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Lisa Bennett (Moderator)
Senior Quality & Compliance Specialist at Cell Therapies
Subrata Chakraborty
Principal Advisor at GxPFONT Consulting GroupSubrata Chakraborty is a Pharmaceutical professional having over 24yrs of experience handling Manufacturing operations, Quality assurance, Validations, cGMP-compliance, Training and Project management.
Apart from being an SME of Aseptic Processing and Validations, Subrata played important roles in people and organization development in his past industry tenures, which included over ten years of senior leadership roles in global MNCs like Cipla, Pfizer, Novartis and Fresenius-Kabi.
Subrata is currently leading GxPFONT Consulting group, a global Pharma Consulting and Technology solutions company, as Principal Advisor.
Francesco Cicirello
Associate Director, Quality Assurance of Adaptimmune- An Innovative & Pragmatic Regulatory Approach to the Classification and Management of ATMP Materials
Francesco Cicirello is Associate Director Quality Assurance (Site Quality Head) at Adaptimmune in the United Kingdom. Before joining Adaptimmune, Francesco worked in a Regulatory Agency. He was an Expert Inspector at the Therapeutic Good Administration (TGA) in Australia. He was elected to several roles in PIC/S including Chairperson of the Working Group revising the PIC/s Annex 2 and Deputy Chair of the Subcommittee on Harmonisation. Francesco represented PIC/S at the EMA IWG and was member of the PIC/S Coordinating Committee on the Human Blood, Tissues, Cells & ATMPs.
Rukman S. De Silva
Chemist/Product Quality Reviewer, Division of Biotechnology Review and Research IV, OBP, OPQ, CDER at U.S. FDARukman De Silva, Ph.D. is currently working as a Chemist/Product Quality Reviewer in FDA/CDER/OBP/Division of Biotechnology Review and Research IV. In 2007, Rukman De Silva received his PhD in Chemistry from Dartmouth College, NH, specializing in protein chemistry. After a short postdoctoral fellowship at Dartmouth College, in 2008 he joined FDA as a Staff Fellow in Dr. Gibbes Johnson’s lab. In addition to review, inspection, training and policy activities, he conducts research on studying the structure-function relationship of ErbB2 receptor at FDA.
He is the co-organizer for the FDA Protein Aggregates Interest Group. He has received several awards including FDA/CDER team excellence awards in 2015 and 2019. He has been an invited speaker in multiple conferences in the area of visible and subvisible particulates testing in past few years. He has published in peer reviewed journals on the subject of subvisible particulate testing in biotherapeutics. Dr. De Silva also serves as a Journal of Pharmaceutical Sciences Editorial Advisory Board Member since 2018.
Massimo Frasson
General Manager at BREVETTI C.E.A. S.p.A.After achieving a Master’s Degree in Mechanical Engineering, Mr. Frasson worked for several international companies in the automation industry. He joined Brevetti C.E.A. in the year 2000 as Mechanic Systems Design Manager. From 2004 he undertook the technical management of the company and later on in 2007 he began the restructuring of Brevetti C.E.A.’s production and the expansion of the entire range of products by introducing new vision’s technologies. In the same period, he was coordinating and supervising a special department dedicated to the pharmaceutical process analysis through the development of artificial vision systems using also neural algorithms. On 2010 he became responsible of the whole operations process and in February 2014 he has been appointed as the General Manager of Brevetti C.E.A. Company.
Karen Ginsbury
Owner at PCI Pharmaceutical Consulting IsraelKaren Ginsbury is a pharmaceutical consultant. A UK trained pharmacist with an MSc in Microbiology both from the University of London, Karen has more than 30 years of experience in setting up, maintaining and rehabilitating pharmaceutical quality systems. Karen has been a PDA member for more than 30 years and has served several terms on the Regulatory Affairs and Quality Advisory Board (RAQAB) as well as co-founding and chairing the Outsourced Operations and Pharmacopoeial Interest Groups.
