Explanipedia

Enhancing Translational Research Impact Through Collaborative Process Innovation Open

Marisha E. Palm, Sharon Phares, Gigi Hirsch · 2025

555 Design Lab Methodology Supports Innovation in Clinical Trials Open

Marisha E. Palm, Paul Beninger, Denise H. Daudelin, Noe Duenas, Gigi Hirsch , et al. · 2024

OBJECTIVES/GOALS: Since 2017, we have used the Design Lab methodology to support investigators taking innovative approaches to clinical effectiveness trial design. To date we have held 12 Design Labs and this year we are creating a handboo…

Extending the Vision of Adaptive Point-Of-Care Platform Trials to Improve Targeted Use of Drug Therapy Regimens: A Novel Approach in the Learning Healthcare System Toolkit Open

Gigi Hirsch, Priscilla Velentgas, Jeffrey R. Curtis, Kay Larholt, Jay JH Park , et al. · 2023

Precision Reimbursement for Precision Medicine: Using Real‐World Evidence to Evolve From Trial‐and‐Project to Track‐and‐Pay to Learn‐and‐Predict Open

Hans‐Georg Eichler, Mark Trusheim, Brigitte Schwarzer‐Daum, Kay Larholt, Markus Zeitlinger , et al. · 2021

Basic scientists and drug developers are accelerating innovations toward the goal of precision medicine. Regulators create pathways for timely patient access to precision medicines, including individualized therapies. Healthcare payors ack…

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 Open

Kevin Nam, Kay Larholt, Gigi Hirsch, Paul Beninger, David Fritsche , et al. · 2020

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 Open

Kevin Nam, Kay Larholt, Gigi Hirsch, Paul Beninger, David Fritsche , et al. · 2020

Recognizing that Evidence is Made, not Born Open

Robyn Lim, David K. Lee, Pierre Sabourin, John Ferguson, Marilyn Metcalf , et al. · 2018

Therapeutic product development, licensing and reimbursement may seem a well‐oiled machine, but continuing high attrition rates, regulatory refusals, and patients’ access issues suggest otherwise; despite serious efforts, gaps persist betw…

Leaping Together Toward Sustainable, Patient‐Centered Innovation: The Value of a Multistakeholder Safe Haven for Accelerating System Change Open

Gigi Hirsch · 2018

Successfully delivering on the promise of emerging science in a world of value-driven healthcare requires that we fundamentally reengineer biomedical innovation processes to be both patient centered and sustainable. Massachusetts Institute…

Issue Information – TOC Open

Jacoline C. Bouvy, Páll Jónsson, Carole Longson, Michelle Whirl‐Carrillo, Katrin Sangkuhl , et al. · 2016

This issue of CPT contains a suite of papers on the theme of Adaptive Biomedical Innovation (ABI) which can be defined as a multi-stakeholder approach to product and process innovation aimed at accelerating the delivery of clinical value t…

Adaptive Biomedical Innovation: Evolving Our Global System to Sustainably and Safely Bring New Medicines to Patients in Need Open

Gigi Hirsch, Mark Trusheim, E Cobbs, M Bala, S Garner , et al. · 2016

The current system of biomedical innovation is unable to keep pace with scientific advancements. We propose to address this gap by reengineering innovation processes to accelerate reliable delivery of products that address unmet medical ne…

The next frontier: Fostering innovation by improving health data access and utilization Open

KA Oye, Geetika Jain, M. Amador, Ramy Arnaout, Jeffrey S. Brown , et al. · 2015

Beneath most lively policy debates sit dry-as-dust theoretical and methodological discussions. Current disputes over the EU Adaptive Pathways initiative1, 2 and the proposed US 21st Century Cures Act3 may ultimately rest on addressing arca…

The next frontier: Fostering innovation by improving health data access and utilization Open

Kenneth A. Oye, Gagan Jain, M. Amador, Ramy Arnaout, Jeffrey S. Brown , et al. · 2015

Beneath most lively policy debates sit dry-as-dust theoretical and methodological discussions. Current disputes over the EU Adaptive Pathways initiative and the proposed US 21st Century Cures Act may ultimately rest on addressing arcane is…

From adaptive licensing to adaptive pathways: Delivering a flexible life‐span approach to bring new drugs to patients Open

H‐G Eichler, LG Baird, Richard Barker, Brigitte Bloechl‐Daum, Finn Børlum Kristensen , et al. · 2015

The concept of adaptive licensing (AL) has met with considerable interest. Yet some remain skeptical about its feasibility. Others argue that the focus and name of AL should be broadened. Against this background of ongoing debate, we exami…

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