PDA Universe of Pre-Filled Syringes and Injection Devices Conference 2025

CEST Daylight Time (UTC +2:00)

• 09:00 – 09:20

  Welcome and and Innovation Award Announcement

  • Committee Member:

    

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

• 09:20 – 09:25

  Welcome From the Co-Chairs

  • Co-Chair:

    

    Theresa E. Bankston, PhD
    VP Combination Products & Capabilities, BD

  • Co-Chair:

    

    Jakob Lange, PhD
    VP & Head of Account and Business Development, Ypsomed AG

• 09:25 – 10:05

  Opening Session Part I

  • Moderator:

    

    Jakob Lange, PhD
    VP & Head of Account and Business Development, Ypsomed AG

  • 09:25 – 09:45

    Title To Be Announced
  • 09:45 – 10:05

    Title To Be Announced
• 10:05 – 11:05

  Networking Coffee Break, Exhibition, and Guided Poster Walk

• 10:05 – 11:05

  Tech Talks

• 11:05 – 12:40

  Opening Session Part II

  • Moderator:

    

    Jakob Lange, PhD
    VP & Head of Account and Business Development, Ypsomed AG

  • 11:05 – 11:25

    A Holistic Assessment of Drug/Device Deliverability: From Molecule to Patient

    • Presenter:

      

      Galen Shi, PhD
      Vice President of Engineering – Delivery Devices, Eli Lilly and Company

  • 11:25 – 11:45

    Transforming Traditional Pharma into a Combination Products Company

    • Presenter:

      

      Karthik Vaideeswaran, PhD, MBA
      Associate Vice President, Delivery, Device & Connected Solutions, Merck

  • 11:45 – 11:55

    Interactive Questionnaire
  • 11:55 – 12:40

    Plenary Discussion

    • Moderator:

      

      Jakob Lange, PhD
      VP & Head of Account and Business Development, Ypsomed AG

• 12:40 – 13:10

  Tech Talks

• 12:40 – 14:10

  Networking Lunch Break, Poster Session & Exhibition

• 14:10 – 15:30

  Session 1, Track A

  • Moderator:

    

    Galen Shi, PhD
    Vice President of Engineering – Delivery Devices, Eli Lilly and Company

  • 14:10 – 14:25

    Lessons Learned: A Device Manufacturer's Perspective on the Launch of the First Biosimilar in an On-Body Injector

    Read more

    In 2024, the launch of Udenyca™ marked a significant milestone in the biosimilar landscape as the first biosimilar drug delivered via an on-body electromechanical pump. This presentation will explore the possible advancements allowed by the FDA, in the design and functionality of an on-body device to be used for the delivery of a biosimilar compared to its originator. Key enhancements include a reduced injection time and the introduction of an auto-deploying needle, replacing the traditional healthcare professional-inserted cannula, thereby streamlining the patient experience. Attendees will learn how biosimilar companies are investing in cutting-edge delivery technologies that rival those of innovator products. This leap forward not only enhances patient convenience but also demonstrates a proactive approach to differentiation in the competitive biosimilar market. For instance, a 5 mL drug traditionally administered in the innovator product through multiple injections could now be delivered in the biosimilar combination product via a single on-body device, showcasing the potential for innovative delivery methods that outpace those of originators. Join us to understand the collaboration between our team, our pharmaceutical partner, and the FDA to elevate the patient experience with a biosimilar combination product, reinforcing the importance of innovation in the evolving landscape of drug delivery.

    • Presenter:

      

      Andrei Yosef, PhD
      General Manager and President, LTS Device Technologies

  • 14:25 – 14:40

    Analysis Framework for Wearable Injector Systems to Improve Functionality, Safety and Reliability

    Read more

    Early clinical results for wearable large volume injectors are promising; however, published real-world clinical data is limited and the systems will need to evolve to address critical challenges related to their usability, reliability, safety, cost and sustainability. This presentation lays out a framework of additional tools that can be implemented to test and improve performance, as well as potentially drive innovation in this space. This framework will include discussion, analysis examples addressing the following: •Adhesive Performance: Investigating the reliability and performance of adhesives during user testing. This will include analysis of adhesive patches after use, with a focus on the adhesive surface as interfacial with the user. •Injector Malfunction: Simulation of injector cannula position, orientation, and insertion depth for varying abdominal morphologies, user postures and wearable geometries using finite element analysis. •Reliability for High-Viscosity Biologics: Evaluation of flow analysis of the injectate using computational fluid dynamics (CFD) and in vitro testing. •Skin Reactions: Evaluation of leachables and extractables in adhesives and other housing plastics. The study will include additional discussion on the continuous innovation in the functionality, size, and cost of the systems. Examples will be detailed for the methods above, including best practices and insight from the authors.

    • Presenter:

      

      Scott Lovald, PhD
      Senior Managing Engineer, Exponent

  • 14:40 – 14:55

    Advancing Platform Technologies for Combination Products

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    As drug manufacturers and device vendors increasingly seek to leverage existing device technologies and components from previously approved combination products, the industry faces a growing challenge: how to efficiently manage platform technologies while ensuring safety, effectiveness, and regulatory acceptance. There are multiple approaches to platform adoption, each with distinct technical, regulatory, and lifecycle management challenges: • Minor modifications to an existing combination product to accommodate regional regulatory requirements, improve usability, or address post-market feedback and complaints. • Repurposing an entire device or key components of it for a new drug or biologic combination product. • Developing a platform technology from the outset to support a family of drugs or biologics. • Marketing platform technologies to support as many drug products as possible, emphasizing efficiency, standardization, and lifecycle management. This presentation will dive into these approaches, walk through real-world case studies, and provide practical insights into how to successfully implement and manage platform technologies, ensuring they meet regulatory expectations, patient needs, and lifecycle considerations. Attendees will also gain insights into structured and integrated approaches for tracking and managing platform reuse across multiple applications, reducing inefficiencies, driving consistency, and ensuring safety and regulatory alignment.

