Speakers

2018 Early Confirmed Speakers

Jacques Morenas
Deputy Director, The National Drug and Health Products Safety Agency, France

Vladmir Orlov
Deputy Head, Educational Center for Good Practices, State Institute of Drugs and Good Practices, Russia

Vee Revithi
Ex-Head of EOF/Greece GMDP Inspectorate and Ex-External Relations Europe, Greece

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

Vincent Loret
Site Director, GlaxoSmithKline

Jincai Li
Vice President, Biologics CMC Development, Tech Transfer, Scale-up & Clinical Manufacturing, WuXi Biologics

Chai Meng Chong
Head of Mammalian Manufacturing, Lonza Biologics

Raman Sirinivasan
Vice President Operations, Biocon

Marc O’Donoghue
Site Director API and Biologics Operations, AbbVie

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

Jeff Chen
Production Manager, Pharma Essentia Corporation

Charlie Wakeham
Informatics CSV Consultant, Waters Australia Pty Ltd

Pierre Winnepenninckx
Past Chair of ISPE Asia Pacific and Chair ISPE Singapore Conference 2017

Nicole Pierson
Patient Advocate, Mother of Gavin Pierson; Keynote Speaker at ISPE Atlanta 2016 Conference, United States

Regulators, Government and International Experts

Nigel Cheong
Head of Biomedical Sciences, Singapore Economic Development Board

Gerald W Heddell
Director, Inspection Enforcement & Standards Division, Medicines and Healthcare Products Regulatory Agency (MHRA), UK

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

Maurice Parlane
2016 ISPE Member of the Year, Director of ISPE Australasian Affiliate and Director of Centre for Biopharmaceutical Excellence, Australia

Suchart Chongprasert
Director of Post Marketing Control Division, Bureau of Drug Control, Thai FDA

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

Leading Manufacturers

Hang Zhou
Director of Cell Culture Process Development
WuXi Biologics, China

Chris Sweeney
Senior General Manager
PT Kalbio Global Medika, Indonesia

Jaspreet Singh
Vice President Quality
Intas Pharmaceutical Ltd, India

Martin Hermanto
Senior Chemometrician
Glaxo Wellcome Manufacturing Pte Ltd, Singapore

Jack Wong, Head of Regulatory Affairs, APCA, Baxter Healthcare and Founder and Secretariat Asia Regulatory Professional Association (ARPA)

Mohammad Ovais
Ex-Scientific Affairs Manager
Xepa Soul Pattinson, Malaysia

Wong Poh Mun
Manufacturing Science and Technology (MS&T) Validation Expert, Novartis Singapore Pharmaceutical Manufacturing

Mountain Yueh-Chun Hsieh, Head of Transfer & Manufacturing Science and Technology (MSAT), Boehringer Ingelheim BioPharmaceuticals (China)

Matthew Luo
Vice President, Quality Assurance
Livzon Mabpharm Inc., China

Effendi Widjaja
Senior Manager, Technical Operations – Asia Pacific
Johnson & Johnson Pte Ltd, Singapore

Aziza Ahmed
Director, Regulatory Affairs CMC APAC
MSD International GMbH, Singapore

Robin Toh
Associate Director, Validation
Lonza Biologics, Singapore

Pradeep Chakravarty
Vice President, Corporate Quality
Lupin Ltd, India

Christian Cater
Associate Director, Business Excellence
Roche, Singapore

Hazem Eleskandarani, P.E., Global Director, Commissioning & Qualification, Johnson and Johnson Engineering and Property Services, USA

Clarence Wong
Technical Development Manager
Glaxo Wellcome Manufacturing Pte Ltd, Singapore

Vee Revithi
Head of External Relations
Roche, Switzerland

Vincent Vagenende
Validation Expert, MS&T
Novartis BioProduction Operations, Singapore

Yang Ying, Analytical Science and Technology (AS&T) Facilitator, Novartis Singapore Pharmaceutical Manufacturing Pte Ltd

Industry Experts

Terry Nguyen Khuong
Associate Staff Scientist, Bioprocessing Technology Institute A*STAR, Singapore

Damian Thornton
Vice President Asia
C.A.I, Singapore

Jayant Kaushal
Director Product and Project Management Office
Camfil, Singapore

Pierre Landais
Business Manager, APAC
Powder Systems Ltd (PSL APAC), Australia

Scott Patterson
Vice President Commercial Sales
ILC Dover, USA

John Duggan
Asia Director of Life Sciences
PM Group, China

Wellyana Chua, LC and Informatics Business Development Specialist, Southeast Asia, Waters Pacific Pte Ltd, Singapore

Steve Williams
Director and Senior Partner
Centre for Biopharmaceutical Excellence, Australia Pacific

Jerome Chua
Division Manager
ITS Science and Medical (Representative for IWT Italy), Singapore

Ghislain Dousset
Director of Operations
Pierre Guerin SAS, China

Dr. Georg H. Thiessen
CEO
Cryo Life Science Technologies GmbH, Austria

Jerome Pionchon
Engineering Consultant – BioReliance E2E Solutions
Merck Life Sciences, France

Joseph Micsko
Operations Manager
PSC Biotech, Singapore

Jeff Wong, Global Associate Sales Director Bio Production Core Accounts and Integrated Solutions, Thermo Fisher Scientific, USA

