Pharmaceutical Development and Regulation of Advanced Therapy Products

Prof. Joan Zuo is the Director and Professor of the School of Pharmacy at the Chinese University of Hong Kong. She holds a B. Sc. and a Ph.D. in Pharmaceutical Sciences and has had over 20 years’ experience in the biopharmaceutics and pharmacokinetics fields. Since joining the School of Pharmacy at the Chinese University of Hong Kong in January 2000, Prof. Zuo has secured over 10 million continuous support from various granting agencies such as University Grant Council, Innovation Technology Foundation, Food and Health Bureau, Hospital Authority in Hong Kong SAR. Her research on the biopharmaceutics and quality of bioactive herbal components has created the framework for in vitro and in vivo models for evaluating the quality of complex herbal products, improvement in delivery of herbal components in vivo, elucidation or even prediction of potential herb/herb or herb/drug interactions in vivo. Prof. Zuo’s research findings in the above fields have generated over 300 original research and conference papers and patents of USA, China, Hong Kong and Malaysia.

In Hong Kong, Prof. Zuo is serving in the Pharmacy & Poisons Board, Pharmacy Internship Training Committee, Pharmacovigilance Committee, Traditional Chinese Medicine (TCM) Research and Development Committee, and Proprietary Traditional Chinese Medicine Registration Committee at the Government of Hong Kong Special Administration Region. She is currently the Council member of the Open University of Hong Kong and Expert Panel of the Hong Kong Science & Technology Parks Corporation.

Internationally, Prof. Zuo has served as nomination committee member for International Society of Xenobiotics (ISSX) and is currently the regional editor of European Journal of Pharmaceutical Sciences and editorial board member for  Biopharmaceutics and Drug Dispositions, Xenobiotica, Chinese Medicine. She is also grant reviewer for National Natural Science Foundation of China (NSFC), Health and Medical Research Fund (HMRF) of Hong Kong, Macau Science and Technology Development Fund (FDCT), and as journal reviewer for more than 50 international peer reviewed journals.

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Prof. Yin Ting Cheung received her training in pharmacoepidemiology and pharmacy practice from the National University of Singapore (NUS) and St. Jude Children’s Research Hospital (Memphis, USA). Her work with the Cognitive Neuroscience Team at St. Jude involved characterizing the pharmacological, biological and genetic determinants of brain function and other treatment-related complications in survivors of pediatric cancer. She had previous teaching appointments with Rhodes College (Memphis, USA) as an Adjunct Assistant Professor. She hopes that her collaborative research with students, clinicians and scientists can help to improve health outcomes in survivors of cancer and other chronic diseases.

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Prof. Billy Ng obtained his B.Sc. degree in Chemistry (1st Class Hons.) and Ph.D. in Organic Chemistry from the Chinese University of Hong Kong (CUHK). During his graduate study, he was a Fulbright Scholar at Massachusetts Institute of Technology (MIT), under the generous funding supports from the Lee Hysan Foundation and the Fulbright Program. From 2014 – 2016, he joined the University of Oxford as a Croucher Foundation Postdoctoral Fellow. He was then recruited to Harvard Medical School / Dana-Farber Cancer Institute as a research fellow from 2016 – 2019. His research interests are chemical biology, drug discovery, and medicinal chemistry. The Ng lab uses chemical, biological, and bioinformatics tools to develop novel small molecules for the treatment and diagnosis of various diseases, including cancers, diabetes, and neurodegenerative diseases.

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Prof. Hon Fai Vivas Chan is an Assistant Professor at the Institute for Tissue Engineering and Regenerative Medicine and School of Biomedical Sciences at The Chinese University of Hong Kong (CUHK). He received his B.Eng. in 2010 from The University of Hong Kong. He then pursued his M.S. and Ph.D. degree at Duke University with the support of the Sir Edward Youde Memorial Fellowships for Overseas Studies. During his Ph.D. training, he focused on developing several microfluidic technologies to perform 3D spheroid culture of mesenchymal stem cells and hepatocytes, and investigated the effect of supplementing extracellular matrix cues on spheroid functions. After graduation in 2015, Prof. Chan spent one year at Columbia University as a postdoctoral researcher. He performed high-throughput screening of synthetic genes for optimization of protein expression using microfluidic droplets. In 2016, Prof. Chan joined Massachusetts Institute of Technology as a postdoctoral associate. There he conducted organ-on-a-chip research and develop biomechanics-guided folded hydrogel to recapitulate morphogenesis of mucosal folding which is observed in many hollow or tubular organs in human body.

