23 Jan, 2025
The Institute for Innovation, Translation and Policy Research (ITPR) and Wu Jieh Yee Institute of Translational Chinese Medicine Research at Hong Kong Baptist University (HKBU) organised the Drug Development – Roadmap to U.S. FDA Clinical Trial symposium today (23 January) in conjunction with the support of Hong Kong Science and Technology Parks Corporation.
This symposium, held at the Hong Kong Science Park, is dedicated to showcase the advancements in pharmaceutical development at HKBU, and to foster knowledge transfer and partnerships among the academia, government, industry, and the investment community. It also highlighted various projects that are developing some of the Chinese medicine into Western drugs based on a standard pharmaceutical development approach.
In her opening address, Ms Lillian Cheong, Under Secretary for Innovation, Technology and Industry of the HKSAR Government, said: “The Innovation, Technology and Industry Bureau has been actively promoting collaboration among industry, academia and research institutions through various initiatives to support the development of R&D results into commercial products. Through various schemes, we aim to establish a holistic ecosystem which fuels Hong Kong’s technology development and translation. I am glad to be here to witness the collaboration between Hong Kong Baptist University, Macau University of Science and Technology and Avalon Biomedical Management Limited, which demonstrates the integration of university expertise and industry capability to drive technology transfer and commercialisation of research outputs, paving the way for another new drug which will be developed in Hong Kong.”
Professor Alex Wai, President and Vice-Chancellor of HKBU, said: “As many of us know, there is a challenging gap between initial drug discovery and securing regulatory approval. This symposium aims to shed light on this complicated process, highlighting the innovative strategies to bridge this gap. It is our pleasure to welcome several esteemed experts today who will share their latest innovation as well as their substantial experiences in novel drugs development. We are confident that this symposium will provide valuable insights, foster collaboration, and inspire new market potential. Importantly, some of the projects presented today have represented our attempts to develop some of the Chinese medicine with single active moiety into Western medicine using a standard pharmaceutical development approach. This expertise represents one of the innovations in medical education that we would like to build into our proposal for the new medical school, which will be submitted to the Task Group on the New Medical School soon.”
Speakers of the symposium introduced their latest innovations and shared some key elements for success in new drug development from innovation, translation to application. Emphasis was put on the importance of a comprehensive roadmap in the translational and regulatory compliance process leading to U.S. Food and Drug Administration (FDA) clinical trials in order to make the drug available to all patients in need.
Highlighted speakers of the symposium include Professor Dennis Lam, Adjunct Senior Investigator of HKBU and a world-leading ophthalmologist. He is also Hong Kong Deputy to the National People's Congress and Member of the Legislative Council of the HKSAR Government. Professor Lam gave a presentation on the development of a highly absorbed oral Berberine for metabolic diseases. He said that based on preclinical and some clinical data in the literature, it is important to note that this oral drug candidate is likely to cover potential clinical indications, including fatty liver for inducing weight loss, and also for Alzheimer’s disease, together affecting a very large patient pool.
Professor Johnson Lau, Adjunct Senior Investigator of HKBU who plays a key role in the development of five globally approved novel drugs, gave a brief introduction of the potential challenges in drug development, and also introduced the development of a new oral drug absorption enhancement platform with an anti-cancer for the first candidate, to establish a patient-friendly and affordable oral dosage form.
Professor Bian Zhaoxiang, Associate Vice-President (Clinical Chinese Medicine) of HKBU, who has made significant milestone in herbal medicine development including obtaining regulatory allowance for the Investigational New Drug (IND) applications from U.S. FDA and the National Medical Products Administration of China, explained the innovations in his herbal drug development effort.
An exhibition showcasing 12 remarkable drug development projects at HKBU was held concurrently. These projects represent the diverse range of research being conducted at the University, covering drug development, AI for health science, medical device, to Chinese medicine in One Health applications. They represent the dedication of HKBU researchers as they tackle some of the most pressing public health challenges.
During the symposium, a tri-partite research collaboration was announced between HKBU, the Faculty of Medicine at Macau University of Science and Technology (MUST), and Avalon Biomedical Management Limited (Avalon) on a joint research project titled “The Development of a Highly Absorbed Oral Berberine for Metabolic Diseases”. The project aims to develop an oral formulation of berberine and encequidar to achieve high bioavailability form of berberine to treat metabolic disorders by integrating Chinese medicine and Western drug development approach. It incorporates the expertise and clinical resources of MUST and HKBU which facilitate translational and clinical research, as well as Avalon’s capabilities in technology transfer in inventing and driving the commercialisation of research outputs, with the objective of obtaining regulatory allowance for clinical trial for the new drugs in the foreseeable future.
HKBU has long been committed to advancing health sciences and new drug development. Researchers at HKBU endeavour to integrate cutting-edge sciences to break barriers and bring various groundbreaking research in drug development. By leveraging its transdisciplinary strengths, HKBU is spearheading the development of next-generation preventive measures, diagnosis, and therapeutic interventions for complex human diseases.