Precision Financing of Durable, Potentially Curative Therapies
Pharmaceutical Executive, January 27, 2019
Trusheim, Jane Barlow Russell Teagarden Mark
Adaptive licensing: taking the next step in the evolution of drug approval
Clinical Pharmacology and Therapeutics, March 2012
H.-G. Eichler, K. Oye, L. G. Baird, E. Abadie, J. Brown, C. L. Drum, J. Ferguson, S. Garner, P. Honig, M. Hukkelhoven, J. C. W. Lim, R. Lim, M. M. Lumpkin, G. Neil, B. O'Rourke, E. Pezalla, D. Shoda, V. Seyfert-Margolis, E. V. Sigal, J. Sobotka, D. Tan, T. F. Unger, and G. Hirsch
The future of drug development: advancing clinical trial design
Nature Reviews Drug Discovery, December 2009
John Orloff, Frank Douglas, Jose Pinheiro, Susan Levinson, Michael Branson, Pravin Chaturvedi, Ene Ette, Paul Gallo, Gigi Hirsch, Cyrus Mehta, Nitin Patel, Sameer Sabir, Stacy Springs, Donald Stanski, Matthias R. Evers, Edd Fleming, Navjot Singh, Tony Tramontin, and Howard Golub
Comparison of Stakeholder Metrics for Traditional and Adaptive Development and Licensing Approaches to Drug Development
Therapeutic Innovation & Regulatory Science, July 1, 2013
Lynn G. Baird, Mark R. Trusheim, Hans-Georg Eichler, Ernst R. Berndt, and Gigi Hirsch
Curing Consortium Fatigue
Science Translational Medicine, August 28, 2013
Magdalini Papadaki and Gigi Hirsch
Legal Foundations of Adaptive Licensing
Clinical Pharmacology & Therapeutics, September 1, 2013
Oye, L. G. Baird, A. Chia, S. Hocking, P. B. Hutt, D. Lee, L. Norwalk, and V. Salvatore
The Janus initiative: A multi-stakeholder process and tool set for facilitating and quantifying Adaptive Licensing discussions
Health Policy and Technology, December 1, 2014
Mark R. Trusheim, Lynn G. Baird, Sarah Garner, Robyn Lim, Nitin Patel, and Gigi Hirsch
Access and availability of orphan drugs in the United States: advances or cruel hoaxes?
Expert Opinion on Orphan Drugs, November 1, 2014
Russell Teagarden, Thomas F. Unger, and Gigi Hirsch
Accelerated Access to Innovative Medicines for Patients in Need
Clinical Pharmacology & Therapeutics, November 1, 2014
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, and G. Hirsch
A community consultation survey to evaluate support for and success of the IMMEDIATE trial
Clinical Trials, April 1, 2014
Joni R. Beshansky, Patricia R. Sheehan, Kenneth J. Klima, Nira Hadar, Ellen M. Vickery, and Harry P. Selker
The clinical benefits, ethics, and economics of stratified medicine and companion diagnostics
Drug Discovery Today, December 1, 2015
Mark R. Trusheim and Ernst R. Berndt
The next frontier: Fostering innovation by improving health data access and utilization
Clinical Pharmacology & Therapeutics, November 1, 2015
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, and G. Hirsch
Health Technology Assessment in the Context of Adaptive Pathways for Medicines in Europe: Challenges and Opportunities
Clinical Pharmacology & Therapeutics, December 1, 2016
C. Bouvy, P. Jonsson, C. Longson, N. Crabb, and S. Garner
A Benefit–Risk Analysis Approach to Capture Regulatory Decision-Making: Non-Small Cell Lung Cancer
Clinical Pharmacology & Therapeutics, December 1, 2016
K. Raju, K. Gurumurthi, R. Domike, D. Kazandjian, G. Blumenthal, R. Pazdur, and J. Woodcock
Pharmaceuticals Licensing and Reimbursement in the European Union, United States, and Japan
Clinical Pharmacology & Therapeutics, December 1, 2016
A. Oye, H. G. Eichler, A. Hoos, Y. Mori, T. M. Mullin, and M. Pearson
Medicines Adaptive Pathways to Patients (MAPPs): A Story of International Collaboration Leading to Implementation
Therapeutic Innovation & Regulatory Science, December 10, 2015
Duane Schulthess, Lynn G. Baird, Mark Trusheim, Thomas F. Unger, Murray Lumpkin, Anton Hoos, Sarah Garner, Pamela Gavin, Michel Goldman, Nathalie Seigneuret, Magda Chlebus, Karin Van Baelen, Richard Bergstrom, Gigi Hirsch
PIPELINEs: Creating Comparable Clinical Knowledge Efficiently by Linking Trial Platforms
Clinical Pharmacology & Therapeutics, September 19, 2016
Trusheim, Aa. Shrier, Z. Antonijevic, Ra. Beckman, Rk. Campbell, C. Chen, Kt. Flaherty, J. Loewy, D. Lacombe, S. Madhavan, Hp. Selker, and Lj. Esserman
“Threshold‐crossing”: A Useful Way to Establish the Counterfactual in Clinical Trials?
