연사 ⇽ PDA Aseptic Processing of Biopharmaceuticals Conference 2024 |Parenteral Drug Association EventBank

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James Agalloco

President, Agalloco & Associates

James Agalloco is President of Agalloco & Associates, a technical service firm to the pharmaceutical and biotechnology industry. Since the formation of Agalloco & Associates in 1991, Jim has assisted more than 200 health care firms in a wide range of validation, automation, and compliance areas. Jim has 50+ years of industry experience and has worked in organic synthesis, pharmaceutical formulation, pharmaceutical production, project and process engineering, validation, and process automation during his career at Merck, Pfizer, Squibb, and Bristol-Myers Squibb. He received his BS in Chemical Engineering from Pratt Institute in 1968 and his MS, also in Chemical Engineering from Polytechnic Institute of New York in 1979. He received his MBA in Pharmaceutical Studies from Fairleigh Dickinson University in 1983. He is a past President of the Parenteral Drug Association and served as an Officer or Director from 1982 to 1993. He was a member of USP’s Microbiology Expert Committee from 2005-2022. Jim serves on the scientific advisory boards of MEDInstill and Eniware. He is a frequent author and lecturer on the subjects of sterilization, aseptic processing, and process validation.

Brooke Higgins

Branch Chief, CDER Office of Compliance / Office of Manufacturing Quality, US FDA

Brooke K. Higgins is the Branch Chief CDER Office of Compliance / Office of Manufacturing Quality at US FDA. In this role, Ms. Higgins oversees the review of domestic and international pharmaceutical cases and handling of associated regulatory actions. Ms. Higgins has also served as an expert witness on CGMP violations in federal court. Prior to joining CDER in 2014, she spent 12 years with the Office of Regulatory Affairs, first as an Investigator and later as a Pre-Approval Manager, both for the Baltimore District. While working as the Pre-Approval Manager, Ms. Higgins continued performing drug manufacturing inspections, both domestically and internationally, became a member of the Pharmaceutical Inspectorate in 2009, and was a Level II drug certification auditor. Ms. Higgins received a M.S. in Food Science, focusing on food microbiology, and a B.S. in Biology from Virginia Tech.

Kir Henrici

Chief Executive Officer, The Henrici Group

Kir Henrici has extensive industry experience serving as a quality and compliance consultant in the areas of Data Governance, Data Integrity and Data Management. She has led global and site level data governance programs to include developing Data Governance plans, policies, and procedures, and executing Data Integrity risk assessments and remediations. Kir has special interest in enabling business-wide data governance as a critical enabler to the successful adoption of advanced digital technologies to drive quality management, business excellence, and innovation.

Won Min Kim

Assistant Manager, Bio-Process Team, GC Biopharma

Won Min Kim is the Leader for GC Biopharma’s Drug Product 2 team, manufacturing department which specified for Visual inspection (AVI, MVI) process and packaging process.

In his current role, he is responsible for establishing and maintaining AVI & MVI data such as AVI validation & MVI Qualification. He is also responsible for Vial packaging machine (1 Multi-packaging line & 1 Single Packaging Line). He set up new vial auto inspection machine from Koerber and entire manual inspection procedure and executed entire whole Validation not only initial validation but also regular validation or additional validation after change control.

He joined the company in 2022 as an experenced AVI engineer from Celltrion Pharm, in charge of maintaining the hardware and software of the company’s equipment. In Celltrion Pharm, he was mainly responsible for establishing & maintaining Syringe Auto inspection machine. He was also responsible for establishing & executing validation for part washer & auto-clave & Laminar flow hood.

Juhong Liu

President, GlobalSubmissions Consulting, LLC

Dr. Juhong Liu received his Ph.D. in Biochemistry and Molecular Biology in 1995 and trained as a cancer biologist at the US National Cancer Institute. He joined the US FDA, Office of Biotechnology Products (OBP) in 2008. Serving as CMC reviewer, Team Leader, and Review Chief, he managed CMC reviews of over 50 licensed biologics and over 300 biologics under IND. In 2018, Dr. Liu funded GlobalSubmissions Consulting firm. He focused on helping biotechnology companies to bring their products to global market. He successfully advanced Evive biotechnology’s Ryzneuta to obtain FDA, EMA, and NMPA approval in 2023.

