2024 PDA Parenteral Packaging Conference
Navigating Complexity: Quality, Innovation, and Supply Chain Resilience in Packaging
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Program Highlights
The agenda is out now!
We are excited to announce that this year's opening plenary talk will include a patient perspective.
Related PDA Letter Article: The14th Parenteral Packaging Conference authored by our Co-Chair, Philippe Lauwers, Terumo.
Dear Colleagues,
On behalf of the Scientific Program Planning Committee, it is our distinct pleasure to extend a warm welcome to you for the 14th PDA Parenteral Packaging Conference hosted by the Parenteral Drug Association (PDA) which will take place on 23 - 24 April 2024 in Copenhagen, Denmark.
The overarching conference theme is “Navigating Complexity: Quality, Innovation, and Supply Chain Resilience in Packaging”.
Packaging development activities for parenteral drugs extend far beyond isolated discussions around just the packaging aspects themselves. It requires a holistic and integrated approach that takes into account the different development interfaces.
In an era marked by unprecedented challenges and rapid advancements, our overarching theme reflects the core issues facing the pharmaceutical packaging industry. Throughout the conference, we will delve into crucial topics such as Container Closure Integrity and deep cold storage, innovation in packaging technologies, and the imperative need for supply chain resilience. Additional agenda topics include regulatory updates, interactions between drugs and primary containers, sustainability, and many more.
Beyond the presentations in the plenary and parallel tracks, this conference also offers guided poster walks, tech talk sessions, an exhibition as well as a networking event allowing you to catch up with friends and peers in the industry.
Thank you for your continued commitment to advancing the field of parenteral packaging.
We hope you share our excitement of bringing together industry leaders, experts, and professionals to explore the dynamic environment of parenteral packaging
and we look forward to welcoming you in Copenhagen.
Sincerely,
The Co-Chairs
Derek Duncan, LIGHTHOUSE Instruments
Philippe Lauwers, Terumo
SCIENTIFIC PROGRAM PLANNING COMMITTEE:
- Derek Duncan, LIGHTHOUSE Instruments
- Philippe Lauwers, Terumo
- Bettine Boltres, WEST
- Madushini Dharmasena, U.S. FDA
- Ryan Forrey, BD
- Sinue Gomez, Corning
- Bram Jongen, Datwyler
- Arne Kloke, SCHOTT Pharma on behalf of Alliance to Zero
- Coralie Richard, Eli Lilly and Company
- Miho Soma, Gilead
- Folker Steden, SCHOTT Tubing
- Jessie Lindner, PDA
- Falk Klar, PDA Europe
- Stefanie Nebelin, Senior Manager Programs & Events, PDA Europe
Networking Opportunities
Tuesday, 23 April 2024
Reffen Werkstatt
You are cordially invited to attend our urban industrial party! Hosted at the port on one of the islands of Copenhagen, this event promises an evening of great food, stimulating conversations, unparalleled networking opportunities, and dance the night away. Please dress in industrial chic attire. Think casual yet stylish with an industrial flair.
Immerse yourself in an evening filled with pulsating beats, delectable cuisine, and a unique atmosphere while connecting with partners, peers, and friends. Reserve your spot now and join us for an evening of inspiration, connection, and celebration of Danish craftsmanship!
A transfer to the venue will be provided.
We look forward to raising a glass with you in celebration of a successful networking event!
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Member Price
€ 2.480GovernmentMember Only
€ 1.190
Health AuthorityMember Only
€ 1.190
Early Career ProfessionalMember Only
€ 1.190
StudentMember Only
€ 1.190
AcademicMember Only
€ 1.190
Non-Member
€ 2.780
ALL PRICES IN EURO (EUR), EXCLUDING VAT.
WAYS TO REGISTER: 1. Online Registration 2. [email protected]
PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact [email protected] before registering.
If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.
Monday, 22 April CEST
13:00 – 18:00 | Registration Open
Tuesday, 23 April CEST
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Registration Open
The Hangar 1-3
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Welcome and Introduction
The Hangar 4-5
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Committee Member: Falk Klar, PhD, General Manager, Vice President Europe, Parenteral Drug Association
Falk Klar, PhD, General Manager, Vice President Europe, Parenteral Drug Association
Falk Klar holds a Ph.D. in Applied Physics and has over 19 years of experience in Quality Assurance and Compliance in the life science industry. Falk held positions in pre-clinical research and development in a medical product company and clinical research in a CRO. He has gained experience with biopharmaceutical and pharmaceutical products including monoclonal antibodies, vaccines, parenteral, narcotics, and animal drugs in several positions in quality management. Falk joined PDA Europe in 2015 as Senior Director of Training & Education. Since 2016 he has been appointed General Manager and Vice President of PDA Europe.
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Welcome from the Co-Chairs
The Hangar 4-5
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Co-Chair: Philippe Lauwers, Technology Development Director, Terumo Pharmaceutical Solutions
Philippe Lauwers, Technology Development Director, Terumo Pharmaceutical Solutions
Philippe Lauwers has been active in the medical device and pharmaceutical packaging sector for the last fifteen years with growing responsibilities in business development and technical roles. He is currently the Director of Technology Development at Terumo Pharmaceutical Solutions in Belgium. Philippe graduated in Biotechnology from the University in Ghent, Belgium, and worked as a scientific researcher at the Catholic University of Leuven. Upon obtaining an additional degree in Biomedical Engineering at the Catholic University of Leuven he moved from an academic to an industrial environment. Philippe is a volunteer at the PDA organization and also serves as an expert in ISO technical committees TC76 and TC84. -
Co-Chair: Derek I. Duncan, PhD, Director Product Lines, LIGHTHOUSE Instruments
Derek I. Duncan, PhD, Director Product Lines, LIGHTHOUSE Instruments
Dr. Derek Duncan began his career as a Research Scientist at the Dutch Institute for Atomic & Molecular Physics in Amsterdam. He then moved into the 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, lyo chamber moisture mapping, and automated media fill inspection. Dr. Duncan has been a PDA member since 2004 and has been a regular contributor to PDA conferences, IG Groups, and Conference Program Committees.
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Opening Plenary Part I
The Hangar 4-5
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Moderator: Derek I. Duncan, PhD, Director Product Lines, LIGHTHOUSE Instruments
Derek I. Duncan, PhD, Director Product Lines, LIGHTHOUSE Instruments
Dr. Derek Duncan began his career as a Research Scientist at the Dutch Institute for Atomic & Molecular Physics in Amsterdam. He then moved into the 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, lyo chamber moisture mapping, and automated media fill inspection. Dr. Duncan has been a PDA member since 2004 and has been a regular contributor to PDA conferences, IG Groups, and Conference Program Committees.
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How to Package Presents for a Patient?
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Patient Presenter: Paul Guijt, Volunteer, International Gaucher Alliance
Paul Guijt, Volunteer, International Gaucher Alliance
Paul Guijt, a volunteer with the International Gaucher Alliance (IGA), is 62 years now living with a rare enzyme deficiency. He had over 50 hospital admissions in the first two decades of his life, including extensive surgery and tons of medication. He studied theology and philosophy in Amsterdam, became a public officer at the Dutch Council on Health Insurance, and ended his career in 2010 as a policy advisor on quality management of national screening programs like neonatal and cancers. Among other positions, he was co-founder of the Dutch Gaucher Association, a board member of the Dutch umbrella organization on hereditary and congenital diseases, and prepared what became the IGA which is celebrating its 30th anniversary. He has some 30 years of experience with infusions at home, most of the time self-infusing. With the IGA, he currently leads the development of guidelines on self-management and home infusion therapy.
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Updates from USP Packaging Chapters
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Regulatory Presenter: Desmond G Hunt, PhD, Sr. Principal Scientist, USP
Desmond G Hunt, PhD, Sr. Principal Scientist, USP
Dr. Desmond G. Hunt has been with USP since 2005 and holds the position of Sr. Principal Scientist in the Compendial Science Group-General Chapters. He works with the Packaging and Distribution and Dosage Forms Expert Committees, where he works to develop and revise USP Standards. He has authored many publications and peer-reviewed articles and is a frequent speaker and instructor on topics related to pharmaceutical packaging, particulate matter in parenteral and ophthalmic dosage forms, and good storage and transportation practices. He participates in several industry Working Groups and Technical Committees related to his areas of expertise. Dr. Hunt obtained his M.S. and Ph.D. from the University of Texas at Austin.
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Looking Across Borders – Aseptic Filling in the Food Industry
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Presenter: Hanno Gereon Geissler, Head of Technology Services, SIG
Hanno Gereon Geissler, Head of Technology Services, SIG
Hanno Geissler studied Food Chemistry at the University of Münster, Germany, and graduated as a “state–certified” food chemist. He worked for TÜV ESSEN, Germany as a DIN ISO 9000 co–auditor and in various positions for the German Food Safety Authority, Duisburg. He started with SIG Combibloc in 1999 as a field microbiologist to run commissioning tests with SIG customers and support them during troubleshooting worldwide. He is responsible for the Technology Services teams inside the Global R&D organization. These include various labs and aseptic and product processing specialists. As part of the SIG process authority group, he is also responsible for the validation of SIG`s aseptic systems. Hanno has been a member of the IFTPS since 2007 and part of the Aseptic Processing Committee.
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Networking Coffee Break & Exhibition
The Hangar 1-3
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Opening Plenary Part II
The Hangar 4-5
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Moderator: Derek I. Duncan, PhD, Director Product Lines, LIGHTHOUSE Instruments
Derek I. Duncan, PhD, Director Product Lines, LIGHTHOUSE Instruments
Dr. Derek Duncan began his career as a Research Scientist at the Dutch Institute for Atomic & Molecular Physics in Amsterdam. He then moved into the 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, lyo chamber moisture mapping, and automated media fill inspection. Dr. Duncan has been a PDA member since 2004 and has been a regular contributor to PDA conferences, IG Groups, and Conference Program Committees.
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Regulatory Updates of Container Closure Systems for Drugs, Including Biological Products
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Regulatory Presenter: Madushini N. Dharmasena, PhD, Senior Pharmaceutical Quality Assessor, OPQ, CDER, U.S. FDA
Madushini N. Dharmasena, PhD, Senior Pharmaceutical Quality Assessor, OPQ, CDER, U.S. FDA
Madushini Dharmasena, Ph.D. is currently working as a Senior Pharmaceutical Quality Assessor in the FDA/CDER/ Office of Pharmaceutical Manufacturing Assessment (OPMA) Office of Pharmaceutical Quality (OPQ). Dr. Dharmasena joined the Division of Bacterial, Parasitic, and Allergenic Products in CBER in 2010 following a postdoctoral fellowship at the National Cancer Institute. At CBER she reviewed INDs and BLA supplements with a focus on product quality and manufacturing for biological products including live attenuated bacterial vaccine candidates, recombinant protein vaccine candidates, and live biotherapeutic products. In addition to review, she maintained an active research program and developed bifunctional oral vaccine candidates for the prevention of shigellosis and typhoid (FDA patent E-2012-016). In 2018 she joined OPMA, DMA Branch IV as a primary reviewer and has led numerous pre-license inspections of biologics manufacturing facilities. Dr. Dharmasena holds a Ph.D. degree in Microbiology and Immunology from Dartmouth Medical School, New Hampshire.
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Interactive Questionnaire Session
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Moderator: Derek I. Duncan, PhD, Director Product Lines, LIGHTHOUSE Instruments
Derek I. Duncan, PhD, Director Product Lines, LIGHTHOUSE Instruments
Dr. Derek Duncan began his career as a Research Scientist at the Dutch Institute for Atomic & Molecular Physics in Amsterdam. He then moved into the 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, lyo chamber moisture mapping, and automated media fill inspection. Dr. Duncan has been a PDA member since 2004 and has been a regular contributor to PDA conferences, IG Groups, and Conference Program Committees.
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Plenary Discussion
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Moderator: Derek I. Duncan, PhD, Director Product Lines, LIGHTHOUSE Instruments
Derek I. Duncan, PhD, Director Product Lines, LIGHTHOUSE Instruments
Dr. Derek Duncan began his career as a Research Scientist at the Dutch Institute for Atomic & Molecular Physics in Amsterdam. He then moved into the 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, lyo chamber moisture mapping, and automated media fill inspection. Dr. Duncan has been a PDA member since 2004 and has been a regular contributor to PDA conferences, IG Groups, and Conference Program Committees. -
Regulatory Panelist: Desmond G Hunt, PhD, Sr. Principal Scientist, USP
Desmond G Hunt, PhD, Sr. Principal Scientist, USP
Dr. Desmond G. Hunt has been with USP since 2005 and holds the position of Sr. Principal Scientist in the Compendial Science Group-General Chapters. He works with the Packaging and Distribution and Dosage Forms Expert Committees, where he works to develop and revise USP Standards. He has authored many publications and peer-reviewed articles and is a frequent speaker and instructor on topics related to pharmaceutical packaging, particulate matter in parenteral and ophthalmic dosage forms, and good storage and transportation practices. He participates in several industry Working Groups and Technical Committees related to his areas of expertise. Dr. Hunt obtained his M.S. and Ph.D. from the University of Texas at Austin. -
Panelist: Hanno Gereon Geissler, Head of Technology Services, SIG
Hanno Gereon Geissler, Head of Technology Services, SIG
Hanno Geissler studied Food Chemistry at the University of Münster, Germany, and graduated as a “state–certified” food chemist. He worked for TÜV ESSEN, Germany as a DIN ISO 9000 co–auditor and in various positions for the German Food Safety Authority, Duisburg. He started with SIG Combibloc in 1999 as a field microbiologist to run commissioning tests with SIG customers and support them during troubleshooting worldwide. He is responsible for the Technology Services teams inside the Global R&D organization. These include various labs and aseptic and product processing specialists. As part of the SIG process authority group, he is also responsible for the validation of SIG`s aseptic systems. Hanno has been a member of the IFTPS since 2007 and part of the Aseptic Processing Committee. -
Panelist: Paul Guijt, Volunteer, International Gaucher Alliance
Paul Guijt, Volunteer, International Gaucher Alliance
Paul Guijt, a volunteer with the International Gaucher Alliance (IGA), is 62 years now living with a rare enzyme deficiency. He had over 50 hospital admissions in the first two decades of his life, including extensive surgery and tons of medication. He studied theology and philosophy in Amsterdam, became a public officer at the Dutch Council on Health Insurance, and ended his career in 2010 as a policy advisor on quality management of national screening programs like neonatal and cancers. Among other positions, he was co-founder of the Dutch Gaucher Association, a board member of the Dutch umbrella organization on hereditary and congenital diseases, and prepared what became the IGA which is celebrating its 30th anniversary. He has some 30 years of experience with infusions at home, most of the time self-infusing. With the IGA, he currently leads the development of guidelines on self-management and home infusion therapy. -
Regulatory Panelist: Madushini N. Dharmasena, PhD, Senior Pharmaceutical Quality Assessor, OPQ, CDER, U.S. FDA
Madushini N. Dharmasena, PhD, Senior Pharmaceutical Quality Assessor, OPQ, CDER, U.S. FDA
Madushini Dharmasena, Ph.D. is currently working as a Senior Pharmaceutical Quality Assessor in the FDA/CDER/ Office of Pharmaceutical Manufacturing Assessment (OPMA) Office of Pharmaceutical Quality (OPQ). Dr. Dharmasena joined the Division of Bacterial, Parasitic, and Allergenic Products in CBER in 2010 following a postdoctoral fellowship at the National Cancer Institute. At CBER she reviewed INDs and BLA supplements with a focus on product quality and manufacturing for biological products including live attenuated bacterial vaccine candidates, recombinant protein vaccine candidates, and live biotherapeutic products. In addition to review, she maintained an active research program and developed bifunctional oral vaccine candidates for the prevention of shigellosis and typhoid (FDA patent E-2012-016). In 2018 she joined OPMA, DMA Branch IV as a primary reviewer and has led numerous pre-license inspections of biologics manufacturing facilities. Dr. Dharmasena holds a Ph.D. degree in Microbiology and Immunology from Dartmouth Medical School, New Hampshire.
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Networking Lunch Break, Poster Session & Exhibition
The Hangar 1-3
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Guided Poster Walk
The Hangar 1-3
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Moderator: Bram Jongen, PhD, VP Materials and Surface Technologies, Datwyler
Bram Jongen, PhD, VP Materials and Surface Technologies, Datwyler
After his Masters in Polymer Chemistry at the University of Louvain, Belgium, Bram Jongen acquired a Ph.D. in Water Soluble Polymers used for advanced drug administration. Bram started as Technical Support Manager for Datwyler 18 years ago, and picked up the role of heading the Global Product Introduction & Support team, a global team of highly experienced and educated people, having each their expertise in the world of pharmaceutical closures. Bram himself acquired profound Extractables & Leachables expertise. From 2013 till 2020, he has been acting as Head of R&D, leading a group that focuses on developing new rubber and new coating materials. Since early 2020, he has become VP of Materials & Technologies, overseeing the development teams in Datwyler’s HealthCare branch, but also the Mobility, Food & Beverages, General Industry, and Connectors teams. -
Bettine Boltres, PhD, Director Scientific Affairs & Technical Solutions, Integrated Systems, West Pharmaceutical Services
As Director of Scientific Affairs & Technical Solutions, Glass Systems, Dr. Bettine Boltres is supporting the scientific exchange between West and the pharmaceutical industry. This complements her work as Product Manager for Schott Pharmaceutical Tubing, where she provided scientific consulting for glass primary packaging. Since 2015 Bettine has been an active member of the USP Packaging and Distribution Expert Committee as well as the ISO TC76/WG 2 on rigid container systems and WG 4 on elastomers. Additionally, in 2018 joined the European Pharmacopoeia Commission Group of Experts 16 (elastomers and plastics) and the GLS Working Party (glass). Since January 2019 she is also a member of the PDA Board of Directors, actively supporting the role of PDA in the global pharma world. She was part of the PDA Glass Handling Task Force finalizing TR 87, is actively involved in the Task Force working on an Annex to TR 73 addressing MDR GSPRs for PFS, and is part of the Pharmacopeia Interest Group. In 2015 she published the book "When Glass Meets Pharma", which builds the bridge between glass for pharmaceutical primary packaging and drug substances.
