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1.
Public Health Rep ; 136(5): 554-561, 2021.
Article in English | MEDLINE | ID: mdl-34139910

ABSTRACT

OBJECTIVES: Federal open-data initiatives that promote increased sharing of federally collected data are important for transparency, data quality, trust, and relationships with the public and state, tribal, local, and territorial partners. These initiatives advance understanding of health conditions and diseases by providing data to researchers, scientists, and policymakers for analysis, collaboration, and use outside the Centers for Disease Control and Prevention (CDC), particularly for emerging conditions such as COVID-19, for which data needs are constantly evolving. Since the beginning of the pandemic, CDC has collected person-level, de-identified data from jurisdictions and currently has more than 8 million records. We describe how CDC designed and produces 2 de-identified public datasets from these collected data. METHODS: We included data elements based on usefulness, public request, and privacy implications; we suppressed some field values to reduce the risk of re-identification and exposure of confidential information. We created datasets and verified them for privacy and confidentiality by using data management platform analytic tools and R scripts. RESULTS: Unrestricted data are available to the public through Data.CDC.gov, and restricted data, with additional fields, are available with a data-use agreement through a private repository on GitHub.com. PRACTICE IMPLICATIONS: Enriched understanding of the available public data, the methods used to create these data, and the algorithms used to protect the privacy of de-identified people allow for improved data use. Automating data-generation procedures improves the volume and timeliness of sharing data.


Subject(s)
COVID-19/epidemiology , Centers for Disease Control and Prevention, U.S./organization & administration , Confidentiality/standards , Data Anonymization/standards , Centers for Disease Control and Prevention, U.S./standards , Humans , Pandemics , SARS-CoV-2 , United States/epidemiology
2.
FASEB Bioadv ; 2(11): 638-652, 2020 Nov.
Article in English | MEDLINE | ID: mdl-33205005

ABSTRACT

Therapeutic monoclonal antibodies (mAbs) represent one of the most important classes of pharmaceutical proteins to treat human diseases. Most are produced in cultured mammalian cells which is expensive, limiting their availability. Goats, striking a good balance between a relatively short generation time and copious milk yield, present an alternative platform for the cost-effective, flexible, large-scale production of therapeutic mAbs. Here, we focused on cetuximab, a mAb against epidermal growth factor receptor, that is commercially produced under the brand name Erbitux and approved for anti-cancer treatments. We generated several transgenic goat lines that produce cetuximab in their milk. Two lines were selected for detailed characterization. Both showed stable genotypes and cetuximab production levels of up to 10 g/L. The mAb could be readily purified and showed improved characteristics compared to Erbitux. The goat-produced cetuximab (gCetuximab) lacked a highly immunogenic epitope that is part of Erbitux. Moreover, it showed enhanced binding to CD16 and increased antibody-dependent cell-dependent cytotoxicity compared to Erbitux. This indicates that these goats produce an improved cetuximab version with the potential for enhanced effectiveness and better safety profile compared to treatments with Erbitux. In addition, our study validates transgenic goats as an excellent platform for large-scale production of therapeutic mAbs.

3.
Acad Emerg Med ; 11(11): 1142-8, 2004 Nov.
Article in English | MEDLINE | ID: mdl-15528577

ABSTRACT

As part of the broader informatics consensus initiative sponsored by Academic Emergency Medicine, this report addresses the issues of integration, interfaces, and data standards and how they are relevant to information management in emergency medicine. The purpose of this report, and the workgroup that contributed to its content, is to provide emergency physicians and other stakeholders in the emergency informatics community a sense of direction as they design, build, and/or choose systems. Problems are identified, strategies to address these problems are discussed, and consensus recommendations are provided.


Subject(s)
Emergency Medicine/standards , Information Systems/standards , Integrated Advanced Information Management Systems/standards , Emergency Medicine/trends , Humans , Information Systems/trends , Quality of Health Care , Safety Management , United States
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