Ditte Kivsmose Kaldor

Quality Director, PS Aseptic Manufacturing QA, Novo Nordisk

As a leader in Novo Nordisk, I am passionate about collaboration towards good solutions for employees and for the business. We ensure that people who rely on our products can feel safe – by making decisions based on regulatory requirements, business needs and patient safety. We work for a future where the lives of people with chronic diseases are not limited by their condition.

With over 20 years of experience in the industry, I have a broad understanding of the requirements for production of aseptic drug product and active pharmaceutical ingredients, produced in a controlled and classified area. I have experience from different roles in production, quality assurance (QA) and manufacturing science and technology (MSAT). My background is environmental and analytical chemistry.

Hue Kwon

Member, RAQAB, Parenteral Drug Association

Dr. Hue Kwon served leads a global quality team providing GxP quality and compliance oversight for the end -to-end drug development and lifecycle.

Hue was the former Vice President and Quality Team Leader at Samsung Bioepis, and prior to joining Samsung Bioepis, she was the Head of Business Management and Head of Quality and Compliance in Roche, as a member of a senior management team and leading international GxP capability building and interaction with foreign regulatory agencies to influence in the decision making and building consensus.

She also served as a senior advisor consultant in regulatory strategies for multiple organizations and global matrix environment and for digital health strategy, global IT and global operational alignment project in drug development.

Until December 2010, she served at US FDA for about 9 years on the development of regulatory guidance, emerging regulatory strategy and review and data integrity inspections.

Emily Cheah

Senior Managing Director, 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.

Hannah Lee

Site Process Owner Of Data Integrity, Johnson and Johnson

Hannah Lee is the site process owner of data integrity at a manufacturing site, J&J Innovative Medicine since 2023. Experienced in document and training management systems for 3 years. Supported supplier qualification and internal audits for a while. Spent 4 years at a GMP consulting firm and 1.5 years in cosmetics, OTC and quasi-drugs quality at Kenvue (formally J&J Consumer Health).

Sebastian Scheler

Managing Director, Innerspace GmbH

Sebastian is passionate about pushing the boundaries of advanced risk assessment technologies and Virtual Reality (VR) to unlock new possibilities for managing risks in highly critical environments. He spearheads a dynamic team of visionary professionals, driving the development of high-end Virtual Reality simulators and advanced risk assessment methodologies. The core focus of his professional work lies in Frame-by-Frame Risk Profiling—an innovative, automated approach to risk assessment. This cutting-edge technology facilitates process improvement, process automation, autogenerated SOPs, and immersive training curricula, empowering organizations to achieve unparalleled levels of efficiency, compliance and safety in drug manufacturing. With a profound background in psychology, he has always been captivated by the intersection of human behavior and technology. His passion for Virtual Reality has culminated in pioneering VR simulator methodologies that push the boundaries of experiential learning, training, and behavior measurement systems.

Michael de la Torre

CEO, Redica Systems

Michael, the founder and CEO of Redica Systems, is a data analyst at heart. Michael is leading the way in applying advanced analytics and AI to regulatory and vendor intelligence. He began his career at McKinsey & Company, and has held executive roles in Product Management, Marketing, and Business Development. Michael received his Bachelors in International Finance from Texas A&M University and his MBA from University of Chicago Booth School of Business.

Niraj Mehta

Executive Director and Global Quality Lead, Strategic Programs and Regulatory Intelligence, MSD

Steve Langille

Senior Microbiology Consultant, Valsource

Dr. Stephen Langille is a Senior Microbiology Consultant at ValSource, Inc. He specializes in microbiological and particulate matter contamination control of drug, device, and biological products. He holds a BS degree in Biology from the University of Massachusetts and a PhDin Microbiology from the University of Maryland. Prior to joining ValSource in 2019, he spent 19 years with the FDA as a Microbiology Reviewer, Branch Chief, and Director of the Division of Microbiology Assessment in the Center for Drug Evaluation and Research. He currently serves as a member of the United States Pharmacopoeia’s Visual Inspection Expert Panel and serves on several PDA task forces related to microbiological product quality.

