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Technology Networks (March 22, 2023) Passage of the FDA Modernization Act Enables New Era for Preclinical Testing
The 11th-hour passage of The FDA Modernization Act, in late December 2022, gave a much-needed boost to the advocates of new alternative methods (NAMs) for preclinical testing. For years, the scientific community has worked with the U.S. Food and Drug Administration (FDA) to create opportunities for the consideration of data generated from NAMs in the investigational new drug (IND) process. In the absence of clarifying legislation, many pharmaceutical companies have been reluctant to invest in new methods because they lacked confidence that the associated data would be accepted by regulators. Change has been slow, but the passage of the FDA Modernization Act will provide the assurance the pharmaceutical industry has been waiting for.
Genetic Engineering & Biotechnology News (March 20, 2023) AI-Proofing Workflows in Drug Development
Processes of drug discovery and the early stages of drug development remain enigmatic and rely heavily on experience-induced intuition and chance. Pharmaceutical companies have developed workflows that have proven expensive and lacked efficiency, resulting in tremendous overall costs in moving a candidate drug from the laboratory to the clinics. AI (artificial intelligence)-based software solutions can offer a key ingredient—a substratum of connectivity—that drug companies often lack. The art of injecting such AI tools into existing workflows requires careful planning and a deep understanding of the industry’s management systems.
The Guardian (March 20, 2023) Fate of 1,000 trafficked lab monkeys at center of US investigation in limbo
Long-tailed macaques at risk of being killed, or laundered or re-trafficked if returned to Cambodia, animal welfare groups say
Fierce Biotech (March 13, 2023) Heart tissue on a chip is headed back up to the International Space Station
A new set of heart-on-a-chip experiments are heading back up to the International Space Station. Projects by teams from Stanford University and Johns Hopkins University will be part of the payload March 14 on SpaceX CRX-27, a resupply mission to the ISS. The researchers hope to leverage microgravity’s aging effects on heart muscle cells to ultimately help identify new treatments for cardiovascular disease.
Fox News (March 13, 2023) PETA asks Pentagon to cease animal testing related to ‘Havana syndrome’
The animal rights group PETA sent a letter to the Pentagon on Monday, demanding that they cease testing on live animals in their quest to understand the mysterious ailments known as “Havana syndrome” arguing that animal testing is counterproductive because many of the results don’t translate to humans, writing that other more effective methods are available.
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