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SJS TenMarch 3 - 4, 2015

Building 31 Conference Center (6th floor of 31C)
NIH Main Campus
Bethesda, Md.

On March 3-4, 2015, the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) sponsored a workshop - Research Directions in Genetically-Mediated Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis - at Building 31 on the NIH main campus.

The objectives of the workshop are to:

  1. Review the current state of knowledge of the surveillance, pathogenesis and treatment of Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN).
  2. Examine the role of genomics and pharmacogenomics in the etiology, treatment and eradication of preventable causes of drug-induced SJS/TEN.
  3. Identify the gaps, unmet needs and priorities for future research to eliminate genetically mediated SJS/TEN globally.

Printable Agenda | Participants List | Full Meeting Summary | Executive Summary


Video Playlist

Tuesday, March 3, 2015

Location: NIH Building 31 Conference Center 6C Room 10

Time Topic Moderator/Presenter
8:00 a.m. Registration
Session 1: State of the Science
Moderator: Ricardo Cibotti
8:30 a.m Welcome, Introduction and Goals

Video | Slides

Teri Manolio
9:00 a.m. Clinical syndromes, epidemiology, genomics, diagnosis and treatment

Video | Slides

Neil Shear
9:30 a.m. Basic science of pathogenesis, functional genomics and mechanisms

Video | Slides

Wen-Hung Chung
10:00 a.m. Defining and prioritizing unmet research needs for a rare but deadly disease

Video | Slides

Elizabeth Phillips
10:30 a.m. Discussion All
11:00 a.m. Break
Session 2: International Experience Part 1
Moderator: Steven Katz
11:30 a.m. Europe

Video | Slides

Maja Mockenhaupt
11:45 a.m. Taiwan

Video | Slides

Shuen-Iu Hung
12:00 p.m. International Serious Adverse Events Consortium (iSAEC)

Video | Slides

Munir Pirmohamed
12:15 p.m. Thailand

Video | Slides

Wasun Chantratita
12:30 p.m. Break (pick up food for working lunch)
1:00 p.m. Discussion

Video

All
Session 3: Challenges in Case Finding and Surveillance
Moderator: Dan Roden
1:30 p.m. Pharmacosurveillance for SJS/TEN in the United States

Video | Slides

Lois La Grenade
2:00 p.m. Potential for electronic phenotyping

Video | Slides

Josh Denny
2:30 p.m. Pharmacovigilance in Thailand

Video | Slides

Wimon Suwankesawong
3:00 p.m. Discussion

Video

All
3:30 p.m. Break (move to breakout group rooms)

Workshop Planning Group Members: Mark Avigan (FDA), Ricardo Cibotti (NIAMS/NIH), Robert Davis (U Tennessee), Josh Denny (Vanderbilt),
Carolyn Hutter (NHGRI/NIH), Lois La Grenade (FDA), Teri Manolio (NHGRI/NIH), Neil Shear (U Toronto), Lisa Wheatley (NIAID/NIH)

Session 4: Working Groups
4:00 - 5:45 p.m. Group 1: Basic research gaps and opportunities:
mechanisms, risk alleles, other biomarkers, animal models (6C Room 10)
Lauren Trepanier
Wen-Hung Chung
Group 2: Clinical implementation gaps and opportunities:
PGx Screening, CPIC guidelines, and global eradication, recurrence prevention, cost effectiveness (6C Room 7)
Howard McLeod
Surakameth Mahasirimongkol
Group 3: Pharmacosurveillance gaps and opportunities: phenotype definitions, EMRs, resource needs (6C Room 9) Robert Davis
Simone Pinheiro
7:00 p.m. Conference Dinner (Bistro Provence, 4933 Fairmont Ave, Bethesda; participants pay own way)

Wednesday, March 4, 2014

Location: NIH Building 31 Conference Center Room 6C Room 6

Time Topic Moderator/Presenter
Session 5: International Experience Part 2
Moderator: Juan Lertora
8:30 a.m. Recap - Day 1

Video | Slides

Neil Shear
8:45 a..m. Singapore

Video | Slides

Cynthia Sung
9:00 a.m. Indonesia

Video | Slides

Rika Yuliwulandari
9:15 a.m. United States

Video | Slides

Steven Leeder
9:30 a.m. Discussion

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All
10:00 a.m. Break
Session 6: Special Topics
Moderator: Michael Lee
10:30 a.m. Regulatory consideration of pharmacogenomics data in labeling

Video | Slides

Mike Pacanowski
10:50 a.m. Challenges in characterizing and interpreting HLA sequence variation

Video | Slides

Mary Carrington
11:10 a.m. Drug-induced liver injury and cross-reactivity across drugs/organs

Video | Slides

Jay Hoofnagle
11:30 a.m. Health economics, policy implementation, and cost-effectiveness research

Video | Slides

Dave Veenstra
11:50 a.m. Discussion

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All
12:10 p.m. Break (pick up food for working lunch)
Session 7: Report of Working Groups
Moderator: Carolyn Hutter
12:45 p.m. Group 1: Basic Research Working Group Report

Video | Slides

Lauren Trepanier
Wen-Hung Chung
1:00 p.m. Discussion of basic research opportunities All
1:15 p.m. Group 2: Clinical Implementation working group report

Video | Slides

Howard McLeod
Surakameth Mahasirimongkol
1:30 p.m. Discussion of clinical implementation research opportunities All
1:45 p.m. Group 3: Pharmacosurveillance working group report

Video | Slides

Robert Davis
Simone Pinheiro
2:00 p.m. Discussion of pharmacosurveillance research opportunities

Video

All
Session 8: Wrap-Up and Next Steps
Moderator: Santa Tumminia
2:15 p.m Discussion of Next Steps

Video | Slides

Teri Manolio
3:00 p.m. Adjourn

Last updated: March 03, 2015