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Aseptic Transfer of RTU Containers in Light of the New Annex 1
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Poster Presenter: Christian Vaas
Christian Vaas
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CCI Testing of Fusion Sealed Parenterals
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Poster Presenter: Heinz Wolf, General Manager, PTI
Heinz Wolf, General Manager, PTI
Heinz Wolf received his Bachelor of Science degree in mechanical engineering from the Ingenieurschule in Bern, Switzerland. Wolf joined PTI in 1985 as a service engineer. He joined the sales team in 1996 and has held the position of general manager of PTI Inspection Systems since 1997. Heinz Wolf has focused on developing inspection technologies for the packaging industry that perform with a high degree of precision and reliability, and simplify testing and validation processes in the pharmaceutical, medical device, and food industries. He focuses on global quality solutions and deterministic quantitative inspection technologies for package testing that are robust, faster, cleaner, and reduce manufacturing waste. PTI, 8 Skyline Drive, Hawthorne, NY 10532 Office: 914.337.2005; Cell: 914.523.0475 e-mail: [email protected] PTI Inspection Systems: www.ptiusa.com
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Container Closure Integrity Test Methods - Status Quo
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Poster Presenter: Domingo Olivares Postigo, PhD, Laboratory Engineer in Primary Packaging Material and Device Testing, ten23
Domingo Olivares Postigo, PhD, Laboratory Engineer in Primary Packaging Material and Device Testing, ten23
Domingo Olivares Postigo, PhD. Laboratory Engineer in Primary Packaging Materials and Device Testing. Ten23. Domingo Olivares Postigo studied Chemistry at the Complutense University of Madrid, Spain, where he earned his Bachelor’s degree with a focus on Raman spectroscopy, followed by a Master’s degree in Chemical Science and Technology, specializing in Microfluidics from the same university. During his academic tenure, he also worked at a Quality Control Chemical Analysis Laboratory at Ainprot S.A. and as a Nuclear Magnetic Resonance spectroscopy Scientist at Aarhus University. He furthered his education by pursuing a Ph.D. in Physical Chemistry at the University of Turin and the Italian Institute of Technology, where he delved into research on nitrogen-vacancy centers in diamonds. Transitioning to the pharmaceutical industry, he moved as Quality Control Scientist of Primary Packaging and Raw Materials in Lonza and currently, he serves as a Laboratory Engineer in Primary Packaging Materials and Device Testing in ten23. -
Poster Presenter: Sarah S. Peláez, PhD Student & Senior Scientist Primary Packaging, ten23 health
Sarah S. Peláez, PhD Student & Senior Scientist Primary Packaging, ten23 health
Sarah Peláez works as a PhD Student and Senior Scientist in the primary packaging and manufacturing group at ten23 health, a CDMO founded in 2021 in Basel (Switzerland). Before she joined ten23 health in 2021, she worked three years at Lonza in different groups, including the phys.-chem. analytical department and in primary packaging and device development. Sarah is experienced in the development of container closure systems (CCS) for parenteral drug products. Her current research focuses on process characterization of disposable materials used in biopharmaceutical manufacturing. She holds a BSc and MSc degree in Life Sciences, Pharmaceutics from the University of Applied Sciences and Arts Northwestern Switzerland, and is currently enrolled in a PhD program at the University of Frankfurt.
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Determining CCI Failure Temperature and Mechanism of PFS Performance at Ultra-Low Temperatures
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Poster Presenter: Lena Mungenast, Scientist, University of Applied Sciences Northwestern Switzerland
Lena Mungenast, Scientist, University of Applied Sciences Northwestern Switzerland
Lena Mungenast works as a scientist in the pharmaceutical technology of macromolecular substances group led by Professor Germershaus at University of Applied Sciences Northwestern Switzerland (FHNW). Her current research focuses on the development of drug delivery systems, formulation of parenteral drug products and container closure systems. Lena is currently enrolled as a PhD student at the University of Freiburg working in the field of tissue engineering on spinal cord research. She holds a BSc degree in Chemistry from University Wuerzburg and MSc degree in Molecular technologies from University of Applied Sciences Northwestern Switzerland.
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Electron Beam Technology – Transfer Technology for Pre-Sterilized RTU Components
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Poster Presenter: Manfred Holzer, Strategic Product Manager E-Beam Technology, SKAN AG
Manfred Holzer, Strategic Product Manager E-Beam Technology, SKAN AG
Manfred studied Mechanical Engineering and is engaged as Sales Manager for isolators in the pharmaceutical industry since 1995. He joined SKAN AG in 2000 in various positions in international sales & project management, as well as USA business coordinator. Since 2008 he covered in sales the E-Beam technology and is today the Strategic Product Manager E-Beam technology for pharma E-Beam applications at SKAN.
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Headspace Analysis versus Helium Leak Testing
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Poster Presenter: Suzanne Kuiper, PhD, Application Manager, Lighthouse Instruments
Suzanne Kuiper, PhD, Application Manager, Lighthouse Instruments
At LIGHTHOUSE since 2011, Dr. Kuiper has been a headspace analysis application expert on process monitoring and finished product inspection. These include using headspace analysis for container closure integrity testing, lyo chamber moisture mapping, headspace oxygen monitoring, and automated media fill inspection. -
Poster Presenter: Marissa Kateva, MSc, Laboratory Analyst, Lighthouse Instruments
Marissa Kateva, MSc, Laboratory Analyst, Lighthouse Instruments
My name is Marissa Kareva, my bachelor's degree was in chemistry obtained from the University of Crete in Greece. I also hold a master's degree in Biomolecular Sciences obtained from the Vrije University of Amsterdam. Currently, for the last one and a half years I have been working as a Laboratory Analyst for Lighthouse Instruments in Amsterdam.
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Industry Perspective on a Holistic Approach to Container Closure Integrity
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Poster Presenter: Carine Huon, BSC, Container Closure Integrity Scientist, Sanofi
Carine Huon, BSC, Container Closure Integrity Scientist, Sanofi
After 2 years in bioanalysis and 12 years as an analytical specialist in dry pharmaceutical forms. I spent the last 4 years working on CCI control strategy as a technical development engineer at Sanofi on different components (syringe, cartridge, vial, etc.). I am also part of different multi-company expert communities such as the SFSTP (French Society of Pharmaceutical Sciences and Techniques) on topics such as the robustness of analytical methods or aQBD (Analytical Quality By Design) and Biophorum on topics such as "sample sizing approaches for CCI testing" or "the holistic approach to container closure integrity".
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Interaction of Machine and Packaging Material
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Poster Presenter: Klaus Ullherr, Senior Product Manager, Syntegon Technology GmbH
Klaus Ullherr, Senior Product Manager, Syntegon Technology GmbH
Klaus Ullherr (Senior Product Manager) has a degree in electrical engineering. After university, he worked for several years as a project manager in the electrical industry. In March 2000 he joined Robert Bosch GmbH, Packaging Technology, Product Division Pharma Liquid, now Syntegon Technology. During the first two years, he was the project manager responsible for handling complex customer orders. Since 2002 he has been a product manager for the business fields of syringes and RTU (ready-to-use) containers with global product responsibility. His main functions are market analysis, initiating new product developments, business development, and expert in syringe/nested container processing. He is a member of the PDA and trainer at the PDA training course "All about pre-filled syringes" and works as an expert in the DIN/ISO group for primary packaging. Klaus is also a member of ISPE and a member of the program committee of the yearly ISPE Aseptic Conference. He is a well-known speaker and trainer covering trends and solutions for fill/finish equipment, especially for pre-filled syringes and other pre-sterilized containers.
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On the Evolution of Stability and Quality of Bake-on PDMS Coatings upon Extended Thermal Treatments
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Poster Presenter: Chiara Passet
Chiara Passet
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Positive Controls - From Kirsch to Now
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Poster Presenter: Christian Proff, PhD, Senior Verification Engineer, F. Hoffmann-La Roche Ltd
Christian Proff, PhD, Senior Verification Engineer, F. Hoffmann-La Roche Ltd
Dr. Christian Proff is a materials scientist with degrees from Chalmers, Gothenburg (S), and Darmstadt (D) Universities of Technology, and a Ph.D. from Grenoble (F) University (INPG) with extensive experience in materials research in Sweden (Chalmers), USA (Argonne National Laboratory), and Switzerland (Paul-Scherrer-Institut). Within device and packaging development at F. Hoffmann-La Roche, he has been working in verification engineering since 2018 on improvements in CCI testing and the development of new device test methods.
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Pre-filled Syringes for Deep Cold Storage
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Poster Presenter: Philip Bortner, M.Sc., Global Product Manager Syringes, Gerresheimer Regensburg GmbH
Philip Bortner, M.Sc., Global Product Manager Syringes, Gerresheimer Regensburg GmbH
Philip Bortner is a medical engineer (M.Sc.) by education and graduated from the Technical University in Regensburg, Germany. He started his career as Global Product Manager of Syringes in the Business Development department at Gerresheimer in 2020 with the focus being on polymer syringes. In his position, he is responsible for expanding the product portfolio for polymer solutions according to the market's needs and is supporting customers with all kinds of technical questions.
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Probability of Detection Study
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Poster Presenter: Bram J.J. KEYMOLEN, Co-Founder, eyetec
Bram J.J. KEYMOLEN, Co-Founder, eyetec
Graduated pharmacist at the university of Antwerp, Bram Keymolen obtained a second master degree in Industrial Pharmacy in 1999. Over twenty years of GMP experience in different roles, initially mainly in qualification and validation, evolving into several QA and QP positions in mainly biotech companies – both startups and corporate structures. After taking a position as Process Engineer in the field of visual inspection in 2006, created his own consultancy company in this domain in 2011. Eye-Tec supports visual inspection and CCIT projects under GMP. Missions vary from CAPA-development to major CAPEX projects or corporate strategy development for visual inspection and CCIT. Eye-Tec offers both technical solutions (vision tuning and optical/mechanical improvement) and compliance support to customers worldwide.
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The Need for High Quality in Primary Packaging
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Poster Presenter: Ana Kuschel, PhD, Principal Scientific Affairs, West Pharmaceutical Services, Inc.
Ana Kuschel, PhD, Principal Scientific Affairs, West Pharmaceutical Services, Inc.
As Principal Scientific Affairs Europe, Ana is providing technical support relating to West’s packaging components and delivery systems for injectable drugs and healthcare products. As well as bridging scientific information through industry outreach. This complements her previous role as Manager of Material Development, where she worked on both existing and new rubber formulations. Ana holds a PhD in macromolecular chemistry and is an active member of the ISO TC 76 and PDA Packaging Science groups.
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Using Finite Element Analysis to Model Stopper Raising
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Poster Presenter: Ana Kuschel, PhD, Principal Scientific Affairs, West Pharmaceutical Services, Inc.
Ana Kuschel, PhD, Principal Scientific Affairs, West Pharmaceutical Services, Inc.
As Principal Scientific Affairs Europe, Ana is providing technical support relating to West’s packaging components and delivery systems for injectable drugs and healthcare products. As well as bridging scientific information through industry outreach. This complements her previous role as Manager of Material Development, where she worked on both existing and new rubber formulations. Ana holds a PhD in macromolecular chemistry and is an active member of the ISO TC 76 and PDA Packaging Science groups.
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Session 1, Track A: Primary Packaging Components
The Hangar 5
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Moderator: Arne Kloke, PhD, Head of Service and Sustainability Management, SCHOTT Pharma
Arne Kloke, PhD, Head of Service and Sustainability Management, SCHOTT Pharma
Arne Kloke serves as the Head of Service and Sustainability Management at SCHOTT Pharma, overseeing the development and implementation of the company's sustainability strategy and action program. Additionally, he holds the position of President at the Alliance to Zero, a pharma supply chain initiative focused on facilitating the transition of injection devices to net-zero. In both roles, his primary objective is to foster the creation of product solutions and service models that harmonize environmental responsibility with financial viability. With a background in science, Arne is also a member of the PDA Parenteral Packaging Conference Committee and is committed to collaborating with partners in the injectables industry to realize innovative primary packaging and processing solutions.
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Materials for Drug Containers: Glass versus Polymer, Basics, Pros, Cons and Different Applications
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Presenter: Jochen Heinz, MEng, PhD, Head of New Products & Technology, Transcoject GmbH
Jochen Heinz, MEng, PhD, Head of New Products & Technology, Transcoject GmbH
Dr.-Ing. Jochen Heinz holds an M.Eng. in Material-Science and Technology and a Ph.D. from a cooperation of the University of Clausthal and Schott-Glass on Glass-Platinum interactions. From there he continued since 1991 as a scientist at SCHOTT Central Research working on different topics of material- and technology. In 1995 within Schott-Glass he joined the pharmaceutical packaging unit with the task of development the polymer TOPAS for use in pharmaceutical packaging and refillable containers including their production technology. This became the Schott-Topac-System. Since 1999 he became responsible for the New Product Development of the Pharmaceutical Packaging unit. He left Schott in 2001 and joined Transcoject a manufacturer of Medical Devices. He set up an aseptic filling operation and worked beside development in different functions. He is the Director of Development and Technology of the company. Since about 2000 Trancoject has been developing prefillable containers of COC and since about 2005 refillable COP and COC syringes with a portfolio from 0.3ml to 250ml.
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How Strong is That Vial Anyway? Applying Glass Fractography to the Evaluation of Novel Glass Parenteral Packaging Technologies
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Presenter: Brandon Aldinger, PhD, Senior Scientist, American Glass Research
Brandon Aldinger, PhD, Senior Scientist, American Glass Research
Brandon Aldinger PhD is a Senior Scientist at American Glass Research (AGR), where he focuses on pharmaceutical fracture analysis, container testing, and stone identification. Dr. Aldinger has written over 1000 customer reports, taught hundreds of students in fracture analysis, and is the co-author of two books on glass technology. Prior to joining AGR, he was a Materials Scientist at a defense contractor, where he designed and tested transparent armor (i.e. bullet-resistant glass) for military vehicles. Dr. Aldinger earned his B.S. in Chemistry at Penn State University and his Ph.D. at Cornell University.
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The Effects of the Rubber Component and the Selected Analytical Method on the Moisture Content of a Freeze-Dried Cake
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Presenter: Elke Geuzens, PhD, Technical and Scientific Expert, Datwyler
Elke Geuzens, PhD, Technical and Scientific Expert, Datwyler
Elke Geuzens graduated with a doctorate in chemistry from Hasselt University, Belgium. Before she joined Datwyler in 2010 as a product support manager, she had several years of experience in the chemical industry. Currently, Elke is a Technical and Scientific Expert and she has more than 10 years of experience in similar roles within the company. In her current role, Elke consults with pharmaceutical and medical device companies on parenteral packaging solutions to develop safe and efficacious drug-delivery systems. She holds global responsibility for several key clients, where she is responsible for technical projects from the ideation to the commercialization stage.
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Q&A, Discussion
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Moderator: Arne Kloke, PhD, Head of Service and Sustainability Management, SCHOTT Pharma
Arne Kloke, PhD, Head of Service and Sustainability Management, SCHOTT Pharma
Arne Kloke serves as the Head of Service and Sustainability Management at SCHOTT Pharma, overseeing the development and implementation of the company's sustainability strategy and action program. Additionally, he holds the position of President at the Alliance to Zero, a pharma supply chain initiative focused on facilitating the transition of injection devices to net-zero. In both roles, his primary objective is to foster the creation of product solutions and service models that harmonize environmental responsibility with financial viability. With a background in science, Arne is also a member of the PDA Parenteral Packaging Conference Committee and is committed to collaborating with partners in the injectables industry to realize innovative primary packaging and processing solutions. -
Panelist: Jochen Heinz, MEng, PhD, Head of New Products & Technology, Transcoject GmbH
Jochen Heinz, MEng, PhD, Head of New Products & Technology, Transcoject GmbH
Dr.-Ing. Jochen Heinz holds an M.Eng. in Material-Science and Technology and a Ph.D. from a cooperation of the University of Clausthal and Schott-Glass on Glass-Platinum interactions. From there he continued since 1991 as a scientist at SCHOTT Central Research working on different topics of material- and technology. In 1995 within Schott-Glass he joined the pharmaceutical packaging unit with the task of development the polymer TOPAS for use in pharmaceutical packaging and refillable containers including their production technology. This became the Schott-Topac-System. Since 1999 he became responsible for the New Product Development of the Pharmaceutical Packaging unit. He left Schott in 2001 and joined Transcoject a manufacturer of Medical Devices. He set up an aseptic filling operation and worked beside development in different functions. He is the Director of Development and Technology of the company. Since about 2000 Trancoject has been developing prefillable containers of COC and since about 2005 refillable COP and COC syringes with a portfolio from 0.3ml to 250ml. -
Panelist: Brandon Aldinger, PhD, Senior Scientist, American Glass Research
Brandon Aldinger, PhD, Senior Scientist, American Glass Research
Brandon Aldinger PhD is a Senior Scientist at American Glass Research (AGR), where he focuses on pharmaceutical fracture analysis, container testing, and stone identification. Dr. Aldinger has written over 1000 customer reports, taught hundreds of students in fracture analysis, and is the co-author of two books on glass technology. Prior to joining AGR, he was a Materials Scientist at a defense contractor, where he designed and tested transparent armor (i.e. bullet-resistant glass) for military vehicles. Dr. Aldinger earned his B.S. in Chemistry at Penn State University and his Ph.D. at Cornell University. -
Panelist: Elke Geuzens, PhD, Technical and Scientific Expert, Datwyler
Elke Geuzens, PhD, Technical and Scientific Expert, Datwyler
Elke Geuzens graduated with a doctorate in chemistry from Hasselt University, Belgium. Before she joined Datwyler in 2010 as a product support manager, she had several years of experience in the chemical industry. Currently, Elke is a Technical and Scientific Expert and she has more than 10 years of experience in similar roles within the company. In her current role, Elke consults with pharmaceutical and medical device companies on parenteral packaging solutions to develop safe and efficacious drug-delivery systems. She holds global responsibility for several key clients, where she is responsible for technical projects from the ideation to the commercialization stage.
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Session 1, Track B: Container Closure Integrity Testing
The Hangar 4
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Moderator: Coralie A Richard, PhD, Senior Director, Eli Lilly and Company
Coralie A Richard, PhD, Senior Director, Eli Lilly and Company
Coralie Richard is the Director of Packaging Systems in Delivery and Device Connected Solutions (DDCS) at Eli Lilly and Company, Indianapolis, USA. A native of France, she came to the USA to pursue her PhD in Organic Chemistry at the Georgia Institute of Technology. After working as an R&D scientist in a material company, she joined the primary packaging system team at Eli Lilly, supporting container closure systems development activities and container-related research projects. Her contributions were recognized with two Eli Lilly Top 100 Innovator Awards half a dozen articles and a patent. In her current role, she provides technical and organizational leadership in the areas of primary packaging/container closure development, secondary packaging, shipping & distribution, surface science, and several related DDCS laboratories. Her global team supports clinical and commercial development activities across all business units.
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Fully Leveraging Robust CCIT Techniques when Developing PFS within a Holistic Approach
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Co-Presenter: Jean-Sebastien Steffen, MS, PhD, Group Lead Primary Packaging and Combination Products, Lonza
Jean-Sebastien Steffen, MS, PhD, Group Lead Primary Packaging and Combination Products, Lonza
Jean-Sébastien Steffen leads the Combination Product and Primary Packaging development organization with Lonza Drug Product Services (Basel, Switzerland). He supports Lonza’s customers with a long experience in the technical development of combination products for clinical and commercial applications. Jean-Sebastien has also been a key player in establishing global prefilled syringe technology platforms for different large pharmaceutical companies and developed extensive expertise regarding container closure integrity, drug-container interaction, and combination product functionality questions. -
Federico Sabini, MD in Biomedical Engineering, QC Senior Specialist Primary Packaging Materials and Combination Products, Lonza AG
Accomplished primary packaging material expert with a master's degree in Bioengineering and over 9 years of experience in primary packaging development. After university, he joined Baxter Healthcare as a Product Development Engineer, supporting the V&V activities of new flexible bags for peritoneal dialysis treatment and design change control tasks for products already on the market. Then, he moved to the glass primary packaging material industry working for Nuova Ompi, Pharmaceutical System Division of Stevanato Group, as Technical Project Lead. In this role, he was leading the development activities of an innovative multi-products platform of sterile glass primary packaging systems (e.g. syringes, cartridges, and vials) for injectable, highly sensitive drugs from design concept to commercialization. Later, he joined Lonza DPS as an Associate Principal Scientist in Primary Packaging and Combination Products leading the implementation of a Container Closure System Qualification strategy for Vialed Drug Products and Pre-filled Syringes in the Lonza DPS manufacturing sites network. He is currently working as QC Senior Expert for PPMs at Lonza DPS. In this role, he is building up a global QC strategy for the incoming release of PPMs (including vials, pre-fillable syringes, rubber stoppers and plungers, and flip-off seal caps) and defining related internal specifications and requirements.
