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Luigi Annoni
Senior Aseptic Specialist at IMA LifeLuigi holds an Electromechanichal Engineering Degree from ISTIM Milano. He is currently Aseptic Specialist & Strategic Marketing advisor at IMA LIFE Italy. He joined the IMA group in 1989 as Area Sales Manager, Italy & Russia. Before joining IMA, he was employed by an engineering company working on ISPRA Nuclear power plant. He then joined Alpina, an engineering company, as a Junior Proposal Manager and after some time, was appointed to be responsible for proposals.
Enrico Barichello
Product Manager at Stevanato Group- Glass Prefillable Syringes: A Manufacturing Strategy to address Bio-Drugs Concerns
- Panel Discussion and Q&A
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®.
Jia Min Boo
Technical Account Specialist at West Pharmaceutical ServicesJia Min, Boo is from Singapore and holds a Bachelor's Degree in Material Science Engineering from Nanyang Technological University in Singapore.
She joined West Pharmaceuticals Singapore in July 2013 as a technical account specialist. In her role, she provides technical support to pharma companies in the AP region, providing product recommendations, technical trainings and advices to ensure smooth and easy uptake of West’s wide product portfolio as required for customer’s drug product application.
Javier Camposano
Vice President - Head of the Global Drug Product Expansion Division at Celltrion, Inc.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.
Richard Chai
Technical Service Manager at SterisRichard Chai is a Technical Service Manager in the Life Sciences Division of STERIS Corporation. He currently provides global technical support related to process equipment cleaning and contamination control in cleanrooms. Richard has more than 20 years of industry experience in manufacturing, validation and technical support. He has published several articles in contamination control and is a frequent speaker at industry events.
Derek Duncan
Director of LIGHTHOUSE Instruments- Use of Quality Risk Management to Generate a Contamination Control Strategy for Container Closure Integrity of a COVID-19 Vaccine
- Panel Discussion and Q&A
Dr. Derek Duncan began his career as a Research Scientist at the Dutch Institute for Atomic & Molecular Physics in Amsterdam. He then moved into industry holding various Product & Application Development positions. Currently at LIGHTHOUSE and based in Amsterdam since 2003, Dr. Duncan is responsible for developing applications for pharmaceutical process monitoring and finished product inspection. These include using headspace analysis for container closure integrity testing, packaging permeation studies, lyo chamber moisture mapping, and automated media fill inspection.
Michael Edey
Principal Engineer, Component Control & Optimization at Pfizer- Use of Quality Risk Management to Generate a Contamination Control Strategy for Container Closure Integrity of a COVID-19 Vaccine
- Panel Discussion and Q&A
Michael Edey is a Principal Engineer, Component Control at Pfizer Inc. The role is undertaken as a member of a corporate team with responsibilities for Primary Packaging for the Pfizer Sterile Injectables Network. Michael has a diverse background in Pharmaceuticals over 25 years’ experience in Production Management, Quality Assurance and Technical Leadership. More recently with a global technical leadership role supporting CCIT initiatives with an emphasis on quality risk management approach and the introduction of deterministic methods.
Max Fernandez
Vice President of Quality, Regulatory and Compliance at Shenzhen Cheerland Biomedicine Investment Co.- SESSION 5: Container Closure
- Panel Discussion and Q&A
- SESSION 6: Container Closure
- Panel Discussion and Q&A
- A Review of Current Regulatory Requirements for the Licensure of Biosimilars, in the US and in China
- Panel Discussion and Q&A
Max Fernandez has over 20 years of experience and leadership in global regulatory strategy, regulatory CMC, quality, manufacturing, and technical operations for biological products spanning preclinical development through commercialization and lifecycle management. He is currently Vice President of Quality, Regulatory and Compliance at Cheerland Biomedicine (CLB), an investment group with diverse interests, including biologics contract development and manufacturing, innovative therapies, and molecular diagnostics. He is responsible for establishing and implementing quality, regulatory and compliance systems and processes to support a large-scale greenfield biologics facility and multiple business divisions within the group. Prior to joining CLB, Dr. Fernandez was the Head of Global Regulatory Affairs at Samsung Biologics in Incheon, South Korea, where he was responsible for ensuring all site-related Quality Assurance and regulatory activities were conducted in compliance with applicable regulations and corporate standards. During his tenure, SBL clients received over 100 product approvals from major regulatory agencies (US FDA, EMA, PMDA, Health Canada), and others including Swissmedic, TGA (Australia), Medsafe (New Zealand), MFDS (Korea), ANVISA (Brazil), Cofepris (Mexico), TMMDA (Turkey), and the Ministry of Industry and Trade (Russia). Before relocating to the Asia Pacific region, Dr. Fernandez worked in California, USA for 18 years within the Baxter/Baxalta/Shire global R&D and manufacturing network in various leadership roles in quality and regulatory, most recently as a global regulatory leader in blood disorders, where he successfully received BLA approval for VONVENDI, the first and only recombinant treatment for von Willebrand disease.
