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.
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.
Javier Camposano serves as the Chief Operations Officer- at Lifera, Saudi Arabia and is also a member of the PDA Board of Directors and past chair of the APAC PDA. As COO, Javier is tasked with executing Lifera's overall vision to become the leading Biopharmaceutical company in the MENA region by implementing strategies to develop the local pharma sector and building state-of-the-art manufacturing facilities to supply lifesaving medicinal products to patients in need.
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 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).
DeokSeok is a Head of QA (NPI and Commercial) at Janssen Vaccines Incheon site and responsible for overall New Product Introduction (NPI) and commercial product manufacturing. His background comes from more than 17 years of industry experience in GMP manufacturing, MSAT and Quality. DeokSeok has served as a SME in aseptic area for many years and has a diverse experience in project management which includes plant construction, new-line project, NPI, and tech transfer activities. DeokSeok also has extensive regulatory inspection experience including recent successful US FDA inspection as well as UK (MHRA), EU, WHO, and MFDS inspections. DeokSeok holds a Bachelor's degree in Biological Science from Seoul National University and member of local & global communities (VP of PDA Korea chapter). DeokSeok is also involved in many pharmaceutical training program (K-NIBRT).
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.
Michael Lopez is currently the President and CEO of HSL BioTechnologies. Prior to this, he was a Senior Vice-President at Medytox Inc., Korea where he 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.
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.