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Li Wei Chan
Microbiology Manager at MSD International GmbH (Singapore)Li Wei joined MSD International GmbH (Singapore) Biotech Sterile Fill- Finish site as the Microbiology Manager since Nov 2020. In this role, Li Wei is responsible for managing the EM program for aseptic cleanrooms & critical utilities, contamination control strategy for sterile final drug products and qualifications for new product introduction. He also ensures compliance to corporate and regulatory standards and supported regulatory inspections e.g. FDA PAI for Keytruda. In his previous roles, Li Wei was responsible for developing microbial control strategies, developing microbiological test methods, managing laboratory compliance and managed internal quality audits.
Li Wei received his Bachelor of Science (Biotechnology) from Monash University, certified Quality Auditor and had 16 years of experience in the pharmaceutical and medical devices industry (sterile & non-sterile manufacturing facilities).
Emily Cheah
Senior Managing Director of Charles River LaboratoriesA pharmacist by training, Emily is currently Senior Managing Director of Charles River Laboratories Singapore (Microbial Solutions) and APAC Technical Operations Lead. Emily oversees the APAC laboratory operations, as well as site operations including R&D / Centre of Excellence, and market development operations. She oversees technical programme roll outs in APAC and is involved in the evaluation and implementation of new technology & services within the Microbial Solutions division and serves on various committees within the company.
She received her Ph.D. (Pharm. Technology) from the National University of Singapore and her EMBA from INSEAD.
Emily is one of the founding members of the PDA Singapore Chapter and has served as a Board Member in various capacities since its inception in 2013. Emily is the current President of PDA Singapore Chapter.
Mark Chua
Principal Research Engineer II Manufacturing Control Tower at Singapore Institute of Manufacturing Technology, Agency for Science, Technology and Research (A*STAR)A veteran business leader with over 40 years of cross-functional leadership roles and solid working experience in manufacturing in the pharmaceutical, and medical device industry, championing Process Improvement via Lean Six Sigma, advocating Industry 4.0 Transformation and passionate about Talent & Leadership Development through mentoring and coaching. Held general manager position in GSK, Novaris and Alcon over 18 years period and consistently delivered outstanding performance results and achieved expanding growth in these organizations he had led. Mark retired in early 2022 and has recently assumed a role in A*STAR SIMTech to help manufacturing companies in implementing Digital Transformation & Innovation to improve their business performance.
Meow Hoe Boon
Deputy Director - OA of Health Sciences Authority of Singapore- Update from Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S)
- Panel Discussion and Q&A
Boon Meow Hoe holds a Bachelor’s degree in Pharmacy from the National University of Singapore. He has been with the Singapore Health Sciences Authority (HSA) since 1 June 2001. With 15 years of experience in the pharmaceutical industry, he made a mid-career transition from the industry to join the HSA as a regulator, serving as an active senior GMP inspector, conducting both local and overseas GMP inspections. In addition, he holds the position of Deputy Director of Overseas Audit Unit, Audit Branch, Audit & Licensing Division at the Health Products Regulation Group for over 20 years.
Beyond Singapore, he contributes his GMP expertise at various international technical forums such as EMA-PIC/S-WHO Revised Annex 1 (sterile product manufacture) drafting group, EMA-PIC/S WHO Revised Annex 1 implementation working group, PIC/S Working Group on Inspection Reliance, as an invited speaker or trainer by professional and industry associations, academia, and WHO, etc.
He actively participates in regional meetings and other international meetings and harmonization initiatives as a GMP expert (e.g., Korea-Singapore MRA on GMP inspection). In particular, he has been an official Pharmaceutical Inspection Co-Operation Scheme (PIC/S) representative for Singapore/HSA in the PIC/S Committee of Officials since 2002 to date. He actively establishes and develops international collaborative relationships in PIC/S and served as a PIC/S Executive Bureau (EB) member-cum-Chair of Subcommittee on Training of Inspectors from 2010 to 2019. He mooted the idea and has been instrumental in setting up the PIC/S Inspectorates' Academy (PIA), a web based sharing platform for training international GMP inspectors globally. He diligently works to enhance Singapore’s leadership in the field of GMP, as evidenced by his successful election as the first PIC/S Chairman from the Asian continent (in PIC/S history) from 2018 – 2019. In the latest PIC/S Committee of Officials meeting in November 2023, he was elected again as the PIC/S EB member-cum-Chair of PIC/S Subcommittee on Training of Inspectors for another 2 years starting from Jan 2024.
