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Bruce Loxley (Co-Chair) (Senior GMP Compliance Advisor, Inspection Readiness and Compliance at GSK)

Bruce Loxley (Co-Chair)

Senior GMP Compliance Advisor, Inspection Readiness and Compliance at GSK

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).

Lisa Bennett (Co-Chair) (Senior GMP Consultant and Trainer at SeerPharma)

Lisa Bennett (Co-Chair)

Senior GMP Consultant and Trainer at SeerPharma

Lisa is an active member of the PDA Regulatory Affairs and Quality Advisory Board (RAQAB) and the PDA Australia Chapter. Lisa’s experience comes from a background in Forensic & Analytical Chemistry, accompanied by a Masters in Forensic Science. After beginning her career as an analytical chemist in the petrochemical industry, Lisa moved into roles within the Pharmaceutical Industry where she gained hands on experience in a wide breadth of disciplines such as QC, Stability and Clinical Trials, Supply Chain Logistics, R&D, Aseptic Fill and Finish, QA, Release for supply and auditing. The majority of her time in the industry has been in roles working within the CSL group which manufactures biological products such as vaccines, antivenoms and blood products.

Matthew Davis (Virtual) (Inspections Team Lead & Senior Inspector Manufacturing Quality Branch at Therapeutic Goods Administration)

Matthew Davis (Virtual)

Inspections Team Lead & Senior Inspector Manufacturing Quality Branch at Therapeutic Goods Administration

Matt Davis is the Chair for the PIC/S Working Group on Data Management and Integrity, and TGA representative for the PIC/S EMA revision of Annex 1.

At TGA, Matt is a Senior Inspector and Team Leader at the Inspection Section with the Manufacturing Quality Branch. Matt has been with TGA since 2009. Before joining TGA, Matt held positions in the pharmaceutical industry sector in quality and technical roles, and has spent time in the UK as a GMDP Inspector for the MHRA.

His current role at the TGA involves performing both domestic and overseas inspections of manufacturers.

Meow Hoe Boon (Deputy Director - OA of Health Sciences Authority)

Meow Hoe Boon

Deputy Director - OA of Health Sciences Authority

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

After graduation, he served in 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 was an elected Pharmaceutical Inspection Co-operation Scheme (PIC/S) Chairman cum Member of the PIC/S Executive Bureau for year 2018 to 2019. He continues to serve as the official HSA Representative in the PIC/S Committee of Officials.

Renee Buthe (Virtual) (Technical Services Specialist at STERIS)

Renee Buthe (Virtual)

Technical Services Specialist at STERIS

Renee Buthe has been a member of STERIS Life Sciences Contamination Control Solutions as Technical Services Specialist since October 2021. In this role, Renee has responsibility for providing global technical support primarily for Sterility Assurance (i.e. biological and chemical indicators) and Barrier Products (i.e. sterilization wrapping), application and validation.

For five years, Renee has held positions within the Pharmaceutical Industry, specializing in environmental monitoring, sterility assurance, disinfection, sterilization and contamination control in parenteral drug manufacturing.

Renee holds a bachelor’s degree in Biology with a minor in Animal Sciences from the University of Kentucky.

Emily Cheah (Senior Managing Director of Charles River Laboratories)

Emily Cheah

Senior Managing Director of Charles River Laboratories

A 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.

Francesco Cicirello (Virtual) (Senior Director, Quality Assurance of Evelo Biosciences)

Francesco Cicirello (Virtual)

Senior Director, Quality Assurance of Evelo Biosciences

Prior to Evelo, Antonio was the Site Quality Head at Adaptimmune an ATMP company headquartered both in UK and USA, with a gene therapy drug products with PRIME and RMAT designation. Before joining Adaptimmune, he worked at the Therapeutic Good Administration (TGA) in Australia, a Regulatory Agency, as an Expert Inspector. He was elected to several roles in PIC/S (Pharmaceutical Inspection and Cooperation Scheme) including Chairperson of the Working Group that revised the PIC/s Annex 2 and Deputy Chair of the Subcommittee on Harmonization. He also represented PIC/S at the EMA IWG and was a member of the PIC/S Coordinating Committee on the Human Blood, Tissues, Cells & ATMPs. He authored the recently published PIC/S Annex 2A & 2B, contributed to the revision of EU Annex 1 and the PIC/S transposition of Annex 16.

