2024 PDA Parenteral Packaging Conference

Registration Open

The Hangar 1-3

Welcome and Introduction

The Hangar 4-5

• Committee Member: Falk Klar, PhD, Parenteral Drug Association

  

  Falk 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.

Welcome from the Co-Chairs

The Hangar 4-5

• Co-Chair: Philippe Lauwers, Director Technology Development, Terumo Pharmaceutical Solutions

  

  Philippe Lauwers, Director Technology Development, 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.

Opening Plenary Part I

The Hangar 4-5

• 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.

• 09:15 – 09:40

  How to Package Presents for a Patient?

  • 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.

• 09:40 – 10:05

  Updates from USP Packaging Chapters

  • 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.

• 10:05 – 10:30

  Looking Across Borders – Aseptic Filling in the Food Industry

  • 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.

Networking Coffee Break & Exhibition

The Hangar 1-3

Opening Plenary Part II

The Hangar 4-5

• 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.

• 11:15 – 11:40

  Regulatory Updates of Container Closure Systems for Drugs, Including Biological Products

  • 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.

• 11:40 – 11:55

  Interactive Questionnaire Session

  • 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.

• 11:55 – 12:35

  Plenary Discussion

  • 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.

Networking Lunch Break, Poster Session & Exhibition

The Hangar 1-3

Guided Poster Walk

The Hangar 1-3

• 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 a role of heading the Global Product Introduction & Support team, a global team of highly experienced and educated people, having each their own 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 became VP Materials & Technologies, overseeing the development teams in Datwyler’s HealthCare branch, but also the Mobility, Food & Beverages, General Industry and Connectors teams.

• Moderator: Bettine Boltres, PhD, Director Scientific Affairs & Technical Solutions, Glass Systems, West Pharmaceutical Services

  

  Bettine Boltres, PhD, Director Scientific Affairs & Technical Solutions, Glass 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.

• 13:20 – 13:50

  Aseptic Transfer of RTU Containers in Light of the New Annex 1

  • Poster Presenter: Christian Vaas

    

    Christian Vaas
    

• 13:20 – 13:50

  CCI Testing of Fusion Sealed Parenterals

  • Poster Presenter: Heinz Wolf, General Manager, PTI

    

    Heinz Wolf, General Manager, PTI
    

    BIOGRAPHY Heinz Wolf, General Manager PTI Inspection Systems 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 that 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

• 13:20 – 13:50

  Container Closure Integrity Test Methods - Status Quo

  • 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.

• 13:20 – 13:50

  Determining CCI Failure Temperature and Mechanism of PFS Performance at Ultra-Low Temperatures

  • Poster Presenter: Lena Mungenast

    

    Lena Mungenast
    

• 13:20 – 13:50

  Electron Beam Technology – Transfer Technology for Pre-Sterilized RTU Components

  • Poster Presenter: Manfred Holzer, Sales Manager IRE & Product Manager Ebeam Technology, SKAN AG

    

    Manfred Holzer, Sales Manager IRE & Product Manager Ebeam Technology, SKAN AG
    

    Manfred Holzer studied Mechanical Engineering and has been engaged as a sales manager for isolators in the pharmaceutical industry since 1995. Joining SKAN AG in 2000 he worked in various positions, e.g. as international sales & project manager, and USA business coordinator. Since 2016 dedicated Sales Manager for Ireland, he also covered 2008 the strategic product management sPM for pharma beam applications at SKAN.

• 13:20 – 13:50

  Headspace Analysis versus Helium Leak Testing

  • Poster Presenter: Suzanne Kuiper, PhD, Application Manager, Lighthouse Instruments

    

    Suzanne Kuiper, PhD, Application Manager, Lighthouse Instruments
    

    At LIGHTHOUSE since 2011, Dr. Kuiper is 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 degree was in chemistry obtained from the University of Crete in Greece. I also hold a master degree in Biomolecular Sciences obtained from the Vrije University of Amsterdam. Currently, for the last one and a half year I am working as a Laboratory Analyst for Lighthouse Instruments in Amsterdam.

