Accelerating Product Development for Pediatric Systemic Lupus Erythematosus (SLE)
Thursday, July 30 and Friday, July 31, 2026
Agenda & Speakers
Day 1: 9 a.m.-4:40 p.m.
Welcome & Introduction
9-9:05 a.m.
Welcome and Overview Scope of Workshop
Lily Mulugeta, Pharm.D.
Associate Director for Policy and Research, DPMH, ORPURM, CDER, FDA
9:05-9:15 a.m.
Introductory Remarks
Mary Tran Thanh Hai, M.D.
Director, OND, CDER, FDA
9:15-9:30 a.m.
Keynote Talk — Patient Perspective
9:30-9:45 a.m.
Regulatory Framework for Drug Development and Pediatric Extrapolation
9:45-10:15 a.m.
Landscape of Pediatric SLE Drug Development: Regulatory Perspective
Emily C. Gotschlich, M.D.
Clinical Reviewer, DRTM, CDER, FDA
Roberto De Lisa, M.D., M.Sc.
Clinical Pharmacologist; Scientific Officer at EMA - Paediatric Medicines
Session 1: Evaluation of Disease in Adult and Pediatric SLE
10:15-10:45 a.m.
Pediatric SLE Presentation and relationship to adult SLE: Clinical and Pathophysiological Considerations
Stephen Balevic, M.D., MHS, Ph.D.
Associate Professor, Pediatrics, Medicine, Dept of Medicine, Duke University School of Medicine
Laura B. Lewandowski, M.D., M.S.
Assistant Clinical Investigator; Head, Lupus Genomics and Global Health Disparities Unit; NIAMS (NIH)
Stacy Ardoin, M.D.
Associate Professor, Division of Rheumatology and Immunology, The Ohio State University College of Medicine
10:45-11 a.m.
Break
11-11:15 a.m.
Treatment Paradigm, Landscape of Products Used, and Unmet Needs in Pediatric SLE
Ekemini A. Ogbu, M.D., M.Sc.
Director, Neuroinflammatory Disease Services in Rheumatology; Co-director, Cincinnati Children’s Lupus Center; Associate Professor, UC Dept of Pediatrics, Cincinnati Children’s
11:15 a.m.-12 p.m.
Panel Discussion
Moderated by Suzette Peng, M.D.Medical Reviewer, DRTM, CDER, FDA
Panelists:
Brian Dizon, M.D., Ph.D.Medical Officer (Clinical Reviewer), FDA
Laura B. Lewandowski, M.D., M.S.
Assistant Clinical Investigator; Head, Lupus Genomics and Global Health Disparities Unit; NIAMS (NIH)
Stacy Ardoin, M.D.
Associate Professor, Division of Rheumatology and Immunology, The Ohio State University College of Medicine
Ekemini A. Ogbu, M.D., M.Sc.
Director, Neuroinflammatory Disease Services in Rheumatology; Co-director, Cincinnati Children’s Lupus Center; Associate Professor, UC Dept of Pediatrics, Cincinnati Children’s
Reshma Patel, M.D.
Global Associate Medical Director, Lupus, Biogen
12-1 p.m.
Lunch
Session 2: Evaluation of Dose Selection and Response in Adult and Pediatric SLE
1-1:15 p.m.
Drug Pharmacology and Response: Similarities and Differences Between Adult and Pediatric SLE
Tao Liu, Ph.D.
Clinical Pharmacology Team Leader, FDA
Satyajit Ghosh, Ph.D.
Mathematical Statistician, DB II, OB, CDER, FDA
1:15-1:30 p.m.
Similarities and Differences of Response and Exposure-Response
Stephen Balevic, M.D., MHS, Ph.D.
Associate Professor, Pediatrics, Medicine, Dept of Medicine, Duke University School of Medicine
1:30-1:45 p.m.
Role of MIDD to Accelerate Dose Selection and Optimization
Vikram Sinha, Ph.D.