He earned a Degree in Chemistry and Pharmaceutical Technology from the University of Florence, a MSc in Oncology Pharmacology from the University of Milan and a MSc in Cosmetic production from the University of Siena.

He is a member of the PDA ATMP board, and of the ISPE SIG Biotech and CoP in ATMP.

Matthew Cokely (Global Technical Consultant Regional Leader at Ecolab)

Matthew Cokely

Global Technical Consultant Regional Leader at Ecolab

Matt has 10 years’ experience within the pharmaceutical industry working as a microbiologist in GMP accredited facilities. He has had first-hand experience of working in graded cleanrooms and in the manufacture of a wide and diverse range of pharmaceutical formats including solid oral dosage units, oral liquids, powders and sterile injectable products. Matt began his career testing raw materials and finished products, conducting sterility testing and antibiotic assays, performing environmental monitoring within the manufacturing areas and sampling and testing purified water in accordance with cGLP/cGMP. He performed similar activities in his next company, but then progressed to performing investigations of atypical or non-compliant results/events, supervising the preparation of all technical documentation, and managing projects including validation of laboratory procedures, systems and equipment, method validation and cleaning (sanitisation) validation of new manufacturing equipment. He also worked with R&D to ensure the microbiological quality of batches being manufactured for Phase II and II clinical trials and was also called to represent the microbiology group for his company at an EMEA regulatory meeting in London.

Richard Denk (Senior Consultant Aseptic Processing & Containment at Skan AG)

Richard Denk

Senior Consultant Aseptic Processing & Containment at Skan AG

Richard Denk is working at SKAN AG, headquartered in Allschwil Switzerland as a Senior Consultant Aseptic Processing & Containment. Richard is a Member of the PDA ATMP Advisory Board and chairs the PtC of the Manufacturing of ATMPs. Richard also chaired the 2022 PDA ATMP Conference in Brussels and is a Member of the Program Committee of the PDA 2022 Annex 1 workshops. Richard is a member of the PDA Isolator Expert Group and publisher of the PDA Paper “Isolator Surfaces and Contamination Risk to Personnel and Patient”. Furthermore, Richard is a member of the ISPE Annex 1 and PIC/s Annex 2A commenting group. Richard is a global recognized subject matter expert on Containment and has developed the containment pyramid.

Derek Duncan (Director of Product Line at LIGHTHOUSE)

Derek Duncan

Director of Product Line at LIGHTHOUSE

Dr. Duncan began his career at the Dutch Institute for Atomic & Molecular Physics. He moved into the industry and has been based at the LIGHTHOUSE office in Amsterdam since 2003, responsible for developing applications for pharmaceutical process monitoring and finished product inspection. Dr. Duncan has been a regular contributor to PDA conferences and was the recipient of the 2015 PDA Europe Service Appreciation Award and the 2020 PDA Edward Smith Packaging Science Award. He holds a degree in Physics and Mathematics from Louisiana State University and a Ph.D. in Atomic & Molecular Physics from the University of Virginia.

Michael Edey (Senior Principal Engineer at Pfizer)

Michael Edey

Senior Principal Engineer at Pfizer

Michael Edey is a Senior Principal Engineer, Global Technology & Engineering at Pfizer Inc. The role is undertaken as a member of a corporate team with responsibilities for Primary Packaging for the Pfizer Sterile Injectables Network. Michael has a diverse background in Pharmaceuticals with over 25 years’ experience in Production Management, Quality Assurance and Technical Leadership. More recently with a global technical role in packaging innovation including leading CCIT initiatives, with an emphasis on quality risk management as part of the application of a holistic science-based approach.

He is a contributor to global quality/technical conferences and article publication for multiple industry organizations.

