| Submission declined on 25 June 2024 by DoubleGrazing (talk). Resubmitted without any meaningful improvement (one source was added to support a statement already supported by two sources - what was the point of that?), therefore previous decline still stands.
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| Submission declined on 3 April 2024 by ToadetteEdit (talk). This draft's references do not show that the subject qualifies for a Wikipedia article. In summary, the draft needs multiple published sources that are: Declined by ToadetteEdit 7 months ago.
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| Submission declined on 5 November 2023 by Stuartyeates (talk). This draft's references do not show that the subject qualifies for a Wikipedia article. In summary, the draft needs multiple published sources that are: Declined by Stuartyeates 12 months ago.
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Comment: Wikipedia articles require reliable independent secondary sources with in depth coverage of the subjects. If decent sources are added to the article, feel free to ping my talk page once you've resubmitted the article for review. Stuartyeates (talk) 06:48, 5 November 2023 (UTC)
Strategic Clinical Innovation Organization (SCIO) is an early development procedure that overcomes silos and eliminates the "one at a time" method.[1][2][3] It uses computational methods to investigate epigenetics, genetics, and bioinformatics.[4] It was developed by Boston Biotech Clinical Research (BBCR).[3][5]
History
editBoston Biotech Clinical Research was founded by Candida Fratazzi.[6][7] To reduce costs and speed up development, the company works with biotech, pharmaceutical, and medical device companies to create clinical protocols, programs, and efficient trials.[4]
Concept
editThe SCIO concept is predicated on three pillars: clinical investigation, trial design and analysis of data gathered during phases I and II, and compliance with regulatory mandates and the use of surrogate biomarkers. The aim of the SCIO method is to stratify the patient population in order to increase the proportion of patients who respond favorably to a given medication, raising it from about 20 percent to 80 percent.[4]
Using the SCIO method, non-clinical molecular proteomics can be integrated into clinical research. This improves the regulatory strategy of accumulating efficacy and safety evidence from the first human trials onwards, which in turn reduces the risk of late-stage clinical trials and better positions the product for the market.[4]
References
edit- ^ https://zealjournals.com/wjapmr/sites/default/files/WJAPMR-2022-0021.pdf
- ^ Candida Fratazzi; Jixiao Niu (January 21, 2022). "Accelerated orphan drug approval: surrogate endpoints". World Journal of Advanced Pharmaceutical and Medical Research. 2: 001–007. doi:10.53346/wjapmr.2022.2.1.0021. S2CID 246338312.
- ^ a b Bs, Wade Fox (September 26, 2023). "Precision medicine for all common diseases with the SCIOSM method". GSC Biological and Pharmaceutical Sciences. 24 (3): 149–153. doi:10.30574/gscbps.2023.24.3.0255. S2CID 262029797 – via gsconlinepress.com.
- ^ a b c d "BBCR". Life Sciences Review. Retrieved 2024-02-01.
- ^ Fratazzi, Candida (2015-10-26). "Cost-effective clinical trial design to detect immunogenicity and efficacy differences between biosimilar and innovator product". Journal of Bioanalysis & Biomedicine. ISSN 1948-593X.
- ^ https://www.hilarispublisher.com/conference-abstracts-files/1948-593X-C3-043-004.pdf
- ^ "Challenges Exist in Implementing Biosimilars for Rheumatoid Conditions". Pharmacy Times. November 28, 2016.