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05.03.21 -- How IRBs And IBCs Impact Clinical Trial Design


05.03.21 How IRBs And IBCs Impact Clinical Trial Design
 
 
The growing gene therapy market presents a multitude of challenges that sponsors, CROs, institutions, and their sites must consider when running clinical trials. To meet these challenges, all stakeholders need to understand the role of not only the institutional review board (IRB), but also the institutional biosafety committee (IBC), in facilitating a safe and effective study. This article shares the four biggest takeaways for drug developers in this booming space.
 
The critical difference between these two study designs is whether the intervention occurs because it is a component of participation in a research protocol, or because a clinical decision was made that the intervention was the appropriate treatment option. Learn how sponsors and investigators can design research protocols that clearly indicate whether the clinical intervention is occurring within, ....

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DARPA to Fund CRISPR Diagnostics Using Mammoth, IDbyDNA Technologies


DARPA to Fund CRISPR Diagnostics Using Mammoth, IDbyDNA Technologies
January 18, 2021
Mammoth Biosciences will apply its DETECTR™ platform, and IDbyDNA its proprietary pathogen database and algorithms, toward the development of CRISPR-based diagnostics and biosurveillance technologies against infectious disease threats for the U.S. Department of Defense (DoD). [Source: MR.Cole Photographer / Moment / Getty Images]
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Mammoth Biosciences will apply its DETECTR™ platform, and IDbyDNA, its proprietary pathogen database and algorithms, toward the development of CRISPR-based diagnostics and biosurveillance technologies against varied disease threats for the U.S. Department of Defense (DoD).
Mammoth and IDbyDNA are among subcontractors under a four-year, up-to-$36.7 million CRISPR diagnostics contract inked by DoD’s Defense Advanced Research Projects Agency (DARPA) with prime contractor MRIGlobal. ....

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