Biblio

Found 35 results
2022
C. Young, Quinn, C., and Trusheim, M., “Durable cell and gene therapy potential patient and financial impact: US projections of product approvals, patients treated, and product revenues”, Drug Discovery Today, vol. 27, no. 1, 2022.
2021
H. - G. Eichler, Trusheim, M., Schwarser-Daum, B., Larholt, K., Zeitlinger, M., Brunninger, M., Sherman, M., Strutton, D., and Hirsch, G., “Precision reimbursement for precision medicine: using real world evidence to evolve from trial-and-project to track-and-pay to lean-and-predict”, Clinical Pharmacology & Therapeutics, 2021.
N. A. Ivica and Young, C. M., “Tracking the CAR-T Revolution: Analysis of Clinical Trials of CAR-T and TCR-T Therapies for the Treatment of Cancer (1997–2020)”, Healthcare, vol. 9, no. 8, 2021.
2020
K. Nam, Larholt, K., Beninger, P., Fritsche, D., Shoda, D., Ferguson, J., Bourgeois, F., Palmer, D., Katz, K., and Courtney, M., “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”, Therapeutic Innovation & Regulatory Science, 2020.
J. F. Barlow, Courtney, M. W., and Trusheim, M., “Payer Perspectives on Gene Therapy Reimbursement”, Pharmaceutical Executive, vol. 40, no. 4, 2020.
J. F. Barlow, Courtney, M. W., and Trusheim, M., “Payer Perspectives on Reimbursement of One-Time High-Cost Durable Therapies”, Pharmaceutical Executive, 2020. [Online]. Available: http://www.pharmexec.com/payer-perspectives-reimbursement-one-time-high-cost-durable-therapies.
2019
J. F. Barlow, Yang, M., and J. Teagarden, R., “Are Payers Ready, Willing, and Able to Provide Access to New Durable Gene Therapies?”, Value in Health, vol. 22, no. 6, p. 6, 2019.
G. Hirsch, “Leaping Together Toward Sustainable, Patient-Centered Innovation: The Value of a Multistakeholder Safe Haven for Accelerating System Change”, Clinical Pharmacology & Therapeutics, vol. 105, no. 4, 2019.
J. Barlow, Teagarden, R., and Trusheim, M., “Precision Financing of Durable, Potentially Curative Therapies”, Pharmaceutical Executive, 2019.
2018
M. R. Trusheim, Cassidy, W. M., and Bach, P. B., “Alternative State-Level Financing for Hepatitis C Treatment- The "Netflix Model"”, JAMA, 2018.
D. Han, Mytelka, D. S., Warren, G. L., Ciarametaro, M., and Trusheim, M., “Improving Management of Gene and Cell Therapies: The Orphan Reinsurer and Benefit Manager (ORBM)”, PharmaExec,com, 2018. [Online]. Available: http://www.pharmexec.com/improving-management-gene-and-cell-therapies.
2017
S. Blackburn, “Adaptive Pathways are Creating Win-Win Scenarios for Patients and Pharma”, AccessPoint, QuintilesIMS Real-World Insights, vol. 7, no. 13, 2017.
M. J. Cziraky, Larholt, K. M., and Pollock, M., “Conducting Pragmatic Trials: Design and Infrastructure Considerations for Successful Implementation of Trials Based on Real-World Evidence”, HealthCore. HealthCore, 2017.
M. Boname, Gee, A. Wagner, Addie, S., Beachy, S. H., Wizemann, T., and Trusheim, M., “Enabling Precision Medicine: The Role of Genetics in Clinical Drug Development: Proceedings of a Workshop”, Forum on Drug Discovery, Development, and Translation. National Academies Press, 2017.
2016
G. Hirsch, Trusheim, M., Cobbs, E., Bala, M., Garner, S., Hartman, D., Isaacs, K., Lumpkin, M., Lim, R., Oye, K., Pezalla, E., Saltonstall, P., and Selker, H., “Adaptive Biomedical Innovation: Evolving Our Global System to Sustainably and Safely Bring New Medicines to Patients in Need”, Clinical Pharmacology & Therapeutics, vol. 100, pp. 685–698, 2016.
