Ethical Alternatives to Drug Testing

**🚀 FDA's Bold Shift: Phasing Out Animal Testing for Monoclonal Antibodies & Other Drugs!** **🌍 Leveraging AI & Human-Based Models for Safer, Faster Drug Development!** As a Founder, witnessing innovation that blends ethics and efficiency truly excites me. Here's what the FDA's new plan means for us: - FDA is replacing animal testing with human-relevant methods like AI-driven computational models and organoid lab tests. - This move aims to boost drug safety, lower R&D costs, and speed up the evaluation process. - The requirement for animal testing will be reduced or replaced immediately in investigational new drug applications. - Real-world safety data from other countries will be used to support drug efficacy determinations. - Computer simulations will predict drug behavior and side effects more accurately than traditional animal tests. - Human organ-on-a-chip systems offer a direct look at how drugs affect human organs, improving safety insights. - Regulatory incentives will encourage companies to adopt these modern testing methods showcasing strong safety data. - Faster drug development means quicker patient access to cutting-edge therapies without compromising safety. - This paradigm shift also marks a major ethical advancement by sparing thousands of animals annually. - FDA is solidifying its position as a global leader in modern regulatory science with this roadmap. How do you think this shift will impact the future of drug development and patient care?

Excited to share our latest review in Current Opinion in Biomedical Engineering: 👉 “Diversity in a Dish: Leveraging Organoids to Reflect Genetic Ancestry and Sex Differences in Health and Disease” 🔗 https://lnkd.in/eCpAZSBH Together with colleagues from Doppl SA and the University of Cape Town, our team at Cincinnati Children’s explores how stem cell–derived organoid models can help close persistent gaps in biomedical research—by modeling population-level diversity in ancestry and sex from the earliest stages of drug development. This comes at a pivotal moment for the microphysiological systems (MPS) field: 🔹 The FDA Modernization Act 2.0 enables drug developers to use human-based models in place of traditional animal testing 🔹 The NIH has committed to prioritizing funding for non-animal, human-relevant technologies (🔗 https://lnkd.in/eghDFAYZ) 🔹 The FDA recently laid out its roadmap to formally phase in alternatives to animal testing (🔗 https://lnkd.in/eGnw_CzQ) As organoids gain traction for safety, efficacy, and disease modeling, their ability to reflect true human biological variation offers a powerful tool for advancing both precision and equity in medicine. Proud of this global collaboration and what it represents for the future of inclusive, human-relevant science. #Organoids #MPS #iPSC #DrugDiscovery #PersonalizedMedicine #RegulatoryScience #DiversityInResearch #CuSTOM #CincinnatiChildrens

They write: This has led to the development of 3R principles (Replacement, Reduction, Refinement), introduced in 1959, advocating for alternative methods and improved animal welfare in research. Furthermore, regulatory frameworks and recent legislation, such as the 2022 FDA Modernisation Act, emphasize modern scientific alternatives to traditional animal testing. Emerging approaches, known as the 3Cs─cell culture, computer simulation, and phase 0 clinical trials─offer promising nonanimal solutions that could accelerate drug development and address ethical concerns, potentially rendering preclinical research more humane and efficient.

🚨 Breaking News from the FDA: A groundbreaking development in drug research and ethical practices. The FDA has introduced a pioneering pilot program aiming to potentially eliminate the necessity for animal testing in specific monoclonal antibody (mAb) drug evaluations. This initiative signifies a monumental shift in regulatory protocols, embracing innovative nonclinical techniques such as in vitro assays and computational simulations to evaluate safety, moving away from traditional animal trials. For professionals engaged in biotechnology and pharmaceutical research, this initiative holds the promise of streamlining early-stage drug development, cutting down expenses, and most significantly, expediting the delivery of safe and efficient treatments to patients. Initially directed towards mAbs with proven safety records, the impact of this program is far-reaching. It serves as a clear indication that modern scientific methodologies are reshaping the landscape of preclinical assessments in the 21st century. 💬 What are your thoughts on the future implications for translational research and regulatory science? Could this progressive regulatory approach become the norm in upcoming drug development endeavors? #FDA #Biotech #MonoclonalAntibodies #DrugDevelopment #AnimalTestingAlternatives #TranslationalScience #RegulatoryInnovation

New commentary by Greenstone Biosciences published in Circulation. The "FDA Modernization Act 2.0" has ushered in a new era, recognizing the significance of New Approach Methods (NAMs) in evaluating drug safety and efficacy. By leveraging innovations such as human induced pluripotent stem cells (iPSCs) and "clinical trials in a dish", combined with computational modeling and AI, we are witnessing a transformation in predictive accuracy. These technological advancements not only offer a promising increase in drug approval success rates but also herald a move towards more ethical and methodologically robust practices. A promising stride for both the scientific community and patients awaiting breakthrough therapies. https://lnkd.in/gQkhrHJn #DrugDiscovery #iPSCs #ComputationalBiology #FDA #InnovationsInScience

This newsletter highlights the transformative potential of organoid models as an alternative to traditional mouse models in biomedical research. Organoids, derived from human tissue or stem cells, have the potential to provide insights relevant to humans while reducing reliance on animal models. We explore the use of organoids in cancer, brain, liver, intestine, and lung research, demonstrating their value in drug discovery, disease modeling, and regenerative medicine. As organoid technology continues to advance, it brings us closer to personalized medicine and ethical and efficient research models. #Organoids #BiomedicalResearch #3DModels #PrecisionMedicine #AlternativesToAnimalTesting #StemCells #HumanModels #DrugDiscovery #NextGenResearch #CSTEAMBiotech

More than 92% of drugs that clear animal testing end up failing in clinical trials. Many of those drugs that initially get the green light from animal models have unexpected toxicity in humans. The fail rate means that pharma is wasting time and money — not to mention needlessly putting human well-being at risk. Just a few weeks ago, the #FDA took the issue head-on in a focused workshop, together with #NIH and global regulators. FDA Commissioner Marty Makary M.D., M.P.H., heralded alternative testing methods as capable of delivering drugs faster, reducing R&D costs, encouraging more innovation (reducing capital requirement), and treating animals more humanely. This move away from animal testing and toward new approach methodologies (NAMs), such as organoids and computational simulations, reflects the principles of the FDA Modernization Act 2.0, which removed the requirement that drugs be tested in animals before human trials. The approach, however, has long been advocated by researchers Ronald Li and Kevin Costa, cofounders of Medera’s Novoheart. For more than 25 years, the two have been building what’s now known as heart-in-a-jar technology — a tiny human ticker primed for testing investigational drugs. Link in comments 🔗 #clinicaltrials #clinicalresearch #animaltesting Ronald Li / Kevin Costa / Medera Inc. / Novoheart / Sardocor