Dean M Calhoun, CIH
President
Affygility Solutions LLC, USA

Igor Nazarov
Strategic Account Manager
Kaiser Optical Systems Inc., USA

Jonathan Toke
Vice President
Haskell, USA

David Kapitula
Operations Partner, C-Bridge Capital, China & Vice President Quality, CMAB, China

Lionel Savin
Global Clean Process Product Manager
Camfil, Singapore

Firman Ghouze
Bioprocess Strategy Director
GE Healthcare Life Sciences, Singapore

Paul Daniel
Senior Regulatory and Compliance Expert
Vaisala, USA

Marcel Langoor
Director Business Development
Eurofins Sinensis, Netherlands

Stefan Kappeler
Senior Project Manager, Compliance & Validation
M+W Group, Switzerland

Ivo Backx
Business & Project Development Manager for Pharmaceutical Industry, Siemens AG, Germany

Richard Chai
Technical Service Manager
STERIS Corporation | Life Sciences, Singapore

Workshop Leaders

John Hyde
Chairman and Founder
Hyde Engineering + Consulting, USA

Bo Xu
Chief Operating Officer
Zhejiang Teruisi Pharmaceuticals, China

Walid El Azab
Technical Service Manager
STERIS Corporation Life Science, Belgium

Aziza Ahmed
Director, Regulatory Affairs CMC APAC
MSD International GMbH, Singapore

Aziza has 16 years of experience in various regulatory affairs functions. She has handled regulatory responsibilities both at manufacturing site as well as country and regional regulatory affairs in Asia for close to 8 years.

She previously worked with Baxter Healthcare heading the country RA teams for ASEAN, Korea and India. Aziza holds Masters in Regulatory Science and in Organic Chemistry.


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 also the ISPE Regulatory Affairs Advisor for the Asia-Pacific region.


Bo Xu
Chief Operating Officer
Zhejiang Teruisi Pharmaceuticals, China

Dr. Bo Xu received his bachelor degree in Biology at Xiamen University, master degree in Chemistry from Chinese Academy of Sciences, and Ph D in Biotechnology at Royal Institute of Technology in Stockholm, Sweden. He has a deep experience with multinational collaborations among academic institutes, universities and industry. He began his professional career at AstraZeneca working with various expression systems to supply target proteins. Dr. Xu in 2003 joined CMC Biologics A/S, and European CMO in Copenhagen where he worked with many international clients on process development/transfer, process characterization and GMP manufacturing supports. Dr. Xu returned to China and joined a local CMO company, designing and constructing a full disposable technology-based bio-manufacturing facility. This facility has won the Best Mention Award of Year 2014 by ISPE. Dr. Cu in 2012 joined Bioehringer Ingelheim, (BI) to implement BI’s bio-manufacturing technology and platforms to serve both international and domestic biopharma/biotech clients in China. Presently Dr. Xu is serving at Tesuisi Pharmaceuticals Inc., as Chief Operational Officer with an overall responsibility of constructing a commercial-scale bio-manufacturing facility that meets international cGMP requirements, and building the capability and organization to manufacture monoclonal antibody products.


Clarence Wong
Technical Development Manager
Glaxo Wellcome Manufacturing Pte Ltd, Singapore

Prior to joining GSK in 1992, Clarence worked in the oil and gas industry for 4 years both as a process and a project engineer.

He has over 24 years’ experience in GSK, encompassing technical transfer of both marketed APIs and New Molecular Entities, facility/equipment design and commissioning, validation life cycle, regulatory dossier development, facility/site master planning and capital projects management.

Clarence is currently the site project manager for implementing GSK’s first continuous primary manufacturing process. He holds a Bachelor of Chemical Engineering from the University of Wisconsin-Madison and an MBA from the University of Strathclyde.


Christian Cater
Associate Director, Business Excellence
Roche, Singapore

Christian has over 20 years of experience working in manufacturing plants both in United States and Singapore.  He has held both Continuous Improvement and Operational roles at the site leadership level. He has been a key leader in organizational transformation programs and has led large teams of up to 120 people with multiple shift responsibilities.

Chris’ passion in leading people and organizations is to create a culture of trust, innovation, and competitiveness through developing people’s skills and abilities that enable the organization to achieve superior business results.

Christian has a Bachelor of Arts (History), Master of Science (Industrial Relations) from West Virginia University and has completed post-graduate studies in Regulatory Affairs from Temple-National University of Singapore.  Currently, he is completing the requirements for a Master of Science in Pharmaceutical Science and Technology from National University of Singapore.

Christian is a certified Black Belt, Program Leader for Kepner-Tregoe, and certified Strategic Planner.


Chris Sweeney
Senior General Manager
PT Kalbio Global Medika, Indonesia

Chris is a pharmaceutical professional with over 30 years’ experience in GMP manufacture of Pharma and Biopharma products.

He has extensive knowledge of the regulations governing the manufacture of biopharmaceuticals and pharmaceuticals. In 2004, he was the EU GMP Expert for ASEAN on the EC-ASEAN GMP Harmonisation Programme. He trained the ASEAN Regulatory Bodies in PIC/S GMP standards.

For the last four years, Chris has been the Senior General Manager of Kalbio Global Medika, where he designed, built, commissioned and validated a Biotech facility to PIC/S standards.