Taehoon Kim

Manufacturing Process Specialist in Operations, Johnson & Johnson

Taehoon has been with Johnson & Johnson Innovative Medicine and excels in aseptic manufacturing process. As a manufacturing process specialist in operations, he participates in aseptic operations as a filling operator, played a key role in newly establishing the RABs setup/intervention procedure, and contributes to the site's sterility assurance team to achieve a high level of contamination control.

Haneul Jie

Subject Matter Expert of Lab Equipment Lifecycle Management, Johnson & Johnson

Haneul is the subject matter expert of Lab Equipment Lifecycle Management including Analytical Instrument Qualification at J&J Innovative Medicine. In addition to the execution of qualification and CSV of lab instruments, she has led multiple cross-functional projects with focuses on introducing new technologies and digitalization solutions to the QC laboratory, contributing to achieving the highest level of data integrity and risk control.

Enrico Barichello

Product Manager, Stevanato Group

With a background in Industrial Engineering and a Master’s in Management at the University of Padua, Enrico Barichello acquired broad-spectrum skills in technical concepts and complex processes. He joined Stevanato Group in 2017 as a Product Management Specialist for syringe platform. He defined and coordinated all the activities required to bring the products to market, bridging gaps between different company functions and aligning the involved teams. From January 2021, he is the product owner, responsible for the roadmap and execution of the new innovative platform SG Alba®.

Jaehee Kim

Engineer in Manufacturing Science and Technology, Johnson & Johnson

Jaehee has been with Johnson & Johnson Innovative Medicine and has expertise in aseptic process simulation. As an engineer in Manufacturing Science and Technology, she led initial validation of aseptic process, participated in risk assessment of the filling process, and contributed to the development of technical solutions to achieve a higher level of controls in aseptic processing as part of mitigation efforts to obtain FDA approval.

Javier Camposano

Vice President of Drug Product Operations, Samsung Biologics

Javier is the Vice President of Drug Product Operations at Samsung Biologics (SBL). In this capacity, Javier oversees day-to-day fill finish and packaging operations while defining strategies to proactively identify issues and propose solutions to ensure efficient operations. Prior to SBL, Javier worked in Saudi Arabia as the COO for Lifera, a PIF owned company. Before Lifera, he worked for Celltrion Inc. in South Korea for over 12 years in multiple Drug Product manufacturing roles ending his tenure as the Head of the DP Global expansion. Prior to moving to South Korea, Javier worked for Baxter USA in the Bioscience division. He holds a BS in Mechanical engineering from UC Davis and a MBA from Pepperdine University.

Hilary Chan

Global Sterility Assurance and Microbiology Lead, Takeda

Hilary Chan is a Global Sterility Assurance and Microbiology Lead at Takeda where she is responsible for leading various technical improvement initiatives related to microbiological issues/contamination control for Takeda’s global manufacturing operations. She is a global business process owner and community of practice network lead for microbiology and contamination control related topics. She is an invited speaker at industry conferences, has authored various scientific publications, and is active in industry collaborations. Hilary has 24 years of experience in the industry and holds a Bachelor’s degree in Zoology from Colorado State University and a Master’s degree in Biomedical Science from Northeastern University.

Paolo Golfetto

Director of Business Development, Drug Delivery Systems, Stevanato Group

Paolo Golfetto is the Director of Business Development for Drug Delivery Systems and CDMO since 2016. In this position, he leads the development and execution of the business strategy and plan in the fields of pen and auto injectors, large dose wearables and respiratory drug delivery systems. While managing the external technical communication, dissemination and promotion of the global Drug Delivery Product platforms, services and solutions, he also supports the projects acquisition and the transfer to the internal development structures of the Group.