• 13:20 – 13:50

  Industry Perspective on a Holistic Approach to Container Closure Integrity

  • 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 on 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".

• 13:20 – 13:50

  Interaction of Machine and Packaging Material

  • 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.

• 13:20 – 13:50

  On the Evolution of Stability and Quality of Bake-on PDMS Coatings upon Extended Thermal Treatments

  • Poster Presenter: Chiara Passet

    

    Chiara Passet
    

• 13:20 – 13:50

  Positive Controls - From Kirsch to Now

  • 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-La - La Roche, he has been working in verification engineering since 2018 on improvements in CCI testing and the development of new device test methods.

• 13:20 – 13:50

  Pre-filled Syringes for Deep Cold Storage

  • 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 carreer as Global Product Manager Syringes in the Business Development department at Gerresheimer in 2020 with the focus being set to polymere 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 in all kind of technical questions.

• 13:20 – 13:50

  Probability of Detection Study

  • Poster Presenter: Bram Keymolen

    

    Bram Keymolen
    

• 13:20 – 13:50

  The Need for High Quality in Primary Packaging

  • 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.

• 13:20 – 13:50

  Using Finite Element Analysis to Model Stopper Raising

  • 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.

Session 1, Track A: Primary Packaging Components

The Hangar 5

• 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 is a Commitee Member of the Alliance to Zero and Manager for Strategic Innovation at SCHOTT Pharma. Within both organization, he is working towards service models enabling a simultaneous match of environmental responsibility and financial viability. He is a scientist by training and well experienced in realizing parenteral packaging and processing solutions with partners throughout the injectables industry.

• 13:50 – 14:05

  Materials for Drug Containers: Glass versus Polymer, Basics, Pros, Cons and Different Applications

  • 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 a 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-developments. In 1995 within Schott-Glass he joined the pharmaceutical packaging unit with the task to development the polymer TOPAS for the use in pharmaceutical packaging and according prefillible containers including their production tech-nology. 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 differ-ent functions. Actually he is Director of Development and Technology of the company. Since about 2000 Trancoject is developing prefillable containers of COC and since about 2005 of prefillable COP and COC syringes with a portfolio from 0.3ml to 250ml.

• 14:05 – 14:20

  How Strong is That Vial Anyway? Applying Glass Fractography to the Evaluation of Novel Glass Parenteral Packaging Technologies

  • 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.

• 14:20 – 14:35

  The Effects of the Rubber Component and the Selected Analytical Method on the Moisture Content of a Freeze-Dried Cake

  • 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.

• 14:40 – 15:10

  Q&A, Discussion

  • 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 is a Commitee Member of the Alliance to Zero and Manager for Strategic Innovation at SCHOTT Pharma. Within both organization, he is working towards service models enabling a simultaneous match of environmental responsibility and financial viability. He is a scientist by training and well experienced in realizing parenteral packaging and processing solutions with partners throughout the injectables industry.

  • 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 a 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-developments. In 1995 within Schott-Glass he joined the pharmaceutical packaging unit with the task to development the polymer TOPAS for the use in pharmaceutical packaging and according prefillible containers including their production tech-nology. 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 differ-ent functions. Actually he is Director of Development and Technology of the company. Since about 2000 Trancoject is developing prefillable containers of COC and since about 2005 of prefillable 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.

Session 1, Track B: Container Closure Integrity Testing

The Hangar 4

• 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 from France, she came to the USA to pursue her PhD in Organic Chemistry at the Georgia Institute of Technology. After working as a 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 and half a dozen articles and 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 support clinical and commercial development activities across all business units.

• 13:50 – 14:05

  Fully Leveraging Robust CCIT Techniques when Developing PFS within a Holistic Approach

  • 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.

  • Co-Presenter: Federico Sabini, MD in Biomedical Engineering, QC Senior Specialist Primary Packaging Materials and Combination Products, Lonza AG

    

    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.

