Speakers ⇽ 2023 PDA Asia Pacific Regulatory Conference | Parenteral Drug Association on Glue Up

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Jenny Burnett

Head, Manufacturing Quality Branch at Therapeutic Goods Administration

Jenny Burnett is the current Chair of the Pharmaceutical Inspection Convention/Pharmaceutical Inspection Cooperation Scheme (PIC/S) Sub-committee on Strategic Development, representing the Therapeutic Goods Administration as a PIC/S Participating Authority. She is the Assistant Secretary of the Manufacturing Quality Branch (MQB), TGA. MQB assists in the timely supply of therapeutic goods, ensuring they are of appropriate quality for their entire lifecycle. This primarily relies on assessing manufacturers' compliance with Good Manufacturing Practice for medicines, blood, tissues and cellular therapy products and conducting product recalls for all types of therapeutic goods. MQB also has responsibility for the quality requirements for medicinal cannabis, psilocybin and MDMA products.

Jenny has a science background, working as a chemist in both private industry and government laboratories. After a number of years in the TGA Laboratories Branch, and a stint of living overseas for 3 years, she worked in various TGA pre-market assessment areas in medicine regulation before moving to MQB in 2021.

Matt Davis

Inspections Team Leader at Therapeutic Goods Administration - Australian Government

Matt Davis is a Senior Inspector – Team Leader, 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. Matt is also the Chair for the PIC/S Working Group on Data Management and Integrity, and is the TGA representative for the PIC/S EMA revision of Annex 1.

Qing (Joanna) Zhou

Review Chief in the Office of Biotechnology Products, CDER at US Food and Drug Administration

Dr. Qing Zhou is a Review Chief in the Office of Biotechnology Products (OBP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA). She provides direction and supervision to regulatory review staff on risk and science-based assessment of technical and scientific data submitted for CDER regulated biologic products. Dr. Zhou also serves as a member of Q12 Assessment Implementation Team (Q12AIT) and Post-Market Quality Committee (PQC) at CDER, FDA. She possesses a Ph.D. degree in Cell and Molecular Biology, and a B.S. degree in Biochemistry.

Peter Qiu

External Advocacy Lead China 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.

Ben Stevens

Director, CMC Policy and Advocacy of GSK

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.

Chris (Kwangyong) Nam

Director, Quality Assurance of Samsung Bioepis

Chris is QA lead at Samsung Bioepis responsible for quality oversight of multiple CMOs. Prior to Samsung Bioepis he served as market quality manager at Janssen Korea and as quality assurance manager at SK Biopharmaceuticals. He has about 20 years of experience in the pharmaceutical/biopharmaceutical industry with a discipline of chemical engineering.

Marguerite Evans Galea

Director, Cell & Gene Catalyst of AusBiotech

Dr Marguerite Evans-Galea AM is an accomplished scientist, executive, board chair and director. She is Director of the Cell & Gene Catalyst, a national joint venture of two industry peak bodies, AusBiotech and Medicines Australia. Together with an expert steering group of industry partners, Dr Evans-Galea leads the strategic direction, development and delivery of the Catalyst with the aim of ensuring everyone in Australia has ready access to world-class advanced therapeutics such as CAR-T immunotherapies for cancer, and cell & gene therapies and gene-editing for debilitating inherited diseases. Prior to this, Dr Evans-Galea was Director, STEM Careers Strategy at the Australian Academy of Technological Sciences & Engineering (ATSE) where she led the strategic development and delivery of ATSE’s $43M portfolio of prestigious national STEM Careers initiatives, including Elevate: Boosting Women in STEM funded by the Department of Industry, Science and Resources; the IMNIS Industry engagement initiative; and the STELR STEM Education program. During her 18-year research career, Dr Evans-Galea led international pre-clinical research programs in cell and gene therapy for inherited diseases at St. Jude Children’s Research Hospital in the United States and at the Murdoch Children’s Research Institute in Australia. She has received multiple awards for her research and leadership. Dr Evans-Galea is also an experienced consultant, editor, author and peer reviewer. An advocate for STEMM research, education and innovation, Dr Evans-Galea routinely engages and collaborates across multiple professional sectors in the broader STEM ecosystem and has served with government advisory groups. She communicates on a range of science-related topics via social and mainstream media.