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Ready to Use Cartridges: Quantitative Assessment of Container Closure Integrity
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Presenter: Serena Casanova, PhD, Technical Leader, Stevanato Group
Serena Casanova, PhD, Technical Leader, Stevanato Group
Serena is a Chemical Engineer and has a PhD in Nanotechnology applied to water purification. She studied at several Universities across Europe, and this gave her education an international and diverse imprint. Today, she works in R&D at Stevanato Group, developing primary packaging solutions for injectors in the healthcare sector. Her subject matter expertise is Ready to Fill Cartridges: critical material attributes, critical process parameters, critical to quality attributes, and the link between the above. Serena acts as technical lead and process developer for multi-disciplinary projects from their early evaluation from the industrial implementation, going through the feasibility, development, validation, and verification.
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A Finite Elements Modeling-Multiscale Contact Mechanics (FEM-MCM) Simulation Approach to Predict the Sealing Performance of a Luer Lock Connector Involving a Polymer-Glass Interface
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Presenter: Julien Singer, PhD, R&D Senior Engineer, BD
Julien Singer, PhD, R&D Senior Engineer, BD
After holding different positions in the semiconductor field, from microelectronics to photovoltaics, Julien Singer reached BD in 2013 as a modeling and simulation expert. In his current role, Julien uses various modeling tools to understand and predict how medical devices behave. He supports project teams and subject matter experts to address the problems they face during the whole product life cycle, by defining the best modeling strategy and ensuring the best outcome of physics-based models. Another important aspect of his role is to capitalize on and disseminate modeling expertise across the R&D community and beyond. His fields of interest include structural mechanics, fluid mechanics, and tribology. Julien holds an engineering degree in Material Science from the National Institute of Applied Sciences (INSA) of Lyon, France, and a PhD in Modeling and Numerical Simulation from INSA Lyon.
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Q&A, Discussion
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Moderator: Coralie A Richard, PhD, Senior Director, Eli Lilly and Company
Coralie A Richard, PhD, Senior Director, Eli Lilly and Company
Coralie Richard is the Director of Packaging Systems in Delivery and Device Connected Solutions (DDCS) at Eli Lilly and Company, Indianapolis, USA. A native of France, she came to the USA to pursue her PhD in Organic Chemistry at the Georgia Institute of Technology. After working as an R&D scientist in a material company, she joined the primary packaging system team at Eli Lilly, supporting container closure systems development activities and container-related research projects. Her contributions were recognized with two Eli Lilly Top 100 Innovator Awards half a dozen articles and a patent. In her current role, she provides technical and organizational leadership in the areas of primary packaging/container closure development, secondary packaging, shipping & distribution, surface science, and several related DDCS laboratories. Her global team supports clinical and commercial development activities across all business units. -
Panelist: Serena Casanova, PhD, Technical Leader, Stevanato Group
Serena Casanova, PhD, Technical Leader, Stevanato Group
Serena is a Chemical Engineer and has a PhD in Nanotechnology applied to water purification. She studied at several Universities across Europe, and this gave her education an international and diverse imprint. Today, she works in R&D at Stevanato Group, developing primary packaging solutions for injectors in the healthcare sector. Her subject matter expertise is Ready to Fill Cartridges: critical material attributes, critical process parameters, critical to quality attributes, and the link between the above. Serena acts as technical lead and process developer for multi-disciplinary projects from their early evaluation from the industrial implementation, going through the feasibility, development, validation, and verification. -
Federico Sabini, MD in Biomedical Engineering, QC Senior Specialist Primary Packaging Materials and Combination Products, Lonza AG
Accomplished primary packaging material expert with a master's degree in Bioengineering and over 9 years of experience in primary packaging development. After university, he joined Baxter Healthcare as a Product Development Engineer, supporting the V&V activities of new flexible bags for peritoneal dialysis treatment and design change control tasks for products already on the market. Then, he moved to the glass primary packaging material industry working for Nuova Ompi, Pharmaceutical System Division of Stevanato Group, as Technical Project Lead. In this role, he was leading the development activities of an innovative multi-products platform of sterile glass primary packaging systems (e.g. syringes, cartridges, and vials) for injectable, highly sensitive drugs from design concept to commercialization. Later, he joined Lonza DPS as an Associate Principal Scientist in Primary Packaging and Combination Products leading the implementation of a Container Closure System Qualification strategy for Vialed Drug Products and Pre-filled Syringes in the Lonza DPS manufacturing sites network. He is currently working as QC Senior Expert for PPMs at Lonza DPS. In this role, he is building up a global QC strategy for the incoming release of PPMs (including vials, pre-fillable syringes, rubber stoppers and plungers, and flip-off seal caps) and defining related internal specifications and requirements. -
Panelist: Julien Singer, PhD, R&D Senior Engineer, BD
Julien Singer, PhD, R&D Senior Engineer, BD
After holding different positions in the semiconductor field, from microelectronics to photovoltaics, Julien Singer reached BD in 2013 as a modeling and simulation expert. In his current role, Julien uses various modeling tools to understand and predict how medical devices behave. He supports project teams and subject matter experts to address the problems they face during the whole product life cycle, by defining the best modeling strategy and ensuring the best outcome of physics-based models. Another important aspect of his role is to capitalize on and disseminate modeling expertise across the R&D community and beyond. His fields of interest include structural mechanics, fluid mechanics, and tribology. Julien holds an engineering degree in Material Science from the National Institute of Applied Sciences (INSA) of Lyon, France, and a PhD in Modeling and Numerical Simulation from INSA Lyon. -
Panelist: Jean-Sebastien Steffen, MS, PhD, Group Lead Primary Packaging and Combination Products, Lonza
Jean-Sebastien Steffen, MS, PhD, Group Lead Primary Packaging and Combination Products, Lonza
Jean-Sébastien Steffen leads the Combination Product and Primary Packaging development organization with Lonza Drug Product Services (Basel, Switzerland). He supports Lonza’s customers with a long experience in the technical development of combination products for clinical and commercial applications. Jean-Sebastien has also been a key player in establishing global prefilled syringe technology platforms for different large pharmaceutical companies and developed extensive expertise regarding container closure integrity, drug-container interaction, and combination product functionality questions.
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Networking Coffee Break & Exhibition
The Hangar 1-3
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Session 2, Track A: Deep Cold Storage
The Hangar 5
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Moderator: Madushini N. Dharmasena, PhD, Senior Pharmaceutical Quality Assessor, OPQ, CDER, U.S. FDA
Madushini N. Dharmasena, PhD, Senior Pharmaceutical Quality Assessor, OPQ, CDER, U.S. FDA
Madushini Dharmasena, Ph.D. is currently working as a Senior Pharmaceutical Quality Assessor in the FDA/CDER/ Office of Pharmaceutical Manufacturing Assessment (OPMA) Office of Pharmaceutical Quality (OPQ). Dr. Dharmasena joined the Division of Bacterial, Parasitic, and Allergenic Products in CBER in 2010 following a postdoctoral fellowship at the National Cancer Institute. At CBER she reviewed INDs and BLA supplements with a focus on product quality and manufacturing for biological products including live attenuated bacterial vaccine candidates, recombinant protein vaccine candidates, and live biotherapeutic products. In addition to review, she maintained an active research program and developed bifunctional oral vaccine candidates for the prevention of shigellosis and typhoid (FDA patent E-2012-016). In 2018 she joined OPMA, DMA Branch IV as a primary reviewer and has led numerous pre-license inspections of biologics manufacturing facilities. Dr. Dharmasena holds a Ph.D. degree in Microbiology and Immunology from Dartmouth Medical School, New Hampshire.
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Vials for Deep Cold Storage - Part II
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Presenter: Diana Löber, Global Product Manager Vials, SCHOTT Pharma AG & Co. KGaA
Diana Löber, Global Product Manager Vials, SCHOTT Pharma AG & Co. KGaA
Diana started her career in the medical device industry prior she joining SCHOTT in the summer of 2018. With more than 10 years of experience in the area of product management, as a global product manager for vials, she is responsible for the product strategy, including the identification of new market opportunities and the development and launch of innovative products.
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Challenges and Solutions of Container Closure Integrity Syringe Testing at -180°C
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Co-Presenter: Tom Van Ginneken, Head of Product Management, SCHOTT AG
Tom Van Ginneken, Head of Product Management, SCHOTT AG
Tom Van Ginneken is the Head of Product Management for Polymer Solutions at SCHOTT Pharma. In this role, he works on the strategic orientation and innovation pipeline of the product group. His educational background includes studying Chemical Engineering in Antwerp, Belgium, and earning an MBA from the University of Sankt Gallen, Switzerland. Following three years in the chemical and pharmaceutical sector in Belgium, Tom joined SCHOTT Pharma in 2008. -
Co-Presenter: Paula Bracco, PhD., R&D Lab Director, LIGHTHOUSE Instruments
Paula Bracco, PhD., R&D Lab Director, LIGHTHOUSE Instruments
Paula Bracco is the R&D Lab Director at Lighthouse Instruments Europe. Paula is a chemist with a PhD in biotechnology. She is responsible for the discovery of new application areas in the field of non-destructive headspace analysis. In her role, she directs R&D studies, internally, for customers, or in cooperation with partners. Paula manages part of the customer portfolio within Europe, including pharmaceutical companies and packaging suppliers. She has a particular interest in research and development projects involving moisture determination by headspace water activity analysis.
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Q&A, Discussion
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Moderator: Madushini N. Dharmasena, PhD, Senior Pharmaceutical Quality Assessor, OPQ, CDER, U.S. FDA
Madushini N. Dharmasena, PhD, Senior Pharmaceutical Quality Assessor, OPQ, CDER, U.S. FDA
Madushini Dharmasena, Ph.D. is currently working as a Senior Pharmaceutical Quality Assessor in the FDA/CDER/ Office of Pharmaceutical Manufacturing Assessment (OPMA) Office of Pharmaceutical Quality (OPQ). Dr. Dharmasena joined the Division of Bacterial, Parasitic, and Allergenic Products in CBER in 2010 following a postdoctoral fellowship at the National Cancer Institute. At CBER she reviewed INDs and BLA supplements with a focus on product quality and manufacturing for biological products including live attenuated bacterial vaccine candidates, recombinant protein vaccine candidates, and live biotherapeutic products. In addition to review, she maintained an active research program and developed bifunctional oral vaccine candidates for the prevention of shigellosis and typhoid (FDA patent E-2012-016). In 2018 she joined OPMA, DMA Branch IV as a primary reviewer and has led numerous pre-license inspections of biologics manufacturing facilities. Dr. Dharmasena holds a Ph.D. degree in Microbiology and Immunology from Dartmouth Medical School, New Hampshire. -
Panelist: Diana Löber, Global Product Manager Vials, SCHOTT Pharma AG & Co. KGaA
Diana Löber, Global Product Manager Vials, SCHOTT Pharma AG & Co. KGaA
Diana started her career in the medical device industry prior she joining SCHOTT in the summer of 2018. With more than 10 years of experience in the area of product management, as a global product manager for vials, she is responsible for the product strategy, including the identification of new market opportunities and the development and launch of innovative products. -
Panelist: Paula Bracco, PhD., R&D Lab Director, LIGHTHOUSE Instruments
Paula Bracco, PhD., R&D Lab Director, LIGHTHOUSE Instruments
Paula Bracco is the R&D Lab Director at Lighthouse Instruments Europe. Paula is a chemist with a PhD in biotechnology. She is responsible for the discovery of new application areas in the field of non-destructive headspace analysis. In her role, she directs R&D studies, internally, for customers, or in cooperation with partners. Paula manages part of the customer portfolio within Europe, including pharmaceutical companies and packaging suppliers. She has a particular interest in research and development projects involving moisture determination by headspace water activity analysis. -
Panelist: Tom Van Ginneken, Head of Product Management, SCHOTT AG
Tom Van Ginneken, Head of Product Management, SCHOTT AG
Tom Van Ginneken is the Head of Product Management for Polymer Solutions at SCHOTT Pharma. In this role, he works on the strategic orientation and innovation pipeline of the product group. His educational background includes studying Chemical Engineering in Antwerp, Belgium, and earning an MBA from the University of Sankt Gallen, Switzerland. Following three years in the chemical and pharmaceutical sector in Belgium, Tom joined SCHOTT Pharma in 2008.
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Session 2, Track B: Traceability
The Hangar 4
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Moderator: Sinue Gomez, PhD Materials Science, Technology Director, Corning Incorporated
Sinue Gomez, PhD Materials Science, Technology Director, Corning Incorporated
Dr. Sinue Gomez is the business technology director, of Corning Pharmaceutical Technologies (CPT) in May 2021. Gomez leads the development of new products and process technology for CPT. She is responsible for developing and helping execute CPT’s technology strategy and developing the technology roadmap. Gomez joined Corning in 2006 as a research scientist in the glass research group, where she was one of the key inventors of the first Gorilla® glass and subsequent generations of ion-exchangeable glasses and glass ceramics for the Gorilla glass business and adjacencies. Gomez transitioned to glass development in 2014 and then joined CPT in 2016 as a glass surfaces manager, where she delivered a washing process for high-volume manufacturing. Most recently, she was responsible for delivering the product design of CPT's newest product, Viridian Vial™. Gomez earned a Ph.D. in Materials Science from the University of Connecticut and a bachelor’s degree in Materials Engineering from Universidad Simon Bolivar in Caracas, Venezuela. She has over 50 granted patents and several trade secrets.
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Towards the Batch Report of One: Connecting Traceability Across Machines and Batches
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Presenter: Robert T Urquhart, MBA, CEO, Eagas
Robert T Urquhart, MBA, CEO, Eagas
Tod Urquhart has more than 14 years of experience in digitalization and product traceability including software systems, regulatory compliance, process efficiency, and supply chain visibility. He has worked with Pfizer, GSK, Novartis, Merck, Danone, and the Stevanato Group. Currently he is a pharma industry advisor working with software systems. He is also the Vice chairman of an ISPE Community of Practise [CoP] and chair of the Filling & Inspection working group which is creating an industry Good Practise Guide for the use and implementation of unique containers across the parenteral manufacturing supply chain.
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Seamless Traceability from a Single Device incl. GMP Process Parameter Tracking up to Pallet Aggregation
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Co-Presenter: Georg Schick, Dipl.-Ing., Strategic Product Manager Track & Trace, Uhlmann Pac-Systeme GmbH & Co KG
Georg Schick, Dipl.-Ing., Strategic Product Manager Track & Trace, Uhlmann Pac-Systeme GmbH & Co KG
Georg Schick is the Strategic Product Manager for all "Track & Trace" solutions from Uhlmann Pac-Systeme GmbH & Co. KG, a global leader in providing systems for packing pharmaceuticals. After completing his degree in electrical engineering at the Ulm University of Applied Sciences, he began his career in 1999 at Uhlmann, working as an electrical designer for cartoners and end-of-line packaging machines. From this position, he was promoted to Project Manager for automation. His many years of experience in diverse fields of automation engineering and his extensive project work with clients were the perfect preparation for his current role in Sales and Strategic Product Management for "Track & Trace" solutions. He forms part of a team of experts at Uhlmann, whose in-depth knowledge has earned them a reputation as valued contact partners among pharmaceutical companies. -
Co-Presenter: Frank Bixenmann, Consultant Digital Solutions, Consultant Digital Solutions, Uhlmann Pac-Systeme GmbH & Co. KG
Frank Bixenmann, Consultant Digital Solutions, Consultant Digital Solutions, Uhlmann Pac-Systeme GmbH & Co. KG
Frank Bixenmann is Consultant Digital Solutions of the Business Unit Digital of Uhlmann Pac-Systeme GmbH & Co. KG. After completing his further education as a state-certified automation technology technician, the trained mechatronics engineer began his career in 2010 as a project manager for printing and camera systems and track and trace applications at Uhlmann, one of the world's leading system suppliers for the packaging of pharmaceuticals. He then developed further to become an Electrical Engineer in Automation Projects. Many years of experience with digital solutions and intensive project work with customers were the best qualifications for his current job in sales. As a Consultant for Digital Solutions, he is now one of Uhlmann's experts for automation and software solutions, whose in-depth expertise makes him a valued contact for pharmaceutical companies.
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Q&A, Discussion
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Moderator: Sinue Gomez, PhD Materials Science, Technology Director, Corning Incorporated
Sinue Gomez, PhD Materials Science, Technology Director, Corning Incorporated
Dr. Sinue Gomez is the business technology director, of Corning Pharmaceutical Technologies (CPT) in May 2021. Gomez leads the development of new products and process technology for CPT. She is responsible for developing and helping execute CPT’s technology strategy and developing the technology roadmap. Gomez joined Corning in 2006 as a research scientist in the glass research group, where she was one of the key inventors of the first Gorilla® glass and subsequent generations of ion-exchangeable glasses and glass ceramics for the Gorilla glass business and adjacencies. Gomez transitioned to glass development in 2014 and then joined CPT in 2016 as a glass surfaces manager, where she delivered a washing process for high-volume manufacturing. Most recently, she was responsible for delivering the product design of CPT's newest product, Viridian Vial™. Gomez earned a Ph.D. in Materials Science from the University of Connecticut and a bachelor’s degree in Materials Engineering from Universidad Simon Bolivar in Caracas, Venezuela. She has over 50 granted patents and several trade secrets. -
Panelist: Robert T Urquhart, MBA, CEO, Eagas
Robert T Urquhart, MBA, CEO, Eagas
Tod Urquhart has more than 14 years of experience in digitalization and product traceability including software systems, regulatory compliance, process efficiency, and supply chain visibility. He has worked with Pfizer, GSK, Novartis, Merck, Danone, and the Stevanato Group. Currently he is a pharma industry advisor working with software systems. He is also the Vice chairman of an ISPE Community of Practise [CoP] and chair of the Filling & Inspection working group which is creating an industry Good Practise Guide for the use and implementation of unique containers across the parenteral manufacturing supply chain. -
Panelist: Georg Schick, Dipl.-Ing., Strategic Product Manager Track & Trace, Uhlmann Pac-Systeme GmbH & Co KG
Georg Schick, Dipl.-Ing., Strategic Product Manager Track & Trace, Uhlmann Pac-Systeme GmbH & Co KG
Georg Schick is the Strategic Product Manager for all "Track & Trace" solutions from Uhlmann Pac-Systeme GmbH & Co. KG, a global leader in providing systems for packing pharmaceuticals. After completing his degree in electrical engineering at the Ulm University of Applied Sciences, he began his career in 1999 at Uhlmann, working as an electrical designer for cartoners and end-of-line packaging machines. From this position, he was promoted to Project Manager for automation. His many years of experience in diverse fields of automation engineering and his extensive project work with clients were the perfect preparation for his current role in Sales and Strategic Product Management for "Track & Trace" solutions. He forms part of a team of experts at Uhlmann, whose in-depth knowledge has earned them a reputation as valued contact partners among pharmaceutical companies. -
Frank Bixenmann, Consultant Digital Solutions, Consultant Digital Solutions, Uhlmann Pac-Systeme GmbH & Co. KG
Frank Bixenmann is Consultant Digital Solutions of the Business Unit Digital of Uhlmann Pac-Systeme GmbH & Co. KG. After completing his further education as a state-certified automation technology technician, the trained mechatronics engineer began his career in 2010 as a project manager for printing and camera systems and track and trace applications at Uhlmann, one of the world's leading system suppliers for the packaging of pharmaceuticals. He then developed further to become an Electrical Engineer in Automation Projects. Many years of experience with digital solutions and intensive project work with customers were the best qualifications for his current job in sales. As a Consultant for Digital Solutions, he is now one of Uhlmann's experts for automation and software solutions, whose in-depth expertise makes him a valued contact for pharmaceutical companies.
