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Speakers
Johann Bonnet
Market Manager
Pharmaceutical Competence Centre
Veolia Water Solutions & Technologies
Johann took over, in 2006, the responsibility of the pharmaceutical market of Veolia Water Solutions & Technologies (VWS) as global Market Manager and joined the Pharmaceutical Competence Centre.
Main responsibilities include Marketing and Communication related to the Pharmaceutical market, key account management, implementation of the sales strategy to the product and service offering and sales support on major international pharmaceutical projects.
Johann Bonnet joined Veolia Water Solutions & Technologies in 2001 as Sales Engineer with the responsibility to develop the pharmaceutical water treatment business in western France. He has been directly involved in a number of Purified Water (PW) and Water for Injection (WFI) turnkey projects with success.
He has 13 years of strong experience in Sales in Food & Beverage and Pharmaceutical industries. Prior to joining Veolia Water Solutions & Technologies, he held the positions of Sales Engineer with Tetra Pak Hoyer and Product Manager with Tetra Pak Processing in France. Johann has professional membership with ISPE.
Dr. Joe Brady, PhD
Educational and Training Specialist
DPS Engineering
As a trained trainer, Joe is a full-time educationalist/trainer with DPS Engineering. Joe has a B.Sc. and Ph.D. in Biotechnology, and also has formal education in process- and computer-instrumentation. He has over 11-years experience in the pharmaceutical and biopharmaceutical industries, predominantly in the areas of process-mechanical validation and computer-system validation.
Joe is part of a core DPS team whom in conjunction with the Dublin Institute of Technology (DIT) has designed and developed a B.Sc. degree course in ‘Validation of Medicinal Products’ and a M.Sc. degree course in ‘Pharmaceutical Validation Technology’. Joe with DPS also contributes significantly to other industry-specific academic programs for the pharmaceutical sciences.
Joe’s current specialities include: (1) researching, teaching and facilitating quality risk management processes, (2) assessing techniques for the implementation of continuous improvement initiatives, and (3) running training programs and workshops on GAMP® 5.
Dr. H. Gregg Claycamp
Director, Division of Compliance Risk Management and Surveillance
Centre for Drug Evaluation & Research
Office of Compliance
Food & Drug Administration
H. Gregg Claycamp, Ph.D., recently joined CDER's Office of Compliance as the Associate Director for Risk Analysis and Strategic Policy Assessment in early 2007. He was appointed as permanent Director of the Division of Compliance Risk Management and Surveillance early this year. Dr. Claycamp directs a division working on a portfolio of risk problems, risk management systems, strategic policy analysis and surveillance inspections. He is active in FDA groups developing risk management tools, risk management policy and specific risk assessments, including the CDER team who developed the risk-based site selection model for field inspections and a CVM team developing risk-based pre-approval inspection tools. Recently, Dr. Claycamp served on the International Conference for Harmonization, Expert Working Group on "Quality Risk Management," for which he was the rapporteur for the final internationally-harmonized guidance document. Prior to joining FDA in June 2001 as a Senior Biomedical Research Service (SBRS) appointee, Dr. Claycamp was a Professor at the University of Pittsburgh where he directed graduate training programs in Risk Assessment and Radiation Health while maintaining an active research and teaching career. Dr. Claycamp’s bachelor’s degree is in Human Biology from Stanford University, and M.S. and Ph.D. degrees are in Radiological Health Engineering from Northwestern University.
Dr. Guy Deloach
Professor, Business Department
Lee University
Guy is currently a professor with Lee University in Cleveland, USA sharing his insights on various topics of specialization which include strategic planning, operational excellence, and finance. Guy was the former Executive Vice President of Operations with Toyota and has over 20 years experience in the automotive industry. He is also President of the Lean Advantage Group, a consulting group specializing in applying Toyota production system and Lean sigma concepts to the pharmaceutical and health care industry.
