PDA Parenteral Packaging Conference 2025

CET Standard Time (UTC +1:00)

• 09:00 – 09:05

  Welcome and Introduction

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  • Committee Member:

    

    Falk Klar, PhD
    General Manager, Vice President Europe, Parenteral Drug Association

• 09:05 – 09:15

  Welcome from the Co-Chairs

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  • Co-Chair:

    

    Coralie A. Richard, PhD
    Director, Eli Lilly and Company

  • Co-Chair:

    

    Philippe Lauwers
    Technology Development Director, Terumo Pharmaceutical Solutions

• 09:15 – 10:25

  Opening Plenary Part I

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  • Moderator:

    

    Philippe Lauwers
    Technology Development Director, Terumo Pharmaceutical Solutions

  This session will explore how thoughtful packaging design can enhance usability for healthcare providers and improve patient outcomes in hospital settings. Updates on the new Umbrella Guidance for Container Closure Systems will be presented, outlining its implications for regulatory compliance and drug safety. Additionally, cutting-edge research on silicone oil coatings will reveal their impact on protein aggregation and biopharmaceutical packaging performance.

  • 09:15 – 09:40

    Optimizing Drug Packaging for Healthcare Providers: Bridging Design, Usability, and Patient Impact in Hospitals

    • Keynote Speaker:

      

      Prit Patel, PharmD, BCSCP
      Pharmacy Supply Chain Supervisor, Atrium Health

  • 09:40 – 10:00

    Understanding the Patients Perspective: Key Insight for Safe and Effective Packaging-Remote Presentation-

    • Presenter:

      

      Penney Cowan
      Co-Founder, World Patient Alliance

  • 10:00 – 10:25

    Evaluating Silicone Oil Coatings: From Layer Mobility to Protein Aggregation in Biopharmaceutical Packaging

    • Academic Presenter:

      

      Daniel Fuchs, Pharmacist
      PhD student, Ludwig-Maximilians-Universität München

• 10:25 – 11:05

  Guided Poster Walk Part I

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  • Moderator:

    

    Miho Soma
    Sr. Engineer, Gilead Sciences, Inc

• 10:35 – 11:05

  Networking Coffee Break & Exhibition

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• 11:05 – 12:35

  Opening Plenary Part II

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  • Moderator:

    

    Philippe Lauwers
    Technology Development Director, Terumo Pharmaceutical Solutions

  • 11:25 – 11:45

    New Umbrella Guidance on Container Closure Systems for Drugs, Including Biological Products that Replaced the 1999 Guidance

    • Regulatory Presenter:

      

      Madushini N. Dharmasena, PhD
      Senior Pharmaceutical Quality Assessor, OPQ, CDER, U.S. FDA

  • 11:45 – 11:55

    Interactive Questionnaire Session

    • Moderator:

      

      Philippe Lauwers
      Technology Development Director, Terumo Pharmaceutical Solutions

  • 11:55 – 12:35

    Plenary Discussion

    • Moderator:

      

      Philippe Lauwers
      Technology Development Director, Terumo Pharmaceutical Solutions

    • Panelist:

      

      Penney Cowan
      Co-Founder, World Patient Alliance

    • Regulatory Panelist:

      

      Madushini N. Dharmasena, PhD
      Senior Pharmaceutical Quality Assessor, OPQ, CDER, U.S. FDA

    • Academic Panelist:

      

      Daniel Fuchs, Pharmacist
      PhD student, Ludwig-Maximilians-Universität München

    • Regulatory Panelist:

      

      Claudia Müller
      

    • Panelist:

      

      Prit Patel, PharmD, BCSCP
      Pharmacy Supply Chain Supervisor, Atrium Health

• 12:35 – 13:50

  Networking Lunch Break, Exhibition & Tech Talks

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• 13:50 – 15:10

  Session 1 Track A: Container Closure Integrity Testing

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  • Moderator:

    

    Madushini N. Dharmasena, PhD
    Senior Pharmaceutical Quality Assessor, OPQ, CDER, U.S. FDA

  Container Closure Integrity Testing (CCIT) is a test to check if a container is properly sealed and prevents leaks. The container's closure system should maintain a sterile barrier against contamination, ensuring the safety and stability of a drug product throughout its shelf life by preventing external factors like air, moisture, and microorganisms from entering the primary package. This session will discuss Glass Containers used for Cryogenic Storage Solutions, CCIT method development, validation, and controls used.

