U.S. Department of Health and Human Services

Glomerular Disease: Pathophysiology, Biomarkers, and Registries for Facilitating Translational Research

4/17/2012 7:00 AM
4/18/2012 7:00 AM
 
No
Bethesda
 
Natcher Conference Center

Event Details

​ Meeting Objective:

  • Discuss mechanisms that initiate and drive progression of glomerular diseases to End Stage Kidney Disease.
  • Explore Targets and Pathways to therapeutic development for each glomerular disease.
  • Assess existing biomarkers that define the diagnosis, initiation, progression, and/or relapse of glomerular disease.
  • Discuss approaches to cooperation among industry, academia, government, and non-nephrology researchers who deal with other organ systems.

Agenda

Tuesday, April 17, 2012

7:00 - 8:00 a.m. Registration
8:00 - 8:15 a.m.

Introdu​ction: Dr. Griffin Rodgers Dr. Robert Star and Dr. Michael Flessner

Opening Remarks and Objectives: Dr. Robert Star and Dr. Michael Flessner
8:00 - 8:15 a.m. Introduction: Dr. Gregory Germino, Deputy Director, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Opening Remarks and Objectives

Dr. Robert Star, Director, Division of Kidney, Urologic, and Hematologic Diseases, and
Dr. Michael Flessner, NIDDK
8:15 - 9:15 a.m. State of the Art Lectures (20 minutes each followed by 10 minute discussion)

Moderator: Dr. Charles Alpers, University of Washington
  • Challenges in Therapy Development for Rare Diseases: Cystic Fibrosis - Dr. Frank Accurso, Children's Hospital Colorado
  • Lessons from lupus rrials/network - Dr. Neil Solomons, Vifor Pharma
  • Glomerular Disease: Recent Travels and the Road Ahead - Dr. William Couser, University of Washington
9:15 - 9:45 a.m. Break
9:45 a.m. - 12:00 p.m.

Disease-Specific Pathophysiologic Mechanisms and Translational Tools (to answer the question: Where are we? with emphasis on therapeutic targets and Potential diagnostic, prognostic, and alternative outcome biomarkers/diagnostic tests)
(15 minutes each followed by 10 minute discussion)

Moderator: Dr. Roger Wiggins, University of Michigan
  • Minimal change/FSGS: Genetics of Primary Podocytopathies - Dr. Friedhelm Hildebrandt, University of Michigan
  • Minimal change/FSGS: Mechanisms and Biomarkers for Primary Podocytopathies - Dr. Jochen Reiser, University of Miami
  • Membranous - Dr. David Salant, Boston University
  • IgA Nephropathy - Dr. Jan Novak, University of Alabama
  • Vasculitis - Dr. Ron Falk, University of North Carolina
  • C3 Glomerular Disease - Dr. Terry Cook, Imperial College
12:00 - 1:00 p.m.

Lunch (bag lunch in breakout rooms)

1:00 - 3:00 p.m. Outcomes for Translational and Clinical Research: Patient Reported Outcomes (PROs), Biomarkers, Role of Registry (15 minutes each followed by 5 minute discussion)

Moderator: Dr. Michael Flessner, NIDDK
  • Clinical Trial Outcome Assessments (symptoms = patient reported outcomes, particularly in pediatrics) in glomerular diseases - Dr. Elektra Papadopoulos, U.S. Food and Drug Administration (FDA)
  • Use of Data Standards and Disease Models in PKD. Why do this prospectively? - Dr. Ron Perrone, Tufts University
  • Qualification of diagnostic or severity/stratification biomarkers - Dr. Courtney Lias, FDA
  • Possible bases of approval for progression or relapse of glomerular diseases - Dr. Aliza Thompson, FDA
  • CKD Biomarker Consortium: Sample requirements for discovery and reproducibility of renal biomarkers - Dr. Jennifer Van Eyk, The Johns Hopkins University
  • Pros, Cons, Pitfalls of a Biological Repository - Dr. Elizabeth Wagner, National Heart, Lung, and Blood Institute
3:00 - 3:15 p.m. Break
3:15 - 5:00 p.m.

