Dr. Alison Armstrong is Senior Director and Global Head of the Technical and Scientific Solutions team. She established a client facing scientific consultancy team in 2015. This team is responsible for scientific and regulatory advice and fully supports customers worldwide. Dr. Armstrong has authored a number of articles on trends in biosafety testing and is a member of regulatory taskforce groups related to rapid technologies. She is an invited speaker at global conferences.
Dr. Armstrong holds a PhD in Molecular Virology from the University of Glasgow
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®.
Mr. Simone Bertoni is the Area Manager Asia Pacific within Barrier Isolation Technology unit within Tema Sinergie S.p.A. and based in Italy.
Simone, a graduated electronic engineer, has been working for Tema Sinergie S.p.A since 2020 and his focus is to develop the market in the assigned area. From Aseptic processes (Aseptic Filling, Sterility Testing, Aseptic Dispensing & Sampling, Aseptic Transfers, etc) to Containment processes (Product Transfer, Manual Sampling, Weighing and Dispensing operations), to Glove leak tests, the Barrier Isolation Technology field covers a wide range of applications.
Ashwini works as Technical Key Account Manager with Datwyler Pharma Packaging. In her current profile, she delivers technical support to the business and pharma clients and also leads and supports the in-house customer-oriented technical projects.
She has 9 years of experience in several techno-commercial roles of Pharma packaging components for Injectable. She has received Bachelor’s degree in Biotechnology, MBA in Biotechnology Management and Graduate Diploma in Packaging Technology from Indian Institute of packaging.
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.
Martin Düblin is a mechanic and process engineer and highly experienced in the field of the life science industry, infrastructure and health care community. During more than 30 years he has been involved in many major strategic projects in Europe, US and Asia for various applications covering program management and execution functions. He has undertaken all aspects in the project initiation phase, through the execution till handing over and hold key roles for critical phases. Since more than 10 years he is well involved in all kind of technical «revolutions» as with robotic, AI and digitalisation.
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.
Carol Rea Flynn has 30 years’ experience in the pharmaceutical glass industry, in Engineering, Manufacturing, Quality, Regulatory Compliance and Technical Services. In her current position at Corning Pharmaceutical Technologies, as the Glass Converting Quality Manager, LST, she is responsible for the development and support of technical content related to global glass standards for parenteral packaging including Valor and Velocity, as well as, managing the supplier quality for converted products. She continues to support patient safety teams, DOE’s, and development and research in the areas of aluminosilicate and borosilicate glass. Carol Rea earned a Bachelor of Science in Mechanical Engineering from Drexel University and holds a Master of Science in Engineering with focus in Chemical obtained from Rowan University.
Carol Rea has been an active member of the Parenteral Drug Association (PDA), Packaging Science Interest Group, and contributed to the development and publication of PDA Technical Report 43: Identification and Classification of Nonconformities in Moulded and Tubular Glass Containers for Pharmaceutical Manufacturing (co-chair) and PDA Technical Report on Glass Handling. She is also a member of International Commission on Glass TC 12 Pharma Packaging Technical committee with recent studies on delamination, current member of USP Pharmaceutical Glass Expert Panel focused on USP <660> and <1660>, and active member of ASTM / ISO Tag glass technical committees. She enjoys sharing her glass knowledge at various venues such as Rx360, Glass Quality Conference, A3P, CPhL China, PharmaEd, ICG, CNPPA Suzhou Dialogue, Parenteral Drug Industry Congress, and PDA Particle and Lyophilization, PDA Joint Regulatory, and PDA Parenteral Packaging.
Mr Jack Gill earned his BSME from the University of Illinois in Chicago and MBA from the University of Illinois. He began his career in Nuclear power but shifted to Pharmaceutical and Medical Devices almost 30 years ago. He worked in sterilization engineering with direct support to manufacturing sites, through Sr. Quality roles with responsibility for multiple sites and $1B in manufacturing. Most recently with Hospira and then Pfizer, he has focused on supplier quality with the bulk of that being glass and plastic primary containers.
Dr. Juliana Gutierrez is Scientific Affairs manager at bioMérieux Industrial Microbiology Unit Asia Pacific and is based in Singapore.
Juliana provides scientific expertise and support to the bioMérieux Healthcare Business across Asia. She has been working in Asia for more than 6 years in different capacities, initially in Japan as Scientific Affairs and more recently in Singapore as Regional Marketing.
Ms. Cathy Joa works at Datwyler Pharma Packaging as Key Account Manager in Korea.