  • 13:50 – 14:05

    Cryogenic Storage Solutions in Glass Containers

    • Presenter:

      

      Adam Sarafian, PhD
      Research Associate, Corning

  • 14:05 – 14:20

    Sample Controls for CCIT Method Development and Validation

    • Presenter:

      

      Francesca Caprioli, PhD
      Laboratory Director, Lighthouse Instruments

  • 14:20 – 14:35

    Fit-for-Purpose Container Closure Integrity Method Development for the Container Closure

    • Presenter:

      

      Liang Fang, PhD
      Associated Director, Primary Packaging, GSK

  • 14:35 – 15:10

    Q&A Discussion

    • Moderator:

      

      Madushini N. Dharmasena, PhD
      Senior Pharmaceutical Quality Assessor, OPQ, CDER, U.S. FDA

    • Panelist:

      

      Francesca Caprioli, PhD
      Laboratory Director, Lighthouse Instruments

    • Panelist:

      

      Liang Fang, PhD
      Associated Director, Primary Packaging, GSK

    • Panelist:

      

      Adam Sarafian, PhD
      Research Associate, Corning

• 13:50 – 15:10

  Session 1 Track B: Optimizing Packaging Quality

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  • Moderator:

    

    Jean-Sebastien Steffen, MS, PhD
    Group Lead Primary Packaging and Combination Products, Lonza

  The quality of primary packaging components is of utmost importance to protecting the safety, efficacy, and quality of drug products. This session will provide multiple perspectives on how to assess and optimize the quality of primary packaging, including process simulation tools, evaluating particulate contamination in ready-to-use components, and recently proposed revisions to compendial chapters concerning glass containers.

  • 13:50 – 14:05

    Distilling Primary Packaging Insights via Digital Twin Technology

    • Presenter:

      

      Max Dixon
      

  • 14:05 – 14:20

    Quality of Nested Ready-to-Use Primary Packaging Material

    • Presenter:

      

      Andrea Allmendinger, Prof Dr
      Chief Scientific Officer, ten23 health

  • 14:20 – 14:35

    Review of Proposed Revisions to USP Glass Guidance Documents 660 and 1660

    • Co-Presenter:

      

      Matthew Hall, PhD
      Technical Affairs Director, Corning Pharmaceutical Technologies

    • Co-Presenter:

      

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

  • 14:35 – 15:10

    Q&A Discussion

    • Moderator:

      

      Jean-Sebastien Steffen, MS, PhD
      Group Lead Primary Packaging and Combination Products, Lonza

    • Panelist:

      

      Max Dixon
      

    • Panelist:

      

      Andrea Allmendinger, Prof Dr
      Chief Scientific Officer, ten23 health

    • Panelist:

      

      Matthew Hall, PhD
      Technical Affairs Director, Corning Pharmaceutical Technologies

    • Panelist:

      

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

• 15:10 – 15:40

  Guided Poster Walk Part II

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  • Moderator:

    

    Philippe Lauwers
    Technology Development Director, Terumo Pharmaceutical Solutions

• 15:25 – 15:55

  Networking Coffee Break & Exhibition

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• 15:55 – 17:15

  Session 2 Track A: Sustainability in Pharma Packaging

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  • Moderator:

    

    Bettine Boltres, PhD
    Director Scientific Affairs & Technical Solutions, Integrated Systems, West Pharmaceutical Services

  Session Description: I think sustainability is here to stay! So, it is not whether or not we need to do something, it is about what we can do and how we can do it. So, this session provides some very useful insights into how you can integrate sustainability into your daily business routine and ensure that your company reaches its set sustainability goals! Be inspired by the success of others.

