2018 Speakers

Achiraya Praisuwan
GMP Inspector, Ministry of Public Health, Bureau of Drug Control, Thai FDA

Albert Dyrness
Chief Technology Officer, ADVENT Engineering, US

Ameet Ambarkhane
Lead Engineer, Global Technical Operations, Merck, Sharp and Dohme Corporation, Singapore

Andy Rayner
Chief Technology Officer, PM Group, Ireland

Arnan Ben-David
former Director, Global Sterile Engineering, Teva Pharmaceutical Industries, Israel

Boon Meow Hoe
PIC/S Chairman (2018-2019), Singapore

Bob Tribe
Asia Pacific Regulatory Affairs Advisor, ISPE, former Chairman, PIC/S, Australia

Chai Chong Meng
Head of Mammalian Manufacturing, Lonza Biologics

Charlie Wakeham
Informatics CSV Consultant, Waters Australia Pty Ltd

Chang Teck Chung
Quality Director, FQMR, Shire, Singapore

Chong Hock Sia
Senior Consultant, Audit & Licensing, Director, Quality Assurance, Health Products Regulation Group,Health Sciences Authority (HSA), Singapore

Christine Moore
Global Head and Executive Director, GRACS CMC –Policy, Merck, Sharp and Dohme Corporation, USA

Christian Wolbeling
Senior Director Global Accounts, Werum IT Solutions, Germany

Dave Bartlett
Senior Automation Manager, No deviation Pte Ltd, Singapore

Daniel Sanchez
Senior Manager Operational Excellence, GlaxoSmithKline, Belgium

Denise Tan
Principal Engineer, Process Development, Amgen, Singapore

David Staunton
Director of Site Services, Zenith Technologies, Ireland

Ee Lynn Kok
Director, Enterprise Regulatory Compliance, Johnson & Johnson, Singapore

Elad Mark
ISPE Singapore, Director/Principal Engineer, Antero Engineering, Singapore

Felix Mausolf
Regional Sales Manager, Groninger, Germany

Frédéric Dietrich
Managing Director, Dietrich Engineering Consultants sa, Switzerland

Ferry Soetikno
Chief Executive Officer, Dexa Group, Indonesia

Foo Suan East
Global Product Lead, Process Sciences and Technical Services, Shire, Singapore

Dr. Georg Singewald
ISPE Singapore & Head Quality, External Supply Operations, Novartis Pharmaceuticals, APAC & MEA, Singapore.

Gunnar Danielson
Head of Global Software Solutions, Mettler Toledo GmbH, Switzerland

Gary Khoo
Head of Process Development (CMC/ MSAT), Tessa Therapeutics Pte Ltd, Singapore

Hazem Eleskandarani
Global Director, Commissioning & Qualification, Johnson & Johnson, US

Harry Benson
Director of Human Performance Services, Commissioning Agents International (CAI), US

Immaculada Gomez
Tech Transfer Lead, MS&T, Novartis, Singapore

Jim Davidson
Vice President of Science and Technology Practice, Lachman Consultant Service, USA

Joseph Micsko
ISPE Singapore & Operations Director, PSC Biotech Pte Ltd, Singapore

Jack Wong
Founder, Asia Regulatory Professional Association, Head of Regulatory Affairs, Asia Pacific, Baxter, Singapore

Jeff Chen
Production Manager, Pharma Essentia Corporation

Jeroen Kyto
Global Key Account Manager, Pharma, Ceva Logistics, The Netherlands

Jordi Vall-Lossera
Global Head Supply Chain Quality, Novartis, Switzerland

Dr. Jincai Li
Vice President, Drug Substance Manufacturing (MFG1), WuXi Biologics, China

Jeff Surmon
Global Industry Manager, Alfa Laval China, China

Johann Bonnet
Vice President Business Development – Pharma & Cosmetics, Veolia, France

James Weidner
Process Development Site Head, Executive Director, Amgen, Singapore

Liu Shan Shan
Vice President, ISPE Singapore Affiliate

Linda Evans O’Connor
Vice President, Chief of Staff, Lachman Consultants, USA

Manuel Ungerer
Head Process Engineering & Technical Services, Novartis Singapore Pharmaceutical Manufacturing Pte Ltd, Singapore

Mehul Patel
Global Director of Training, Microbial Solutions, Charles River Laboratories, United States

Melis Tay
Operations Start Up Manager, AbbVie, Singapore

Michelle Peake
Senior General Manager, PT Kalbio Global Medika, Indonesia

Marc O’Donoghue, PhD
Site Director for AbbVie Operations Singapore

Maurice Parlane
ISPE PV Chapter Lead, Director, ISPE Australasia & Director, Centre for Biopharmaceutical Excellence, Australia

Michael Lee
Senior Vice President, Mab Venture Bio Company, China

Nigel Cheong
Head, Biomedical Sciences, Economic Development Board (EDB), Singapore

Paolo Rampichini
Head Supply Chain, Pharma, Asia Pacific, Hoffmann-La Roche, Singapore

Paul Si
Head Project Management Asia, Novartis, Singapore

Pierre Landais
Asia-Pacific Manager, Powder Systems Limited (PSL), Australia

Pierre Winnepenninckx
Conference Chair, ISPE Singapore 2018

Qiwei Wu
Vice President and Process Development and Manufacturing, Livzon Mabpharm Inc.

Rateb Al Jallad
Head of Supply Chain, Julphar Gulf Pharmaceutical Industries, UAE

Robert Lutskus
Global Product Delivery Manager – Informatics, Lonza Informatics, USA

Richard Chai
Technical Service Manager, STERIS Corporation, Singapore

Raymond Dallago
Director of Sales, Sanisure, USA

Samuele Bissola
Technical Sales Manager, F.P.S. Food Pharma Systems srl, Italy

Sim Li Jun
Technology Manager, Singapore & Malaysia, Biologics Lead-Southeast Asia, Merck Life Science, Singapore

Dr. Stefan Kappeler
Technology Manager Life Sciences, Exyte, Switzerland

Sergio Mauri
President, ASSCCA, Director of Marketing and Business Intelligence, Fedegari, Italy

Sook Peng Chua
ASEAN Regulatory & Quality Compliance Director, Johnson & Johnson, Singapore

Thomas Halfmann
Partner, Halfmann Goetsch Partner AG, Switzerland

Thomas Terranova
Managing Director, Terra Asia Consulting Pte Ltd., Singapore

Vladimir Orlov
Deputy Head of Scientific, Methodology & Training Department of FSI «SID&GP», State Institute of Drugs and Good Practices, Russia

Dr. Vasiliki (Vee) Revithi
Ex-Head of EOF / Greece, GMDP Inspectorate, Greece

Vincent Loret
Site Director, GlaxoSmithKline

Wee Ming Chua
Managing Director, Halfmann Goetsch Partner AG, Singapore

Wallace Torres
Executive Director Quality Site, Amgen, Singapore

Ms Achiraya  Praisuwan is currently a GMP Inspector at the Inspectorate Unit, Division of Post-marketing Control, Bureau of Drug Control of the Food and Drug Administration in Thailand. She is a professional pharmacist with a doctor of pharmacy degree from the faculty of pharmaceutical science, Naresuan University, Thailand.