• 14:05 – 14:20

  Ready to Use Cartridges: Quantitative Assessment of Container Closure Integrity

  • 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.

• 14:20 – 14:35

  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

  • 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.

• 14:40 – 15:10

  Q&A, Discussion

  • 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 from France, she came to the USA to pursue her PhD in Organic Chemistry at the Georgia Institute of Technology. After working as a 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 and half a dozen articles and 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 support 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.

  • Panelist: Federico Sabini, MD in Biomedical Engineering, QC Senior Specialist Primary Packaging Materials and Combination Products, Lonza AG

    

    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.

Networking Coffee Break & Exhibition

The Hangar 1-3

Session 2, Track A: Deep Cold Storage

The Hangar 5

• 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.

• 15:55 – 16:20

  Vials for Deep Cold Storage - Part II

  • 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.

• 16:20 – 16:45

  Challenges and Solutions of Container Closure Integrity Syringe Testing at -180°C

  • 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, Senior Study Manager, Lighthouse Instruments B.V.

    

    Paula Bracco, PhD, Senior Study Manager, Lighthouse Instruments B.V.
    

    Paula Bracco is a Sr. Study Manager at Lighthouse Instruments B.V. Paula is a chemist with a PhD in biotechnology, responsible for the Analytical Service laboratory in Amsterdam, its analysts, and customer projects. In her role, she designs studies and manages part of the customer portfolio within Europe, including pharmaceutical companies and packaging suppliers. Paula has a particular interest in research and development projects for customers and, in particular, involving moisture determination by headspace water activity analysis.

• 16:45 – 17:15

  Q&A, Discussion

  • 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, Senior Study Manager, Lighthouse Instruments B.V.

    

    Paula Bracco, PhD, Senior Study Manager, Lighthouse Instruments B.V.
    

    Paula Bracco is a Sr. Study Manager at Lighthouse Instruments B.V. Paula is a chemist with a PhD in biotechnology, responsible for the Analytical Service laboratory in Amsterdam, its analysts, and customer projects. In her role, she designs studies and manages part of the customer portfolio within Europe, including pharmaceutical companies and packaging suppliers. Paula has a particular interest in research and development projects for customers and, in particular, 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.

Session 2, Track B: Traceability

The Hangar 4

• 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, 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. In Most recently, she was responsible for delivering the product design of CPT 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.

• 15:55 – 16:20

  Towards the Batch Report of One: Connecting Traceability Across Machines and Batches

  • 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.

• 16:20 – 16:45

  Seamless Traceability from a Single Device incl. GMP Process Parameter Tracking up to Pallet Aggregation

  • 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.

• 16:45 – 17:15

  Q&A, Discussion

  • 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, 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. In Most recently, she was responsible for delivering the product design of CPT 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.

  • Panelist: 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.

End of Conference Day 1 & Networking Event

Registration Open

The Hangar 1-3

Track A: Packaging Science Morning Session - MDR Cobalt Requirement Regulations

The Hangar 5

• 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

• 08:00 – 08:10

  The Impact of the MDR Cobalt Requirement Regulations

  • 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.

• 08:10 – 08:45

  Open Discussion

  • 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.

Track B: Pre-Filled Syringes Morning Session - Meet Future Market & Regulatory Requirements for Filling & Assembly of Pre-Filled Syringes

The Hangar 4

• 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.

• 08:00 – 08:15

  The Success and Challenges of Ready-to-Use Packaging Material for Fill & Finish

  • 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.

• 08:15 – 08:30

  Key Points of Attention and Lessons Learned from the PFS-Device Assembly Point of View

  • 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.

• 08:30 – 08:45

  Panel Discussion, Q&A

  • 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.

