Latest news with #FDAModernizationAct
Business Wire
4 days ago
- Business
- Business Wire
Javelin Biotech Strengthens Board with Robin Robinson as Drug Discovery Shifts Towards Human-Based Models
WOBURN, Mass.--(BUSINESS WIRE)--Javelin, a pioneer in human-centric preclinical drug discovery, today announced the appointment of Robin Robinson, PhD to its Board of Directors, effective February 2025. This strategic addition comes at a pivotal time, as the pharmaceutical industry accelerates its transition from traditional animal models to advanced human-based approaches in drug development. "Javelin is committed to be a leader in this change, ensuring that new therapeutics are designed with human biology at their core." Embracing the Future: The FDA Modernization Act and Human-Based Models The recent passage of the FDA Modernization Act 3.0 marks a significant paradigm shift in drug development, enabling the use of non-animal alternative methods (NAMs) for drug safety and effectiveness testing. This landmark legislation underscores a growing recognition within the scientific and regulatory communities that human-based models offer a more accurate and predictive understanding of drug efficacy and toxicity, ultimately leading to safer and more effective therapies for patients. Javelin has been at the forefront of this movement, championing the development and adoption of technologies that bridge the gap between preclinical research and clinical outcomes. Dr. Robinson is a renowned international scientific and public health leader with extensive experience in novel vaccines and biothreat medical countermeasures, having served as Vaccine Director at Novavax, Inc. and the founding Director of the Biomedical Advanced Research and Development Authority (BARDA). He is currently the CEO of Esperovax. 'We are excited to welcome Robin to the Javelin Board,' said Auro Nair, Executive Chairman of Javelin. 'His over 4 decades of leadership in academia, government and industry coupled with his deep domain expertise in NAMs make Robin an ideal Board Director. Robin's insights will be critical as Javelin accelerates its deployment of clinically-relevant applications at the preclinical stage of drug development.' A Vision for Precision Medicine: CEO Dr. Cirit on Javelin's Path Forward "We are incredibly proud to welcome Dr. Robinson to our Board of Directors," said Murat Cirit, PhD, CEO of Javelin. "His unparalleled expertise will be invaluable as we navigate this exciting new chapter in drug discovery. The FDA's recent announcement, to phase out animal testing requirements for monoclonal antibodies (mAbs) has been a pivotal moment towards human-centric drug development. We firmly believe that other human-specific modalities for precision medicine, such as gene-editing technologies, nucleotide-based therapeutics, antibody-drug conjugates and cell therapies, will follow a similar path, revolutionizing how we treat complex diseases. Javelin is committed to be a leader in this change, ensuring that new therapeutics are designed with human biology at their core." Dr. Robinson joins existing board members Auro Nair, Executive Chairman of Javelin; Murat Cirit, CEO, President, and Co-founder of Javelin; Venkat Srinivasan, Founder and Managing Director of Innospark Ventures; and Jane Hirsh, a leader in the generic drug industry. This newly expanded board brings together a wealth of expertise in biotechnology, preclinical pharma services, AI, and strategic leadership. Javelin's Next-Gen Platform: Bridging Preclinical and Clinical Insights Javelin's predictive platform merges next-generation human tissue chips and digital twin technology to accelerate the development of superior therapies. This next-gen platform is uniquely designed to provide highly clinically-relevant, patient-centric data early in the drug discovery process – before strategic decisions are made, large investments are deployed, and patient populations are at risk. By accurately modeling human physiological responses, disease states, and drug interactions, Javelin is accelerating the development of safe and efficacious therapies, reducing preclinical failure rates, and ultimately bringing life-changing treatments to patients faster and more efficiently. About Javelin Born from MIT's interdisciplinary ecosystem, Javelin is a leading biotechnology company providing cutting-edge organ-on-a-chip platforms that offer unparalleled fidelity and insight into human biology and disease states. Our technology generates high-quality, human-relevant data essential for robust AI/ML integration, accelerating the development of safer, more effective, and personalized therapeutics, while significantly reducing costs and the reliance on animal testing.