Lisa Bennett (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.

Pauline Deng

Pharmacovigilance Excellence & Compliance Manager at CSL Behring (Australia)

Pauline is a young professional with a background in biological science research and in the pharmaceutical industry. In her current role, she is involved in global Pharmacovigilance Excellence & Compliance, leading PV system improvement projects and supporting global and local PV compliance and processes. Previously, her role was in Quality Assurance and Manufacturing within a highly regulated manufacturing environment.

Her areas of interest include continuous improvement, project management, Pharmacovigilance and Regulatory Affairs. She is passionate about advocating for STEM opportunities for students and young professionals (SYP) and establishing a local SYP community through her role as previous president and current committee member serving the PDA SYP AU chapter.

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 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 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.

Daniel Flewellen

Senior Consultant / Contracting Services Manager at Seerpharma

Daniel has 20 years broad pharmaceutical experience across various technological areas (scientific and IT) as a validation and IT compliance specialist. He has experience conducting IT, CSV and DI gap analysis and compliance audits for companies on quality systems and CSV programs. Daniel trains in computer validation (21 CFR Part 11, Annex 11, Data Integrity and GAMP) and assists companies establish IT compliance and computer validation programs.

He regularly gets involved with specific validation projects in clinical, manufacturing and laboratory environments and has expertise in ISO 13485, IEC 62304 and CFR 820 regulations.

Juliana Gutierrez

Scientific Affairs Manager at bioMérieux

Dr. Juliana Gutierrez is Scientific Affairs Manager at bioMérieux, where she offers her scientific expertise and support to the bioMérieux Pharma Quality Control segment across Asia. With over 7 years of experience in the region, Juliana has held various roles, starting in Japan as Scientific Affairs and more recently in Singapore as Regional Marketing. She holds a PhD in Molecular Biology from the École Normale Supérieure de Lyon, France, and has authored several peer-reviewed papers in biology. Juliana is also a frequent guest speaker at international conferences.

Patrick James

CSIRO

Patrick James is currently Principal Experimental Scientist and Analytical Lead in the Regulated Biomanufacturing Group at CSIRO. In this role he is tasked with developing, qualifying/validating analytical assays to support client projects and those from other business units with CSIRO. Additionally, Patrick provides CMC advice to the Regulated Biomanufacturing Group and other business units within CSIRO. Patrick has over 10 years’ experience in the biotechnology industry within companies such as CSL, Nexvet/Zoetis, Exopharm and AdAlta Ltd. working in areas including product, analytical and formulation development, and CMC.

Patrick holds a Ph.D. in analytical biochemistry specializing in protein and small molecule mass spectrometry characterization from the University of Melbourne, with post-doctoral experience from the University of Virginia.

Mylinh La

Senior Lab Manager at CSIRO

Mylinh is currently the Senior Lab Manager within the CSIRO's National Vaccine and Therapeutics Laboratory with over 20 years of experience working in both the academic research environment and the Biotech industry (Murex Biotech, Abbott Laboratory). Mylinh gained her Ph.D at the University of Melbourne (Department of Pharmacology), she is also an Alexander Von Humboldt Fellow, and a Research Fellow at the William Harvey Research Institution (University of London, UK), and an honorary senior lecturer in immunopharmacology. Mylinh areas of expertise and interests include large scale manufacture of monoclonal and recombinant protein using single use bioreactor, she also spent several years within the Supply Chain Management team at Murex Biotech and had first-hand experience with Lean Six Sigma for process improvement.