Martin Gabler
Product Manager at Körber Pharma InspectionMartin Gabler was born in Germany in 1992. He finished his Master of Science in the field of Management & Technology at the Technical University of Munich in 2019. Since January 2020, Mr. Gabler has been working as a Product Manager for inspection machines at Seidenader Maschinenbau GmbH in Markt Schwaben. As a product market expert, he continuously observes the latest market and technology trends to provide the pharma & biotech industry with inspection machines equipped with state-of-the-art technology.
In July 2021, Martin Gabler wrote a whitepaper on the principle of particle inspection, which represents a simple and compact summary of the USP <1790> guideline, illustrating the individual inspection methods by using Körber inspection machines as examples.
Kavita Ramalingam Iyer
Director/ Team Leader, BioPharm CMC Regulatory Affairs of GSK- An Industry's Perspective on the Current Challenges and Potential Solutions for the Regulatory Lifecycle Management of Biologicals and Vaccines in South Korea
- Panel Discussion and Q&A
Dr. Kavita Ramalingam Iyer is the Regulatory CMC Team and Program Lead for the oncology program within Global Regulatory Affairs Organization at GSK. She has more than 11 years of Pharmaceutical industry experience leading vaccines manufacturing, process development, establishment of GMP facilities, vaccines and biologics technology transfer, talent development and strategic initiatives and performed site audits. During her time at Merck & Co., Inc. she held positions of responsibility for multiple programs and product portfolios including novel mRNA therapy and combination products that cover investigational and commercial space across vaccines and biologics. Kavita is a certified lean six sigma black belt and has championed significant process improvements through employment of Kaizen, six sigma and lean principles. In her current role as a regulatory professional, Kavita is responsible for managing end to end product dossier life cycle activities investigational, initial registration & post approval phases; developing, shaping and implementing CMC regulatory strategies in compliance with global regulations, developing regulatory documentation to support worldwide registration, lead regulatory CMC representative on matrix teams and mentors early development and cross-functional teams. She also serves as a GSK Regulatory CMC representative in the industry forum called BioPhorum Operations Group (BPOG); has given several conference talks and published multiple position papers in collaboration with industry experts addressing emerging regulations and guidance documents covering product development, registration and post-approval changes. She was one of the BPOG delegates who recently interacted with ANVISA and presented on complexity and impact of post approval changes. Recently she was inducted as a CASSS Associate Director.
Kavita graduated with a Ph.D. in Biotechnology from Anna University, India and pursued her post-doctoral research at University of Minnesota focusing on antibody engineering and synthetic biology prior to joining Merck.
Jin-Hyun Jeong
Professor, College of Pharmacy at Yonsei UniversityDr Jeong is a professor at the College of Pharmacy, Yonsei University International Campus, and holds the positions of Executive General of K-NIBERT Project and Director, Graduate Program of Industrial BioPharmaceutical Science. The Yonsei Campus is located near the plants of Samsung Biologics and Celltrion, a world-class bio companies, and Dr. Jeong maintains a close relationship with these two companies, which is expected to greatly contribute to the development of Korean PD.
Christina Juli
Head of Tech RA Germany III at Boehringer Ingelheim Pharma GmbH & Co. KG- An Industry's Perspective on the Current Challenges and Potential Solutions for the Regulatory Lifecycle Management of Biologicals and Vaccines in South Korea
- Panel Discussion and Q&A
Dr. Christina Juli studied pharmacy at the University of Wuerzburg, Germany. After her Ph.D. thesis in the fields of pharmaceutical chemistry, in 2012, she joined the ratiopharm GmbH in Ulm, Germany. She started her professional career as Senior Manager in the department of EU Regulatory Affairs Generic Maintenance. Since 2018, she is working in the Tech RA department at Boehringer Ingelheim Pharma GmbH & Co. KG in Biberach, Germany. In her role as Head of Tech RA Germany III, she focuses on the CMC development for biologics and is responsible for the definition, compilation and review of the CMC documentation for clinical trial and new drug applications as well as for post approval submissions worldwide. Beyond that, as regulatory intelligence responsible for her business unit, she monitors the regulatory legislation, regulations, guidelines and position papers from pharmaceutical and biological industry worldwide. She is an active participant in the BioPhorum Operations Group (Post Approval Strategy working group).