Achiraya has relevant experiences in domestic and overseas GMP inspections, handling of products quality defects, and GDP/GSP inspection at vaccine distribution channels. She has been a speaker on Data Integrity and Data Management at ISPE Thailand Affiliate Seminar, a speaker on Current Challenges to GxP Compliance at ISPE Philippines Affiliate 2018 Annual Meeting, a principle investigator on a WHO-USP Project on Quality of Antimalarial Medicines in the GMS Countries, a Temporary Advisor to WHO on the national regulatory authority observed audit in Hyderabad and New Delhi.

Mr. Dyrness co-founded ADVENT Engineering Services, Inc., an engineering and compliance solution provider to the life science industry. Mr. Dyrness is a Principal and Chief Technical Officer. Mr. Dryness is a member of the American Society of Mechanical Engineers Bioprocess Equipment (ASME BPE) Standards Committee, and is serving as the Chairperson for the ASME BPE System Design subcommittee. Mr. Dyrness is also an Industrial Advisory Board Member of the University of the Pacific’s Bioengineering program. Mr. Dyrness received an M.S. in Mechanical Engineering from Massachusetts Institute of Technology and holds professional engineering licenses in the state of California for Chemical Engineering and Mechanical Engineering.

Ameet has a broad experience of working from drug discovery and development to commercial manufacturing and supply. He is from a Material Science background and holds a PHD from School of Pharmacy in London, UK. After working for almost 10 years in the UK he moved to Novartis Singapore Site. Since last 2 years he is working with MSD, Singapore and oversees the end to end process for drug device combination product.

Andy is the Executive Director (Pharma) & Chief Technical Officer (CTO) for PM Group. PM Group is an architecture and engineering company of 2,300 people, and within PM Group, as a member of the board, Andy is responsible overall for the pharmaceutical business that PM Group executes globally. Andy is a Fellow of the UK Institute of Chemical Engineers, has over 30 years’ experience in design of pharmaceutical facilities in various lead process engineering, design management and project management roles for many pharmaceutical companies, for both large and small molecule biologics projects, for both Drug Substance and Drug Product operations. Andy has most recently been involved in execution of a number of projects for ATMP products. Andy as the CTO of PM Group also has overall responsibility for SME’s within PM Group, is a past chairman of IChemE in Ireland & Andy currently sits on the steering committee for the BPOG pharmaceutical industry technology roadmap.

Arnan Ben-David has 30 years of experience in engineering within the pharmaceutical and biopharmaceutical industries, working at Teva Pharmaceutical Industries and Omrix biopharmaceuticals (which become a company of JnJ Ethicon) as an engineering director and subject matter expert. Arnan specialized in sterile production including facilities design, aseptic processing equipment, clean utilities and sterile processes.

Boon Meow Hoe holds a Bachelor’s degree in Pharmacy from the National University of Singapore.

After graduation, he served the commercial pharmaceutical manufacturing industry for 15 years.

He is an active Senior GMP Auditor conducting both local and overseas GMP audits since year 2001. He is also the Deputy Director of Overseas Audit Unit, Audit Branch, Audit & Licensing Division at the Health Products Regulation Group of the Singapore Health Sciences Authority (HSA).

Outside of Singapore, he is an elected Pharmaceutical Inspection Co-operation Scheme (PIC/S) Chair for year 2018 to 2019 cum Executive Bureau Member.

Bob Tribe, Asia Pacific Regulatory Affairs Advisor, ISPE, former Chairman, PIC/S, Australia

Bob joined the Therapeutic Goods Administration (TGA), Australia in 1971 as a GMP inspector, having worked in the pharmaceutical industry in a senior Quality Assurance position. He became Chief GMP Inspector in 1980, a position he held until his retirement in 2004. While at TGA he was elected Chairman of PIC/S in 2000-2001.

After retiring from TGA he established “Bob Tribe Consulting” and has assisted many GMP regulatory authorities around the world reach the PIC/S level of regulatory control. Of the sixteen regulatory authorities that he has assisted to date, ten have obtained PIC/S membership. He also consults to pharmaceutical manufacturers wishing to achieve compliance with PIC/S GMP requirements.

Bob is a member of the WHO Expert Committee on Specifications for Pharmaceutical Preparations and undertakes GMP inspections for the WHO under its Pre-qualification Programme.

He is an Executive Consultant with PharmOut Pty. Ltd., Australia and the ISPE Regulatory Affairs Advisor for the Asia-Pacific region.

Chong Meng currently heads the Manufacturing function of a large scale biotechnology facility with a headcount in excess of 160 and is responsible for all cell culture as well as purification operations in addition to production scheduling and deviations investigation. His scope has recently expanded to include master batch record documentation. He has also led his team through multiple successful FDA and EMA PAIs.

Prior to his current role, he was Senior Cell Culture Manager and was at one time managing the Production Support and Deviation Investigation teams concurrently.

Before moving into the biotechnology industry, he was acting Manufacturing Lead for an antibiotic production facility with a high throughput of 1900 tonnes per annum, followed by Manufacturing Lead for a multi-modular bulk steroidal API facility producing the company’s best selling franchise with an annual sales of GBP 6 billion.

Between 2006-2010, Chong Meng was a Senior R&D Process Engineer and led the commissioning effort for a GBP 38 million new late-phase pilot plant facility. Subsequently, he led the scale-ups & developments for 8 new chemical entities (NCEs) across 17 chemical transformational stages. He was also managing capital projects totalling GBP 2 million simultaneously.

In his career, Chong Meng has been frequently placed in roles to accelerate/ spearhead changes, identify best practices, streamline workflows. He is also known for his ability to make critical decisions.

Chong Meng received his MS in Chemical & Biomolecular Engineering from the University of Illinois at Urbana-Champaign with a perfect GPA.

Charlie Wakeham has twenty years of industry experience developing and validating computerized systems for regulated production and laboratory environments. She is Waters Corporation’s Regional CSV Consultant, providing validation services and presales support for Waters’ laboratory Informatics solutions to regulated manufacturers throughout the APAC region.

