2020 JITC – Establishing guidelines to harmonize tumor mutational burden (TMB): in silico assessment of variation in TMB quantification across diagnostic platforms View PDF
2019 An Exploratory Analysis of Real-World End Points for Assessing Outcomes Among Immunotherapy-Treated Patients With Advanced Non–Small-Cell Lung Cancer View PDF
Incorporating Patient Advocates in Oncology Clinical Development: Lessons Learned From a Novel Pilot Program View PDF
Use of FDA-Approved and Laboratory-Developed Tests in Advanced Non-Small Cell Lung Cancer: Results of a Retrospective Market Analysis View PDF
2016 A Century of Medical Product Regulation: The Historic Framework for Medical Product Regulation View PDF
2016 Regulatory watch: Impact of breakthrough therapy designation on cancer drug development View PDF
2013 Considerations for the successful co-development of targeted cancer therapies and companion diagnostics. View PDF
2013 Use of multiple endpoints and approval paths depicts a decade of FDA oncology drug approvals. View PDF