Clinical Pharmacology & Therapeutics, September 21, 2016
Hans-Georg Eichler
Leveraging Industry-Academia Collaborations in Adaptive Biomedical Innovation
Clinical Pharmacology & Therapeutics, December 1, 2016
R. Stewart, P. W. Barone, A. Bellisario, C. L. Cooney, P. A. Sharp, A. J. Sinskey, S. Natesan, and S. L. Springs
Leveraging Industry‐Academia Collaborations in Adaptive Biomedical Innovation
Clinical Pharmacology & Therapeutics, September 12, 2016
SR Stewart, PW Barone, A Bellisario, CL Cooney, PA Sharp, AJ Sinskey, S Natesan, and SL Springs
Adaptive Biomedical Innovation: Evolving Our Global System to Sustainably and Safely Bring New Medicines to Patients in Need
Clinical Pharmacology & Therapeutics, September 14, 2016
G Hirsch, M Trusheim, E Cobbs, M Bala, S Garner, D Hartman, K Isaacs, M Lumpkin, R Lim, K Oye, E Pezalla, P Saltonstall, and H Selker
Enabling Precision Medicine: The Role of Genetics in Clinical Drug Development: Proceedings of a Workshop
Forum on Drug Discovery, Development, and Translation and the Roundtable on Genomics and Precision Health of the National Academies of Sciences, Engineering, and Medicine, March 8, 2017
Improving Management of Gene and Cell Therapies
Pharmaceutical Executive, September 10, 2018
Michael Ciarametaro, Mark Trusheim, Daniel S. Mytelka, Gregory L. Warren, and Donald Han
Alternative State-Level Financing for Hepatitis C Treatment—The “Netflix Model”
JAMA, October 29, 2018
Mark R. Trusheim, William M. Cassidy, and Peter B. Bach
Are Payers Ready, Willing, and Able to Provide Access to New Durable Gene Therapies?
Value in Health, June 2019
Jane F. Barlow, Mo Yang, and J. Russell Teagarden
Estimating the Clinical Pipeline of Cell and Gene Therapies and Their Potential Economic Impact on the US Healthcare System
Value in Health, June 2019
Casey Quinn, Colin Young, Jonathan Thomas, and Mark Trusheim
Leaping Together Toward Sustainable, Patient‐Centered Innovation: The Value of a Multistakeholder Safe Haven for Accelerating System Change
Clinical Pharmacology & Therapeutics, November 2, 2018
Gigi Hirsch
AccessPoint is published twice yearly by QuintilesIMS Real-World Insights
QuintilesIMS, May 2017
Jon Resnick
From adaptive licensing to adaptive pathways: Delivering a flexible life-span approach to bring new drugs to patients
Clinical Pharmacology & Therapeutics, March 2015
H-G Eichler, Lg 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, Pd Siviero, M Skinner, Jr Teagarden, T Tominaga, Mr Trusheim, S Tunis, Tf Unger, S Vamvakas, G Hirsch
Payer Perspectives on Reimbursement of One-Time High-Cost Durable Therapies
Pharmaceutical Executive, January 9, 2020
Matt W. Courtney, Jane F. Barlow, Mark Trusheim