The FDA's recently established Digital Health Advisory Committee (DHAC) took a significant step last week with its first meeting. This committee is dedicated to ensuring the agency closely monitors medical devices equipped with GenAI throughout their entire life cycles. A 30-page document provided to committee members ahead of their November inaugural meeting sheds light on their concerns and considerations. Let's delve into the key aspects discussed.

Why a Total Product Life Cycle (TPLC) Strategy is Critical

The FDA has long been committed to a TPLC approach, and this becomes even more relevant for medical devices incorporating rapidly evolving GenAI technologies. As these devices are intended to iterate more frequently during their use life, a TPLC approach helps manage them effectively. "A TPLC approach is likely to remain important to the management of future, safe and effective GenAI-enabled medical devices." This ensures that safety and effectiveness are maintained across the device's lifespan.

How the TPLC Approach Relates to the AI Lifecycle Template

For manufacturers of GenAI-enabled devices, considering the FDA's AI Lifecycle is an important way to manage their products throughout the TPLC. "Additionally, the AI Lifecycle can be used as a helpful model to identify where new techniques, approaches or standards may be needed to assure adequate management of these new technologies across the TPLC." It provides a framework for addressing the unique challenges posed by GenAI.

Defining 'GenAI'

GenAI refers to the class of AI models that mimic input data structures and characteristics to generate synthetic content. This includes various forms such as images, videos, audio, text, and digital content. "GenAI models can analyze input data and produce contextually appropriate outputs that may not have been explicitly seen in its training data." Understanding this definition is crucial for proper regulation and oversight.

GenAI vs. Traditional AI/Machine Learning

Like other AI/ML models, GenAI models are developed on large datasets that human developers often can't fully understand during development. However, datasets for GenAI model development can be intentionally broad and not initially tailored to a specific task. "In contrast to the datasets used to develop other AI/ML models, datasets for GenAI model development can be intentionally broad and may not be initially tailored to a specific task." This difference impacts how GenAI operates and is regulated.

What Makes GenAI Tricky to Regulate

GenAI's ability to handle diverse, new, and complex tasks can lead to uncertainty about the limits of a device's output. "When insufficiently controlled, this uncertainty can translate to difficulty in confirming the bounds of a device's intended use, which can introduce challenges to FDA's regulation of GenAI-enabled devices." Regulators need to carefully navigate these uncertainties to ensure proper oversight.

Why Foundation Models Matter

Foundation models are trained on a wide range of data and can be applied to multiple AI applications. If a manufacturer uses a foundation model in a medical device with a specific intended use, it becomes the focus of FDA's device regulatory oversight. "If a manufacturer uses a foundation model or other GenAI tool as part of a product with a specific intended use that meets the definition of a medical device, the product that leverages the foundation model may be the focus of FDA's device regulatory oversight."

How to Avoid FDA Rejection

Manufacturers and developers should consider whether a GenAI implementation is beneficial to public health. If it could provide erroneous or false content, it may not be the best technology for a specific intended use. "It is helpful for manufacturers and developers to consider when GenAI may or may not be the best technology for a specific intended use." Additionally, performance evaluation methodologies will depend on the specific intended use and design of the GenAI-enabled device. "As with all devices, the totality of evidence—which may include premarket and postmarket evidence—can support reasonable assurance of safety and effectiveness of these devices across the TPLC."Read the full report.

Semaglutide, a key player in the GLP-1 drug arena, is currently under investigation for a wide range of applications. From heart disease to Alzheimer's and various other conditions, its impact is being closely studied. This article delves into the diverse uses and promising future of semaglutide.

Unlock the Potential of Semaglutide in Healthcare

Heart Disease

Novo Nordisk® recently announced that Rybelsus® demonstrated a 14% reduction in the risk of major adverse cardiovascular events in adults with type 2 diabetes. With Wegovy® already approved for certain cardiovascular disease treatments, Novo Nordisk® is now seeking FDA approval for Rybelsus® for similar use. This shows the significant potential of semaglutide in addressing heart-related issues. It highlights the importance of continuous research and development in this field to provide better treatment options for patients.Furthermore, the increasing acceptance and use of these drugs by the public have led to a surge in demand. The revenue generated from these drugs has seen a remarkable increase, from just $300 million in 2018 to an estimated $30 billion in 2024. This growth indicates the growing recognition of the role of semaglutide in cardiovascular health.

