U.S. Department of Health and Human Services
overcoming-barriers-acute-kidney-injury_15_910x220.jpg

Overcoming Barriers in Acute Kidney Injury (AKI)

2/10/2015 6:30 PM
2/12/2015 6:30 PM
No
No
Bethesda
 
Natcher Conference Center, Balconies A, B, & C

Event Details

AKI is a common, deadly complication of medical and surgical illnesses, which more frequently affects African Americans, those with diabetes mellitus, the elderly, and those with chronic kidney disease (CKD). Outcomes associated with AKI include progressive diminution of renal function in those with CKD, loss of renal function in those with previously normal renal function, the development and progression of cardiovascular disease, and increased disability and decreased quality of life.

The purpose of the workshop is to facilitate the development and testing of therapies that may have a meaningful impact on clinical outcomes of AKI. This may entail the development of clinically relevant animal models that mimic Phase 2 and 3 clinical trial designs, identification of new druggable cellular and molecular targets, new pharmacological screening methodologies, and advances in clinical trials in the field. As in the past, industry participation in the workshop will be encouraged. This multidisciplinary meeting will bring together basic and clinical scientists to propose (a) pilot and feasibility projects on the development of clinically relevant animal models of AKI, and (b) clinical trials designed in specific patient populations to ameliorate short- and long-term outcomes of AKI. The long-term goal is to stimulate research using novel animal models, by developing new therapies and proposing clinically relevant, feasible clinical trials.

This workshop will review present AKI research and make recommendations regarding needed changes. The outcome of this workshop will be a report outlining the gaps in evidence that need to be filled, which will be made available to the research community. Each of the speakers or discussion group leaders will provide a summary of his/her session after the meeting so a formal report may be developed. It is envisioned that the workshop report will provide important new information for AKI research communities—especially for those within the NIDDK mission. 
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Agenda

DRAFT AGENDA

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Pre-

Conference:


Tuesday, February 10, 2015, 7:00–8:30 p.m. at Hyatt Hotel, Bethesda

7:30 p.m. Robert Califf
8:00 p.m. Robert Temple

Day 1:

Wednesday, February 11, 2015 at Building 45 (Natcher) on NIH campus

Registration: 7 A.M. – 8 A.M.
8:00 a.m. Introduction…....…….……………………….......……......…...........……. Robert Star
  How Do We Move the Field Forward?
8:15 a.m. Session 1
  How to Get Beyond Dark Matter—Lessons from Other Fields…Taylor Thompson
 

Is it Possible to Succeed? Lessons from Other Disciplines.
(15 min. presentation, followed by 15 min. discussion)

  1. Lessons Learned from Subtypes in Adult Respiratory Distress Syndrome.............................................................................. Carolyn Caffee
  2. Lessons from Asthma ………………………………………………Geoffrey Chupp
  3. Sepsis: Differences Between Subtypes…………………...………….. John Marshall
9:45 a.m. Break
10:00 a.m. Session 2
 

Design Feasible Phase 2 Proof-of-Concept Study…….…. Moderator: Paul Palevsky

Early Secondary Prevention, Delayed Graft Function; Repair/Recovery; Primary Prevention (20 min. presentation, followed by 15 min. discussion)

  1. "What's Feasible Now?"…..…………………………………....….… Paul Palevsky
  2. How to Design a Bad Translational Research Project………….…….. Frank Harrell
11:10 a.m. Break
11:30 a.m. Breakout Discussion (4 Groups)—Breakout Leaders
 

Breakout Group Issues:

  1. Primary prevention
      Lakhmir Chawla, Mark de Caestecker, James Kaufman, Taylor Thompson
  2. Secondary prevention after insult
      Anupam Agarwal, Tom Greene, Mark Okusa, Paul Palevsky
  3. Hasten recovery
      Joseph Bonventre, Laura Dember, Kathleen Liu
  4. Delayed transplant graft function—Phase 2 trials.
      Linda Fried, Frank Harrell, Samina Khan, Diane McKay

Identify 3–4 feasible designs in humans.

1:30 p.m. Lunch
2:30 p.m. Session 3
 

Build Preclinical Animal Models that Match Phase 2 Proof of Concept
Studies
……………………………………………………..... Moderator: Lakhmir Chawla
                       (15 min. presentation, followed by 15 min. discussion)

"Animal Models and Drug Development – Where Have We Gone
Wrong and How Can We Fix Things?" …………………………..…......… Steve Perrin

3:00 p.m. Break
3:15 p.m. Breakout Discussion (4 Groups)—Breakout Leaders
 

Breakout Group Issues:

  1. Primary prevention
  2. Secondary prevention after insult
  3. Hasten recovery
  4. Delayed transplant graft function—Phase 2 trials.

How to replicate: pick 3–4 Proof of Concept designs in animals, based on human subject considerations.