Career Highlights:

  • Member of GAMP® Global Council and GAMP® Data Integrity Special Interest Group Leadership Team, managing the ongoing production and editing of multiple GAMP Data Integrity guides written by industry volunteers
  • Contributing author and/or co-lead on ISPE GAMP® guides: Practical Approaches to Data Integrity Key Concepts (due July2018); Records and Data Integrity Guide 2017; A Risk-Based Approach to Testing of GxP Systems 2nd edition 2012; A Risk-Based Approach to Operation of GxP Systems 2009; Testing of GxP Systems 2006.

Charlie holds a BEng in Mechanical Engineering and an MSc in Advanced Manufacturing Technology. She is a Chartered Engineer, a Fellow of the Institute of Mechanical Engineers, and an IRCA-registered ISO 9001 auditor.

Teck Chung is the Quality Director and FQMR, Shire, based in Singapore since 2016.

Shire is the global leader in serving patients with rare diseases. We strive to develop best-in-class therapies across a core of rare disease areas including hematology, immunology, genetic diseases, neuroscience, and internal medicine with growing therapeutic areas in ophthalmics and oncology. Our diversified capabilities enable us to reach patients in more than 100 countries who are struggling to live their lives to the fullest. We feel a strong sense of urgency to address the high unmet medical needs of these patient communities.

Prior to joining Shire, Teck Chung held the position of QA Operations Director (Asia), Abbott Nutrition (Asia) and Site QA Director, Abbott Manufacturing Singapore during 2011-2016. Prior to that, he was the Quality Director at Pfizer/Wyeth Nutrition Singapore and Senior Technical Services Manager since the infant formula & adult nutrition greenfield startup in 2000 to 2011.

Between 1990 and 2000, he held various regional supply chain and API manufacturing operations positions with Exxon Chemicals/Shell joint venture startup, Schering-Plough Singapore API greenfield startup and GlaxoSmithKline Pharmaceuticals API.

He was a technical committee member of the WSQ Pharmaceuticals Quality (Food Science) Technical Committee, Workforce Development Agency (WDA), Singapore Ministry of Manpower. He is also appointed as WSG SkillsFuture Career Advisor (Manufacturing sector), Workforce Singapore (WSG), Singapore Ministry of Manpower.

Teck Chung holds a MBA from University of Tasmania (Australia), a Graduate Diploma in Business Administration from Singapore Institute of Management and a Bachelor Honours degree in Chemical Engineering from University College Dublin, Ireland.

Sia Chong Hock holds a Bachelor’s degree in Pharmacy from the National University of Singapore, as well as a Master’s degree in Healthcare Management (with distinction) from the University of Wales.

Currently, he is the Director of Quality Assurance and Senior Consultant of Audit & Licensing at the Health Products Regulation Group of the Singapore Health Sciences Authority. He is also an Adjunct Associate Professor with the National University of Singapore. At the supranational level, he is the Chairman of the ASEAN Joint Sectoral Committee (JSC) tasked with the implementation of a pan-ASEAN Mutual Recognition Agreement (MRA) on GMP Inspection.

Periodically, Mr Sia contributes review articles to ISPE’s Pharmaceutical Engineering and other international scientific journals in the field of comparative pharmaceutical regulations for health products, including herbal medicines and health/dietary supplements, control of active pharmaceutical ingredients (APIs) and pharmaceutical excipients, supply chain integrity, and ASEAN harmonization on GMP Inspection.

In August 2016, he received the International Pharmaceutical Society of Pharmaceutical Engineering (ISPE) Singapore Affiliate Lifetime Achievement Award for his contributions to the field of Pharmaceutical Regulatory Practices and for his leadership in driving the harmonization of GMP Inspection standards across the 10 Member States of ASEAN. And more recently, in January 2017, an article which Mr Sia co-authored was named the winner of the ISPE Roger Sherwood Article of the Year 2016 Award.

Dr. Christine Moore is Global Head and Executive Director, GRACS CMC – Policy at Merck. Christine joined Merck after 11 years in various positions in the US FDA, including Acting Office Director of the Office of New Drug Quality Assessment and of the Office of Process and Facilities. Prior to moving into the regulatory CMC area, she spent 10 years at Pfizer and Searle/Pharmacia in API process development, process analytical technologies, scale-up, and technology transfer. She holds a BS in Chemical Engineering from Northwestern University and a PhD in Chemical Engineering from MIT.

Throughout her career, Christine has focused on the development of scientific and regulatory approaches for advancing pharmaceutical manufacturing technologies, modernizing regulatory guidance, and progressing international harmonization.  She has been a thought leader in progressive regulatory approaches for pharmaceutical manufacturing in the areas of Quality by Design, process analytical technology, and continuous pharmaceutical manufacturing. Christine has given over 100 invited and keynote presentations and has served on multiple ICH working groups.

Christian Woelbeling is Senior Director Global Accounts at Werum IT Solutions based in Lueneburg, Germany, part of the Körber Medipak Systems Group. Werum is the market leader in Manufacturing Execution Systems / MES Solutions for the Life Science industries, working for 17 out of the Global Top 30 Pharma Companies with more than 800 installations. He helds a Master Degree in Mechanical Engineering. Since more than 25 years working in Life Sciences Manufacturing IT Christian has had great experience in all GMP related processes. He has broad activities inside the ISPE as Chairman of the Special Interest Group “Pharma 4.0”, ISPE “GAMP MES Special Interest Group” Co-Chair, ISPE GAMP Member at large of the European Steering Committee, “Knowledge Network Council” Co-Chair, “PAT & Lifecycle Control Strategy” CoP Steering Member, ISPE Affiliate DACH Board Member.

Dave Bartlett is the ISPE Singapore Affiliate’s Automation & Data Integrity SME. Getting his start in the Philadelphia biotech cluster, Dave moved to the APAC region in 2014: first helping Samsung Biologics start one of the largest Mammalian Cell facilities, and later moving to Singapore to work with No deviation.  With his position as the chapter’s Automation & DI SME, Dave has written articles for ISPE around Data Integrity and Cyber Security, and helps to broadcast the chapter’s ‘Technical Tuesdays’ on Facebook.

With GSK since 2011, Daniel is Senior Manager Operational Excellence for Vaccines Industrial Operations in Belgium.

He has held other support and operational roles as PMO, Training Manager and Production Head.

Before joining GSK, Daniel worked more than 10 years for top Japanese companies (Sony & Toyota) across Europe and Asia.

With his background as an Industrial Engineer, he held different roles including Industrialization and Manufacturing engineering, NPI lead and European Project Manager.

Denise Tan has 12 years of experience in process development, manufacturing operations and program management in Amgen and Lonza Biologics Singapore. She is currently the cell culture process team lead and drug substance team lead at Amgen Singapore Manufacturing and played a major role in qualification and licensure of Amgen’s new state-of-the-art next-generation biomanufacturing facility in Singapore.