Session 3, Track A: Drug-Primary Container Interaction

The Hangar 5

• Moderator: Folker Steden, Dr, Senior Principal Expert, Director Product Management, Schott Tubing

  

  Folker Steden, Dr, Senior Principal Expert, Director Product Management, Schott Tubing
  

  Dr. Folker Steden Senior Principal Expert Pharma Glass, Director Product Management and Scientific Service, SCHOTT AG 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 is leading the Product Management Team of the tubing division of SCHOTT. With his excellent scientific background and profound intercultural communication skills he is working world wide as a “missing link” between customers and local R&D units, focusing on future customer needs and presents frequently on international conferences on subjects related to special glass for technical and pharmaceutical applications.

• 09:00 – 09:25

  Impact of Primary Container on PS80 and Protein Oxidation

  • 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.

• 09:25 – 09:50

  Factors Affecting the Formation of Chemically Derived Particles in Pharmaceutical Glass Containers

  • 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.

• 09:50 – 10:20

  Q&A, Discussion

  • Moderator: Folker Steden, Dr, Senior Principal Expert, Director Product Management, Schott Tubing

    

    Folker Steden, Dr, Senior Principal Expert, Director Product Management, Schott Tubing
    

    Dr. Folker Steden Senior Principal Expert Pharma Glass, Director Product Management and Scientific Service, SCHOTT AG 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 is leading the Product Management Team of the tubing division of SCHOTT. With his excellent scientific background and profound intercultural communication skills he is working world wide as a “missing link” between customers and local R&D units, focusing on future customer needs and presents frequently on 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.

Session 3, Track B: Administration Routes Different from Intravenously and Subcutaneous

The Hangar 4

• 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 from France, she came to the USA to pursue her PhD in Organic Chemistry at the Georgia Institute of Technology. After working as a 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 and half a dozen articles and 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 support clinical and commercial development activities across all business units.

• 09:00 – 09:25

  Advancing Ocular Device Delivery: Exploring Routes, Challenges, and Innovations to Meet Patient Needs

  • 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.

• 09:25 – 09:50

  Case Study of a Drug Delivery Solution for Complex Intravitreal Drugs Using Pre-Filled Syringes

  • 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.

• 09:50 – 10:20

  Q&A, Discussion

  • 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 from France, she came to the USA to pursue her PhD in Organic Chemistry at the Georgia Institute of Technology. After working as a 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 and half a dozen articles and 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 support 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.

Networking Coffee Break, Poster Session & Exhibition

The Hangar 1-3

Session 4, Track A: Bag Systems & Large Volume Parenterals

The Hangar 5

• Moderator: Bettine Boltres, PhD, Director Scientific Affairs & Technical Solutions, Glass Systems, West Pharmaceutical Services

  

  Bettine Boltres, PhD, Director Scientific Affairs & Technical Solutions, Glass 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.

• 10:50 – 11:15

  Positive Controls in Flexible Parenteral Packaging Container Closure Integrity Testing

  • 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.

• 11:15 – 11:40

  Nitrosamines in Flexible Packaging Materials – A Challenge for Large Volume Parenterals

  • Presenter: Andreas Meiser, Dr-Ing, Sr. Director of Component Development, Fresenius Medical Care Deutschland GmbH

    

    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.

• 11:40 – 12:10

  Q&A, Discussion

  • Moderator: Bettine Boltres, PhD, Director Scientific Affairs & Technical Solutions, Glass Systems, West Pharmaceutical Services

    

    Bettine Boltres, PhD, Director Scientific Affairs & Technical Solutions, Glass 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.

  • Panelist: Andreas Meiser, Dr-Ing, Sr. Director of Component Development, Fresenius Medical Care Deutschland GmbH

    

    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.

Session 4, Track B: Sustainability

The Hangar 4

• 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 a role of heading the Global Product Introduction & Support team, a global team of highly experienced and educated people, having each their own 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 became VP Materials & Technologies, overseeing the development teams in Datwyler’s HealthCare branch, but also the Mobility, Food & Beverages, General Industry and Connectors teams.

• 10:50 – 11:15

  Consequences From the EU Packaging Waste Directive

  • 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 CMO`s in the EMEA region. She holds a doctorate in chemistry from the university of Hasselt in Belgium, has more than 15 years experience in primary, secondary and tertairy packaging and started building her expertise in pharmaceutical and combination product packaging in 2015.