    • Co-Presenter:

      

      Fubin Wu, MS
      Co-founder & President, GessNet

    • Co-Presenter:

      

      Nicole M. Bergmann, PhD, MBA
      Sr. Director - Device, Design and Connected Solutions, Eli Lilly and Company

  • 14:55 – 15:30

    Session 1, Track A: Q&A, Discussion

    • Moderator:

      

      Galen Shi, PhD
      Vice President of Engineering – Delivery Devices, Eli Lilly and Company

• 14:10 – 15:30

  Session 1, Track B

  • Moderator:

    

    Frank Bamberg, MA
    Head of Primary Packaging and Medical Devices - Product Care, CSL Behring

  • 14:10 – 14:25

    Exploring At-Home Cancer Treatment Potentials: A Comparative Study of Oncology Nurses' Perspectives and Practices in the EU and US

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    This study examines the perspectives and preferences of oncology nurses from the European Union (EU) and the United States (US) regarding at-home cancer treatment. A qualitative approach was used to gather insights from 16 nurses (6 from the EU and 10 from the US) through in-depth interviews. The findings highlight a strong interest in expanding at-home care options to improve patient outcomes and quality of life. Nurses emphasized the need for comprehensive support services, including psychological support, education on self-care, and financial assistance, to facilitate successful at-home treatment. They also underscored the importance of interdisciplinary collaboration and adequate resources to address the complex needs of cancer patients. The study reveals both similarities in the challenges faced by nurses across both regions, such as managing mental health issues and ensuring access to necessary care resources, and differences due to the healthcare systems in both geographies. Overall, the results suggest that oncology nurses see significant potential in at-home treatment but require better support systems to implement these care models effectively. This study contributes to the development of more effective and patient-centered cancer care strategies, suggesting a hybrid model of treatment that consists of both at-home and clinic-based care while relying on mobile providers for certain therapy aspects.

    • Presenter:

      

      Reza Abedian, PhD
      Senior Medical Affairs Manager, Gerresheimer

  • 14:25 – 14:40

    Driving Adherence and Improving the Patient Experience through At-home Engagement

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    The healthcare industry is undergoing a major transformation toward patient-centric care, powered by advancements in science and the increasing adoption of self-administered treatments. However, poor adherence remains a significant challenge, with prescription abandonment, inconsistent training, low persistence rates, and underutilization of patient support programs limiting the full potential of these therapies. At-home patient engagement solutions—combining tailored device training, digital tools, and real-world data insights—are emerging as a key strategy to improve persistence and adherence. In a recent study with a leading specialty pharmacy, patients using an at-home engagement program demonstrated: • 38% faster time to first self-injection • 15% quicker first refill ordering • 40% higher adherence (≥80% proportion of days covered, PDC) • 19% increase in six-month medication persistence Recognizing this opportunity, Noble partnered with a leading self-injectable brand and specialty pharmacy to develop an at-home engagement program that accelerates patient onboarding, builds confidence, and enhances persistence. This presentation will share key findings and best practices for designing effective patient engagement solutions and strategies for scaling data-driven programs. Attendees will leave with actionable insights on how to implement these solutions within their own organizations to drive measurable impact.

    • Co-Presenter:

      

      Aude Ouensanga, MPH
      Head of Strategy and Patient Engagement, Noble an Aptar Pharma company

    • Co-Presenter:

      

      Joseph Reynolds, MS
      Director of UX/HF, Noble International, LLC

  • 14:40 – 14:55

    B-COMPASS: Improving Patient Support, Treatment Adherence, and Outcomes

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    Non-adherence to treatment has a major impact both on the effectiveness of the products we deliver to patients and the wider societal costs of poor health. Increasing adherence levels requires understanding the key drivers for a patient’s adherence behavior and expanding our definition of ‘product’ to meet their changing support needs as well as their delivery needs. The pan-industry IMI-sponsored BEAMER project has developed the pragmatic B-COMPASS framework to understand these drivers and the impact they have on a patient’s support needs across the patient journey. The B-COMPASS framework identifies the support needs of patient sub-groups, enabling the future design and delivery of effective and targeted patient support. It also predicts relative adherence, allowing prioritization of resources. The support can be linked with drug products, devices, packaging, and training to create a broader product eco-system enabling more effective outcomes.

    • Presenter:

      

      Claire J Everitt, MEng, BSc (Psych)
      Design Engineering Lead - Medical Devices, Pfizer

  • 14:55 – 15:30

    Session 1, Track B: Q&A, Discussion

    • Moderator:

      

      Frank Bamberg, MA
      Head of Primary Packaging and Medical Devices - Product Care, CSL Behring

• 14:10 – 15:30

  Session 1, Track C

  • Moderator:

    

    Philippe Lauwers
    Technology Development Director, Terumo Pharmaceutical Solutions

  • 14:10 – 14:25

    Innovative Design and Testing Strategy for an Autoinjector to Precisely Determine Leaks in the Prefilled Syringe

    Read more

    Autoinjectors are widely used drug delivery devices designed to ensure convenient and reliable self-administration of injectable medications. However, accurately measuring Container Closure Integrity (CCI) on the prefilled syringe (PFS) inside a fully assembled autoinjector presents significant challenges. Fundamentally, the convoluted design of autoinjectors restricts access to the PFS and limits the use of established vacuum-based CCI testing. Such methods rely on stabilisation of the syringe plunger as vacuum effects alter its position. Hence, testing is commonly conducted on isolated PFS only which require autoinjector disassembly. Disruptive dismantling methods in combination with autoinjector design constraints pose significant risk to the sterility of the PFS. To overcome these challenges, we propose a novel testing strategy that evaluates the autoinjector in a partially disassembled state: The distal drive package is removed from the finally assembled autoinjector and solely the PFS-containing section is tested for CCI using deep vacuum (LFC). This approach minimizes the risk on PFS sterility as the partial disassembly does not involve PFS removal and splits the autoinjector at an inherent separation point. The gained access allows the syringe plunger to be precisely positioned and held in place using a floating pin concept.

