J Ferguson
Novartis
4 Papers
J Ferguson is an academic researcher from Novartis. The author has contributed to research in topics: Medicine & European union. The author has an hindex of 4, co-authored 4 publications.
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Papers
From adaptive licensing to adaptive pathways: delivering a flexible life-span approach to bring new drugs to patients.
H G Eichler,Lynn G. Baird,R Barker,Brigitte Bloechl-Daum,F Børlum‐Kristensen,Jeffrey S. Brown,R Chua,S Del Signore,U Dugan,J Ferguson,Sarah Garner,Wim G. Goettsch,J Haigh,Peter Honig,Anton Hoos,P Huckle,Tatsuya Kondo,Y Le Cam,Hubert G. M. Leufkens,Hubert G. M. Leufkens,Robyn Lim,Carole Longson,Murray Lumpkin,J Maraganore,Brian O'Rourke,Kenneth A. Oye,E Pezalla,Francesco Pignatti,J Raine,J Raine,Guido Rasi,Guido Rasi,Tomas Salmonson,D. Samaha,Sebastian Schneeweiss,PD Siviero,M Skinner,JR Teagarden,Toshiyoshi Tominaga,Trusheim,S. Tunis,Thomas F. Unger,Spiros Vamvakas,Gigi Hirsch +43 more
TL;DR: The environmental changes that will likely make adaptive pathways the preferred approach in the future are examined and a life‐span approach to bringing innovation to patients is expected to help address the perceived access vs. evidence trade‐off, help de‐risk drug development, and lead to better outcomes for patients.
195
Development of a framework for enhancing the transparency, reproducibility and communication of the benefit-risk balance of medicines
TL;DR: The Benefit Risk Action Team framework is a set of processes and tools for selecting, organizing, summarizing, and interpreting data that is relevant to decisions based on benefit–risk assessments that provides a standardized yet flexible platform for incorporating study outcomes and preference weights.
138
Application of the BRAT framework to case studies: observations and insights.
Bennett Levitan,Elizabeth Andrews,Alicia Gilsenan,J Ferguson,RA Noel,Paul Coplan,Paul Coplan,F Mussen +7 more
TL;DR: Insight is described into the BRAT Framework's performance in a variety of constructed benefit–risk scenarios, focusing on a hypothetical example of a triptan for migraine.
83
Adaptive licensing: taking the next step in the evolution of drug approval.
H. G. Eichler,H. G. Eichler,Kenneth A. Oye,Lynn G. Baird,E. Abadie,Jeffrey S. Brown,Chester L. Drum,J Ferguson,Sarah Garner,Sarah Garner,P. Honig,Mathias Hukkelhoven,John C W Lim,Robyn Lim,M. M. Lumpkin,G. Neil,Brian O'Rourke,E Pezalla,Diane Shoda,Vicki L. Seyfert-Margolis,E. V. Sigal,J. Sobotka,D. Tan,Thomas F. Unger,Gigi Hirsch +24 more
TL;DR: This article summarizes recent adaptive licensing proposals; discusses how proposals might be translated into practice, with illustrations in different therapeutic areas; and identifies unresolved issues to inform decisions on the design and implementation of AL.