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Prof. Bo Feng is an Associate Professor in the School Biomedical Sciences, Faculty of Medicine, The Chinese University of Hong Kong (CUHK). She is an active staff member in the Developmental and Regenerative Biology Thematic Research Program, Institute for Tissue Engineering and Regenerative Medicine, Ministry of Education (MoE) Key Laboratory for Regenerative Medicine and CUHK- Guangzhou Institute of Biomedicine and Health, Chinese Academy of Sciences (GIBH) Joint Laboratory on Stem Cell and Regenerative Medicine. Prof. Feng graduated from Nankai University with B.Sc. (1993) and M.Sc (1996), and received her Ph.D. (2006) from National University of Singapore. After graduation, Prof. Feng joined Prof. Ng Huck Hui’s lab in Genome Institute of Singapore as a postdoc. She worked on stem cells and reprogramming and published her works in Nature Cell Biology, Cell Stem Cell and Nature. In Nov 2010, Prof. Feng joined CUHK and her current research interest lies within the molecular mechanism that controls pluripotency and differentiation of Embryonic stem cells (ESCs)/ Induced pluripotent stem cells (iPSCs), as well as development of new tools for gene and cell-based therapy.

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Prof. Elmer Ker completed his Ph.D. in Biological Sciences from Carnegie Mellon University and postdoctoral training from the Department of Orthopaedic Surgery at Stanford University. He is an Assistant Professor at The Chinese University of Hong Kong with appointments in the School of Biomedical Sciences and the Institute for Tissue Engineering and Regenerative Medicine. His research interests include developing biomaterials and computer vision-based approaches for repairing injured bone-tendon and bone-ligament tissue units.

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Prof. Jingying ZHOU obtained her Ph.D. degree in Microbiology from the AIDS Institute, Department of Microbiology, The University of Hong Kong (HKU) in 2013 and received the Awards for Outstanding Research Postgraduate Student (HKU). She continued her research as a postdoctoral fellow and then promoted as in a Research Assistant Professor in 2018 at School of Biomedical Sciences. Prof. Zhou has published in international journals including Cancer research, Gut, Journal of Clinical Investigation, Nature Communications, Science Translational Medicine and served as co-inventor of two U.S. patents on DNA vaccines. Prof. Zhou’s research interests are mainly focused on cancer immunology and immunotherapy.

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Dr. Daniel Lee is appointed as Associate Vice-President (Innovation and Enterprise) of The Chinese University of Hong Kong from 2019. Dr. Lee is a clinical biochemist and has been an Advisory Committee Member of the School of Pharmacy, and Scientific Advisor of the Clinical Trial Centre, Prince of Wales Hospital, for CUHK. He obtained his BSc and PhD in Pathology from The University of Hong Kong. After teaching at The University of Hong Kong for seven years, he joined the pharmaceutical industry and served for over 25 years in pharma companies including Johnson and Johnson USA, Biogen USA, GlaxoSmithKline (GSK) China and served as General Manager and Head of site for Roche Pharma R&D China from 2010. He has broad experience of both small molecule and biologic drug discovery and development, including companion diagnostics, covering therapeutic areas from central nervous system, infectious diseases, diabetes complications to oncology and inflammation. He joined the Hong Kong Science and Technology Parks Corporation as Head of the Biomedical Technology Cluster from 2013 to 2018 and contributed significantly to the biotech industry and translational medicine development in Hong Kong. He has published over 50 peer-reviewed papers, actively engaged in teaching and journal manuscript reviews, and co-invented 14 published patents. He has served as CEO and board director of biotech companies, consultant for several institutes and companies, Adjunct Professor of the Division of Life Science, The Hong Kong University of Science and Technology and Honorary Professor of the Faculty of Medicine, The University of Hong Kong.

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Prof. Chi Kong Li graduated from the University of Hong Kong in 1981. He completed general paediatric training at Hong Kong and then specialised in paediatric/ haematology/ oncology/ BMT, with further training at John Radcliff Hospital, Oxford, and Great Ormond Street Hospital, London in 1986, and Fred Hutchison Cancer Research Centre, Seattle in 1992. Prof. Li joined Prince of Wales Hospital (PWH) in 1989 as Senior Medical Officer and became consultant in 1993, and is now a professor. Currently he is also honorary professor in 3 medical universities in China. His main interest is in childhood leukaemia, haematopoietic stem cell transplantation and thalassaemia. He is the study chair for acute lymphoblastic leukaemia trials in Hong Kong and also local coordinators for several international multicenter studies. He introduced the new treatment methods for Hong Kong children including double unit umbilical cord blood transplantation, Metaiodobenzylguanidine (MIBG) treatment for neuroblastoma. Prof. Li also actively involves in the development of paediatric oncology in mainland China. He is vice chairman of China Children Cancer Group, and vice-chairman of steering committee for two consecutive multi-center leukaemia studies in China. Currently he is the President of Asia Continent of International Society of Pediatric Oncology. In recent years he also actively involved in the development of children’s palliative care in Hong Kong and mainland China. He has published over 300 peer-reviewed papers, written chapters in 4 books and editor of one book. He also serves as editors in medical journals including Pediatric Blood Cancer, Chinese Journal of Pediatrics, China Journal of Pediatric Hematology & Oncology.

