DELFT, Netherlands, March 11, 2024 /PRNewswire/ — InnoGI Technologies, formerly The TIM Company, announced today that The U.S. Food and Drug Administration (FDA) acquired a tiny-TIMsg System. This system is part of InnoGI Technology’s SurroGUT™ platform, which provides invitro gastrointestinal research solutions. The funding for this acquisition was enabled through FDA contract #75F40123P00476.
In the acquisition document, it was stated that the FDA’s Office of Pharmaceutical Quality Research (OPQR) is currently investigating the efficacy, quality, and safety of oral drug products, crucial for assessing marketed drugs. OPQR has requested a system capable of faithfully replicating the complex gastrointestinal conditions in both adults and children to enhance their comprehension of oral drug absorption in the gastrointestinal tract. Traditional dissolution research equipment needs to account for important physiological processes of the gastrointestinal tract, potentially limiting the quality and applicability of the results when compared to real-life situations. After a thorough evaluation of OPQR, the tiny-TIMsg emerged as the only available solution in the market that could perfectly align with the FDA’s research requirements. The system’s purchase is aimed at supporting OPQR’s crucial work in evaluating the quality and safety of oral drug products.
InnoGI Technologies provides innovative CRO services to the Pharmaceutical and Food Industries related to Gastrointestinal (GI) research and Oral Drug Delivery. It utilizes the most advanced and accurate gastrointestinal technology, mimicking the dynamics of a real human gut (SurroGUT™). It has shown a correlation range of 76% to 99.9% with human formulation rankings, outperforming dogs’ 37% correlation rate.
OPQR obtaining the tiny-TIMsg represents a substantial milestone as it aligns with the FDA Modernization Act 2.0. This Act, implemented in December 2022, marked a significant move toward reducing mandated animal testing for investigational drugs. The legislation acknowledges its constraints and encourages the use of advanced non-animal methods. The tiny-TIMsg is well-aligned with this progressive approach, reflecting the Act’s emphasis on embracing innovative non-animal testing methods.
“The acquisition of the tiny-TIMsg System by the U.S. Food and Drug Administration marks a significant milestone for the Pharmaceutical industry. The decision underlines their commitment to utilizing models capable of accurately simulating the human GI tract. At the same time, the Technology, part of our SurrGUT™ platform, adheres to the FDA Modernization Act 2.0,” said Dr. Behzad Mahdavi, Ph.D., MBA, CEO of InnoGI Technologies. “This move supports the FDA’s vital work in evaluating the quality and safety of oral drug products, which increase in complexity and therefore need more innovative solutions to de-risk and accelerate pharmaceutical drug development. The tiny-TIMsg helps to provide better insight into the release and dissolution of such complex drug products while exhibiting a higher predictive value for the human situation versus, for example, traditional dog studies with lower correlation. With that, it represents a step toward phasing out unnecessary animal research methodologies, and we are proud to actively participate in this paradigm shift.”
The tiny-TIMsg is scheduled to be installed at the FDA in the first quarter of 2024, with funding for this acquisition facilitated by the FDA through contract ward 75F40123P00476. InnoGI Technologies remains committed to advancing gastrointestinal solutions, which are pivotal in successfully evaluating oral formulation behavior and performance and their delivery. This dedication ensures that clients worldwide are guided in various stages of oral drug development by obtaining valuable data from our SurroGUT™ technologies. This will lead to decreased drug development times and help de-risk clinical trials to ultimately shorten the time-to-market of much-needed treatments.
Views expressed in this press release do not necessarily reflect the official policies of the Department of Health and Human Services, nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government.
About InnoGI TechnologiesInnoGI Technologies, formerly The TIM Company, expands its legacy of expertise within in vitro gastrointestinal models, combining years of experience in oral drug testing. InnoGI Technologies, headquartered in Delft, The Netherlands, has successfully evaluated over 250 active pharmaceutical ingredients found in commercial drug products from both large and small pharmaceutical companies. As per its name, InnoGI Technologies is driven by the goal of developing innovative technologies and solutions related to realistic GI tract simulations and oral drug delivery for Pharma and Food. InnoGI Technologies has helped guide clients worldwide with decision-making in different stages of oral drug development, i.e., led to decreased formulation iterations, effectively de-risked clinical trials, and shortened time-to-market. This is also evidenced throughout its 250+ scientific publications. For more information, visit our website at www.innogitechnologies.com /www.thetimcompany.com or follow us on LinkedIn.
About The U.S. Food and Drug AdministrationThe FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and regulating tobacco products. For more information, please visit: www.fda.gov
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SOURCE InnoGI Technologies