Guy had previously served as an advisor to both state and federal agencies within the US including the Department of Defense, Department of Commerce, the Executive Office of the Governor for Florida, and served on the board of directors and as a judge for the Michigan and Florida state quality programs. He has also served as an advisor to Dutch Government of Aruba for improvements in economic development and tourism.
Guy has written and presented papers on Strategic Planning & Quality Improvement Techniques at the Sterling Conference in Florida (a national performance excellence conference) and was also a speaker at the General Motors Continuous Improvement Symposium 8 where he presented a paper on “Graphical Analysis Techniques”, which was jointly authored with Tom Jacoby. In 2007, he also jointly authored “Critical Thinking for Continuous Improvement” with Tom. Guy has also contributed to the Certified Reliability Engineer and the Certified Quality Engineer. He is also a certified Auditor for Business Management Systems by IRCA since 1995.
Goh Yong Keng
Director, Engineering & Maintenance
Schering-Plough Ltd
Yong Keng joined Schering-Plough Ltd in 1998 and currently is the Director of Engineering and Maintenance. Responsible for all Engineering and Maintenance activities for the site, which includes four API’s Facility, a Biotech Sterile Facility, a Tablet Facility and a Dry Powder Inhaler Facility. In addition to the Engineering and Maintenance function, Yong Keng was actively involved in all Projects development of the site. Involvement includes participation in the engineering design, construction, commissioning, validation and successful start-up of Multi-Purpose Facility, R&D Pilot plant, Biotech Sterile, Tablet Facility and Dry Powder Inhaler Facility.
His other responsibilities include operation and maintenance of the central utilities system and process/project engineering.
Prior to Schering-Plough, Yong Keng had more than 12 years operation engineering experiences in the Power and Petrochemical industry, which was followed by another 6 years in Project/Maintenance experiences in GlaxoSmithKline pharmaceutical manufacturing facility in Singapore. He was involved in Project management of two mega-sized petrochemicals green field projects.
With extensive and diversified experiences in plant operation, design and project management, Yong Keng has acquired the synergistic knowledge and skills for establishing good engineering design feature in equipment and process system, selection of equipment, maintainability of equipment at design stage. He is also involved in the design, operation and maintenance of several purified water systems in the plant.
Alan Halstead
Validation & Regulatory Consultant
PM Project Services Ltd.
Alan is an electro-mechanical engineer whose career has centred on providing technical, validation and compliance expertise and engineering project management in the integrated construction, installation, commissioning and validation of Pharmaceutical facilities, (API, Secondary and Biotech). He has spent 26 years in pharmaceutical manufacture after spending 17 years as a Weapons Engineer, and is the Co-author of “Calibration Management”, a Pharmaceutical Industry Guide.
Alan is a member of the ISPE UK Southern Region Committee and has been Chair of the ISPE UK & Ireland Community of Practice for Process Analytical Technology since March 2005 where he continues to work with the pharma industry, US and EU regulators, academia, suppliers and manufacturers on the challenges of developing processes using PAT techniques.
Paul Hochi
Manager, Project Development
Jacobs Charleston
Paul Hochi is a Manager of Project Development for Jacobs' Charleston operations. Jacobs Charleston is Jacobs' modular design and construction center. Paul has 17 years experience in engineering and construction in a variety of positions, with the last 10 years specializing in the front-end development and coordination of modular projects. He specializes in evaluating optimal modular execution strategies, schedules and layout configurations. Paul received a B.A. degree from the University of Southern California and is a member of ISPE.
Ms Hui Foong Mei
Head, Good Distribution Practice (GDP) Unit
Health Sciences Authority
Ms Hui Foong Mei is the Head of Good Distribution Practice (GDP) Unit under the Manufacturing and Quality Audit (MAQ) Division in the Health Products Regulations Groups (HPRG) of Health Sciences Authority (HSA), Singapore. She is also a Senior Good Manufacturing Practice (GMP) Auditor of HSA.
The GDP Unit, which is under her charge, administers the regulation of pharmaceutical importers and wholesale dealers as well as pharmacies in Singapore, through licensing and audit regime.