  • 15:55 – 16:10

    Navigating Today's Challenges and Tomorrow's Innovations in Medical and Pharmaceutical Disposal

    • Academic Presenter:

      

      Srividya Narayanan, MDS MSc
      Student , Northeastern University

  • 16:10 – 16:25

    Enhancing Circularity in Pharmaceutical Packaging: The Case of Tubular Pharma Glass Recycling

    • Co-Presenter:

      

      Claus-Juergen Maier
      

    • Co-Presenter:

      

      Marius Amschler, MEng
      Senior Product Manager Pharmaceutical Tubing, SCHOTT AG

  • 16:25 – 16:40

    Supplier Management of Parenteral Packaging Materials

    • Presenter:

      

      Marc Egen, PhD
      Director Pharmaceutical Development , Boehringer Ingelheim Pharma GmbH & Co KG

  • 16:40 – 17:15

    Q&A, Discussion

    • Moderator:

      

      Bettine Boltres, PhD
      Director Scientific Affairs & Technical Solutions, Integrated Systems, West Pharmaceutical Services

    • Panelist:

      

      Marius Amschler, MEng
      Senior Product Manager Pharmaceutical Tubing, SCHOTT AG

    • Panelist:

      

      Marc Egen, PhD
      Director Pharmaceutical Development , Boehringer Ingelheim Pharma GmbH & Co KG

    • Panelist:

      

      Claus-Juergen Maier
      

    • Panelist:

      

      Srividya Narayanan, MDS MSc
      Student , Northeastern University

• 15:55 – 17:15

  Session 2 Track B: Managing the PFAS Challenge

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  • Moderator:

    

    Bram Jongen, PhD
    VP Materials and Surface Technologies, Datwyler

  Joining this session will help to further understand why a restriction on Per- and Polyfluoroalkyl Substances (PFAS) was proposed, how it impacts the pharmaceutical world, and bring insights into some possible examples of how to select alternative materials.

  • 15:55 – 16:10

    Briefing on Proposed EU Ban on PFAS (Per and Poly-Fluoroalkyl) Substances

    • Presenter:

      

      Louise Loughran, BSc, PGCert, PGDip, MSc
      Senior Advisor – Chemicals Management , Eli Lilly and Company

  • 16:10 – 16:25

    Considerations for Early-Stage Testing of Chemicals for PFAS Replacement

    • Presenter:

      

      Dieter Hennecke
      Head of Department "Ecological Chemistry", Fraunhofer Institute for Molecular Biology and Applied Ecology IME

  • 16:25 – 16:40

    PFAS Concerns in the Packaging of Biopharmaceutical Components

    • Presenter:

      

      Alexander N. Mitropoulos, PhD, MBA
      Director, Strategic Programs, Merck

  • 16:40 – 17:15

    Q&A, Discussion

    • Moderator:

      

      Bram Jongen, PhD
      VP Materials and Surface Technologies, Datwyler

    • Panelist:

      

      Dieter Hennecke
      Head of Department "Ecological Chemistry", Fraunhofer Institute for Molecular Biology and Applied Ecology IME

    • Panelist:

      

      Louise Loughran, BSc, PGCert, PGDip, MSc
      Senior Advisor – Chemicals Management , Eli Lilly and Company

    • Panelist:

      

      Alexander N. Mitropoulos, PhD, MBA
      Director, Strategic Programs, Merck

CET Standard Time (UTC +1:00)

• 08:00 – 08:45

  Packaging Science Morning Session, Track A: PFAS in the Life Cycle of Drug Delivery Devices

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  • Moderator:

    

    Tony A. Perry
    Regional Director of Quality, SCHOTT Pharma

  The Packaging Science Interest Group Team will carry on the ECHA PFAS restriction proposal discussion with the aim to promote collaboration between manufacturers, suppliers and regulatory authorities to ensure safe, effective, and compliant drug production. In particular: what does the restriction mean for you as pharmaceutical, medical device and supplier companies? And what should you be doing now?

  • 08:00 – 08:10

    PFAS Ban - A Trainwreck for the Pharma Industry?

    • Presenter:

      

      Ana Kuschel, PhD
      Principal Scientific Affairs, West Pharmaceutical Services, Inc.