Kalbio Global Medika has been awarded a Honourable Mention in the recent ISPE Facility of The Year Awards.


Carissa Choh
Consultant
HGP Asia, Singapore

Carissa has more than 9 years of experience in the pharmaceutical industry covering both chemical API and biologics. She has worked in various functions in clinical development to manufacturing, in UK and Singapore with expertise in Process Analytical Technology (PAT), manufacturing, commissioning, cleaning validation, resin life cycle management and process validation. She is both the Honorary Treasurer in the ISPE Singapore Executive Committee as well as a core team member of PAT Community of Practice.


Chew Wee, Scientist, Institute of Chemical and Engineering Sciences, A* Star, Singapore

Wee is a Research Scientist at A*STAR, and holds joint appointments at the Biotransformation Innovation Platform (BioTrans) and Institute of Chemical and Engineering Sciences (ICES). His research areas include deploying in situ spectroscopy in process development for chemical reaction synthesis, crystallisation, and more recently in microbial fermentation.

Wee founded the Process Analytical Technology (PAT) Community of Practice (COP) under the ISPE Singapore affiliate for nurturing a local group of PAT enthusiasts, and he is a member of the ISPE PAT&LCS global steering committee. He recently joined the Singapore Institute of Technology (SIT) as an Associate Faculty member to teach PAT related topics under the Pharmaceutical Engineering program.


Damian Thornton
Vice President Asia
C.A.I, Singapore

Thirty Years experience in the operation, design, construction and qualification of Industrial facilities, with more than 20 years specialist Pharmaceutical experience. Damian is former VP for Pharmaceuticals for Europe and Asia for CH2M, Director of Pharmaceutical Operations and Business Development for M&W in China and former board member of Keyplants, specialising in Modular Design.

Currently Damian is Vice President of Asia for CAI, specialising in Process Design and optimisation, C&Q and Regulatory compliance within the Pharmaceutical sector.

Specialties: Specialist Knowledge in the Design and Qualification of Pharmaceutical Facilities, with particular emphasis in the Design of High Potent  and Modular Pharmaceutical Facilities.

Damian has been Project Director for Multilpe large Scale Pharmaceutical Projects.


Dean M Calhoun, CIH
President
Affygility Solutions LLC, USA

Dean has over 29 years of environmental, health and safety experience, in occupational safety and environmental compliance, potent compound safety and categorization, setting of occupational exposure limits (OELs) and acceptable daily exposure (ADEs) values for active pharmaceutical ingredients, industrial hygiene and containment validation. His expertise is in establishing environmental, health and safety management systems for the biotechnology, pharmaceutical, and medical device industry.


David Kapitula
Operations Partner
C-Bridge Capital, China & Vice President Quality, CMAB, China

David is based in Shanghai and is currently an Operations Partner with C-Bridge Capital a Venture Capital Fund focusing on investments in healthcare including ATMPs/CATs, biotechnology, medical device, and pharmaceutical companies.

With more than 20 years experience in the industry he has been involved in the design, build, qualification, and operations (Manufacturing and Quality) for global biologic therapeutics including Genentech/Roche; Bayer; ImClone Systems (Eli Lilly); JHL Biotech; and Cell Genesys. This spans facilities supporting Research & Development, Process Development, and the manufacture of Clinical and Commercial therapeutic API’s and Products.

He is actively involved in multiple design projects in Asia/China to support the development and manufacture of ATMP’s and CAT’s to support regional and global product distribution.


Effendi Widjaja
Senior Manager, Technical Operations – Asia Pacific
Johnson & Johnson Pte Ltd, Singapore

Effendi holds a PhD in Chemical Engineering from National University of Singapore and did his postdoctoral research works in Analytical Chemistry (Raman microscopy analysis) at the University of Michigan, Ann Arbor, United States.

He has two granted patents and over 80 published manuscripts in peer-reviewed journals. Currently at Johnson & Johnson, he is responsible for execution of the Technical Operations strategy in Asia Pacific, including providing technical support to the internal and external pharmaceutical manufacturing networks. This includes the use of Process Analytical Technology (PAT) for technology transfer, process characterization and validation, identifying and supporting process improvement, troubleshooting and root-cause analysis.

Before joining J&J, he worked at Abbvie, Merck, and ICES, A*STAR. His main areas of interest are PAT and chemometrics, physical characterization techniques, statistical on-line process monitoring as well as analytical method development and validation.


Firman Ghouze
Bioprocess Strategy Director
GE Healthcare Life Sciences, Singapore

Firman is responsible for developing GE’s commercial strategy and partnerships in the Bioprocess space.  He has worked in the biomanufacturing industry, encompassing both protein and cell therapeutics, for the last ten years.

He has worked with large pharma, biotechs, hospitals and governments in US, Europe and Asia to support the growth of the field and to expand GE’s presence. Previously, he held roles in GE, including Product Management, Corporate Strategy, Marketing, Business Development, Risk Analysis and R&D.


Dr. Georg H. Thiessen
CEO
Cryo Life Science Technologies GmbH,
Austria

Georg has been CEO of Cryo Life Science Technologies GmbH for 12 years. Father of four children, he studied particle physics in Hamburg, Ottawa and Heidelberg, where he gained his Ph.D.