David is the Global Director of Managed Services at Zenith Technologies and leads the delivery of site services to the Life Science Industry, with a team of over 400 engineers working out of 16 offices globally.

David has over 20 years’ experience in Project and Risk Management in the Life Science Industry.  He has delivered Automation and MES projects for clients including: Sanofi, Pfizer, MSD, GSK, AbbVie and Amgen.  David has integrated risk management into project management to improve delivery, decision making, accountability and prioritisation.

David has direct experience ensuring that Automation and MES projects and services have clear business cases and deliver on their promised benefits.

David has a BEng Hons in Aerospace Engineering, an MSc in Project Management and lectures in project management on Masters Programmes at UCD.

Kok Ee Lynn is a Director with the Johnson & Johnson Enterprise Regulatory Compliance team of 12 Independent Auditors, and is the only member based outside the US. Lynn has extensive experience in auditing of Pharmaceutical, Medical Devices, Consumer and Food companies globally, specializing in Laboratories, and in the past one year she has audited in 20 countries.   Lynn has conducted many Training courses for J&J sites globally on Auditing and Data Integrity.

Lynn has 36 years of Research, Quality and Operational experience including commissioning, validation and successful FDA approval of a pharmaceutical green-field startup API manufacturing site, in companies including Sanofi-Aventis, Tetra Pak etc.  Lynn holds a M.Sc. in Food Science and Joint Honours in Biochemistry and Physiology from U.K. Universities.

Elad Mark is a principal engineer with over 10 consecutive years’ of experience in the field of Biotechnology within diverse project stages including feasibility study, conceptual and detail design, commissioning, qualification and process validation. Elad has led a Global Engineering company through multiple projects, coordinating between projects different stages to deliver clients project requirements.

  • Studies National Economics and Business Administration at University in Tübingen (Germany) and Pforzheim (Germany) with a degree as MBA.
  • More than 15 year experience in sales of investment goods for: food, beverage, cosmetic and pharmaceutical industries.
  • Sales experience in EMEA and Asia.
  • Regional Sales Manager Asia at groninger since 2013.
  • Sales responsibility for Singapore, China, Japan and Korea.
  • Also responsible for developing of new sales markets like Thailand or Indonesia.

Frédéric Dietrich is the managing director of Dietrich Engineering Consultants. Dec are experts in supplying safe and contained powder handling solutions in the fine chemical and pharmaceutical industries.

Over the past 30 years Dec has gained extensive knowledge and experience concerning health, safety and containment in relation to powder processing.

Mr. Dietrich is a frequent speaker at conferences worldwide and his articles promoting safety aspects of powder handling have been published in scientific journals.

Mr. Dietrich holds a Master of Science (MSc) in Mechanical Engineering (Swiss Federal Institute of Technology Lausanne/EPFL).

Formal Education and Certifications

  • 2016 M.Sc, Industrial and Systems Engineering (Project Management), University of Singapore
  • 2010 B.Eng (Hon), Bioengineering, National University of Singapore

Employment History

  • 2017 Global Product Lead, Shire, Singapore
  • 2014 Lifecycle Management Project Coordinator, Baxalta, Singapore
  • 2012 Process Engineer, Baxter BioScience, Singapore
  • 2011 Manufacturing Engineer, Baxter BioScience, Singapore
  • 2010 Process Development Scientist, GlaxoSmithKline, USA

Georg currently leads the Quality Organization having oversight of External Supply Operations in Asia-Pacific, Middle East & Africa, Novartis Technical Operations. Previous assignments include Quality- and Operational- Roles at Solids and Biologics Sites incl Quality Head and Site Director. Georg holds a Master’s Degree in Pharmacy and a PhD in Pharmacology from the University of Innsbruck, Austria. He is a trained Qualified Person and Executive MBA in Supply Chain Management (Swiss Federal Institute of Technology – ETH)

With more than 20 years involvement with computerized systems, Gunnar has for the past 8 years focused specifically on laboratory workflow optimization, technical controls and regulation compliance. At METTLER TOLEDO, he leads a global group of lab specialists and consultants advocating for data integrity and workflow solutions. With increased regulatory focus on benchtop instruments, computerized systems and data integrity in the lab, Gunnar is actively involved in trainings, white papers and seminars to increase awareness of this important topic.

Gary Khoo is currently the Head of Process Science and Technology at Tessa Therapeutics, a T Cell Immuno-Oncology start-up company. He has spent over 15 years in Biologics manufacturing, CMC, MSAT and process development roles, including the Head of Manufacturing at Shire and CMC Director at Takada Vaccines. He has carried out transfers of early phase, late phase and commercial products; both within organizations and to CMOs.

Hazem Eleskandarani holds a master degree in Mechanical Engineering from the University of Utah and is a licensed Professional Engineer.  Hazem has 30 years of diverse experience that includes manufacturing, plant engineering, process design, technology management, and project engineering.  He began his career in 1988 in the steel industry as an equipment engineer responsible for equipment PM and plant annual shutdown repairs.  In 1996, Hazem joined Fluor Daniel working on pharmaceutical projects, before moving to Jacobs Engineering process equipment group.  In 2000, Hazem joined Merck Process Engineering working on several global projects in Spain, Italy, Ireland, US and Singapore.  Hazem’s current role with Johnson &Johnson – since joining in 2014- is providing global leadership for C&Q planning and execution across J&J’s global portfolio of capital projects.  Hazem lives in Worcester, Pennsylvania.

As the Director Human Performance Services at CAI, Harry Benson leads a team of experienced professionals in developing and executing programs, processes, and tools with industry organizations to standardize and improve the performance of their people.  A former nuclear-trained submarine officer and Master Training Specialist, he is an expert in organizational culture, performance improvement, and learning solutions design and delivery with over 20 years of experience in applying current methods for organizational effectiveness and learning within highly technical environments.  His methods have led to major skill improvement, driving results-based performance for the U.S. Nuclear Navy and companies ranging from small to Fortune 500.  Mr. Benson has a Bachelor’s degree from the U.S. Naval Academy, and a Master’s in International Business Administration from Wright State University.

Imma Gomez has worked at Novartis for 24 years, the last 3 as Technical Transfer Lead and Life Cycle manager. She graduated in Pharmacy from Barcelona University (Spain) in 1991 and obtained her MBA in Pharmaceutical Industry from Barcelona University in 1993. Since 1991 she held several position in Ciba-Geigy in Quality Control laboratory continuing after the merge with Sandoz to become Novartis in 1997. Roles in QA and QC include Microbiology, Packaging Material, Drug Product Laboratory Head, and Qualified Person for Spanish market. Imma joined Novartis Singapore in 2012 as Analytical Science and Technology Facilitator and moved to Technical Transfer lead in 2014. She likes to work in the area of interface between science and practice with pharmaceutical development and commercial sites.

