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Therapeutic Innovation & Regulatory Science|September 9, 2021
Common Commentary on Paediatric Oncology Drug Development Published: Another Step in Optimising Global Regulatory Coordination of Paediatric Development PlansDominik Karres, Gregory Reaman, Franca Ligas, et al.Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology|August 10, 2022
The Critical Role of Academic Clinical Trials in Pediatric Cancer Drug Approvals: Design, Conduct, and Fit for Purpose Data for Positive Regulatory DecisionsBram De Wilde, Elly Barry, Elizabeth Fox, et al.The Oncologist|April 17, 2020
Blinatumomab for Acute Lymphoblastic Leukemia: The First Bispecific T-Cell Engager Antibody to Be Approved by the EMA for Minimal Residual DiseaseSahra Ali, Alexandre Moreau, Daniela Melchiorri, et al.Frontiers in Medicine|July 25, 2025
New medicines for childhood-onset systemic lupus erythematosus: an EU perspective on paediatric drug developmentRoberto De Lisa, Fernando de Andres-Trelles, Ralph Bax, et al.Frontiers in Medicine|October 31, 2025
A model structure for describing uncertainties in benefit-risk assessment of oncology drug applicationsNikolaos Zafiropoulos, Francesco Pignatti, Andreas Kouroumalis, et al.European Journal of Cancer (Oxford, England : 1990)|November 2, 2022
European regulatory strategy for supporting childhood cancer therapy developmentsDominik Karres, Giovanni Lesa, Franca Ligas, et al.Clinical Pharmacology and Therapeutics|June 20, 2020
Can a Multistakeholder Prioritization Structure Support Regulatory Decision Making? A Review of Pediatric Oncology Strategy Forums Reflecting on Challenges and Opportunities of this ConceptDominik Karres, Giovanni Lesa, Franca Ligas, et al.The Oncologist|March 11, 2020
EMA Recommendation for the Pediatric Indications of Plerixafor (Mozobil) to Enhance Mobilization of Hematopoietic Stem Cells for Collection and Subsequent Autologous Transplantation in Children with Lymphoma or Malignant Solid TumorsDominik Karres, Sahra Ali, Paula B van Hennik, et al.The Oncologist|March 23, 2019
The EMA Review of Mylotarg (Gemtuzumab Ozogamicin) for the Treatment of Acute Myeloid LeukemiaSahra Ali, Helen-Marie Dunmore, Dominik Karres, et al.Journal of the National Cancer Institute|November 17, 2023
Impact of ACCELERATE Paediatric Strategy Forums: a review of the value of multi-stakeholder meetings in oncology drug developmentAndrew D J Pearson, Teresa de Rojas, Dominik Karres, et al.Pageof 3