HKUST-NEU Webinar

HKUST-NEU Webinar 

Recent Advances in Global Cell Gene Therapy Development

The impact of cell gene therapy has grown significantly in recent years for many disease treatments and patient cares.  It is important to understand its origin, current practices, and future growth globally; as the technology is being applied worldwide.  Thus far, we have assembled a panel of international experts in this field, who can elaborate the beginning of this technology, current biomanufacturing practices, new commercial products, and the global regulatory guidance for this industry.  We trust this international expert panel discussion will advance the technology development and its applications.  The webinar will be the outcome of an international academic collaboration along with the participation of biopharmaceutical professional societies.

Event will be held at two-time zone simultaneously:

Date:   October 31, 2024 (Thursday) for Boston, USA

Time:   8:30 – 10:00 PM

Date:   November 1, 2024 (Friday) for Hong Kong, China

Time:   8:30 – 10:00 AM

Registration:

https://hkust.zoom.us/webinar/register/WN_HzglfCWsTHaQF4dYbKoKlQ

Organizing Committee Members:

Dr. Jared Auclair (Northeastern U.):  Event Moderator

Dr. Jing Bao (HKUST)

Dr. Ava Kong (HKUST)

Dr. Sunny Tam (HKUST):  Event Moderator

Dr. Karl Tsim (HKUST):  Event Moderator

Speaker Bios

Prof. Lo Yuk Lam, President, Hong Kong Bio-Med Innotech Association (HKBMIA)

Professor Lo has extensive experience in biotechnology industry, corporate management, academic research and community service. Currently Professor Lo is serving as the President of HK Bio-Med Innotech Association, Strategic Advisor to the President and Adjunct Professor to the Division of Life Science of Hong Kong University of Science and Technology. He is also the Honorary Founding Chairman of Hong Kong Biotechnology Organization. In the educational area, Professor Lo has been elected an Honorary Fellow of the Hong Kong University of Science and Technology. He is also the Honorary Professor of several universities in China.

Professor Lo was heavily involved in several committees of the HKSAR Government. He had been served as the Chairman of the Advisory Council for Food Safety of the Food and Health Bureau HKSAR, Director of the Hong Kong Applied R&D Fund Co. Ltd., Chairman of the Biotechnology Committee of the Hong Kong Industry & Technology Development Council, and Chairman of Biotechnology Projects Vetting Committee of the Innovation and Technology Fund, HKSAR.

In Mainland China, Professor Lo was a member of Chinese People’s Political Consultative Conference in Jilin Province from 2007 to 2022. He was also a consultant of the Centre for Disease Control and Prevention of China. In recognition of his leadership in the community and dedication to his field, Professor Lo has received many awards, such as the “Pericles International Prize” in 2019. He is the second Asian and the first person from Hong Kong to be awarded the Prize since it was founded in 1986. In 2020, Professor Lo was awarded the Bronze Bauhinia Star from the HKSAR government for his outstanding services over the past decades.

In the business sector, Professor Lo had been served as the Chairman of Asia Pacific of PerkinEImer (NYSE: PKI) and the President of Asia Pacific of Bio-Rad Laboratories (NYSE: BIO). Currently he is the Chairman of GT Healthcare Capital Partners, and Partner & Investment Committee Member of Hongsen Investment Management Limited.

Dr. Simon Fricker, Chief Development Officer, Pepper Bio

Simon Fricker is an experienced discoverer and developer of novel cancer therapies. He obtained his training in the UK with a Ph.D. in Chemistry and Molecular Science from the University of Warwick and postdoctoral training at the University of Cambridge. He has worked in small company and large multi-national corporate environments, in the UK, Canada and USA. As a founding member of Canadian biopharma company he was involved in the discovery and development of a novel drug for hematopoietic stem cell transplant for patients with hematologic cancers, and for NDA filing and approval with Genzyme/Sanofi. As VP R&D at Phio Pharmaceuticals he was responsible for research on novel siRNA for empowering cell therapies (TILs, CAR-T, TCR T cells, and NK cells) leading to an IND and clinical trial for Tumor Infiltrating Lymphocyte (TIL) therapy. He is currently Chief Development Office for Pepper Bio.