Ms Hui joined HSA in 2001 as the Drug Evaluator and assumed the post of Deputy Head (Licensing) of the Drug Registration Branch before joining the Manufacturing and Quality Audit Division. Prior to joining to HSA, Ms Hui has worked in the field of hospital and retail pharmacy, manufacture, import and wholesale of medicinal products.
Ms Hui has been involved in the ASEAN Harmonization projects in relation to ASEAN Common Technical Dossiers & ASEAN Common Technical Requirements, ASEAN Cosmetics GMP, ASEAN Mutual Recognition Agreement (MRA) on GMP inspection. Besides these, Ms Hui had acted as the WHO Short Term Consultant on the control of pharmaceutical supply chain at the Workshop on Post Marketing Regulation of Drugs organized by China SFDA in Sep 2004. She had also played a lead coordinator role in the development of the ASEAN Process Validation Guidelines.
Johan Hultman
Manager
MKS Umetrics
Johan Hultman is the Manager for MKS Umetrics activities in Asia, Denmark Belgium, Netherlands, Spain and Portugal. He has been working within the Umetrics organization since 1999, advising customers, teaching and finding solutions to complex problems using Design of Experiments and Multivariate Data Analysis, most of the time with customers within the pharma, biotech and medical device industry. His expertise is to find the right solution and application to manufacturing problems and monitoring and controlling the process in real time.
Johan's has a background as a teacher in Mathematics and Natural science (Chemistry, Biology & Physics) in Sweden.
Bryce Johannes
Director of Marketing
Blue Mountain Quality Resources
Bryce Johannes is Director of Marketing at Blue Mountain Quality Resources, Inc., a developer of technologically advanced asset management software solutions for FDA regulated life sciences organizations since 1989. In this role, Bryce keeps up with the latest industry trends, authoring articles and white papers as well as presenting webinars on a broad range of topics. Bryce has a Masters of International Management from the Thunderbird School of Global Management.
Kelly Keen
Senior Project Manager
Genentech, Inc
Kelly Keen is a Senior Project Manager in the Corporate Engineering department for one of the leading biotechnology companies, Genentech, Inc. In May 2007, she began work on Genentech’s first Greenfield site in Singapore for the ECP1 Lucentis manufacturing plant. The process modules for this project are being constructed in the United States and were shipped through the Suez Canal to Singapore to integrate into the 7,500 m2/ 80,000sf facility. She is also managing work on a Biosafety Mycoplasma and Cell Culture Lab in Science Park. This lab will be used to support testing of product manufactured in Singapore.
She received a Maters of Architecture from the University of Illinois in Champaign, attended L'ecole d'Architecture et d'Urbanisme in Versailles, France and is currently enrolled in an MBA program, specializing in International Business, at the Edward S. Ageno School of Business at Golden Gate University in San Francisco.
Ms. Keen has previously worked as a Senior Project Manager for general contractors where she managed projects for Chiron, Alza, Exelixis, Lucas Digital Arts, Electronic Arts and Stanford University. She began her career at Flad & Associates, an architectural firm specializing in Research & Development.
She serves on the International Society of Pharmaceutical Engineering (ISPE) Board of Directors in San Francisco and the Executive Board in Singapore. She also chairs a class in Bio-Engineering at the University of California at Berkeley.
In her spare time, Ms. Keen enjoys traveling South East Asia, riding with the ANZA bicycling team and teaching pilates and other fitness classes in both California and Singapore.