5:30 p.m. Adjourn (Day 1)

Day 2:

Thursday, February 12, 2015 at Building 45 (Natcher) on NIH campus

7:30 a.m. Session 4
 

How to Prove that Animal Models Reproduce Human Situations, and Vice Versa

……….…………………….……….…………………….…………Moderator: Kathleen Liu

(20 min. presentation, followed by 10 min. discussion)

  1. How to Detect Staging/Severity/Mechanistic Pathways….……..…Robert Gerszten
  2. What Can We Learn from Special Cases (Cisplatin, Aminoglycosides) that May
    Not Be Amenable to Industry Phase 2 studies………….…………..... Frank Sistare
8:30 a.m. ​(15 min. presentation, followed by 10 min. discussion)
  1. Lessons from Oncology: Tissue is the Issue!……………………………...… Kimryn Rathmell
  2. Can We Use the Kidney Biopsy as a Research Tool?
    Practical and Ethical Aspects, Challenges, and Barriers……......… William Whittier
9:20 a.m. Break
9:35 a.m. Industry panel:​ Issues in Drug Development (1 hour, incl. Questions & Answers)
.......................................................................................Moderator: Paul Kimmel
Jacques Arend, Samina Khan, Frank Sistare, Steven Textor, Anna Zuk 
10:35 a.m. Breakout Group: Finalize recommendations regarding preclinical & clinical studies.
12:30 p.m.
Lunch

1:15 p.m.

Session 5: Full circle—Building a pipeline...... Moderators: Paul Kimmel/Robert Star

Reports from Breakout Groups (20 min. presentation, followed by 10 min. discussion for each group)

3:15 p.m. Break

3:30 p.m.

Session 6: Moderator: Ben Humphreys

Panel Discussion: What did we learn at this workshop? What are the challenges? What are the opportunities?
     Joseph Bonventre, Kathleen Liu, Mark Okusa, Paul Palevsky, Aliza Thompson

Patients, Animal Models, Linkages, Small Phase Zero Studies, Small Proof of Mechanism Studies

4:30 p.m. Putting it all together …….………………………………….… Taylor Thompson and Robert Star
5:30 p.m. Adjourn
   

Directions/Travel

​​​​MEETING LOCATION
Natcher Conference Center, Balconies A, B, & C
Building 45, National Institutes of Health
45 Center Drive
Bethesda, MD  20892

HOTEL ACCOMMODATIONS 

Hyatt Regency Bethesda Hotel
One Bethesda Metro Center
7400 Wisconsin Avenue
Bethesda, MD  20814 
Telephone: (301) 657-1234 or (888) 421-1442
Fax: (301) 657-6453

Website: http://www.hyattregencybethesda.com
(More hotel information can be obtained from this website.)
 
Sleeping Room Rate: $177 per night, plus 13% tax (or prevailing government rate)
Check-In Time: 3:00 p.m.
Check-Out Time: 12:00 p.m.
Parking: The current cost for daily parking in the hotel garage is $20 per day. These rates are subject to change.

A limited number of sleeping rooms for conference participants have been reserved at the Hyatt Regency Bethesda Hotel. To reserve a hotel room at the group rate, call Reservations at (888) 421-1442 and identify yourself as a member of the AKI Outcomes Workshop, or book online at https://resweb.passkey.com/go/AKIO. THE ROOM BLOCK WILL BE IN EFFECT AT THE GOVERNMENT RATE ONLY UNTIL TUESDAY, JANUARY 20, 2015, OR UNTIL FULL, WHICHEVER COMES FIRST. ANY ROOM RESERVATIONS RECEIVED AFTER THIS DATE WILL BE ACCEPTED ON A SPACE- AND RATE-AVAILABILITY BASIS. Reservations should be made for arrival on February 10, 2015, with departure on February 12, 2015.

Please be certain that the hotel provides you with a confirmation number for your reservation. After January 20, 2015, the official room block will be released, and the hotel may charge significantly higher rates and may be sold out. If you need to cancel your reservation, please do so by 3:00 p.m. on the day prior to arrival, or you will be charged a no-show fee for 1 night on your credit card.

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://www.ors.od.nih.gov/maps/Pages/NIH-Visitor-Map.aspx.

NIH Security
NIH, like all Federal Government facilities, has instituted security measures to ensure the safety of NIH employees, patients, and visitors.

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:  driver'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 IDs 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 U.S. Department of Health and Human Services-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 2½ 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 the Metro station or the West Gateway Center (see the Visitor Map at http://www.ors.od.nih.gov/maps/Pages/NIH-Visitor-Map.aspx). 