Hirohito Katayama
Head of Supplier Relationship Management of Cell & Gene Franchise at Novartis Pharma K.K.- Visual Inspection in The Japanese Market: How a Standardized Calibration is Useful to see Operator’s Unique Capability in Manual Visual Inspection
- Panel Discussion and Q&A
Hirohito Katayama is the Head of Supplier Relationship Management of Cell & Gene Franchise in Novartis Pharma KK. He has over 35 years of experience in pharmaceutical formulation & technology development, validation, visual inspection, rapid microbiological testing and manufacturing. He is currently the chair of the PDA Japan Chapter Sterile Product GMP Taskforce Regenerative medicine working team. He has been an active member of PDA since 1996. He was a member of the Japanese Pharmacopeia editors in Microbiological Testing for 14 years. He is the chair of ISO TC198 WG9 in Japan.
Jerome Kim
Director General of International Vaccine Institute- Keynote Speech: From Efficacy to Implementation: Regulatory Strategy and COVID-19 Vaccine Development
- Panel Discussion and Q&A
Jerome H. Kim, M.D., is the Director General of the International Vaccine Institute (IVI). He served as the Principal Deputy and Chief, Laboratory of Molecular Virology and Pathogenesis at MHRP as well as the Project Manager for the HIV Vaccines and Advanced Concepts Evaluation Project Management Offices, U.S. Army Medical Materiel Development Activity USA. Dr. Kim was a Professor, Division of Infectious Diseases, Department of Medicine, Uniformed Services University of the Health Sciences. From 2004 – 2009 he led the Army’s Phase III HIV vaccine trial (RV144), the first demonstration that an HIV vaccine could protect against infection, as well as subsequent studies that identified laboratory correlates of protection and sequence changes in breakthrough HIV infections after vaccination. He has authored over 200 publications. Dr. Kim graduated from the Yale University School of Medicine in 1984 and completed his training in Internal Medicine and fellowship in Infectious Diseases at Duke University Medical Center. In 2013 he received the John Maher Award for Research Excellence from the Department of Medicine, Uniformed Services University of the Health Sciences.
Won Min Kim
Assistant Manager, Bio-Process Team at Celltrion PharmWon Min Kim is the Assistant Manager for Celltrion Pharm’s Bio-Process Team, Manufacturing Department. In his current role, he is responsible for the establishment and execution of validation for Part Washer, Auto Clave and Laminar Flow hood. He set up new Pre-filled syringe auto inspection machines from Seidenader and executed their entire validation. Currently, he is overseeing the additional validation for Syringe Auto Inspection Machines and improving auto inspection operating line.
He joined the company in 2016 as a granulation equipment engineer, in charge of maintaining the hardware and software of the company’s equipment. He also established the QMS document (Deviation, CAPA and Change control) and new granulation equipment.
Won Min Kim earned his degree in Industrial Safety Engineering from Chungbuk National University, South Korea.
David King
Director, Drug Product Operations of Samsung Biologics- From Monoclonal Antibodies to Vaccines: Overcoming Barriers and Providing a Rapid Response to Meet Pandemic Requirements
- Panel Discussion and Q&A
David King holds a bachelor’s in biology and has 29 years of experience in pharmaceutical and medical device industries. He was a microbiologist during first 5 years of his career at filter manufacturer Gelman Sciences and with a parenteral manufacture, Fuji-Sawa. He spent 7 years as a quality engineer with medical device manufacturers (Volcano and Tandem Diabetes) with a focus on sterilization (steam, gamma and ETO), leading the design/validation of a new sterilization process in-line with production. He has managed aseptic filling production facilities (Parke-Davis, Genentech, Jubilant HollisterStier, Samsung Biologics) for 18 years. He has extensive experience that include: complicated formulations, most container closure systems, tight project timelines, and leading manufacturing to profitability. David currently is the Director of Drug Product Operation at Samsung Biologics in South Korea, leading a team of 200+ employees in the introduction of biopharmaceuticals into established aseptic filling lines for both clinical and commercial markets.
Sok Tiang Koh
Vice President - Scientific Affairs & Technical Services at West Pharmaceutical ServicesSok Tiang is an industrial pharmacist with extensive experience in the life cycle mgmt. of injectables from its packaging requirements to the manufacturing in the final finishing for market in a regulated environment. Currently the Vice President - Scientific Affairs & Technical Services for Asia Pacific, she joined West as the Regional Technical Services Manager after extensive experience in aseptic manufacturing in a multinational pharmaceutical company. Over her tenure in West, she has taken on differing roles of increasing responsibilities, from Business Development to Marketing and R&D.
