This week we look at a paper published by the U.S. Food and Drug Administration related to artificial intelligence. We also highlight a statement from the World Health Organization declaring that mpox is no longer a global health emergency, a venture fund focused on blood-related research, and an effort to expand cancer screening across the globe. Finally, we look at new guidance from the FDA related to decentralized trials.
Each week we highlight five things affecting the life sciences industry. Here’s the latest.
The FDA has released a discussion paper and request for feedback on the use of AI and machine learning in drug development. The paper aims to address the potential benefits and risks associated with AI and machine learning in drug development, including ethical and security considerations, and outlines areas where AI and machine learning can be potentially used in the life sciences industry, including drug discovery, pharmaceutical manufacturing, clinical research and safety surveillance.
The World Health Organization recommended an end to the mpox (previously known as monkeypox) public health emergency of international concern (PHEIC) that had been issued in July 2022. The PHEIC creates an agreement between countries to abide by the WHO’s recommendations. Though there were 90% fewer cases reported over the last three months compared to the previous 90 days, WHO Director-General Tedros Adhanom Ghebreyesus noted that “mpox continues to pose significant public health challenges that need a robust, proactive and sustainable response.”
NYBC Ventures announced its launch of its inaugural fund with a $50 million investment from New York Blood Center, Inc. The goal of the fund is to accelerate innovation in blood-related fields, cellular therapies and enabling technologies. This is the first venture fund solely dedicated to advancing innovation in blood and cell-based therapies, according to Christopher D. Hillyer, M.D., president and CEO, New York Blood Center Inc., and general partner, NYBC Ventures. The fund aims to address needs in benign hematology, transfusion medicine and infectious disease.
Thermo Fisher and Pfizer are collaborating to expand key cancer screening technology to over 30 countries including many in Latin America, Africa and the Middle East. Genome sequencing is an effective way of determining the best treatments for cancer patients but is currently only available in 12 countries across the globe. Thermo Fisher is taking the lead on identifying and developing infrastructure to advance this project and Pfizer is working to reduce the cost of this type of testing.
Last week the FDA issued new guidance related to decentralized trials. Such trials often involve lab tests and other procedures taking place at remote facilities, rather than traditional trials which require the majority of patient monitoring at a research medical center associated with the trial. The FDA’s new guidance supports such decentralization but encourages companies running such trials to ensure that appropriate procedures are in place to review and store data at a central location and to monitor data for precision and variability.