Javier Camposano serves as the Vice President - Head of the Global Drug Product Expansion Division at Celltrion Inc. Previously, Mr. Camposano worked for Baxter in a variety of Fill and Finish Engineering and Management positions leading Aseptic Filling CAPEX, technology transfers, commercial development projects and supervising cross functional functions.
After joining Celltrion in 2011 he co-led a new Drug Product Division to fill and finish Biosimilar products. He was responsible for the alignment, development and establishment of Celltrion's DP manufacturing standards, procedures, in compliance to international regulatory requirements.
In 2013 and 2016 Celltrion's first mAb Biosimilar Remsima, was respectively approved by the EMA and the US FDA for commercial market distribution, first in the world. In 2014 Mr. Camposano assumed the leadership of the DP Division becoming responsible for the DP global commercial manufacturing operations. In 2017 Mr. Camposano begun overseeing the expansion of the division into PFS applications including Auto injectors and in December 2018 the GDPE division was created to expand Celltrion's manufacturing operations overseas.
As head of this division Mr. Camposano is responsible for the evaluation and selection of future Celltrion DP manufacturing facilities. Mr. Camposano holds a BS in Mechanical Engineering from the University of California at Davis and a MBA from Pepperdine University - California.
DeokSeok is a QA Lead (NPI and Commercial) at Janssen Vaccines Incheon site. DeokSeok has about 15 years experiences in Quality & Aseptic area and diverse experiences in project which are plant construction project, new-line project and overseas project before joining in J&J. DeokSeok has also diverse inspection experiences including Korean (MFDS), UK (MHRA) and WHO.
Dr. Yoon earned the BS in Food and Biotechnology, MS in Packaging, Ph.D. in packaging and finish Mechnical Engineering master program as a continuing education. He worked at Eli Lilly and Company as a packaging and device development engineer from 2003 to 2016. He developed a product-packaging stability modeling program and used the modeling tool to develop container closure systems for small molecule products. He also applied 1st principles (FEA, heat transfer, tolerance stack-up analysis etc) to develop parenteral CCS and devices (PFS, AI, Pen) at Lilly. He moved his career to AbbVie (Legacy Allergan) in 2016 and he led packaging and device development projects. He has many opportunities working with PDA to publish the mass extraction CCI testing method and develop the PDA technical report 86 "Industry Challenges and Current Technologies for Pharmaceutical Package Integrity Testing" (2021)" as an author. He is leading the device development group in Samsung Bioepis since Aug 2021.
Michael Lopez is currently an independent adviser to PDA Asia Pacific and a former Sr. Vice-President at Medytox Inc., Korea. Michael was responsible for Global projects and strategic leadership of Quality functions and systems, including clinical and commercial manufacturing for US, EU and Asian markets. As a member of the Medytox Executive Team he was actively involved in promoting and providing cGMP and EU GMP training and SME development for his biopharma employees in Korea.
Prior to his 6 years in Korea, Michael was Head of Quality for Merck Group (EMD Serono), Canada. He has 35 years of pharmaceutical quality, sterile manufacturing and product development experience, including leadership roles with Pfizer Canada, GSK, Merck/EMD and Sanofi Pasteur.
Michael is an active member of the PDA in the USA and Canada becoming a member of the PDA Asia-Pacific Steering Committee in Korea in 2021 to help promote the quality mindset and critical thinking approach as important enablers to manufacturing excellence and business success in biopharma.
Michael has his science degree (Biochemistry) from the U. of Toronto and his business degree from Western University, Canada. Michael is pleased to be with the PDA in Korea, to share his passion for biopharma quality and manufacturing, and to use his passion for leadership and coaching to contribute to the growth and development of the industry in Asia, to achieve long-term excellence in global markets, with focus on USA and EU markets.
Degree in Sociology of Mass Communication in 1997 and member of Mass Communication Research Group at University of Padua, 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).
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.
Geoffrey Sortais has over twenty years of experience working with the equipment manufacturing industry serving the pharmaceutical, biotech, and medical device markets. He is based in China since 2009. Geoffrey is currently Sales Director at IMA Life Freeze Drying division, in charge of the Asia Pacific region.
Prior to joining IMA, Geoffrey started his career in Europe, where he worked for different equipment suppliers specialized in process technology and manufacturing processes of sterile products.
He has recently joined the Korea PDA committee.
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 for PDA Inc.
Dr. Hue Kwon has been serving as a Vice President and Quality Team Leader at Samsung Bioepis since April 2020. She leads a global quality team providing GxP quality and compliance oversight for the end -to-end drug development and lifecycle.
Prior to joining Samsung Bioepis, she served as 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.