Mr. Edward Armstrong, Vice-President, Head of Quality, Vedanta Biosciences

Edward is the Vice-President and Head of Quality at Vedanta Biosciences, a trailblazing company based in Cambridge, Massachusetts. Vedanta is at the forefront of developing innovative drugs to treat serious gastrointestinal diseases by harnessing the power of essential gut bacteria. Edward is known for his deep expertise in Quality and Regulatory trends, coupled with a pragmatic, common-sense approach to quality and compliance. Over his impressive 30-year career, Edward has proven himself to be a resourceful, imaginative, and dynamic leader and team builder. His extensive experience spans Good Manufacturing Practice (GMP) for Pharmaceuticals, Medical Devices, Biotechnology, Microbiome, and Cell/Gene Therapy. Edward’s proficiency covers a wide array of quality, regulations, guidance, and processes, including 21 CFR 4, 21 CFR 11, 21 CFR 210-211, 21 CFR 820, 21 CFR 610, EudraLex - Volume 4, ISO-13485, ISO-14971, ICH-Q7, ICH-Q8, ICH-Q9, ICH-Q10, ICH-Q13, and ICH-Q14. His comprehensive knowledge and innovative mindset make him an invaluable asset in the industry he has chosen to serve.

Prof. Victoria Elegant, Professor, MSc DRAP Program, HKUST

Victoria qualified as a physician, and joined the pharmaceutical industry after postgraduate training in obstetrics and gynaecology in the United Kingdom. She has held positions in global drug development, Medical Affairs, Regulatory Affairs and Drug Safety in Japan, Australia, Europe and Asia Pacific. Her career allowed her to travel around the globe and live in 14 different countries

Dr Victoria Elegant’s most recent role was Vice-President, JAPAC (Asia Pacific) Regional Medical Head, and Global Lead, Access to Healthcare for Amgen. Prior to moving back to Hong Kong to take on the Amgen role, Prof Elegant was the Vice-President, Regulatory and Medical Affairs, APAC, based in Shanghai for 10 years for Baxter, and Vice President, Medical Affairs, Asia for Shire, and before that, Medical Director, sanofi in Sydney, Australia. Victoria has been pivotally involved in the development of drugs to treat heart disease, cancer, osteoporosis, allergies and in the development of vaccines amongst others.  She has extensive experience in pharmaceuticals, biologics, and devices. She is also passionate about developing women leaders, instituted the Women in Leadership programme for AMGEN in Asia Pacific, and has been involved in mentoring for the Australian Chamber of Commerce and The Women’s Foundation in Hong Kong. Victoria is also the Chair of the Aust Cham Women in Business Network.

Prof Elegant is a Fellow of the Faculty of Pharmaceutical Medicine, and a Global Fellow in Medicines Development. She is on the Board of Studies for the Masters in Pharmaceutical Medicine, UNSW, and Adjunct Professor, Faculty of Medicine, University of New South Wales, Sydney, on the Advisory Board for the Masters in Pharmaceutical Medicine, University of Sydney, and Adjunct Professor, University of Sydney and Adjunct Professor, HKUST. She will be teaching undergraduate and post graduate courses in Biotechnology, Pharmaceutical Medicine and Medical Affairs She is also on the advisory committee for the Pharmaceutical Industry Practice, University of Queensland.  She has a Certificate in Sustainability from the University of Cambridge Institute for Sustainability Leadership.  She is President of the Asia Pacific chapter of the Medical Affairs Professional Society (MAPS), a Board Member of the  global MAPS Board, and a member of the Faculty of Pharmaceutical Medicine Global Forum. She is on the Hong Kong Stock Exchange biotech advisory panel. She is also on the board of the Cambodian Children’s Fund.

Prof. Zhigang Sun, Group Senior Vice President & Head of Global Product Development, Luye Pharma Group Ltd., China

Dr. Zhigang Sun is Senior Vice President at Luye Pharma Group Ltd., and responsible for global drug product development, global quality, and global pharmacovigilance. He previously served as Vice President of Regulatory Affairs at Sun Pharmaceutical Industries, Inc. in the United States, where he was responsible for the marketing registration and post-market change management of innovative drugs and generic drugs. Prior to joining industry, Dr. Sun has worked at U.S. FDA for 12 years, where he served as the acting Branch Chief at Office of Process and Facilities, and was responsible for quality review and pre-approval inspection (PAI) of innovative drugs and generic drugs. He also served as the CMC team Leader at Office of Generic Drugs, FDA, and the acting Assistant Country Director for Drugs at FDA China Office (Beijing).  In addition to drug review and CGMP inspection, Dr. Sun has involved in developing CDER Manual of Policies and Procedures (MaPP) and FDA Guidance for Industry in several FDA technique committees. Currently he is a member of the US Pharmacopeia Expert Committee and a member of the US Pharmacopeia Expert Panel in 2020-2025, as well as a member of the International Innovative Drug Regulatory Committee of the China Association for the Promotion of Pharmaceutical Innovation.