She holds a bachelor (Bangalore university) & Master degree in business management (Korea University) and brings experience handling our products in the last 3 years in sales.
She has more than 10 years’ experience in product management and sales.
Sona Kovackova holds a PhD degree in Organic Chemistry from the University of Chemistry and Technology, Prague, Czech Republic.
She started her career as a Scientist at the Rega Institute for Medical Research KU Leuven, Belgium and later worked in Quality Control of medicines at the Belgian Institute of Public Health.
In 2017, Sona took the position of Study Director at Nelson Labs
Europe. She currently specializes in Extractables & Leachables studies with a main focus on injectable applications.
Holger is a subject matter expert in Isolator/RABS Technology and No-Touch-Transfer (NTT) methodology, actively involved in writing guidance documents (Contamination Control Attributes and Qualification). With ten year of scientific background; Holger combined his passion for science and technology through working for Franz Ziel GmbH. At Ziel, Holger has been involved in numerous aseptic filling line projects applying NTT to introduce RTU containers. As an active member of the Pharmaceutical and Helathcare Sciences Society (PHSS), Holger strives to improve knowledge on aseptic processing and aseptic containment across the pharmaceutical community.
Hyongwon Kwon earned his Bachelor of Microbioengineering in Degree from KonKuk University. He currently is a Product specialist in bioMérieux and was previously a QC Manager at Biocorp.
Lee Sooho earned his Bachelor's degree on Chemistry from University of Victoria, Canada. He joined Janssen Vaccines Corp | Johnson & Johnson in December 2011 as an Operations and Project Engineer. Since 2019, he has been the Quality Assurance / Commercial Lead at the firm.
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.
Wilson has been in the healthcare industry for the past 30 years, helping developments within the medical device and pharmaceutical industry. Currently advise/ support pharmaceutical companies on CCI-Container Closure Integrity solutions. His experience spans from medical device and prefillable syringes applications and manufacturing while working for BD in Europe, US, Japan and Singapore as well as pharmaceutical processing equipment at Syntegon/ Bosch Packaging. His cross functional experience in managing product development and projects helps partners in bringing successful solutions to the market. Wilson has joined Datwyler in 2019 and is supporting customers across SEA, Japan and Korea advising on the right packaging recommendations for medicine applications. He believes in supporting Asian pharmaceutical customers to be more successful on their aspirations to raise people’s quality of life. Wilson graduated in engineering from Sao Paulo University and with a MBA from Fox School of Business.
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.
Dharti is an experienced executive leader with strategic business perspective as well as technical knowledge. Dharti possess Masters’ degree in chemical engineering with emphasis in biotechnology and over 2 decades of experience. Dharti has spent most of her career working in the biotech-pharmaceutical industry in both engineering / consulting service providing firms and user (owner) side companies. Dharti’s early career for ~10 years includes being employed with three user side public and private companies, where she successfully led multiple biotech, vaccine and API processes from late stage R&D to clinical and commercial manufacturing. For past ~10 years, Dharti has been involved with providing consulting services to many bio-pharma companies primarily within USA, and for some projects in Europe and Asia. Her technical expertise spans from process engineering, process development, engineering and project management, operations, change management, process automation, quality, compliance, and CQV; and working from all project phases including capital projects. Having led single use bioreactor (SUB) for one of her employers in 2006 and working on many single use technology projects afterwards, disposable technologies remains her personal interest area.
Dr In-sook Park is the current Director General responsible for leading Biopharmaceuticals and Herbal Medicine Evaluation Department at the Korean Ministry of Food and Drug Safety (MFDS).
In her current position, Dr Park oversees Biologics, Recombinant Protein Products, Gene and Cell Therapy Products, Herbal Medicines and Cosmetics Evaluation divisions.
Her vast professional experience spans over 30 years in the fields of Pharmaceuticals and Medical Devices safety and efficacy evaluation and Research Planning and Coordination based on Regulatory Science.
In 2021, Dr Park became a member of the Regional Vaccine Advisory Group (RVAG) of ADB.
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. Polarine is a senior technical service manager at STERIS Corporation. Mr. Polarine is a 2019 PDA Michael S. Korczynski Award recipient. He was a co-author of PDA’s Technical Reports #70 and #88. Mr. Mr. Polarine currently teaches the cleaning and disinfection course as part of the PDA Aseptic Processing Course and at the University of Tennessee Parenteral Medications Course. Mr. Polarine is current President for the PDA Missouri Valley Chapter and Technical Coordinator for the IEST. Mr. Polarine has a Master of Arts in Biology from the University of Illinois in Champaign, IL.