Since 1992 he has worked in medical technology companies, starting in radiology, where he built small CT scanners to being responsible for technical research and development. He moved to deep temperature medical equipment companies as CEO, responsible for applications of cryobiology in medical fields including developments in automation and robotics at temperatures below -100°C.


Geoffrey B. Brown
President
ISPE Singapore Affiliate

Geoffrey Brown is the International Society for Pharmaceutical Engineering Singapore Affiliate President and is a Senior Project Manager for No Deviation.


Gerald W Heddell
Director, Inspection Enforcement & Standards Division
Medicines and Healthcare Products Regulatory Agency (MHRA), UK

Gerald joined the MHRA as Director of the Inspection, Enforcement & Standards Division in 2005. He is a microbiologist who is a Chartered Biologist and a member of the Society of Biology and the Royal Society of Chemistry.

Since leaving the UK National Health Service in 1978, he has worked in a succession of progressively senior roles in manufacturing and quality assurance in the pharmaceutical industry.  Gerald has experience in most aspects of pharmaceutical manufacture and control.   This has included microbiological development, analytical laboratory management, quality assurance, business development, director of a large steriles manufacturing facility and, most recently, European Quality and Compliance Director for GlaxoSmithKline.

In his current position with the MHRA, Gerald’s responsibilities focus on the quality of medicines in the UK and include a comprehensive surveillance, inspection and enforcement programme, the licensing of pharmaceutical manufacturers and wholesalers, defective medicines reporting, unlicensed imports, borderline products, medicines testing and the British Pharmacopoeia.


Ghislain Dousset
Director of Operations
Pierre Guerin SAS, China

During his 5 years at Biolafitte, Ghislain has been in charge of the Life Sciences commissioning activities.

Since 1998, when Biolafitte was acquired by Pierre Guerin, he was Project Manager for Biopharma projects and then Manager of the Project Management department till 2013. Today his role is to develop the Chinese subsidiary of Pierre Guerin.


Howard Yu
Quality System and Compliance Lead
Novartis BioProduction Operations, Singapore

Howard is leading the quality team to set up quality systems for the new start-up biologics manufacturing facility. He is responsible for site inspection management and regulatory affairs, with over 17 years’g experience in QA, Validation, Process Engineering and Manufacturing in the pharmaceutical industry.


Hazem Eleskandarani
P.E., Global Director, Commissioning & Qualification
Johnson and Johnson Engineering and Property Services, USA

Hazem holds a Masters in Mechanical Engineering from the University of Utah and is a licensed Professional Engineer. He has over 28 years’ diverse experience that includes manufacturing, plant engineering, process design, technology management, and project engineering.  He began his career in as an equipment engineer responsible for process equipment PM. Then he moved on to Fluor Daniel, Jacobs Engineering and then Merck Process Engineering, where he worked on several global projects in Spain, Italy, Ireland, Singapore, and North Carolina.

Hazem’s current role with J&J is providing global leadership for C&Q planning and execution across J&J global portfolio of capital projects.  He lives in Worcester, Pennsylvania.


Hang Zhou
Director of Cell Culture Process Development
WuXi Biologics, China

Dr Zhou leads a team in continuous cell culture process development for biologics, from scale-down model to pilot and GMP production. Successfully overcame multiple challenges in high cell density and long duration perfusion culture, while achieving high volumetric productivity and desirable product quality.

Previously, in Commercial Cell Culture Development at SANOFI GENZYME, he led efforts in the next-generation perfusion platform development.

Dr Zhou holds a B.S. in Chemical Engineering from Tsinghua University and Ph.D. in Chemical Engineering from Massachusetts Institute of Technology in U.S.


Ivo Backx
Business & Project Development Manager for Pharmaceutical Industry
Siemens AG, Germany

Ivo started his career as an automation engineer in the food & beverage industries. Later, he joined the Siemens engineering department for industrial automation, realizing automation projects in different industries.  As technical project leader, he has led several industrial Automation-IT solution projects in the pharmaceutical industry worldwide.

In his current position, he has a special focus on innovation and the Digital Enterprise for Pharma. Applying Process Analytical Technology to enable Continuous processing, Real Time Product Release based on in-line / on-line quality measurements and advanced process control is one of the topics Ivo is driving.


Igor Nazarov
Strategic Account Manager
Kaiser Optical Systems Inc., USA

Igor began his industrial/analytical career with Brimrose Corporation, to provide Near InfraRed (NIR) solutions for Pharmaceuticals, Food, Chemicals, Agricultural, and other industries. He has also worked closely with pharma and Government Agencies on Process Analytical Technology (PAT) initiatives, presenting multiple papers at PAT Conferences worldwide.

Previously, Igor worked in Polychromix and ThermoFisher Scientific. At Kaiser Optical Systems, he introduced the first Handheld NIR and various Raman Analyzers solutions for Pharmaceutical, Bio-Pharmaceuticals, Food, Agricultural, and other industries.

He holds a Masters in System, Electronics Engineering from National Aviation University in Kiev, Ukraine.


Jack Wong
Head of Regulatory Affairs, APCA, Baxter Healthcare and Founder and Secretariat
Asia Regulatory Professional Association (ARPA), Singapore

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

He also plays 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. He is also very active in ASEAN, APEC, ISO and WHO projects.