Breakout sessions : These will begin on Day 1 and carry forward to Day 2.

Topics for individual breakout sessions :

  1. Minimal Change/FSGS - Dr. Bill Smoyer, Nationwide Children�s Hospital, and Dr. Jochen Reiser, University of Miami
  2. Membranous - Dr. David Salant, Boston University, Dr. Fernando Fervenza, Mayo Clinic, and Dr. Daniel Cattran, University of Toronto
  3. IgA Nephropathy - Dr. Heather Reich, University of Toronto, and Dr. Jan Novak, University of Alabama
  4. Vasculitis - Dr. Peter Merkel, University of Pennsylvania
  5. C3 Glomerular Disease - Dr. Terry Cook, Imperial College, and Dr. Gerry Appel, Columbia University
  6. Cross-Cutting Data standards and alternative outcome biomarkers (proteinuria, podocyte products, quantitative pathology, functional data, etc?) needed by all glomerular diseases? - Dr. Larry Holzman, University of Pennsylvania, Dr. Roger Wiggins, University of Michigan, and Dr. Agnes Fogo, Vanderbilt University

Goals for breakout groups:

  1. Establish targets for future research in each disease.
  2. Provide specific suggestions on moving the field forward.

Discussion questions for breakout groups :

  1. What are the key questions to be answered for this disease? Can we define the critically important next steps?
  2. Can we use mechanistic knowledge of the disease to identify specific biological targets? Are there biomarkers for diagnosis, onset, severity, progression, or relapse of the disease?
  3. What steps are needed to qualify specific biomarkers for specific purposes?
  4. What cross-cutting tools are needed across all of these diseases (data standards, common alternative outcome biomarkers, partnerships, etc.)?
  5. What is needed in a disease registry to facilitate therapeutic development? Can this be obtained using existing clinical EHRs (HMOs, VA, and large health care consortia)?
  6. How does the nephrology community partner with industry, advocacy groups, and government?
5:00 - 6:00 p.m. Preliminary Reports from the Breakout Sessions and General Discussion
6:00 p.m. ADJOURN - Day 1

Wednesday, April 18, 2012

7:00 - 8:00 a.m. Registration
8:00 - 10:00 a.m. Perspective From Industry: Drug Development for Glomerular Diseases

Moderator: Paul Kimmel, NIDDK

Suggested participants :
Dr. Frank Dieterle, Novartis
Dr. Paul Brunetta, MD Genentech: Phase III Planning for Novel Therapies in Autoimmune Glomerulonephritis - An Industry Perspective
Dr. Loghman-Adham and Dr. Scheiflinger: An Anti-Macrophage Migration Inhibitory Factor Antibody for Treatment of Lupus Nephritis
Dr. Matt Breyer, Lilly
Dr. Tom Daniels, Celgene
Dr. Tracy McGowan J and J, Centocor
Dr. Maria Bobadilla, Roche
Dr. Glenn Reinhart, Boehringer-Ingelheim (may send substitute)
Dr. Yuuichi Tomura, Astellas
Dr. Camille Bedrosian, Alexion
Dr. Alan Cohen, Interimmune
Dr. Dennis Andress, Abbott
Dr. Steve Ledbetter, Genzyme

Industry Panel Discussion - Panel of Speakers and Moderator (30 minutes)
10:00 - 10:30 a.m. Break
10:30 - 12:30 p.m.

Registry/Collaboration Roundtable: What have we learned from other diseases and existing glomerular disease registries? What are the critical issues?
(10 minutes each followed by 5 minute discussion)

Moderator: Dr. William Schnaper, Northwestern University

  • Office of Rare Diseases, NIH - Dr. Stephen Groft
  • Public-Private Partnerships/Collaborative Opportunities/An NIH View - Dr. Barbara Mittleman
  • UNC Glomerular Disease Collaborative Network - Dr. Patrick Nachman, University of North Carolina
  • Toronto Glomerulonephritis Registry Group - Dr. Dan Cattran, University of Toronto
  • Lessons from NEPTUNE/biopsy registries/recruitment challenges - Dr. Matthias Kretzler, University of Michigan
  • European Registry for Glomerular Diseases - Dr. Charles Pusey, Imperial College
  • Nephcure - Dr. Larry Holzman, University of Pennsylvania
  • Would a consortium of clinical EHRs (such as the proposed HMO-collaboration in the "Health Care Systems Collaboratory") coupled with "cloud computing" have more utility than registries? - Dr. John Sedor, Case Western University
12:30 - 3:00 p.m.

