21 June, 2012, Renaissance Shanghai Pudong Hotel, China
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Shelley Huang Parry is established specialist and trainer in the biotech and Pharma quality and licensing field. With Ms. Parry’s 15 plus years of experience in manufacturing, validation, change control management, regulatory and quality, she had successfully been involved with 5 major new biologic and generic pharmaceutical product lines with regulatory approvals. Two of five major product lines are still major drug buster products since the early eighties and nineties, specifically a leading recombinant FVIII therapy, Kogenate® FS* [Antihemophilic Factor (Recombinant)], for the treatment of people living with hemophilia A and Betaseron, is the only high dose high frequency interferon-beta FDA-approved for treatment in the first MS event.
Currently, Ms. Parry is Associate Director, Quality & Regulatory Affair at the A-Bio Pharma Ltd in Singapore. Prior to A-Bio Pharma, Ms. Parry was working in Change Control Management for 10 years with Bayer Health Care-Main Supply Chain in Biologic at Berkeley, California.
Her previous position included QA manager/QA Validation Scientist for Bayer Health Care-Biologic/Main Supply Chain in Berkeley, California. She has held varies positions in Impax Laboratory. Chiron Corporation and BioMarin Pharmaceutical Inc.
Shelley Huang Parry graduated from University of California, Davis with degree in Human Physiology and currently is pursing a graduate degree in Business Administration in Technology at the University of Phoenix in United States.
Associate Director of Quality and Regulatory Affair, A-BIo Pharma (Former) President & CEO
BIO-TECH CAPITAL Pte Ltd.
Dr. Frank Ho has been working in the biotechnology industry since 1992 after spending 10 years in the academia. His industry experience has been in the areas of process development, process transfer, manufacturing, and contract manufacturing at several biotech companies in the San Francisco Bay Area, including Chiron, Fibrogen, Applied Biosystems, Raven, BioMarin and most recently in Asia working at PharmaEssentia in Taipei, and now at A-Bio in Singapore..
His experience in process development and manufacturing covers microbial and mammalian, and operationally encompasses upstream and downstream. He has accomplished 10 FDA-approved biologics through process development, and has led and transferred more than 40 biologics for GMP manufacturing internally, and externally has led several international contract manufacturing campaigns in Europe, North America and Asia. He has held positions in responsible for manufacturing facility design, start-up and operation, also has led setting up development and operation teams and infrastructures. He is well versed in bioprocess equipment design and qualification for large scale fermentor, bioreactor, recovery and chromatography skid in GMP manufacturing.
Dr. Frank Ho
Head of Biologics Operations and Global Technology Transfer
Jason has over 15 years of experience in Biotechnology Industry, and over 10 years of Development and manufacturing of biopharmaceuticals in U.S., such as Global Process Engineering in Amgen and Process Development in Invitrogen. The products he worked on include Blockbuster Drugs Epogen and Neupogen, monoclonal antibodies for Oncology, gene therapy vectors, etc. He majored in Biochemical Engineering, with Masters of Engineering from Tianjin University and Masters of Science from University of Maryland. His main responsibilities in Genor Biopharma cover many aspects of product commercialization, including downstream process development, process validation, technology transfer and new facility. His recent presentations include topics on process analytical technology (PAT) in chromatography and monoclonal antibodies.
Director, Downstream Process Development
Shanghai Biomabs Pharmaceutical Co., Ltd., located at Zhangjiang Hi-tech Park in Shanghai, is in the business of research, development and marketing of antibody drugs.
He is also contributing to the BioPharma & Pharma Industry by acting as the Board Member of ISPE (the International Society for Pharmaceutical Engineering) China and as the member of its Technical Committee & Training Committee．
Before joining the current company, Mr. Lee was the Director of Manufacturing Projects of Merial China.
His other past employment include：
Michael has also extensive experience in establishing the new GMP pharmaceutical & BioPharmaceutical plants, Plant operation & GMP compliance, ERP operation systems (SAP, BPCS) configuration. He was also involved in cold chain management.
Dr Scott Liu is a Molecular Biologist by training and holds a Ph.D. degree from Purdue University. Before started Henlius Biopharmaceuticals in 2009, he hold key leadership positions in several biopharmaceutical companies, including Amgen, Bristol-Myers Squibb, and United Biomedicals (UBI). He was the QC Director of Amgen-Fremont before he founded Henlius. Scott helped UBI establish UBI-Asia in Taiwan and served as the R&D VP of UBI-Asia, and later on the VP of Scientific Affairs of UBI. His diverse background in R&D, quality, business development, and regulatory affairs, provided a solid foundation for him to lead Henlius toward a mission of making antibody-based therapeutics universally available and affordable to all patients in need.
President & CEO
Dr. Sun is responsible for all manufacturing activities and technology platforms at AutekBio (Beijing), Inc. which is a contract manufacture organization specialized in development and manufacturing of biologics using large scale mammalian cell cultures. In the past few years, Dr. Sun has successfully established technology platforms for manufacturing biologics from cell line development to final large scale product production at AutekBio in China. He has extensive experience in drug discovery and commercialization in US. Dr. Sun has more than ten years of experience in the development of therapeutic biologics and their commercial manufacturing. Prior to joining AutekBio, Dr. Sun held various positions in academic institutions and pharmaceutical companies including DSM/Crucell, Shire Pharmaceutical, UCB Pharma, University of Minnesota, Harvard Medical School, etc.
President Manufacturing Business
Tony has over 26 years of experience in the large-scale manufacture of biopharmaceuticals. Tony has held positions in the Blood Products Laboratory (Elstree) and at Zeneca Pharmaceuticals in the protein process development department. Tony was a founding staff member of Cobra and has been responsible for the development of much of Cobra’s DNA manufacturing technology. Tony has published several papers in the field and is an inventor on two families of Cobra’s process patents. He also has extensive experience in chromatographic purification. Within Cobra, he has had a number of senior roles, managing both manufacturing and development functions within the company, and his current role is based on the development and introduction of new technologies into the company, with specific emphasis on single use systems.
He is currently a member of the steering committee of the UK Bioprocess Research Industry Club (BRIC), the scientific advisory of the Pharmaceutical Centre for Excellence (COEBP) at the University of Manchester and the industrial advisory board for the Astbury Centre at the University of Leeds. and an assessor for the UK Research Councils (EPSRC, BBSRC and MRC) Chemical Biology Collaborative Networks initiative.
Head of Manufacturing Technologies
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