    • Presenter:

      

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

  • 14:25 – 14:40

    Evaluation of Container Closure Integrity and Failure Modes of Prefilled Syringes at Cryogenic Storage Temperatures

    Read more

    Advanced Therapy Medicinal Products (ATMPs) such as gene therapy and somatic cell therapies require long-term storage at extremely low temperatures (-80°C to -196°C) to maintain biological activity, stability, and efficacy. Challenges include cryopreservation, efficient delivery of small volumes, and ensuring container closure integrity (CCI) throughout the product's shelf life. Prefilled syringes (PFS) offer a promising solution due to their dosing accuracy, low residual volume, and ease of use. The integrity of PFS at ultra-low temperatures depends on the interaction between its components, considering distinct material properties. This study examines the CCI and failure mechanisms of PFS stored at -50 to 196°C. Key factors critical for CCI failure include storage temperature, fill volume, storage orientation, and freezing/thawing rates. Changes in headspace composition during freeze-thaw cycles were assessed for PFS filled with water or a drug analog. Using differential scanning calorimetry (DSC), microscopy, and thermo-mechanical characterization, the physical and thermal properties of syringe components were analyzed. Results showed CCI failure at temperatures below the glass transition temperature of the stopper or needle shield. This work enhances the understanding of CCI failure conditions and highlights the need for specialized testing setups and container-closure systems for cryogenic temperatures.

    • Academic Presenter:

      

      Oliver Germershaus, PhD
      Professor for Pharmaceutical Technology of Macromolecular Drugs, University of Applied Sciences and Arts Northwestern Switzerland

  • 14:40 – 14:55

    Unraveling Pre‑filled Syringe Needle Clogging by Neutron and Synchrotron X-ray Imaging

    Read more

    Needle clogging becomes a challenge with the shift toward higher-concentration monoclonal antibody and protein formulations designed for a single injection delivery [1]. Increased viscosity in these formulations can lead to greater resistance to fluid flow and an elevated risk of clogging. Additionally, chemical stability issues, such as zinc (Zn) migration from the rigid needle shield (RNS), may contribute to increased viscosity, gelation, and clogging [2]. This study utilizes neutrons and synchrotron X-rays to visualize clogging inside pre-filled syringes (PFS) needles. These non-destructive techniques enable in-situ investigation of needle contents without removing the RNS. We monitor PFS under temperature and pressure conditioning to assess their impact on clog formation [3]. Particularly, synchrotron X-ray tomography provides detailed morphological insights into the liquid inside the needle. Furthermore, we present a novel approach to investigate Zn migration from the RNS to the drug formulation using synchrotron-based X-ray fluorescence imaging [4]. This research advances understanding of needle clogging and can guide strategies to improve PFS performance. [1] Sánchez-félix M, et al. Adv Drug Deliv Rev. 2020;167:66 77. [2] Fukuda M, et al. Eu. J. Ph. Bioph. 2022;178:179 86. [3] Hu G., et al. Ph. Res. 2024;41:547 556. [4] Hu G., et al. Ph. Res. 2025 submitted.

    • Presenter:

      

      Vlad Novak, PhD
      Group Leader, ANAXAM

  • 14:55 – 15:30

    Session 1, Track C: Q&A, Discussion

    • Moderator:

      

      Philippe Lauwers
      Technology Development Director, Terumo Pharmaceutical Solutions

• 15:30 – 16:00

  Tech Talks

• 15:30 – 16:30

  Networking Coffee Break, Exhibition and Guided Poster Walk

• 16:30 – 17:50

  Session 2, Track A

  • Moderator:

    

    Christian Helbig
    Vice President Glass Syringe Business, SCHOTT Pharma

  • 16:30 – 16:45

    Dual Liquid Drug Formulation Trends & Challenges: Incremental Innovation to Enable Usage of Standard Platform Components and Address Growing Needs

    Read more

    With advancements in drug development, there is a growing trend of co-administration or co-formulation of two or more unique liquid drugs, such as with GLP-1s, recombinant hyaluronidase, and mAbs. The development of co-formulated or co-administered injectable drugs may enable opportunities for enhanced clinical and patient experience benefits. When two unique liquid molecules are incapable of being co-formulated, they may need to be stored and injected separately. Coformulation efforts may pose unforeseen compatibility, manufacturing, and regulatory challenges, leading to delays and increased costs. Various dual-chamber container systems and devices are available today, although they may require validation of new materials, additional components, and/or significant changes to secondary device systems to allow for integration. This presentation aims to explore the rising trends in co-administration and co-formulation of biologic therapeutics and existing solutions. BD will showcase exploratory studies, some conducted in partnership with critical industry stakeholders, including pharma, device suppliers, and machine makers, to inform the design of a novel sequential injection plunger stopper. Leveraging an incremental innovation approach, this solution has been designed to allow for the separation and sequential injection of multiple liquid drugs in a single standard prefillable syringe and auto-injector.

