Following decades of no approved therapies for various forms of Nephrotic Syndrome, potentially paradigm-changing therapies are now on the horizon. Increased understanding in disease pathophysiology, regulatory approval evolutions, and breakthroughs within drug development have led to a recent surge in the number of NS clinical trials. The continued success of these potential future therapies now requires unprecedented collaborations of collective stakeholders and champions in this community.
This will be an action-oriented meeting bringing together various senior level stakeholders from government, clinical practice, professional societies, industry, and patients to enhance clinical trial participation.
DRAFT Agenda (subject to change)
7:00-8:00 AM – Check-in and Breakfast
8:00-8:30 AM – Welcome & Opening Remarks (NephCure, KHI, FDA)
8:30 – 10:30 AM – Presentations from Workgroup Co-Leads; Situational Analysis
Facilitator - TBD
Ex-US Inclusion: Drs. Stuart Shankland & Tobias Huber
Consortia/Registries: Drs. Matthias Kretzler & Moin Saleem
Study Overlap: Drs. Barbara Gillespie and Meg Jardine
Clinicians: Drs. James Tumlin & Ron Falk
Pediatric Inclusion: Dr. Debbie Gipson
Pathologists: Drs. Patrick Walker and Laura Barisoni
10:30-11:00 AM – Break
11:00 AM – 1:00 PM – Workgroup Breakout Sessions & Boxed Lunch
1:00 – 1:30 PM – Break
1:30 – 3:30 PM – Report-Outs from Workgroups (from Co-Lead or Other Representative)
3:30 – 4:00 PM – Closing Remarks and Future Plans (Josh Tarnoff)
Key attendees, Drs. Norm Stockbridge and Aliza Thompson of the FDA's Center for Drug Evaluation and Research, will be joined by other leaders in the field and NephCure to launch this meeting and further the work generated from it.
Please respond by September 17 to ensure your participation. There is no cost to attend this meeting.
For questions, please contact Chelsey Fix: CFix@NephCure.org
NephCure Kidney International
Kidney Health Initiative (of The ASN)
Members of the renal pathology community
and representatives from the Division of Cardiovascular and Renal Products of FDA
November 15, 2018
Time 8:00 AM Wardman Park Marriott, Washington, DC 20008
Meeting time: 8 AM - 4 PM EST. For more information, please contact Chelsey Fix: CFix@NephCure.org