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End of Conference Day 1 & Networking Event
Wednesday, 24 April CEST
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Registration Open
The Hangar 1-3
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Track A: Packaging Science Morning Session - MDR Cobalt Requirement Regulations
The Hangar 5
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Moderator: Tony A Perry, Regional Director of Quality, SCHOTT Pharma
Tony A Perry, Regional Director of Quality, SCHOTT Pharma
More than thirty years in the manufacture of Pharmaceutical Containers Six years working in the Pharmaceutical Industry Six Sigma Black Belt: ASQ Certified SSBB A Degree Mathematics Born in the UK, but have lived and worked in the US for the last twenty years
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The Impact of the MDR Cobalt Requirement Regulations
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Presenter: Ana Kuschel, PhD, Principal Scientific Affairs, West Pharmaceutical Services, Inc.
Ana Kuschel, PhD, Principal Scientific Affairs, West Pharmaceutical Services, Inc.
As Principal Scientific Affairs Europe, Ana is providing technical support relating to West’s packaging components and delivery systems for injectable drugs and healthcare products. As well as bridging scientific information through industry outreach. This complements her previous role as Manager of Material Development, where she worked on both existing and new rubber formulations. Ana holds a PhD in macromolecular chemistry and is an active member of the ISO TC 76 and PDA Packaging Science groups.
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Open Discussion
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Moderator: Tony A Perry, Regional Director of Quality, SCHOTT Pharma
Tony A Perry, Regional Director of Quality, SCHOTT Pharma
More than thirty years in the manufacture of Pharmaceutical Containers Six years working in the Pharmaceutical Industry Six Sigma Black Belt: ASQ Certified SSBB A Degree Mathematics Born in the UK, but have lived and worked in the US for the last twenty years -
Panelist: Maria Bauer, Product Reviewer BC, TÜV SÜD PRODUCT SERVICE GmbH
Maria Bauer, Product Reviewer BC, TÜV SÜD PRODUCT SERVICE GmbH
My professional background: I am a Pharmacist, additionally experienced in Medical Device Regulatory Affairs. I have been with TÜV SÜD PRODUCT SERVICE GmbH since 2017. The main tasks are the Medical Device Technical Documentation Review in terms of 1) Biocompatibility (esp. for class III medical devices, class III MDR Annex XVI devices), and for 2) Drug Device Consultations.
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Track B: Pre-Filled Syringes Morning Session - Meet Future Market & Regulatory Requirements for Filling & Assembly of Pre-Filled Syringes
The Hangar 4
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Moderator: Brigitte Reutter-Haerle, Vice President Product Management & Marketing, Vetter
Brigitte Reutter-Haerle, Vice President Product Management & Marketing, Vetter
Brigitte Reutter-Haerle is Vice President Product Management & Marketing for Vetter. In this role, she is responsible for both existing and new product and service offerings that support Pharma & biotech companies as well as marketing and public relations activities. She joined Vetter in 1996, serving in the company’s sales and marketing function and later transferring to corporate marketing. She began her career in 1983, holding various positions in the sales organizations of companies including Hilton International and TNT Express Worldwide. Brigitte has been a PDA member since 2005, and as of 2024, she serves as a member of the Board of Directors. She has also been a leader of PDA’s Pre-Filled Syringe Interest Group/Europe since 2007 and served on various committees, including as Chair of the PDA UPS Program Planning Committee. In 2014, Brigitte received the PDA Distinguished Service Award and, in 2017, the PDA Europe Service Appreciation Award for her long-standing commitment. The awards were in recognition of special acts, contributions, or services that have helped build on the success and strength of the PDA. Ms. Reutter-Haerle earned a BA and a degree in business administration from Baden-Wuerttemberg Cooperative State University.
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The Success and Challenges of Ready-to-Use Packaging Material for Fill & Finish
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Presenter: Klaus Ullherr, Senior Product Manager, Syntegon Technology GmbH
Klaus Ullherr, Senior Product Manager, Syntegon Technology GmbH
Klaus Ullherr (Senior Product Manager) has a degree in electrical engineering. After university, he worked for several years as a project manager in the electrical industry. In March 2000 he joined Robert Bosch GmbH, Packaging Technology, Product Division Pharma Liquid, now Syntegon Technology. During the first two years, he was the project manager responsible for handling complex customer orders. Since 2002 he has been a product manager for the business fields of syringes and RTU (ready-to-use) containers with global product responsibility. His main functions are market analysis, initiating new product developments, business development, and expert in syringe/nested container processing. He is a member of the PDA and trainer at the PDA training course "All about pre-filled syringes" and works as an expert in the DIN/ISO group for primary packaging. Klaus is also a member of ISPE and a member of the program committee of the yearly ISPE Aseptic Conference. He is a well-known speaker and trainer covering trends and solutions for fill/finish equipment, especially for pre-filled syringes and other pre-sterilized containers.
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Key Points of Attention and Lessons Learned from the PFS-Device Assembly Point of View
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Presenter: Alessandro Pettenuzzo, Technical Sales Manager, Stevanato Group S.p.a.
Alessandro Pettenuzzo, Technical Sales Manager, Stevanato Group S.p.a.
Alessandro Pettenuzzo has been working in Stevanato Group S.p.a. since 2016 as technical sales manager for pharmaceuitcal and medical equipment and machineries. In his career he has achieved extensive sales and marketing experience in the area of glass production machineries, food processing equipment, and pharmaceutical technologies working with customers globally.
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Panel Discussion, Q&A
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Panelist: Klaus Ullherr, Senior Product Manager, Syntegon Technology GmbH
Klaus Ullherr, Senior Product Manager, Syntegon Technology GmbH
Klaus Ullherr (Senior Product Manager) has a degree in electrical engineering. After university, he worked for several years as a project manager in the electrical industry. In March 2000 he joined Robert Bosch GmbH, Packaging Technology, Product Division Pharma Liquid, now Syntegon Technology. During the first two years, he was the project manager responsible for handling complex customer orders. Since 2002 he has been a product manager for the business fields of syringes and RTU (ready-to-use) containers with global product responsibility. His main functions are market analysis, initiating new product developments, business development, and expert in syringe/nested container processing. He is a member of the PDA and trainer at the PDA training course "All about pre-filled syringes" and works as an expert in the DIN/ISO group for primary packaging. Klaus is also a member of ISPE and a member of the program committee of the yearly ISPE Aseptic Conference. He is a well-known speaker and trainer covering trends and solutions for fill/finish equipment, especially for pre-filled syringes and other pre-sterilized containers. -
Panelist: Alessandro Pettenuzzo, Technical Sales Manager, Stevanato Group S.p.a.
Alessandro Pettenuzzo, Technical Sales Manager, Stevanato Group S.p.a.
Alessandro Pettenuzzo has been working in Stevanato Group S.p.a. since 2016 as technical sales manager for pharmaceuitcal and medical equipment and machineries. In his career he has achieved extensive sales and marketing experience in the area of glass production machineries, food processing equipment, and pharmaceutical technologies working with customers globally. -
Panelist: Brigitte Reutter-Haerle, Vice President Product Management & Marketing, Vetter
Brigitte Reutter-Haerle, Vice President Product Management & Marketing, Vetter
Brigitte Reutter-Haerle is Vice President Product Management & Marketing for Vetter. In this role, she is responsible for both existing and new product and service offerings that support Pharma & biotech companies as well as marketing and public relations activities. She joined Vetter in 1996, serving in the company’s sales and marketing function and later transferring to corporate marketing. She began her career in 1983, holding various positions in the sales organizations of companies including Hilton International and TNT Express Worldwide. Brigitte has been a PDA member since 2005, and as of 2024, she serves as a member of the Board of Directors. She has also been a leader of PDA’s Pre-Filled Syringe Interest Group/Europe since 2007 and served on various committees, including as Chair of the PDA UPS Program Planning Committee. In 2014, Brigitte received the PDA Distinguished Service Award and, in 2017, the PDA Europe Service Appreciation Award for her long-standing commitment. The awards were in recognition of special acts, contributions, or services that have helped build on the success and strength of the PDA. Ms. Reutter-Haerle earned a BA and a degree in business administration from Baden-Wuerttemberg Cooperative State University. -
Moderator: Frank Bamberg, MA, Associate Director of Primary Packaging and Medical Devices, CSL Behring
Frank Bamberg, MA, Associate Director of Primary Packaging and Medical Devices, CSL Behring
Frank Bamberg has more than 20 years of experience in the pharmaceutical industry in various leading roles in research & development, business development, and project management. Before joining CSL Behring in Bern CH as Associate Director for Medical Device and Primary Packaging in July 2019, Frank has been with Hoffmann-La Roche since 2011, responsible as Section Head of Pre-Fillable syringes for the development of primary packaging and device which will be in contact with the drug. Additionally, Frank has gained experience in various positions at SCHOTT Pharmaceutical Packaging. He was leading at SCHOTT the global business development and customer service for Pre-Fillable syringes. Frank has an MBA in industrial engineering and management from the University of Bern/Zürich and he is a plastic Engineer by education.
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Session 3, Track A: Drug-Primary Container Interaction
The Hangar 5
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Moderator: Folker Steden, Dr, Senior Principal Expert, Director Product Management, Schott Tubing
Folker Steden, Dr, Senior Principal Expert, Director Product Management, Schott Tubing
Folker Steden graduated as a Chemist from the Rheinische Friedrich-Wilhelms University in Bonn Germany. After finishing his awarded PhD doctoral thesis in inorganic Chemistry at the Universities of Bonn Germany and Fredericton New Brunswick in Canada he transferred to the high tech Start-Up company belChem as the Head of R&D, responsible for product development and ramp-up. Fifteen years ago, he joined SCHOTT as a scientific Consultant for technical and pharmaceutical tubing applications. In the years 2010 to 2012 he was located in Shanghai responsible for Scientific Consulting, Business Development, and B&I activities in Asia. Since 2012, he has been leading the Product Management Team of the tubing division of SCHOTT. With his excellent scientific background and profound intercultural communication skills, he is working worldwide as a “missing link” between customers and local R&D units, focusing on future customer needs and presenting frequently at international conferences on subjects related to special glass for technical and pharmaceutical applications.
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Impact of Primary Container on PS80 and Protein Oxidation
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Presenter: Tingting Wang, PhD, Senior Director, Eli Lilly and Company
Tingting Wang, PhD, Senior Director, Eli Lilly and Company
Tingting Wang is currently a Sr. Director in the Department of Bioproduct Research and Development at Eli Lilly and Company. She earned her Bachelor of Science at Jilin University, China, and her PhD in Chemistry from the University of Wisconsin-Madison. Dr. Tingting Wang finished her Post-Doc work in Macromolecule and Vaccine Stabilization Center at the University of Kansas and worked for Novartis and GSK on large molecule formulation development before joining Eli Lilly and Company. She has been working for the Eli Lilly formulation team for more than 8 years. Dr. Wang's team at Eli Lilly is responsible for formulation development and process development of parenteral formulations, including biologics and synthetic molecules. Dr. Tingting Wang has a strong scientific interest and contribution in the area of surfactant application in large molecule formulation and interactions between drug products and container/closure systems.
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Factors Affecting the Formation of Chemically Derived Particles in Pharmaceutical Glass Containers
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Presenter: Luis A González, MSc, Research Scientist, Corning
Luis A González, MSc, Research Scientist, Corning
Luis González currently works as a Research Scientist at Corning European Technology Center (CETC) in Fontainebleau, France. He has conducted research into parenteral glass packaging-formulation interactions for over 3 years and developed in-depth scientific expertise for a variety of glass containers and solution chemistries relevant to commercial drug products. He is also dedicated to the development of CETC's capabilities for the chemical and structural characterization of inorganic materials and provides support to glass structure and crystallization studies. Luis holds a master’s degree in Materials Engineering from Polytech Montpellier, France, a bachelor’s degree (cum laude) in Materials Engineering from Simón Bolívar University, Venezuela, and is fluent in English, French, and Spanish.
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Q&A, Discussion
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Moderator: Folker Steden, Dr, Senior Principal Expert, Director Product Management, Schott Tubing
Folker Steden, Dr, Senior Principal Expert, Director Product Management, Schott Tubing
Folker Steden graduated as a Chemist from the Rheinische Friedrich-Wilhelms University in Bonn Germany. After finishing his awarded PhD doctoral thesis in inorganic Chemistry at the Universities of Bonn Germany and Fredericton New Brunswick in Canada he transferred to the high tech Start-Up company belChem as the Head of R&D, responsible for product development and ramp-up. Fifteen years ago, he joined SCHOTT as a scientific Consultant for technical and pharmaceutical tubing applications. In the years 2010 to 2012 he was located in Shanghai responsible for Scientific Consulting, Business Development, and B&I activities in Asia. Since 2012, he has been leading the Product Management Team of the tubing division of SCHOTT. With his excellent scientific background and profound intercultural communication skills, he is working worldwide as a “missing link” between customers and local R&D units, focusing on future customer needs and presenting frequently at international conferences on subjects related to special glass for technical and pharmaceutical applications. -
Panelist: Tingting Wang, PhD, Senior Director, Eli Lilly and Company
Tingting Wang, PhD, Senior Director, Eli Lilly and Company
Tingting Wang is currently a Sr. Director in the Department of Bioproduct Research and Development at Eli Lilly and Company. She earned her Bachelor of Science at Jilin University, China, and her PhD in Chemistry from the University of Wisconsin-Madison. Dr. Tingting Wang finished her Post-Doc work in Macromolecule and Vaccine Stabilization Center at the University of Kansas and worked for Novartis and GSK on large molecule formulation development before joining Eli Lilly and Company. She has been working for the Eli Lilly formulation team for more than 8 years. Dr. Wang's team at Eli Lilly is responsible for formulation development and process development of parenteral formulations, including biologics and synthetic molecules. Dr. Tingting Wang has a strong scientific interest and contribution in the area of surfactant application in large molecule formulation and interactions between drug products and container/closure systems. -
Panelist: Luis A González, MSc, Research Scientist, Corning
Luis A González, MSc, Research Scientist, Corning
Luis González currently works as a Research Scientist at Corning European Technology Center (CETC) in Fontainebleau, France. He has conducted research into parenteral glass packaging-formulation interactions for over 3 years and developed in-depth scientific expertise for a variety of glass containers and solution chemistries relevant to commercial drug products. He is also dedicated to the development of CETC's capabilities for the chemical and structural characterization of inorganic materials and provides support to glass structure and crystallization studies. Luis holds a master’s degree in Materials Engineering from Polytech Montpellier, France, a bachelor’s degree (cum laude) in Materials Engineering from Simón Bolívar University, Venezuela, and is fluent in English, French, and Spanish.
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Session 3, Track B: Administration Routes Different from Intravenously and Subcutaneous
The Hangar 4
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Moderator: Coralie A Richard, PhD, Senior Director, Eli Lilly and Company
Coralie A Richard, PhD, Senior Director, Eli Lilly and Company
Coralie Richard is the Director of Packaging Systems in Delivery and Device Connected Solutions (DDCS) at Eli Lilly and Company, Indianapolis, USA. A native of France, she came to the USA to pursue her PhD in Organic Chemistry at the Georgia Institute of Technology. After working as an R&D scientist in a material company, she joined the primary packaging system team at Eli Lilly, supporting container closure systems development activities and container-related research projects. Her contributions were recognized with two Eli Lilly Top 100 Innovator Awards half a dozen articles and a patent. In her current role, she provides technical and organizational leadership in the areas of primary packaging/container closure development, secondary packaging, shipping & distribution, surface science, and several related DDCS laboratories. Her global team supports clinical and commercial development activities across all business units.
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Advancing Ocular Device Delivery: Exploring Routes, Challenges, and Innovations to Meet Patient Needs
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Presenter: Vincent Cazanave, Device Team Leader, Roche
Vincent Cazanave, Device Team Leader, Roche
Principal Medical Device Engineer and more than 13 years of experience in drug delivery and combination product development in various leading roles. Belonging to the Device & Packaging development group at Roche, leading device teams in developing specific drug delivery solutions for molecules in the pipeline, and leading the global Roche/Genentech Ophthalmology Device Technology Center.
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Case Study of a Drug Delivery Solution for Complex Intravitreal Drugs Using Pre-Filled Syringes
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Presenter: Nicolas Eon, PhD, Senior Technology Development Manager, Terumo Europe nv
Nicolas Eon, PhD, Senior Technology Development Manager, Terumo Europe nv
Dr. Nicolas Eon, graduated from the University of Nancy and Nantes in France holds a Fluid Mechanics & Energy Science Engineering degree, a Master Degree in Energetics and Heat Transfer, and a PhD. in Biomechanics, worked for 10 years in the Automotive Safety Industry where he led the System Engineering Department in a global leading company. Dr. Eon started to build his expertise in Primary Containers for Pharmaceuticals and Injection Devices 15 years ago. He had several managing positions from Product Development to Strategic Marketing in global leading companies covering the full range of Primary Packaging from Vials to Prefilled Syringes (both in glass and polymer) where he launched successful products on the market and built sustainable long-term strategies. Dr. Eon has recently joined Terumo Medical Care Solutions in 2020 as Senior Technology Development Manager. Since 2010, he has been an active expert in ISO Technical Committees (ie. TC 76 WG4 & WG2, TC 210) as part of the French and Swiss delegations.