Breakout Sessions (Lunch in Breakout sessions)

Topics for individual breakout sessions : sam​e as Day 1
3:00 - 4:30 p.m. Reports from the Breakout Sessions: Discussion and Next Steps
4:30 - 5:00 p.m. Summary -Dr. Robert Star and Dr. Michael Flessner, NIDDK
5:00 p.m. ADJOURNMENT

Directions/Travel

Meeting Location:

Natcher Conference Center
NIH Campus
45 Center Drive
Bethesda, MD 20892 

NIH Visitor Information

The Natcher Conference Center is located on the NIH Campus in building 45.For a map, general information, and directions to and around the NIH Campus, visit http://parking.nih.gov/visitor_access_map.htm

NIH Security

The NIH, like all federal government facilities, has instituted security measures to ensure the safety of NIH employees, patients, and visitors.The national threat advisory level, determined by the Department of Homeland Security ( http://www.whitehouse.gov/homeland /), currently is yellow (elevated). 

Perimeter Security

All visitor vehicles, including taxicabs, hotel and airport shuttles, delivery trucks, and vans will be inspected before being allowed on campus.Visitors will be asked to show one (1) form of identification (a government-issued photo ID: drive's license, passport, green card, etc.) and to state the purpose of their visit. Be sure to allow at least 15-20 minutes for this vehicle inspection procedure. 

Building Security

Due to the checking of IDs at the perimeter, employees and visitors will not be required to show their ID again to gain access to the majority of buildings on the NIH Campus during the normal business day.
 

Employees and visitors should continue to wear their identification prominently at all times while on campus.Guards will remain at certain buildings to address specific program requirements, such as sensitive research and safety concerns.At building entrances where guards are posted:

  • Employees must show a DHHS-issued photo ID (for example, your NIH-issued ID badge).
  • Visitors may be required to log-in, wear a visitor's pass, and be escorted by an employee through the building.
  • Visitors may be required to pass through a metal detector and have bags, backpacks, or purses inspected or x-rayed as they enter buildings.
  • Security staff will confiscate any suspicious or potentially dangerous materials. U.S. code prohibits bringing any dangerous weapons onto federal property, including anything with a blade longer than 21/2 inches. Meeting participants may want to leave extra bags or personal materials at their hotel to minimize the time needed for inspection.

Weekday Pedestrian Campus Access

All visitors must enter through the NIH Gateway Center at Metro or the West Gateway Center (see the Visitor Map at http://parking.nih.gov/visitor_access_map.htm ).
  • Gateway Center
    Wisconsin Avenue at Gateway Drive (near the Metro)
    Open 24 hours, 7 days per week
  • West Gateway Center
    Near Old Georgetown Road and South Drive
    Open 6 a.m. - 12 p.m., Monday-Friday

Driving Directions to NIH

From Points North and East:
Take I-95 South to I-495 West (Capital Beltway) toward Silver Spring. Follow I-495 West for 9 miles to Exit 34 (Bethesda/Wisconsin Avenue). Follow signs for Route 355 South and stay in the right lane. Travel approximately 1 mile and turn right at the light onto South Drive. Pass through NIH security and follow the signs to Building 45.
 

From Points North and West:
Take I-270 South to I-495 East (Capital Beltway) toward Washington, DC. Stay in one of the three left lanes. Follow signs for Route 355 South, a left-lane exit, onto Wisconsin Avenue. Travel approximately 1 mile and turn right at the light onto South Drive. Pass through NIH security and follow the signs to Building 45.

