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Evidence generation throughout paediatric medicines life cycle: findings from collaborative work between European Medicines Agency (EMA) and EUnetHTA on use of extrapolation.
Karres D, Pino-Barrio MJ, Benchetrit S, Benda N, Cochat P, Galluzzo S, García-Solís A, Gonzalez S, de Lisa R, Khan D, Lankester R, Lentz F, Martínez-Ortega PA, Montilla S, Morales DR, Tshinanu FM, Sánchez SP, Montero AR, Scherer S, Thomson A, Garrido BT, Umuhire D, Wang S, Bax R, Hedberg N. Karres D, et al. Br J Pharmacol. 2024 Nov 22. doi: 10.1111/bph.17396. Online ahead of print. Br J Pharmacol. 2024. PMID: 39574299 Review.
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: karres d. 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.
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: karres d. 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 DNA damage response pathway inhibitors in children and adolescents with cancer: ACCELERATE in collaboration with the European Medicines Agency with participation of the Food and Drug Administration.
Pearson ADJ, Federico S, Gatz SA, Ortiz M, Lesa G, Scobie N, Gounaris I, Weiner SL, Weigel B, Unger TJ, Stewart E, Smith M, Slotkin EK, Reaman G, Pappo A, Nysom K, Norga K, McDonough J, Marshall LV, Ludwinski D, Ligas F, Karres D, Kool M, Horner TJ, Henssen A, Heenen D, Hawkins DS, Gore L, Bender JG, Galluzzo S, Fox E, de Rojas T, Davies BR, Chakrabarti J, Carmichael J, Bradford D, Blanc P, Bernardi R, Benchetrit S, Akindele K, Vassal G. Pearson ADJ, et al. Among authors: karres d. Eur J Cancer. 2023 Sep;190:112950. doi: 10.1016/j.ejca.2023.112950. Epub 2023 Jun 21. Eur J Cancer. 2023. PMID: 37441939 Free article. Review.
Paediatric Strategy Forum for medicinal product development in mitogen-activated protein kinase pathway inhibitors: ACCELERATE in collaboration with the European Medicines Agency with participation of the Food and Drug Administration.
Pearson AD, Allen C, Fangusaro J, Hutter C, Witt O, Weiner S, Reaman G, Russo M, Bandopadhayay P, Ahsan S, Barone A, Barry E, de Rojas T, Fisher M, Fox E, Bender JG, Gore L, Hargrave D, Hawkins D, Kreider B, Langseth AJ, Lesa G, Ligas F, Marotti M, Marshall LV, Nasri K, Norga K, Nysom K, Pappo A, Rossato G, Scobie N, Smith M, Stieglitz E, Weigel B, Weinstein A, Viana R, Karres D, Vassal G. Pearson AD, et al. Among authors: karres d. Eur J Cancer. 2022 Dec;177:120-142. doi: 10.1016/j.ejca.2022.09.036. Epub 2022 Oct 14. Eur J Cancer. 2022. PMID: 36335782 Free article. Review.
ACCELERATE Paediatric Strategy Forums: an advance for oncological drug development?
Pearson ADJ, de Rojas T, Karres D, Reaman G, Scobie N, Fox E, Lesa G, Ligas F, Norga K, Nysom K, Pappo A, Weigel B, Weiner S, Vassal G. Pearson ADJ, et al. Among authors: karres d. Lancet Oncol. 2022 Nov;23(11):1354-1357. doi: 10.1016/S1470-2045(22)00619-2. Lancet Oncol. 2022. PMID: 36328007 No abstract available.
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: karres d. 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.
23 results