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Q&A, Discussion
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Moderator: Coralie A Richard, PhD, Senior Director, Eli Lilly and Company
Coralie A Richard, PhD, Senior Director, Eli Lilly and Company
Coralie Richard is the Director of Packaging Systems in Delivery and Device Connected Solutions (DDCS) at Eli Lilly and Company, Indianapolis, USA. A native of France, she came to the USA to pursue her PhD in Organic Chemistry at the Georgia Institute of Technology. After working as an R&D scientist in a material company, she joined the primary packaging system team at Eli Lilly, supporting container closure systems development activities and container-related research projects. Her contributions were recognized with two Eli Lilly Top 100 Innovator Awards half a dozen articles and a patent. In her current role, she provides technical and organizational leadership in the areas of primary packaging/container closure development, secondary packaging, shipping & distribution, surface science, and several related DDCS laboratories. Her global team supports clinical and commercial development activities across all business units. -
Panelist: Vincent Cazanave, Device Team Leader, Roche
Vincent Cazanave, Device Team Leader, Roche
Principal Medical Device Engineer and more than 13 years of experience in drug delivery and combination product development in various leading roles. Belonging to the Device & Packaging development group at Roche, leading device teams in developing specific drug delivery solutions for molecules in the pipeline, and leading the global Roche/Genentech Ophthalmology Device Technology Center. -
Panelist: Nicolas Eon, PhD, Senior Technology Development Manager, Terumo Europe nv
Nicolas Eon, PhD, Senior Technology Development Manager, Terumo Europe nv
Dr. Nicolas Eon, graduated from the University of Nancy and Nantes in France holds a Fluid Mechanics & Energy Science Engineering degree, a Master Degree in Energetics and Heat Transfer, and a PhD. in Biomechanics, worked for 10 years in the Automotive Safety Industry where he led the System Engineering Department in a global leading company. Dr. Eon started to build his expertise in Primary Containers for Pharmaceuticals and Injection Devices 15 years ago. He had several managing positions from Product Development to Strategic Marketing in global leading companies covering the full range of Primary Packaging from Vials to Prefilled Syringes (both in glass and polymer) where he launched successful products on the market and built sustainable long-term strategies. Dr. Eon has recently joined Terumo Medical Care Solutions in 2020 as Senior Technology Development Manager. Since 2010, he has been an active expert in ISO Technical Committees (ie. TC 76 WG4 & WG2, TC 210) as part of the French and Swiss delegations.
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Networking Coffee Break, Poster Session & Exhibition
The Hangar 1-3
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Session 4, Track A: Bag Systems & Large Volume Parenterals
The Hangar 5
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Bettine Boltres, PhD, Director Scientific Affairs & Technical Solutions, Integrated Systems, West Pharmaceutical Services
As Director of Scientific Affairs & Technical Solutions, Glass Systems, Dr. Bettine Boltres is supporting the scientific exchange between West and the pharmaceutical industry. This complements her work as Product Manager for Schott Pharmaceutical Tubing, where she provided scientific consulting for glass primary packaging. Since 2015 Bettine has been an active member of the USP Packaging and Distribution Expert Committee as well as the ISO TC76/WG 2 on rigid container systems and WG 4 on elastomers. Additionally, in 2018 joined the European Pharmacopoeia Commission Group of Experts 16 (elastomers and plastics) and the GLS Working Party (glass). Since January 2019 she is also a member of the PDA Board of Directors, actively supporting the role of PDA in the global pharma world. She was part of the PDA Glass Handling Task Force finalizing TR 87, is actively involved in the Task Force working on an Annex to TR 73 addressing MDR GSPRs for PFS, and is part of the Pharmacopeia Interest Group. In 2015 she published the book "When Glass Meets Pharma", which builds the bridge between glass for pharmaceutical primary packaging and drug substances.
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Positive Controls in Flexible Parenteral Packaging Container Closure Integrity Testing
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Presenter: Guerney D.H Hunt, MS, Research Engineer 1, Packaging Technologies and Inspection
Guerney D.H Hunt, MS, Research Engineer 1, Packaging Technologies and Inspection
Guerney Hunt is a research engineer at Packaging Technologies and Inspection. Guerney holds both a bachelor’s and master’s degree in mechanical engineering. His graduate research focused on thermal regulation for vaccine distribution in rural hot climates. Since entering the container closure integrity space in 2020, Guerney has worked with vacuum decay, pressure decay, force decay, Helium, and ultrasonic leak detection systems. His primary work has focused on the development of vacuum decay leak detection systems.
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Nitrosamines in Flexible Packaging Materials – A Challenge for Large Volume Parenterals
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Andreas Meiser, Dr-Ing, Sr. Director of Component Development, Fresenius Medical Care Deutschland GmbH
Andreas Meiser, Dr.-ing. in Materials Science, is Sr. Director of Component Development at Fresenius Medical Care, the world’s leading provider of products and services for individuals with kidney diseases. He has 10+ years of experience in the development of container closures for large volume parenteral and packing components, esp. flexible films, and tubes.
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Q&A, Discussion
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Bettine Boltres, PhD, Director Scientific Affairs & Technical Solutions, Integrated Systems, West Pharmaceutical Services
As Director of Scientific Affairs & Technical Solutions, Glass Systems, Dr. Bettine Boltres is supporting the scientific exchange between West and the pharmaceutical industry. This complements her work as Product Manager for Schott Pharmaceutical Tubing, where she provided scientific consulting for glass primary packaging. Since 2015 Bettine has been an active member of the USP Packaging and Distribution Expert Committee as well as the ISO TC76/WG 2 on rigid container systems and WG 4 on elastomers. Additionally, in 2018 joined the European Pharmacopoeia Commission Group of Experts 16 (elastomers and plastics) and the GLS Working Party (glass). Since January 2019 she is also a member of the PDA Board of Directors, actively supporting the role of PDA in the global pharma world. She was part of the PDA Glass Handling Task Force finalizing TR 87, is actively involved in the Task Force working on an Annex to TR 73 addressing MDR GSPRs for PFS, and is part of the Pharmacopeia Interest Group. In 2015 she published the book "When Glass Meets Pharma", which builds the bridge between glass for pharmaceutical primary packaging and drug substances. -
Panelist: Guerney D.H Hunt, MS, Research Engineer 1, Packaging Technologies and Inspection
Guerney D.H Hunt, MS, Research Engineer 1, Packaging Technologies and Inspection
Guerney Hunt is a research engineer at Packaging Technologies and Inspection. Guerney holds both a bachelor’s and master’s degree in mechanical engineering. His graduate research focused on thermal regulation for vaccine distribution in rural hot climates. Since entering the container closure integrity space in 2020, Guerney has worked with vacuum decay, pressure decay, force decay, Helium, and ultrasonic leak detection systems. His primary work has focused on the development of vacuum decay leak detection systems. -
Andreas Meiser, Dr-Ing, Sr. Director of Component Development, Fresenius Medical Care Deutschland GmbH
Andreas Meiser, Dr.-ing. in Materials Science, is Sr. Director of Component Development at Fresenius Medical Care, the world’s leading provider of products and services for individuals with kidney diseases. He has 10+ years of experience in the development of container closures for large volume parenteral and packing components, esp. flexible films, and tubes.
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Session 4, Track B: Sustainability
The Hangar 4
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Moderator: Bram Jongen, PhD, VP Materials and Surface Technologies, Datwyler
Bram Jongen, PhD, VP Materials and Surface Technologies, Datwyler
After his Masters in Polymer Chemistry at the University of Louvain, Belgium, Bram Jongen acquired a Ph.D. in Water Soluble Polymers used for advanced drug administration. Bram started as Technical Support Manager for Datwyler 18 years ago, and picked up the role of heading the Global Product Introduction & Support team, a global team of highly experienced and educated people, having each their expertise in the world of pharmaceutical closures. Bram himself acquired profound Extractables & Leachables expertise. From 2013 till 2020, he has been acting as Head of R&D, leading a group that focuses on developing new rubber and new coating materials. Since early 2020, he has become VP of Materials & Technologies, overseeing the development teams in Datwyler’s HealthCare branch, but also the Mobility, Food & Beverages, General Industry, and Connectors teams.
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Consequences From the EU Packaging Waste Directive
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Presenter: Lize Jaspers, PhD, Environmental Sustainability Requests Mgr’, Amgen
Lize Jaspers, PhD, Environmental Sustainability Requests Mgr’, Amgen
Lize Jaspers is a Sr. Packaging Engineer at Amgen Europe B.V. in the Netherlands. She leads the Amgen global packaging sustainability workstream and is responsible for packaging development and packaging lifecycle management at Amgen sites and CMOs in the EMEA region. She holds a doctorate in chemistry from the University of Hasselt in Belgium, has more than 15 years of experience in primary, secondary, and tertiary packaging, and started building her expertise in pharmaceutical and combination product packaging in 2015.
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Secure Blister-Free Syringe Supply – A New, Sustainable Dress Code for Pre-Filled Syringes Providing More Value with Less Packaging
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Presenter: Nadine K Lampka, PhD, Senior Product Manager Pharma-Security, Schreiner MediPharm
Nadine K Lampka, PhD, Senior Product Manager Pharma-Security, Schreiner MediPharm
Dr. rer. nat. Nadine Lampka holds a PhD and master´s degree in chemistry. She has over 12 years of experience in managing and consulting integrity and authentication solutions for the life sciences and healthcare industry. At Schreiner MediPharm, she leads the innovation to commercialization process, aligns the security portfolio to tackle changing threat challenges to supply chains, and provides holistic drug protection guidance to customers and stakeholders. Her current focus is on holistic and disruptive approaches that contribute to a sustainable supply chain and at the same time improve supply chain security. Nadine is also a representative for Schreiner MediPharm within the Alliance to Zero. Her core competencies include strategy, product management, storytelling, technical marketing, brand protection, functional labels, printing solutions, and anti-counterfeiting technologies. She is passionate, visionary, and full of energy, and loves to scout for new technologies, mediate and analyze complex scientific content, and bring new solutions to market. Raising awareness about the importance of supply-chain security and all aspects that have an impact, is of her major interest.
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Q&A, Discussion
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Moderator: Bram Jongen, PhD, VP Materials and Surface Technologies, Datwyler
Bram Jongen, PhD, VP Materials and Surface Technologies, Datwyler
After his Masters in Polymer Chemistry at the University of Louvain, Belgium, Bram Jongen acquired a Ph.D. in Water Soluble Polymers used for advanced drug administration. Bram started as Technical Support Manager for Datwyler 18 years ago, and picked up the role of heading the Global Product Introduction & Support team, a global team of highly experienced and educated people, having each their expertise in the world of pharmaceutical closures. Bram himself acquired profound Extractables & Leachables expertise. From 2013 till 2020, he has been acting as Head of R&D, leading a group that focuses on developing new rubber and new coating materials. Since early 2020, he has become VP of Materials & Technologies, overseeing the development teams in Datwyler’s HealthCare branch, but also the Mobility, Food & Beverages, General Industry, and Connectors teams. -
Presenter: Lize Jaspers, PhD, Environmental Sustainability Requests Mgr’, Amgen
Lize Jaspers, PhD, Environmental Sustainability Requests Mgr’, Amgen
Lize Jaspers is a Sr. Packaging Engineer at Amgen Europe B.V. in the Netherlands. She leads the Amgen global packaging sustainability workstream and is responsible for packaging development and packaging lifecycle management at Amgen sites and CMOs in the EMEA region. She holds a doctorate in chemistry from the University of Hasselt in Belgium, has more than 15 years of experience in primary, secondary, and tertiary packaging, and started building her expertise in pharmaceutical and combination product packaging in 2015. -
Panelist: Nadine K Lampka, PhD, Senior Product Manager Pharma-Security, Schreiner MediPharm
Nadine K Lampka, PhD, Senior Product Manager Pharma-Security, Schreiner MediPharm
Dr. rer. nat. Nadine Lampka holds a PhD and master´s degree in chemistry. She has over 12 years of experience in managing and consulting integrity and authentication solutions for the life sciences and healthcare industry. At Schreiner MediPharm, she leads the innovation to commercialization process, aligns the security portfolio to tackle changing threat challenges to supply chains, and provides holistic drug protection guidance to customers and stakeholders. Her current focus is on holistic and disruptive approaches that contribute to a sustainable supply chain and at the same time improve supply chain security. Nadine is also a representative for Schreiner MediPharm within the Alliance to Zero. Her core competencies include strategy, product management, storytelling, technical marketing, brand protection, functional labels, printing solutions, and anti-counterfeiting technologies. She is passionate, visionary, and full of energy, and loves to scout for new technologies, mediate and analyze complex scientific content, and bring new solutions to market. Raising awareness about the importance of supply-chain security and all aspects that have an impact, is of her major interest.
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Networking Lunch Break, Poster Session & Exhibition
The Hangar 1-3
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Tech Talks
The Hangar 1-3
Tech Talks-
Gx Elite Vials: Superior Quality for De-Risking of Fill & Finish Operations
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Tech Talk Presenter: Lothar Haaf, Dipl.-Ing.(FH), Senior Manager Technical Service Tubular Glass, Gerresheimer Glas GmbH
Lothar Haaf, Dipl.-Ing.(FH), Senior Manager Technical Service Tubular Glass, Gerresheimer Glas GmbH
Lothar Haaf studied mechanical engineering in Schweinfurt (Germany) and then worked for 10 years in various positions in the food industry. He joined Gerresheimer 2004 as Head of Technology and Quality at the Wertheim plant. He was promoted to Plant Manager in 2007 and was appointed as General Manager 2013 for this ampoule manufacturing site. As of 2018 Lothar Haaf was responsible as the Director Product Management Vials & Ampoules Gerresheimer Europe. Since the beginning of 2024, Lothar Haaf has taken over the Technical Service for Tubular Glass products, both internally and for customers.
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How Secondary Packaging Supports Your Sustainability Goals
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Tech Talk Presenter: Sandro Furlan
Sandro Furlan
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VIALEX™ Vials - Exceptional Inner Surface Durability
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Tech Talk Presenter: Clement Condouret
Clement Condouret
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Interactive Questionnaire Session
The Hangar 4-5
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Moderator: Philippe Lauwers, Technology Development Director, Terumo Pharmaceutical Solutions
Philippe Lauwers, Technology Development Director, Terumo Pharmaceutical Solutions
Philippe Lauwers has been active in the medical device and pharmaceutical packaging sector for the last fifteen years with growing responsibilities in business development and technical roles. He is currently the Director of Technology Development at Terumo Pharmaceutical Solutions in Belgium. Philippe graduated in Biotechnology from the University in Ghent, Belgium, and worked as a scientific researcher at the Catholic University of Leuven. Upon obtaining an additional degree in Biomedical Engineering at the Catholic University of Leuven he moved from an academic to an industrial environment. Philippe is a volunteer at the PDA organization and also serves as an expert in ISO technical committees TC76 and TC84.
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Closing Plenary Part I
The Hangar 4-5
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Moderator: Philippe Lauwers, Technology Development Director, Terumo Pharmaceutical Solutions
Philippe Lauwers, Technology Development Director, Terumo Pharmaceutical Solutions
Philippe Lauwers has been active in the medical device and pharmaceutical packaging sector for the last fifteen years with growing responsibilities in business development and technical roles. He is currently the Director of Technology Development at Terumo Pharmaceutical Solutions in Belgium. Philippe graduated in Biotechnology from the University in Ghent, Belgium, and worked as a scientific researcher at the Catholic University of Leuven. Upon obtaining an additional degree in Biomedical Engineering at the Catholic University of Leuven he moved from an academic to an industrial environment. Philippe is a volunteer at the PDA organization and also serves as an expert in ISO technical committees TC76 and TC84.
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2023 Revision of the PDA Technical Report 43
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Co-Presenter: Alicia Gallagher, Sr. Product Development Scientist, Corning Incorporated
Alicia Gallagher, Sr. Product Development Scientist, Corning Incorporated
Alicia Gallagher, Sr. Product Development Scientist at Corning Incorporated, has 12 years’ experience in glass mechanical reliability and is a subject matter expert in fractography with fracture analysis experience across all pharma glass container types. Alicia holds a BS degree in Biology from Houghton University and is pursuing an MS degree in Product Development from Rochester Institute of Technology. -
Co-Presenter: Carol Rea Flynn, M. Eng., Director of Field Quality, Primary Packaging Glass, Gerresheimer Glass Inc.
Carol Rea Flynn, M. Eng., Director of Field Quality, Primary Packaging Glass, Gerresheimer Glass Inc.
30 years’ experience in the pharmaceutical glass industry, in Engineering, Quality, Manufacturing, Laboratory Services, Regulatory Compliance, and Technical Services. Skilled in Process Engineering, Business Process Improvement, Cross-functional Team Leadership, Quality Management, and Six Sigma. An active member of the Parenteral Drug Association (PDA), Packaging Science Interest Group, VisPar (Particulate task force), and contributed to the development and publication of PDA Technical Report (TR43): Identification and Classification of Nonconformities in Moulded and Tubular Glass Containers for Pharmaceutical Manufacturing, TR Glass Handling, and TR Response Curve Visual Inspection of Particles. Member of International Commission on Glass TC 12 Pharma Packaging Technical committee, served on USP Glass Expert Panel focused on USP <660> and <1660>, and serves on many standards committees within ASTM and ISO. Enjoys sharing glass knowledge at various venues and is a co-author of the Pharmaceutical Dosage Forms: Parenteral Medications, Fourth Edition Chapter 21 Glass Container for Parenteral Products. Earned a Bachelor of Science in Mechanical Engineering from Drexel University and holds a Master of Science in Engineering with a focus in Chemical obtained from Rowan University. Currently, the Director of Field Quality Primary Packaging Glass for Gerresheimer Glass Inc.
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ISO 11040-Pre-filled Syringes: Update from ISO TC76/WG2
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Presenter: Horst Koller, Dipl.-Ing., CEO, HK Packaging Consulting
Horst Koller, Dipl.-Ing., CEO, HK Packaging Consulting
Before becoming a consultant, Horst Koller worked for Abbott Diagnostic and SCHOTT Pharmaceutical Packaging with a total of more than 30 years of industry experience. His consulting company is focussing on Technical, Regulatory, and QM-Support around Primary and Secondary Packaging Systems including Medical Devices. He is an active member within the technical ISO Committees TC76 and TC84 as well as an active member of the WG16 for the EDQM. He is a speaker at international conferences and holds customized training. He holds an Engineering degree in Biotechnology from the University of Applied Sciences in Mannheim / Germany.
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Networking Coffee Break, Poster Session & Exhibition
The Hangar 1-3
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Passport Raffle
The Hangar 4-5
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Moderator: Melanie Decker, Parenteral Drug Association
Melanie Decker, Parenteral Drug Association
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Closing Plenary Part II
The Hangar 4-5
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Moderator: Philippe Lauwers, Technology Development Director, Terumo Pharmaceutical Solutions
Philippe Lauwers, Technology Development Director, Terumo Pharmaceutical Solutions
Philippe Lauwers has been active in the medical device and pharmaceutical packaging sector for the last fifteen years with growing responsibilities in business development and technical roles. He is currently the Director of Technology Development at Terumo Pharmaceutical Solutions in Belgium. Philippe graduated in Biotechnology from the University in Ghent, Belgium, and worked as a scientific researcher at the Catholic University of Leuven. Upon obtaining an additional degree in Biomedical Engineering at the Catholic University of Leuven he moved from an academic to an industrial environment. Philippe is a volunteer at the PDA organization and also serves as an expert in ISO technical committees TC76 and TC84.