    • Presenter:

      

      Matthieu CHARVIN
      Senior Project Manager - New Product Development, BD Medical - Pharmaceutical Systems

  • 16:45 – 17:00

    Addressing Challenging Formulations: A Novel Drug Delivery System Supporting the Automated Reconstitution and Delivery of Lyophilized Solutions

    Read more

    Maintaining the stability of liquid formulations is a well-recognized challenge in the pharmaceutical industry, as some drugs and biologics cannot be formulated into a stable liquid. Lyophilization can enhance stability by removing water under low-temperature and low-pressure conditions (freeze-drying), preserving structural integrity, physicochemical attributes, and bioactivity, while extending shelf life. Lyophilized products are typically packaged in a vial and presented in a kit. These kits include separately packaged diluent, transfer syringes, and other supplemental materials to facilitate reconstitution and administration. Vial kits have complex and burdensome user steps, sometimes requiring training, which pose patient compliance challenges. It is readily recognized that the Critical Quality Attributes (CQA) for a dual-chamber cartridge used in an autoinjector are unique, wherein the formulation needs to be designed with those CQA in mind. The device presented in this work enables the automated reconstitution and self-administration of lyophilized drugs with a dual-chamber cartridge. The device supports automated reconstitution and is built with SHL’s Needle Isolation Technology (NIT®) to avoid clogging during reconstitution and optimize cannula gauge, thickness, and length. The successful collaboration between SHL and Lyo-Tech Inc. showcases the viability of a combination dual-chamber cartridge autoinjector for improved patient compliance with the delivery of lyophilized formulations

    • Co-Presenter:

      

      Seda Aksel, PhD
      Product Manager, SHL Medical AG

    • Co-Presenter:

      

      Michael S Thomas, Maters in Pharmaceutics
      Research Fellow, Lyophilization Technology Inc.

  • 17:00 – 17:15

    Challenging Design Requirements to Unlock Innovation and Improve Sustainability

    Read more

    In a world where rising production volumes demand greater manufacturing efficiency and sustainability, this presentation explores the crucial need for precisely defining device design requirements. Properly specified requirements are key to balancing safety, functionality, and innovation. Yet, the industry’s tendency to maintain the status quo often leads to unnecessary contingencies and over-engineered solutions. While this risk-averse mindset may enhance reliability, it can result in devices that are unnecessarily complex, costly, and harder to use.
    
    Consider autoinjectors: the typical conservative approach specifies drive spring force based on fixed-speed syringe testing to meet a set dispense time, adding significant safety margins to prevent stalls. This method, while safe, is flawed - spring-driven systems are force-limited, not speed-controlled. Evidence shows that testing based on constant force, rather than speed, drastically reduces force requirements while still meeting performance needs.
    
    Lowering the force specification doesn’t just impact spring size; it decreases long-term stresses, reduces actuation forces, cuts material usage, and minimizes the risk of syringe breakage. Chasing minimum injection times and aligning with conventional needle insertion depth are other examples where industry norms should be challenged, rather than simply adopted. By rethinking design requirements, we can create safer, more efficient, and more sustainable devices.

    • Presenter:

      

      Will Marsh
      Senior Sector Manager Medical & Scientific, DCA Design International

  • 17:15 – 17:50

    Session 2, Track A: Q&A, Discussion

    • Moderator:

      

      Christian Helbig
      Vice President Glass Syringe Business, SCHOTT Pharma

• 16:30 – 17:50

  Session 2, Track B

  • Moderator:

    

    Shirish Ingawale, PhD
    Director, Device Development, Takeda

  • 16:30 – 16:45

    A Study of Factors Impacting User Perceptions of Reusable and Disposable Autoinjectors

    Read more

    This study examined the different factors that may influence patient and health care professional perceptions on the ease of use and overall preferability of different autoinjector types (single-use disposable, reusable electro-mechanical and reusable mechanical).
    The study comprised 52 participants, including experienced and naïve adult and adolescent users, as well as healthcare professionals across 3 different areas of the US, intending to cover a wide spectrum of potential viewpoints.
    The data gathered provides insight into whether and how perceptions of the relative importance of these different factors and preferences change with increased exposure to information:
    1) When provided with specifications and descriptions of devices only
    2) When provided with samples that could be looked at and touched, but not used
    3) Following use experience with each device
    Further analysis also challenges the long-held and common hypothesis that reusable devices are considered non-preferred over single-use disposable devices because of the additional use steps involved and how readily translatable ease of use and overall preference are.

    • Co-Presenter:

      

      Gemma Wood, MBA, CMgr
      Director, Platform Management, Phillips Medisize

    • Co-Presenter:

      

      Amanda Tilles, MS
      Human Factors Engineering Manager, Phillips Medisize

  • 16:45 – 17:00

    Autoinjector considerations for generic GLP-1 drug-device development: Utilizing comparative human factors studies to assess the usability impact and preference of differing activation mechanisms

    Read more

    With global GLP-1 sales projected to reach $139 billion by the end of the decade, generic development is expected to accelerate in the coming years. Beyond demonstrating bioequivalence between the generic drug-device combination product and the Reference Listed Drug, generic manufacturers should carefully consider the user interface, inclusive of the drug delivery system, to ensure there is no impact on the safety and efficacy of the generic combination product. Among drug delivery systems used to deliver medications in the treatment of chronic conditions such as type 2 diabetes and chronic obesity, autoinjectors are widely used and can be generally categorized into two groups based on their activation mechanism: push-on-skin and button-activated autoinjectors. In order to assess the risks associated with switching between autoinjector types, two formative human factors studies were conducted in patients with a high BMI. During this presentation, we will explore the user interface for both types of autoinjectors, assessing patients’ usability and preference. The first study evaluated usability implications when switching from a push-on skin autoinjector to a button-activated autoinjector, while the second study assessed patient comfort and preference when activating autoinjectors directly on their skin.

