Chia-Hua Maggie Ho

Chief Operating Officer
Amarex Taiwan, LLC. 美商安美睿生技有限公司
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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

Early Engagement Strategies to Cell and Gene Therapies Up for Success

Cell and gene therapies (CGTs) are revolutionizing healthcare, offering groundbreaking advancements in medical treatment. Many companies in biotech industry are at the forefront of developing these therapies, but CGTs development often faces significant uncertainties. The pioneering nature of these technologies means limited reference information, and their complexity introduces numerous risks. Additionally, the targeted diseases often have small patient populations, complicating enrollment goals and impacting early-stage development progress.
Our presentation will explore the clinical landscape of CGT development, providing insights into the current status of various CGT products across different regions, highlighting the diversity of therapeutic approaches and the geographical distribution of developers. We will then discuss regulatory opportunities, focusing on how developers can engage with the US FDA for guidance to accelerate product development. Early engagement with regulatory authorities is crucial for navigating the complex landscape and addressing potential hurdles. By understanding various regulatory pathways and leveraging strategic interactions with agencies, developers can gain critical insights and support to streamline the development process.
Given that traditional trial designs may not always be applicable to CGTs, we will introduce the concept of innovative clinical trial designs (ICTDs). Traditional trial designs often fall short in addressing the unique challenges posed by CGTs, such as variability in response rates and the need for flexible adaptation. We will introduce specific trial design strategies that can address these challenges. These innovative approaches allow for modifications based on real-time data, enhancing the robustness, efficiency, and agility of clinical trials.
By understanding and applying regulatory recommendations and leveraging cutting-edge trial designs, developers can optimize their chances of success and bring transformative therapies to patients in need.