November 8, 2021
Barry Bunin, PhD Founder & CEO
Collaborative Drug Discovery
AI and Machine Learning Getting a Boost from the FDA, Canada, and the UK. You know that artificial intelligence and machine learning are growing in importance for healthcare research when the FDA gets involved. The FDA has announced it is collaborating with Health Canada and the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) to foster good machine learning practices. A release includes this quote from Bakul Patel, director of the FDA's Digital Health Center of Excellence in the Center for Devices and Radiological Health: "With artificial intelligence and machine learning progressing so rapidly, our three regulatory agencies, together, see a global opportunity to help foster good machine learning practice by providing guiding principles that we believe will support the development and maturation of good machine learning practice. This will help stakeholders to advance device development, which has the potential to significantly improve the quality of patient care and transform health care."
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"Historic Moment as WHO Recommends Groundbreaking Malaria Vaccine for Children." While much of the world remains focused on bringing COVID vaccines to younger children, it was good to see news of a malaria vaccine make the headlines. The above headline was in Pharma Business International, which quotes Dr. Tedros Adhanom Ghebreyesus, World Health Organization Director-General, as saying: "This is a historic moment. The long-awaited malaria vaccine for children is a breakthrough for science, child health and malaria control. Using this vaccine on top of existing tools to prevent malaria could save tens of thousands of young lives each year." Dr Matshidiso Moeti, WHO Regional Director for Africa, said "For centuries, malaria has stalked sub-Saharan Africa, causing immense personal suffering. We have long hoped for an effective malaria vaccine and now for the first time ever, we have such a vaccine recommended for widespread use."
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Microrobots to Hunt Down Cancer Cells? That's the premise of a very interesting article from Drug Discovery News, with the subtitle "Sperm, bacteria, bubbles, and shuttles are just some of the latest cancer-treating microrobots in development for human use in the next few years." The article begins: "Tiny robots tumbling through blood vessels, making pit stops in the brain, and swimming through intestines is no longer a scene out of a science fiction movie. Scientists and engineers are developing microscale robots as small as bacterial cells to as large as the sharpened tip of a pencil with the ability to propel themselves through the body and penetrate deep into tissues. These micro machines function like mini doctors, delivering drugs and performing diagnostic tests in precise locations around the body." Not surprisingly, these tiny bots haven't yet entered into clinical trials, but the article says "The microrobotics research field is poised to make exciting gains in the translational space in the next few years. The future of cancer treatment may just be micro."
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A Farewell to Mice? Mimicking in Vivo Experiments with Organ-on-a-Chip Systems. Drug Discovery & Trends has an article on jump-starting the transition from animal models to human preclinical models-using organ-on-a-chip technologies to "recapitulate functional human organ-like structures that react to pharmacological intervention with in vivo-like physiological responses." The technology, also referred to as "3D cell cultures" could prove to be a powerful tool for drug discovery. The article quotes Jim McGorry, CEO of AIM Biotech, which is involved in creating such chips, as saying: "We believe that human 3D cell cultures will become imperative for the transition from animal models to human assays. … As a result, not only researchers but also biopharma and biotech companies can exploit this product. It is an easy-to-use, reproducible and scalable technology that facilitates and predicts human data before stepping to human trails."
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"Science 37 Partners with 2 CROs in Japan as Part of Decentralized Trials Push." That's the headline on a recent FIERCE Biotech article that reports "The deals are with CMIC, billed as the first and largest CRO in Japan, and 3H Medi Solution. … The pacts come just a few weeks after Science 37 landed on the Nasdaq, on Oct. 7, via a special purpose acquisition merger that gave the Los Angeles-based CRO about $235 million in cash proceeds." The article notes in both collaborations, the Japanese counterparts will use Science 37's clinical trial operating system and tech platform for decentralized, or virtual, studies.
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Best Quote from the Nobel Prize for Chemistry Committee? It was good to read about the Nobel Prize in Chemistry going to Benjamin List, a German chemist who is director at the Max Planck Institute for Coal Research, and David W.C. MacMillan, a Scottish chemist and a professor at Princeton University for their development of a new tool to build molecules. The New York Times writes that their work "has spurred advances in pharmaceutical research and lessened the impact of chemistry on the environment." The article reads, in part: "Until the discovery by the Nobel laureates, some of the catalysts used by chemists could be harmful to the environment or lead to vast amounts of waste. … The new process paved the way for creating molecules that can serve purposes as varied as making lightweight running shoes and inhibiting the progress of disease in the body." The Times gave last word to the Nobel committee which wrote: "Why did no one come up with this simple, green and cheap concept for asymmetric catalysis earlier? This question has many answers. One is that the simple ideas are often the most difficult to imagine."
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Barry A. Bunin, PhD, is the Founder & CEO of Collaborative Drug Discovery, which provides a modern approach to drug discovery research informatics trusted globally by thousands of leading researchers. CDD Vault® is a hosted biological and chemical database that securely manages your private and external data.