    • Presenter:

      

      Chloé Stoll, PhD
      Clinical and Human Factors Senior Specialist, BD

  • 17:00 – 17:15

    Epinephrine Autoinjector Re-imagined: An Introduction to Design Thinking and User-centered Innovation

    Read more

    Innovation is essential for businesses seeking to remain competitive and foster growth by creating new products and services that meet user needs. Design thinking provides a user-centered approach to identify what is valued by users. Through contextual research, user pain points are uncovered and prioritized, revealing a new and meaningful future state. This mindset guides an iterative process of conceptualization, prototyping, and user testing, allowing design teams to explore ideas and thoughtfully develop features and design elements that resonate with users. Ultimately, insights from this process transform unmet needs into a compelling expression of form and function, delivering relevant and delightful user experiences. This case study explores a conceptual design for an epinephrine autoinjector and introduces the principles and processes of design thinking. It discusses key topics, including an overview of design thinking and its user-centric approach, as well as strategies for transforming research data into insights that lead to higher-value products. Additionally, it examines the relationship between aesthetics, usability, user adoption, and cognitive engagement, while highlighting the importance of user experience in supporting behavior change, adherence, compliance, and improved patient outcomes. Finally, the case study outlines best practices for nurturing new ideas and fostering an environment of creative confidence.

    • Presenter:

      

      James Best
      Design Manager, Studio lead, Flex

  • 17:15 – 17:50

    Session 2, Track B: Q&A, Discussion

    • Moderator:

      

      Shirish Ingawale, PhD
      Director, Device Development, Takeda

• 16:30 – 17:50

  Session 2, Track C

  • Moderator:

    

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

  • 16:30 – 16:45

    AI-Driven Automated Visual Inspection for Combination Products: Challenges and Solutions in Large-Scale such as GLP-1 Manufacturing

    Read more

    The increasing demand for medicines such as GLP-1-based therapies has led to large-scale manufacturing of combination products such as prefilled syringes and cartridges. This shift presents new challenges for Automated Visual Inspection (AVI), requiring advanced defect detection while maintaining efficiency at high throughput. Artificial intelligence (AI) and machine learning (ML) are emerging as transformative technologies for AVI, enhancing defect classification, reducing false rejects, and improving process robustness.
    This presentation is structured into four key sections:
    First, we explore the evolving challenges of AVI in the context of AI and large-batch GLP-1 production.
    Second, we outline the prerequisites for successfully qualifying an AVI system for combination products, addressing defect libraries, validation strategies, including compliant visual inspection validation test sets.
    Third, we examine AI applications in AVI, discussing how ML algorithms improve detection accuracy and system adaptability, but also AI's limitations.
    Finally, we focus on the specific challenges of large-scale cartridge inspection, such as high-speed image processing, container
    variability, and defect classification.
    
    This session will provide valuable insights into how to utilize AI in AVI and practical recommendations for the implementation and validation of AVI for large-scale manufacturing.

    • Co-Presenter:

      

      Roman Mathaes, Dr.
      Chief Executive Officer, Clear Solutions Laboratories AG

    • Co-Presenter:

      

      Massimo Frasson
      CEO & General Manager, Brevetti CEA

  • 16:45 – 17:00

    Minimizing Particulate Matter in Intravitreal PFS by Improving Syringe Manufacturing Process

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    Intravitreal injection is a procedure to place a medication directly into the space in the back of the eye called the vitreous cavity. The cases of intravitreal injection have been increasing over years, led by an increasing number of patients for ocular diseases, as well as wider availability of intravitreal injection drugs, including innovative biopharmaceuticals and their biosimilars. Prefilled syringes (PFS) are widely used for intravitreal injection for multiple advantages, including ease of use, potential prevention of endophthalmitis cases, and lower overfill. One of the challenges in developing and manufacturing an intravitreal PFS is particle management, and there are strict limits in compendial requirements such as USP < 790> and USP < 789>. On the other hand, particle management in PFS products requires a holistic approach through a collaboration between the pharma company and the primary container supplier to optimize every step of the value chain. In this presentation, Roche will share pharma’s perspective for the ideal intravitreal PFS solution with a focus on particle load management throughout the value chain. Terumo will co-present to share the primary container supplier’s perspective with a case study in improving the ready-to-fill syringe manufacturing process to achieve a lower and more consistent particle level in the primary container used for intravitreal injection.

    • Presenter:

      

      Yuki Takeuchi, MS
      Global Product Manager, PLAJEX, Terumo Pharmaceutical Solutions

  • 17:00 – 17:15

    Cross-Industry Collaboration: A Fast and Effective Approach to face Market Challenges for Drug Product

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    In the pharmaceutical industry, supply chain disruptions present critical risks that can compromise drug availability and patient care. Ensuring supply continuity requires a proactive and structured approach to risk management, particularly in highly regulated environments like the pharma industry. This case study explores the strategic collaboration between Stevanato Group, a leading manufacturer of primary packaging solutions, and Johnson & Johnson Innovative Medicine, a pharmaceutical company, in resolving a critical supply chain issue that had the potential to impact drug product supply. By leveraging a cross-functional and data-driven methodology, the two organizations successfully identified the root cause of the disruption and implemented a comprehensive mitigation strategy. A systematic RCA was performed to investigate the underlying failure modes, incorporating statistical process control, historical data trend analysis, and real-time monitoring of critical quality attributes. The team thoroughly explored and generated data for all potential root causes, which enabled them to develop a predictive digital tool that integrated all the learnings from the investigation. This approach led to the formulation of targeted CAPA. The resolution strategy involved process optimization and the application of risk-based decision-making. Mutual trust, effective stakeholder communication, and transparent information sharing were essential in accelerating issue resolution and preventing recurrence

    • Co-Presenter:

      

      Fitore Kasumaj, PhD
      MSAT Biotherapeutics DP Primary Packaging Principal Engineer, Johnson & Johnson Innovative Medicine

    • Co-Presenter:

      

      Jessica Rocco, MD
      Technical Leader - Product Development DCS, Stevanato Group

  • 17:15 – 17:50

    Session 2, Track C: Q&A, Discussion

    • Moderator:

      

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

• 17:50 – 22:00

  End of Day 1 and Networking Event

  PDA Goes Rockabilly VS. Viennese Opera Ball Opposites attract, let the contrast shine Experience a night where classic elegance meets rock ,n' roll rebellion. Dress to impress in your best vintage rockabilly attire or come as a vision of Viennese sophistication. Dance to the beat of rockabilly band and waltz under the chandeliers.