In his professional career, Jack developed the First Asia Regulatory Affairs Certificate course since 2007 with more than 1500 alumni and founded ARPA (Asia Regulatory Professional Associations) in 2010.


Jayant Kaushal
Director Product and Project Management Office
Camfil, Singapore

Jayant joined Camfil in 2015 and he is responsible for developing new products related to improving Indoor Air Quality.  He has over 20 years’ experience in marketing & sales, business development and new product development.

 


Jeff Wong
Global Associate Sales Director  Bio Production Core Accounts and Integrated Solutions
Thermo Fisher Scientific, USA

Jeff started with Applied BioSystems (AB) as an Engineer developing next generation tools for Protein and DNA Analysis.   He then moved to Protein Design Labs where he was responsible for the Process Development team in MABs scale up, tech transfer, analytical characterization, and CMC regulatory filings. Jeff also held numerous commercial positions in the area of lab robotics, flow cytometry, chromatography, mass spectrometry, and downstream process application.

Since 2011, Jeff has been with Thermo Fisher Scientific Bioproduction Division where he is globally responsible for managing strategic core accounts and Integrated Solutions program positioning Single Use Technology in a Bioproduction workflow.


Jerome Pionchon
Engineering Consultant – BioReliance E2E Solutions
Merck Life Sciences, France

Jerome, an Engineer, joined Merck in 2000 at the Semoy Pharma facility (France) where he held several positions from industrial and organizational projects to management in Production and Engineering & Maintenance. In 2012, he took over as the Head of the Technical department in the Martillac Bioprocessing facility (near Bordeaux) and since 2016 he provides external customers engineering consulting services within the BioReliance End To End Services of Merck.


Joseph Micsko
Operations Manager
PSC Biotech, Singapore

Joseph is an experienced validation professional with over 10 years consulting the pharmaceutical and biotech industry across the global. He has been involved in various pharmaceutical and biotech projects including upstream and downstream process, technology transfer, cleaning validation, equipment & utilities qualification, and pharmaceutical green-fields. He joined the PSC Biotech Asia in 2015 and is currently working as Operations Manager in Asia.


John Duggan
Asia Director of Life Sciences
PM Group, China

John is an experienced project manager and process engineer who has undertaken roles such as operations engineer, process development engineer, plant manager, lead designer, project manager, department manager and consultant over the past 30 years.

He has worked at all stages of project execution from early feasibility studies, through to commissioning, validation and handover. His technical strengths include fill finish, OSD, biotechnology, fermentation, sterile engineering, tablet production, and the development of GMP documentation including plant SOPs and validation protocols.


Jonathan Toke
Vice President
Haskell, USA

Jonathan is a key resource for the company’s international expansion, and leads the effort to develop and implement best practices for the Engineer-Procure-Construct (EPC) delivery method.

His focus includes supplier management, project management support, risk identification and mitigation, customer accounting, and implementing EPC best practices across Haskell’s project delivery teams.


John Hyde
Chairman and Founder
Hyde Engineering + Consulting, USA

John is Chairman and Founder of Hyde Engineering + Consulting, Inc., a firm of 280 engineers and scientists, founded in 1993 and specializing in process engineering, process and equipment validation, and compliance consulting for biopharmaceutical and pharmaceutical manufacturers. The company has operations in the United States, Europe, India, Singapore and China.

Previously, John was Senior Project Engineer with Synergen, a biopharmaceutical research and manufacturing company located in Boulder, CO. His work included design, start-up and validation of key process systems and the overall responsibility for the cleaning validation programs for the firm’s large scale and clinical manufacturing facilities.  From 1982 to 1992, John was Manager, Process Design with Seiberling Associates, Inc., an engineering firm specializing in the design and start-up of biopharmaceutical, food and beverage process systems and the application of CIP technology.


Jaspreet Singh
Vice President Quality
Intas Pharmaceutical Ltd, India

Jaspreet is a microbiologist by education, with 25 years’ experience in Biotechnology and vaccines. His roles have spanned reputable Indian biotech companies such as Lupin, Biologicals E, Panacea and Intas.

At Intas, he heads both QA and QC for the last 2 years and has seen 7 audit approvals during this time, which include EMA, Health Canada, Turkey, Invima, ANVISA. He has also overseen 12 biosimilar product filings in the Indian market and pipeline products under filing during his additional responsibility as Regulatory Affairs Head, Intas.


Jerome Chua
Division Manager
ITS Science and Medical (Representative for IWT Italy),
Singapore

Jerome graduated with a Masters in Biotechnology & a Hons degree in Economics. Having more than 8 years of experience in the Pharmaceutical & Scientific industry, his role includes managing both the sales team as well as working with consultants for projects & lab set-ups.


Lionel Savin
Global Clean Process Product Manager
Camfil, Singapore

Lionel develops new products for Life Science, Food & Beverage and Healthcare. Previously, he worked in Sanofi Pasteur, the vaccine division of Sanofi where his team was in charge of Procurement and Contract Management for all the new production facilities. Lionel holds a Masters Degree in Mechanical Engineering in strategic procurement.


Martin Hermanto
Senior Chemometrician
Glaxo Wellcome Manufacturing Pte Ltd, Singapore

Martin has a Bachelor degree in Chemical and Biomolecular engineering at National University of Singapore, where in his PhD, he developed novel techniques for simulation, modeling and control of polymorphic crystallization.

