Ziva Abraham
CEO of MicroriteZiva Abraham is the President and Founder of Microrite, Inc., a California based consulting firm providing consulting and training services to pharmaceuticals, biotechnology, medical devices and in vitro diagnostics in the areas of quality assurance, quality control, microbiology, and validation.
She has over 35 years of academic, research, clinical and industrial experience in microbiology, and quality assurance. Ziva has received her Master’s Degree in microbiology with a focus on Mycology and has conducted research on developing microbial Insecticides using entomogenous bacteria and fungi. Her career also includes founding and managing clinical laboratories for Maccabi Medical in Israel. She has trained personnel from various industries in microbiology techniques and methods. She uses her extensive experience to teach why assessing risk of microbial contamination should be in the forefront of any company that has products for human/veterinary use. Her experience in clinical laboratories has provided her with the framework to understand the effects of microbial contamination in products from a patient safety perspective.
Aaron Allen
Director, Global Quality External Engagement of Moderna- Challenges and Solutions to Development and Scale-Up of mRNA Platform Products
- Panel Discussion and Q&A
Aaron Allen is an experienced Manufacturing Sciences and Technology professional with more than 25 years of process engineering, manufacturing and MS&T experience. Mr. Allen has transferred and executed process validation for multiple vaccines within Novartis and Moderna. He has recently transitioned to a new role as Global Quality External Engagement.
Mr. Allen’s previous experience includes positions with Diosynth, Biogen, Jacobs Engineering and Novartis Vaccines. Mr. Allen holds a bachelor’s degree in Chemical Engineering from the University of California at Santa Barbara.
Yen Tong Chan
QC Team Leader at RocheYen Tong has over 12 years of pharmaceutical industry experience in Microbiology, QA System and Validation and currently works as QC Team Leader in Roche Singapore. He was previously affiliated with MSD Singapore where he gained his first technical experience in supporting microbiological testing, thermal equipment validation, and cleaning monitoring program in Sterile Fill-Finish facility. After that, he was part of the startup team in Amgen Singapore, responsible for laboratory equipment qualification, method validation, utilities and environmental characterization. Yen Tong graduated with a BSc (Hons) in Microbiology and Biotechnology from University of Saskatchewan, Canada
Richard Denk
Senior Consultant Aseptic Processing & Containment at Skan AG- Aseptic Processing New Technologies: Closed Isolators and Gloveless Isolators
- Panel Discussion and Q&A
- PDA PtC on ATMP Manufacturing
- Panel Discussion and Q&A
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.
James Drinkwater
Head of GMP Compliance and Aseptic Processing Support at Franz Ziel- The Role of Enzymatic Indicators (EIs) to Improve Efficiencies in VHP Cycle Development and Associated GMP Manufacturing Applications
- Panel Discussion and Q&A
James is the former Chairman and honorary member of the Pharmaceutical and Healthcare Sciences Society (PHSS), a not-for-profit educational platform for GxP. He also is the current leader of the PHSS special interest groups on Aseptic processing and Biocontamination. PHSS was one of the European Commission appointed commenting platforms in the Targeted Consultation process and he served as the co-lead of the focus group for Annex 1 revision and implementation. He also was the co-lead for PHSS’ focus group on Contamination Control Strategy (CCS) Guidance initiative.
In his capacity as the Head of GMP Compliance at Franz Ziel GmbH, James is actively involved on projects for Pharmaceutical, Biologics and ATMP product GMP manufacturing, specifically Fill & Finish projects. Based in the UK, James has a global support role and is also a qualified trainer on Aseptic processing with training collaborations through the University College London (UCL School of Pharmacy).
Max Fernandez
Vice President at Intellective Bio- Case Studies of Efficient Biologics Process Development, Tech Transfer, and Scale-up: Balancing Speed and Risk
- Panel Discussion and Q&A
Dr. Max Fernandez is a regulatory, quality and compliance professional with over 20 years of experience and global leadership in biologics development, regulatory strategy, CMC, quality and compliance, manufacturing and tech transfer covering preclinical to commercial product lifecycle management.
Dr. Fernandez has been based in California for most of his career, making significant contributions to Baxter’s global efforts in the recombinant and plasma products space, and culminating in the US FDA licensure of VONVENDI, the first and only recombinant protein therapy for von Willebrand disease, in 2015. Before coming to China, he was the Head of Global Regulatory Affairs at Samsung Biologics in Korea, where he helped international and domestic clients obtain more than 100 approvals from major health authorities (US FDA, EMA, PMDA, Health Canada, ANVISA, Cofepris, etc.) for over 40 commercial products in 3 years. This remarkable success rate was enabled by over 20 on-site regulatory inspections with no critical observations. As Vice President of Intellective Bio, Dr. Fernandez is committed to helping one of China’s fastest-growing CDMOs meet global standards and making accessible advanced therapies for all.
Dr. Fernandez received his PhD in Analytical Chemistry from the University of California.
Somasundaram G.
Senior Consultant at Merck Pty LtdSomasundaram G. is a Senior Consultant at Merck Life Sciences‘ Asia Pacific Process Solutions Division based in Singapore. He provides customers with consulting services in training and BioPharmaceutical applications. Previously, Somasundaram headed the Technology Management team for South Asia & Oceania. His team of Technology Managers worked with customers in Product Adoption and trained them in best practices. For the last 19 years, he worked in different capacities within Merck and Millipore. He also worked for a year in QA/QC and another year of academic experience in Microbiology.