CEST Daylight Time (UTC +2:00)

• 09:00 – 10:20

  Opening Session Day 2

  • Moderator:

    

    Jakob Lange, PhD
    VP & Head of Account and Business Development, Ypsomed AG

  • 09:00 – 09:25

    Reflections on the (EU) 2017/745 Art. 117 'Notified Body Opinion' – a Pharma Company experience

    Read more

    MDR's Article 117 introduced an amendment to the medicinal product Directive 2001/83/EC requiring a separate assessment of the device part to the relevant GSPRs. For the majority of new or modified integral drug-device combinations, a Notified Body Opinion (NBOp) is required, adding complexity to the submission and approval process. The unpredictable nature of this process, with its varying timelines, uncertain scope, and lack of firm dates, contrasts starkly with the EMA's predictable timelines and poses a significant challenge for stakeholders. This session will give a recap of the MDR requirements for integral drug-device combinations (Article 1(9), second subparagraph), provide an overview of the NBOp process, describe lessons learned from a NBOp for a Prefilled Syringe, and will talk about some insights to ensure a smart NBOp process.

    • Presenter:

      

      Mike Wallenstein
      Head Regulatory Medical Devices & Combination Products, Novartis Pharma AG

  • 09:25 – 09:50

    To Be Announced
  • 09:50 – 10:20

    Q&A, Discussion

    • Moderator:

      

      Dominik Ziegler, MSc
      Executive Director Device Technology Solution Center, Novartis Pharma

• 10:20 – 11:10

  Networking Coffee Break, Exhibition and Poster Session

• 10:20 – 11:10

  Tech Talks

• 11:10 – 12:30

  Session 3, Track A

  • Moderator:

    

    Flora Felsovalyi, PhD
    Associate Director, Lonza

  • 11:10 – 11:25

    Simulation of Large Volume, High-Viscosity Subcutaneous Injections with Transport and Absorption

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    Multiphysics simulations of subcutaneous injections are an emerging tool to supplement experimental, animal, and clinical studies for large volume, high viscosity injection solutions. The authors previously developed a generalized model for high-viscosity subcutaneous injections, which was used to study the effect of different injection and tissue variables on injection pressures and drug transport. COMSOL Multiphysics software was used to develop poroelastic tissue models with subsurface flow. The model was validated against five separate clinical studies with pressure and drug distribution data in humans and animals, including data for injection viscosities up to 20 cP and flow rates up to 400 µL/sec. The current study updates the previous model to simulate the absorption kinetics of different solutions through the lymphatics. The model is adapted to evaluate injected monoclonal antibody solutions (mAbs) and insulin. The model explores the effect of injection location (e.g., abdomen, thigh), needle size, subcutaneous tissue thickness, flow rate, viscosity, and volume. In addition to other results, the study found that the tissue pressure increased by ~1.5 to 2.5 kPa/cP for viscosities above 8 cP. The presentation will also discuss the relationship between model outputs and clinical data, including subject pain and discomfort.

    • Presenter:

      

      Scott Lovald, PhD
      Senior Managing Engineer, Exponent

  • 11:25 – 11:40

    Injection Rate Impact on Depot Morphology of a High Viscosity Long Acting Injectable in Physiologically Relevant Ex Vivo Porcine Tissue

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    Subcutaneous delivery of long-acting injectable (LAI) pharmaceuticals with in situ forming depots often requires high-concentration formulations that prove challenging to manually deliver using traditional syringes due to their increased viscosity. Once delivered, the pharmacokinetic (PK) release profile of LAI compounds is governed largely by the API depot morphology, specifically the surface area to volume ratio. Choice in delivery device features such as needle gauge, needle length, and injection speed can impact both the aspect ratio and the degree of porosity of the LAI depot – and hence the resulting PK profile. Herein, we characterized and compared the depot morphology of a high viscosity LAI following injection via manual syringe, autoinjector, and on-body injection systems in ex vivo porcine tissue, assessed by micro-computed tomography and machine learning. These data provide an indicative design space by which drug developers may select the optimal injection device to achieve their pharmacokinetic aims.

    • Co-Presenter:

      

      Robert CH Gresham, PhD
      Post Doctoral Scientist, Gilead Sciences

    • Co-Presenter:

      

      Tyler A. Novak, PhD
      Director of Drug Delivery Innovation, Gilead Sciences

  • 11:40 – 11:55

    Large Volume Subcutaneous Injections and the Patient`s Perspective: How Usability and Tolerability Data Help Define the Performance Characteristics of a 5.5 ml Drug Delivery System – a Case Study

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    Abstract: Recent advances in large-volume subcutaneous drug formulations have been driven by the desire to increase convenience of drug administration. Novel delivery systems are an inherent part of this development, where the system must be carefully specified to meet the requirements of different patient populations and drug formulations. The decision regarding the target design space is key for the successful development of a novel drug delivery system. If the design space is defined too broad, the system might become excessively complex. If it is too narrow, the number of future applications is unnecessarily restricted. This presentation elaborates on how newly acquired usability data and a literature review of tolerability data was leveraged to define the injection time target range for a novel 5.5ml syringe-autoinjector-system. We show how this injection time target, together with the viscosity range and the volume range of potential formulations, determined the specifications and performance characteristics of the prefilled syringe and the autoinjector, respectively, and we present the respective performance data of the system.
    
    Please list and/or describe the objectives of this abstract.: The attendees of this presentation will learn: • how to consider usability and tolerability data when determining the injection period for a large volume delivery system. • how injection time and other requirements of the drug are taken into account when designing the delivery system.
    
