Publications

S Blackburn
Adaptive Pathways are Creating Win-Win Scenarios for Patients and Pharma

AccessPoint, QuintilesIMS Real-World Insights, Volume 7, Issue 13, May 2017
MJ Cziraky, KM Larholt, M Pollock
Conducting Pragmatic Trials: Design and Infrastructure Considerations for  Successful Implementation of Trials Based on Real-World Evidence

HealthCore, May 24, 2017
G Hirsch, M Trusheim, E Cobbs, M Bala, S Garner, D Hartman, K Isaacs, M Lumpkin, R Lim, K Oye, et al
Adaptive Biomedical Innovation: Evolving Our Global System to Sustainably and Safely Bring New Medicines to Patients in Need.

Clinical Pharmacology & Therapeutics, special issue on Adaptive Biomedical Innovation, published 14 November 2016 DOI:10.1002
GK 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, special issue on Adaptive Biomedical Innovation, published 14 November 2016 DOI:10.1002
KA Oye, HG Eichler, A Hoos, Y Mori, TM Mullin, M Pearson
Pharmaceuticals Licensing and Reimbursement in the European Union, United States, and Japan.

Clinical Pharmacology & Therapeutics, special issue on Adaptive Biomedical Innovation, published 14 November 2016 DOI:10.1002
MR Trusheim, AA Shrier, Z Antonijevic, RA Beckman, RK Campbell, C Chen, KT Flaherty, J Loewy, D Lacombe, S Madhavan, et al
PIPELINEs: Creating Comparable Clinical Knowledge Efficiently by Linking Trial Platforms.

Clinical Pharmacology & Therapeutics, special issue on Adaptive Biomedical Innovation, published 14 November 2016 DOI:10.1002
H‐G Eichler, B Bloechl‐Daum, P Bauer, F Bretz, J Brown, LV Hampson, P Honig, M Krams, H Leufkens, R Lim, et al
“Threshold-crossing”: A Useful Way to Establish the Counterfactual in Clinical Trials?

Clinical Pharmacology & Therapeutics, special issue on Adaptive Biomedical Innovation, published 14 November 2016 DOI:10.1002
SR Stewart, PW Barone, A Bellisario, CL Cooney, PA Sharp, AJ Sinskey, S Natesan, SL Springs
Leveraging Industry-Academia Collaborations in Adaptive Biomedical Innovation.

Clinical Pharmacology & Therapeutics, special issue on Adaptive Biomedical Innovation, published 14 November 2016 DOI:10.1002
JC Bouvy, P Jonsson, C Longson, N Crabb and S Garner
Health Technology Assessment in the Context of Adaptive Pathways for Medicines in Europe: Challenges and Opportunities

Clinical Pharmacology & Therapeutics, special issue on Adaptive Biomedical Innovation, published 14 November 2016 DOI:10.1002
Trushiem M, & Brendt, E.
The Clinical Benefits, Ethics and Economics of Stratified Medicine and Companion Diagnostics

Drug Discovery Today, Special Issue on Precision Medicine. December, 2015; doi:10.1016
Schulthess D, Baird L, et al.
Medicines Adaptive Pathways to Patients (MAPPs): A Story of International Collaboration Leading to Implementation

Therapeutic Innovation & Regulatory Science, published online December 10, 2015; doi: 10.1177/2168479015618697
Oye K, Jain G, et al.
The Next Frontier: Fostering Innovation by Improving Health Data Access and Utilization

Clinical Pharmacology & Therapeutics, published online August 3, 2015; 10.1002/cpt.191
Eichler HG, Baird L, et al.
From adaptive licensing to adaptive pathways: Delivering a flexible life-span approach to bring new drugs to patients

Clinical Pharmacology & Therapeutics, published online December 12, 2014; DOI: 10.1002/cpt.59
Trusheim M, Baird, L, Garner, S, Lim, R, Patel, N and Hirsch, G.
The Janus initiative: A multi-stakeholder process and tool set for facilitating and quantifying adaptive licensing discussions

Health Policy and Technology, published online October 20, 2014
Teagarden R, Unger T, and Hirsch G.
Access and availability of orphan drugs in the United States: advances or cruel hoaxes?

Informa healthcare, September 26, 2014
Baird LG, Banken R, Eichler HG, Kristensen FB, Lee DK, Lim JCW, Lim R, Longson C, Pezalla E, Salmonson T, Samaha D, Tunis S, Woodcock J, & Hirsch G.
Accelerated Access to Innovative Medicines for Patients in Need

Clinical Pharmacology & Therapeutics,13 August 2014; doi: 10.1038
Baird LG & Hirsch G.
Be bold and creative: food for thought for drug sponsors pursuing adaptive licensing

Scrip Regulatory Affairs, August 2014
Beshansky J, Sheehan P, Klima K, Hadar N, Vickery E, Selker H.
A community consultation survey to evaluate support for and success of the IMMEDIATE trial

Clinical Trials, 11: 178 March 31, 2014
Baird LG and Hirsch G.
Adaptive Licensing: Creating a Safe Haven for Discussions

Scrip Regulatory Affairs, 10-11, 5 September 2013
Baird LG, Teagarden R, Unger T, Hirsch G.
New medicines eight years faster to patients: blazing a new trail in drug development with adaptive licensing

Scrip Regulatory Affairs, June 2013
Papadaki M and Hirsch G.
Curing Consortium Fatigue

Sci. Transl. Med. 5, 200fs35, 2013
Oye K, Baird LG, et al.
Legal Foundations of Adaptive Licensing

Clin. Pharmacol. Ther. 94 : 309-311; doi:10.1038/clpt.2013.95
Baird LG, Berndt ER, Eichler HG, Hirsch G, Trusheim MR.
Comparison of Stakeholder Metrics for Traditional and Adaptive Development and Licensing Approaches to Drug Development

Therapeutic Innovation & Regulatory Science. 47 (4), July 2013. (p. 474-483)
Baird LG, Teagarden R, Unger T, Hirsch G.
New Medicines Eight Years Faster to Patients: Blazing a New Trail in Drug Development with Adaptive Licensing

Scrips Regulatory Affairs. June 2013
Olson S, Claiborn A.
Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development: Workshop Summary

Institute of Medicine of the National Academies, The National Academies Press. Apr 2012. (p. 57-60)
Eichler HG, Oye K, Baird LG, Brown J, Drum CL, Ferguson J, Garner S, Honig P, Hukkelhoven M, Lim JCW, Lim R, Lumpkin M, Neil G, O’Rourke B, Pezalla E, Shoda D, Seyfert-Margolis V, Sigal EV, Sobotka J, Tan D, Unger TF and Hirsch G.
Adaptive Licensing: Taking the Next Step in the Evolution of Drug Approval

Nature, 91(3):426-437, Mar 2012
Orloff, J, Douglas F, Pinheiro J, Levinson S, Branson M, Chaturvedi P, Ette E, Gallo P, Hirsch G, Mehta C, Patel N,Sabir S, Springs S, Stanski D, Evers MR, Fleming E, Singh N, Tramontin T and Golub H.
The Future of Drug Development: Advancing Clinical Trial Design

Nature Reviews Drug Discovery, 8(12):949-57, Dec 2009