Before taking this position, since 2006 Paolo Golfetto has been leading the Product Design and Development, including the technical support to the Group's biopharmaceutical clients, coordinating experts in glass technology, process engineers and designers. Member of PDA, Mr. Golfetto provides presentations and lectures widely in the healthcare industry Organizations and Associations; furthermore, he is the author of some papers for important magazines in the field.

Formerly Mr. Golfetto was the R&D Manager of the Appliances Engineering Team within a well known worldwide manufacturer of Household Appliances. During his latest 5 years in this position, he was in charge of the harmonization team, made of local engineers and designers, responsible of moving the Company's production plants to Guangdong area, China. Mr. Golfetto contributed to the development of European Norms and Regulations focused on users safety and environmental friendly consumer products.

Alan Hoffmeister

Senior Global Scientific Portfolio Specialist, Charles River Laboratories

Alan Hoffmeister is the Senior Global Scientific Portfolio Specialist for Charles River, Microbial Solutions Division, specialising in the Bacterial Endotoxins Test. Alan’s experience with the Bacterial Endotoxins Test (BET) dates to 1988, since when he has been actively involved in all aspects of the assay. Alan has directed workshops and training courses and lectured internationally on a variety of BET topics including, amongst others, LAL Methodologies, Product Validations, Interference Matrices, Data Integrity and BET Regulatory Affairs. He has also contributed to the development of BET protocols, technical guides and fact sheets internally as well as for clients and industry organisations.

Songback Hong

Operations Director, Körber Korea

Product Demo by Körber: Innovation in BioPharma Data Analysis: Accelerate Insights with PAS-X Savvy

Songback is the Operations Director at Körber Korea, where he excels in project management for MES, L2 integration, and the digital transformation of business processes within the biopharmaceutical sector. Leveraging his industrial engineering background, Songback has been instrumental in streamlining operations and driving innovation. Also with a deep understanding of MES and L2 integration, Songback is a sought-after expert in optimizing manufacturing processes.
He is currently at the forefront of promoting Pharma 4.0 initiatives in Korea.

Chris Hurlstone

Director of Drug Delivery, Team Consulting

Chris is Director of Drug Delivery at Team and has a 30-year track record in the design, development and industrialisation of medical devices, primarily drug delivery systems. He has worked across all stages of product life cycle, from direction setting and requirements capture to industrialisation and post launch support, supporting companies ranging from small start-ups to large multi-national organisations. As part of multi-disciplinary teams he has delivered full developments of innovative, robust, commercially viable device technologies whilst also working on stand alone programmes such as technical due diligence and production trouble-shooting. Chris regularly presents at international industry conferences and is a member of ISO committee TC84 which develops new standards and guidance for drug delivery devices.

Sunhye Hwang

Senior Scientist, Microbiology Team, Samsung Biologics

Sunhye has been with Samsung Biologics QC Microbiology team, and is subject expert in micro testing and technical transfer. She led the project to implement the Growth Direct (GD) System, which is a rapid Micro system automation platform for faster results of environmental monitoring (EM) data, bringing Samsung Biologics into the forefront of advance technology.

Seulgi Kim

Team Leader of QC Microbiology, Samsung Biologics

Seulgi Kim is team leader of QC microbiology team at Samsung Biologics (SBL), where she has joined since2011. With over 15 years of experience, she has extensive Microbiology, Environmental Monitoring(EM), Quality system and Quality Control expertise within Biopharmaceuticals. She has served as lead Subject Matter Expert for QC during regulatory inspections and has contributed to cross functional projects and initiatives, playing a key role in QC decision making processes in the area of Microbiology.

