WCG Clinical
NOVEMBER 17, 2023
Although the NIH Guidelines were originally written with non-clinical laboratory research in mind, they also apply to human gene transfer (HGT) research, wherein rsNA or rsNA-containing products are administered to research participants. Since then, however, certain genetic engineering technologies (e.g.,
Camargo
NOVEMBER 11, 2020
In November 2017, Foundation Medicine received approval for FoundationOne CDx , a genomic profiling test for solid state tumors, which paved the way for partnerships with pharma companies’ therapeutics. Manager of Regulatory Compliance. In 2019, Foundation Medicine and Bayer Healthcare Pharmaceuticals, Inc. Co-Authors: Jenny Fielder.
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Drug Discovery World
MARCH 27, 2023
Genomics is driving a revolution in drug development and, in the long run, the state of public healthcare. The first draft human genome took a decade to create, and 13 years to complete. A robust environment will contain secure access controls that can prevent and detect misuse of data.
Drug Discovery World
MAY 17, 2024
Cancer datasets are particularly sensitive since they contain confidential health information, necessitating stringent ethical and privacy measures. The need to protect this data isn’t just about compliance with laws like HIPAA or GDPR; it’s about maintaining trust. National Human Genome Research Institute.
Advarra
SEPTEMBER 29, 2022
regulatory agencies recommend written ICFs contain easy-to-read and understandable information so a lay person can make an informed decision about participating in a study. For research regulated by the Common Rule: For research involving biospecimens , whether the research will (if known) or might include whole genome sequencing.
The Pharma Data
DECEMBER 12, 2020
AstraZeneca has developed a broad range of technologies, initially focused on small molecules and biologics and with a growing focus in precision medicine, genomics, oligonucleotides and epigenetics. More recently, AstraZeneca has increased its efforts in immunology research and the development of medicines for immune-mediated diseases.
XTalks
FEBRUARY 4, 2021
The power of leveraging clinical data to decipher disease mechanisms and fuel drug discovery has rapidly grown in the era of genomics and personalized medicine. Genuity Science focuses on population genomics as a tool to derive novel biological insights through partnerships with industry-leading pharmaceutical and biotech companies.
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