At the Institute of Chemical and Engineering Sciences (A*STAR) as a crystallization and PAT scientist, his research area mainly focused on the implementation of PAT for monitoring and controlling crystallization process.

He was in-charge of implementing advanced informatics and analytics for a continuous manufacturing process, involving deployment of SIPAT and SIMCA online, development of MVA models for realtime predictive maintenance. As part of the PAT team in GSK, he supports overall PAT applications at both Jurong and Quality road sites.


Maurice Parlane
2016 ISPE Member of the Year, Director of ISPE Australasian Affiliate and Director of Centre for Biopharmaceutical Excellence, Australia

Maurice 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 Asia Pacific.

He has a Bachelor of Manufacturing Technology alongside 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.


Matthew Luo
Vice President, Quality Assurance
Livzon Mabpharm Inc., China

Matthew’s past experience includes roles as VP, Head of Quality Unit, Zhejiang Teruisi Pharmaceutical Inc. and roles in Wuxi Biologics, Amgen, Inc., Eli Lilly and Abbott Laboratories.

His expertise spans Quality Operations under cGMP and Quality Systems from Document management, Training; Risk management and validation., resource Management and Analytical Chemistry and Quality Control.


Marcel Langoor
Director Business Development
Eurofins Sinensis, Netherlands

Dr Langoor is an organic chemist with a PhD in molecular spectroscopy from the University of Utrecht.  He worked for a contract lab in the (petro)chemical industry, heading its analytical services division and later in its corporate business development department.

In 2002 he joined PROXY Laboratories, a contract lab for the life sciences industry, being responsible for its commercial activities. In 2004 he became shareholder and in 2012 a management buy out was completed. In subsequent years he led the acquisitions of MicroSafe Laboratories, Bactimm, Farmalyse, Prolepha Labs and Spinnovation Analytical as well as their consolidation into Sinensis Life Sciences. As Chief Business Officer he was responsible for its corporate strategy, M&A and BD activities.

In 2016 he completed the trade sale of Sinensis to Eurofins and currently is Director BD of the Eurofins Sinensis group.


Mohammad Ovais
Ex-Scientific Affairs Manager
Xepa Soul Pattinson,
Malaysia

Mohammad has extensive experience in product/process development, quality by design, validation, quality assurance and Quality Risk Management. He has more than ten years of hands-on experience learning validation of cleaning procedures and occasionally provides training and consulting services on the subject.


Mountain Yueh-Chun Hsieh
Head of Transfer & Manufacturing Science and Technology (MSAT)
Boehringer Ingelheim BioPharmaceuticals (China) Co., Ltd

Dr. Hsieh received his Ph.D. from the Graduate Institute of Life Sciences, co-sponsored by National Defense Medical Center, Academia Sinica and National Health Research Institutes. He has over 20 years’ experience ranging from cell line development, process development, quality and regulatory system to product design/development and GMP manufacturing.

Previously, Dr. Hsieh was Director of Quality Control, Director of Process Development, and Director of GMP Factory and has held several leadership positions at other companies.  He has led efforts in acquiring cGMP, ISO17025 and ISO13485 certifications, with wide-ranging experience in the protein production process development and technical transfer from/to CMC.


Nicole Pierson
Patient Advocate, Mother of Gavin Pierson; Keynote Speaker at ISPE Atlanta 2016 Conference, United States

Nicole is the mother of Gavin, age 10, a pediatric brain tumor survivor. Diagnosed at age five with a rare teratoma, he was the first pediatric patient to receive compassionate use for the drug Palbociclib. Nicole is an advocate for pediatric brain tumor research and a guest author for Caring Bridge and Children’s Hospitals of Minnesota. She is a math teacher with a master’s degree in education and an education specialist degree in brain-based teaching. Nicole is also the author of “Be Strong and Brave”, a memoir about how Gavin’s faith and hope saved his life. She will be signing copies of her book, available after this session.

Nicole, and her husband Steve live in Ramsey, Minnesota with their three children


Nigel Cheong
Head of Biomedical Sciences
Singapore Economic Development Board

Nigel joined EDB in 2010, placed in charge of key accounts in both research instrumentation and pharmaceuticals sectors. Following this, he 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.


Paul Daniel
Senior Regulatory and Compliance Expert
Vaisala, USA

Paul has 20 years’ of validation experience in pharmaceutical and medical device industries, on a wide range of qualification projects, including process, cleaning, shipping, laboratory equipment, packaging, software, network and computer validation. He has an extensive practical grounding in applying the GMP principles found in 21 CFR Parts 11, 210, 211, and 820. His specialties include: authoring and executing validation protocols (IQ and OQ) for pharmaceutical manufacturing and software validation with a risk-based approach drawn from GAMP guidelines.


Pierre Winnepenninckx
Past Chair of ISPE Asia Pacific and Chair
ISPE Singapore Conference 2017

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


Pierre Landais
Business Manager, APAC
Powder Systems Ltd (PSL APAC), Australia

Pierre established PSL’s Asia-Pacific operations in 2014 with an office in Perth, Australia and in 2016 opened a second office in Singapore to support the increasing demand for advanced process technologies in the region. PSL has completed a number of high containment projects for high potent API manufacturing including facilities in Singapore, Australia and South Korea.

