Last updated: March 03, 2015
Research Directions in Genetically-Mediated Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis
March 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:
- Review the current state of knowledge of the surveillance, pathogenesis and treatment of Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN).
- Examine the role of genomics and pharmacogenomics in the etiology, treatment and eradication of preventable causes of drug-induced SJS/TEN.
- 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
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 | Teri Manolio |
| 9:00 a.m. | Clinical syndromes, epidemiology, genomics, diagnosis and treatment | Neil Shear |
| 9:30 a.m. | Basic science of pathogenesis, functional genomics and mechanisms | Wen-Hung Chung |
| 10:00 a.m. | Defining and prioritizing unmet research needs for a rare but deadly disease | 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 | Maja Mockenhaupt |
| 11:45 a.m. | Taiwan | Shuen-Iu Hung |
| 12:00 p.m. | International Serious Adverse Events Consortium (iSAEC) | Munir Pirmohamed |
| 12:15 p.m. | Thailand | Wasun Chantratita |
| 12:30 p.m. | Break (pick up food for working lunch) | |
| 1:00 p.m. | Discussion | All |
| Session 3: Challenges in Case Finding and Surveillance Moderator: Dan Roden |
||
| 1:30 p.m. | Pharmacosurveillance for SJS/TEN in the United States | Lois La Grenade |
| 2:00 p.m. | Potential for electronic phenotyping | Josh Denny |
| 2:30 p.m. | Pharmacovigilance in Thailand | Wimon Suwankesawong |
| 3:00 p.m. | Discussion | 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 | Neil Shear |
| 8:45 a..m. | Singapore | Cynthia Sung |
| 9:00 a.m. | Indonesia | Rika Yuliwulandari |
| 9:15 a.m. | United States | Steven Leeder |
| 9:30 a.m. | Discussion | All |
| 10:00 a.m. | Break | |
| Session 6: Special Topics Moderator: Michael Lee |
||
| 10:30 a.m. | Regulatory consideration of pharmacogenomics data in labeling | Mike Pacanowski |
| 10:50 a.m. | Challenges in characterizing and interpreting HLA sequence variation | Mary Carrington |
| 11:10 a.m. | Drug-induced liver injury and cross-reactivity across drugs/organs | Jay Hoofnagle |
| 11:30 a.m. | Health economics, policy implementation, and cost-effectiveness research | Dave Veenstra |
| 11:50 a.m. | Discussion | 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 | 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 | 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 | Robert Davis Simone Pinheiro |
| 2:00 p.m. | Discussion of pharmacosurveillance research opportunities | All |
| Session 8: Wrap-Up and Next Steps Moderator: Santa Tumminia |
||
| 2:15 p.m | Discussion of Next Steps | Teri Manolio |
| 3:00 p.m. | Adjourn | |