Liver Disease

Currently, there are no FDA-approved treatments for metabolic dysfunction-associated steatohepatitis ("MASH") liver disease or non-alcoholic fatty liver disease. However, GLP-1RAs have shown promising results in reducing liver fat content, liver enzymes, oxidative stress, and improving hepatic de novo lipogenesis and histopathology. Pfizer is investigating its own GLP-1 molecule, danuglipron, as a potential daily tablet solution for MASH, although it is still in the early stages of development.Merck® agreed to pay up to $860 million in milestone payments to acquire the rights and license to efinopegdutide, a GLP-1/GIP drug granted a Fast Track designation by the FDA for MASH treatment. Boehringer Ingelheim® has also received a Fast Track designation for its molecule survodutide, another GLP-1 drug originally designed for obesity but now being examined for certain liver diseases. These developments suggest the potential of semaglutide in addressing liver diseases and opening up new treatment avenues.

Sleep Apnea, Knee Pain

Eli Lilly announced that it would be seeking FDA approval for Zepbound® to be used for treating sleep apnea after a Phase III study showed a 63% reduction in apnea-hypopnea. The company is also investigating its triple-agonist drug, retatrutide, for use in knee osteoarthritis and sleep apnea. Novo Nordisk® reported that overweight individuals place additional stress on the knee and its protective cartilage, and in a study of 407 people with knee arthritis, semaglutide treatment led to more thorough reduction in knee pain compared to a placebo. This indicates the potential of semaglutide in alleviating pain and improving the quality of life for patients with knee problems.

Alzheimer's and Dementia

While GLP-1 drugs are known for their gastro-intestinal effects in treating obesity and diabetes, many investors are realizing their potential in the brain. Commercially available GLP-1 drugs have shown the ability to bind with brain receptors, and Lexaria's DehydraTECH technology has demonstrated the potential to improve drug delivery into brain tissue. Lexaria's recent animal study, WEIGHT-A24-1, is investigating the brain absorption of DehydraTECH-processed GLP-1 drugs, with data expected to be released in December or January 2025.Dulaglutide, owned by Eli Lilly, has shown a particular affinity for entering the brain and has shown significant benefits in cognition in a large human study. Liraglutide, owned by Novo Nordisk®, has also shown the ability to slow cognitive decline and reduce brain shrinkage in a Phase 2b clinical trial. Semaglutide is showing promising early-stage reduced risks against neurodegeneration and neuroinflammation. These findings suggest the potential of semaglutide in addressing Alzheimer's and dementia.

Chronic Kidney Disease

Eli Lilly is conducting active research, including a Phase II study expected to complete in early 2026, examining tirzepatide as a possible treatment for chronic kidney disease ("CKD"). In a large analysis of over 165,000 patients, type-2 diabetic patients with acute kidney disease receiving GLP-1 drugs showed lower mortality rates and incidences of major cardiovascular and kidney events compared to those not receiving GLP-1 drugs. Novo Nordisk® also announced a successful human trial of 3,533 people with CKD and type 2 diabetes using injected semaglutide, demonstrating a statistically significant and superior reduction in kidney disease progression and cardiovascular and kidney death by 24%. These results highlight the potential of semaglutide in treating chronic kidney disease and improving patient outcomes.Conclusion:The applications of GLP-1 and related drugs are constantly evolving. With the widespread adoption of these drugs by millions of people, real-time data is being generated at an unprecedented scale. While the benefits of weight loss and diabetic control are evident, the potential in other areas of human health is still being discovered. Lexaria is committed to continuing research and development of its DehydraTECH drug delivery platform technology with as many GLP-1 and related drug molecules as possible to identify new areas of commercial applicability.About Lexaria Bioscience Corp.:Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, GLP-1 and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 46 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com.Caution Regarding Forward-Looking Statements:This press release includes forward-looking statements. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed. Factors which could cause actual results to differ materially from those estimated by the Company include government regulation, managing and maintaining growth, adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects of the technology, and other factors. The Company provides links to third-party websites only as a courtesy and disclaims any responsibility for the information at those websites. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease.Investor Contact:George Jurcic – Head of Investor Relationsir@lexariabioscience.comPhone: 250-765-6424, ext 202SOURCE: Lexaria Bioscience Corp.View the original press release on accesswire.com