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Turning Pharma Manufacturing Circular for Zero
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Presenter: Bo Gottlieb, MA, Senior Project Manager, Novo Nordisk A/S
Bo Gottlieb, MA, Senior Project Manager, Novo Nordisk A/S
Bo Gottlieb, Senior Project Manager, PSQIT Sustainability, Circular for Zero project office, Novo Nordisk A/S. Bo is a subject matter expert on waste and resources and support the strategic priorities and decisions in relations to waste and resources within Novo Nordisk A/S. Bo Gottlieb has almost 20 years of experience within sustainability developing political strategies and activities within Circular economy, Environmental technology development, Industry regulation and Climate. Bo Gottlieb has been part of Novo Nordisk A/S Sustainability department for 2 years and has previously been part of Danish Ministry of Environment, Danish Environmental Agency, Ministry of Utilities, Energy and Climate and City of Copenhagen.
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Plenary Discussion
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Moderator: Philippe Lauwers, Technology Development Director, Terumo Pharmaceutical Solutions
Philippe Lauwers, Technology Development Director, Terumo Pharmaceutical Solutions
Philippe Lauwers has been active in the medical device and pharmaceutical packaging sector for the last fifteen years with growing responsibilities in business development and technical roles. He is currently the Director of Technology Development at Terumo Pharmaceutical Solutions in Belgium. Philippe graduated in Biotechnology from the University in Ghent, Belgium, and worked as a scientific researcher at the Catholic University of Leuven. Upon obtaining an additional degree in Biomedical Engineering at the Catholic University of Leuven he moved from an academic to an industrial environment. Philippe is a volunteer at the PDA organization and also serves as an expert in ISO technical committees TC76 and TC84. -
Regulatory Panelist: Madushini N. Dharmasena, PhD, Senior Pharmaceutical Quality Assessor, OPQ, CDER, U.S. FDA
Madushini N. Dharmasena, PhD, Senior Pharmaceutical Quality Assessor, OPQ, CDER, U.S. FDA
Madushini Dharmasena, Ph.D. is currently working as a Senior Pharmaceutical Quality Assessor in the FDA/CDER/ Office of Pharmaceutical Manufacturing Assessment (OPMA) Office of Pharmaceutical Quality (OPQ). Dr. Dharmasena joined the Division of Bacterial, Parasitic, and Allergenic Products in CBER in 2010 following a postdoctoral fellowship at the National Cancer Institute. At CBER she reviewed INDs and BLA supplements with a focus on product quality and manufacturing for biological products including live attenuated bacterial vaccine candidates, recombinant protein vaccine candidates, and live biotherapeutic products. In addition to review, she maintained an active research program and developed bifunctional oral vaccine candidates for the prevention of shigellosis and typhoid (FDA patent E-2012-016). In 2018 she joined OPMA, DMA Branch IV as a primary reviewer and has led numerous pre-license inspections of biologics manufacturing facilities. Dr. Dharmasena holds a Ph.D. degree in Microbiology and Immunology from Dartmouth Medical School, New Hampshire. -
Carol Rea Flynn, M. Eng., Director of Field Quality, Primary Packaging Glass, Gerresheimer Glass Inc.
30 years’ experience in the pharmaceutical glass industry, in Engineering, Quality, Manufacturing, Laboratory Services, Regulatory Compliance, and Technical Services. Skilled in Process Engineering, Business Process Improvement, Cross-functional Team Leadership, Quality Management, and Six Sigma. An active member of the Parenteral Drug Association (PDA), Packaging Science Interest Group, VisPar (Particulate task force), and contributed to the development and publication of PDA Technical Report (TR43): Identification and Classification of Nonconformities in Moulded and Tubular Glass Containers for Pharmaceutical Manufacturing, TR Glass Handling, and TR Response Curve Visual Inspection of Particles. Member of International Commission on Glass TC 12 Pharma Packaging Technical committee, served on USP Glass Expert Panel focused on USP <660> and <1660>, and serves on many standards committees within ASTM and ISO. Enjoys sharing glass knowledge at various venues and is a co-author of the Pharmaceutical Dosage Forms: Parenteral Medications, Fourth Edition Chapter 21 Glass Container for Parenteral Products. Earned a Bachelor of Science in Mechanical Engineering from Drexel University and holds a Master of Science in Engineering with a focus in Chemical obtained from Rowan University. Currently, the Director of Field Quality Primary Packaging Glass for Gerresheimer Glass Inc. -
Panelist: Alicia Gallagher, Sr. Product Development Scientist, Corning Incorporated
Alicia Gallagher, Sr. Product Development Scientist, Corning Incorporated
Alicia Gallagher, Sr. Product Development Scientist at Corning Incorporated, has 12 years’ experience in glass mechanical reliability and is a subject matter expert in fractography with fracture analysis experience across all pharma glass container types. Alicia holds a BS degree in Biology from Houghton University and is pursuing an MS degree in Product Development from Rochester Institute of Technology. -
Panelist: Bo Gottlieb, MA, Senior Project Manager, Novo Nordisk A/S
Bo Gottlieb, MA, Senior Project Manager, Novo Nordisk A/S
Bo Gottlieb, Senior Project Manager, PSQIT Sustainability, Circular for Zero project office, Novo Nordisk A/S. Bo is a subject matter expert on waste and resources and support the strategic priorities and decisions in relations to waste and resources within Novo Nordisk A/S. Bo Gottlieb has almost 20 years of experience within sustainability developing political strategies and activities within Circular economy, Environmental technology development, Industry regulation and Climate. Bo Gottlieb has been part of Novo Nordisk A/S Sustainability department for 2 years and has previously been part of Danish Ministry of Environment, Danish Environmental Agency, Ministry of Utilities, Energy and Climate and City of Copenhagen. -
Panelist: Paul Guijt, Volunteer, International Gaucher Alliance
Paul Guijt, Volunteer, International Gaucher Alliance
Paul Guijt, a volunteer with the International Gaucher Alliance (IGA), is 62 years now living with a rare enzyme deficiency. He had over 50 hospital admissions in the first two decades of his life, including extensive surgery and tons of medication. He studied theology and philosophy in Amsterdam, became a public officer at the Dutch Council on Health Insurance, and ended his career in 2010 as a policy advisor on quality management of national screening programs like neonatal and cancers. Among other positions, he was co-founder of the Dutch Gaucher Association, a board member of the Dutch umbrella organization on hereditary and congenital diseases, and prepared what became the IGA which is celebrating its 30th anniversary. He has some 30 years of experience with infusions at home, most of the time self-infusing. With the IGA, he currently leads the development of guidelines on self-management and home infusion therapy. -
Panelist: Horst Koller, Dipl.-Ing., CEO, HK Packaging Consulting
Horst Koller, Dipl.-Ing., CEO, HK Packaging Consulting
Before becoming a consultant, Horst Koller worked for Abbott Diagnostic and SCHOTT Pharmaceutical Packaging with a total of more than 30 years of industry experience. His consulting company is focussing on Technical, Regulatory, and QM-Support around Primary and Secondary Packaging Systems including Medical Devices. He is an active member within the technical ISO Committees TC76 and TC84 as well as an active member of the WG16 for the EDQM. He is a speaker at international conferences and holds customized training. He holds an Engineering degree in Biotechnology from the University of Applied Sciences in Mannheim / Germany.
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Co-Chairs Conference Summary
The Hangar 4-5
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Co-Chair: Derek I. Duncan, PhD, Director Product Lines, LIGHTHOUSE Instruments
Derek I. Duncan, PhD, Director Product Lines, LIGHTHOUSE Instruments
Dr. Derek Duncan began his career as a Research Scientist at the Dutch Institute for Atomic & Molecular Physics in Amsterdam. He then moved into the 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, lyo chamber moisture mapping, and automated media fill inspection. Dr. Duncan has been a PDA member since 2004 and has been a regular contributor to PDA conferences, IG Groups, and Conference Program Committees. -
Co-Chair: Philippe Lauwers, Technology Development Director, Terumo Pharmaceutical Solutions
Philippe Lauwers, Technology Development Director, Terumo Pharmaceutical Solutions
Philippe Lauwers has been active in the medical device and pharmaceutical packaging sector for the last fifteen years with growing responsibilities in business development and technical roles. He is currently the Director of Technology Development at Terumo Pharmaceutical Solutions in Belgium. Philippe graduated in Biotechnology from the University in Ghent, Belgium, and worked as a scientific researcher at the Catholic University of Leuven. Upon obtaining an additional degree in Biomedical Engineering at the Catholic University of Leuven he moved from an academic to an industrial environment. Philippe is a volunteer at the PDA organization and also serves as an expert in ISO technical committees TC76 and TC84.
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Closing Remarks & Farewell
The Hangar 4-5
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Committee Member: Falk Klar, PhD, General Manager, Vice President Europe, Parenteral Drug Association
Falk Klar, PhD, General Manager, Vice President Europe, Parenteral Drug Association
Falk Klar holds a Ph.D. in Applied Physics and has over 19 years of experience in Quality Assurance and Compliance in the life science industry. Falk held positions in pre-clinical research and development in a medical product company and clinical research in a CRO. He has gained experience with biopharmaceutical and pharmaceutical products including monoclonal antibodies, vaccines, parenteral, narcotics, and animal drugs in several positions in quality management. Falk joined PDA Europe in 2015 as Senior Director of Training & Education. Since 2016 he has been appointed General Manager and Vice President of PDA Europe.
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Posters
Aseptic Transfer of RTU Containers in Light of the New Annex 1- Christian Vaas
CCI Testing of Fusion Sealed Parenterals
- Heinz Wolf, General Manager, PTI
Container Closure Integrity Test Methods - Status Quo
- Domingo Olivares Postigo, PhD, Laboratory Engineer in Primary Packaging Material and Device Testing, ten23
- Sarah S. Peláez, PhD Student & Senior Scientist Primary Packaging, ten23 health
Determining CCI Failure Temperature and Mechanism of PFS Performance at Ultra-Low Temperatures
- Lena Mungenast, Scientist, University of Applied Sciences Northwestern Switzerland
Electron Beam Technology – Transfer Technology for Pre-Sterilized RTU Components
- Manfred Holzer, Strategic Product Manager E-Beam Technology, SKAN AG
Headspace Analysis versus Helium Leak Testing
- Marissa Kateva, MSc, Laboratory Analyst, Lighthouse Instruments
- Suzanne Kuiper, PhD, Application Manager, Lighthouse Instruments
Industry Perspective on a Holistic Approach to Container Closure Integrity
- Carine Huon, BSC, Container Closure Integrity Scientist, Sanofi
Interaction of Machine and Packaging Material
- Klaus Ullherr, Senior Product Manager, Syntegon Technology GmbH
On the Evolution of Stability and Quality of Bake-on PDMS Coatings upon Extended Thermal Treatments
- Chiara Passet
Positive Controls - From Kirsch to Now
- Christian Proff, PhD, Senior Verification Engineer, F. Hoffmann-La Roche Ltd
Pre-filled Syringes for Deep Cold Storage
- Philip Bortner, M.Sc., Global Product Manager Syringes, Gerresheimer Regensburg GmbH
Probability of Detection Study
- Bram J.J. KEYMOLEN, Co-Founder, eyetec
The Need for High Quality in Primary Packaging
- Ana Kuschel, PhD, Principal Scientific Affairs, West Pharmaceutical Services, Inc.
Using Finite Element Analysis to Model Stopper Raising
- Ana Kuschel, PhD, Principal Scientific Affairs, West Pharmaceutical Services, Inc.
Presenters
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Brandon Aldinger, PhD
Senior Scientist, American Glass Research
Panelist
Presenter
Read BioBrandon Aldinger, PhD
American Glass Research
Brandon Aldinger PhD is a Senior Scientist at American Glass Research (AGR), where he focuses on pharmaceutical fracture analysis, container testing, and stone identification. Dr. Aldinger has written over 1000 customer reports, taught hundreds of students in fracture analysis, and is the co-author of two books on glass technology. Prior to joining AGR, he was a Materials Scientist at a defense contractor, where he designed and tested transparent armor (i.e. bullet-resistant glass) for military vehicles. Dr. Aldinger earned his B.S. in Chemistry at Penn State University and his Ph.D. at Cornell University. -
Frank Bamberg, MA
Associate Director of Primary Packaging and Medical Devices, CSL Behring
Moderator
Read BioFrank Bamberg, MA
CSL Behring
Frank Bamberg has more than 20 years of experience in the pharmaceutical industry in various leading roles in research & development, business development, and project management. Before joining CSL Behring in Bern CH as Associate Director for Medical Device and Primary Packaging in July 2019, Frank has been with Hoffmann-La Roche since 2011, responsible as Section Head of Pre-Fillable syringes for the development of primary packaging and device which will be in contact with the drug. Additionally, Frank has gained experience in various positions at SCHOTT Pharmaceutical Packaging. He was leading at SCHOTT the global business development and customer service for Pre-Fillable syringes. Frank has an MBA in industrial engineering and management from the University of Bern/Zürich and he is a plastic Engineer by education. -
Maria Bauer
Product Reviewer BC, TÜV SÜD PRODUCT SERVICE GmbH
Panelist
Read BioMaria Bauer
TÜV SÜD PRODUCT SERVICE GmbH
My professional background: I am a Pharmacist, additionally experienced in Medical Device Regulatory Affairs. I have been with TÜV SÜD PRODUCT SERVICE GmbH since 2017. The main tasks are the Medical Device Technical Documentation Review in terms of 1) Biocompatibility (esp. for class III medical devices, class III MDR Annex XVI devices), and for 2) Drug Device Consultations. -
Frank Bixenmann, Consultant Digital Solutions
Consultant Digital Solutions, Uhlmann Pac-Systeme GmbH & Co. KG
Co-Presenter
Panelist
Read BioFrank Bixenmann, Consultant Digital Solutions
Uhlmann Pac-Systeme GmbH & Co. KG
Frank Bixenmann is Consultant Digital Solutions of the Business Unit Digital of Uhlmann Pac-Systeme GmbH & Co. KG. After completing his further education as a state-certified automation technology technician, the trained mechatronics engineer began his career in 2010 as a project manager for printing and camera systems and track and trace applications at Uhlmann, one of the world's leading system suppliers for the packaging of pharmaceuticals. He then developed further to become an Electrical Engineer in Automation Projects. Many years of experience with digital solutions and intensive project work with customers were the best qualifications for his current job in sales. As a Consultant for Digital Solutions, he is now one of Uhlmann's experts for automation and software solutions, whose in-depth expertise makes him a valued contact for pharmaceutical companies. -
Bettine Boltres, PhD
Director Scientific Affairs & Technical Solutions, Integrated Systems, West Pharmaceutical Services
Committee Member
Moderator
Read BioBettine Boltres, PhD
West Pharmaceutical Services
As Director of Scientific Affairs & Technical Solutions, Glass Systems, Dr. Bettine Boltres is supporting the scientific exchange between West and the pharmaceutical industry. This complements her work as Product Manager for Schott Pharmaceutical Tubing, where she provided scientific consulting for glass primary packaging. Since 2015 Bettine has been an active member of the USP Packaging and Distribution Expert Committee as well as the ISO TC76/WG 2 on rigid container systems and WG 4 on elastomers. Additionally, in 2018 joined the European Pharmacopoeia Commission Group of Experts 16 (elastomers and plastics) and the GLS Working Party (glass). Since January 2019 she is also a member of the PDA Board of Directors, actively supporting the role of PDA in the global pharma world. She was part of the PDA Glass Handling Task Force finalizing TR 87, is actively involved in the Task Force working on an Annex to TR 73 addressing MDR GSPRs for PFS, and is part of the Pharmacopeia Interest Group. In 2015 she published the book "When Glass Meets Pharma", which builds the bridge between glass for pharmaceutical primary packaging and drug substances. -
Philip Bortner, M.Sc.
Global Product Manager Syringes, Gerresheimer Regensburg GmbH
Poster Presenter
Read BioPhilip Bortner, M.Sc.
Gerresheimer Regensburg GmbH
Philip Bortner is a medical engineer (M.Sc.) by education and graduated from the Technical University in Regensburg, Germany. He started his career as Global Product Manager of Syringes in the Business Development department at Gerresheimer in 2020 with the focus being on polymer syringes. In his position, he is responsible for expanding the product portfolio for polymer solutions according to the market's needs and is supporting customers with all kinds of technical questions. -
Paula Bracco, PhD.
R&D Lab Director, LIGHTHOUSE Instruments
Co-Presenter
Panelist
Read BioPaula Bracco, PhD.
LIGHTHOUSE Instruments
Paula Bracco is the R&D Lab Director at Lighthouse Instruments Europe. Paula is a chemist with a PhD in biotechnology. She is responsible for the discovery of new application areas in the field of non-destructive headspace analysis. In her role, she directs R&D studies, internally, for customers, or in cooperation with partners. Paula manages part of the customer portfolio within Europe, including pharmaceutical companies and packaging suppliers. She has a particular interest in research and development projects involving moisture determination by headspace water activity analysis. -
Serena Casanova, PhD
Technical Leader, Stevanato Group
Panelist
Presenter
Read BioSerena Casanova, PhD
Stevanato Group
Serena is a Chemical Engineer and has a PhD in Nanotechnology applied to water purification. She studied at several Universities across Europe, and this gave her education an international and diverse imprint. Today, she works in R&D at Stevanato Group, developing primary packaging solutions for injectors in the healthcare sector. Her subject matter expertise is Ready to Fill Cartridges: critical material attributes, critical process parameters, critical to quality attributes, and the link between the above. Serena acts as technical lead and process developer for multi-disciplinary projects from their early evaluation from the industrial implementation, going through the feasibility, development, validation, and verification. -
Vincent Cazanave
Device Team Leader, Roche
Panelist
Presenter
Read BioVincent Cazanave
Roche
Principal Medical Device Engineer and more than 13 years of experience in drug delivery and combination product development in various leading roles. Belonging to the Device & Packaging development group at Roche, leading device teams in developing specific drug delivery solutions for molecules in the pipeline, and leading the global Roche/Genentech Ophthalmology Device Technology Center. -
Clement Condouret
Tech Talk Presenter
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Melanie Decker
Parenteral Drug Association
Moderator
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Madushini N. Dharmasena, PhD
Senior Pharmaceutical Quality Assessor, OPQ, CDER, U.S. FDA
Committee Member
Moderator
Regulatory Panelist
Regulatory Presenter
Read BioMadushini N. Dharmasena, PhD
U.S. FDA
Madushini Dharmasena, Ph.D. is currently working as a Senior Pharmaceutical Quality Assessor in the FDA/CDER/ Office of Pharmaceutical Manufacturing Assessment (OPMA) Office of Pharmaceutical Quality (OPQ). Dr. Dharmasena joined the Division of Bacterial, Parasitic, and Allergenic Products in CBER in 2010 following a postdoctoral fellowship at the National Cancer Institute. At CBER she reviewed INDs and BLA supplements with a focus on product quality and manufacturing for biological products including live attenuated bacterial vaccine candidates, recombinant protein vaccine candidates, and live biotherapeutic products. In addition to review, she maintained an active research program and developed bifunctional oral vaccine candidates for the prevention of shigellosis and typhoid (FDA patent E-2012-016). In 2018 she joined OPMA, DMA Branch IV as a primary reviewer and has led numerous pre-license inspections of biologics manufacturing facilities. Dr. Dharmasena holds a Ph.D. degree in Microbiology and Immunology from Dartmouth Medical School, New Hampshire. -
Derek I. Duncan, PhD
Director Product Lines, LIGHTHOUSE Instruments
Co-Chair
Moderator
Read BioDerek I. Duncan, PhD
LIGHTHOUSE Instruments
Dr. Derek Duncan began his career as a Research Scientist at the Dutch Institute for Atomic & Molecular Physics in Amsterdam. He then moved into the 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, lyo chamber moisture mapping, and automated media fill inspection. Dr. Duncan has been a PDA member since 2004 and has been a regular contributor to PDA conferences, IG Groups, and Conference Program Committees. -
Nicolas Eon, PhD
Senior Technology Development Manager, Terumo Europe nv
Panelist
Presenter
Read BioNicolas Eon, PhD
Terumo Europe nv
Dr. Nicolas Eon, graduated from the University of Nancy and Nantes in France holds a Fluid Mechanics & Energy Science Engineering degree, a Master Degree in Energetics and Heat Transfer, and a PhD. in Biomechanics, worked for 10 years in the Automotive Safety Industry where he led the System Engineering Department in a global leading company. Dr. Eon started to build his expertise in Primary Containers for Pharmaceuticals and Injection Devices 15 years ago. He had several managing positions from Product Development to Strategic Marketing in global leading companies covering the full range of Primary Packaging from Vials to Prefilled Syringes (both in glass and polymer) where he launched successful products on the market and built sustainable long-term strategies. Dr. Eon has recently joined Terumo Medical Care Solutions in 2020 as Senior Technology Development Manager. Since 2010, he has been an active expert in ISO Technical Committees (ie. TC 76 WG4 & WG2, TC 210) as part of the French and Swiss delegations. -
Carol Rea Flynn, M. Eng.