  • Gateway Center

Wisconsin Avenue at Gateway Drive (near the Medical Center Metro station)
Open 24 hours a day, 7 days a week

  • West Gateway Center

Near Old Georgetown Road and South Drive
Open 6 a.m. – 12 p.m., Monday – Friday

DRIVING DIRECTIONS  

From Points North (Baltimore, Philadelphia, Wilmington, New York, and New Jersey): Take I-95 South toward Washington, DC. At I-495 (Capital Beltway), proceed west toward Silver Spring/Bethesda. Take Exit 34 (Route 355 or Rockville Pike/Wisconsin Avenue) and proceed south toward Washington/Bethesda. Travel approximately 1 mile and turn right past the light at South Drive onto NIH Gateway Drive. Park in the visitor garage, pass through NIH security, and follow the signs to Building 45.
 
From Points South (Richmond, Virginia Beach, and North and South Carolina): Take I-95 North toward Washington, DC. Take I-395 North via Exit 170A-B on the left. Merge onto I-495 North/Capital Beltway via Exit 170B toward Tysons Corner. Take Exit 34 (Route 355 or Wisconsin Avenue/Rockville Pike) and proceed south toward Washington/Bethesda. Travel approximately 1 mile and turn right past the light at South Drive onto NIH Gateway Drive. Park in the visitor garage, pass through NIH security, and follow the signs to Building 45.
 
From Route 66 East (Northern Virginia, McLean, and Fairfax): Take Route I-66 East to I-495 North/Capital Beltway Baltimore. Take Exit 34 (Route 355 or Wisconsin Avenue/Rockville Pike) and proceed south toward Washington/Bethesda. Travel approximately 1 mile and turn right past the light at South Drive onto NIH Gateway Drive. Park in the visitor garage, pass through NIH security, and follow the signs to Building 45.
 
From I-270 South: From I-270 South, take the left spur toward I-495 East. Just before the spur ends, take Exit 34/Route 355 (Wisconsin Avenue/Rockville Pike) on the left and proceed south toward Washington/Bethesda. Travel approximately 1 mile and turn right past the light at South Drive onto NIH Gateway Drive. Park in the visitor garage, pass through NIH security, and follow the signs to Building 45.
 
From Ronald Reagan Washington National Airport (DCA): Take the George Washington Parkway North to I-495 North toward Maryland. From I-495, take Exit 34 (Route 355 or Wisconsin Avenue/Rockville Pike) and proceed south toward Washington/Bethesda. Travel approximately 1 mile and turn right past the light at South Drive onto NIH Gateway Drive. Park in the visitor garage, pass through NIH security, and follow the signs to Building 45.
 
From Baltimore Washington International Thurgood Marshall Airport (BWI): Take the Baltimore Washington Parkway South toward Washington, DC. At I-495 (Capital Beltway), proceed west toward Silver Spring/Bethesda. Take Exit 34 (Route 355 or Wisconsin Avenue/Rockville Pike) and proceed south toward Washington/Bethesda. Travel approximately 1 mile and turn right past the light at South Drive onto NIH Gateway Drive. Park in the visitor garage, pass through NIH security, and follow the signs to Building 45.
 
From Washington Dulles International Airport (IAD): Take the Dulles Access Road East to I-495 (Capital Beltway) heading north to Bethesda/Baltimore. From I-495, take Exit 34 (Route 355 or Wisconsin Avenue/Rockville Pike) and proceed south toward Washington/Bethesda. Travel approximately 1 mile and turn right past the light at South Drive onto NIH Gateway Drive. Park in the visitor garage, pass through NIH security, and follow the signs to Building 45.

GROUND TRANSPORTATION  

METRO INFORMATION
The Metro system is clean, reliable, and safe. It operates from 5:00 a.m. to 12:00 midnight Monday through Thursday; 5:00 a.m. to 3:00 a.m. on Friday; 7:00 a.m. to 3:00 a.m. on Saturday; and 7:00 a.m. to 12:00 midnight on Sunday. Each passenger must purchase 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 of the system. A map of the system is available at: www.wmata.com/rail/maps/map.cfm. The hotel is located at the Bethesda Metro Station, and the meeting is within walking distance from the Medical Center Metro Station (one station north of Bethesda). Station attendants on duty at each station can provide additional information on request.
 
From the Ronald Regan Washington National Airport station, take the Yellow Line toward Mt. Vernon Square or Fort Totten. At the Gallery/Chinatown stop, transfer to the Red Line toward Shady Grove or Grosvenor-Strathmore. The Hyatt Regency Bethesda Hotel is located at the Bethesda Metro Station.

SHUTTLES
SuperShuttle offers service to most hotels from Ronald Reagan National Airport, Washington Dulles International Airport, and Baltimore/Washington International (BWI) 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 BWI 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 located at the Bethesda Metro Station.

PARKING

Parking on the NIH campus is limited and is $12 per day in the visitor lots. A large parking garage is located at Gateway Center, just outside security. It is a 5-minute walk from there to Building 45.

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Minutes

​Meeti​ng minutes are not available at this time.

Attendees

Meeti​ng attendees are not available at this time.

Abstracts

​Meeting abstract information is not available at this time.

Location

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  • 45 Center Drive
  • Building 45, National Institutes of Health
  • MD 20892
Webinar

Contacts

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