Sankar Dharmaraj
Director of Hilleman Laboratories- Newly-built Facilities: How to Manage Cost Without Compromising With Standards
- Panel Discussion and Q&A
Sankar Dharmaraj is a seasoned professional with a degree in Chemical Engineering and over 25 years of extensive experience in the biopharmaceutical industry. Throughout his career, he has made significant contributions across multiple functions including Engineering, Manufacturing, MS&T, Program Management, and Business Excellence. Having worked in three prominent biopharmaceutical companies in Singapore, Sankar has demonstrated his expertise from startup ventures to driving Commercial Manufacturing Excellence. His journey has seen him progress from an Engineer to holding Director-level positions, showcasing his ability to take on increasing responsibilities and deliver results.
Currently serving as the Site Operational Leader at the newly established cutting-edge cGMP facility in Hilleman Laboratories, Sankar takes pride in his role in completing the facility within record time, which entailed careful transformation of a space within an existing multi-tenanted building. The Hilleman ACES cGMP Facility is dedicated to enhancing accessibility of vaccines and biologics for low- and middle-income countries (LMICs), reflecting the company’s commitment to improving global health outcomes.
Kurt Jaecques
Senior Advisor, GSK Vaccines Sterility Assurance Centre of Excellence at GlaxoSmithKline Vaccines- Particulate Counter Installation and Qualification to Manage Particle Loss: Lessons Learned
- Panel Discussion and Q&A
- Replacing traditional Viable EM Methods for Air in Grade A by Implementation of Biofluorescence Particle Counters (BFPC): a Case Study
- Panel Discussion and Q&A
Kurt Jaecques has 25+years of experience within the pharmaceutical industry. He is working for GSK Vaccines as Global Aseptic Technologies Lead within the Global Sterility Assurance organization. He started his career at MSD (formally Schering-Plough Pharmaceuticals) responsible for the qualification of lab equipment and as lab supervisor Quality Operations microbiology. He worked for CMO’s and start-ups as Microbiology Manager or as consultant. He built up an extensive expertise in pharmaceutical microbiology with specific focus on Environmental monitoring and clean utilities. Kurt holds a Master’s degree in Biochemical Engineering.
Jaime Kaho`ohanohano
Microbiology Consultant at Microrite, Inc- Panel Discussion and Q&A
- Get Out from Behind Your Computer to Conduct Comprehensive EM Investigations
- Panel Discussion and Q&A
Jaime Kaho’ohanohano has 15 years of direct work experience in quality control testing and microbial contamination control ranging from clinical to commercial facilities. She began her career in the lab and facility collecting and testing of microbial samples. Her attention to detail and inquisitiveness led her to lead high-level microbial investigations, trending of data, client audits, risk assessments, and regulatory audit SME. Later in her career as a manager, she worked to improve the overall contamination control of a facility that assessed all aspects of microbial risk to the product from gowning, cleaning and disinfection, to a risk-based Environmental Monitoring program. She now rounds out her career as a Senior Microbiology Consultant for Microrite Inc., for the last 7 years. She applies her hands-on knowledge and experience to help clients from many different disciplines. She has a bachelor’s degree in microbiology from Arizona State University. She is passionate about sharing her love for science to inspire young students to pursue careers in STEM.
Wayne Lee
Fast Trak™ Validation Services Leader, Global at CYTIVAWayne has more than 23 years of combined experience in the pharmaceutical and biopharmaceutical, R&D, and manufacturing industry. He has broad experience in pharmaceutical synthetic chemistry unit operations, as well as biologics downstream processing.
He is currently the Global GM for Fast-TrakTM Validation Services, for Cytiva. Prior to his current role, he has spent more than 13 years in Pall Biotech; in roles of increasing responsibilities. His previous tenure includes Global Head of Validation and Laboratory Operations; Head of APAC (+China) technical support (MS&T); and BioProcess (MS&T) leader for ASEAN. Earlier, he has mixed experience from the Singapore Polytechnic, Merck Sharp & Dohme (Global Technical Operations); Galileo Pharmaceuticals and the Port of Singapore.
He was one of the founding board members of the PDA Singapore Chapter; current board member of the Singapore Chapter, previous board member of the UK Chapter and life-member of the Singapore National Institute of Chemistry (SNIC).
He is a seasoned practitioner of multiple Danaher Business system (DBS) tools; fluent in PSP, DM, SLXII, and is working towards Certified Practitioner (CP) for TPI, and is CP for VS 2.0. He holds a Ph.D. (Organic Chemistry; National University of Singapore) and an M.B.A. (Strategic and Operations Management; University of Bradford); and Double Bachelor’s Degree (Honors and Merit; Chemistry; National University of Singapore).
