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Comprehensive functional characterization of cancer–testis antigens defines obligate participation in multiple hallmarks of cancer
TLDR
A multidimensional functional genomics approach is implemented that incorporates 7 different phenotypic assays in 11 distinct disease settings and discovers that Foetal and Adult Testis Expressed 1 (FATE1) is a key survival factor in multiple oncogenic backgrounds.
Multiple Cancer Testis Antigens Function To Support Tumor Cell Mitotic Fidelity
TLDR
It is demonstrated that combining paclitaxel with a small-molecule inhibitor of the gametogenic and tumor cell mitotic protein TACC3 leads to enhanced centrosomal abnormalities, activation of death programs, and loss of anchorage-independent growth.
The Role of Public–Private Partnerships in Catalyzing the Critical Path
TLDR
Collaborations with Public–Private Partnerships (PPPs) helped address several CPOL priorities to yield meaningful results to benefit public health.
2018 White Paper on Recent Issues in Bioanalysis: focus on flow cytometry, gene therapy, cut points and key clarifications on BAV (Part 3 - LBA/cell-based assays: immunogenicity, biomarkers and PK
TLDR
The 2018 White Paper encompasses recommendations emerging from the extensive discussions held during the workshop and is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance.
SIK2 Restricts Autophagic Flux To Support Triple-Negative Breast Cancer Survival
TLDR
Findings indicate that claudin-low tumor cells rely on Sik2 to restrain maladaptive autophagic activation, and inhibition of SIK2 presents itself as an intervention opportunity to reactivate this tumor suppressor mechanism.
Role of Guidance and Policy in Enhancing the Impact of Clinical Pharmacology in Drug Development, Regulation, and Use
TLDR
The operational model for guidance development is shared, the philosophy on collaboration is described, and the impact on clinical pharmacology guidances and policies is detail with a goal of increasing transparency among stakeholders.
Proceedings of a Workshop: Precision Dosing: Defining the Need and Approaches to Deliver Individualized Drug Dosing in the Real‐World Setting
Defining and predicting drug dosing has improved substantially over the past 20 years. However, dosing for newly approved drugs by the US Food and Drug Administration (FDA) often does not include
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