Mr. Matthias Poslovski, a graduate mechanical engineer, has been with the Optima Group since 1998. He began his career with Optima as the sales manager of the former division Inova pharma systems GmbH. From 2000 until 2002 he managed the Optima division of Kugler whose expertise was in non sterile filling and packaging technology. Today, Mr. Poslovski holds the title of Vice President Sales Turnkey of the OPTIMA pharma GmbH. His responsibilities encompass the overall support of technical sales worldwide.
He currently holds the role of Aseptic Processing, Sales Director Asia-Pacific at IMA Life, a division of IMA S.p.A. His focus is to develop the aseptic filling market, in the assigned area.
In the previous 10 years he holds the role of Isolation Technology Product Manager, within IMA Life.
He held previous positions as Isolation Technology Product and Sales Manager at Comecer S.p.A. and as Technical Trainer for Olivetti S.p.A. His education includes a specialization in electronics.
Dr. Peter Qiu is the External Advocacy Lead China at Roche Genentech with over 13 years of experience working with the US FDA. He was the Division Director in the Division of Biotechnology Manufacturing, Office of Pharmaceutical Manufacturing Assessment, CDER. He led the assessment of manufacturing processes, facilities, and microbiological control for CDER’s Biologics License Application review and inspection program.
Dr. Qiu has extensive knowledge in microbial controls and sterility assurance assessment as well as in pre-license and pre-approval inspections for biotech products.
Dr. Qiu graduated from the University of Southern California with a Ph.D. in Biological Sciences.
Presently an additional director, production (viral vaccines) at Serum Institute of India Pvt. Ltd., Pune, India. Trained in regulatory affairs at UMASS in Boston, USA and Chumakov Institute, Moscow, Russia. He is Ex.IITian and has a Doctorate in virology with more than 33 years of rich experience in various departments such as production, quality assurance, quality control in the Biotechnological industry and Research Institute. He has expertise in upstream processing of viral vaccines. He is specialized in purification of viral vaccines and has developed WHO approved Oral polio vaccine and Rabies vaccine at SIIPL.
After 13 years working at Seidenader in the field for configuration and qualification of inspection machines I got the opportunity to change my position and started to work for a pharmaceutical company to adjust and qualify an inspection machine on site as SME. As i hold now more than 17 years experience in Automatic inspection i got the opportunity to work at Körber Pharma Inspection as Area Sales Manager, responsible for South Korea, Japan, China and Taiwan, where I can share and use the past 17 years to support and offer the right solution for our Customers’ needs regarding semi and automatic vision inspection and related products.
James “Jim” Stumpff, RPh, is Principal Consultant at Parexel International. He leverages over 34 years’ experience including 23 years as an FDA Investigator, Supervisor and Acting Director of Compliance to assist biopharmaceutical and medical device clients. He provides a full range of services at all stages from development and clinical to commercial compliance. His primary role is project management and execution at client sites throughout the world. He also speaks at industry organization meetings and publishes relevant articles.
Jim graduated from the University of Missouri-Kansas City with a Bachelor of Science Degree in Pharmacy. He worked as a pharmacist in the United States Public Health Service (USPHS) assigned to the Indian Health Service, transferred to the FDA New York District Office, then the Los Angeles District office and retired a USPHS Captain after 26 years.
Jim assists clients in maintaining regulatory compliance. He also provides training on a variety of topics, including Inspection Management. Jim has published several articles covering remote inspections, investigations, and data integrity. Jim authored the first chapter in the PDA text, “Assuring Data Integrity for Life Sciences”.
Jo helps clients by leading a cross-disciplinary Parexel SME team to get ready for regulatory inspections. She specializes in gap analysis of manufacturing processes and regulatory submission, and troubleshoots issues present in the quality management system.
Prior to joining Parexel in 2021, she was a reviewer and inspection investigator at the FDA, as Acting Branch Chief and Acting Team Lead in CDER/OPQ. She has significant R&D experience in complex drug delivery, drug-device combination product, and cell/tissue therapy.
Jo holds a PhD in Biomedical Engineering from Johns Hopkins School of Medicine and a BS in Chemical Engineering from MIT.
Tobias Wetzel joined Bausch + Ströbel in 2010, after completing his degree in business administration he took different positions in the sales and project management department from 2013.
Since 2020 he is covering the Korean, Japanese and South-East-Asian markets as Area Sales Manager for various pharmaceutical applications, from small table top machine up to high-speed customized filling lines.