Global Head, Therapeutics Areas, Novartis Institutes for BioMedical Research
1:45-2:30 p.m.
Panel Discussion
Moderated by Lily Mulugeta, Pharm.D.
Associate Director for Policy and Research, DPMH, ORPURM, CDER, FDA
Panelists:
Tao Liu, Ph.D.
Clinical Pharmacology Team Leader, FDA
Amit Golding, M.D.
DRTM, CDER, FDA
Flora Musuamba Tshinanu, Ph.D.
Pharmacometrics and Pharmacovigilance Internal Expert, Belgian Federal Medicines Agency (FAMHP), European Medicines Agency (EMA)
Stephen Balevic, M.D., MHS, Ph.D.
Associate Professor, Pediatrics, Medicine, Dept of Medicine, Duke University School of Medicine
Vikram Sinha, Ph.D.
Global Head, Therapeutics Areas, Novartis Institutes for BioMedical Research
2:30-2:45 p.m.
Break
Session 3: Extrapolation of Efficacy
2:45-3:15 p.m.
Lessons Learned from Conducting Clinical Trials in Pediatric SLE
Hermine I. Brunner, M.D., M.Sc., MBA
Director, Division of Rheumatology; Professor, UC Dept of Pediatrics, Cincinnati Children’s Hospital
3:15-3:35 p.m.
Patient/Family Panel: Risk Tolerance and Enrollment in Clinical Trials
3:35-3:50 p.m.
Extrapolation of Efficacy from Adults: Gaps in Knowledge and Remaining Uncertainties
Rebecca Sadun, M.D., Ph.D.
Associate Professor, Medicine, Pediatrics, Dept of Medicine, Duke University School of Medicine
3:50-4:30 p.m.
Panel Discussion and Q&A
Moderated by DPMH/Academia
Panelists:
Raj Nair, Ph.D.
Branch Chief (Acting), FDA
Rebecca Sadun, M.D., Ph.D.
Associate Professor, Medicine, Pediatrics, Dept of Medicine, Duke University School of Medicine
Hermine I. Brunner, M.D., M.Sc., MBA
Director, Division of Rheumatology; Professor, UC Dept of Pediatrics, Cincinnati Children’s Hospital
4:30-4:40 p.m.
Closing Remarks
Suzette Peng, M.D.Medical Reviewer, DRTM, CDER, FDA
Day 2: 9 a.m.-12:30 p.m.
Session 4: Trial Design Considerations (Efficacy & Safety)
9-9:10 a.m.
Opening Remarks
9:10-9:25 a.m.
Safety Assessment in Pediatric SLE — Challenges and Opportunities
Aimee O. Hersh, M.D.
Associate Professor, Division Chief of Pediatric Rheumatology, Spencer Fox Eccles SOM, University of Utah and Primary Children’s Hospital
9:25-9:40 a.m.
Safety Assessment and Extrapolation in Pediatric SLE — Challenges and Opportunities
Industry Perspective
9:40-10:15 a.m.
Alternative Approaches/Trial Design Considerations
Hermine I. Brunner, M.D., M.Sc., MBA
Professor, Pediatrics, Dept of Pediatrics, Duke University School of Medicine
10:15-10:30 a.m.
Break
10:30 a.m.-12:15 p.m.
Panel Discussion and Q&A (Future Direction)
Moderated by Raj Nair, Ph.D.
Branch Chief (Acting), FDA
Panelists:Stacy Ardoin, M.D.
Associate Professor, Division of Rheumatology and Immunology, The Ohio State University College of Medicine
Hermine I. Brunner, M.D., M.Sc., MBA
Director, Division of Rheumatology; Professor, UC Dept of Pediatrics, Cincinnati Children’s Hospital
Stephen Balevic, M.D., MHS, Ph.D.
Associate Professor, Pediatrics, Medicine, Dept of Medicine, Duke University School of Medicine
12:15-12:30 p.m.
Closing Remarks
Raj Nair, Ph.D.Branch Chief (Acting), FDA