  • 08:10 – 08:45

    Discussion Round of PFAS

    • Moderator:

      

      Tony A. Perry
      Regional Director of Quality, SCHOTT Pharma

    • Panelist:

      

      Dieter Hennecke
      Head of Department "Ecological Chemistry", Fraunhofer Institute for Molecular Biology and Applied Ecology IME

    • Panelist:

      

      Bram Jongen, PhD
      VP Materials and Surface Technologies, Datwyler

    • Panelist:

      

      Louise Loughran, BSc, PGCert, PGDip, MSc
      Senior Advisor – Chemicals Management , Eli Lilly and Company

    • Panelist:

      

      Alexander N. Mitropoulos, PhD, MBA
      Director, Strategic Programs, Merck

• 08:00 – 08:45

  Pre-Filled Syringes Morning Session, Track B: Integrated Combination Product Development: How to De-Risk Your Way to Market

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  • Moderator:

    

    Brigitte Reutter-Haerle
    Vice President Product Management & Marketing, Vetter

  Join us for a dynamic presentation and panel session on leveraging device platforms to de-risk developments. Hear viewpoints and experiences from both device and prefilled syringes manufacturers. The goal is to share benefits, and challenges in deploying standardized delivery device platforms.

  • 08:05 – 08:20

    Key Requirements for PFS Addressing Autoinjection

    • Presenter:

      

      Stefano Pilati
      Technical Evaluation and Product Development Coordinator, Stevanato Group

  • 08:20 – 08:35

    How a Flexible Autoinjector Platform Con Accepted Different PFS Variation

    • Presenter:

      

      Bal Johal
      

  • 08:35 – 08:45

    Q&A, Discussion

    • Moderator:

      

      Alessandro Morandotti
      Director Product Development - Drug Containment Solutions, Stevanato Group

    • Panelist:

      

      Frank Bamberg, MA
      Associate Director of Primary Packaging and Medical Devices, CSL Behring

    • Panelist:

      

      Bal Johal
      

    • Panelist:

      

      Stefano Pilati
      Technical Evaluation and Product Development Coordinator, Stevanato Group

• 09:00 – 10:20

  Session 3 Track A: Innovative Solutions for Packaging Integrity

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  • Moderator:

    

    Derek I. Duncan, PhD
    Director Product Lines, LIGHTHOUSE Instruments

  Primary packaging systems and the therapies being filled into these systems are becoming more complex. This session presents a series of innovative approaches for assuring that the pre-filled syringe and cartridge packaging system provides appropriate protection for the drug product.

  • 09:00 – 09:10

    A Novel Approach for CCIT and AVI of Fusion-Sealed Pre-Filled Syringes (PFS) with opaque suspensions

    • Presenter:

      

      Matthias Kahl
      Head of R&D and Lab Services, WILCO AG

  • 09:10 – 09:20

    A Holistic CCI Strategy for Ready-to-Use Cartridges

    • Presenter:

      

      Serena Casanova, PhD
      Technical Leader, Stevanato Group

  • 09:20 – 09:30

    Moist Heat Sterilization as a Viable Alternative to EtO for Ready-to-Fill (RTF) Containers: Insights from a Cartridges Case Study

    • Co-Presenter:

      

      Juergen Tuschka
      Program Manager, Gerresheimer Regensburg GmbH

    • Co-Presenter:

      

      Roberta Michelini
      Process Development Scientist, Fedegari Group

  • 09:30 – 09:40

    Syringe - Functional Label Combinations: A Symbiosis for Product Integrity

    • Co-Presenter:

      

      Nadine K. Lampka, PhD
      Senior Product Manager Pharma-Security, Schreiner MediPharm

    • Co-Presenter:

      

      Christoph Zauner
      Head of product managment polymer solutions, Schott Pharma

  • 09:45 – 10:20

    Q&A Discussion

    • Moderator:

      

      Derek I. Duncan, PhD
      Director Product Lines, LIGHTHOUSE Instruments

    • Panelist:

      

      Serena Casanova, PhD
      Technical Leader, Stevanato Group

    • Panelist:

      

      Matthias Kahl
      Head of R&D and Lab Services, WILCO AG

    • Panelist:

      

      Nadine K. Lampka, PhD
      Senior Product Manager Pharma-Security, Schreiner MediPharm

    • Panelist:

      

      Roberta Michelini
      Process Development Scientist, Fedegari Group

    • Panelist:

      

      Juergen Tuschka
      Program Manager, Gerresheimer Regensburg GmbH

    • Panelist:

      

      Christoph Zauner
      Head of product managment polymer solutions, Schott Pharma

• 09:00 – 10:20

  Session 3 Track B: Modern Packaging Solutions

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  • Moderator:

    

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

  This is how we like it! Modern packaging solutions are provided short and snappy by industry experts. Learn more about how to increase patient safety significantly by evaluating barrier properties of packaging materials (PDA Technical Report 27), in aseptic transfers, during intravitreal injection, and by avoiding/managing particles in Ready-To-Use (RTU) devices in modern packaging solutions.