From Points South:
Take I-95 North to I-495 (Capital Beltway) toward Tyson's Corner/Rockville. Follow I-495 for 20 miles. Take Exit 34 (Bethesda/Wisconsin Avenue). Travel approximately 1 mile and turn right at the light onto South Drive. Pass through NIH security and follow the signs to Building 45.

From Baltimore/Washington International Thurgood Marshall Airport (BWI):
Take the Route 195 connector to I-95 South. Take I-95 South to I-495 West (Capital Beltway) toward Silver Spring. Follow I-495 West for 9 miles to Exit 34 (Bethesda/Wisconsin Avenue). Follow signs for Route 355 South and stay in the right lane. Travel approximately 1 mile and turn right at the light onto South Drive. Pass through NIH security and follow the signs to Building 45.

From Washington Dulles International Airport (IAD):
Take the Dulles Access Road for approximately 13 miles to Exit 18. Move to the right on the Dulles Toll Road (Route 267) and take Exit 18. Stay left on the ramp for Bethesda/Baltimore, and proceed toward Bethesda (I-495). Continue approximately 9 miles on I-495. Stay on I-495 at the I-495/I-270 split (bear right). Take Exit 34 (Wisconsin Avenue South/Route 355) toward Bethesda. Travel approximately
1 mile and turn right at the light onto South Drive. Pass through NIH security and follow the signs to
Building 45.

From Ronald Reagan Washington National Airport (DCA):
Take the George Washington Parkway North for 12 miles to I-495 toward Maryland (Capital Beltway). Take Exit 34 (Bethesda/Wisconsin Avenue). Travel approximately 1 mile and turn right at the light onto South Drive. Pass through NIH security and follow the signs to Building 45.

Parking

Parking on the NIH campus is limited and is $12 per day in the visitor lots. The closest visitor lot is the Gateway Parking Garage (MLP-11) located at the Gateway Drive entrance. From here, it is a 5 minute walk to the building. The NIH Campus shuttle is also an option which runs every 15 minutes.

Hotel Accommodations:

Hyatt Regency Bethesda Hotel
One Bethesda Metro Center
7400 Wisconsin Avenue
Bethesda, MD 20814
Telephone: (301) 657-1234 or (800) 233-1234
Website: http://www.hyattregencybethesda.com

A block of sleeping rooms has been reserved at the Hyatt Regency Bethesda, Bethesda, MD, for out-of-town guests attending the GLOMERULAR DISEASE: PATHOPHYSIOLOGY, BIOMARKERS, AND REGISTRIES FOR FACILITATING TRANSLATIONAL RESEARCH on April 17-18, 2012. The room rate is $224 plus tax per night. You will be responsible for the room cost and your incidental charges upon checkout. To make a hotel reservation, please call the Hyatt Regency Bethesda by March 20, 2012, at (301) 657-1234 or 1 (800) 233-1234, and reference the NIDDK's Glomerular Disease Conference when making your sleeping room reservations. Please be certain that the hotel provides you with a confirmation number. After March 20, 2012, the hotel will accept reservations on a space-available basis at the prevailing hotel rate. When making a reservation, please provide your room and bedding preferences. The hotel will assign specific room types at check-in, based on availability. Please be advised that requests are not guaranteed. Check-in time is at 3:00 p.m., and check-out time is 12:00 noon.

If for any reason you need to cancel your hotel reservation, please do so 48 hours in advance of your check-in date.

Directions to the Hyatt Regency Bethesda

From Points North
From I-95:

Take I-95 South to I-495 (Capital Beltway) West toward Silver Spring. Take Exit 34 (Wisconsin Avenue/Route 355). Follow Route 355 South for approximately 3 miles and the Hyatt Regency Bethesda will be on the right, on the corner of Wisconsin Avenue and Old Georgetown Road.

From I-270: 

Take I-270 South to I-495 (Capital Beltway) East toward Washington, DC. Stay in one of the three left lanes. Follow signs for 355 South, a left-lane exit, onto Wisconsin Avenue. Follow Route 355 South for approximately 3 miles and the Hyatt Regency Bethesda will be on the right, on the corner of Wisconsin Avenue and Old Georgetown Road.