• 11:15 – 11:40

  Secure Blister-Free Syringe Supply – A New, Sustainable Dress Code for Pre-Filled Syringes Providing More Value with Less Packaging

  • Presenter: Nadine K. Lampka, PhD, Senior Product Manager Pharma-Security, Schreiner Group GmbH & Co. KG

    

    Nadine K. Lampka, PhD, Senior Product Manager Pharma-Security, Schreiner Group GmbH & Co. KG
    

    Nadine Lampka, PhD Senior Product Manager Pharma-Security 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 of integrity and authentication solutions for the life sciences and healthcare industry. She leads the innovation to commercialization process, aligns the 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 to 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.

• 11:40 – 12:10

  Q&A, Discussion

  • 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 a role of heading the Global Product Introduction & Support team, a global team of highly experienced and educated people, having each their own 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 became VP 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 CMO`s in the EMEA region. She holds a doctorate in chemistry from the university of Hasselt in Belgium, has more than 15 years experience in primary, secondary and tertairy 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 Group GmbH & Co. KG

    

    Nadine K. Lampka, PhD, Senior Product Manager Pharma-Security, Schreiner Group GmbH & Co. KG
    

    Nadine Lampka, PhD Senior Product Manager Pharma-Security 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 of integrity and authentication solutions for the life sciences and healthcare industry. She leads the innovation to commercialization process, aligns the 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 to 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.

Networking Lunch Break, Poster Session & Exhibition

The Hangar 1-3

Tech Talks

The Hangar 1-3

• 12:45 – 12:55

  Gx Elite Vials: Superior Quality for De-Risking of Fill & Finish Operations

  • 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.

• 12:55 – 13:05

  How Secondary Packaging Supports Your Sustainability Goals

  • Tech Talk Presenter: Sandro Furlan

    

    Sandro Furlan
    

• 13:05 – 13:15

  VIALEX™ Vials - Exceptional Inner Surface Durability

  • Tech Talk Presenter: Clement Condouret

    

    Clement Condouret
    

Interactive Questionnaire Session

The Hangar 4-5

• Moderator: Philippe Lauwers, Director Technology Development, Terumo Pharmaceutical Solutions

  

  Philippe Lauwers, Director Technology Development, 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.

Closing Plenary Part I

The Hangar 4-5

• Moderator: Philippe Lauwers, Director Technology Development, Terumo Pharmaceutical Solutions

  

  Philippe Lauwers, Director Technology Development, 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.

• 13:40 – 14:00

  2023 Revision of the PDA Technical Report 43

  • 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.

• 14:00 – 14:25

  ISO 11040-Pre-filled Syringes: Update from ISO TC76/WG2

  • 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.

Networking Coffee Break, Poster Session & Exhibition

The Hangar 1-3

Passport Raffle

The Hangar 4-5

• Moderator: Melanie Decker, Parenteral Drug Association

  

  Melanie Decker, Parenteral Drug Association
  

Closing Plenary Part II

The Hangar 4-5

• Moderator: Philippe Lauwers, Director Technology Development, Terumo Pharmaceutical Solutions

  

  Philippe Lauwers, Director Technology Development, 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.

• 15:00 – 15:25

  Turning Pharma Manufacturing Circular for Zero

  • 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.

• 15:25 – 16:10

  Plenary Discussion

  • Moderator: Philippe Lauwers, Director Technology Development, Terumo Pharmaceutical Solutions

    

    Philippe Lauwers, Director Technology Development, 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.

  • Panelist: 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.

  • 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.

  • 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.

Co-Chairs Conference Summary

The Hangar 4-5

• 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, Director Technology Development, Terumo Pharmaceutical Solutions

  

  Philippe Lauwers, Director Technology Development, 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.

Closing Remarks & Farewell

The Hangar 4-5

• Committee Member: Falk Klar, PhD, Parenteral Drug Association

  

  Falk 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.