS ARE ACCEPTABLE FOR APPROVAL?

Chairpersons: Stephen Harrisson (San Antonio, TX, USA) & Faiez Zannad (Paris, FRA)
  • Panelists

    Henry Chang (Fatty Liver Foundation, USA), Joao Ferreira (Porto, POR), Stephen Harrisson (San Antonio, TX, USA), Chirag Parikh (Baltimore, MD, USA), Arun Sanyal (Richmond, VA, USA), Norman Stockbridge (FDA, USA), Karsten Strauss (Olink, SWE), Aliza Thompson (FDA, USA), Joe Toerner (FDA, USA), Jessica Williams (Somalogic, USA), Faiez Zannad (Paris, FRA) and guests

Chairpersons: TBD & David Yankelevitz (New York, USA)

02:00 PM  – 04:00 PM

Agenda

  • 02.00 PM – 02.10 PM
    Imaging based assessment of NAFLD
    Scott Reeder (Madison, WI, USA)
  • 02.10 PM – 02.20 PM
    Imaging Methods for Assessment of Co-Morbidities in Metabolic Disease
    Vidhya Kumar (Perspectum, USA)
  • 02.20 PM – 02.30 PM
    Integrated clinical imaging of heart, liver and kidneys.
    Lars Johansson (Antaros, SWE)
  • 02.30 PM – 02.40 PM
    Regulatory perspective
    Norman Stockbridge (FDA, USA), Aliza Thompson (FDA, USA)
  • 02.40 PM – 02.50 PM
    Industry viewpoints
    Kay Pepin (Resoundant, USA), Laurent Sandrin (Echosens, USA)
  • 02.50 PM – 02.55 PM
    Patient viewpoints
    Henry Chang (Fatty Liver Foundation, USA)

02.55 PM – 04.00 PM
THE MOSAIC MODERATED MULTISTAKEHOLDER DEBATE – WHAT IMAGING TESTS ARE ACCEPTABLE FOR APPROVAL?
Chairpersons: TBD & David Yankelevitz (New York, USA)
  • Panelists

    Henry Chang (Fatty Liver Foundation, USA), Lars Johansson (Antaros, SWE), Vidhya Kumar (Perspectum, USA), Kay Pepin (Resoundant, USA), Scott Reeder (Madison, WI, USA), Laurent Sandrin (Echosens, USA), Jennifer Sargent (Nature Medicine, USA), Norman Stockbridge (FDA, USA), Aliza Thompson (FDA, USA), Joe Toerner (FDA, USA), David Yankelevitz (New York, NY, USA) and guests

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

04:30 PM – 07:00 PM

Agenda

  • 04.30 PM – 04.40 PM
    Reviewing the therapeutic landscape for Cardiometabolic disease trials
    Faiez Zannad (Paris, FRA)
  • 04.40 PM – 04.50 PM
    Reviewing the therapeutic landscape for Cardiorenal disease trials
    Faiez Zannad (Paris, FRA)
  • 04.50 PM – 05.00 PM
    Reviewing the therapeutic landscape for obesity
    Filipe Moura (Boston, MA, USA)
  • 05.00 PM – 05.10 PM
    Reviewing the therapeutic landscape in NAFLD
    Stephen Harrison (San Antonio, TX, USA)
  • 05.10 PM – 05.20 PM
    Regulatory viewpoints
    Norman Stockbridge (FDA, USA), Aliza Thompson (FDA, USA)
  • 05.20 PM – 05.25 PM
    Industry viewpoints
    Rami Younes (Boehringer, GER)
  • 05.25 PM – 05.45 PM
    Journal Editor perspective:
    Stuart Spencer (The Lancet, UK), Jane Leopold (NEJM, USA)
  • 05.45 PM – 05.50 PM
    Patient viewpoints
    Jennifer Berg (USA)

05.50 PM – 07.00 PM
THE MOSAIC MODERATED MULTISTAKEHOLDER DEBATE – ARE THE CURRENT TRIALS ADDRESSING THE MULTI-ORGAN MULTI-SYSTEM DIMENSIONS OF NASH ?
Chairpersons: Stephen Harrison (San Antonio, TX, USA) & Faiez Zannad (Paris, FRA)
  • Panelists

    Jennifer Berg (USA), Stephen Harrison (San Antonio, TX, USA), Jane Leopold (NEJM, USA), Filipe Moura (Boston, MA, USA), Ray Soccio (FDA, USA), Stuart Spencer (The Lancet, UK), Norman Stockbridge (FDA, USA), Aliza Thompson (FDA, USA), Joe Toerner (FDA, USA), Rami Younes (Boehringer, GER), Faiez Zannad (Paris, FRA) and guests

THE FUTURE OF MOSAIC CLINICAL TRIALISTS MEETINGS
Chairpersons : Stephen Harrison (San Antonio, TX, USA), Veronica Miller (Berkley, CA, USA), Arun Sanyal (Richmond, VA, USA), Faiez Zannad (Paris, FRA)
  • The MOSAIC group is committed to draft a position paper summarizing the recommendations of the forum.