Lee Chin Hoo
Engineering Services Director/Team leader
Pfizer Asia Pacific
Chin Hoo joined Pfizer Singapore in Mar 2001as the Engineering Services Director/Team Leader involved in engineering services set up which include maintenance (mechanical, electrical/instrument and facility), utilities operation and projects and utility. Upon the engineering services set up, he was directly involved in the startup of the utilities and Organic Synthesis Production (OSP) and the successful passing of the inspection by FDA. Prior to joining Pfizer, he was with Chevron Oronite , Singapore , a green field plant where he was the General Manager, Maintenance, Engineering and Purchasing Services for about 5 years. Chin Hoo was also with Schering Plough Singapore , another greenfield plant as the Engineering Department Manager at the construction till startup of the production before he moved to Chevron. His early career was with Smithkline Beecham (now under G SK ) as the Project & Maintenance Manager for about 7 years and Project Engineer with Petrochemical Corporation of Singapore for about 5 years.
He has a degree in Mechanical Engineering (National University of Singapore), Advanced Diploma in Business Administration and a registered Professional Engineer with the Professional Engineers Board, Singapore.
In his spare time, he enjoys reading, running and listens to music.
Dr. William Leong
Senior Development Fellow
Synthetic Chemistry, Chemical and Physical Sciences
Schering-Plough Research Institute
William Leong completed his undergraduate work at the University of San Francisco, and received his doctorate from the University of California working under the direction of George Zweifel. He went on to complete a post-doctoral fellowship at Iowa State University with Richard Larock.
His professional career began with the chemical development group at the Schering-Plough Research Institute in 1990. He has worked on development projects spanning from pre-clinical to commercial phases. His research responsibilities include route scouting, synthetic methodology, process development, pilot and commercial manufacturing. He is currently a Senior Development Fellow in the Chemical and Physical Sciences Department at Schering-Plough.
William is married and is the father of two teenaged children. He resides in Westfield, New Jersey, U. S. A.
Dr. Liu Mingsheng
Professor of Architectural Engineering
Charles W. Durham School of Architectural Engineering & Construction
University of Nebraska-Lincoln
Dr. Mingsheng Liu, has a Ph.D. in mechanical engineering from Texas A&M University (1992). He has conducted extensive research in the following areas: building system commissioning and fault detection, control system optimization, heat and mass transfer in building, air infiltration and air infiltration energy consumption, and development of renovated HVAC systems. He has published 50 journal papers, 200 reviewed proceeding papers, 2 textbooks and an education booklet. He is the primary founder of the Continuous Commissioning technology (CC®). He is the founder and CEO of the following energy technology companies: Bes-Tech, USA; Best-Shenzhen, China; Best-Zhozhao, China, DTL Controls, USA.
Bob Livingston
President & Chief Technical Officer
Arion Water, Inc
Bob Livingston is the President of Arion Water, Inc., a 23-year-old consulting engineering and analytical testing laboratory addressing all aspects of high purity water for pharmaceutical, semiconductor and related industries. Arion Water’s high purity water services include system design, analytical testing, operation, application, specifications and validation. Bob has worked for environmental testing laboratories, water system manufacturers and equipment service providers.
Bob has spoken on numerous occasions for the ISPE, ASQ the ASPE, and taught the course on Pharmaceutical Water System Design for the PDA. He lectures often for Barnett, IVT and IPA on all aspects of High Purity Water production and use.
Bob graduated with a Bachelor of Science (Zoology) from Kent State University in 1980 and has published numerous articles in varied publications including Ultrapure Water, Biopharm International and Genetic Engineering News. He has also co-authored a chapter with Dr. Ted Meltzer on high purity water production for a Marcel Dekker Publication on Aseptic Processing.
Bart Moors
Business Development Manager
Pharmaceutical Industry, South East Asia
Siemens AG
Bart is the Business Development Manager South East Asia of the Competence Center for Pharmaceutical industries, which is part of the Siemens Headquarters. He started his profession with Philips where he was product specialist and rose to become Project Manager (Lean manufacturing) of a division responsible for worldwide supplies to the automotive industry.
Bart started his career at Siemens as the International Project Manager for the pharmaceutical industry in 1997. He realized projects for customers such as Janssen Pharmaceutica, UCB, Genzyme and Schering & Plough. In 2005 Bart joined the Competence Center Pharma group and is now responsible for the pharmaceutical industries within South East Asia.
