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Federico Goodsaid

Center for Drug Evaluation and Research
Food and Drug Administration

74

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Characterization and Validation of Biomarkers in Drug Development: Regulatory Perspective

2020
- Federico Goodsaid
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A precision medicine framework using artificial intelligence for the identification and confirmation of genomic biomarkers of response to an Alzheimer's disease therapy: Analysis of the blarcamesine (ANAVEX2-73) Phase 2a clinical study.

2020 Alzheimer's & Dementia: Translational Research & Clinical Interventions
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Biomarker Qualification and Companion Diagnostics

2019
- Federico Goodsaid
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A robust targeted sequencing approach for low input and variable quality DNA from clinical samples

2018 npj Genomic Medicine
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Regulatory landscapes for biomarkers and diagnostic tests: Qualification, approval, and role in clinical practice:

2018 Experimental Biology and Medicine
- William Mattes
- Federico Goodsaid
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Abstract 4019: A PCR-bias free capture-based library preparation platform permitting highly accurate and sensitive CNA detection in tumor molecular profiling and liquid biopsy

2017 Cancer Research
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TOMA OS-Seq: An efficient oligo-selective sequencing solution to identify tumor-specific mutations and copy number alterations.

2016 Journal of Clinical Oncology
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Abstract 2712: Joint somatic mutation and germline variant identification and scoring from tumor molecular profiling and ct-DNA monitoring of cancer patients by high-throughput sequencing

2016 Cancer Research
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Recommendations for the development of rare disease drugs using the accelerated approval pathway and for qualifying biomarkers as primary endpoints

2015 Orphanet Journal of Rare Diseases
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Impact of Biomarker Qualification Regulatory Processes on the Critical Path for Drug Development

2013
- Federico Goodsaid
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