From Points South
Take I-95 North to I-495 (Capital Beltway) toward Tysons Corner/Rockville. Follow I-495 for 20 miles. At the I-495/I-270 split, stay to the right on I-495. Take Exit 34 (Wisconsin Avenue/Route 355). Follow Route 355 South for approximately 3 miles and the Hyatt Regency Bethesda will be on the right, on the corner of Wisconsin Avenue and Old Georgetown Road.

From Baltimore/Washington International Thurgood Marshall Airport (BWI)
Take Route 195 West to Exit 4 (I-95 South). From I-95 take I-495 (Capital Beltway) West toward Silver Spring. Take Exit 34 (Wisconsin Avenue/Route 355). Follow Route 355 South for approximately 3 miles and the Hyatt Regency Bethesda will be on the right, on the corner of Wisconsin Avenue and Old Georgetown Road.

From Washington Dulles International Airport
Take the Dulles Access Road for approximately 13 miles to Exit 18. Move to the right on the Dulles Toll Road (Route 267); get off at Exit 18. Stay to the left on the ramp for Bethesda/Baltimore and proceed toward Bethesda on I-495 (Capital Beltway) for approximately 9 miles. At the I-495/I-270 split, stay to the right on I-495. Take Exit 34 (Wisconsin Avenue/Route 355 South). Follow Route 355 South for approximately 3 miles and the Hyatt Regency Bethesda will be on the right, on the corner of Wisconsin Avenue and Old Georgetown Road.

From Ronald Reagan National Airport
Take the George Washington Parkway North to I-495 (Capital Beltway) and follow the signs to Maryland. At the I-495/I-270 split, stay to the right on I-495. Take Exit 34 (Wisconsin Avenue/Route 355). Follow Route 355 South for approximately 3 miles and the Hyatt Regency Bethesda will be on the right, on the corner of Wisconsin Avenue and Old Georgetown Road.

METRO INFORMATION

The Metro System is clean, reliable, and safe. It operates from 5:30 a.m. to 12:00 midnight Monday through Thursday; 5:00 a.m. to 2:00 a.m. on Fridays; 8:00 a.m. to 2:00 a.m. on Saturdays; and 8:00 a.m. to 12:00 midnight on Sundays. Each passenger must buy a farecard to travel in the system. Guides for purchasing farecards are posted on the vending machines in each station. Each Metro car features a complete color-coded map. Station attendants on duty at each station can provide additional information on request.

From Union Station or downtown Washington (main Metro Lines into the city converge at Metro Center Station and Gallery Place Station), take the Metro Red Line toward Shady Grove or Grosvenor. Exit at the Bethesda Metro Station. The Hyatt is directly above the Bethesda Metro Station.

SHUTTLES

SuperShuttle offers service to most hotels from Ronald Reagan National Airport, Washington Dulles International Airport, and Baltimore/Washington International Thurgood Marshall Airport. The shuttle leaves on an as-needed basis between the hours of 5:30 a.m. and 11:00 p.m. During other times, arrange for a shuttle by calling 800-258-3826 from the airport.

TAXIS

The taxi fare is approximately $45-$55 from Ronald Reagan Washington National Airport, approximately $55-$65 from Washington Dulles International Airport, and approximately $65-$75 from Baltimore/Washington International Thurgood Marshall Airport. Fares may differ during peak travel hours.

MARC TRAINS

From BWI Airport, take the MARC train on the Penn Line to Union Station. Take the Metro Red Line toward Grosvenor or Shady Grove and exit at the Bethesda Metro Station. The hotel is directly above the Bethesda Metro Station.

PARKING INFORMATION

Self-parking at the hotel is $15 per day/overnight. Valet parking is $20 per day/overnight.

Minutes

​Minutes are currently unavailable.

Attendees

​​Attendees are currently unavailable.

Abstracts

​​Abstracts are currently unavailable.

Location

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  • 45 Center Drive, NIH Campus
  • MD 20892
Webinar

Contacts

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