Jim Davidson, Ph.D., is the Vice President of the Science and Technology Practice at Lachman Consultants with over 30 years’ experience in the pharmaceutical industry. He held positions of increasing levels of responsibility during his tenure at a major global pharmaceutical company, including executive-level positions. Dr. Davidson is eminently experienced in all aspects of technical, chemical, analytical, and pharmaceutical development, from new product development concept through marketed product. In the Science & Technology practice, Dr. Davidson manages the overall Lachman efforts involving Analytical and Bioanalytical laboratory compliance, drug development, including Quality by Design, and data integrity in pharmaceutical manufacturing and testing.

Joseph is currently the Operations Director for PSC Biotech and ISPE Singapore Affiliate President.  Currently he hold a Bachelor’s of Art in Business Management from Kingston University. With over 12+ years experience, Joseph has a wealth of expertise consulting for various Multi-National Pharma and Biotech Companies in US, Canada, Brazil, Singapore & China. He has managed various projects such as C&Q of start up facilities, Cleaning  and Process Validation. Some of his clients are J&J, Roche, AbbVie, Novartis, Merck and GSK.

Currently RA Head, APAC of Baxter Healthcare

Over 20 years of Regulatory, Clinical Trial and Pharmacovigilence experience in Asia with good knowledge in the field of Medical Devices, Pharmaceuticals, Nutritional, Consumer Healthcare and Biological products.

Externally, playing a leading role among all the Regional Regulatory professionals in AHWP (Asian Harmonization Working Party), and was invited to provide regulatory training to local universities and industry organizations. Prof Wong also very active in ASEAN, APEC, ISO and WHO projects

In his professional career, Prof Wong developed the First Asia Regulatory Affairs Certificate course since 2007 with more than 1500 students in alumni. He is also the founder of ARPA (Asia Regulatory Professional Associations) since 2010 with more than 1600 members and Asia GRP (Good Regulatory Practice) Research Centre since 2011 with more than 10 companies supporting. His is the author of First Asia Regulatory Book in Asia (Handbook of Medical Device Regulatory Affairs in Asia) and the book was launched in May 2013

Jeff Chen is the production head of Pharmaessentia, he is in charge of production site design/development, technical transfer, validation, process optimization and commercial biological product production. Previous position to Pharmaessentia, he worked for Impax Taiwan as technical service Engineer, he was responsible of multiple kinds of production related validations and process developments in small molecule. He obtained his master degree in Leiden University (The Netherlands) in protein NMR Chemistry and PhD candidate in University of Texas (USA) in biophysics. Before joining to pharmaceutical industry, he also worked as Genetic analyst in Baylor College of Medicine, Texas USA for 2 years.

With over 20 years supply chain logistics experience, Jeroen has an in-depth knowledge of the supply chain industry pertaining to cold chain shipping.

He is based from the company’s Amsterdam Airport facility.

During his career, he has worked in a number of operational and business development roles within the CEVA’s Industrial, Oil & Gas and High tech sector’s and for the last 7 years in the Healthcare sector as GKAM Pharma.

Jordi Vall-llossera has worked at Novartis for 14 years, with the current position as Global Head Supply Chain QA. He is an Engineer by the Universitat Politecnica de Catalunya (Spain). He started working as Quality Management consultant and in the year 2000 joined Andersen Consulting / Accenture as Business consultant.

Since 2004 he joined Novartis and held different positions in QA and in IT. He started working in a manufacturing site in Spain and moved to Basel offices in 2009 to implement Laboratory Information Management System (LIMS)  to all Pharma manufacturing sites. In 2010 became Global Quality Operational Manager and afterwards, in 2014, moved to Global Quality Process Lead. Later on, in 2015 Jordi took the position as Head Pharma Supply Chain QA and Responsible Person for GDP licenses for Novartis Pharma AG and Novartis Pharma Services AG. Since 2016, he is working as the Global Head Supply Chain QA.

He is married with two kids.

Dr. Jincai (Jimmy) Li is currently Vice President of WuXi Biologics.  Dr. Li has over 17 years’ experience in Biologics process development, scale-up and cGMP manufacturing.  His group contributed to over 40 IND submissions, both in and outside of China, as well as BLA submission works.   Dr. Li joined WuXi Biologics in 2011, helped built and led the Cell Culture Process Development & pilot plant production group, and then managed the cGMP Drug Substance manufacturing facility.

Before joining WuXi Biologics, Dr. Li was a cell culture process development Group Leader at Genentech Inc.  Before that, Dr. Li also worked at Tanox, Inc, where he led the manufacturing sciences group supporting PhIII production of a mAb product, and at Diversa Corporation (now BASF), in charge of process development for multiple recombinant enzyme projects.

Dr. Li holds B.S. degree from Tsinghua University, and Ph.D. degree from University of Maryland Baltimore County, majoring in Chemical and Biochemical Engineering.

Working with Alfa Laval for 24 years
Held the position of Equipment division Manager Australia and New Zealand for 8 years
Global Industry Manager Phrama for 2 years based in China
Studied engineering trade 4 years
Marketing Management Diploma 3 years

Johann Bonnet is Vice President Business Development of Veolia in charge of the
Pharmaceutical and Cosmetics activities, leading the business development of Energy, Waste, Water new offers to the Beauty and Life Science industrials. Johann reports to the Innovation & Markets Department.

Johann joined Veolia, then Vivendi Water, in 2001 at the agency of Antony as Sales Engineer. After five years of accomplishments in developing the market in France, in 2006, he took over the position of Market Manager for the Pharmaceutical activity with the mission to drive the market to international business, then followed by developing Blue Chips relations as Strategic Account Manager, in 2011. Johann actively launched new global partnerships around product developments, research programs and sustainability.
In 2013, he is appointed Vice President Business Development of Veolia in charge of the
Pharmaceutical and Cosmetics activities.

James Weidner has 23 years of large and small molecule experience with Amgen, Hoffmann-La Roche, and Biogen Idec. He has led Process Development, Manufacturing, Engineering and Automation groups in commercial facilities in the USA, Puerto Rico and Singapore. Mr. Weidner currently serves as the Process Development Site Head at Amgen, Singapore.

Shanshan serves as Vice President for the current year for ISPE Singapore Affiliate. In her role, she is greatly involved in conference and event planning, promoting ISPE, providing technical input and supporting the President and the Affiliate with all relevant business. With a few other EXCO members, they initiated Technical Tuesday, a series of recurrent events where experience and knowledge is shared and issues and solutions are discussed within the industry.