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Mr. Raccoon Chung has been working in the Drug Office of the Department of Health for more than 10 years. He obtained his Bachelor degree of Pharmacy from the Chinese University of Hong Kong, and his Master degree in Clinical Pharmacy and in Regenerative Medicine from the University of Sunderland and the University of Edinburgh respectively. He also obtained his Bachelor and Master degrees of Laws from the University of London. Mr Chung has a working experience in the Pharmacovigilance Unit and Manufacturers Regulatory Unit of the Drug Office before and he was a qualified GMP inspector. In recent years, Mr Chung engaged in preparing guidance on the proposed regulatory framework of Advanced Therapy Products in Hong Kong. Mr Chung is now working in the Adverse Event Following Immunization Team of the Drug Office.

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Ms. Gigi Cham obtained her Bachelor degree in Food Science from the University of California, Davis and her Master degree in Pharmaceutical Manufacturing and Quality (PMQ) from the Chinese University of Hong Kong. She has been certified by the American Society for Quality as the Quality Auditor and Pharmaceutical GMP Professional.
Prior returning to Hong Kong, Ms. Cham worked in several US pharmaceutical companies such as Johnson & Johnson to support the analysis and production for drug products and medical devices that have obtained the approval of various global regulatory agencies. She has acquired various experience in several drug delivery technologies, including transdermal, implantable, intravenous, and electro-transport.
Ms. Cham is currently the Quality and Regulatory Affairs Director of a local manufacturer, leading the quality and regulatory functions and serving as management representative. Her role focuses on optimizing quality, ensuring regulatory compliance, and reducing risk through implementation of company’s policy and standard operating procedures. Furthermore, she is responsible for new product registration in the global market such as US, China, Singapore, United Arab Emirates (UAE), European Union (EU), Australia, etc., to support product expansion.

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Dr. Paul Cheng who is a practicing medical oncologist and haematologist, founded BCT (Bio-Cancer Treatment Ltd). Dr. Cheng has been an Adjunct Associate Professor of Applied Biology and Chemical Technology of the Hong Kong Polytechnic University and was on the faculty of medical school of University of Hong Kong and the medical school of Chinese University of Hong Kong. He has extensive experience in research as well as clinical trials and is an author of over 30 publications in medical journals as well as a chapter of a textbook on oncology. His current research interests are arginine restriction in cancer therapy and cycle signaling control in cancer. Dr. Cheng graduated with MBChB in 1979 from the University of Wales College of Medicine where he also obtained his haematology training and his MD. Dr. Cheng obtained his medical oncology training at Memorial Sloan-Kettering Cancer Center in the U.S.

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Dr. Hovhannes J. Gukasyan (Hovik) obtained his PhD from University of Southern California (USC), School of Pharmacy, Department of Pharmaceutical Sciences in 2004. 18 years in pharma industry, he is currently the technology and CMC lead consultant at 6 different small- to medium-sized biotech firms. He is an expert in pharmaceutical R&D contributions in development, characterization, and application of drug delivery systems/technologies in novel/early clinical studies. He supported >80 ‘Pipeline’ programs, at Pfizer Inc and Allergan plc, with successful examples marketed as Diquas®, Vyzulta®, Lorbrena®. His contributions included enabling development of new chemical entities (NCE), new biological entities (NBE), nonbiological complex drugs (NBCD) using molecular biopharmaceutics and digital modeling & simulation sciences. He recently joined the University of Southern California (USC) School of Pharmacy as Associate Professor of Pharmacology and Pharmaceutical Sciences.

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Ms. Gloria Hung has contributed to local, regional and global regulatory strategy and operations at Pfizer since 2006. She currently oversees Regulatory Affairs of North Asia Cluster. She manages the country teams to attain portfolio expansion and life cycle management. Her previous role was the Head of the Asia Regional Regulatory Strategist Hub where she set up the first virtual Asia regional team liaising strategy between local and global stakeholders. Prior to joining Pfizer, She was the Authorized Person of Jean-Marie Pharmacal Company, Hong Kong.
Ms. Hung is a pharmacist by training and obtained her Bachelor of Pharmacy from the University of Nottingham, England. She then practised in Ipswich Hospital (NHS), England before studying prostaglandin EP3 receptor pharmacology for her MPhil at The Chinese University of Hong Kong. She has also obtained Postgraduate Diploma of Public Health from the University of Hong Kong.

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Dr. Lu is the co-founder and CSO of TriArm Therapeutic Co., a company specializing in developing innovative cellular immunotherapies for unmet medical needs. Prior to joining TriArm, he worked at US FDA as an expert reviewer at OTAT, CBER, FDA. He was a recognized expert in cell and gene therapy field and coauthored several FDA Guidance for Industries. Dr Lu served on the scientific committee of Oncology Center of Excellence, FDA and was the recipient of the CBER award for Excellence in Regulatory Science Research in 2015.
Prior to joining the FDA, Dr Lu worked in the biotechnology industry as a senior scientist, manager and consultant in the development of viral vaccines and of viral vectors for cancer therapy.

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