Cheryl Essex (Virtual) (Head of Quality Operations R&D Genomic Medicine Unit at Sanofi)

Cheryl Essex (Virtual)

Head of Quality Operations R&D Genomic Medicine Unit at Sanofi

Ms. Essex oversees Quality for Sanofi’s cell and gene therapy clinical manufacturing unit and was previously a recognized global expert in Microbial Contamination Control at Sanofi. Ms. Essex co-led the PDA author team for Technical Report 90 on Contamination Control Strategy.

Ms. Essex has 19 years’ experience in GMP Quality mainly focused on Microbiological Contamination Control at large pharmaceutical companies, contract manufacturers, and emerging biotechnology working in mammalian, microbial and human cell systems. Ms. Essex’s undergraduate education focused on Biology and Microbiology and she holds graduate degrees in Bioengineering and Stem Cell Medicine.

Andrew Hopkins (Director of Compliance at AbbVie)

Andrew Hopkins

Director of Compliance at AbbVie

Andrew has a BSC (Hons) in Microbiology with Genetics and a Post Graduate Diploma in Industrial Pharmaceutical Science. His career history covers a number of areas over approximately 35 years.

Currently Andrew is a Director of Compliance at Abbvie the role includes Auditing of manufacturing sites, Training and mentoring, and interaction with regulatory agencies.

Prior to this, Andrew was an Inspector with the MHRA for nearly 14 years.

Dinesh Khokal (Director and Regional Lead, External Affairs, JAPAC of Amgen)

Dinesh Khokal

Director and Regional Lead, External Affairs, JAPAC of Amgen

Dinesh. as a Director and Regional Lead of External Affairs in Amgen, is currently responsible for shaping external regulatory and GXP landscape in collaboration with industry peers and regulators in Japan Asia Pacific. Additionally, Dinesh holds the position of Adjunct Associate Professor at the Faculty of Health and Medical Sciences, Taylor’s University, Malaysia.

He is an accomplished pharmaceutical professional with distinguished career of over 35 years of combined experience in regulatory agency, biopharmaceutical & diagnostic industries, and academia.
Prior to Amgen, Dinesh held the role of Director of Therapeutic Products Branch at the Singapore Health Sciences Authority (HSA). During his tenure in HSA, Dinesh held many different roles including Senior GMP Inspector. He has also played several key roles in multiagency consortiums and World Health Organization initiatives working towards capability building, shaping regulatory landscape, regulatory harmonisation, and mutual reliance.

Dinesh received his Ph.D. in Cell and Molecular Biology from the National University of Singapore. He is currently on the PDA Regulatory Affairs and Quality Advisory Board (RAQAB). He is a recipient of 2020 PDA Distinguished Service Award.

Heng Mui Lee (Quality Assurance Manager at GSK)

Heng Mui Lee

Quality Assurance Manager at GSK

Heng Mui LEE is the Quality Assurance Manager (Sterility Assurance) at GSK with over 2 decades of experience in quality control (Microbiology), quality operation and sterility assurance. She holds a Bachelor of Science degree in Molecular Biotechnology from Curtin University of Australia. Before joining GSK, she instrumented the technical transfer of test methodologies between donor site (Switzerland) and Singapore before returning to Singapore to oversee the setup of Microbiology laboratory and various validation activities of new BioScience manufacturing plant. Her current responsibilities includes strengthening of site’s sterility assurance capabilities in both production and quality unit, oversee the site’s contamination control strategy and aseptic process simulation.

Wayne Lee (Senior Director, Global Validation Services and Laboratory Operations of Pall Corporation)

Wayne Lee

Senior Director, Global Validation Services and Laboratory Operations of Pall Corporation

Wayne has >23 years of experience, in the pharmaceutical, 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 Head of Validation Services and Laboratory Operations, and has spent >13 years in Pall Biotech, in roles of increasing responsibilities. His previous tenure includes Head of APAC technical support (MS&T); and MS&T leader for ASEAN. Previous experience includes roles of increasing responsibility in Merck Sharp & Dohme (GTO) & Galileo Pharmaceuticals. He holds a Ph.D. (Organic Chemistry; NUS); an M.B.A. and double degrees in Chemistry.