    

    • Co-Presenter:

      

      Reto Jost, MSc
      Director, Category Lead Large Volume Injectors, Ypsomed AG

    • Co-Presenter:

      

      Sven Pohle, PhD
      Product Manager, SCHOTT Pharma

  • 11:55 – 12:30

    Session 3, Track A: Q&A, Discussion

    • Moderator:

      

      Flora Felsovalyi, PhD
      Associate Director, Lonza

• 11:10 – 12:30

  Session 3, Track B

  • Moderator:

    

    John Burke
    Senior Consultant, Team Consulting

  • 11:10 – 11:25

    Empowering Patients: The Benefits of Connected Injection Devices on Health Outcomes – A Focus on Autoinjectors

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    In the evolving landscape of digital healthcare, connected injection devices can transform patient outcomes by enhancing adherence, optimizing treatment efficacy, and potentially providing real-time data access. This session, led by experts at Flex and Merck KGaA, Darmstadt, Germany, will explore the design of connected autoinjectors tailored to data-driven patient needs, highlighting the potential impact of connectivity in autoinjectors used for chronic diseases, examining how digitalization improves both patient experience and healthcare provider (HCP) decision-making. Potential medical benefits of connected injection devices may be amplified by adopting a platform-based approach and flexible configurations, enabling single devices to potentially serve distinct patient populations through tailored software adaptations. A real-world case study will be presented. The integration of smart monitoring and automated data logging in connected autoinjectors may enable precise tracking of adherence, allowing patients to potentially follow treatment regimens with greater confidence. By leveraging connectivity features, HCPs and the scientific community might gain access to comprehensive therapy data, facilitating proactive interventions and personalized care adjustments. The session will highlight key evidence-based findings in clinical literature, how connected injection devices might contribute to therapy success, discussing their potential role in fostering engagement between patients and physicians while considering cybersecurity implications and countermeasures.

    • Co-Presenter:

      

      Marco Rigamonti
      General Manager, European Health Solutions Design, Flex

    • Co-Presenter:

      

      Matthew Keiser
      Director, Core Team Leader, Device and Connected Solution Engineering Global Healthcare Operations, Merck KGaA, Darmstadt, Germany - EMD Serono, Inc.

  • 11:20 – 11:35

    Supporting Patients to Self-Inject: The Journey to Develop Digital Instructions

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    Despite the careful consideration given to autoinjector device design, many well-known challenges related to patient onboarding for new therapies remain, leading to use-related injection errors and product complaints. Self-injection is becoming commonplace, and patient expectations relating to digital resources are increasing. In recent years, digital instructions and digital patient support materials have become a focus of attention as the medical device and pharma industries look to capitalise on the benefits of digital content, improve patient safety and treatment adherence, enhance the patient experience, and address global regulatory expectations for electronic prescribing information. A collaboration between AstraZeneca and Team Consulting set out to develop digital instructions for an autoinjector platform. Informed by an in-depth understanding of intended users, use-related injection errors, and an iterative and patient-led design process involving representative users, the project team created digital instructions for the US market. This talk will describe the user-centric design process followed by AstraZeneca and Team Consulting, exploring the common challenges associated with digital instructions in the self-injection space, and providing practical tips for how to implement effective digital materials for a range of user populations.

    • Co-Presenter:

      

      Katie Cornish, PhD
      Senior Human Factors Engineer, AstraZeneca

    • Co-Presenter:

      

      Thomas Grant, PhD
      Senior Consultant – Digital Health, Team Consulting

  • 11:40 – 11:55

    RFID-Enabled Prefilled Syringe System: Minimizing Drug Waste While Enhancing User Convenience and Sustainability

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    The use of prefilled syringes in hospitals is a well-established practice aimed at enhancing patient safety, reducing medication errors, and simplifying drug administration. However, integrating prefilled syringes with smart labeling and RFID technology introduces a transformative approach that offers significant advantages for healthcare professionals, hospital operations, and environmental sustainability. This next-generation infusion system is designed with a user-centric focus, addressing specific needs through advanced traceability features, including analog and digital first-opening indicators. RFID integration enables real-time monitoring, ensuring the correct medication is administered at the right time, thus reducing errors and optimizing workflows. Our presentation explores the development process of this innovative system, including human factor evaluations, usability studies, and extensive verification processes. By adopting a holistic approach that encompasses primary and secondary packaging, as well as integrated hardware and software solutions, healthcare delivery organizations can streamline drug preparation, enhance inventory control, and minimize operational inefficiencies. Beyond efficiency gains, this system aligns with sustainability goals by reducing pharmaceutical waste and optimizing resource utilization. The ability to track and manage medications effectively not only improves patient outcomes but also reduces costs associated with expired or unused drugs.

    • Co-Presenter:

      

      Christoph Zauner
      Head of product managment polymer solutions, Schott Pharma

    • Co-Presenter:

      

      Nick Petersen
      VP, Corporate Development, bluesight

  • 11:55 – 12:30

    Session 3, Track B: Q&A, Discussion

    • Moderator:

      

      John Burke
      Senior Consultant, Team Consulting

• 11:10 – 12:30

  Session 3, Track C

  • Moderator:

    

    Jeffrey Givand, PhD
    Executive Director, Device and Combination Product Development, Merck

  • 11:10 – 11:25

    Does Needle Clogging Change the Spatial Distribution of Injected Drugs in Tissue? New Insights by X-Ray Computed Tomography

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    With the growing use of ever more concentrated biopharmaceuticals in prefilled syringes, needle clogging as a result of solidification due to evaporative water loss is becoming an increasingly frequent issue. This study investigates the impact of needle clogging on the distribution of injected drug solutions in the s.c. tissue, with a focus on potential effects of drug absorption from the injection site. Using tube-based and synchrotron-based X-ray computed tomography, we analyzed the spreading of the injected liquid in porcine hypodermis. The tissue distribution was correlated with the plunger force profile and the jet flow dynamics. It could be demonstrated that most clogs of solidified protein (monoclonal antibodies) redissolve in the needle during injection. The first portion of liquid escapes through a narrow channel in the clog as a highly pressurized jet, forming a long tail that penetrates deep into the tissue. However, as the volume fraction of this tail is very low, a significant effect on the overall absorption kinetics can be excluded. Despite needle clogging altering the tissue distribution of the drug, it is unlikely to affect pharmacokinetics and bioavailability. It has also been shown that even in the hypothetical event of clogs entering the tissue, they would quickly dissolve.