Pierre has expertise in Project Management and has been a Technical and Tendering Manager at PSL for over 6 years. He has a Master’s degree in Industrial Engineering and Business Management.


Pradeep Chakravarty
Vice President, Corporate Quality
Lupin Ltd, India

Pradeep is an Engineer by qualification with 23 years’ rich experience across key functions including Quality Assurance, Regulatory Affairs, Pharmacovigilance, Formulation and Analytical Development.

His experience includes working in allied areas such as supply chain, production maintenance and project management. He is well versed with the US FDA, UK MHRA, EDQM, MCC, Australian- TGA, WHO- GMP & ISO 9000 System, with experience in managing quality function of sterile manufacturing operations. Troubleshooting technical issues with innovative and practical solutions excites him as a professional.


Robin Toh
Associate Director, Validation
Lonza Biologics,
Singapore

Robin holds a Bachelor in Chemical Engineering from National University of Singapore. He has 13 years of industry experience in Asia Pacific with the last 5 years in F&E, cleaning and computerized system validation.

A tech geek in process automation with specialization in the Emerson DeltaV system and Manufacturing Execution System (Syncade), Robin spent his early career in process automation design, commissioning and fine tuning his design during commissioning. He progressed into FEED, process design, CQV and project management. His passion is to make potentially complicated process understandable to the different disciplines and using basic scientific principles to demystify the art of validation.

In his current role in Lonza, Robin is responsible for the validation of the GMP facility and equipment at the large-scale biotech and cell therapy Singapore facility.


Richard Chai
Technical Service Manager
STERIS Corporation | Life Sciences, Singapore 

Richard has been providing technical training to customers in topics related to cleaning and bioburden control for cleanrooms, disinfectant validation, cleaning validation for product contact surfaces as well as technical support related to cleaning and microbial control.

Before joining STERIS, he 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, excursion investigations as well as best practices in bioburden control.


Steve Williams
Director and Senior Partner
Centre for Biopharmaceutical Excellence, Australia Pacific

Steve has over 40 years’ experience in the Biotechnology, Pharmaceutical and Medical Device industries in quality and manufacturing, including over 25 years consulting in GxP Quality Management and Regulatory Compliance.

He conducts FDA and EU/TGA/PICs compliance audits and gap analyses, assists companies in remediation programs and prepares companies for regulatory inspection. He has developed multiple training courses in PQS, GMP, GLP, Process Validation, Risk Management, Sterile Manufacture and Medical Device Quality Systems. He specializes in sterile products, risk management and compliance training solutions for the Life Sciences Industry.


Scott Patterson
Vice President Commercial Sales
ILC Dover, USA

Scott celebrates 11 years at ILC Dover, developing containment systems for the pharmaceutical industry and biopharmaceutical powder processes. With over 37 years in manufacturing process equipment, his experience includes pharmaceutical, biopharmaceutical, chemical and food processing solutions with specific expertise in size reduction and end of the line inspection. Scott is active with ISPE, AAPS, Interphex, HPAPI Summit and speaks as a subject matter expert at other industry events concerning containment of powder processes. His education is in the field of Mechanical Engineering Technology.


Suchart Chongprasert
Director of Post Marketing Control Division, Bureau of Drug Control
Thai FDA

Dr. Suchart is a registered pharmacist by profession, holding his Doctorate in Industrial Pharmacy from Pharmacy, Purdue University, US.   His post doctorate training at the University of Colorado Health Sciences Center, CO, US was in the area of freeze-drying of biotechnology-derived pharmaceuticals, and the roles of polyhydroxy-based stabilizers in protein formulations during freeze drying.  He also holds a bachelor’s degree in law (LLB) from Thammasat University, Thailand.

Dr Suchart has served in several positions in Food and Drug Administration, Thailand. He also officially represents the Thai FDA as member of the PIC/S Committee since Thai FDA became the 49th Participating Authority of PIC/S in August 2016.   He is currently involved more in building up and strengthening the capacities of the GMP Inspectorate and Surveillance Office to keep pace with a rapidly changing demand for GMP inspection of domestic and overseas drug manufacturers according to the latest PIC/S GMP Guide for Medicinal Products.


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

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

In addition to his role in Singapore’s Health Sciences Authority, he is the Chairman of the ASEAN Joint Sectoral Committee on GMP Inspection and Member of the PIC/S Committee of Officials. Periodically, he contributes review articles to ISPE’s Pharmaceutical Engineering and other international scientific journals in the field of comparative pharmaceutical regulations, traditional and herbal medicines, process analytical technology, control of APIs and pharmaceutical excipients, supply chain integrity and ASEAN pharmaceutical harmonization. In 2014 and 2015, two papers which he co-wrote were selected as Finalists of the ISPE Roger Sherwood Article of the Year Award.


Stefan Kappeler
Senior Project Manager, Compliance & Validation
M+W Group, Switzerland

Dr. Stefan has an MSc from the Swiss Federal Institute of Technology in Zurich, Switzerland and a PhD in molecular biotechnology. He has 16 years of experience in the pharmaceutical industry with a focus on biotechnology and has completed a variety of projects in the areas of R&D, tech transfer, USP and DSP production, QA, plant design and engineering and Q&V.


