The NEWDIGS Publication Creation & Dissemination Policy can be found here.
Publications
Durable cell and gene therapy potential patient and financial impact: US projections of product approvals, patients treated, and product revenues
Drug Discovery Today ,
01/2022 ,
2022 ,
Tracking the CAR-T Revolution: Analysis of Clinical Trials of CAR-T and TCR-T Therapies for the Treatment of Cancer (1997–2020)
Healthcare ,
08/2021 ,
2021 ,
10.3390/healthcare9081062
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 ,
10/2021 ,
2021 ,
10.1002/cpt.2471
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 ,
10/2020 ,
2020 ,
Pharmaceutical Executive ,
01/09/2020 ,
2020 ,
Value in Health ,
06/2019 ,
2019 ,
10.1016/j.jval.2018.12.004
Pharmaceutical Executive ,
01/2019 ,
2019 ,
Leaping Together Toward Sustainable, Patient-Centered Innovation: The Value of a Multistakeholder Safe Haven for Accelerating System Change
Clinical Pharmacology & Therapeutics ,
04/2019 ,
2019 ,
10.1002/cpt.1237
JAMA ,
10/29/2018 ,
2018 ,
10.1001
PharmaExec,com ,
2018 ,
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
AccessPoint, QuintilesIMS Real-World Insights ,
05/2017 ,
2017 ,
Conducting Pragmatic Trials: Design and Infrastructure Considerations for Successful Implementation of Trials Based on Real-World Evidence
HealthCore ,
2017 ,
Health Technology Assessment in the Context of Adaptive Pathways for Medicines in Europe: Challenges and Opportunities
Clinical Pharmacology & Therapeutics ,
2016 ,
10.1002/cpt.448
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
Clinical Pharmacology & Therapeutics ,
2016 ,
10.1002/cpt.504
Clinical Pharmacology & Therapeutics ,
2016 ,
10.1002/cpt.515
Clinical Pharmacology & Therapeutics ,
2016 ,
10.1002/cpt.514
Medicines Adaptive Pathways to Patients (MAPPs): A Story of International Collaboration Leading to Implementation
Therapeutic Innovation & Regulatory Science ,
2016 ,
10.1177/2168479015618697
Clinical Pharmacology & Therapeutics ,
2016 ,
10.1002/cpt.505
Clinical Pharmacology & Therapeutics ,
2016 ,
10.1002/cpt.501
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
Clinical Pharmacology & Therapeutics ,
2015 ,
10.1002/cpt.191
Drug Discovery Today ,
2015 ,
https://doi.org/10.1016/j.drudis.2015.10.017
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
Clinical Trials ,
2014 ,
10.1177/1740774514526476
Clinical Pharmacology & Therapeutics ,
2014 ,
10.1038/clpt.2014.145
Expert Opinion on Orphan Drugs ,
2014 ,
10.1517/21678707.2014.947265
Scrip Regulatory Affairs ,
20 August ,
2013 ,
Clinical Pharmacology & Therapeutics ,
2013 ,
10.1038/clpt.2013.95
Comparison of Stakeholder Metrics for Traditional and Adaptive Development and Licensing Approaches to Drug Development
Therapeutic Innovation & Regulatory Science ,
2013 ,
10.1177/2168479013487355
Clin Pharmacol Ther ,
2012 Mar ,
2012 ,
10.1038/clpt.2011.345
Nat Rev Drug Discov ,
2009/12//print ,
2009 ,