  • 09:00 – 09:10

    Aseptic Transfer of Primary Packaging Material to Grade A in Pre-filled Syringes Manufacturing: Bridging the Gap Between Supplier, Client and Health Authorities

    • Presenter:

      

      Elena Celi, MSc
      Process Expert Drug Product Manufacturing Syringes , Lonza

  • 09:10 – 09:20

    A Holistic Approach for Intravitreal Injection Combining Primary Packaging and Injection Device

    • Presenter:

      

      Nicolas Eon, PhD
      Senior Technology Development Manager, Terumo Europe nv

  • 09:20 – 09:30

    Particulate Matter in Ready-to-Use (RTU) Parenteral Packaging: Challenges, Standards, and Future Directions

    • Co-Presenter:

      

      Vincent Cazanave
      Device Team Leader, Roche

    • Co-Presenter:

      

      Riccardo De Rosso
      Senior Packaging Engineer, Roche

  • 09:30 – 09:45

    PDA Technical Report 27 Pharmaceutical Package Integrity – Why It’s Time for a Revision

    • Presenter:

      

      Jennifer M. Roark
      Sr. Manager Scientific Affairs, West Pharmaceutical Services

  • 09:45 – 10:20

    Q&A Discussion

    • Moderator:

      

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

    • Panelist:

      

      Vincent Cazanave
      Device Team Leader, Roche

    • Panelist:

      

      Elena Celi, MSc
      Process Expert Drug Product Manufacturing Syringes , Lonza

    • Panelist:

      

      Riccardo De Rosso
      Senior Packaging Engineer, Roche

    • Panelist:

      

      Nicolas Eon, PhD
      Senior Technology Development Manager, Terumo Europe nv

    • Panelist:

      

      Jennifer M. Roark
      Sr. Manager Scientific Affairs, West Pharmaceutical Services

    • Panelist:

• 10:20 – 10:50

  Networking Coffee Break & Exhibition

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• 10:50 – 12:10

  Session 4 Track A: Sterilization & Decontamination Challenges

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  • Moderator:

    

    Matthew Hall, PhD
    Technical Affairs Director, Corning Pharmaceutical Technologies

  The rise of Ready-To-use (RTU) and decentralized production models prompts diversifying sterilization and decontamination techniques. This session will focus on the impact different techniques may have on the long-term performance of rubber components

  • 10:50 – 11:15

    X-Ray as an Alternative to Gamma Irradiation: Effect on Rubber Properties and Extractables

    • Presenter:

      

      Tine Hardeman, PhD
      Manager Material Development, Datwyler

  • 11:15 – 11:40

    The Impact of Vapor Phase Hydrogen Peroxide Surface Decontamination on Elastomeric Primary Packaging Components

    • Presenter:

      

      Eric Kurtz, MBA
      Manager, Technical Product Development, West Pharmaceutical Services, Inc.

  • 11:40 – 12:10

    Q&A Discussion

    • Moderator:

      

      Matthew Hall, PhD
      Technical Affairs Director, Corning Pharmaceutical Technologies

    • Panelist:

      

      Tine Hardeman, PhD
      Manager Material Development, Datwyler

    • Panelist:

      

      Eric Kurtz, MBA
      Manager, Technical Product Development, West Pharmaceutical Services, Inc.

• 10:50 – 12:10

  Session 4 Track B: Advancing Cold Chain & Pharma

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  • Moderator:

    

    Arne Kloke, PhD
    Head of Service and Sustainability Management, SCHOTT Pharma

  The seamless integration of cutting-edge technologies and innovative strategies is critical to advancing the pharmaceutical cold chain and enabling the delivery of safe, effective, and innovative therapies. This session will explore two transformative areas shaping the future of cold chain and pharmaceutical delivery systems.

