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

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

Senior Inspector 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.

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.

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.

Marc Glogovsky (invited)

Business Unit Manager at Valsource Inc

Marc Glogovsky is currently a senior consultant and manager of the microbiology division with ValSource, Inc. In his current role, he is focusing on development of contamination control strategies, implementation of rapid microbiological methods (RMMs), and establishing risk-based environmental monitoring programs.

Marc has been an active PDA member since 2000 and is currently serving on both the Science and ATMP Advisory Boards and as co-chair of the Microbiology/EM Interest Group. He has co-chaired and contributed to several Technical Reports and Points to Consider documents.

Marc earned his B.S. in Biology from Monmouth University and his M.S. in Microbiology & Molecular Genetics from Rutgers University.

Juliana Gutierrez

Scientific Affairs Manager at bioMérieux

Trends in Cell and Gene Therapy: Market Outlook and Regulatory Developments

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.

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.

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).

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.

Micheal Schafferius

Application Specialist for Separation Technologies and Quality at SARTORIUS

Opening Remarks

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.

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.

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.

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.