G. K. Raju, Gurumurthi, K., Domike, R., Kazandjian, D., Blumenthal, G., Pazdur, R., and Woodcock, J., “A Benefit–Risk Analysis Approach to Capture Regulatory Decision-Making: Non-Small Cell Lung Cancer”, Clinical Pharmacology & Therapeutics, vol. 100, pp. 672–684, 2016.
J. C. Bouvy, Jonsson, P., Longson, C., Crabb, N., and Garner, S., “Health Technology Assessment in the Context of Adaptive Pathways for Medicines in Europe: Challenges and Opportunities”, Clinical Pharmacology & Therapeutics, vol. 100, pp. 594–597, 2016.
, Barone, P. W., Bellisario, A., Cooney, C. L., Sharp, P. A., Sinskey, A. J., Natesan, S., and Springs, S. L., “Leveraging Industry-Academia Collaborations in Adaptive Biomedical Innovation”, Clinical Pharmacology & Therapeutics, vol. 100, pp. 647–653, 2016.
D. Schulthess, Baird, L. G., Trusheim, M., Unger, T. F., Lumpkin, M., Hoos, A., Garner, S., Gavin, P., Goldman, M., Seigneuret, N., Chlebus, M., Van Baelen, K., Bergstrom, R., and Hirsch, G., “Medicines Adaptive Pathways to Patients (MAPPs): A Story of International Collaboration Leading to Implementation”, Therapeutic Innovation & Regulatory Science, vol. 50, pp. 347-354, 2016.
K. A. Oye, Eichler, H. G., Hoos, A., Mori, Y., Mullin, T. M., and Pearson, M., “Pharmaceuticals Licensing and Reimbursement in the European Union, United States, and Japan”, Clinical Pharmacology & Therapeutics, vol. 100, pp. 626–632, 2016.
M. R. Trusheim, Shrier, A. A., Antonijevic, Z., Beckman, R. A., Campbell, R. K., Chen, C., Flaherty, K. T., Loewy, J., Lacombe, D., Madhavan, S., Selker, H. P., and Esserman, L. J., “PIPELINEs: Creating Comparable Clinical Knowledge Efficiently by Linking Trial Platforms”, Clinical Pharmacology & Therapeutics, vol. 100, pp. 713–729, 2016.
H. - G. Eichler, Bloechl-Daum, B., Bauer, P., Bretz, F., Brown, J., Hampson, L. V., Honig, P., Krams, M., Leufkens, H., Lim, R., Lumpkin, M. M., Murphy, M. J., Pignatti, F., Posch, M., Schneeweiss, S., Trusheim, M., and Koenig, F., ““Threshold-crossing”: A Useful Way to Establish the Counterfactual in Clinical Trials?”, Clinical Pharmacology & Therapeutics, vol. 100, pp. 699–712, 2016.
2015
M. R. Trusheim and Berndt, E. R., “The clinical benefits, ethics, and economics of stratified medicine and companion diagnostics”, Drug Discovery Today, vol. 20, pp. 1439 - 1450, 2015.
H. - G. Eichler, Baird, L. G., 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, P. D., Skinner, M., ,, Tominaga, T., Trusheim, M. R., Tunis, S., Unger, T. F., Vamvakas, S., and Hirsch, G., “From adaptive licensing to adaptive pathways: Delivering a flexible life-span approach to bring new drugs to patients”, Clinical Pharmacology & Therapeutics, vol. 97, pp. 234–246, 2015.
K. A. Oye, Jain, G., Amador, M., Arnaout, R., Brown, J. S., Crown, W., Ferguson, J., Pezalla, E., Rassen, J. A., Selker, H. P., Trusheim, M., and Hirsch, G., “The next frontier: Fostering innovation by improving health data access and utilization”, Clinical Pharmacology & Therapeutics, vol. 98, pp. 514–521, 2015.

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