With her training and experience, she provides technical solutions to address the customers in their pharmaceutical containment and delivery system challenges. In addition, she also offers insights in industry trends and regulatory requirements to support their needs.
Sok Tiang holds a Bachelor of Science in Pharmacy with Honors and MBA from the National University of Singapore.
Beth Kroeger
Technical Services Senior Manager, Life Sciences Division at STERIS CorporationBeth Kroeger is a Technical Services Senior Manager for the Life Sciences Division of STERIS Corporation. She currently provides global technical support related to contamination investigations, cleaning and process validation and cleanroom environmental control, frequently speaking on these topics for several industry and educational organizations. Beth has extensive industry experience in Biopharmaceutical Manufacturing, Validation, Technical Transfer, R&D, Compliance, and Quality from her various positions she has held at Millipore Sigma, Wyeth, Janssen, and Biotest Pharmaceuticals. Her areas of expertise include large-scale continuous perfusion and fed batch systems and downstream operations including large scale purification, viral removal, UF and final fill. She earned a B.S. in Biochemistry from the University of Missouri, St. Louis and is an Adjunct Lecturer, Temple University, School of Pharmacy, RA/QA Graduate Program. She served on the ISPE task force to draft Cleaning Validation Guidelines for Biopharmaceutical Operations.
David Loong
Senior Consultant Novel Modalities APAC, Bioprocessing Strategy at Merck Life ScienceDavid has 14+ years of experience in the pharmaceutical industry spanning the drug discovery and development process. He has held roles as scientist and consultant in biotech startups, consulting, contract research at AMRI Global and GMP manufacturing at GSK. Most recently, he worked on process development and manufacturing strategies to supply material for preclinical and first-in-human studies, including cell and gene therapies. He holds a PhD in Organic Chemistry from the Australian National University and a Bachelor of Technology (Hons) in Chemical Technology from Massey University, New Zealand.
Michael Lopez
Former Senior VP, Global Quality at Medytox- SESSION 1: Aseptic Manufacturing Process in times of COVID-19, Supply Chain, Primary Packaging Materials
- Panel Discussion and Q&A
- Session 7: Accelerating Approvals through Regulatory Convergence in APAC
- Panel Discussion and Q&A
Michael Lopez is currently an independent adviser to PDA Asia Pacific and a former Senior 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.
DeokSeok Oh
QA Lead (NPI and Commercial) at Janssen VaccinesDeokSeok 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.
Frode Pedersen
Computer Scientist at Stevanato Group- Liquid and Lyophilized Products Inspection Combined in a Single Machine. Enhancing Performances and Flexibility with AI: A Success Story
- Panel Discussion and Q&A
Frode Stig Nørgaard Pedersen is a Computer Scientist at Stevanato Group working with Computer Vision problems. His main responsibility is to find solutions for Stevenato projects, with an emphasis on LYO products, using Machine Learning. He has also found solutions through the implementation of more conventional algorithms. Other examples of projects that he has been a part of include the analysis of satellite images of fields to ensure proper growth rates, autonomous driving in simulated environments and an agent that was tasked with learning how to play board games using reinforcement learning and self-play.
Alberto Penati
EU Engineering, Senior Director of Patheon Thermo Fisher ScientificAlberto Penati received a High Technical School Degree in Mechanical Engineering at the Feltrinelli Industry Institute in Milan, in 1990. From 1991 up to 1995 he worked at the FOSTER WHEELER Italy, Machine Dept., HVAC section, as a HVAC and utilities engineer for pharmaceutical and industrial plants. After a brief experience of one year (1995) at Woods (Italy), he was employed at Steril S.p.A up to 1998, as HVAC Engineer for pharmaceutical and biotech plants. After an experience in Eleca S.p.A. from 1998 up to 2000 as Project Engineer of mechanical plants, erection and construction, from 2000-2004 he worked at Jacobs Italy as HVAC and utilities Specialist for pharmaceutical, chemical, biotech and other appliances plants. From 2004 up to 2010, Alberto worked at CSV Life Science, for Project Management and construction activities in the Pharma sector. He is currently at Patheon, Italy (now part of Thermo Fisher Scientific) as EU Engineering Senior Director.
Gabriele Peron
Senior Marketing Advisor at Stevanato Group S.p.A.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.
Nikolai Petrovsky
Professor of Medicine at Flinders University- Keynote Speech: The COVID-19 Pandemic – Where Did It Come From and Where Is It Going?
