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Paediatric Strategy Forum for medicinal product development of multi-targeted kinase inhibitors in bone sarcomas: ACCELERATE in collaboration with the European Medicines Agency with participation of the Food and Drug Administration.
Pearson AD, Gaspar N, Janeway K, Campbell-Hewson Q, Lawlor ER, Copland C, Karres D, Norga K, Benzaghou F, Weiner S, Weigel B, Weiss AR, Strauss SJ, Smith M, Setty BA, Seibel N, Scobie N, Pappo A, Okpara CE, Nysom K, McDonough J, Marshall LV, Ludwinski D, Ligas F, Lesa G, Knudsen S, Kauh J, Hsieh A, Heenen D, Hawkins DS, Graham A, Garmey E, DuBois SG, Fox E, Donoghue M, de Rojas T, Chung J, Casanova M, Brennan B, Bishop M, Buenger V, Reaman G, Vassal G. Pearson AD, et al. Among authors: donoghue m. Eur J Cancer. 2022 Sep;173:71-90. doi: 10.1016/j.ejca.2022.06.008. Epub 2022 Jul 18. Eur J Cancer. 2022. PMID: 35863108 Free article. Review.
ACCELERATE and European Medicines Agency Paediatric Strategy Forum for medicinal product development of checkpoint inhibitors for use in combination therapy in paediatric patients.
Pearson ADJ, Rossig C, Lesa G, Diede SJ, Weiner S, Anderson J, Gray J, Geoerger B, Minard-Colin V, Marshall LV, Smith M, Sondel P, Bajars M, Baldazzi C, Barry E, Blackman S, Blanc P, Capdeville R, Caron H, Cole PD, Jiménez JC, Demolis P, Donoghue M, Elgadi M, Gajewski T, Galluzzo S, Ilaria R Jr, Jenkner A, Karres D, Kieran M, Ligas F, Lowy I, Meyers M, Oprea C, Peddareddigari VGR, Sterba J, Stockman PK, Suenaert P, Tabori U, van Tilburg C, Yancey T, Weigel B, Norga K, Reaman G, Vassal G. Pearson ADJ, et al. Among authors: donoghue m. Eur J Cancer. 2020 Mar;127:52-66. doi: 10.1016/j.ejca.2019.12.029. Epub 2020 Jan 24. Eur J Cancer. 2020. PMID: 31986450 Free article.
Paediatric Strategy Forum for medicinal product development of epigenetic modifiers for children: ACCELERATE in collaboration with the European Medicines Agency with participation of the Food and Drug Administration.
Pearson AD, Stegmaier K, Bourdeaut F, Reaman G, Heenen D, Meyers ML, Armstrong SA, Brown P, De Carvalho D, Jabado N, Marshall L, Rivera M, Smith M, Adamson PC, Barone A, Baumann C, Blackman S, Buenger V, Donoghue M, Duncan AD, Fox E, Gadbaw B, Hattersley M, Ho P, Jacobs I, Kelly MJ, Kieran M, Lesa G, Ligas F, Ludwinski D, McDonough J, Nikolova Z, Norga K, Senderowicz A, Taube T, Weiner S, Karres D, Vassal G. Pearson AD, et al. Among authors: donoghue m. Eur J Cancer. 2020 Nov;139:135-148. doi: 10.1016/j.ejca.2020.08.014. Epub 2020 Sep 26. Eur J Cancer. 2020. PMID: 32992153 Review.
Second Paediatric Strategy Forum for anaplastic lymphoma kinase (ALK) inhibition in paediatric malignancies: ACCELERATE in collaboration with the European Medicines Agency with the participation of the Food and Drug Administration.
Pearson ADJ, Barry E, Mossé YP, Ligas F, Bird N, de Rojas T, Zimmerman ZF, Wilner K, Woessmann W, Weiner S, Weigel B, Venkatramani R, Valteau D, Trahair T, Smith M, Singh S, Selvaggi G, Scobie N, Schleiermacher G, Richardson N, Park J, Nysom K, Norga K, Merino M, McDonough J, Matloub Y, Marshall LV, Lowe E, Lesa G, Irwin M, Karres D, Gajjar A, Doz F, Fox E, DuBois SG, Donoghue M, Casanova M, Caron H, Buenger V, Bradford D, Blanc P, Barone A, Reaman G, Vassal G. Pearson ADJ, et al. Among authors: donoghue m. Eur J Cancer. 2021 Nov;157:198-213. doi: 10.1016/j.ejca.2021.08.022. Epub 2021 Sep 15. Eur J Cancer. 2021. PMID: 34536944 Free article. Review.
Considering Functional Outcomes as Efficacy Endpoints in Pediatric Low-Grade Glioma Clinical Trials: An FDA Educational Symposium.
Fangusaro J, Avery RA, Fisher MJ, Packer RJ, Walsh KS, Schouten-van Meeteren A, Karres D, Bradford D, Bhatnagar V, Singh H, Kluetz PG, Donoghue M, Duke ES. Fangusaro J, et al. Among authors: donoghue m. Clin Cancer Res. 2024 Jun 3;30(11):2303-2308. doi: 10.1158/1078-0432.CCR-23-3386. Clin Cancer Res. 2024. PMID: 38358393 Free PMC article.
Paediatric strategy forum for medicinal product development of PI3-K, mTOR, AKT and GSK3β inhibitors in children and adolescents with cancer.
Pearson AD, DuBois SG, Macy ME, de Rojas T, Donoghue M, Weiner S, Knoderer H, Bernardi R, Buenger V, Canaud G, Cantley L, Chung J, Fox E, Friend J, Glade-Bender J, Gorbatchevsky I, Gore L, Gupta A, Hawkins DS, Juric D, Lang LA, Leach D, Liaw D, Lesa G, Ligas F, Lindberg G, Lindberg W, Ludwinski D, Marshall L, Mazar A, McDonough J, Nysom K, Ours C, Pappo A, Parsons DW, Rosenfeld A, Scobie N, Smith M, Taylor D, Weigel B, Weinstein A, Karres D, Vassal G. Pearson AD, et al. Among authors: donoghue m. Eur J Cancer. 2024 Aug;207:114145. doi: 10.1016/j.ejca.2024.114145. Epub 2024 Jun 8. Eur J Cancer. 2024. PMID: 38936103 Free article. Review.
Modernizing Clinical Trial Eligibility: Recommendations of the American Society of Clinical Oncology-Friends of Cancer Research Minimum Age Working Group.
Gore L, Ivy SP, Balis FM, Rubin E, Thornton K, Donoghue M, Roberts S, Bruinooge S, Ersek J, Goodman N, Schenkel C, Reaman G. Gore L, et al. Among authors: donoghue m. J Clin Oncol. 2017 Nov 20;35(33):3781-3787. doi: 10.1200/JCO.2017.74.4144. Epub 2017 Oct 2. J Clin Oncol. 2017. PMID: 28968169 Free PMC article.
FDA Oncology Center of Excellence Project Renewal: Engaging the Oncology Community to Update Product Labeling for Older Oncology Drugs.
Kluetz PG, Keegan P, Demetri GD, Thornton K, Sul J, Kim J, Katzen H, Burke LB, Harvey RD, Alebachew E, Agrawal S, Nair A, Donoghue M, Pierce WF, Shord SS, Gao JJ, Pazdur R. Kluetz PG, et al. Among authors: donoghue m. Clin Cancer Res. 2021 Feb 15;27(4):916-921. doi: 10.1158/1078-0432.CCR-20-3213. Epub 2020 Nov 30. Clin Cancer Res. 2021. PMID: 33257426
355 results