Mr. Frank Chan, Assistant Director of Health (Drug), Department of Health, HKSAR

Mr. Chan Ling Fung, Frank is Assistant Director in the Department of Health of the Government of the Hong Kong Special Administrative Region of the People’s Republic of China. He possess almost 30 years of regulatory experience in inspection and licensing of retailers, wholesalers and manufacturers, registration of pharmaceutical products, clinical trial certification, pharmacovigilance, risk management and communication, import and export control of medicines, procurement of drugs, etc., Mr. Chan currently is the Head of the Drug Office overseeing a wide spectrum of drug related work executed by 6 divisions including Risk Management and Operations; Licensing and Compliance, Drug Evaluation and Import/Export Control, Drug Procurement and Clinic Service, Drug Information and Pharmacovigilance and Administration.

Event Moderators:

Prof. Karl Tsim, Program Director, MSc DRAP Program, HKUST

Prof. Karl Tsim received his BSc and MPhil from The Chinese University of Hong Kong, and PhD in Molecular Neurobiology from the University of Cambridge, UK. After his post-doctoral training at Medical School of Stanford University, USA, he joined The Hong Kong University of Science and Technology (HKUST) in 1992. Currently, he is a Chair Professor of Division of Life Science, Director of Center for Chinese Medicine and Director of Shenzhen Key Laboratory of Edible & Medicinal Bioresources at the university. He is the Founding Chairman of Hong Kong Association of Biotechnology in Chinese Medicine. Prof. Tsim has developed molecular technique to determine the genetic and chemical properties of Chinese herbs. He has published about 500 scientific papers and serves as editors for many scientific journals internationally. His works on Chinese herbal medicine have been awarded twice for Research Excellence in Natural Sciences from Ministry of Education of China. He also serves as an adviser/consultant/member to various organizations, both nationally and internationally, in the standardization of Chinese herbs, which include WHO and HKSAR Government in Testing and Certification of Chinese herbs. He is an active entrepreneur and is the founding director of few companies.

Dr. Jared Auclair, Interim Dean, Northeastern University, College of Professional Studies

Jared Auclair serves as the Interim Dean of the College of Professional Studies. Appointed in December 2023, Jared leads all academic and administrative functions of the college.

With more than a decade of experience at Northeastern, starting first as a post-doc and most recently, Vice Provost Research Economic Development and Director of Bioinnovation, Jared is a champion of innovation and collaboration and deeply values the promise that the College of Professional Studies brings to students as one of Northeastern’s most diverse and dynamic colleges committed to meet students where they are.

Prior to his role as Vice Provost Research Economic Development, Jared served as the Associate Dean of Professional Programs and Graduate Affairs in the College of Science, and still holds a faculty appointment in the Department of Chemistry and Chemical Biology. His past experience with the College of Professional Studies includes leadership on a variety of economic and workforce development and research programs, including PlusOne, a dynamic program that gives students the opportunity to accelerate their education by earning both a bachelor’s and master’s degree in five years.

With an extensive leadership background, Jared’s passion for progress drives essential strategic initiatives for the College of Professional Studies. His focus on strengthening the connections between education, research, and community, along with fostering a global mindset is core to the College of Professional Studies’ commitment to delivering a world-class experiential education tailored to students’ needs.

Prior to joining Northeastern, Jared held a variety of research and consulting roles for leading biopharmaceutical firms. He holds a bachelor’s degree in biotechnology from Worcester Polytechnic Institute and a PhD in Biomedical Science from the University of Massachusetts Medical.

Prof. Sunny Tam, Program Co-Director, MSc DRAP Program, HKUST

Sunny Tam, PhD has 30 years of biotechnology and academic experiences in early stage R&D, preclinical testing, assay and technology development following his training from the Harvard University School of Public Health. He has held numerous scientific and management positions in small molecule discovery and protein therapeutic companies.  Dr. Tam is a pioneer in protein microarray development and application of proteomic tools in drug discovery, biomarker discovery and assay development.  He is well published and has contributed significantly toward a number of issued patents and federally awarded grants.  During his tenure as Program Director at Charles River Laboratories and then University of Massachusetts Medical School, Dr. Tam successfully completed numerous projects for major US biopharmaceutical and government sponsors in new protein technology development, further advancing biomarker discovery and product applications in a number of chronic human diseases.  He has built GLP facilities for the development of FDA regulated clinical diagnostic assays with novel biomarkers.  At Clark University, he has established a state of art Proteomic and Metabolomic laboratory for internal research and student teaching.  As the Associate Dean at Framingham State University, he has led a vibrant graduate education and biotech regulatory training.  Recently, being a Professor at the Hong Kong University of Science & Technology, Dr. Tam is again building another cutting edge educational program in training a new generation of regulatory scientists.