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: Ven Manda (President, Mozarc) - Creating and Innovation Substrate for Novel Dialytic Therapies

• Industry perspective: : Rob Kossman (Fresenius Medical Care, USA) - Implementation of New Therapies in ESKD:  of Patients, Policy, and Payment

• Industry perspective: Peter Friedman (Hemotech, USA)

• FDA-CDRH: Gema Gonzalez

• 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)

• Industry perspective: Anna Szafranski (Medtronic, Minneapolis St Paul, USA)

• Industry perspective: Mahesh Krishnan (Davita, Washington DC) - Implementation of Vascular Access Innovation into Dialysis Care Pathways

• 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)

Speakers (10 minutes each):

• Academic perspective: Lesley Inker (Boston, USA)

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

Discussants (5 minutes each):

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

• Academic perspective: Tim Friede (Göttingen, Germany)

• Patient perspective: Kerry Willis (National Kidney Fondation)

• 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: Harv Feldman (PCORI)

• Industry perspective: Sarah Hamlett (CSL Vifor USA)

• Industry perspective: Sibylle Hauske (Boehringer-Ingelheim)

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

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)

• Industry perspective: Dustin Little (AstraZeneca, USA)

• Industry perspective: Katja Rohwedder (Bayer, Germany)

• Industry perspective: Sibylle Hauske (Boehringer-Ingelheim)

• NIDDK: Ivonne Schulman

• FDA: TBD

• CMS: TBD

Panel discussion with all the above

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

Discussant (5 minutes):

• Patient Perspective: Glenda Roberts (Mt. Sinai, USA) - Who Should we Test These Novel Therapies On?

Speakers (10 minutes each):

• Joseph Bonventre (Harvard, USA) - Kidney Regenerative Approaches

• Vineeta Kumar (University of Alabama, USA) - Clinical Trial Design for Xenotransplantation

Discussants (5 minutes each):

• Academic perspective: Mark Lim (Washington, USA)

• Industry perspective: Martine Rothblatt, President and CEO United Therapeutics (Silver Spring, Maryland)

• Industry perspective: Matt Tector, CSO, Makana Therapeutics

• NIDDK: Eric Brunskill, Program Officer

• FDA: Celia Witten, Deputy Director, CBER

• Bioethics of Xenotransplantation: Robyn Shapiro, Health Sciences Law Group

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)

• 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: TBD

• 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: Harv Feldman (PCORI)

• Industry perspective: Martin Cowie (Astra-Zeneca)

• 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: Patrick Archdeacon (FDA, USA)

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

• Industry perspective: Dominik Steubl (Boehringer-Ingelheim)

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

• Industry perspective: Nadia Ahmad (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