Bart has a Masters in Engineering (Electrical-Mechanical Engineering) from the University of Hasselt, Belgium specializing in Polymers, and a Masters degree in Applied Economics.
Claus Munk
Area Sales Manager, India / South east Asia / Asia Pacific
rommelag
Claus Munk is area sales manager for Blow-Fill-Seal (BFS) bottelpack® machines for rommelag® in Buchs, Switzerland responsible for India, South East Asia, Australia and New Zealand. In this role he is directly involved with the customers’ expanding requirements and the development of customer specific bottelpack® machines and solutions.
Before moving into sales of pharmaceutical machinery in 2006, Claus Munk spent almost his entire 19 years career in international sales and marketing, covering high end medical diagnostic equipment for hospitals and clinics and also investment- & industrial systems for professional and innovative off-street-parking solutions.
Living in Switzerland since 1981, he has studied economics, specializing in Investment-/industrial- and international marketing.
Jeffrey Michael Okun
Biopharm Market Director
Siemens Water Technologies
Jeffrey M. Okun is Biopharm Market Director for Siemens Water Technologies. He is responsible for global sales, marketing and business development for high purity and wastewater systems to the pharmaceutical, biotechnology, and cosmetics industries. Mr. Okun has over 20 years of experience in marketing, sales and engineering of high purity water systems, primarily for the pharmaceutical industry. He frequently leads training sessions and workshops on various topics related to pharmaceutical water purification. Workshop venues have included ISPE, Interphex, PDA, and other professional and corporate organizations. Prior to joining Siemens (formerly USFilter) in 1997, Mr. Okun worked for Ionics, Fluor Daniel, and STERIS Corporation. He has earned a BS in Chemical Process Engineering from Northwestern University and an MBA focusing on High Technology Management from Northeastern University.
Mr. Okun lives near Boston in the USA with his wife and two daughters.
Ong Chin Teck
Director for Engineering
Merck Sharp & Dohme
Chin Teck is currently the Engineering Services, Reliability and Maintenance Manager with Merck Sharp & Dohme. He leads the Reliability Centered Maintenance Program in MSD using the Lean Six Sigma Methodology.
Prior to joining MSD, Chin Teck held the position of Southeast Asia Electronics Operation Manager with a US$8 billion MNC in the Gas and Chemical Industry.
Chin Teck started his career in the Semiconductor Industry with an EDB Specialist Manpower Award. He had led a team of engineers to Taiwan for Technology Transfer and started up a Greenfield Semiconductor plant in Singapore.
Chin Teck had been an adjunct lecturer for the bachelor degree program in Engineering with New Castle University of Australia.
Chin Teck obtained his Master Degree in Business Administration from the Nanyang Technological University of Singapore. He also has a Master Degree in Mechantronics and Bachelor Degree in Mechanical Engineering from the National University of Singapore.
Dr KPP Prasad
Quality Operations Director/ Team Leader
Pfizer Asia Pacific Pte Ltd
Prasad completed a PhD program in Pharmacy from the National University of Singapore (NUS) in 1989 and subsequently carried out post-doctoral research at West Virginia University, USA under an international exchange fellowship. He has over 20 research publications in international journals/ books. Prasad has about 23 years of experience in Manufacturing, Quality Operations, Technical Support, Regulatory Compliance and Continuous Improvement with leading pharmaceutical manufacturers such as GlaxoSmithKline, sanofi-aventis, Wyeth and Pfizer. He is a member of ISPE and a Fellow of the Royal Society of Chemistry.
Prasad is an Associate Professor (Adjunct) of Pharmaceutics at NUS. He is also nominated as a Member of the Quality Control Advisory Committee by the Minister of Health, Government of Singapore. He is currently the Quality Operations Director/ Team Leader at Pfizer’s manufacturing plant in Singapore that supplies active pharmaceutical ingredients to global markets.
