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, DPMH, ORPURM, CDER, FDA
9:05-9:15 a.m.
Introductory Remarks
Mary Tran Thanh Hai, M.D.
Office Director, OND, CDER, FDA
9:15-9:30 a.m.
Keynote Talk — Patient Perspective
Mckenna Bowes, B.S.
9:30-9:45 a.m.
Regulatory Framework for Drug Development and Pediatric Extrapolation
Lily Mulugeta, Pharm.D.
Associate Director, DPMH, CDER, FDA
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 European Medicines Agency (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., Ph.D.
Associate Professor of Medicine and Pediatrics, Duke University
Rebecca Sadun, M.D., Ph.D.
Associate Professor of Medicine and Pediatrics, Duke University
Stacy Ardoin, M.D., M.Sc.
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.
Associate Professor of Pediatrics, Cincinnati Children’s Hospital Medical Center
11:15 a.m.-12 p.m.
Panel Discussion
Moderated by Suzette Peng, M.D.
Medical Reviewer, DRTM, CDER, FDA
Panelists:
Tresa Ambooken, M.D.
Medical Officer (Clinical Reviewer), FDA
Rebecca Sadun, M.D., Ph.D.
Associate Professor, Departments of Medicine and Pediatrics, Duke University
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
Alvina Chu, M.D.
Head of Mid-Stage Programs, Immunology Clinical Development, AbbVie
Reshma Patel, M.D.
Global Associate Medical Director, Lupus, Biogen
Miah Andrade
Patient/Family Representative
Elizabeth SantaCruz, B.S.
Patient/Family Representative
12-1 p.m.
LUNCH
Session 2: Evaluation of Dose Selection and Response in Adult and Pediatric SLE
1-1:15 p.m.
Response Similarity Between Adult and Pediatric SLE: Lessons Learned from Belimumab
Tao Liu, Ph.D.
Team Leader, Division of Inflammation and Immune Pharmacology, Office of Clinical Pharmacology, CDER, 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., Ph.D.
Associate Professor, Departments of Medicine and Pediatrics, Duke University
1:30-1:45 p.m.
Role of MIDD to Accelerate Dose Selection and Optimization
Vikram Sinha, Ph.D.
Senior Vice President, Translational and Quantitative Medicine, Flagship Pioneering
1:45-2:30 p.m.
Panel Discussion
Moderated by Lily Mulugeta, Pharm.D.
Associate Director, DPMH, CDER, FDA
Panelists:
Jianmeng Chen, M.D., Ph.D.
Associate Director, Division of Inflammation and Immune Pharmacology Clinical Pharmacology, Office of Clinical Pharmacology, FDA
James Travis, Ph.D.
Master Statistician, Office of Biostatistics, FDA
Amit Golding, M.D., Ph.D.
Lead Physician, 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., Ph.D.
Associate Professor, Departments of Medicine and Pediatrics, Duke University
Vikram Sinha, Ph.D.
Senior Vice President, Translational and Quantitative Medicine, Flagship Pioneering
Laura E. Schanberg, M.D.
Professor, Pediatrics, Duke Clinical Research Institute, Duke University School of Medicine
Mckenna Bowes, B.S.
Patient Perspective
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
Professor of Pediatrics, University of Cincinnati Director, Division of Rheumatology at Cincinnati Children’s Hospital
Sule Yavuz, M.D.
Global Clinical Program Lead, AstraZeneca
3:15-3:35 p.m.
Patient/Family Panel: Risk Tolerance and Enrollment in Clinical Trials
Moderated by Stacy Ardoin, M.D.
Associate Professor, Division of Rheumatology and Immunology, The Ohio State University College of Medicine
Panelists:Mckenna Bowes, B.S.
Patient Representative
Chloe Raymond
Patient Representative
Nia Cooper
Patient Representative
Miah Andrade
Patient/Family Representative
Elizabeth SantaCruz, B.S.
Patient/Family Representative
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, Departments of Medicine and Pediatrics, Duke University
3:50-4:30 p.m.
Panel Discussion and Q&A
Moderated by Laura E. Schanberg, M.D.
Professor, Pediatrics, Duke Clinical Research Institute, Duke University School of Medicine
Lily Mulugeta, Pharm.D.
Associate Director, DPMH, CDER, FDA
Panelists:
Raj Nair, M.D.
Division Director, DRTM, CDER, FDA
Caroline Benichou-Auriche, M.D.
EMA-Senior Clinical Expert; Icelandic Medicines Agency - Lyfjastofnun
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
Professor of Pediatrics, University of Cincinnati Director, Division of Rheumatology at Cincinnati Children’s Hospital
Richard Dimelow, Ph.D.
Director, Clinical Pharmacology at GlaxoSmithKline (GSK)
Jordan Roberts, M.D., MPH
Global Development Medical Associate Director, AstraZeneca
Sule Yavuz, M.D.
Global Clinical Program Lead, AstraZeneca
Chloe Raymond
Patient Representative
4:30-4:40 p.m.
Closing Remarks
Suzette Peng, M.D.
Acting Clinical Team Leader, 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
Lily Mulugeta, Pharm.D.
Associate Director, DPMH, CDER, FDA
9:10-9:25 a.m.
Safety Assessment in Pediatric SLE — Challenges and Opportunities
Mary Beth Son, M.D.
Associate Professor, Clinical Chief, Division of Immunology Section Chief, Rheumatology Program, Boston Children's Hospital, Harvard Medical School
9:25-9:40 a.m.
Safety Assessment and Extrapolation in Pediatric SLE — Challenges and Opportunities
Laurie Conklin, M.D.
Director, Child Health Innovation and Leadership Department, Johnson & Johnson
9:40-10:15 a.m.
Alternative Approaches/Trial Design Considerations
Hermine I. Brunner, M.D., M.Sc., MBA
Professor of Pediatrics University of Cincinnati Director, Division of Rheumatology at Cincinnati Children’s Hospital
Martine Dehlinger-Kremer, Ph.D., MS
Senior Development Strategy Lead Pediatrics, Special Patient Populations, UCB Biosciences
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, M.D.
Division Director, DRTM, CDER, FDA
Panelists:
Lynne Yao, M.D.
Division Director, DPMH, CDER, FDA
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
Professor of Pediatrics University of Cincinnati Director, Division of Rheumatology at Cincinnati Children’s Hospital
Stephen Balevic, M.D., Ph.D.
Associate Professor, Departments of Medicine and Pediatrics, Duke University
Sarah Ringold, M.D., MS
Medical Director, Pediatric Development Team, Immunology, Johnson & Johnson
Kalyanee Appanna, Ph.D.
Vice President, Global Head of Biostatistics, EMD Serono, Inc
Jordan Roberts, M.D., MPH
Global Development Medical Associate Director, AstraZeneca
Caroline Benichou-Auriche, M.D.
EMA-Senior Clinical Expert; Icelandic Medicines Agency - Lyfjastofnun
Nia Cooper
Patient Representative
12:15-12:30 p.m.
Closing Remarks
Raj Nair, M.D.
Division Director, DRTM, CDER, FDA