She later moved to CSIRO and helped to establish the CSIRO Tissue Culture Facility and more recently was involved in the design/ establishment/ qualification of a new manufacture clean room suites, CSIRO's new National Vaccine and Therapeutics Laboratory. Mylinh current interests are Environmental Monitoring; Contamination Control Strategy; Equipment and Process Validations and Phase Appropriate Manufacturing.

Mylinh is a committee member of the Parenteral Drug Association (PDA), Australian Chapter since 2018.

Bruce Loxley

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).

Janet Macpherson

BDM, Cell Therapy Enterprise, APAC at Cytiva

Janet Macpherson, PhD, joined Cytiva in 2019 and is responsible for Cell Therapy manufacturing solutions across the Asia Pacific Region. Janet has more than 25 years’ experience in research and product development in the Cell & Gene Therapy sector. She has held leadership roles in both industry (Johnson & Johnson Research) and healthcare/academia (Sydney Local Health District) where she was responsible for cross-functional cell and gene therapy product development teams, cell therapy process development, closed system personalised manufacturing and clinical trial development and execution. Janet is an active member of the International Society for Cell and Gene Therapy (ISCT).

Justine Mann

Chief Executive Officer at CBE Pure Solutions

Justine is Chief Executive Officer at CBE Pure Solutions, Contract Manufacturing and testing services in Melbourne.

Justine is also a Director of CBE, Centre of Biopharmaceutical Excellence, leading consulting firm providing service to Biopharmaceutical Industry in the areas of strategy, operations, compliance, training, regulatory & clinical support and facility design.

As a senior leader with extensive technical and management experience in Quality and Manufacturing in the Pharmaceutical, Biotechnology and Medical Device industries, Justine has worked on assignments in USA, Europe and Asia over a career span over 25 years.

Formally, a Senior Director of Quality Operations for ANZ and India at Hospira Corp. Pty Ltd and Pfizer Corp. Pty Ltd, Justine has had responsibility for providing technical, operational and strategic leadership to ensure site compliance in accordance with US FDA, EU-TGA-PIC/s regulations and local and international standards. Justine has particular expertise in Microbiology, environmental monitoring and aseptic processing compliance.

Justine is a registered auditor for the Australian Pesticides and Veterinary Manufacturing Authority (APVMA) on behalf of the Australian government, a technical assessor for National Association of Authorities (NATA) and current president elect for the PDA, Australian chapter

Gerry McKiernan

Director of Increment4

Piper O'Keeffe

Student at University of Melbourne

Piper is a recent Master of Biotechnology graduate from the University of Melbourne with a background in biochemistry and molecular biology. At the beginning of 2023, she embarked on a project with SeerPharma investigating the impact of large language models on quality management systems. Leveraging her background in both the biotechnology industry and RNA sequencing research, she is eager to aid the advancement of innovative biotechnology solutions.

Micheal Schafferius

Application Specialist for Separation Technologies and Quality at SARTORIUS

Micheal Schafferius currently holds the position of Application Specialist for Separation Technologies and Quality at Sartorius Australia, working for Sartorius for the past 10 years. Micheal has worked in the pharmaceutical and biopharmaceutical industries for more than 20 years. His experience includes roles focused on Filtration, Single Use Technologies, Quality Assurance, Validation and Sterile Manufacturing with local and international companies. Micheal is the current PDA Australia chapter President.

Adam Thomas

Post-Doctoral Scientist, Life Sciences Division at Burnet Institute

Shortly after his PhD in Biochemistry and Molecular Biology, Adam joined the pharmaceutical industry as a scientist at CSL’s Recombinant & Gene Product Development group where he gained valuable experience in various pharmaceutical products development, large scale manufacturing, quality control and quality assurance. During his time at CSL, Adam was part of the UQ Covid-19 vaccine manufacturing development project, and the AstraZeneca Covid-19 vaccine manufacturing. He implemented continuous improvements in processes and led the internal CSL Innovation Awards initiative. He was also the Health and Safety Representative for his department and completed the operations risk assessments across functions.