Nagisa Kobashi

Product Manager of Global Emerging Technologies and Digital Health, SHL MEDICAL

Product Demo by SHL Medical: Elexy™: SHL Medical's Drug-agnostic Electromechanical device Platform Designed to Facilitate the flexible development of Combination Products

Nagisa Kobashi joined SHL Medical as a Product Manager of Global Emerging Technologies and Digital Health, working cross-functionally with the global emerging technologies and digital health teams, as well as with the global product management team. In this role, Ms. Kobashi leads product strategy for SHL Medical’s emerging technologies and digital health solutions, and oversees leading customer projects based on the company’s emerging technologies and digital health platforms. She has a master’s degree in Human Movement Sciences from the ETH (Zurich, Switzerland) as well as a Swiss Federal Diploma as a marketing expert.

Seung Hwan Oh

Site Quality Head, Johnson & Johnson

SeungHwan Oh is a highly accomplished professional with 21+ years of experience in biopharmaceutical/vaccines parenteral products. He has extensive knowledge and experience in process development, equipment qualification, quality management, process validation, lean manufacturing, process quality improvement, technology transfer, life cycle management, and project management. SeungHwan has demonstrated highly sophisticated project management skills and strategies through multiple successful projects. He is experienced in diverse multicultural working environments in Netherlands and Vietnam. SeungHwan is currently the Site Quality Head at Johnson & Johnson. Incheon and holds a Master's degree in Biochemical Engineering from HanYang University, Seoul, Korea.

Michael Robert Shanks

Principal Consultant, Roan Mountain Biologics Consulting, LLC

Michael Shanks has had a dynamic professional career as an Immunology and Cell Biology Researcher at Johns Hopkins University, and a Process Development, Assay Development and Technology Transfer Scientist in the biotech industry, and finally as a Biologic Drug Application CMC Reviewer/Inspector at the U.S. Food and Drug Administration. During his 13 years at Johns Hopkins he developed a new polarized hepatoma cell line that has been used in research for now over 25 years for polarized vesicular transport, and published numerous papers. In the fifteen years of industry experience he worked in downstream purification, assay development and technology transfer for both cGLP and cGMP environments, was involved in the successful development and scale-up of a live oncolytic virus manufacturing process, as well as other protein drug products. His experience in industry included product characterization and assay development, a technology transfer liaison for R&D, manufacturing, facilities, quality control and quality assurance groups during several phase I/II clinical studies, as well as being involved with new technology development, such as sterile chromatography and drug product filling using pre-stoppered sterile vials. Over the past eleven years at the U.S. Food and Drug Administration, he has been involved with the BLA CMC review for the microbiology, facilities and equipment sections, inspectional compliance reviews, training, and has conducted approximately 80 biologic inspections. He has just recently retired from the U.S. F.D.A and has started working as a principal consultant at Roan Mountain Biologics Consulting in support of Biologic License Application CMC sections and their associated inspections.

Wendy Tan

Senior Consultant - Microbiology, ValSource, Inc.

Dr. Wendy Tan is a Senior Consultant - Microbiology at Valsource Inc. Dr. Tan has over 13 years working experience at FDA. Here regulatory experience at the Division of Biotechnology Manufacturing, Office of Pharmaceutical Manufacturing Assessment in CDER includes conducting pre-license and pre-approval facility inspections and performed product quality microbiology reviews of BLA, NDA, and ANDA. She aims to help industry meets or exceeds regulatory compliance requirements with her extensive knowledge in microbiological contamination control, aseptic techniques, and regulatory strategy.

Dr, Tan receives her BSc and PhD in Biological Sciences from Western Michigan University, USA.

연사

James Agalloco

Brooke Higgins

Kir Henrici

Won Min Kim

Juhong Liu

Ditte Kivsmose Kaldor

Hue Kwon

Emily Cheah

Hannah Lee

Sebastian Scheler

Michael de la Torre

Niraj Mehta

Steve Langille

Taehoon Kim

Haneul Jie

Enrico Barichello

Jaehee Kim

Javier Camposano

Hilary Chan

Paolo Golfetto

Alan Hoffmeister

Songback Hong

Chris Hurlstone

Sunhye Hwang

Seulgi Kim

Nagisa Kobashi

Seung Hwan Oh

Michael Robert Shanks

Wendy Tan

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