Director of Field Quality, Primary Packaging Glass, Gerresheimer Glass Inc.
Co-Presenter
Panelist
Read BioCarol Rea Flynn, M. Eng.
Gerresheimer Glass Inc.
30 years’ experience in the pharmaceutical glass industry, in Engineering, Quality, Manufacturing, Laboratory Services, Regulatory Compliance, and Technical Services. Skilled in Process Engineering, Business Process Improvement, Cross-functional Team Leadership, Quality Management, and Six Sigma. An active member of the Parenteral Drug Association (PDA), Packaging Science Interest Group, VisPar (Particulate task force), and contributed to the development and publication of PDA Technical Report (TR43): Identification and Classification of Nonconformities in Moulded and Tubular Glass Containers for Pharmaceutical Manufacturing, TR Glass Handling, and TR Response Curve Visual Inspection of Particles. Member of International Commission on Glass TC 12 Pharma Packaging Technical committee, served on USP Glass Expert Panel focused on USP <660> and <1660>, and serves on many standards committees within ASTM and ISO. Enjoys sharing glass knowledge at various venues and is a co-author of the Pharmaceutical Dosage Forms: Parenteral Medications, Fourth Edition Chapter 21 Glass Container for Parenteral Products. Earned a Bachelor of Science in Mechanical Engineering from Drexel University and holds a Master of Science in Engineering with a focus in Chemical obtained from Rowan University. Currently, the Director of Field Quality Primary Packaging Glass for Gerresheimer Glass Inc. -
Ryan Forrey
Committee Member
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Sandro Furlan
Tech Talk Presenter
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Alicia Gallagher
Sr. Product Development Scientist, Corning Incorporated
Co-Presenter
Panelist
Read BioAlicia Gallagher
Corning Incorporated
Alicia Gallagher, Sr. Product Development Scientist at Corning Incorporated, has 12 years’ experience in glass mechanical reliability and is a subject matter expert in fractography with fracture analysis experience across all pharma glass container types. Alicia holds a BS degree in Biology from Houghton University and is pursuing an MS degree in Product Development from Rochester Institute of Technology. -
Hanno Gereon Geissler
Head of Technology Services, SIG
Panelist
Presenter
Read BioHanno Gereon Geissler
SIG
Hanno Geissler studied Food Chemistry at the University of Münster, Germany, and graduated as a “state–certified” food chemist. He worked for TÜV ESSEN, Germany as a DIN ISO 9000 co–auditor and in various positions for the German Food Safety Authority, Duisburg. He started with SIG Combibloc in 1999 as a field microbiologist to run commissioning tests with SIG customers and support them during troubleshooting worldwide. He is responsible for the Technology Services teams inside the Global R&D organization. These include various labs and aseptic and product processing specialists. As part of the SIG process authority group, he is also responsible for the validation of SIG`s aseptic systems. Hanno has been a member of the IFTPS since 2007 and part of the Aseptic Processing Committee. -
Elke Geuzens, PhD
Technical and Scientific Expert, Datwyler
Panelist
Presenter
Read BioElke Geuzens, PhD
Datwyler
Elke Geuzens graduated with a doctorate in chemistry from Hasselt University, Belgium. Before she joined Datwyler in 2010 as a product support manager, she had several years of experience in the chemical industry. Currently, Elke is a Technical and Scientific Expert and she has more than 10 years of experience in similar roles within the company. In her current role, Elke consults with pharmaceutical and medical device companies on parenteral packaging solutions to develop safe and efficacious drug-delivery systems. She holds global responsibility for several key clients, where she is responsible for technical projects from the ideation to the commercialization stage. -
Sinue Gomez, PhD Materials Science
Technology Director, Corning Incorporated
Committee Member
Moderator
Read BioSinue Gomez, PhD Materials Science
Corning Incorporated
Dr. Sinue Gomez is the business technology director, of Corning Pharmaceutical Technologies (CPT) in May 2021. Gomez leads the development of new products and process technology for CPT. She is responsible for developing and helping execute CPT’s technology strategy and developing the technology roadmap. Gomez joined Corning in 2006 as a research scientist in the glass research group, where she was one of the key inventors of the first Gorilla® glass and subsequent generations of ion-exchangeable glasses and glass ceramics for the Gorilla glass business and adjacencies. Gomez transitioned to glass development in 2014 and then joined CPT in 2016 as a glass surfaces manager, where she delivered a washing process for high-volume manufacturing. Most recently, she was responsible for delivering the product design of CPT's newest product, Viridian Vial™. Gomez earned a Ph.D. in Materials Science from the University of Connecticut and a bachelor’s degree in Materials Engineering from Universidad Simon Bolivar in Caracas, Venezuela. She has over 50 granted patents and several trade secrets. -
Luis A González, MSc
Research Scientist, Corning
Panelist
Presenter
Read BioLuis A González, MSc
Corning
Luis González currently works as a Research Scientist at Corning European Technology Center (CETC) in Fontainebleau, France. He has conducted research into parenteral glass packaging-formulation interactions for over 3 years and developed in-depth scientific expertise for a variety of glass containers and solution chemistries relevant to commercial drug products. He is also dedicated to the development of CETC's capabilities for the chemical and structural characterization of inorganic materials and provides support to glass structure and crystallization studies. Luis holds a master’s degree in Materials Engineering from Polytech Montpellier, France, a bachelor’s degree (cum laude) in Materials Engineering from Simón Bolívar University, Venezuela, and is fluent in English, French, and Spanish. -
Bo Gottlieb, MA
Senior Project Manager, Novo Nordisk A/S
Co-Presenter
Panelist
Presenter
Read BioBo Gottlieb, MA
Novo Nordisk A/S
Bo Gottlieb, Senior Project Manager, PSQIT Sustainability, Circular for Zero project office, Novo Nordisk A/S. Bo is a subject matter expert on waste and resources and support the strategic priorities and decisions in relations to waste and resources within Novo Nordisk A/S. Bo Gottlieb has almost 20 years of experience within sustainability developing political strategies and activities within Circular economy, Environmental technology development, Industry regulation and Climate. Bo Gottlieb has been part of Novo Nordisk A/S Sustainability department for 2 years and has previously been part of Danish Ministry of Environment, Danish Environmental Agency, Ministry of Utilities, Energy and Climate and City of Copenhagen. -
Paul Guijt
Volunteer, International Gaucher Alliance
Panelist
Patient Presenter
Read BioPaul Guijt
International Gaucher Alliance
Paul Guijt, a volunteer with the International Gaucher Alliance (IGA), is 62 years now living with a rare enzyme deficiency. He had over 50 hospital admissions in the first two decades of his life, including extensive surgery and tons of medication. He studied theology and philosophy in Amsterdam, became a public officer at the Dutch Council on Health Insurance, and ended his career in 2010 as a policy advisor on quality management of national screening programs like neonatal and cancers. Among other positions, he was co-founder of the Dutch Gaucher Association, a board member of the Dutch umbrella organization on hereditary and congenital diseases, and prepared what became the IGA which is celebrating its 30th anniversary. He has some 30 years of experience with infusions at home, most of the time self-infusing. With the IGA, he currently leads the development of guidelines on self-management and home infusion therapy. -
Lothar Haaf, Dipl.-Ing.(FH)
Senior Manager Technical Service Tubular Glass, Gerresheimer Glas GmbH
Tech Talk Presenter
Read BioLothar Haaf, Dipl.-Ing.(FH)
Gerresheimer Glas GmbH
Lothar Haaf studied mechanical engineering in Schweinfurt (Germany) and then worked for 10 years in various positions in the food industry. He joined Gerresheimer 2004 as Head of Technology and Quality at the Wertheim plant. He was promoted to Plant Manager in 2007 and was appointed as General Manager 2013 for this ampoule manufacturing site. As of 2018 Lothar Haaf was responsible as the Director Product Management Vials & Ampoules Gerresheimer Europe. Since the beginning of 2024, Lothar Haaf has taken over the Technical Service for Tubular Glass products, both internally and for customers. -
Jochen Heinz, MEng, PhD
Head of New Products & Technology, Transcoject GmbH
Panelist
Presenter
Read BioJochen Heinz, MEng, PhD
Transcoject GmbH
Dr.-Ing. Jochen Heinz holds an M.Eng. in Material-Science and Technology and a Ph.D. from a cooperation of the University of Clausthal and Schott-Glass on Glass-Platinum interactions. From there he continued since 1991 as a scientist at SCHOTT Central Research working on different topics of material- and technology. In 1995 within Schott-Glass he joined the pharmaceutical packaging unit with the task of development the polymer TOPAS for use in pharmaceutical packaging and refillable containers including their production technology. This became the Schott-Topac-System. Since 1999 he became responsible for the New Product Development of the Pharmaceutical Packaging unit. He left Schott in 2001 and joined Transcoject a manufacturer of Medical Devices. He set up an aseptic filling operation and worked beside development in different functions. He is the Director of Development and Technology of the company. Since about 2000 Trancoject has been developing prefillable containers of COC and since about 2005 refillable COP and COC syringes with a portfolio from 0.3ml to 250ml. -
Manfred Holzer
Strategic Product Manager E-Beam Technology, SKAN AG
Poster Presenter
Read BioManfred Holzer
SKAN AG
Manfred studied Mechanical Engineering and is engaged as Sales Manager for isolators in the pharmaceutical industry since 1995. He joined SKAN AG in 2000 in various positions in international sales & project management, as well as USA business coordinator. Since 2008 he covered in sales the E-Beam technology and is today the Strategic Product Manager E-Beam technology for pharma E-Beam applications at SKAN. -
Desmond G Hunt, PhD
Sr. Principal Scientist, USP
Panelist
Regulatory Panelist
Regulatory Presenter
Read BioDesmond G Hunt, PhD
USP
Dr. Desmond G. Hunt has been with USP since 2005 and holds the position of Sr. Principal Scientist in the Compendial Science Group-General Chapters. He works with the Packaging and Distribution and Dosage Forms Expert Committees, where he works to develop and revise USP Standards. He has authored many publications and peer-reviewed articles and is a frequent speaker and instructor on topics related to pharmaceutical packaging, particulate matter in parenteral and ophthalmic dosage forms, and good storage and transportation practices. He participates in several industry Working Groups and Technical Committees related to his areas of expertise. Dr. Hunt obtained his M.S. and Ph.D. from the University of Texas at Austin. -
Guerney D.H Hunt, MS
Research Engineer 1, Packaging Technologies and Inspection
Panelist
Presenter
Read BioGuerney D.H Hunt, MS
Packaging Technologies and Inspection
Guerney Hunt is a research engineer at Packaging Technologies and Inspection. Guerney holds both a bachelor’s and master’s degree in mechanical engineering. His graduate research focused on thermal regulation for vaccine distribution in rural hot climates. Since entering the container closure integrity space in 2020, Guerney has worked with vacuum decay, pressure decay, force decay, Helium, and ultrasonic leak detection systems. His primary work has focused on the development of vacuum decay leak detection systems. -
Carine Huon, BSC
Container Closure Integrity Scientist, Sanofi
Poster Presenter
Read BioCarine Huon, BSC
Sanofi
After 2 years in bioanalysis and 12 years as an analytical specialist in dry pharmaceutical forms. I spent the last 4 years working on CCI control strategy as a technical development engineer at Sanofi on different components (syringe, cartridge, vial, etc.). I am also part of different multi-company expert communities such as the SFSTP (French Society of Pharmaceutical Sciences and Techniques) on topics such as the robustness of analytical methods or aQBD (Analytical Quality By Design) and Biophorum on topics such as "sample sizing approaches for CCI testing" or "the holistic approach to container closure integrity". -
Lize Jaspers, PhD
Environmental Sustainability Requests Mgr’, Amgen
Presenter
Read BioLize Jaspers, PhD
Amgen
Lize Jaspers is a Sr. Packaging Engineer at Amgen Europe B.V. in the Netherlands. She leads the Amgen global packaging sustainability workstream and is responsible for packaging development and packaging lifecycle management at Amgen sites and CMOs in the EMEA region. She holds a doctorate in chemistry from the University of Hasselt in Belgium, has more than 15 years of experience in primary, secondary, and tertiary packaging, and started building her expertise in pharmaceutical and combination product packaging in 2015. -
Bram Jongen, PhD
VP Materials and Surface Technologies, Datwyler
Committee Member
Moderator
Read BioBram Jongen, PhD
Datwyler
After his Masters in Polymer Chemistry at the University of Louvain, Belgium, Bram Jongen acquired a Ph.D. in Water Soluble Polymers used for advanced drug administration. Bram started as Technical Support Manager for Datwyler 18 years ago, and picked up the role of heading the Global Product Introduction & Support team, a global team of highly experienced and educated people, having each their expertise in the world of pharmaceutical closures. Bram himself acquired profound Extractables & Leachables expertise. From 2013 till 2020, he has been acting as Head of R&D, leading a group that focuses on developing new rubber and new coating materials. Since early 2020, he has become VP of Materials & Technologies, overseeing the development teams in Datwyler’s HealthCare branch, but also the Mobility, Food & Beverages, General Industry, and Connectors teams. -
Marissa Kateva, MSc
Laboratory Analyst, Lighthouse Instruments
Poster Presenter
Read BioMarissa Kateva, MSc
Lighthouse Instruments
My name is Marissa Kareva, my bachelor's degree was in chemistry obtained from the University of Crete in Greece. I also hold a master's degree in Biomolecular Sciences obtained from the Vrije University of Amsterdam. Currently, for the last one and a half years I have been working as a Laboratory Analyst for Lighthouse Instruments in Amsterdam. -
Bram J.J. KEYMOLEN
Co-Founder, eyetec
Poster Presenter
Read BioBram J.J. KEYMOLEN
eyetec
Graduated pharmacist at the university of Antwerp, Bram Keymolen obtained a second master degree in Industrial Pharmacy in 1999. Over twenty years of GMP experience in different roles, initially mainly in qualification and validation, evolving into several QA and QP positions in mainly biotech companies – both startups and corporate structures. After taking a position as Process Engineer in the field of visual inspection in 2006, created his own consultancy company in this domain in 2011. Eye-Tec supports visual inspection and CCIT projects under GMP. Missions vary from CAPA-development to major CAPEX projects or corporate strategy development for visual inspection and CCIT. Eye-Tec offers both technical solutions (vision tuning and optical/mechanical improvement) and compliance support to customers worldwide. -
Falk Klar, PhD
General Manager, Vice President Europe, Parenteral Drug Association
Committee Member
Read BioFalk Klar, PhD
Parenteral Drug Association
Falk Klar holds a Ph.D. in Applied Physics and has over 19 years of experience in Quality Assurance and Compliance in the life science industry. Falk held positions in pre-clinical research and development in a medical product company and clinical research in a CRO. He has gained experience with biopharmaceutical and pharmaceutical products including monoclonal antibodies, vaccines, parenteral, narcotics, and animal drugs in several positions in quality management. Falk joined PDA Europe in 2015 as Senior Director of Training & Education. Since 2016 he has been appointed General Manager and Vice President of PDA Europe. -
Arne Kloke, PhD
Head of Service and Sustainability Management, SCHOTT Pharma
Committee Member
Moderator
Read BioArne Kloke, PhD
SCHOTT Pharma
Arne Kloke serves as the Head of Service and Sustainability Management at SCHOTT Pharma, overseeing the development and implementation of the company's sustainability strategy and action program. Additionally, he holds the position of President at the Alliance to Zero, a pharma supply chain initiative focused on facilitating the transition of injection devices to net-zero. In both roles, his primary objective is to foster the creation of product solutions and service models that harmonize environmental responsibility with financial viability. With a background in science, Arne is also a member of the PDA Parenteral Packaging Conference Committee and is committed to collaborating with partners in the injectables industry to realize innovative primary packaging and processing solutions. -
Horst Koller, Dipl.-Ing.
CEO, HK Packaging Consulting
Panelist
Presenter
Read BioHorst Koller, Dipl.-Ing.
HK Packaging Consulting
Before becoming a consultant, Horst Koller worked for Abbott Diagnostic and SCHOTT Pharmaceutical Packaging with a total of more than 30 years of industry experience. His consulting company is focussing on Technical, Regulatory, and QM-Support around Primary and Secondary Packaging Systems including Medical Devices. He is an active member within the technical ISO Committees TC76 and TC84 as well as an active member of the WG16 for the EDQM. He is a speaker at international conferences and holds customized training. He holds an Engineering degree in Biotechnology from the University of Applied Sciences in Mannheim / Germany. -
Kurt Kugler, PhD
Business Development Manager, Schreiner MediPharm
Panelist
Read BioKurt Kugler, PhD
Schreiner MediPharm
Dr.-Ing. Kurt Kugler holds a Diploma in Chemical Engineering (2010) and a PhD in Electrochemistry (2015). Kurt has been working for Schreiner Group since 2015. He has deep knowledge and experience in product and process development for Printed Electronics and RFID applications. Since 2020 he is Business Development Manager for Healthcare Solutions at Schreiner MediPharm. His main focus is on Sustainability since 2021, being the Product Manager for Sustainable Solutions at Schreiner MediPharm. In this position he is also a Co-Founder and representative for Schreiner MediPharm within the Alliance to Zero. -
Suzanne Kuiper, PhD
Application Manager, Lighthouse Instruments
Poster Presenter
Read BioSuzanne Kuiper, PhD
Lighthouse Instruments
At LIGHTHOUSE since 2011, Dr. Kuiper has been a headspace analysis application expert on process monitoring and finished product inspection. These include using headspace analysis for container closure integrity testing, lyo chamber moisture mapping, headspace oxygen monitoring, and automated media fill inspection. -
Ana Kuschel, PhD
Principal Scientific Affairs, West Pharmaceutical Services, Inc.
Poster Presenter
Presenter
Read BioAna Kuschel, PhD
West Pharmaceutical Services, Inc.