  • 10:50 – 11:15

    Leveraging Simulation and Operation (S&O) Data and AI for Enhanced Visibility and Risk Mitigation in Cold Chains

    • Presenter:

      

      Taner Chakar
      Head of Product - SkyMind, SkyCell AG

  • 11:15 – 11:40

    Advancing Innovation and Tackling Challenges when Transitioning to Large Volume Pharmaceuticals Devices

    • Co-Presenter:

      

      Jeremy Hemingway, PE
      Pharma Practice Lead, Stress Engineering Services

    • Co-Presenter:

      

      Patrick Hoopes
      Senior Scientific Manager, Johnson and Johnson Innovative Medicine

  • 11:40 – 12:10

    Q&A Discussion

    • Moderator:

      

      Arne Kloke, PhD
      Head of Service and Sustainability Management, SCHOTT Pharma

    • Panelist:

      

      Taner Chakar
      Head of Product - SkyMind, SkyCell AG

    • Panelist:

      

      Jeremy Hemingway, PE
      Pharma Practice Lead, Stress Engineering Services

    • Panelist:

      

      Patrick Hoopes
      Senior Scientific Manager, Johnson and Johnson Innovative Medicine

• 12:10 – 13:25

  Networking Lunch Break, Exhibition & Tech Talks

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• 13:25 – 14:45

  Closing Plenary Part I

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  • Moderator:

    

    Coralie A. Richard, PhD
    Director, Eli Lilly and Company

  The closing plenary session will delve into the latest updates on US Pharmacopeia, exploring the changes and their implications for our industry. Following this, the closing panel discussion will provide a platform for an interactive exchange of ideas. The conference will end with innovative round table discussions on topics such as CCIT, USP <382>, sustainability, AI, and regulatory insights, fostering collaboration and actionable takeaways.

  • 13:25 – 13:35

    Interactive Questionnaire Session

    • Moderator:

      

      Coralie A. Richard, PhD
      Director, Eli Lilly and Company

  • 13:35 – 14:00

    Current USP Standards Activities Related to Drug-Device Combinations, Container Closure Integrity, Extractables and Leachables, and Elastomeric Component Functionality

    • Regulatory Presenter:

      

      Desmond G. Hunt, PhD
      Sr. Principal Scientist, USP

  • 14:00 – 14:45

    Plenary Discussion

    • Moderator:

      

      Coralie A. Richard, PhD
      Director, Eli Lilly and Company

    • Panelist:

      

      Bettine Boltres, PhD
      Director Scientific Affairs & Technical Solutions, Integrated Systems, West Pharmaceutical Services

    • Panelist:

      

      Penney Cowan
      Co-Founder, World Patient Alliance

    • Regulatory Panelist:

      

      Madushini N. Dharmasena, PhD
      Senior Pharmaceutical Quality Assessor, OPQ, CDER, U.S. FDA

    • Regulatory Panelist:

      

      Desmond G. Hunt, PhD
      Sr. Principal Scientist, USP

    • Regulatory Panelist:

      

      Claudia Müller
      

    • Panelist:

      

      Prit Patel, PharmD, BCSCP
      Pharmacy Supply Chain Supervisor, Atrium Health

    • Panelist:

      

      Jean-Sebastien Steffen, MS, PhD
      Group Lead Primary Packaging and Combination Products, Lonza

• 14:45 – 15:20

  Networking Coffee Break & Exhibition

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• 15:15 – 15:20

  Raffle Card Announcement

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• 15:20 – 15:25

  Best Poster Presenter

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• 15:25 – 16:20

  Closing Plenary Part II

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  • Moderator:

    

    Coralie A. Richard, PhD
    Director, Eli Lilly and Company

  • 15:25 – 16:20

    Interactive Round Table Session

    • Moderator:

      

      Coralie A. Richard, PhD
      Director, Eli Lilly and Company

• 16:20 – 16:30

  Co-Chairs Conference Summary

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  • Co-Chair:

    

    Coralie A. Richard, PhD
    Director, Eli Lilly and Company

  • Co-Chair:

    

    Philippe Lauwers
    Technology Development Director, Terumo Pharmaceutical Solutions

• 16:30 – 16:35

  Closing Remarks & Farewell

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  • Committee Member:

    

    Falk Klar, PhD
    General Manager, Vice President Europe, Parenteral Drug Association