- Panel Discussion and Q&A
Nikolai is a Professor of Medicine at Flinders University and research director of Vaxine Pty Ltd, an Adelaide-based biotechnology company focused on vaccine development. He has been principal investigator on five multimillion dollar NIH vaccine contracts, with a major focus on development of novel adjuvants and pandemic vaccine platforms. He has authored over 200 research papers and has won prestigious awards including 2010 Ernst & Young Entrepreneur of the Year Award. His current focus is development of Covax-19, an adjuvanted recombinant protein vaccine against COVID-19 that is just about to enter Phase 3 clinical trials.
Andrea Sardella
Pharma Inspection Product Development Manager at Stevanato Group- Liquid and Lyophilized Products Inspection Combined in a Single Machine. Enhancing Performances and Flexibility with AI: A Success Story
- Panel Discussion and Q&A
Andrea earned his Degree in Physics from Padua University in 1989 and his Master’s Degree in Nuclear Engineering in 1990. As researcher at the National Research Council (C.N.R.), he developed several optoelectronic and nuclear scientific instruments for Magnetically Controlled Fusion Research setting up international collaboration with UWA Madison (USA) and Garchin IPP (De). After 10 years in the research sector, he moved to the industrial sector developing optical and vision controls for industrial application as CEO of a small-medium company. This experience drove him into the pharmaceutical field, where he started to develop several control applications with vision and spectroscopy tools. After several years, he joined a leading company in this sector as R&D Manager and he developed innovative inspection technology for the inspection machines.
Since 2008 he has been with Stevanato Group as Pharma Inspection Product Development Manager to develop new automation and inspection products dedicated to the pharmaceutical customers of the group.
Alexander J. Schaefer
Technical Product Manager at Wilco AGAlexander J. Schaefer, graduated from FH Albstadt-Sigmaringen with a degree in pharmaceutical engineering, worked for 15 years in Basel as a process specialist and project manager for visual inspection and aseptic process technologies projects, mostly for Pharmaplan AG, Switzerland as well as NNE/NNIT Switzerland.
He recently joined WILCO AG, Switzerland, as Technical Product Manager for Visual Inspection and is in that capacity responsible for the development of visual inspection solutions and deliver a broad range of Visual Inspection process consultancy, from inception and feasibility to process validation and production support.
Micheal Schafferius
Application Specialist for Separation Technologies and Quality at SartoriusMicheal Schafferius currently holds the position of Application Specialist for Separation Technologies and quality at Sartorius Australia, working for Sartorius for the past 10 years. Micheal has worked in the pharmaceutical and biopharmaceutical industries for more than 20 years. His experience includes roles focused on Filtration, Single Use Technologies, Quality Assurance, Validation and Sterile Manufacturing with local and international companies. Micheal is the current PDA Australia chapter President elect.
Andrea Simonetti
Independent Pharmaceutical AdvisorAndrea Simonetti received a MS and Ph.D. degree in electronic engineering and an EMBA degree. He is an advisor to pharmaceutical machinery industry. He has an extensive experience in leading international sales teams in successfully increasing revenues and profits and improving market reach and positioning in the global pharma machinery sector. He is also experienced in QA, validation, risk management, product R&D, and standardization of equipment and systems.
Andrea is currently working with PDA Prefilled Syringes, Visual Inspection and BFS IOA association task force teams. He has also been part of the workgroup who revised EU GMP Annex 1.
In 2010, he started providing educational support to US FDA Office of Pharmaceutical Science and Office of Generic Drugs. A frequent speaker at conferences, he has also taught master courses at several Universities in Europe. His most recent publications involve developing PAT and CCI strategies for pharmaceutical systems and PDA Technical Report 86.
Edward Wang
Chief Technology Officer, China Operations at Sirnaomics Inc.Dr. Edward Yongxiang Wang has over twenty-five years of experience in pharmaceutical engineering and GMP manufacturing operations and specializes in biologics fill and finish production management. He is the Chief Technology Officer for China Operations of Sirnaomics Inc., a leading global RNAi therapeutics innovator. Dr. Wang’s expertise prior to this has been consulting services focusing in the areas of cGMP compliance on facility design, construction engineering, validation and technical operations.
Dr. Wang previously served as the Vice-President, Technical Operation at WuXiAppTec Biopharmaceuticals Co. Ltd., China responsible for the start-up of its site GMP production and quality system establishment. Prior to that, he was a director responsible for process development and engineering at AERAS Global TB Vaccine Foundation.
Dr. Wang received his Bachelor’s degree in Biophysics from the University of Science & Technology of China and a Doctorate degree in Biotechnology from Helsinki University of Technology, Finland. Dr. Wang has published over 50 peer-reviewed papers and has three patented biotechnology product. He has served on review committees for various biotech journals.
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