Marc Glogovsky
Senior Microbiology Consultant at ValSource, Inc.Marc Glogovsky, MS, S.M. (NRCM) has over 20 years’ experience in the pharmaceutical industry, specializing in aseptic operations, contamination control, and risk-based environmental monitoring. He has written a number of publications involving rapid microbiology, environmental monitoring, Mycoplasma and MALDI-TOF microbial identification. Currently, he is a Senior Microbiology Consultant with ValSource, Inc. Prior to joining ValSource, he was responsible for managing the Environmental Monitoring Control division at Veltek Associates, Inc., and more than 10 years as a senior microbiology specialist at Merck KGaA. Marc earned his B.S. in Biology from Monmouth University and his M.S. in Microbiology from Rutgers University.
Marc is actively involved with Parenteral Drug Association, where he serves on PDA’s Science Advisory Board, Education Advisory Board, chairs the Microbiology/EM Interest Group, is a faculty member at PDA-TRI and has contributed to a number of technical report committees and is currently co-chairing the Microbial Data Deviation technical report and a revision of the Environmental Monitoring (TR13) technical report.
Brian Hawkins
Chief Technology Officer at Pluristyx, Inc.Dr. Brian Hawkins is Chief Technology Officer at Pluristyx, Inc., an advanced therapy tools company providing seamless client support to cell therapy groups through CMC consulting, contract development services, and research- and clinical-grade Ready-To-Differentiate (RTD™) Pluripotent Stem and Ready-to-Use (RTU™) Differentiated Cells. Dr. Hawkins received his Ph.D. in Molecular Cell Biology and Biotechnology from Virginia Tech and completed his postdoctoral training at the University of Pennsylvania, after which he moved to the University of Washington School of Medicine to serve as an assistant professor and founding member of the Mitochondria and Metabolism Center. Dr. Hawkins transitioned to industry and served as Scientific Applications Director at BioLife Solutions, where he aided numerous commercial groups optimize their cryopreservation protocols for their cell therapy products. Dr. Hawkins joined Pluristyx in 2019 and continues to provide cryopreservation expertise through both consulting and wet-bench contract development services. Dr. Hawkins is an internationally recognized cryopreservation expert and conference speaker on cell biopreservation and cell therapy manufacturing and scale-up. Dr. Hawkins is an active member of the PDA, where he serves as President of the Pacific Northwest Chapter, team leader for the PDA Cryopreservation Standards Initiative and as member Biopharmaceutical and Advanced Therapy Medicinal Product Advisory Boards.
Stephan Krause
Director of Product Quality at AstraZenecaStephan Krause is a results-driven leader with technical, managerial, and executive experiences. Proven background in directing quality and technical functions within global operations. Experienced as a key team member in the Biologics Development and Supply Quality Leadership Team. Accomplished leader of industry quality-focused task forces to improve and standardize best practices. Breadth of exposure to various product types, including mAbs, ADCs, Coagulation Factors, ATMPs, Small Molecules, Biosimilars.
Andrew C. Lennard
Reg CMC at AmgenAndrew Lennard is in the global regulatory affairs CMC team at Amgen, based in Uxbridge (UK). Within CMC regulatory affairs, he is part of the External Engagement and Advocacy team with responsibilities in advancing approaches to accelerate CMC in product development. Andrew has over 15 years’ experience in marketing applications, clinical trials and variations/amendments for both biologic, synthetic molecules and drug/device combination products, with a special interest in control strategy and integral drug-device combination products. Andrew participated at the EMA workshops on Prior Knowledge and CMC acceleration in Breakthrough/PRIME. He is also an active member of EFPIA leading several initiatives relating to CMC acceleration, including Risk-based Predictive Stability approaches for biologics. Prior to Amgen, Andrew trained in Regulatory Affairs at ERA Consulting and previously held Principal Scientist positions in drug discovery for Pharma and Biotech spanning 12 years of ‘bench science’; and post-doctoral positions in molecular biology for LGME, INSERM (Strasbourg) and Cancer Research UK (London). Andrew is an active member of EFPIA-MQEG CMC and Biomanufacturing Workstreams and holds a PhD in biochemistry from the University of Cambridge.
