Biblio
Found 35 results
“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.
, “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.
, “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.
, “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.
, “Payer Perspectives on Gene Therapy Reimbursement”, Pharmaceutical Executive, vol. 40, no. 4, 2020.
, “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.
, “Are Payers Ready, Willing, and Able to Provide Access to New Durable Gene Therapies?”, Value in Health, vol. 22, no. 6, p. 6, 2019.
, “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.
, “Precision Financing of Durable, Potentially Curative Therapies”, Pharmaceutical Executive, 2019.
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“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.
, “Adaptive Pathways are Creating Win-Win Scenarios for Patients and Pharma”, AccessPoint, QuintilesIMS Real-World Insights, vol. 7, no. 13, 2017.
, “Conducting Pragmatic Trials: Design and Infrastructure Considerations for Successful Implementation of Trials Based on Real-World Evidence”, HealthCore. HealthCore, 2017.
, “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.
, “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.
, “A Benefit–Risk Analysis Approach to Capture Regulatory Decision-Making: Non-Small Cell Lung Cancer”, Clinical Pharmacology & Therapeutics, vol. 100, pp. 672–684, 2016.
, “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.
, “Leveraging Industry-Academia Collaborations in Adaptive Biomedical Innovation”, Clinical Pharmacology & Therapeutics, vol. 100, pp. 647–653, 2016.
, “Medicines Adaptive Pathways to Patients (MAPPs): A Story of International Collaboration Leading to Implementation”, Therapeutic Innovation & Regulatory Science, vol. 50, pp. 347-354, 2016.
, “Pharmaceuticals Licensing and Reimbursement in the European Union, United States, and Japan”, Clinical Pharmacology & Therapeutics, vol. 100, pp. 626–632, 2016.
, “PIPELINEs: Creating Comparable Clinical Knowledge Efficiently by Linking Trial Platforms”, Clinical Pharmacology & Therapeutics, vol. 100, pp. 713–729, 2016.
, ““Threshold-crossing”: A Useful Way to Establish the Counterfactual in Clinical Trials?”, Clinical Pharmacology & Therapeutics, vol. 100, pp. 699–712, 2016.
, “The clinical benefits, ethics, and economics of stratified medicine and companion diagnostics”, Drug Discovery Today, vol. 20, pp. 1439 - 1450, 2015.
, “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.
, “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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