Ivy Louis (Founder of Vienni Training and Consulting)

Ivy Louis

Founder of Vienni Training and Consulting

Ivy Louis is the Founder of VIENNI TRAINING & CONSULTING LLP, holds a Master's degree in Pharmaceutical Sciences and an MBA in Human Resource Management.

Ivy's combined 33 years spanning across teaching, pharmaceutical manufacturing/quality, and service provider experience is distilled into the consultative and educational approaches that her organization-VIENNI Training & Consulting LLP has been delivering from 2010 onwards. The areas of support for pharmaceutical and biopharmaceutical operations rests on building excellence through consulting in parenteral operations and catering to the learning requirements for operating personnel through training & education.

Ivy has been associated with PDA Inc.(www.pda.org) from 2003, as a member. She has been extremely active in spearheading the activities of the Parenteral Drug Association Chapter in India, from 2013 onwards. Ivy has been contributing in the various capacities as a PDA India Chapter Board member between 2013-2019. She has also been a Member of the Steering Committee for Awards in 2017, Member of the Steering Committee for the PDA letter Editorial Committee and a member of the Task Force that is working on an ANSI standard for Quality Risk Management for Aseptic Processing. She is also a member of the Science Advisory Board and holds a position as Member-Board of Directors for PDA Inc.

Wilson Mizoguchi (Head of Market Development, SEA at Datwyler Healthcare)

Wilson Mizoguchi

Head of Market Development, SEA at Datwyler Healthcare

Wilson has been in the healthcare industry for the past 30 years, helping developments within the medical device and pharmaceutical industry. Currently advise/ support pharmaceutical companies on CCI-Container Closure Integrity solutions.  His experience spans from medical device and prefilled syringes applications and manufacturing while working for BD in Europe, US, Japan and Singapore as well as pharmaceutical processing equipment at Syntegon/ Bosch Packaging. His cross functional experience in managing product development and projects helps partners in bringing successful solutions to the market. Wilson has joined Datwyler in 2019 and is supporting customers across SEA, Japan and Korea advising on the right packaging recommendations for medicine applications. He believes in supporting Asian pharmaceutical customers to be more successful on their aspirations to raise people’s quality of life. Wilson graduated in engineering from Sao Paulo University and with a MBA from Fox School of Business.

Zhihao Peter Qiu (External Advocacy Lead China, Global Quality and Compliance at Roche Genentech)

Zhihao Peter Qiu

External Advocacy Lead China, Global Quality and Compliance at Roche Genentech

Dr. Peter Qiu is the External Advocacy Lead China 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.

Catherine Thomson (Sterility Assurance Director of GSK Vaccines Sterility Assurance Centre of Excellence)

Catherine Thomson

Sterility Assurance Director of GSK Vaccines Sterility Assurance Centre of Excellence

Catherine has 20 years of experience in aseptic manufacturing within the GSK Pharma and Vaccines businesses. Whilst a Chemical Engineer by training, she has undertaken a variety of roles within technical support, operations, engineering, validation, audit and quality.

In her current role, she is a business partner to the GSK Vaccines network, providing support to the GSK internal and external supply network across both clinical and commercial manufacturing.

Catherine has a passion for people development and is currently working on creation of interactive, digital learning solutions to build competency in sterility assurance.

James Vesper (Director of Valsource)

James Vesper

Director of Valsource

James Vesper, PhD, MPH designs and develops instructional courses and workshops for the pharmaceutical and biopharma industries and is Director, of Learning Solutions at ValSource, Inc. He has had more than 40 years experience in the pharmaceutical industry.

Dr. Vesper has written six books, including Root Cause Investigations for CAPA (2020) and multiple technical articles on risk management. He has received the PDA’s Agallico Award for Teaching Excellence and, in 2021, PDA’s Distinguished Author/Editor of the Year. He has also served as a consultant to World Health Organization’s (WHO) Vaccine Quality Network – Global Learning Opportunities and has trained health authority inspectors through WHO and PIC/S in US, Taiwan, London, China, Greece, Turkey and Brazil.