Arrival to the Embassy of France

By Course Director Professor Patrick Rossignol (Monaco, MON) on behalf of the scientific committee

Moderator: Prabir Roy-Chaudhury (Chapel Hill, USA)

Discussant (5 minutes):

Patient Perspective: Nichole Jefferson (Home Dialyzors United, USA)

Speaker (10 minutes):

• Academic perspective: Jonathan Himmelfarb (Mount Sinai, USA) - Innovative Renal Replacement Approaches

Discussants (5 minutes each):

• ACE/ARB-SGLT-2i-MRA-GLP-1 in ESKD: What are the Right Endpoints?: Ron Gansevoort (Groningen, NED)

• Industry perspective: Len A. Usvya (Fresenius Medical Care, USA) - Implementation of New Therapies in ESKD:  of Patients, Policy, and Payment

• FDA-CDRH: TBD

• FDA-CDER: Aliza Thomson

• NIH: Kevin Abbott

• CMS: Abigail Ryan

Panel discussion with all the above

Moderator: Prabir Roy-Chaudhury (Chapel Hill, USA)

Discussant (5 minutes):

Patient Perspective: Caroline Wilkie (National Kidney Foundation, USA) - Vascular Access is my Lifeline.

Speakers (10 minutes each):

• Academic perspective: Robert Lee (Michigan, USA). Clinical Trial Designs for Vascular Access Trials

Discussants (5 minutes each):

• Academic perspective: Vandana Niyyar(Emory, USA) - Choosing the Right End Point for the Right Device

• Academic perspective: Prabir Roy-Chaudhury (University of North Carolina, USA): Precision Medicine Approaches to Vascular Access Care

• Industry perspective: Andrea Acuna (BD, Phoenix, USA)

• NIDDK: Danny Gossett

• FDA: Gema Gonsalez or designee

• CMS: Abigail Ryan

Panel discussion with all the above

In the lobby of the Maison Française

Moderators:

Lesley Inker (Boston, USA) & Amy Mottl (Chapel Hill, USA)

Discussant (5 minutes):

• Patient perspective: Kerry Willis (National Kidney Fondation)

Speakers (10 minutes each):

• Academic perspective: Lesley Inker (Boston, USA)

• Academic perspective: Tom Greene (Salt Lake City, USA)

Discussants (5 minutes each):

• Academic perspective : Niels Jongs (Groningen, NED)

• Academic perspective: Tim Friede (Göttingen, Germany)

• Industry perspective: Dustin Little (Astra Zeneca)

• Industry perspective: Julie Funch Furberg (Novo Nordisk)

Discussion between NIDDK, FDA, EMA, Patient and Payer perspectives

In the lobby of the Maison Française

Moderators: Meg Jardine (Sydney, AUS)& Christoph Wanner (Würzburg, GER)

Treatment exposure in routine care is routinely less than that in the trials supporting indications. Should we, and how would we, create incentives to generate evidence on uptake and adherence? How does implementation research supports patients in getting access to new treatments

Discussant (5 minutes):

Patient Perspective: Steven Macari (Naintré, FRA)

Speaker (10 minutes):

• Academic perspective: Sylvia Rosas (Boston, US)

Discussants (5 minutes each):

• Academic perspective: Janani Rangaswami (Washington DC, USA)

• Academic perspective: Grant Huang (Washington D.C.)

• Academic perspective: Meg Jardine (Sydney, AUS)

• Academic funder perspective: William Lawrence (PCORI)

• Academic perspective: Alain Romero (San Francisco, USA)

• Industry perspective: Katja Rohwedder (Bayer)

• Industry perspective: Juliane Meyerhoff (Boehringer-Ingelheim)

Panel discussion with all the above

Moderator: Adeera Levin (Vancouver, CAN) & Professor Patrick Rossignol (Monaco, MON)

Several therapies are at the horizon to further improve kidney function and cv outcomes  such as new MRAs, aldosterone synthase inhibitor , soluble gyuanylate cyclase activators/stimulators, endothelin antagonists: how to use these therapies in practice? All together or personalized care ? Designing trials for the current era (multiple agents/ multiple actions) which trials are warranted to get this demonstrated ?

Discussant (5 minutes):

Patient Perspective: Patrick Gee (Richmond, USA)

Speakers (10 minutes each):

• Academic perspective: Meg Jardine (Syndey, AUS)

• Academic perspective: Hiddo Heerspink Lambers (Groningen, NED)

Discussants (5 minutes each):

• Academic perspective: Christoph Wanner (Würzburg, GER)

• Academic perspective: Luis Ruilope (Madrid, ESP)

• Academic perspective: Sradha Kotwal (Sydney, AUS)

• Academic perspective: Christopher Wilcox (Washington D.C., USA)

• Industry perspective: Dustin Little (AstraZeneca, USA)

• Industry perspective: Katja Rohwedder (Bayer, Germany)

• Industry perspective: Michaela Petrini (Boehringer-Ingelheim)

• NIDDK: Ivonne Schulman

• FDA: TBD

• CMS: TBD

Panel discussion with all the above

In the lobby of the Maison Française

Moderators: Christoph Wanner (Würzburg, GER) & Luis Ruilope (Madrid, ESP)

Speakers (10 minutes each):