Pao Chun Lin
QC (ASAT) Manager at GSKPao-Chun joined GSK Vaccine site (Singapore) as a Senior QC Specialist for Analytical Science and Technology team in 2020. She is the Project lead for the introduction of innovative technologies into the QC department in Singapore. Apart from equipment qualification and implementation, Pao-Chun is also responsible for bio-related analytical method validation and ensures compliance to regulatory standards. She is the QC Representative for inspection and has supported on-site regulatory inspections by HSA and EMA.
Pao Chun is an experienced scientist with a demonstrated history of working in biologics industry. Skilled in Stable cell line development, Glycosylation, In-vitro based assays, Monoclonal antibody production, Protein purification and analysis and Confocal Microscopy. She has a strong research background with a Doctor of Philosophy (Ph.D.) focused in Cellular and Molecular Biology from NUS (A-star scholarship).
Kai Yee Loo
Director of TeambiosisKai Yee is an Executive Coach specializing in team and leadership development. He is the founder of Teambiosis, a company dedicated to cultivating great leaders and high-performance teams. Additionally, he serves on the faculty of an international coach training school where he trains and mentors coaches.
With over three decades of experience in the biopharmaceutical industry, Kai Yee has held senior positions in manufacturing, HR, and culture change.
He is a Professional Certified Coach accredited by the International Coaching Federation and possesses an Advanced Certification in Team Coaching. He also holds an honours degree in Chemical Engineering and an MBA.
Bruce Loxley
Senior GMP Compliance Advisor at GSK- Opening Remarks
- SESSION II: Facilities: Aging and Newly-Built (Part I)
- Q&A Session
- Day 2 Opening Remarks
- Points to Consider for Implementation of ICH Q12 for Post Approval Change Management
- Panel Discussion and Q&A
Bruce provides inspection readiness and compliance guidance to GSK Vaccines manufacturing network, focusing on AsiaPac. He is responsible for performing pre- Prior Approval Inspection (PAI) Assessments, and now has a specific remit on (i) preparing sites for first inspection, and on (ii) sharing knowledge on regulatory updates and trends into the organization.
Bruce has more than 30 years in the Pharma and Vaccines businesses, including a variety of roles in Validation and Compliance in both Drug Substance and Drug Product Manufacturing in UK, France and Singapore.
Bruce has been a PDA Singapore Chapter member since 2014, and was Chapter President from 2020-2022. Since July 2022 he has been a member of PDA’s Science Advisory Board (SAB).
John Metcalfe
Master Review Microbiologist at FDA/CDER/OPQ/OPMA/Division of Pharmaceutical Assessment III- FDA Concerns Regarding Microbiological Quality of Topical Ophthalmic Products: A CDER Microbiologist’s Perspective
- Q&A Session
Dr. John Metcalfe holds a BA in biology from Merrimack College in Andover, MA, and a PhD in microbiology from the University of Rhode Island. John spent 14 years teaching college microbiology courses prior to beginning a career in CDER in 2003. At FDA, John is a Senior Pharmaceutical Quality Assessor (SPQA) where he performs a microbiological quality assessment of both sterile and non-sterile drug products. He is an FDA Liaison to the USP Expert Committee on Pharmacy Compounding and is a published author in the area of drug product microbiological quality.
Rebecca Michel
Director, Microbiology of Tolmar- Panel Discussion and Q&A
- Process and Challenges of Drafting a Science-based CCS
- Panel Discussion and Q&A
Rebecca Michel is the Director of Microbiology at Tolmar. With over 20 years of pharmaceutical and device experience, she currently oversees microbiology development, quality control and sterility assurance of sterile and non-sterile products at multiple sites. Previously, she held roles in Quality, Manufacturing, Process Development and Technical Services before transitioning to this role in Microbiology. Rebecca Michel holds a Bachelor’s Degree in Microbiology from California Polytechnic State University- San Luis Obispo. She is a certified lead auditor accredited by CQI / IRCA and has been a PDA member for over 10 years. She recently leads the process of developing site specific contamination control strategies and is passionate about collaborative problem solving, continuous improvement and compliance.
Nora Pataut
Program Manager at GSKDriven by a passion for innovation, she accumulated 17 years of experience at GSK across Research, Development and Manufacturing in scientific roles to introduce advanced technologies and innovations that help deliver quality medicines faster and more effectively to patients.
In 2017, she led the Singapore Advanced Manufacturing Technologies team to initiate Digital Twin, Advanced Analytics and Process Intensification solutions and co-led the Digital, Data and Analytics transformation of its Small Molecule API manufacturing site.
