Chia-Hua Maggie Ho

Chief Operating Officer
Amarex Taiwan
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Dr. Chia-Hua Maggie Ho is the Chief Operating Officer of Amarex Taiwan. She oversees regulatory submissions, clinical operations, business development, and client services for the Pan Pacific region. Trained as a Regulatory Specialist in the US, Dr. Ho focuses on developing and reviewing GAP analyses, and managing strategy development for regulatory applications involving small molecule drugs, biologics, botanicals, and devices across various therapeutic indications. She has significant experience in regulatory submissions and multi-country clinical trials for COVID-19 drugs, vaccines, cell and gene therapies (CGTs), and in vitro diagnostics (IVDs) in the US, Europe, and Asia.
 
With over seven years of regulatory and quality assurance experience, Dr. Ho is adept at conducting internal and external GxP audits, providing QA and Quality Management System support (FDA 21 CFR PART 820 and ISO 13485:2016), and coordinating annual reviews of Amarex SOPs.
 
Prior to join Amarex, Dr. Ho was Assistant Vice President at a biotech start-up, where she raised investment funds and developed strategic objectives. As a Senior Scientist at a Taiwanese biopharmaceutical company, she managed CMC documentation for a novel active immunotherapy and ensured adherence to cGMP guidelines. Additionally, she served as Senior Manager for a technology organization, developing and validating analytical methods for protein drug candidates and preparing non-clinical pharmacology study reports.
 
Dr. Ho's career began in 2002, focusing on infectious diseases and oncology at Taiwan's National Health Research Institute and Academia Sinica. At the University of Oxford, her work on oxygenase-catalyzed ribosome hydroxylation, published in Nature Chemical Biology with Nobel Laureate Sir Peter J. Ratcliffe, explored new therapeutic possibilities. Dr. Ho completed postdoctoral research at MIT on RNA and DNA modifications in microbial pathogenesis, and at Helmholtz Zentrum München on epigenetic regulation. Throughout her career, Dr. Ho has presented on topics, including epigenetic mechanisms in health and disease, protein structure and function, the biological chemistry of inflammation in cancer, and the convergence of Omics and cell biology in relation to human health and disease. She published her findings in several pioneer journals, including Nature, Nature Chemical Biology, PNAS, and PLoS Pathogen.​

 

Speech title & Synopsis

From Smart to Approved: FDA’s Roadmap for AI-Enabled Medical Devices

Artificial intelligence (AI) is transforming healthcare by powering a new generation of medical devices that enhance diagnosis, treatment, and patient outcomes. Yet, the path to regulatory approval remains uniquely complex, especially for adaptive, learning systems that evolve in real-world settings. In response, the U.S. FDA released a landmark draft guidance in early 2025 outlining a comprehensive lifecycle-based framework for the development, evaluation, and approval of AI-enabled medical devices.
This talk explores the FDA’s evolving regulatory roadmap, with a focus on key components such as device design and risk management, transparency and bias mitigation, validation protocols, and post-market performance monitoring. Special attention will be given to regulatory strategies that support technologies leveraging generative AI and other emerging innovations. The presentation will also highlight the importance of early engagement with the FDA, cross-center coordination among CDRH, CBER, CDER, and OCP, and tools like predetermined change control plans (PCCPs) to manage iterative model updates.
As a full-service CRO, Amarex plays a critical role in helping device developers navigate this complex pathway—offering deep regulatory expertise and clinical support to accelerate submission success and ensure compliance. Attendees will leave with a clear understanding of the FDA’s regulatory vision and practical strategies to transform AI innovation into approved, market-ready solutions.