Publications by authors named "Jeff D Allen"

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Hurry Up and Wait: Timelines and Takeaways from the Biomarker Qualification Program.
Grace Collins, Jeff D Allen, Hillary S Andrews, Bernat Navarro-Serer, Mark D Stewart

Ther Innov Regul Sci· January 2026

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Enabling access to genetically modified cell therapies through flexible approaches to manufacturing and cost recovery.
Mark D Stewart, Christopher R Cabanski, Jeff D Allen, John E Connolly, Ben M Beneski

J Immunother Cancer· December 2025

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Companion Diagnostic FDA Review Flexibilities: An Assessment of CDx for NSCLC to Support Aligned Approaches for Validation.
Hillary S Andrews, Grace Collins, Bernat Navarro-Serer, Mark D Stewart, Jeff D Allen

Ther Innov Regul Sci· July 2025

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ctDNA Clearance as an Early Indicator of Improved Clinical Outcomes in Advanced NSCLC Treated with TKI: Findings from an Aggregate Analysis of Eight Clinical Trials.
Hillary S Andrews, Nevine Zariffa, Katherine K Nishimura, Stephanie H Choi, Shibing Deng, Jeff D Allen

Clin Cancer Res· June 2025

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Intentional heterogeneity in autologous cell-based gene therapies: strategic considerations for first-in-human trials.
Christopher R Cabanski, EnJun Yang, Mark D Stewart, Jeff D Allen, John E Connolly

J Immunother Cancer· June 2025

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An Evaluation of Novel Oncology Approvals with a PMR/C for Assessing Data in Racial and Ethnic Populations Underrepresented in Premarket Clinical Trials.
Grace Collins, Hillary S Andrews, Brittany McKelvey, Carrigan Rice, Jeff D Allen

Clin Cancer Res· August 2024

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Evaluation of Real-World Tumor Response Derived From Electronic Health Record Data Sources: A Feasibility Analysis in Patients With Metastatic Non-Small Cell Lung Cancer Treated With Chemotherapy.
Brittany A McKelvey, Elizabeth Garrett-Mayer, Donna R Rivera, Amy Alabaster, Hillary S Andrews, Jeff D Allen

JCO Clin Cancer Inform· August 2024

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Accelerating the development of genetically engineered cellular therapies: a framework for extrapolating data across related products.
Mark D Stewart, Michael Kalos, Vicki Coutinho, Marc Better, Jonathan Jazayeri, Jeff D Allen

Cytotherapy· July 2024

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Advancing Evidence Generation for Circulating Tumor DNA: Lessons Learned from A Multi-Assay Study of Baseline Circulating Tumor DNA Levels across Cancer Types and Stages.
Brittany A McKelvey, Hillary S Andrews, Frederick L Baehner, James Chen, Carin R Espenschied, Jeff D Allen

Diagnostics (Basel)· April 2024

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An Analysis of Dosing-Related Postmarketing Requirements for Novel Oncology Drugs Approved by the U.S. Food and Drug Administration, 2012-2022.
Grace Collins, Brittany McKelvey, Hillary S Andrews, Jeff D Allen, Mark D Stewart

Clin Cancer Res· March 2024

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The Friends of Cancer Research Real-World Data Collaboration Pilot 2.0: Methodological Recommendations from Oncology Case Studies.
Donna R Rivera, Henry J Henk, Elizabeth Garrett-Mayer, Jennifer B Christian, Andrew J Belli, Jeff D Allen

Clin Pharmacol Ther· January 2022

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The Value of Addressing Patient Preferences.
Jeff D Allen, Mark D Stewart, Samantha A Roberts, Ellen V Sigal

Value Health· February 2017

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Lung Master Protocol (Lung-MAP)-A Biomarker-Driven Protocol for Accelerating Development of Therapies for Squamous Cell Lung Cancer: SWOG S1400.
Roy S Herbst, David R Gandara, Fred R Hirsch, Mary W Redman, Michael LeBlanc, Jeff D Allen

Clin Cancer Res· April 2015

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Considerations for the successful co-development of targeted cancer therapies and companion diagnostics.
Jane Fridlyand, Richard M Simon, Jessica C Walrath, Nancy Roach, Richard Buller, Jeff D Allen

Nat Rev Drug Discov· October 2013

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Developing standards for breakthrough therapy designation in oncology.
Sandra J Horning, Daniel A Haber, Wendy K D Selig, S Percy Ivy, Samantha A Roberts, Jeff D Allen

Clin Cancer Res· August 2013

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Use of multiple endpoints and approval paths depicts a decade of FDA oncology drug approvals.
Michael B Shea, Samantha A Roberts, Jessica C Walrath, Jeff D Allen, Ellen V Sigal

Clin Cancer Res· July 2013

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Reducing the toxicity of cancer therapy: recognizing needs, taking action.
Charles S Cleeland, Jeff D Allen, Samantha A Roberts, Joanna M Brell, Sergio A Giralt

Nat Rev Clin Oncol· July 2012

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Despite criticism of the FDA review process, new cancer drugs reach patients sooner in the United States than in Europe.
Samantha A Roberts, Jeff D Allen, Ellen V Sigal

Health Aff (Millwood)· July 2011

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