Currently, as Program Manager in Global Innovation & Manufacturing Technologies, she is a dynamic innovator who incubates and amplifies internal and external capabilities by unlocking the untapped potential of people, process, science and technology.
She strongly believes in knowledge sharing and digital transformation, and has thus recently embarked on leading an enterprise project to digitise our Tech Transfer activities for GSK’s CMC organisation.
Kai Yin Po
Associate Principal Scientist at MSD International GmbHKai Yin is an Associate Principal Scientist at MSD International GmbH for the Asia Pacific Region. With over 15 years of Biopharmaceutical experience, she specializes in monoclonal antibodies and vaccine platforms. Previously, she held leadership roles in the Quality organization at manufacturing sites before transitioning to the field of CMC regulatory. Kai Yin holds a Bachelor Degree in Applied Chemistry from the National University of Singapore. She is passionate about staying updated on technological advancements in the biopharmaceutical industry and aims to contribute to the integration of these innovations into future regulatory and quality frameworks.
Timothy Pohlhaus
Consumer Safety Officer, OC, CDER at US FDADr. Timothy Pohlhaus is a Senior Policy Advisor in CDER/OC/OMQ at the FDA. In his 14 years in CDER’s Office of Compliance, he has played significant roles enhancing establishment surveillance programs, assessing facilities for pre-approval/pre-license purposes, advising on CGMP compliance actions, and developing CGMP guidance and policy. He has focused on biotechnology, positron emission tomography, and other sterile drug manufacture. Prior to joining FDA, Timothy worked manufacturing and quality roles in the craft brewing industry. He has a PhD in Biochemistry from Duke University and a BS in Biochemistry from The University of Maryland Baltimore County.
Peter Qiu
External Advocacy Lead, APAC at Roche Genentech- How to Interact with the FDA/CDER when Designing Facilities
- Panel Discussion and Q&A
- EU GMP Annex 1 Implementation: Contamination Control Strategy (CCS)
- Panel Discussion and Q&A
Dr. Peter Qiu is the External Advocacy Lead for Asia Pacific at Roche Genentech with over 13 years of experience working with the US FDA. He was the Division Director in the Division of Biotechnology Manufacturing, Office of Pharmaceutical Manufacturing Assessment, CDER. He led the assessment of manufacturing processes, facilities, and microbiological control for CDER’s Biologics License Application review and inspection program.
Dr. Qiu has extensive knowledge in microbial controls and sterility assurance assessment as well as in pre-license and pre-approval inspections for biotech products.
Dr. Qiu graduated from the University of Southern California with a Ph.D. in Biological Sciences.
Georg Roessling
Consultant for Pharma and Suppliers- SESSION III: Facilities: Aging and Newly-Built (Part II)
- Panel Discussion and Q&A
- Session IV: Annex 1 Implementation Update and Qualification
- Panel Discussion and Q&A
Georg has been a consultant since 2017 with activities for PDA in Asia, Corona Vaccination Center, and companies in the pharma industry. He began serving as Senior Vice President of PDA Europe and started the European Office operations in 2006. He developed several conferences and training courses together with regulatory agencies, pharmaceutical industry and suppliers. Before that, he worked from 1984-2005 with Schering AG, now Bayer, in various positions. These roles included head of pharmaceutical development of Parenterals and head of Global CMC Technology Office.
Georg is a chemist by training and went to the University of Karlsruhe in Germany to earn a PhD in Physical Chemistry. He completed his post-doctoral degree in Chemical Engineering in Berkeley, USA. He has been a PDA member for more than 30 years and has received the PDA Honorary Membership.
Ben Stevens
Director, CMC Policy and Advocacy of GSK- Roundtable Discussion
- Points to Consider for Implementation of ICH Q12 for Post Approval Change Management
- Panel Discussion and Q&A
Ben Stevens is a Director of CMC Policy and Advocacy at GSK and has nearly 15 years of drug discovery and regulatory experience. Prior to GSK, Ben was a Director of Regulatory Affairs CMC at Alnylam where he led the clinical regulatory CMC development of Vutrisiran prefilled syringe in over 30 countries, and the initial US NDA and EU MAA submissions, including one of the earliest Notified Body assessments under the newly implemented EU MDR. Before Ben joined Alnylam, he was a Principal Consultant at PAREXEL and an acting Branch Chief in the Office of New Drug Products (ONDP) at the FDA. At FDA, Ben worked closely with several key policy groups (OPPQ, ORP), partnered with CDRH on matters related to combination product review, and was a government liaison to USP. Before FDA, Ben spent seven years in medicinal chemistry R&D at Pfizer and Merck. Ben has broad regulatory CMC experience in small molecules, peptides, oligonucleotides, botanicals, and combination products. At GSK, Ben leads CMC policy and advocacy for several priority areas, including biologics, CGT, oligonucleotides, and advanced manufacturing. Ben represents GSK in numerous external trade and association working groups (e.g., PhRMA, BIO, IQ, EFPIA, NIIMBL, ISPE, PDA, Biophorum), where he has led and supported policy positions and interactions with global regulators. He received a Ph. D. in Chemistry from the University of Pittsburgh, a M.P.H. from the Johns Hopkins Bloomberg School of Public Health, and is a co-author of over 30 publications and patents.