Shanshan has been in the industry for more than 12 years. Her major role has been process SME, with adequate experience in CQV, project management as well as business development. Shanshan has lived and worked in Europe and Asia. She previously held the role of  Senior Technical Expert within Novartis global engineering team.

By training, Shanshan is a Biochemical Engineer, with a M.Sc. degree received from the University of Birmingham, UK.

Engineer by Education, working in the Pharmaceutical Industry for the last 12 years holing various role in biotech greenfield projects and Tabletting manufactuing. With Expertise in Building Infrastructure / Facility and Energy Systems and large experience in Design, Construction and Start Up / Qualfication. Currently accountable for the Novartis Singapore Site Engineering Team in Process Engineering and Technical Services.

Mehul received his Bachelor of Science degree in cellular and molecular biology from the University of Michigan and his Master of Business Administration in finance from the University of Delaware. Mehul has over 18 years of extensive pharmaceutical and biotechnology industry experience in proteomic R&D, laboratory automation, product development and technical marketing. Currently he is the Global Director of Training for Charles River’s Microbial Solutions division and is responsible for developing and implementing global strategies in support of corporate initiatives.

Melis joined AbbVie in April 2016 as the Manufacturing Manager for the Biologics plant and a member of the Site Leadership Team. In her current role, she is responsible for the start-up of Biologic operations and heads the Biologics purification operations. Prior to joining AbbVie, she has worked in various Operations and Process Development roles. Melis has established experience in four greenfield projects and regulatory audit experience.

Melis attended The National University of Singapore, where she received her B.Sc in Life Sciences, majoring in Biomedical Science.

Michelle Peake has been working in the field of biotechnology for over 20 years, for companies in Australia, England, Malaysia and Indonesia. She has worked in all areas from research, to process development, with her main experience in cGMP manufacturing for biopharmaceuticals. She has extensive experience in protein purification, tech transfer and fill/finish. In December 2003 Michelle was appointed as the Director of Manufacturing for Alpha Biologics, a biopharmaceutical CMO in Penang, Malaysia, where she was responsible for the design and construction of the Alpha cGMP facility and equipment and establishment of the company. Currently she is Senior General Manager at Kalbio Global Medika in Cikarang, Indonesia where she is responsible for multiple functions including QA, finance and business development.

Marc has 20 years’ experience in the pharmaceutical industry having worked in process development, technical support and manufacturing roles. He has worked at AbbVie since its inception in 2013 and assumed his currently role in 2016.

Maurice Parlane, Director, CBE Pty Ltd,, (Australia) and New Wayz Consulting Ltd (New Zealand), is a professional engineer with 29 years’ experience in technical and consulting roles within the biopharmaceutical industry, including 19 years as an industry consultant.

Prior to this; he held senior engineering and manufacturing roles within the Glaxo group of companies.

His core skills and experience are in manufacturing and compliance management; process design and improvement; risk management, validation and operational excellence. Maurice has assisted numerous organisations to establish, improve or scale-up manufacturing operations and GMP compliance in Australasia and the Asia Pacific region.

He has a Bachelor of Manufacturing Technology (Hons) as well as Mechanical and Electrical Engineering qualifications. Maurice is a Past President and current Director of the ISPE Australasian Affiliate, and is a member of ISPE’s Asia Pacific Regulatory and Compliance Committee and the PQLI Process Validation Committee. He is a course instructor for ISPE’s Process Validation training, a technical SME for ISPE International’s Guidance Document Committee and a chapter lead in the development of ISPE’s Good Practice Guide for Process Validation

Michael Lee is currently at Mab-Venture Bio at Shanghai China as Senior VP for establishing the new Bio Mfg facilities.

Michael has extensive New Bio/Pharmaceutical Facility Project Management Experience. These facility projects cover vaccines, monoclonal antibodies, fill/finish, formulations, API. He is also experienced in leading the manufacturing & supply operations for multinational pharma companies including Boehringer Ingelheim, Roche & GSK.

He was involved in several major new biopharma facility projects in China for Merial (vaccines), Shanghai Biomabs (monoclonal antibody), JHL Bio (first Global Bio Modular Facility GE KUBio), BeiGene Bio (the 3rd GE KUBio Facility).

Nigel presently holds the post of Head, Biomedical Sciences.

He joined the Singapore Economic Development Board (EDB) in 2010, placed in charge of key accounts in both the research instrumentation and pharmaceuticals sectors. Following this, Nigel spent three years in New York as Centre Director, building and managing partnerships with companies in the northeast US, across a wide range of industries.

He returned to Singapore in 2016 to head up the Pharmaceuticals & Biotechnology industry sub-group, as part of the Biomedical Sciences division.

Paolo, an Italian citizen, has more than 20 years’ experience in Supply Chain Management in FMCG and Pharma Industries. In the first 9 years he worked for Unilever and Bic leading supply chain operations and projects. In 1999 he has joined Roche Pharmaceuticals as Supply chain and Procurement Director of the Italian affiliate and manufacturing plant. In 2008 he has moved to Roche headquarter in Basel, Switzerland leading Small Molecules Global Supply Chain and Global Supply Chain Transformation project. In 2014 he has relocated to Singapore to lead the Roche Pharma Supply Chain of Asia Pacific region in a highly developing environment. Outside work Paolo enjoys spending time with his family, travelling and the many other good things life can bring every day

An Engineer with over 24 years’ experience delivering major capital projects including a 944MW hydroelectric dam project in Malaysia, a $1Bn Solar Panel fabrication facility and major green field Life Science facilities for GSK Biologic and Schering-Plough in Singapore. Joined Novartis on May 2013 as Technical Project Manager for the Singapore Biotechnology Phase 1 Facility and Utilities team and later promoted to Senior Project Manager for Singapore Biotechnology Phase 2 project. Currently held the position as Head Project Management Asia and is responsible in all capital project execution within the Asia region.

Pierre Landais established in 2014 the Asia-Pacific operations of Powder Systems Ltd (PSL), an international manufacturer of advanced pharmaceutical process equipment. He holds a Master’s Degree in Industrial Engineering and Business Management. Pierre has been working at PSL for 8 years with various management positions held in the UK, France and now Australia. He is currently looking after the production and process requirements of global drug manufacturers operating in APAC countries such as Singapore, Australia, Japan, South Korea, China and Taiwan. Pierre has worked on numerous microsphere projects globally, highlighting the best industry practices to drug manufacturers and helping them overcome various production challenges such as scaling-up production of their Long Acting Release (LAR) injectable drugs.

With a degree in chemistry and chemical engineering, Pierre combines the scientific mindset with the practical approach of the engineer. Applying analytical skill and practical sense has proved the perfect fit for design and commissioning activities in a field that requires accuracy and productivity.