As Principal Scientific Affairs Europe, Ana is providing technical support relating to West’s packaging components and delivery systems for injectable drugs and healthcare products. As well as bridging scientific information through industry outreach. This complements her previous role as Manager of Material Development, where she worked on both existing and new rubber formulations. Ana holds a PhD in macromolecular chemistry and is an active member of the ISO TC 76 and PDA Packaging Science groups. -
Nadine K Lampka, PhD
Senior Product Manager Pharma-Security, Schreiner MediPharm
Panelist
Presenter
Read BioNadine K Lampka, PhD
Schreiner MediPharm
Dr. rer. nat. Nadine Lampka holds a PhD and master´s degree in chemistry. She has over 12 years of experience in managing and consulting integrity and authentication solutions for the life sciences and healthcare industry. At Schreiner MediPharm, she leads the innovation to commercialization process, aligns the security portfolio to tackle changing threat challenges to supply chains, and provides holistic drug protection guidance to customers and stakeholders. Her current focus is on holistic and disruptive approaches that contribute to a sustainable supply chain and at the same time improve supply chain security. Nadine is also a representative for Schreiner MediPharm within the Alliance to Zero. Her core competencies include strategy, product management, storytelling, technical marketing, brand protection, functional labels, printing solutions, and anti-counterfeiting technologies. She is passionate, visionary, and full of energy, and loves to scout for new technologies, mediate and analyze complex scientific content, and bring new solutions to market. Raising awareness about the importance of supply-chain security and all aspects that have an impact, is of her major interest. -
Philippe Lauwers
Technology Development Director, Terumo Pharmaceutical Solutions
Co-Chair
Moderator
Read BioPhilippe Lauwers
Terumo Pharmaceutical Solutions
Philippe Lauwers has been active in the medical device and pharmaceutical packaging sector for the last fifteen years with growing responsibilities in business development and technical roles. He is currently the Director of Technology Development at Terumo Pharmaceutical Solutions in Belgium. Philippe graduated in Biotechnology from the University in Ghent, Belgium, and worked as a scientific researcher at the Catholic University of Leuven. Upon obtaining an additional degree in Biomedical Engineering at the Catholic University of Leuven he moved from an academic to an industrial environment. Philippe is a volunteer at the PDA organization and also serves as an expert in ISO technical committees TC76 and TC84. -
Diana Löber
Global Product Manager Vials, SCHOTT Pharma AG & Co. KGaA
Panelist
Presenter
Read BioDiana Löber
SCHOTT Pharma AG & Co. KGaA
Diana started her career in the medical device industry prior she joining SCHOTT in the summer of 2018. With more than 10 years of experience in the area of product management, as a global product manager for vials, she is responsible for the product strategy, including the identification of new market opportunities and the development and launch of innovative products. -
Andreas Meiser, Dr-Ing
Sr. Director of Component Development, Fresenius Medical Care Deutschland GmbH
Panelist
Presenter
Read BioAndreas Meiser, Dr-Ing
Fresenius Medical Care Deutschland GmbH
Andreas Meiser, Dr.-ing. in Materials Science, is Sr. Director of Component Development at Fresenius Medical Care, the world’s leading provider of products and services for individuals with kidney diseases. He has 10+ years of experience in the development of container closures for large volume parenteral and packing components, esp. flexible films, and tubes. -
Stine Mikkelsen
Panelist
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Lena Mungenast
Scientist, University of Applied Sciences Northwestern Switzerland
Poster Presenter
Read BioLena Mungenast
University of Applied Sciences Northwestern Switzerland
Lena Mungenast works as a scientist in the pharmaceutical technology of macromolecular substances group led by Professor Germershaus at University of Applied Sciences Northwestern Switzerland (FHNW). Her current research focuses on the development of drug delivery systems, formulation of parenteral drug products and container closure systems. Lena is currently enrolled as a PhD student at the University of Freiburg working in the field of tissue engineering on spinal cord research. She holds a BSc degree in Chemistry from University Wuerzburg and MSc degree in Molecular technologies from University of Applied Sciences Northwestern Switzerland. -
Domingo Olivares Postigo, PhD
Laboratory Engineer in Primary Packaging Material and Device Testing, ten23
Poster Presenter
Read BioDomingo Olivares Postigo, PhD
ten23
Domingo Olivares Postigo, PhD. Laboratory Engineer in Primary Packaging Materials and Device Testing. Ten23. Domingo Olivares Postigo studied Chemistry at the Complutense University of Madrid, Spain, where he earned his Bachelor’s degree with a focus on Raman spectroscopy, followed by a Master’s degree in Chemical Science and Technology, specializing in Microfluidics from the same university. During his academic tenure, he also worked at a Quality Control Chemical Analysis Laboratory at Ainprot S.A. and as a Nuclear Magnetic Resonance spectroscopy Scientist at Aarhus University. He furthered his education by pursuing a Ph.D. in Physical Chemistry at the University of Turin and the Italian Institute of Technology, where he delved into research on nitrogen-vacancy centers in diamonds. Transitioning to the pharmaceutical industry, he moved as Quality Control Scientist of Primary Packaging and Raw Materials in Lonza and currently, he serves as a Laboratory Engineer in Primary Packaging Materials and Device Testing in ten23. -
Chiara Passet
Poster Presenter
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Sarah S. Peláez
PhD Student & Senior Scientist Primary Packaging, ten23 health
Poster Presenter
Read BioSarah S. Peláez
ten23 health
Sarah Peláez works as a PhD Student and Senior Scientist in the primary packaging and manufacturing group at ten23 health, a CDMO founded in 2021 in Basel (Switzerland). Before she joined ten23 health in 2021, she worked three years at Lonza in different groups, including the phys.-chem. analytical department and in primary packaging and device development. Sarah is experienced in the development of container closure systems (CCS) for parenteral drug products. Her current research focuses on process characterization of disposable materials used in biopharmaceutical manufacturing. She holds a BSc and MSc degree in Life Sciences, Pharmaceutics from the University of Applied Sciences and Arts Northwestern Switzerland, and is currently enrolled in a PhD program at the University of Frankfurt. -
Tony A Perry
Regional Director of Quality, SCHOTT Pharma
Moderator
Presenter
Read BioTony A Perry
SCHOTT Pharma
More than thirty years in the manufacture of Pharmaceutical Containers Six years working in the Pharmaceutical Industry Six Sigma Black Belt: ASQ Certified SSBB A Degree Mathematics Born in the UK, but have lived and worked in the US for the last twenty years -
Alessandro Pettenuzzo
Technical Sales Manager, Stevanato Group S.p.a.
Panelist
Presenter
Read BioAlessandro Pettenuzzo
Stevanato Group S.p.a.
Alessandro Pettenuzzo has been working in Stevanato Group S.p.a. since 2016 as technical sales manager for pharmaceuitcal and medical equipment and machineries. In his career he has achieved extensive sales and marketing experience in the area of glass production machineries, food processing equipment, and pharmaceutical technologies working with customers globally. -
Christian Proff, PhD
Senior Verification Engineer, F. Hoffmann-La Roche Ltd
Poster Presenter
Read BioChristian Proff, PhD
F. Hoffmann-La Roche Ltd
Dr. Christian Proff is a materials scientist with degrees from Chalmers, Gothenburg (S), and Darmstadt (D) Universities of Technology, and a Ph.D. from Grenoble (F) University (INPG) with extensive experience in materials research in Sweden (Chalmers), USA (Argonne National Laboratory), and Switzerland (Paul-Scherrer-Institut). Within device and packaging development at F. Hoffmann-La Roche, he has been working in verification engineering since 2018 on improvements in CCI testing and the development of new device test methods. -
Brigitte Reutter-Haerle
Vice President Product Management & Marketing, Vetter
Moderator
Panelist
Read BioBrigitte Reutter-Haerle
Vetter
Brigitte Reutter-Haerle is Vice President Product Management & Marketing for Vetter. In this role, she is responsible for both existing and new product and service offerings that support Pharma & biotech companies as well as marketing and public relations activities. She joined Vetter in 1996, serving in the company’s sales and marketing function and later transferring to corporate marketing. She began her career in 1983, holding various positions in the sales organizations of companies including Hilton International and TNT Express Worldwide. Brigitte has been a PDA member since 2005, and as of 2024, she serves as a member of the Board of Directors. She has also been a leader of PDA’s Pre-Filled Syringe Interest Group/Europe since 2007 and served on various committees, including as Chair of the PDA UPS Program Planning Committee. In 2014, Brigitte received the PDA Distinguished Service Award and, in 2017, the PDA Europe Service Appreciation Award for her long-standing commitment. The awards were in recognition of special acts, contributions, or services that have helped build on the success and strength of the PDA. Ms. Reutter-Haerle earned a BA and a degree in business administration from Baden-Wuerttemberg Cooperative State University. -
Coralie A Richard, PhD
Senior Director, Eli Lilly and Company
Committee Member
Moderator
Read BioCoralie A Richard, PhD
Eli Lilly and Company
Coralie Richard is the Director of Packaging Systems in Delivery and Device Connected Solutions (DDCS) at Eli Lilly and Company, Indianapolis, USA. A native of France, she came to the USA to pursue her PhD in Organic Chemistry at the Georgia Institute of Technology. After working as an R&D scientist in a material company, she joined the primary packaging system team at Eli Lilly, supporting container closure systems development activities and container-related research projects. Her contributions were recognized with two Eli Lilly Top 100 Innovator Awards half a dozen articles and a patent. In her current role, she provides technical and organizational leadership in the areas of primary packaging/container closure development, secondary packaging, shipping & distribution, surface science, and several related DDCS laboratories. Her global team supports clinical and commercial development activities across all business units. -
Federico Sabini, MD in Biomedical Engineering
QC Senior Specialist Primary Packaging Materials and Combination Products, Lonza AG
Co-Presenter
Panelist
Read BioFederico Sabini, MD in Biomedical Engineering
Lonza AG
Accomplished primary packaging material expert with a master's degree in Bioengineering and over 9 years of experience in primary packaging development. After university, he joined Baxter Healthcare as a Product Development Engineer, supporting the V&V activities of new flexible bags for peritoneal dialysis treatment and design change control tasks for products already on the market. Then, he moved to the glass primary packaging material industry working for Nuova Ompi, Pharmaceutical System Division of Stevanato Group, as Technical Project Lead. In this role, he was leading the development activities of an innovative multi-products platform of sterile glass primary packaging systems (e.g. syringes, cartridges, and vials) for injectable, highly sensitive drugs from design concept to commercialization. Later, he joined Lonza DPS as an Associate Principal Scientist in Primary Packaging and Combination Products leading the implementation of a Container Closure System Qualification strategy for Vialed Drug Products and Pre-filled Syringes in the Lonza DPS manufacturing sites network. He is currently working as QC Senior Expert for PPMs at Lonza DPS. In this role, he is building up a global QC strategy for the incoming release of PPMs (including vials, pre-fillable syringes, rubber stoppers and plungers, and flip-off seal caps) and defining related internal specifications and requirements. -
Georg Schick, Dipl.-Ing.
Strategic Product Manager Track & Trace, Uhlmann Pac-Systeme GmbH & Co KG
Co-Presenter
Panelist
Read BioGeorg Schick, Dipl.-Ing.
Uhlmann Pac-Systeme GmbH & Co KG
Georg Schick is the Strategic Product Manager for all "Track & Trace" solutions from Uhlmann Pac-Systeme GmbH & Co. KG, a global leader in providing systems for packing pharmaceuticals. After completing his degree in electrical engineering at the Ulm University of Applied Sciences, he began his career in 1999 at Uhlmann, working as an electrical designer for cartoners and end-of-line packaging machines. From this position, he was promoted to Project Manager for automation. His many years of experience in diverse fields of automation engineering and his extensive project work with clients were the perfect preparation for his current role in Sales and Strategic Product Management for "Track & Trace" solutions. He forms part of a team of experts at Uhlmann, whose in-depth knowledge has earned them a reputation as valued contact partners among pharmaceutical companies. -
Julien Singer, PhD
R&D Senior Engineer, BD
Panelist
Presenter
Read BioJulien Singer, PhD
BD
After holding different positions in the semiconductor field, from microelectronics to photovoltaics, Julien Singer reached BD in 2013 as a modeling and simulation expert. In his current role, Julien uses various modeling tools to understand and predict how medical devices behave. He supports project teams and subject matter experts to address the problems they face during the whole product life cycle, by defining the best modeling strategy and ensuring the best outcome of physics-based models. Another important aspect of his role is to capitalize on and disseminate modeling expertise across the R&D community and beyond. His fields of interest include structural mechanics, fluid mechanics, and tribology. Julien holds an engineering degree in Material Science from the National Institute of Applied Sciences (INSA) of Lyon, France, and a PhD in Modeling and Numerical Simulation from INSA Lyon. -
Folker Steden, Dr
Senior Principal Expert, Director Product Management, Schott Tubing
Committee Member
Moderator
Read BioFolker Steden, Dr
Schott Tubing
Folker Steden graduated as a Chemist from the Rheinische Friedrich-Wilhelms University in Bonn Germany. After finishing his awarded PhD doctoral thesis in inorganic Chemistry at the Universities of Bonn Germany and Fredericton New Brunswick in Canada he transferred to the high tech Start-Up company belChem as the Head of R&D, responsible for product development and ramp-up. Fifteen years ago, he joined SCHOTT as a scientific Consultant for technical and pharmaceutical tubing applications. In the years 2010 to 2012 he was located in Shanghai responsible for Scientific Consulting, Business Development, and B&I activities in Asia. Since 2012, he has been leading the Product Management Team of the tubing division of SCHOTT. With his excellent scientific background and profound intercultural communication skills, he is working worldwide as a “missing link” between customers and local R&D units, focusing on future customer needs and presenting frequently at international conferences on subjects related to special glass for technical and pharmaceutical applications. -
Jean-Sebastien Steffen, MS, PhD
Group Lead Primary Packaging and Combination Products, Lonza
Co-Presenter
Panelist
Read BioJean-Sebastien Steffen, MS, PhD
Lonza
Jean-Sébastien Steffen leads the Combination Product and Primary Packaging development organization with Lonza Drug Product Services (Basel, Switzerland). He supports Lonza’s customers with a long experience in the technical development of combination products for clinical and commercial applications. Jean-Sebastien has also been a key player in establishing global prefilled syringe technology platforms for different large pharmaceutical companies and developed extensive expertise regarding container closure integrity, drug-container interaction, and combination product functionality questions. -
Klaus Ullherr
Senior Product Manager, Syntegon Technology GmbH
Panelist
Poster Presenter
Presenter
Read BioKlaus Ullherr
Syntegon Technology GmbH
Klaus Ullherr (Senior Product Manager) has a degree in electrical engineering. After university, he worked for several years as a project manager in the electrical industry. In March 2000 he joined Robert Bosch GmbH, Packaging Technology, Product Division Pharma Liquid, now Syntegon Technology. During the first two years, he was the project manager responsible for handling complex customer orders. Since 2002 he has been a product manager for the business fields of syringes and RTU (ready-to-use) containers with global product responsibility. His main functions are market analysis, initiating new product developments, business development, and expert in syringe/nested container processing. He is a member of the PDA and trainer at the PDA training course "All about pre-filled syringes" and works as an expert in the DIN/ISO group for primary packaging. Klaus is also a member of ISPE and a member of the program committee of the yearly ISPE Aseptic Conference. He is a well-known speaker and trainer covering trends and solutions for fill/finish equipment, especially for pre-filled syringes and other pre-sterilized containers. -
Robert T Urquhart, MBA
CEO, Eagas
Panelist
Presenter
Read BioRobert T Urquhart, MBA
Eagas
Tod Urquhart has more than 14 years of experience in digitalization and product traceability including software systems, regulatory compliance, process efficiency, and supply chain visibility. He has worked with Pfizer, GSK, Novartis, Merck, Danone, and the Stevanato Group. Currently he is a pharma industry advisor working with software systems. He is also the Vice chairman of an ISPE Community of Practise [CoP] and chair of the Filling & Inspection working group which is creating an industry Good Practise Guide for the use and implementation of unique containers across the parenteral manufacturing supply chain. -
Christian Vaas
Poster Presenter
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Tom Van Ginneken
Head of Product Management, SCHOTT AG
Co-Presenter
Panelist
Read BioTom Van Ginneken
SCHOTT AG
Tom Van Ginneken is the Head of Product Management for Polymer Solutions at SCHOTT Pharma. In this role, he works on the strategic orientation and innovation pipeline of the product group. His educational background includes studying Chemical Engineering in Antwerp, Belgium, and earning an MBA from the University of Sankt Gallen, Switzerland. Following three years in the chemical and pharmaceutical sector in Belgium, Tom joined SCHOTT Pharma in 2008. -
Tingting Wang, PhD
Senior Director, Eli Lilly and Company
Panelist
Presenter
Read BioTingting Wang, PhD
Eli Lilly and Company
Tingting Wang is currently a Sr. Director in the Department of Bioproduct Research and Development at Eli Lilly and Company. She earned her Bachelor of Science at Jilin University, China, and her PhD in Chemistry from the University of Wisconsin-Madison. Dr. Tingting Wang finished her Post-Doc work in Macromolecule and Vaccine Stabilization Center at the University of Kansas and worked for Novartis and GSK on large molecule formulation development before joining Eli Lilly and Company. She has been working for the Eli Lilly formulation team for more than 8 years. Dr. Wang's team at Eli Lilly is responsible for formulation development and process development of parenteral formulations, including biologics and synthetic molecules. Dr. Tingting Wang has a strong scientific interest and contribution in the area of surfactant application in large molecule formulation and interactions between drug products and container/closure systems. -
Heinz Wolf
General Manager, PTI
Poster Presenter
Read BioHeinz Wolf
PTI
Heinz Wolf received his Bachelor of Science degree in mechanical engineering from the Ingenieurschule in Bern, Switzerland. Wolf joined PTI in 1985 as a service engineer. He joined the sales team in 1996 and has held the position of general manager of PTI Inspection Systems since 1997. Heinz Wolf has focused on developing inspection technologies for the packaging industry that perform with a high degree of precision and reliability, and simplify testing and validation processes in the pharmaceutical, medical device, and food industries. He focuses on global quality solutions and deterministic quantitative inspection technologies for package testing that are robust, faster, cleaner, and reduce manufacturing waste. PTI, 8 Skyline Drive, Hawthorne, NY 10532 Office: 914.337.2005; Cell: 914.523.0475 e-mail: [email protected] PTI Inspection Systems: www.ptiusa.com
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Ellehammersvej 18Copenhagen, Denmark , Denmark
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Clarion Hotel Copenhagen Airport
Ellehammersvej 20
2770 Kastrup , Denmark
Metro
Take line M2 from central Copenhagen to Copenhagen Airport (approx. 10-15 mins). Then walk through the passageway straight into the hotel lobby.
From the airport
Walk through the passageway from Terminal 3 and straight into the hotel lobby (approx. 2 mins).
Comfort Hotel Copenhagen Airport - The Hangar
Ellehammersvej 18
2770 Kastrup
, Denmark
Metro
Take line M2 from central Copenhagen to Copenhagen Airport.
From the airport
The hotel is just a 5-minute walk from Terminal 3.