Andiyanto Sutandar
Consulting Director of NNIT Singapore Pte. LtdAndiyanto Sutandar is a Consulting Director at NNIT. Andi manages the consultancy operations of NNIT in Singapore where the Consulting team delivers business transformational solutions to the pharmaceutical industry through business process optimisation, industry best practice implementation and digitalization. Prior to his management role, Andi has delivered services in CQV, CSV, technology transfer, deviation and non-conformance management, supply chain optimization and project management. Additionally, Andi is an expert in high containment facilities for infectious diseases research.
Vincent Tan
Director, Information Systems of AmgenVincent Tan is the Director of Information Systems of Amgen Singapore Site Operations, home to Amgen’s first Next Generation Biomanufacturing and Commercial Chemical Synthesis manufacturing plants. Vincent leads the team that support critical manufacturing systems to our manufacturing plants to ensure robust, compliant and reliable supply of high-quality drug substances to improve patients’ lives.
Vincent drives the site Digital Manufacturing Innovation roadmap and is involved in the evaluation and implementation of new technology innovations that helps to transforms and unlocks business value to the enterprise.
Prior to Amgen, Vincent spent 15 years leading regional teams in systems implementations, support and service transformation at Novartis and MSD.
Edward Tidswell
Executive Director, Microbiological Quality and Sterility Assurance of MerckEdward C. Tidswell, BSc, PhD - Dr. Tidswell is Executive Director within the Microbiological Quality and Sterility Assurance organization of Merck & Co., Inc., with ownership over sterility assurance and microbiology quality and compliance issues across all sterile and non-sterile products and manufacturing. His prior appointments include senior global R&D, and quality leadership roles across diverse drug, device and biologics portfolios for the likes of Baxter Healthcare, Eli Lilly and Evans Vaccines. Dr Tidswell actively publishes and is a leading authority on pharmaceutical microbiology, risk, aseptic and sterile manufacturing (ORCID: 0000-0003-0069-1967). Currently a member of the PDA Journal’s Editorial Board and the HT4 Team, prior roles in PDA include serving on the SAB, leading the Aseptic Interest Group, and contribution to numerous Technical Reports and Points to Consider documents. Since June 2010 Dr. Tidswell is honored to serve on the USP’s Expert Committee for Microbiology.
Wallace Torres
VP Site Operations at Amgen Singapore ManufacturingWallace I. Torres is the VP for Site Operations at Amgen Singapore Manufacturing (ASM). He is responsible for the Biologics and Synthetics manufacturing operations in Amgen Singapore.
Wallace is a Senior executive with experience in achieving Quality, Strategic and business growth objectives internationally and within changing environments. Extensive experience on pharmaceutical quality and manufacturing operations with more than 30 years of experience, Wallace worked for 25 years at Hoffmann La Roche in several positions in the QC/QA, Manufacturing, Strategy, and Supply Chain areas. In 2013 he joined Amgen with responsibilities ranging from Quality director to VP of Manufacturing.
His experience includes responsibilities as Manufacturing 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, Brazil, and Singapore.
He holds a Bachelor’s Degree in Biology from the University of Puerto Rico, a Master’s Degree in Management from the University of Phoenix, a Master in Advance Management Practices from the University of South Australia, and a PhD in International Business Management from the Swiss Business School.
Marcus Yambot
Senior Consumer Safety Officer at US FDA/CDER/OPQ/OQSCommander (CDR) Marcus Yambot is currently a Senior Consumer Safety Officer for the Office of Quality Surveillance, within the Office of Pharmaceutical Quality. He is on FDA's Quality Management Maturity Program Development Team. He joined the Agency in October 2008 after graduating with a B.S. in Materials Science and Engineering and M.S. in Biomedical Engineering from the University of California, Los Angeles. Prior to his current position within CDER, CDR Yambot served a variety of roles within the Office of Regulatory Affairs, including Investigator, Drug Specialist, Compliance Officer, and Supervisory Consumer Safety Officer.