    • Presenter:

      

      Fabiano Bonaventura, MSc
      Expert Science & Technology, Novartis Pharmaceutical Manufacturing GmbH

    • Co-Presenter:

      

      Stefan Scheler
      Associate Director Science & Technology, Novartis Pharmaceutical Manufacturing GmbH

  • 11:25 – 11:40

    Proof of Significant Oxygen Ingress Reduction for COC Syringes Through Highly Effective Barrier Labels

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    Medical polymer containers made of COC (Cyclic Olefin Copolymer) offer advantages such as break resistance or less protein absorption compared to glass containers. However, they have reduced oxygen and gas barrier properties, which poses a challenge particularly in the case of oxygen-sensitive biologics and biosimilars, resulting in severe consequences such as adverse biological effects or a reduction of shelf life. To address this challenge and to reduce permeation, functional labels with gas barrier properties are an innovative solution that can be adapted for a wide range of COC syringes. They can be applied flexibly in pharmaceutical production without changing the primary container or manufacturing processes. To assess the effect of labels with integrated gas barrier on COC syringes, it is important for pharmaceutical companies to know how much the oxygen ingress can be reduced by using functional labels. Therefore, extensive oxygen permeation tests were performed in collaboration with SCHOTT Pharma for COC syringes equipped with gas barrier labels (tests conducted by the University of Applied Sciences Munich). In this presentation, the results of the permeation tests will be presented to enable pharmaceutical companies to evaluate the effect of functional labels on the shelf life and effectiveness of their sensitive APIs.

    • Presenter:

      

      Corinna Endres
      Product Manager, Schreiner MediPharm

  • 11:40 – 11:55

    Advantages of Intradermal Injection: From Infection Diseases Vaccine Delivery Toward Lymphatic Vessel Application for Cancer Therapy

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    The dermis is densely populated with immune-competent cells, such as Langerhans and dendritic cells, making it a highly responsive site for immune activation. Intradermal (ID) injection, which targets this layer, has long been recognized for its strong immune response. However, despite these advantages, current intradermal injection techniques present certain challenges in medical practice. A traditional and well-known application for ID injection is vaccine delivery against infectious diseases, and by using a device designed with specific characteristics aimed at overcoming the aforementioned challenges, some promising results in clinical trials were obtained. Nonetheless, more recently, a study on ID lymphatic drug delivery has been performed. The skin's rich network of lymphatic vessels presents new opportunities, particularly for cancer therapy, where ID administration of high molecular weight drugs could offer superior lymphatic targeting.

    • Co-Presenter:

      

      Sakiko Shimizu, MA
      Chief Scientist, Pharmaceutical Solution Devision, Terumo Corporation

    • Co-Presenter:

      

      Michele Guasti
      Global Product Manager, Terumo Europe

  • 11:55 – 12:30

    Session 3, Track C: Q&A, Discussion

    • Moderator:

      

      Jeffrey Givand, PhD
      Executive Director, Device and Combination Product Development, Merck

• 12:30 – 14:30

  Networking Lunch Break, Poster Session & Exhibition

• 12:30 – 14:30

  Tech Talks

• 14:30 – 15:00

  Closing Session Part I

  • Moderator:

    

    Theresa E. Bankston, PhD
    VP Combination Products & Capabilities, BD

  • Moderator:

    

    Marion Briggs, MBA
    Sustainability Manager, HealthBeacon

• 15:00 – 15:45

  Networking Coffee Break, Exhibition and Poster Session

• 15:45 – 16:50

  Closing Session Part II

  • Moderator:

    

    Theresa E. Bankston, PhD
    VP Combination Products & Capabilities, BD

  • Moderator:

    

    Marion Briggs, MBA
    Sustainability Manager, HealthBeacon

  • 15:45 – 15:55

    Title To Be Announced
  • 15:55 – 16:10

    Title To Be Announced
  • 16:10 – 16:50

    Closing Plenary Discussion

    • Moderator:

      

      Theresa E. Bankston, PhD
      VP Combination Products & Capabilities, BD

    • Moderator:

      

      Marion Briggs, MBA
      Sustainability Manager, HealthBeacon

    • Panelist:

      

      Hanns-Christian Mahler, PhD
      CEO, ten23 health

    • Panelist:

      

      Andreas Schneider
      Head Innovation Delivery Systems, Ypsomed AG

    • Panelist:

      

      Karthik Vaideeswaran, PhD, MBA
      Associate Vice President, Delivery, Device & Connected Solutions, Merck

    • Panelist:

      

      Andrea Redd
      Associate Vice President, Global Regulatory Affairs, Drug Device Delivery, Eli Lilly and Company

• 16:50 – 17:05

  Conference Co-Chair Summary

  • Co-Chair:

    

    Theresa E. Bankston, PhD
    VP Combination Products & Capabilities, BD

  • Co-Chair:

    

    Jakob Lange, PhD
    VP & Head of Account and Business Development, Ypsomed AG

• 17:05 – 17:10

  Closing Comments & Farewell

  • Committee Member:

    

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