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From adaptive licensing to adaptive pathways: delivering a flexible life-span approach to bring new drugs to patients.
Eichler HG, Baird LG, Barker R, Bloechl-Daum B, Børlum-Kristensen F, Brown J, Chua R, Del Signore S, Dugan U, Ferguson J, Garner S, Goettsch W, Haigh J, Honig P, Hoos A, Huckle P, Kondo T, Le Cam Y, Leufkens H, Lim R, Longson C, Lumpkin M, Maraganore J, O'Rourke B, Oye K, Pezalla E, Pignatti F, Raine J, Rasi G, Salmonson T, Samaha D, Schneeweiss S, Siviero PD, Skinner M, Teagarden JR, Tominaga T, Trusheim MR, Tunis S, Unger TF, Vamvakas S, Hirsch G. Eichler HG, et al. Among authors: hirsch g. Clin Pharmacol Ther. 2015 Mar;97(3):234-46. doi: 10.1002/cpt.59. Epub 2015 Feb 4. Clin Pharmacol Ther. 2015. PMID: 25669457 Free PMC article.
The next frontier: Fostering innovation by improving health data access and utilization.
Oye KA, Jain G, Amador M, Arnaout R, Brown JS, Crown W, Ferguson J, Pezalla E, Rassen JA, Selker HP, Trusheim M, Hirsch G. Oye KA, et al. Among authors: hirsch g. Clin Pharmacol Ther. 2015 Nov;98(5):514-21. doi: 10.1002/cpt.191. Epub 2015 Sep 10. Clin Pharmacol Ther. 2015. PMID: 26234275 Free PMC article. Review. No abstract available.
Adaptive Biomedical Innovation.
Honig PK, Hirsch G. Honig PK, et al. Among authors: hirsch g. Clin Pharmacol Ther. 2016 Dec;100(6):574-578. doi: 10.1002/cpt.513. Clin Pharmacol Ther. 2016. PMID: 27859144
Recognizing that Evidence is Made, not Born.
Lim R, Lee DK, Sabourin P, Ferguson J, Metcalf M, Smith M, Corriol-Rohou S, Eichler HG, Lumpkin M, Hirsch G, Chen IM, O'Rourke B, Schiel A, Crabb N, Aronson N, Pezalla E, Boutin M, Binder L, Wilhelm L. Lim R, et al. Among authors: hirsch g. Clin Pharmacol Ther. 2019 Apr;105(4):844-856. doi: 10.1002/cpt.1317. Epub 2019 Jan 4. Clin Pharmacol Ther. 2019. PMID: 30472743 Free PMC article.
Dynamic Dossier in the Cloud: A Sociotechnical Architecture for a Real-Time and Metrics-Based Data Tracking System with Gene and Cell Therapies as a Case Study.
Nam K, Larholt K, Hirsch G, Beninger P, Fritsche D, Shoda D, Ferguson J, Bourgeois FT, Palmer D, Katz K, Courtney MW. Nam K, et al. Among authors: hirsch g. Ther Innov Regul Sci. 2021 Mar;55(2):388-400. doi: 10.1007/s43441-020-00227-y. Epub 2020 Oct 28. Ther Innov Regul Sci. 2021. PMID: 33118143 Free PMC article.
438 results