Dr. Alice Redmond
Senior Regulatory and CQ Consultant
PM Group
Alice has over 20 years experience in R&D, Pharmaceutical (API , Formulation Fill, Solid dosage) and Biotechnology industry. Alice has a BSc in Biotechnology and a PhD in Cancer Research (Cell Culture and Genetics). Experienced in Project Management, Regulatory Compliance, Quality, Commissioning, Qualification and Validation.
She was involved in the Sandoz facility from Greenfield as a staff member for 8 years prior to joining PM Group in 2000. Current responsibilities include oversight of the GEP/GMP regulatory compliance and ICQ strategies on a corporate level for PM Group. She continues to work with the pharma industry, US and EU regulators, academia, suppliers and manufacturers on the challenges of streamlined lean Commissioning and Qualification Strategies.
Alice is an active member of the PDA and ISPE and she co-chaired and presented at the ISPE GEP ICQ conference in Copenhagen in 2006. Other affiliations include committee member of the Irish Branch of the PDA, EBA Committee and Bioconnect.
Paul Robinson
Director of Operational Excellence
GlaxoSmithKline
Paul Robinson is a graduate from UMIST in Chemical Engineering and has worked in a variety of roles at many different scales of operation in the last 12 years – from a small family-owned company all the way to the size of operations of GlaxoSmithKline. He has worked on both batch and continuous manufacture in the fine chemical and Pharma industry and executed many CAPEX and improvement projects from capacity optimisation and expansion to waste minimisation and elimination.
Paul’s work in Singapore commenced in 2001 as a Chemical Engineer engaged in solvent recovery process design, Actives technology transfer and CAPEX projects as part of the Technical Development function. He has managed the technology transfer and launch of mature and new products from the Jurong Site as well as leading several clinical trial and development campaigns.
His current role is Operational Excellence Champion for the two GSK manufacturing Sites in Singapore and he has recently been certified as a Master Blackbelt following over 2 years of full-time application of the tools and processes to derive benefits in a range of areas covering Lean and Six Sigma. Particular areas of expertise have been application of statistical tools to aid process understanding – design of experiments, measurement systems analysis, root cause analysis – and more recently applications of Lean in the areas of Laboratory work organisation and Manufacturing Standard Work.
Dr. Abbas Saffari
Technical Officer
World Health Organisation
Dr. Saffari is a Quality Assurance specialist with more than 17 years of direct working experience in implementation of GMP regulations, inspection, quality control, manufacturing, analytical method development, and method validation & process validation of pharmaceutical and bio-pharmaceutical products. He has In-depth working knowledge of cGMP and thorough understanding of international regulatory agencies (FDA, WHO, ICH and EMEA) requirements.
Dr. Saffari has also successfully launched two products in the US market with an FDA approval, “Avonex” ß-interferon injection for the treatment of Multiple Sclerosis received FDA approval in 1997and “Ameviv” for the treatment of chronic plaque Psoriasis (skin disorder) received FDA approval in 2001
Prior to joining WHO, Dr. Saffari was the Director of Quality Assurance at Pacific Pharmaceutical in Pakistan, where he directed and led Pacific Pharmaceutical to the state of GMP compliance for filling with European Health Ministry and subsequently received the certificate of “GMP compliance of manufacturer” from European Union for Pacific Pharmaceutical, the first of its kind in Pakistan in 2007.
Dr. Saffari obtained his Doctorate of Science from the University of Nebraska in 2005.
Lawrence Smiddy
Commissioning and Qualification Manager
GSK Biologicals
Lawrence is currently the Commissioning and Qualification Manager for GSK’s Greenfield Bio-Pharmaceutical Plant being constructed at Tuas, Singapore with responsibility for Site Start-Up of Utilities, Process, Process Support and HVAC and BioSafey Systems.
Prior to this, he was the Leveraged Commissioning and Qualification Manager for “BioCork”, a Greenfield Bio-Pharmaceutical Plant of Centocor Biologics Ireland Limited, Ireland, a subsidiary of J&J Group.
