Papers & Publications

The NEWDIGS Publication Creation & Dissemination Policy can be found here.

Publications

M. Boname; A.Wagner Gee; S. Addie; S.H. Beachy; T. Wizemann; M. Trusheim
Enabling Precision Medicine: The Role of Genetics in Clinical Drug Development: Proceedings of a Workshop
Forum on Drug Discovery, Development, and Translation , 2017 , 10.17226/24829
S. Blackburn
Adaptive Pathways are Creating Win-Win Scenarios for Patients and Pharma
AccessPoint, QuintilesIMS Real-World Insights , 05/2017 , 2017 ,
M.J. Cziraky; K.M. Larholt; M. Pollock
Conducting Pragmatic Trials: Design and Infrastructure Considerations for Successful Implementation of Trials Based on Real-World Evidence
HealthCore , 2017 ,
G.K. Raju; K. Gurumurthi; R. Domike; D. Kazandjian; G. Blumenthal; R. Pazdur; J. Woodcock
A Benefit–Risk Analysis Approach to Capture Regulatory Decision-Making: Non-Small Cell Lung Cancer
Clinical Pharmacology & Therapeutics , 2016 , 10.1002/cpt.501
J.C. Bouvy; P. Jonsson; C. Longson; N. Crabb; S. Garner
Health Technology Assessment in the Context of Adaptive Pathways for Medicines in Europe: Challenges and Opportunities
Clinical Pharmacology & Therapeutics , 2016 , 10.1002/cpt.448
G. Hirsch; M. Trusheim; E. Cobbs; M. Bala; S. Garner; D. Hartman; K. Isaacs; M. Lumpkin; R. Lim; K. Oye; E. Pezalla; P. Saltonstall; H. Selker
Adaptive Biomedical Innovation: Evolving Our Global System to Sustainably and Safely Bring New Medicines to Patients in Need
Clinical Pharmacology & Therapeutics , 2016 , 10.1002/cpt.509
; P.W. Barone; A. Bellisario; C.L. Cooney; P.A. Sharp; A.J. Sinskey; S. Natesan; S.L. Springs
Leveraging Industry-Academia Collaborations in Adaptive Biomedical Innovation
Clinical Pharmacology & Therapeutics , 2016 , 10.1002/cpt.504
H.G. Eichler; B. Bloechl-Daum; P. Bauer; F. Bretz; J. Brown; L.V. Hampson; P. Honig; M. Krams; H. Leufkens; R. Lim; M.M. Lumpkin; M.J. Murphy; F. Pignatti; M. Posch; S. Schneeweiss; M. Trusheim; F. Koenig
“Threshold-crossing”: A Useful Way to Establish the Counterfactual in Clinical Trials?
Clinical Pharmacology & Therapeutics , 2016 , 10.1002/cpt.515
M.R. Trusheim; A.A. Shrier; Z. Antonijevic; R.A. Beckman; R.K. Campbell; C. Chen; K.T. Flaherty; J. Loewy; D. Lacombe; S. Madhavan; H.P. Selker; L.J. Esserman
PIPELINEs: Creating Comparable Clinical Knowledge Efficiently by Linking Trial Platforms
Clinical Pharmacology & Therapeutics , 2016 , 10.1002/cpt.514
D. Schulthess; L.G. Baird; M. Trusheim; T.F. Unger; M. Lumpkin; A. Hoos; S. Garner; P. Gavin; M. Goldman; N. Seigneuret; M. Chlebus; K. Van Baelen; R. Bergstrom; G. Hirsch
Medicines Adaptive Pathways to Patients (MAPPs)
Therapeutic Innovation & Regulatory Science , 2016 , 10.1177/2168479015618697
K.A. Oye; H.G. Eichler; A. Hoos; Y. Mori; T.M. Mullin; M. Pearson
Pharmaceuticals Licensing and Reimbursement in the European Union, United States, and Japan
Clinical Pharmacology & Therapeutics , 2016 , 10.1002/cpt.505
M.R. Trusheim; E.R. Berndt
The clinical benefits, ethics, and economics of stratified medicine and companion diagnostics
