Cross‐company collaboration to leverage analytics for clinical quality and accelerate drug development: The IMPALA industry group

CPT Pharmacometrics & Systems Pharmacology ◽

10.1002/psp4.12677 ◽

2021 ◽

Author(s):

Timothé Ménard ◽

Kyle Young ◽

Laura Siegel ◽

Jennifer Emerson ◽

Robert Studt ◽

...

Keyword(s):

Drug Development ◽

Clinical Quality ◽

Industry Group

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Clinical Quality Considerations when Using Next-Generation Sequencing (NGS) in Clinical Drug Development

Therapeutic Innovation & Regulatory Science ◽

10.1007/s43441-021-00308-6 ◽

2021 ◽

Author(s):

Timothé Ménard ◽

Alaina Barros ◽

Christopher Ganter

Keyword(s):

Clinical Trials ◽

Next Generation Sequencing ◽

Drug Development ◽

Precision Medicine ◽

Service Providers ◽

Clinical Quality ◽

Clinical Drug Development ◽

Next Generation Sequencing Ngs ◽

Generation Sequencing ◽

Clinical Drug

AbstractNext-generation sequencing (NGS) and decreased costs of genomic testing are changing the paradigm in precision medicine and continue to fuel innovation. Integration of NGS into clinical drug development has the potential to accelerate clinical trial conduct and ultimately will shape the landscape of clinical care by making it easier to identify patients who would benefit from particular therapy(ies) and to monitor treatment outcomes with less invasive tests. This has led to an increased use of NGS service providers by pharmaceutical sponsors: to screen patients for clinical trials eligibility and for patient stratification, expanded Companion Diagnostic (CDx) development for treatment recommendations and Comprehensive Genomic profiling (CGP). These changes are reshaping the face of clinical quality considerations for precision medicine. Although some clinical quality considerations do exist in Health Authorities (HA) guidances and regulations (e.g., International Conference of Harmonization Good Clinical Practices—GCP), there is currently no holistic GxP-like detailed framework for pharmaceutical sponsors using NGS service providers in clinical trials, or for the development of CDx and CGP. In this research, we identified existing and applicable regulations, guidelines and recommendations that could be translated into clinical quality considerations related to technology, data quality, patients and oversight. We propose these considerations as a basis for pharmaceutical sponsors using NGS service providers in clinical drug development to develop a set of guidelines for NGS clinical quality.

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