Gerry McKiernan (Moderator)
Director of Quality at Cell Therapies- Advancing Cell and Gene Therapies in the New Normal
- Tools and Methods to Enable Regulatory Excellence
Gerry McKiernan is the Director of Quality covering activities of Cell Therapies Pty Ltd and its affiliated units at the Peter MacCallum Cancer Centre. Gerry has 20 years’ experience in various Quality roles in research and development and cGMP manufacturing in Europe, Asia and Australia.
Gerry’s career has included biotechnology, pharmaceutical and medical device industries, where he was overseeing quality systems for product development, clinical trials, validation and contract commercial manufacturing. He has led large Quality Management System implementation projects for cell therapy manufacturing in China and Japan and was the project lead for the TGA generic clinical trials and commercial GMP manufacturing licences for Cell Therapies Pty Ltd.
Robert J. Miller
Director Sterile Injectables Technology of Pfizer IncRob Miller has been with Pfizer Global Technology and Engineering, Sterile Inectables Technology as a subject matter expert and group leader in visual inspection since 2019. Prior to this he worked within Pfizer Global Quality supporting the sterile injectables network and responsible for internal policy associated with visual inspection. Prior to this role he worked as an automation/controls engineer and inspection process engineer for 22 years. He is responsible for supporting Pfizer’s aseptic network with internal guidance and policy related to manual and automated visual inspection. In addition, he reviews site inspection processes for compliance and directs strategic initiatives to the Pfizer network. Rob has a B.S. in Electrical Engineering, an M.S. in Engineering Management and a Graduate Certificate in Applied Statistics.
David Sattlegger
Research Engineer at MVTec Software GmbHDavid Sattlegger studied physics and mathematics at the Technical University of Munich. He obtained his doctorate in mathematics in 2015 for his work on numerical quantum dynamics. Since then, he has been working as research engineer at MVTec Software GmbH where his primary field of research is deep learning and artificial intelligence. His current focus lies on the development of unsupervised anomaly detection and segmentation methods for natural images and their application to industrial manufacturing processes. His research is published in computer vision conference proceedings and journals, and several of the resulting algorithms are already in use in industrial applications.
Michael Schafferius (Moderator)
Application Specialist at SartoriusMicheal Schafferius currently holds the position of Application Specialist for Separation Technologies and Quality management at Australia, working for Sartorius for the past 9 years. Micheal has worked in the pharmaceutical and biopharmaceutical industries for more than 19 years. His experience includes roles focused on Filtration, Purification technologies, Single Use Technologies, Quality Assurance, Validation and Sterile Manufacturing with local and international companies. Micheal is the current president elect for the PDA Australia chapter.
Christian Scherer
Executive Vice President Sales at Körber Pharma InspectionBorn 1984 in Germany, technical apprenticeship at Seidenader Maschinenbau GmbH (2001 - 2004). Visited University of Supplied Science in Munich from 2005. Graduated in 2009 as Dipl.-Ing. (Business and Engineering). Spending one semester in Seidenader's subsidiary "SV Research - Harrisburg/USA" and at the University of Plymouth / England. September 2009 – Mai 2015: Area Sales Manager at Seidenader Maschinenbau GmbH in Markt Schwaben, Business Unit Inspection Machines. Area responsibilities: 2009-2014: India 2011-2014: plus France Since 2011: plus USA, Canada 2014-2015: plus South & Latin America May 2015: Head of Sales with responsibility for global sales of the Seidenader Business Unit Inspection Machines. Since September 2020: Executive Vice President Sales Responsible for global sales of the Körber Business Area Pharma Inspection.
John Shabushnig
Principal Consultant at Insight Pharma Consulting LLCJohn is the founder of Insight Pharma Consulting and is an expert in visual inspection. He has extensive industry experience including Sr. Manager/Team Leader for microbiology and aseptic support in Pfizer’s Global Quality Operations. He began his career as a Research Scientist with The Upjohn Company responsible for Process Analytical Technology and visual inspection. He served as the Director of Technical Support and Engineering for Pharmacia and later served as the Business Unit Director of the Center for Advanced Sterile Technology.