Tim Kehrli
Director of New Business Development – Asia
Stirling Ultracold, USA

Tim has been a leading advocate and driver in the United States federal energy efficiency and sustainable energy space for over 20 years. At Stirling Ultracold, he works with research and production laboratories across western US and Asia to quantify the impacts of ULT freezer use and develop strategies for improvements in energy efficiency, HVAC loading, critical temperature monitoring and freezer life expectancy.

Tim also supports laboratory energy efficiency and sustainability activities through his work with the International Institute for Sustainable Laboratories (www.i2sl.org) where he has been a board member since 2010.


Terry Nguyen Khuong
Associate Staff Scientist
Bioprocessing Technology Institute A*STAR, Singapore

Terry leads the analytics group at the Bioprocessing Technology Institute, ASTAR. In Feb 2017, he was awarded as a Waters Center of Innovation for innovations in glycoanalytics for biologic discovery, development and production.

He completed his PhD at the University of New South Wales, entering the field of glyco-analytics with his first postdoctoral work under Professor Nicolle Packer characterising the human tear glycome in patients with diabetic retinopathy. He then worked at the ANZAC Research institute before accepting a senior postdoctoral position at the Max Planck Institute for the Dynamics of Complex Technical Systems as part of the Marie Curie, EU funded HTP GlycoMet consortium. There, he was involved in applying mass spectrometry-based glyco-analytics to bioprocessing engineering efforts to improve influenza vaccine production.

His expertise revolves around the development and application of analytical toolsets; both new laboratory techniques and bio-informatic tools to understand the biological roles of glycans in biological processes, diseases and infection.


Vee Revithi
Head of External Relations
Roche, Switzerland

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 Vagenende
Validation Expert, MS&T
Novartis BioProduction Operations,
Singapore

Vincent currently manages the cleaning validation program for Novartis’ new biologics manufacturing site in Singapore. He first joined Novartis in 2013 as Downstream Specialist on the set-up and qualification of the MS&T lab facilities and led the downstream process familiarization for the site’s first product transfer. Then he moved on to MS&T Validation where he manages cleaning validation and coordinates various process validation activities for the site’s New Product Introduction program.

Before joining Novartis, Vincent worked at the Bioprocessing Technology Institute in Singapore, where he managed various projects in drug discovery and downstream process development.

He is also a certified Project Management Professional, invented an international patent and authored 10+ scientific publications.

Vincent holds a master’s degree in Chemical Engineering from Ghent University in Belgium and obtained a PhD in Pharmaceutical Engineering at the Massachusetts Institute of Technology and the National University of Singapore.


Wong Poh Mun
Manufacturing Science and Technology (MS&T) Validation Expert
Novartis Singapore Pharmaceutical Manufacturing Pte Ltd

Poh Mun joined Novartis as a Process Expert, where he gained valuable cGMP and operational experience of the industry. As Validation Expert, he is responsible to ensure the site validation system complies with authority and internal requirement. He was also the team member for Content Uniformity by NIR (CU NIR) implementation, which acquired EMA approval in 2015 and is currently in active use for commercial release


Wellyana Chua
LC and Informatics Business Development Specialist, Southeast Asia
Waters Pacific Pte Ltd, Singapore

Wellyana joined Waters Pacific in 2016, as part of the business development team. In her current role, she is responsible for supporting the LC and Informatics business in Southeast Asia.

She holds a Bachelors Degree in Chemical Engineering from the National University of Singapore, after which she joined the GlaxoSmithKline (UK) as an analytical scientist, then worked in the Food Safety Division of Health Sciences Authority in Singapore, where her research focus includes development of LC, GC and MS analytical assays for food contaminants and residuals of food contact materials.


Walid El Azab
Technical Service Manager
STERIS Corporation Life Science, Belgium

Walid El Azab is a Technical Services Manager for the Life Sciences Division of STERIS Corporation. He currently provides technical support related to cleaning chemistries, disinfectants and sterility assurance products and their application and validation. His areas of expertise include both upstream and downstream biopharmaceutical operation and validation. Walid has held various positions including Project Manager, Inspection Readiness Manager, Quality and Regulatory Manager, and Qualified Person (QP). Walid’s responsibilities and experience have also included handling deviations and complaints, releasing raw materials and drug products, conducting external audits of suppliers, and leading customer and regulatory (FDA, EMA, ANVISA…) audits. Walid earned a Master’s degree in Industrial Pharmaceutical Sciences from the University of Liège, Belgium and is a certified Lean Six Sigma green belt. Walid is a lecturer at the faculty at the University of Liège (Belgium) for the Industrial Pharmaceutical Master and the Radio-Pharmaceutical Master. Finally, Walid is Secretary of the Belgium Qualified Person (UPIP-VAPI) association.


Yang Ying
Analytical Science and Technology (AS&T) Facilitator
Novartis Singapore Pharmaceutical Manufacturing Pte Ltd

Yang Ying currently leads a team to support analytical method validation, transfer, laboratory equipment qualification and annual product quality review. She successfully led the transfer of the Real Time Release Testing (RTRT) with Process Analytical Technology (Content Uniformity by NIR) from Novartis research unit to manufacturing site.

She has a Masters in Chemical Engineering and Graduate diploma in Analytical Chemistry from National University of Singapore and over 13 years’ experience in the pharma industry.