• Academic perspective: Beatriz Fernandez-Fernandez (Madrid, Spain)

• BP management setting: Felix Mahfoud (Hombourg, GER)

Discussants (5 minutes each):

• Academic perspective: Navdeep Tangri (University of Manitoba, CAN)

• AKI perspective: Jay Koyner (Chicago, USA)

• CRO perspective: Barbara Gillespie (Fortrea, USA)

• Academic perspective: Marc Froissart (Lausanne, SUI)

• Industry perspective: Martin Cowie (Astra-Zeneca) 

• Industry perspective: Len A. Usvyat

• NIDDK: Ivonne Schulman

• FDA: TBD

• CMS: TBD

Panel discussion with all the above

In the lobby of la Maison Française

In the Lobby of la Maison Française

Moderators: Dana Fuhrman (Pittsburgh, USA), Ravindra Mehta (San Diego, USA) & Matthieu Legrand (San Francisco, USA)

Speaker (15 minutes):

• Academic perspective: Giovanni Landoni (Milan, Italy)

Discussants (5 minutes each):

• Academic perspective: Alexander Zarbock (Münster, Germany)

• Academic perspective: Andrew Shaw (Cleveland, USA)

• Academic perspective: Marlies Osterman (London, UK)

• Industry perspective: Juliane Bernholz (AM-Pharma, NED)

• Industry perspective: Kai Riecke (Bayer, GER)

• Industry perspective: Michael Reusch (Guard Therapeutics, SWE)

• Industry perspective: Robert Lawatscheck (Bayer)

• NIDDK perspective: Debbie Gipson

• Regulator’s perspective: TBD

• Payer’s perspective: TBD

Panel discussion with all of the above

In the lobby of la Maison Française

Moderators: Kianoush Kashani (Rochester, USA) & Kathleeen Liu (San Francisco, USA)

Discussant (5 minutes):

Patient Perspective: D’arcy Duquette (Calgary, CAN)

Speakers (15 minutes each):

• Academic perspective: Sean Bagshaw (Edmonton, CAN)

Discussants (5 minutes each):

• Academic perspective: Ravindra Mehta (San Diego, USA)

• Academic perspective: Dana Fuhrman (Pittsburg, USA)

• Academic perspective: Jay Koyner (Chicago, USA)

• Industry perspective: Robert Lawatscheck (Bayer)

• NIDDK perspective: Debbie Gipson

• CMS perspective: Abigail Ryan

• Regulator’s perspective: TBD

• Payer’s perspective: TBD

Panel discussion with all of the above

Moderators: Adeera Levin (Vancouver, CAN) & Christoph Wanner (Würzburg, GER)

Speakers (10 minutes each):

• Platform Trial: Sradha Kotwal (Sydney, AUS)

• Academic perspective: Meg Jardine (Sydney, AUS)

Discussants (5 minutes each):

• Academic perspective: Vlado Perkovic (Sydney, AUS)

• Academic perspective: Brad Rovin (Colombus, USA)

• How industry and academia are working together in platform trials: Heather Ascani (Michigan, USA)

• Academic perspective: Hiddo Heerspink (Groningen, NED)

• Insights from Covid platform trials: Yves Rosenberg (NHLBI, USA)

• Feedback on the Solidarity WHO sponsored platform trial : perspective from an academic CRO: Marc Froissart (Lausanne, SUI)

•  AKI (TBD)

•  Oncology trials : Lisa McShane (Rockville, USA)

• Academic funder perspective: William Lawrence (PCORI)

• Industry perspective: Martin Cowie (Astra-Zeneca)

• Industry perspective: Meike Brinker (Bayer)

• NIDDK perspective: Ivonne Schlumann

• Regulator’s perspective: TBD

• Payer’s perspective: TBD

Panel discussion with all of the above

In the lobby of la Maison Française

Moderators: Hiddo Heerspink Lambers (Groningen, NED) & Vlado Perkovic (Sydney, AUS)

Downstream FLOW, are GLP-1 RA alone sufficient or do we need more to further improve outcomes ? New nutrient stimulating hormone therapies may include dual GIP and GLP-1 receptor agonist (e.g tirzepatide), Glucagon/GLP-1RA,  Glucagon-GIP/GLP-1 RA: which trial design is warranted ? Regarding endpoints, how best assessing effects on kidney disease progression in the setting of substantial weight loss ?

Speakers (10 minutes each):

• Investigator’s perspective: Peter Rossing (Copenhagen, DEN)

• Academic perspective: Matt Weir (Baltimore, USA)

Discussants (5 minutes each):

• Academic perspective: Hiddo Lambert Heerspink (Groningen, NED)

• Academic perspective: Amy Mottl (Chapel Hill, USA)

• Industry perspective: Dominik Steubl (Boehringer-Ingelheim)

• Industry perspective: Thomas Idorn (Novo Nordisk, DEN)

• Industry perspective: Ibrahim Turfanda (Eli Lilly, USA)

• Industry perspective: Scott Wasserman (Kalera Therapeutics)

• NIDDK perspective: Ivonne Schlumann

• Regulator’s perspective: TBD

• Payer’s perspective: TBD

Panel discussion with all of the above

Final words by Professor Patrick Rossignol and co-directors, and adjourn