Graduated from Cork Institute of Technology in 1997 with a Bachelor of Mechanical & Manufacturing Engineering, Lawrence spent most of his early career with various pharmaceutical manufacturers based in Ireland, which saw him working on various projects with varied responsibilities including design coordination, construction management and Commissioning and Qualification. Schering-Plough, Janssen Pharmaceuticals, Pharmacia and Novartis are amongst the companies which Lawrence has conducted C&Q services with.
Dr. Naoki Tahara
Leader, Bio Group, Engineering Operations
Life Science Operations, No.2 Project Division
JGC Corporation
Dr. Naoki Tahara joined JGC Corporation in1984 and performed the research and development of the microbe / mammalian cell culture technologies (ie. a murine monoclonal antibody as a diagnostic reagent, scale-up technologies of mammalian cell culture bioreactor, and bacterial cellulose production process by an aeration and agitated culture system, etc. ) for 14 years, and GMP compliance/commissioning & qualification works of biopharmaceutical production facility / the cellular and tissue-based product production facility for next 7 years. He has currently positioned as the group leader of biopharmaceutical process design engineering group since 2006, and has been managing process engineering for biopharmaceutical facility and technical development for fermenter /mammalian cell culture bioreactor system. He received a B.Sc in microbiology from Hokkaido University in Japan, 1984, and Ph.D degree in enzymology from Kyoto University in Japan, 1998.
Masatoshi Takemata
Senior Manager, GMP Technology Department
Life Science Operations, No.2 Project Division
JGC Corporation
Masatoshi Takemata is Senior Manager of the GMP Technology Department which is engaged in GMP compliance consultancy and Commissioning & Qualification (C&Q) work for pharma and biopharma projects. He joined JGC in 1981 and has 22 years experience in GMP Technology in various pharmaceutical-related areas, including bio bulk products, sterile products, solid dosage forms, chemical bulk and medical devices. He has a Bachelor’s degree in mechanical engineering from Chiba University in Japan. He is a Director of the ISPE Japan Affiliate, as well as a member of the Affiliate’s Education Committee and the C&Q COP. He serves also on the GMP committee of JSPME (the Japan Society of Pharmaceutical Machinery and Engineering).
Tan Kay Yong
Vice President, India China Sourcing and Supply
Global Manufacturing and Supply
GlaxoSmithKline
Kay Yong is currently Vice President, India China Sourcing and Supply, Global Manufacturing and Supply at GlaxoSmithKline and based in London, United Kingdom but is often a global nomad. He is a member of the GMS Executive Team. Prior to his current role, Kay Yong was Vice President Operational Excellence, Global Manufacturing and Supply, again based in London, United Kingdom.
Prior to his corporate roles, he has been the Vice President and Managing Director, Singapore, and responsible for the supply of active pharmaceutical ingredients to subsidiaries worldwide. Kay Yong holds a BSc in Mechanical Engineering from Manchester University and an MBA from the National University of Singapore.
He is active in community support and is the current Chairman, Board of Governors, Singapore Polytechnic and Chairman, Singapore Polytechnic International. He has also sat on various committees.
Damian Thornton
Vice-President & Director for Europe & Asia
Manufacturing & Life Sciences
CH2M HILL
Damian Thornton is the Vice President & Director for Europe & Asia in the Manufacturing and Life Sciences Business Group. He has been with CH2M HILL,
Lockwood Greene and IDC group of companies for more than 8 years, and is based out of the Dublin office in Ireland.
Damian studied Chemical Engineering at Queens University, Belfast, and graduated with honours in Bachelor of Science in Engineering.
He has over 20 years of experience as a chemical engineer. His areas of expertise include process design in drug substance and finishing pharmaceutical facilities, bulk chemical and chemical industry with specific expertise in engineering and project management of multi-discipline task force. He is experienced in design, start-up and commissioning of both new and retrofit facilities. Among his areas of expertise are management of process design teams, participation in hazard and operability studies, and computer modeling. He has also given training courses on inherent safety in process plant design.
