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 manager of aseptic & sterilization team in Technical Operations department at Janssen Vaccines Incheon site and is responsible for aseptic processing and New Product Introduction supporting. DeokSeok has about 15 years experience 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.
DeokSeok has been a PDA member since 2007.
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).
Tae-soo Lee is working as director of Drug Product department in Samsung Bioepis. He joined Samsung Bioepis since 2008, and his specialties are development and tech. transfer regarding Purification, Formulation, Fill/Finish and Combination product.
Recently, he was deeply involved in the development and approval from EMA and FDA for the combination products of pre-filled syringe and autoinjector, such as Enbrel biosimilar and Humira biosimilar.
Max Fernandez has 20+ years of experience and leadership in global regulatory strategy, regulatory CMC, quality, and manufacturing/technical operations for biological products.
He is the Director of Regulatory and Compliance at Samsung BioLogics in Incheon, Korea. As Head, he is responsible for ensuring all site-related Quality Assurance and regulatory activities are conducted in compliance with corporate standards and applicable regulations.
Anny Alsup is a consultant at Quality Center, CanSino Biologics in Tianjin, China, focusing on compliance of QC documents. Before moving back to China, Anny was Research Scientist and Facility manager of in vivo Pharmacology at Cubist Pharmaceuticals, Merck Co. in Boston area. Anny also worked as an associate research scientist of Microbiology and Immunology at University of New Mexico (UNM).
Anny Alsup has a MBA from UNM and a BS in Medicinal Chemistry from College of Pharmacology, Peking University.
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.