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Paediatric Strategy Forum for medicinal product development of chimeric antigen receptor T-cells in children and adolescents with cancer: ACCELERATE in collaboration with the European Medicines Agency with participation of the Food and Drug Administration.
Pearson AD, Rossig C, Mackall C, Shah NN, Baruchel A, Reaman G, Ricafort R, Heenen D, Bassan A, Berntgen M, Bird N, Bleickardt E, Bouchkouj N, Bross P, Brownstein C, Cohen SB, de Rojas T, Ehrlich L, Fox E, Gottschalk S, Hanssens L, Hawkins DS, Horak ID, Taylor DH, Johnson C, Karres D, Ligas F, Ludwinski D, Mamonkin M, Marshall L, Masouleh BK, Matloub Y, Maude S, McDonough J, Minard-Colin V, Norga K, Nysom K, Pappo A, Pearce L, Pieters R, Pule M, Quintás-Cardama A, Richardson N, Schüßler-Lenz M, Scobie N, Sersch MA, Smith MA, Sterba J, Tasian SK, Weigel B, Weiner SL, Zwaan CM, Lesa G, Vassal G. Pearson AD, et al. Among authors: lesa g. Eur J Cancer. 2022 Jan;160:112-133. doi: 10.1016/j.ejca.2021.10.016. Epub 2021 Nov 25. Eur J Cancer. 2022. PMID: 34840026 Free article. Review.
ACCELERATE and European Medicine Agency Paediatric Strategy Forum for medicinal product development for mature B-cell malignancies in children.
Pearson ADJ, Scobie N, Norga K, Ligas F, Chiodin D, Burke A, Minard-Colin V, Adamson P, Marshall LV, Balakumaran A, Benettaib B, Bhargava P, Bollard CM, Bolotin E, Bomken S, Buechner J, Burkhardt B, Caron H, Copland C, Demolis P, Egorov A, Farhan M, Zugmaier G, Gross T, Horton-Taylor D, Klapper W, Lesa G, Marcus R, Miles RR, Nottage K, Pacaud L, Ricafort R, Schrappe M, Sterba J, Vezan R, Weiner S, Kim SY, Reaman G, Vassal G. Pearson ADJ, et al. Among authors: lesa g. Eur J Cancer. 2019 Mar;110:74-85. doi: 10.1016/j.ejca.2019.01.013. Epub 2019 Feb 14. Eur J Cancer. 2019. PMID: 30772656
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: lesa g. 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 for acute myeloid leukaemia in children and adolescents: ACCELERATE in collaboration with the European Medicines Agency with participation of the Food and Drug Administration.
Pearson ADJ, Zwaan CM, Kolb EA, Karres D, Guillot J, Kim SY, Marshall L, Tasian SK, Smith M, Cooper T, Adamson PC, Barry E, Benettaib B, Binlich F, Borgman A, Brivio E, Capdeville R, Delgado D, Faller D, Fogelstrand L, Fraenkel PG, Hasle H, Heenen D, Kaspers G, Kieran M, Klusmann JH, Lesa G, Ligas F, Mappa S, Mohamed H, Moore A, Morris J, Nottage K, Reinhardt D, Scobie N, Simko S, Winkler T, Norga K, Reaman G, Vassal G. Pearson ADJ, et al. Among authors: lesa g. Eur J Cancer. 2020 Sep;136:116-129. doi: 10.1016/j.ejca.2020.04.038. Epub 2020 Jul 17. Eur J Cancer. 2020. PMID: 32688206 Free PMC 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: lesa g. 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: lesa g. 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.
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: lesa g. 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.
Accelerating the Global Development of Pediatric Cancer Drugs: A Call to Coordinate the Submissions of Pediatric Investigation Plans and Pediatric Study Plans to the European Medicines Agency and US Food and Drug Administration.
Reaman G, Karres D, Ligas F, Lesa G, Casey D, Ehrlich L, Norga K, Pazdur R. Reaman G, et al. Among authors: lesa g. J Clin Oncol. 2020 Dec 20;38(36):4227-4230. doi: 10.1200/JCO.20.02152. Epub 2020 Sep 18. J Clin Oncol. 2020. PMID: 32946356 No abstract available.
Can a Multistakeholder Prioritization Structure Support Regulatory Decision Making? A Review of Pediatric Oncology Strategy Forums Reflecting on Challenges and Opportunities of this Concept.
Karres D, Lesa G, Ligas F, Annunen P, van Dartel M, Demolis P, Galluzzo S, Herold R, van Criekingen OK, Stoyanova-Beninska V, Norga K. Karres D, et al. Among authors: lesa g. Clin Pharmacol Ther. 2020 Sep;108(3):553-556. doi: 10.1002/cpt.1939. Epub 2020 Jul 8. Clin Pharmacol Ther. 2020. PMID: 32559312 Review.
36 results