After working in several projects around Europe as consultant for one of the leading pharmaceutical company, he opened his own service company in 2007, and is currently providing services on 3 different projects in Singapore and China. He believes in People skill and manages them at their best, to optimize the available competences.

His customer is his concern, whom he advises and supports throughout all project phases, according to identified needs.

Dr. Wu Qiwei has more than 15 years of  US biotech industry experience in CMC development of monoclonal antibody and recombinant protein therapeutics.  In the past few years, his work focused on building the CHO-based monoclonal antibody technology platforms for biosimilar and biobetter in China.   Dr. Wu has a Ph.D. in Biochemistry from Simon Fraser University, Canada and completed his postdoctoral fellowship at Stanford University Medical School, USA.   He currently severs as VP of Process Development at Livzon MabPharma (China) Inc., Prior to this position, he was the VP of CMC, Technical Operation, Mabspace Biosciences Co.Ltd.

Talented professional manager with more than 17 years of robust experience using exceptional leadership skills to coach, manage, and motivate diverse professionals in supply chain.

He is responsible for all supply chain activities including: procurement, planning, inbound logistics, inventory control, materials management, Good Storage Practice (GSP) and warehouse management for one of the biggest leader pharmaceutical in the Middle East (UAE).

He also served earlier as a Production Manager in Julphar for 9 years. He holds B.SC. Certificate in pharmacy and he is  he is also certified in Balanced Score cord amd Certified Supply Chain Manager from IPSCMI with a good experience in handling of temperature sensitive pharmaceuticals.

Rob Lutskus is a subject matter expert on laboratory informatics within quality control for the bio-pharmaceutical industry. Currently Global Product Delivery Manager of Informatics for Lonza Bioscience Solutions, Rob is responsible for the implementation, validation and technical sales support activities of Lonza’s Informatics software portfolio.

Rob has been a MODA SME for over 10 years, and working in QC laboratories and Laboratory Informatics for over 15 years. Originally a QC microbiologist, Rob has worked for Merck, Hoffman La Roche and Baxter before joining ImClone Systems in Branchburg, NJ.   In 2007, Rob led the original implementation of MODA EM as a custom solution then as the first customer of the commercial solution.  He joined Lonza in 2010.

Rob is also an active member in a variety of industry organizations, including the Parenteral Drug Association and ISPE.  He is also a contributing author to Environmental Monitoring: A Comprehensive Handbook, Volume 1.

As a Technical Service Manager with STERIS Corporation based in Singapore, Richard has been providing technical training to customers in topics related to cleaning and bioburden control for cleanrooms, including disinfectant validation, as well as cleaning and cleaning validation for product contact surfaces. He is also an industry speaker at ISPE events in various countries. Prior to joining STERIS, Richard had 13 years of manufacturing and validation experience working in dry powder inhaler plant, biotech sterile fill and finish plant, and medical device and biopharmaceutical facilities. He has in-depth understanding of the requirements of cleaning and disinfection in cleanrooms, as well as best practices in bioburden control. Richard has also worked 3 years as a validation consultant providing validation support to various pharmaceutical customers in the area of equipment validation, cleaning validation for product contact surfaces, disinfectant validation, as well as cleaning procedures for both product and non-product contact surfaces.

Ray Dallago is a Biochemistry Major from Rutgers University with over 20 years of experience selling to the Biopharma industries with a particular focus on Single Use Systems. Currently he is the Director of Sales and Marketing for SaniSure. SaniSure is a global, innovative, manufacturer and integrator of cGMP sterile, customizable single-use products such as bottles, carboys, flasks, centrifuge tubes, tube sets and manifold assemblies for the biopharmaceutical industry, focusing on innovative solutions. SaniSure’s mission is to combine our deep expertise, integrity, and industry knowledge to produce customized solutions and to maximize efficiencies, minimize costs and alleviate risks in the production of biopharmaceutical processes.

I hold a Bachelor’s degree in Physics at Università dell’Insubria, Como Italy.

I have joined FPS company in 2012 as Technical Sales manager and I have experience to propose containment / micronisation solutions. In the last few years I had active role to define the solutions for nanograms isolation technology.

I am now the responsible for the of Asian, Indian, Middle East markets.

Li-Jun Sim is currently Technology Manager, responsible for core technologies in Merck Life Science Process Solutions group. She has more than 6 years of hands-on experience in downstream biologics process optimization, scale-up and technology transfer projects. At her previous role in Manufacturing Sciences & Technology (MSAT) at Merck, she also led the Asian vaccine focal point team on thought leadership activities and innovative projects.

She graduated with a M.Sc. from the National University of Singapore (NUS) and has an Advanced Certificate in Training and Assessment (ACTA) from the Institute of Adult Learning (IAL), SkillsFuture Singapore agency.

Dr. Stefan Kappeler is Technology Manager Life Sciences at M+W Group, a global leader for controlled and regulated environments. He holds a PhD in molecular biotechnology from the Swiss Federal Institute of Technology in Zurich, Switzerland, and has nearly 30 years of experience in life science research and industry. In this time he has completed a variety of projects in the areas of R&D, clinical development, technology transfer, USP and DSP manufacturing of drug substance, quality control and assurance, plant design, engineering, qualification and validation. His main interests are in the advancement of pharmaceutical facility design and process technology, and in finding the best solutions to provide optimal manufacturing environments.

Sergio Mauri holds a Chemical Engineering degree. He has been involved in cleanroom technologies since 1980 and is currently, in charge of Marketing & Business Intelligence at Fedegari Group, after many years dealing with the design and the supply of new solutions for the sterile drug manufacturing including GMP robotics. His Scientific Technical Association activities include member of the board of the Italian association of contamination control (ASCCA: www.ascca.net) since 1986, President 2018-2020 term, and ISPE and PDA member since 2001. Promoter and responsible of the training course on “General introduction on Clean Room Technology, isolation concepts and critical parameters definition”. He is Trainer on pharmaceutical HVAC design for students of chemical and pharmaceutical technology at Italian Universities. Author of several papers on clean technologies and experienced giving training lectures to AIFA GMP Italian inspectors.

Sook-Peng Chua is the Snr Director, Business Quality for Johnson & Johnson based in Singapore. During her 27 years of career, Sook Peng has held technical and quality leadership roles with global healthcare, both pharmaceutical and medical device companies such as Baxter, GSK/GSK Biologicals. Sook Peng earned a Masters in Sciences from National University of Singapore after completing her research on Signal Transduction in Tumor Cells in Institute of Molecular and Cell Biology. She has extensive auditing, operational experience and has led several commissioning – validation projects in medical device, pharmaceutical greenfield startup manufacturing facilities.