John holds a B.S. in Chemistry from Carroll College and a Ph.D. in Analytical Chemistry from Indiana University. He is an active member of the PDA, having served as the Chair of the Board of Directors and as the Chair of the Science Advisory Board. He organized and leads the Visual Inspection Interest Group. He is also an instructor at PDA's Training and Research Institute. John serves on the USP Dosage Forms Expert Committee and chairs the Visual Inspection of Parenterals Expert Panel. He presents and publishes frequently in the fields of spectroscopic analysis, process analytical technology, rapid microbiological test methods and visual inspection. He is a co-author of the recently published book Visual Inspection and Particulate Control.
Christopher J. Smalley
Compounding Pharmacist Advisor at Valsource IncChris Smalley has retired from Merck, where he had responsibility for innovative implementation and validation, including Single Use Systems and Isolators globally. He now is a consultant for Valsource, focused primarily on Compounding Pharmacies. Previously, he had been Director of Quality Operations for Wyeth Pharmaceuticals for 12 years with responsibility for setting validation standards and validation activities globally. His research experience includes responsibility for Quality in the U.S. operations of the Sanofi Research Division, and earlier he had worked for the Johnson & Johnson family of companies, where he was a Plant Manager.
Chris retired after 21 years of service as a LtCol in the USAF. Chris practiced as a compounding pharmacist across the military hospital system, compounding intravenous solutions and total parenteral nutrition products. Chris is a graduate of the Philadelphia College of Pharmacy. His graduate education includes a MBA from TU Fox School of Business, a Masters of Science in Pharmaceutical Chemistry from TU School of Pharmacy, and a PhD in Healthcare Administration from LaSalle University.
Chris has been a member of the PDA Board of Directors, the PDA Science Advisory Board, and is a member of the ISPE Disposables CoP Steering Committee and the Pharmaceutical Engineering Committee.
Kevin Smyth
Global Director Process Technology, Global Strategy and Technology Group of IPSKevin Smyth is a chartered biochemical engineer with over 30 years’ global experience in the design of biopharmaceutical manufacturing facilities. He has led multiple large molecule biologics, vaccines, and sterile fill-finish projects, from the development of project scope, front-end planning, feasibility studies to detailed design. Kevin has extensive biopharmaceutical process design experience, including facility scoping, layout development, regulatory compliance, high containment of toxins and potent biologics , technology evaluation, safety reviews (Hazops/FMEAs), PFD/P&ID design and equipment selection. Kevin is an active committee member of the PDA and ISPE Ireland Committees and has regularly chaired, presented at and organised technical seminars in Ireland/Europe for these organisations. Kevin possesses excellent technical knowledge and has a passion for innovation in design.
Romain Veillon
Senior Manager, Visual Inspection at GSK VaccinesRomain Veillon is Senior Manager Visual Inspection & Leak Testing at GSK Vaccines, in Global MSAT Manufacturing Technologies. As global expert he is leading Visual Inspection performance and expertise network on multiple sites. He now focuses on Quality Integration Lead, New Technology Development, Validation Strategy, Capability assessment, Asset Management programs, Technical Watch, Performance Improvement and Develop Equipment strategy within network. He manages a network of vision experts to develop visual Inspection expertise within GSK Vaccines. Romain is now focusing in machine learning and innovation management with new AVI-LT asset deployment. Last past 22 years he has worked in parenteral manufacturing, he has gained experience at Sanofi Pasteur, Eli Lilly and GSK Vaccines, in support to production and secondary operations projects for filling and freeze-drying. He also developed innovative vision systems with some academic collaborations and regular presentation to PDA conferences. In 2017, romain developed a PDA course "Mastering AVI". Since 2018 Romain is Interest Group Leader for Visual Inspection in PDA Europe. Since 2019, Romain co lead task force to prepare a point to consider document for AI applied to Visual Inspection. In 2020 Romain received PDA James P. Agalloco Award for educational training.