Drug Discovery Today , 2015 , https://doi.org/10.1016/j.drudis.2015.10.017
H.G. Eichler; L.G. Baird; R. Barker; B. Bloechl-Daum; F. Børlum-Kristensen; J. Brown; R. Chua; S. Del Signore; U. Dugan; J. Ferguson; S. Garner; W. Goettsch; J. Haigh; P. Honig; A. Hoos; P. Huckle; T. Kondo; Y. Le Cam; H. Leufkens; R. Lim; C. Longson; M. Lumpkin; J. Maraganore; B. O'Rourke; K. Oye; E. Pezalla; F. Pignatti; J. Raine; G. Rasi; T. Salmonson; D. Samaha; S. Schneeweiss; P.D. Siviero; M. Skinner; ; T. Tominaga; M.R. Trusheim; S. Tunis; T.F. Unger; S. Vamvakas; G. Hirsch
From adaptive licensing to adaptive pathways: Delivering a flexible life-span approach to bring new drugs to patients
Clinical Pharmacology & Therapeutics , 2015 , 10.1002/cpt.59
K.A. Oye; G. Jain; M. Amador; R. Arnaout; J.S. Brown; W. Crown; J. Ferguson; E. Pezalla; J.A. Rassen; H.P. Selker; M. Trusheim; G. Hirsch
The next frontier: Fostering innovation by improving health data access and utilization
Clinical Pharmacology & Therapeutics , 2015 , 10.1002/cpt.191
R. Teagarden; T.F. Unger; G. Hirsch
Access and availability of orphan drugs in the United States: advances or cruel hoaxes?
Expert Opinion on Orphan Drugs , 2014 , 10.1517/21678707.2014.947265
M.R. Trusheim; L.G. Baird; S. Garner; R. Lim; N. Patel; G. Hirsch
The Janus initiative: A multi-stakeholder process and tool set for facilitating and quantifying Adaptive Licensing discussions
Health Policy and Technology , 2014 , https://doi.org/10.1016/j.hlpt.2014.10.004
J.R. Beshansky; P.R. Sheehan; K.J. Klima; N. Hadar; E.M. Vickery; H.P. Selker
A community consultation survey to evaluate support for and success of the IMMEDIATE trial
Clinical Trials , 2014 , 10.1177/1740774514526476
L.G. Baird; R. Banken; H.G. Eichler; F.B. Kristensen; D.K. Lee; J.C.W. Lim; R. Lim; C. Longson; E. Pezalla; T. Salmonson; D. Samaha; S. Tunis; J. Woodcock; G. Hirsch
Accelerated Access to Innovative Medicines for Patients in Need
Clinical Pharmacology & Therapeutics , 2014 , 10.1038/clpt.2014.145
L.G. Baird; M.R. Trusheim; H.G. Eichler; E.R. Berndt; G. Hirsch
Comparison of Stakeholder Metrics for Traditional and Adaptive Development and Licensing Approaches to Drug Development
Therapeutic Innovation & Regulatory Science , 2013 , 10.1177/2168479013487355
K. Oye; L.G. Baird; A. Chia; S. Hocking; P.B. Hutt; D. Lee; L. Norwalk; V. Salvatore
Legal Foundations of Adaptive Licensing
Clinical Pharmacology & Therapeutics , 2013 , 10.1038/clpt.2013.95
M. Papadaki; G. Hirsch
Curing Consortium Fatigue
Science Translational Medicine , 2013 , 10.1126/scitranslmed.3006903
J. Orloff; F. Douglas; J. Pinheiro; S. Levinson; M. Branson; P. Chaturvedi; E. Ette; P. Gallo; G. Hirsch; C. Mehta; N. Patel; S. Sabir; S. Springs; D. Stanski; M.R. Evers; E. Fleming; N. Singh; T. Tramontin; H. Golub
The future of drug development: advancing clinical trial design
Nat Rev Drug Discov , 2009/12//print , 2009 ,

Working Papers

Drug Safety Futures 2020
Catalyzing the Transformation of Healthcare Innovation