He is also an active member of PDA and ISPE, and works closely with these societies‘ Asia Pacific teams.
Somasundaram earned a Post-Graduate Degree in Food & Industrial Microbiology & Business Management.
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
Senior QC Specialist 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).
Ivy Louis
Founder of Vienni Training & Consulting LLPIvy 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 for PDA Inc.
Dr. Priyabrata Pattnaik
Deputy Managing Director of Indian Immunologicals limitedCurrently the Deputy Managing Director of Indian Immunologicals Limited, Dr. Priyabrata Pattnaik has more than 23 years of experience with increasing responsibility dealing with vaccine research & development, biologics operations, global vaccine initiative, applications support, process engineering, and business development.
He is co-author of 90 publications in international journals, eight book chapters and PDA Tech Report 89 on “Strategies for vaccine development life cycle management”.
Dr Pattnaik received a master’s degree in microbiology from Orissa University of Agriculture and Technology, India and PhD in Microbiology from National Dairy Research Institute, India.
Jim Polarine Jr.
Senior Technical Service Manager at Steris CorporationMr. Polarine is a senior technical service manager at STERIS Corporation. He has been with STERIS Corporation for twenty-three years. His current technical focus is microbial control in cleanrooms and other critical environments. Mr. Polarine is a 2019 PDA Michael S. Korczynski Award recipient. He has lectured in North America, Europe, Middle East, Asia, and Latin America on issues related to cleaning and disinfection, microbial control in cleanrooms and validation of disinfectants. Mr. Polarine is a frequent international industry speaker and published several PDA book chapters and articles related to cleaning and disinfection and contamination control. He is active on the PDA’s COVID-19 Task Force. He was a co-author on PDA’s Technical Report #70 on Cleaning and Disinfection and Technical Report #88 on Microbial Deviations. Mr. Polarine is on the PDA Technical Report #88 Planning Committee and TR #88 Workshop Presenter. Mr. Polarine teaches industry regulators as well as the pharmaceutical, biotech, and medical device industries at the PDA and the University of Tennessee. Mr. Polarine currently teaches the cleaning and disinfection course as part of the PDA Aseptic Processing Course, IEST, and at the University of Tennessee Parenteral Medications Course. Mr. Polarine is the current President for the PDA Missouri Valley Chapter and Vice President of Membership for the IEST. He is also a leader on the PDA’s Chapter Council Steering Committee. Mr. Polarine graduated from the University of Illinois with a Master of Arts in Biology. He previously worked as a clinical research manager with the Department of Veterans Affairs in St. Louis, MO and as a biology and microbiology instructor at the University of Illinois. His main hobby is storm chasing and is very active in tornado research and tornado safety.
Micheal Schafferius
Technology Specialist at SARTORIUSMicheal 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.
Yang Si
Head of Drug Product Manufacturing at Wuxi Biologics- Quality, Flexibility, and More: Key Considerations for Outsourced Biopharm Manufacturing
- Panel Discussion and Q&A
Yang Si is head of drug product manufacturing of APAC MFG at WuXi Biologics, responsible for overseeing several sterile drug product facilities and a packaging center. With extensive knowledge in biologics and vaccines production, Yang specializes in sterile process design, technology transfer, validation, quality assurance, GMP pre-licensed/routine compliance inspections, and IND/NDA/BLA filings. Prior to his role at WuXi Biologics, Yang gained valuable experience at world-class facilities in Novartis and GSK. He holds an M.S. degree in Biochemical Engineering from Zhejiang University in China and is a certified PMP® by the American Project Management Institute.
Kim Sobien
Senior Consultant - Microbiology at ValsourceKim Sobien is a Microbiology Senior Consultant with ValSource, Inc. Her pharmaceutical industry career encompasses a breadth of Quality, Compliance, and technical experience with injectable pharmaceutical products, including parenteral pharmaceutical contract manufacturing, pre-filled syringe generics, radiopharmaceuticals, and biologics. Previously she has served as MSAT Contamination Control Lead and a GSK Fellow at GSK, Principal Sterility Assurance Engineer for PETNET Solutions, Associate Director of Regulatory Compliance at Merck, Regulatory Compliance Lead at BD Rx, Inc., and Microbiology Laboratory Manager at Oso BioPharmaceuticals (now Curia).
Kim has a BS in Microbiology from the University of Wisconsin–La Crosse and a Master of Business (MBA) degree with an emphasis in Global Management from the University of Phoenix. She is an active member of the Parenteral Drug Association (PDA), the PDA Southeast Chapter, and a past co-chair of the PDA Annual Global Conference on Pharmaceutical Microbiology.
Andiyanto Sutandar
Consulting Director of NNIT SingaporeAndiyanto Sutandar is a Consulting Director at NNIT. Andi manages the consultancy operations of NNIT in Singapore where the Consulting team of over 40 consultants 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.
Rama Tummala
Principal Quality Audit Manager at GSKPharmacist by education, Rama Tummala has nearly 30 years of pharmaceutical industry experience in Operations, QA, Validations, Technology Transfer, MS&T, Quality and Compliance audits and Greenfield / Brownfield project management.
Rama is currently working with GSK as a Principal Quality Audit Manager operating from Singapore. Rama is conferred with 'GSK Fellow' and is part of GSK Fellowship of Scientific and Technical Excellence. He has previously worked in India with CIPLA LTD., The Himalaya Drug Company and Alcon Labs; in the USA and Singapore with Alcon Labs. He is also currently serving as a PDA Singapore Chapter core board member as Treasurer.