Damian has worked on a number of High Potent facilities in both HAPI and Secondary Pharmaceutical facilities and has developed gap analysis for existing operations to enable high potent manufacture. He is currently the Project Director for a new €50MM OSD facility being designed to 1µg/m3. He was responsible for developing the dispensing, containment and materials handling philosophy for the new facility.
Steve Williams
Director
SeerPharma Pty Ltd
Australia
Steve has over 34 years of experience in the Biotechnology, Pharmaceutical and Medical Device industry, with specialization in Quality Assurance, Manufacturing and Consulting. Steve specialises in Quality Assurance & Management, compliance, risk assessment and validation.
Steve has conducted many pre and post TGA and FDA compliance audits and gap analysis for international companies as well as developed multiple training courses for GMP, GLP, Validation, HACCP and Medical Devices.
In 2006, Steve was appointed to the ISPE Commission for establishment of the Certified Pharmaceutical Industry Professional credential. He is responsible for representation of Australia and Asia on the commission. The commission is a 2 year term.
Steve is also a registered GMP APVMA (Veterinary) auditor and regularly presents at conferences and industry seminars on a range of subjects relating to QA, risk and GMP compliance.
Clarence Wong
Technical Development Manager
GSK Singapore
Clarence is a Technical Development Manager at GSK Singapore, responsible for new product introduction activities and technical support to marketed products in two value streams. He is also the site’s process engineering leader. Clarence has been involved in a number of key initiatives in his 15 years with the Company. These include commissioning/validation of two of the three production facilities on the Jurong site, led the capital project/technology transfer leader of three intermediate stages, Concepts Study leader of the newly installed Chemical Development Pilot Plant, site master plan development, Concepts Study of Glaxo Wellcome’s New Primary Manufacturing Facility and technology transfer of 24 chemical stages to the Jurong site.
One of the key projects he is currently working on concerns the development, technology transfer and regulatory filing of a New Chemical Entity using the GSK’s Quality by Design principles.
Clarence holds a Bachelor of Chemical Engineering Degree (Hon) and an MBA.
Vince Wu
Principal
VLW Associates
Vince Wu is a Principal with VLW Associates, an operations management consulting firm located in the San Francisco Bay Area. Vince is currently working with the Foster Wheeler Asia Pacific team and is taking a lead role in the design of a fill-finish facility in Asia.
Vince has 25 years of experience in the biopharmaceutical industry and has worked on upstream, downstream and fill-finish projects. Vince has held technical management and executive positions at Genetech, Integrated Biosystems, and VaxGen. Vince has a BS in Chemical Engineering from the University of Michigan and an MBA from The University of San Francisco. Vince pioneered large-scale freeze-thaw technology for biopharmaceuticals in the mid-80’s while at Genetech and commercialised the technology at Integrated Biosystems (now part of Sartorious-Stedim Biosystems). While at VaxGen Vince took a lead role in the process design of the Celltrion cell culture plant in Incheon, Korea.
Vince is a member of the ISPE, and the PDA and is a co-author and co-editor of several publications including the Drug Manufacturing series with the late Dr. Kenneth Avis.
Hossein Zarrin
Senior Program Manager
AMKS Instruments, Inc.
Hossein Zarrin has more than 20 years of experience in the ozone and sterilization industries. He is the Program Manager for Ozone sterilization and CIP program at MKS Instruments Inc. While at MKS, He previously had been Engineering Manger for the Ozone product group.
Prior to MKS, he held the position of Project Manager for development of microwave sterilization technology used for biological fluids and cell culture media at Charm Bioengineering Inc. While at Charm Bioengineering, he developed luminescence bioassays using receptor binding techniques for detection of contaminants in food products.
He holds 5 US patents with one patent pending. Hossein is a member of the ISPE and IO3A (International Ozone Association). He also holds a Chemical Engineering degree from the University of Massachusetts.