Thomas Halfmann is founder and managing partner of HGP. HGP is a healthcare industry consulting company with offices in Switzerland, Germany, Poland, Singapore and Indonesia. Before founding HGP, Thomas was Global Head Biopharmaceutical Operations IT and Head of the Global MES Program, both at Novartis. Thomas is an expert in paperless manufacturing, business process analysis and modelling, project management, quality management, and computer system validation with more than 25 years experience in the healthcare industry. Since January 2018 Thomas is Operations Director of the OPEN-SCS Working Group and ISPE member for more than 20 years.

Summary: Professional career of more than 15 years in the pharmaceutical and biotechnology manufacturing industry.

Personal story:

  • German with Engineering background and Business studies
  • Sales and Management career
  • Moved to Asia in 1998
  • Worked for solution providers, equipment manufacturers and distribution companies.
  • Focus on pharmaceutical and biotechnology industry
  • Became an entrepreneur out of passion: Founder of Terra Asia Consulting

In 2013 Thomas founded Terra Asia Consulting, a Singapore based sales and consulting services company specializing in Pharmaceutical Manufacturing. The business area PHARMA provides consulting and sales support in the field of pharmaceutical manufacturing and related technology solutions like capital and processing equipment, machinery and others. The services are dedicated to manufacturers of pharmaceuticals and biotechnology products in Asia as well as solution providers, mainly originating from Europe and North Amerika.

Terra Asia Consulting represent the following clients:

  • BIAR, Switzerland – Inline sampling valves and reactor sampling systems
    Expert in sampling systems suitable for all liquid or gas sampling requirements, safe and efficient.
  • Bopp, Switzerland – High-quality woven wire mesh for filtering, sieving and sizing
    The world’s leading manufacturer of precision metal filter meshes with a comprehensive understanding of filtration processes.
  • HAPA, Switzerland – On Demand Printing and Late Stage Customization
    A global leader in On Demand printing solutions and Late Stage Customization for the pharmaceutical industry.
  • Laetus, Germany – Vision Inspection and Track & Trace Solutions
    An industry leader in inline quality control, vision inspection, serialization and complete track & trace solutions.

Furthermore, Terra Asia Consulting had a collaboration with ILC Dover, USA, for 4 years. As the Strategic Sales Partner for Asia-Pacific Terra Asia Consulting built their business in Containment Systems and Powder Handling Solutions in Asia.

Customers and users of solutions include regional manufacturing entities of well-known international corporations as well as Asian market leaders of the pharmaceutical and biopharma industry.

In addition, Thomas is an active member of the ISPE (International Society of Pharmaceutical Engineering). As the Chair of Member Services Committee of the ISPE Singapore Affiliate he supports the organization in sharing of industry knowledge, education and networking.

Eleven years of professional experience.

Education: St. Petersburg State Chemical Chemical Pharmaceutical Academy; advanced training in GMP/GDP inspections/audit; certified GMP/GDP Inspector.

Professional background: Vladimir Orlov’s embarked on his career at the production site of active pharmaceutical ingredients. From 2008 to 2013 Vladimir worked at the State Research Institute of High Pure Biopharmaceuticals (Federal Bio-Medical AgencySt. Petersburg) as a Validation Engineer. In 2013-2014 he participated in the launch phase of «Novo Nordisk» – an insulin production site in the city of Kaluga. There he was in charge of manufacturing of aseptic and sterile production. In 2014 Vladimir joined the newly created Inspections Department at the FSI «SID & GP», where he progressed from the position of a leading expert/auditor all the way to Deputy Head of the Department. As of November 2016 his professional portfolio also includes supervision of the GMP laboratory at the Education Centre of the FSI «SID & GP».

Vee joined Roche in 2013 and is a Chemist/PhD in Biochemistry, She worked for 36 years in EOF, the Medicines Authority of Greece, as Head of Division for over 15 years, 10 of them as Head of the GMDP Inspectorate of the Agency.

She led the implementation of a Quality System according to EU, PIC/S and ISO 17020 requirements in the Greek GMDP Inspectorate, the relevant Inspections methodology and the accession of EOF to PIC/S in 2002.

She has participated over 25 years in EU meetings in Brussels and in the EMA in London. Between 2002 and 2013 she represented EOF / Greece in the PIC/S Committee and has been a member of its Executive Bureau, more specifically as Chair of Compliance Group (monitoring new applications at PIC/S). She was involved in several Inspectorates’ PIC/S and EU assessment Teams (US FDA, Romania, Austria, Cyprus, Iran, Uganda, Armenia, UNICEF) and was involved at the EU-Japan MRA in 2002-2003.

She performed GMP inspections with EDQM and WHO Prequalification Program in India and China and participated in missions of the “Assistance to CFDA” project by WHO/Global Fund

Vincent Loret is the Site Director for the Tuas Vaccines manufacturing facility in Singapore. Vincent was appointed the GSK Tuas site lead in 2015.

He joined GSK in 2008 as the vaccines site lead in Hungary, where he was successful in improving performance and securing FDA approval for the site in 2010. He was then appointed to lead the Secondary operations in Belgium (formulation, filling, packaging activities) in 2012.

Vincent began his vaccines career with Sanofi Pasteur where he held various leadership roles in bulk production in France and South America.

He has a degree in Biotechnology from INSA, an engineering school in France and married with 3 children.

Wee Ming CHUA is the Managing Director of HGP Asia Pte Ltd. A Biochemical Engineer by training, Ming has over 17 years of life sciences industry and consulting experience in emerging markets and international projects. He has worked in many projects in Pharmaceutical Manufacturing ranging from Biotech, API, Oral Solid Dosage to Aseptic Fill-Finish. Ming has expertise in quality systems, risk management, Validation and CSV. Notably, Ming has supported several business transformation and automation projects as CSV consultant and Project Quality Manager. Systems he has worked with include MES, LIMS, EQMS and other Information Management Systems.

Wallace I. Torres is the Executive Director – Site Quality Head for Amgen Singapore Manufacturing.  He is responsible for all the Quality units that provide support to the Manufacturing operations on a Single Use Systems (SUS) plant. Prior to Singapore, he was the Quality Executive Director for the Drug Products manufacturing facilities in Puerto Rico.

Prior to joining Amgen in 2013, Wallace worked for 25 years at Hoffmann La Roche in several positions in the QC/QA, Manufacturing, Strategy, and Supply Chain areas. His experience includes responsibilities as Site Head, Global Head of Risk Management, Global Quality Manager and QA/QC Head at Contract Manufacturing facilities.  During the years he also held several leadership positions in Switzerland, USA, Mexico and Brazil.

He holds a B.S. degree from the University of Puerto Rico (Biology), an MBA from the University of Phoenix (Management), an MBA in Advance Management Practices from the University of South Australia and a Doctorate on International Business Management (Ph.D.) from the Swiss Business School.