After a few years at CSL, Adam joined St Vincent’s Institute of Medical Research working on an oncology-focused project with Pfizer’s Centres of Therapeutic Innovation. This collaboration aimed to identify potential new small molecules that target the DNA damage response, which is common to most cancers.

Adam then joined La Trobe University to gain skills in research administration, specifically reporting on realised research impact beyond academia. He improved the tracking process for project impact and ensured La Trobe University’s continuous success in the Times Higher Education Impact ranking by aligning its operations and outputs with the United Nations Sustainable Development Goals (SDGs).

Adam is currently a Postdoctoral Research Scientist working on malaria vaccines development as part of the Burnet Institute Vaccine Initiative. He is exploring the mRNA vaccine platform to develop an efficacious vaccine for this challenging and complex disease.

Kerrie Way

Principal Regulatory Affairs Associate at Vaxxas Pty Ltd

Kerrie Way is a Principal Regulatory Affairs Associate with Vaxxas, an Australian-based biotechnology company aiming to develop and commercialize a novel needle-free technology for vaccine administration. Kerrie commenced her regulatory affairs career in 2008 at CSL in Melbourne and over the next 9 years was responsible for managing and developing regulatory strategies to support seasonal influenza vaccine registrations in Asian-Pacific and North-South American markets. Before starting at Vaxxas in 2021 she worked as a regulatory consultant offering services to consultancy and pharmaceutical companies, gaining experience with prescription, generic, OTC and botanical products. Kerrie has a B.Sc. (Hons), Ph.D. in Pharmacology from the University of Melbourne, and previously spent more than 10 years as a research scientist within academia in the US and Australia.

Dean Whelan

Quality Operations Team Leader and QC Manager, Regulated Biomanufacturing Group at CSIRO

Dean completed his PhD in reproductive proteomics at the Monash Institute of Medical Research where he investigated and characterised protein interactions crucial to mammalian fertilization and sperm development.

In 2021, he joined the Regulated Biomanufacturing Group at CSIRO as the quality control Manager, establishing the QC Laboratory to support the activities of the regulated biomanufacturing group. He is currently the Quality Operations Team Lead and part of the leadership group of CSIRO's National Vaccine and Therapeutics Laboratory (NVTL). Dean has over 10 years’ experience working in the biotech industry establishing QC laboratories and quality systems.

Connor White

Student at The University of Melbourne

Connor went to the University of Melbourne to earn his Master's Degree on Biotechnology and Bachelor's Degree , majoring in Cell and Developmental Biology.

Julie Winson

Director, QA & RA of LBT Innovations

Julie Winson is the Director of Quality Assurance & Regulatory Compliance at LBT Innovations. Julie is an industry veteran, with over 40 years in the pharma and more recently medical devices sector of the life science industry. Julie has held varied roles within pharma, including analytical test development, preparing regulatory submissions and project management, quality assurance in IT, consulting in quality management systems, and finally applying all of the experience gained to product development and quality assurance of LBT Innovations’ AI/ML enabled in vitro diagnostic medical device, and leads the processes required for regulatory clearance of the devices in the US and CE Marking in the EU, most recently to the IVDR.

Speakers

Jenny Burnett

Matt Davis

Qing (Joanna) Zhou

Peter Qiu

Ben Stevens

Chris (Kwangyong) Nam

Marguerite Evans Galea

Lisa Bennett (Chair)

Pauline Deng

Richard Denk

Daniel Flewellen

Juliana Gutierrez

Patrick James

Mylinh La

Bruce Loxley

Janet Macpherson

Justine Mann

Gerry McKiernan

Piper O'Keeffe

Micheal Schafferius

Adam Thomas

Kerrie Way

Dean Whelan

Connor White

Julie Winson

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