Hue Kwon (Chair)

Dr. Hue Kwon has been advising and consulting internationally as a senior advisor consultant on GxP quality maturity, remediation and digital transformation for various pharma/biotech organizations. She has over 20 years of experience in GxP quality and regulatory strategies from working within the biopharmaceutical industry including being a Vice President for Samsung Bioepis Quality Team providing GxP quality and compliance oversight for the end-to-end drug development and lifecycle and being the Head of Business Management and Head of Quality and Compliance as a member of a senior management team at Roche and Novartis for leading international GxP capability building and interaction with foreign regulatory agencies to influence in the decision making and building consensus.



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.

Javier Camposano, Samsung Biologics

Javier Camposano is Vice President for Operations at Samsung Biologics. He served as the Chief Operations Officer- at Lifera, Saudi Arabia and was also a member of the PDA Board of Directors and past chair of the APAC PDA.

 

Prior to Lifera, Javier was the Head of the Global Drug Product Expansion Division at Celltrion Inc. directing the design and implementation of DP operations in South Korea. He also co-led Celltrion's Drug Product Division for Biosimilar products attaining US FDA and EMA approvals of the first mAbs in 2016 and 2013 respectively. Mr. Camposano started his pharmaceutical career at Baxter working in a variety of Fill and Finish Engineering and Management positions leading Aseptic Filling CAPEXs, technology transfers, commercial development projects and supervising cross functional functions. 


He holds a BS in Mechanical Engineering from the University of California at Davis and an MBA from Pepperdine University - California.

Gabriele Peron, Stevanato

Gabriele earned a Degree in Sociology of Mass Communication in 1997 and is a member of Mass Communication Research Group at University of Padua, and a visiting professor at Media Unit Glasgow in 1999. 

 

Mr. Peron has been in the field of marketing services for 20 years, with experience in web applications and advanced interactive technologies for pharmaceutical companies. 

 

After holding the role of Marketing & Communication Manager for several years, in charge of coordination and execution of all marketing activities, he is currently Senior Marketing Advisor at Stevanato Group. 

 

Mr. Peron is also member of Executive Committee of PDA Italy Chapter (Treasury) and member of the Steering Committees of ICG (International Commission on Glass). 

Ivy Louis, Vienni Training & Consulting

Ivy 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 and holds a position as Member-Board of Directors for PDA Inc.

Seung Hwan Oh, Janssen Vaccines

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 Janssen Vaccines Corp. Incheon and holds a Master's degree in Biochemical Engineering from HanYang University, Seoul, Korea.

Emily Cheah, Charles River Laboratories

A pharmacist by training, Emily is currently the Senior Managing Director | Head of APAC Operations of Charles River Laboratories. She oversees all aspects of Microbial Solutions' various sites in the APAC region with direct responsibility over P&L and technical operations. She serves on various best practices committees within the Company and is involved in the evaluation and implementation of new technologies and services.


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. She also served as the President of the PDA Singapore Chapter from Feb 2022 - Feb 2024. She is also a PDA Scientific Advisory Board member since July 2023.

Paolo Golfetto, Stevanato

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.