1. Program Subject to Change Updated 5/19/2016
Kidney Health Initiative
Fourth Annual Stakeholders Meeting
May 25-26, 2016
DoubleTree by Hilton Hotel
Silver Spring, Maryland
“Collaborating to Develop Innovative Tools for Success”
Program is Subject to Change
Wednesday, May 25
4:30 PM - Registration Opens
5:30 PM
5:30 PM – Welcome
6:45 PM Patrick Archdeacon, MD (FDA)
Prabir Roy-Chaudhury, MD, PhD, FASN (ASN)
KHI Co-Chairs
KHI Vision, Mission and Process: Assessing our Impact
Ronald Falk, MD, FASN, KHI Board of Directors member
Panel Discussion:
Ronald Falk, MD, FASN (ASN)
Reshma Kewalramani, MD, FASN (Amgen)
Alan Kliger, MD (RPA)
Paul T. Conway (AAKP)
Members of the FDA
7:00 PM – Dinner Buffet
8:00 PM
8:00 PM – Networking Dessert and Coffee Reception
8:30 PM
Thursday, May 26
7:45 AM – New Member Orientation: KHI Project Submission Process and Portal, Hands-on Tutorial
8:15 AM Melissa West and Ryan Murray, KHI Staff
7:45 AM Continental Breakfast
8:15 AM Welcome and Introductions
Patrick Archdeacon, MD (FDA)
8:30 AM – From Vision to Initiative: Examples of Building Broad Research Agendas
9:00 AM Robbie Barbero, PhD
Assistant Director for Biological Innovation
White House Office of Science and Technology Policy

2. Program Subject to Change Updated 5/19/2016
9:00 AM – Breakout #1: Kidney Health Initiative Project Pipeline (4 concurrent rooms)
9:30AM Opportunity for KHI members to present and discuss their project proposals*
1. Evaluating Patient Preferences for Implantable, Wearable and Portable Renal
Replacement Devices
2. Clinical Trial Endpoints for Cardiovascular Interventions in Advanced CKD
3. Guidelines for the Development of Innovations in Vascular Access Care
4. Fostering Development for Fluid Management in Kidney Disease Patients
9:30 AM - Break/ Room Change
9:45AM
9:45 AM- Breakout #2: Kidney Health Initiative Project Pipeline (4 concurrent rooms)
10:15 AM Opportunity for KHI members to present and discuss their project proposals*
1. Development of a Roadmap for Innovations in Renal Replacement Therapy (RRT)
2. Understanding and Overcoming the Exclusion of Patients with Kidney Disease from
Cardiovascular Trials
3. Developing and Coordinating Best Practices for Systematic Banking of Biosamples for
Personalized Kidney Medicine
10:15 AM Coffee Break
10:45 AM
10:45 AM – Patient and Care Partner Engagement: Gaining Wisdom through Collaboration
12:00 AM Moderators:
Celeste Castillo Lee, KHI Patient and Family Partnership Chair (PFPC) and KHI Board of
Directors Member
Richard Fissell, PFPC and Program Committee Member
We Are Better Together: KHI Patient and Family Partnership Council
Celeste Castillo Lee, KHI PFPC Chair and KHI Board of Directors Member
The Intersection between Patient Engagement and Drug Development: Sharing New
Knowledge
Hank Hoang, PharmD
Pharmacist, Professional Affairs and Stakeholder Engagement, FDA’s Center for Drug
Evaluation Research (CDER)
Redesigning Patient Programs: Lessons Learned from the National Kidney Foundation
Jennifer Martin
Vice President of Constituent Services, National Kidney Foundation
Panel Discussion
12:00 M – Lunch
12:45 PM

3. Program Subject to Change Updated 5/19/2016
12:45 AM - Clinical Trials in Nephrology: Tools to Tackle Recruitment and Retention
2:15 PM Moderators:
Barbara Gillespie, MD, FASN Quintiles Global Clinical Research Organization and KHI
Program Committee Member
James A. Sloand, MD, FASN Baxter Healthcare and KHI Board of Directors Member
Telehealth and Remote Patient Monitoring: A Tool to Advance the Research Agenda
Karen S. Rheuban, MD
Director, Office of Telemedicine, University of Virginia
Lessons Learned from Conducting a Remote Clinical Trial
Craig Lipset
Head of Clinical Innovation, Pfizer
Telehealth: Bringing the Trial to the Patient
Jeanne Hecht, MBA, PMP, Senior Vice President, Site & Patient Networks, Quintiles
Panel Discussion
2:15PM Closing Remarks
2:30 PM Patrick Archdeacon, MD and Prabir Roy-Chaudhury, MD, PhD, FASN, KHI Co-Chairs