Yahoo
22-05-2025
- Business
- Yahoo
GATC Health Paper Quantifies AI-Driven Capital Efficiencies and Advances Human-Centered Drug Discovery
IRVINE, Calif., May 22, 2025 /PRNewswire/ -- GATC Health Corp, a leading tech-bio company leveraging artificial intelligence (AI) to transform drug discovery, has published a new paper, AI in Drug Development: Advancing Capital Efficiency, Reducing Animal Testing, and Driving Precision Medicine. The paper details how advancements such as GATC's Multiomics Advanced Technology™ (MAT) platform are reshaping pharmaceutical development by improving speed, cost, and accuracy while reducing reliance on animal testing through human-relevant AI models. Ultimately, these technologies provide practical solutions to the industry's key challenges and promise to deliver better, safer treatments—faster—to patients. Highlights include: Validated, Highly Accurate Predictions: GATC Health's MAT was validated by University of California, Irvine, with predictions of sensitivity at 86% and specificity at 91%. Digital Twin Models: Models of human biological systems can test thousands of drug candidates in silico—achieving results 1,000x faster than conventional methods and at dramatically lower cost. Reduction in Animal Testing: The platform simulates human biology, enabling accurate predictions without animal studies and supporting regulatory shifts like the FDA Modernization Act. AI-driven methods could replace animal testing for up to 38.4 million animals annually. Public Health Impact: Accelerated drug development means faster access to new therapeutics, with the potential to save millions of years of human life. "This paper underscores our commitment to scientific and ethical progress in drug discovery," said Jayson Uffens, Chief Technology Officer at GATC Health. "By improving capital efficiency and reducing animal testing, we aim to advance both innovation and responsibility in the industry." Transforming Drug Development EconomicsTraditional drug development can cost up to $2.4 billion and take 12 years per drug. GATC's MAT platform streamlines discovery and preclinical phases, enabling companies to avoid costly investments in unlikely candidates and reinvest savings into further research. As noted in the paper, AI-driven preclinical assessments can cut animal use, increase human relevance, and reduce expenses by up to 90%. This streamlined process can shorten time to Investigational New Drug (IND) filing from over a decade to under two years. Advancing Ethical, Cost-Effective SolutionsConventional animal models often fail to predict human outcomes and raise ethical issues. GATC's AI-driven approach reduces animal use by up to 70% per drug candidate, aligning with global moves toward non-animal testing. Virtual toxicology datasets and digital twins replace animal models with more accurate and humane alternatives. Aligning with Regulatory TrendsThe paper details how AI technologies support evolving regulatory requirements, enabling faster, more precise, and ethically responsible drug development. GATC Health invites industry stakeholders to review the full paper and participate in the ongoing dialogue about the future of drug discovery. Visit GATC Health's Resources page to download the full paper. About GATC HealthGATC Health Corp. is a technology company transforming drug discovery and development through its AI-driven platform and approach. The company's validated and proprietary Multiomics Advanced Technology™ (MAT) simulates human biochemistry's billions of interactions to rapidly create novel therapeutics, identify and confirm targets, accelerate development, and derisk drug pipelines by predicting efficacy, safety, and off-target more information, visit View original content to download multimedia: SOURCE GATC Health Corp
Yahoo
11-04-2025
- Business
- Yahoo
FDA to phase out animal testing with AI and lab-based models
The US Food and Drug Administration (FDA) has announced plans to begin replacing animal testing in drug development with 'more effective, human-relevant methods', including AI models and lab-based systems like organ-on-a-chip. The shift is grounded by the 2022 FDA Modernization Act, which for the first time authorised the use of non-animal alternatives in preclinical testing. The FDA said the new framework, initially targeting monoclonal antibodies (mAbs), aims to enhance drug safety, as well as reduce R&D costs and drug prices. mAbs form the backbone of many cancer, autoimmune, and infectious disease therapies. Under the plan, developers of investigational new drugs (INDs) are encouraged to submit data from new approach methodologies, which include computational models, organ-on-a-chip systems, and other advanced in vitro platforms. The agency will also begin accepting real-world safety data from countries with comparable regulatory standards, allowing it to assess previously studied drugs without repeating animal trials. While the timeline for full implementation remains unclear, the FDA said immediate changes would apply to IND submissions. A pilot programme will launch in the coming year, offering selected mAb developers the opportunity to use a primarily non-animal-based testing strategy under FDA oversight. FDA Commissioner Martin Makay called the move 'a paradigm shift in drug evaluation' that could accelerate access to treatments while improving animal welfare. William Blair analysts described the announcement as 'a statement of intent' rather than a binding regulatory overhaul. They noted that while the 2022 legislation allowed for non-animal testing, it did not commit to reducing or eliminating animal use. 'We expect these changes to be rolled out gradually over time and believe drug developers will still want to do at least some animal testing,' the analysts wrote. They flagged Charles River Laboratories – which derives around 20% of its revenue from non-human primate testing – as vulnerable. The company's shares dropped 28% following the news. In contrast, William Blair views the development as a long-term tailwind for Certara and Simulations Plus, which offer AI-driven and in silico preclinical models. Outside of regulatory circles, the announcement has drawn attention across the scientific community. Medical sciences professional Paniz Farshadyeganeh on LinkedIn said: 'Animal testing has long been a necessary—but often cruel and poorly regulated—part of research. With advances in patient-derived iPSCs and organ-on-a-chip technologies, we now have the potential to build better, more human-relevant models.' Organ-on-chip technologies have gained traction as new tools for studying human disease, with newer developments such as tumour-on-chip models enabling cancer drug screening. Last month, researchers from Heinrich Heine University Düsseldorf and biotech firm Dynamic42 created a pancreatic cancer chip model, which showed promising results in testing MSD's FDA-approved therapy Zolinza (vorinostat). In parallel, simulation cell technologies are gaining momentum. AstraZeneca, in partnership with biological simulation company Turbine, has been using AI-driven models of cancer cells to predict drug resistance mechanisms and identify viable combination therapies in blood cancers. "FDA to phase out animal testing with AI and lab-based models" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
