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

Shaping the Drug Delivery Ecosystem

21 - 22 Oct 2025
Austria Center Vienna
Vienna, Austria

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Shaping the Drug Delivery Ecosystem

Join us at the PDA Universe of Pre-Filled Syringes and Injection Devices Conference 2025 scheduled to take place on 21-22 October 2025 in Vienna, Austria, a city renowned for its rich history, elegance, and cultural heritage. This year’s theme, Shaping the Drug Delivery Ecosystem, explores the intersection of science, technology, patient experience, and sustainability in injectable combination products.

The program opens with the PDA Drug Delivery Innovation Award and a powerful plenary session featuring perspectives from patients and healthcare professionals. These keynotes will highlight the importance of designing solutions that are not only clinically effective but also patient-centric. Expert presentations will explore how pharmaceutical companies are responding to the evolving demands of combination product development and how evaluating drug and device deliverability - from the molecular scale to the patient experience - can drive meaningful innovation.

Key Topics
  • User Engagement & Digital Health: Leveraging digital tools to enhance usability and adherence
  • Advanced Delivery Systems: Large-volume injections, wearable devices, and new platform technologies
  • Smart Testing & Automation: Integrating AI, automated visual inspection, and usability studies
  • Sustainable Innovation: Strategies for eco-friendly packaging, device reuse, and lifecycle management

The program transitions into dynamic afternoon parallel session tracks that cover a wide range of practical and future-focused topics. Attendees will gain insights from real-world case studies and data on device usability, smart tech integration, needle clogging challenges, and AI-powered testing. Whether it’s about improving self-injection experiences or advancing sustainability strategies, the content is curated to offer tangible impact and foresight.

A vibrant exhibition hall will offer opportunities for discovery and networking. Leading solution providers will showcase the latest innovations in injection devices and packaging. For the first time, emerging startups will present focused pitches, offering a glimpse into the next generation of drug delivery. Complementing these are the well-established Tech Talks and guided poster walks that invite direct interaction and dialogue throughout the event.

Why Attend?
  • Premier Forum: A platform for knowledge exchange and cross-industry dialogue
  • Innovative Perspectives: Real-world case studies and cutting-edge tech demonstrations
  • Unmatched Networking: Engage with industry leaders, innovators, and peers in an inspiring setting

A major highlight is the official networking event on the opening evening. This year’s theme, 'PDA Goes Rockabilly vs. Viennese Opera Ball', promises an unforgettable evening blending classical elegance with vintage rock and roll flair. It’s the perfect setting to continue conversations, make new connections, and enjoy a vibrant cultural experience with colleagues and industry friends.

We look forward to welcoming you to Vienna for an engaging and impactful event.

See you in October 2025!

Sincerely,
The Co-Chairs

Theresa Bankston, BD
Jakob Lange, Ypsomed

Program Highlights

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Agenda

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Tue 21 Oct Wed 22 Oct Workshop Training
Tuesday, 21 October

CEST Daylight Time (UTC +2:00)

  • Registration Open

    Foyer X4

  • Welcome and Innovation Award Announcement

    Hall D

  • Welcome From the Co-Chairs

    Hall D

  • Opening Session Part I

    Hall D

    Part one of the opening plenary focuses on patient and physicians’ perspectives on the treatment of Obesity with GLP1s, providing two contrasting views of how this recent and emerging treatment option fits into the overall management of overweight and obesity. Expect to get fresh perspectives and to learn more about the opportunities and challenges in obesity treatment at present, going forward.

  • Q&A, Disucssion

    Hall D

  • Networking Coffee Break, Exhibition, and Guided Poster Walk

    Foyer X2-X3

  • Tech Talks

    Foyer X3

  • Guided Poster Walk Part I

    Foyer X3

    • A Strategic Approach to Design Control in Large Volume Ready-to-Use Cartridges

    • Accelerating Autoinjector Clip Design Verification with Digital Twin Technology

      Haughton Design’s Digital Twin Technology is revolutionizing the validation of autoinjector components, particularly retention clips, which are crucial for patient safety. Traditional design verification relies on physical prototyping and mechanical testing, leading to long development cycles, high costs, and regulatory challenges.

      This innovative approach combines customized finite element analysis (FEA) with precise sample testing to predict mechanical behaviour, deformation under load, and potential failure points. By identifying issues early, reliance on extensive physical testing is significantly reduced, accelerating development. Additionally, strategic sample testing refines digital models for greater accuracy, ensuring confident design decisions while minimizing costly, time-consuming trials.

      Beyond simulation, advanced tolerance and variability analysis help uncover manufacturing inconsistencies at the earliest stages, preventing expensive rework or production delays. By integrating these capabilities, Haughton Design delivers a more efficient, reliable, and cost-effective validation process compared to traditional methods.

      Leveraging digital twin technology enables medical device developers to achieve faster iteration cycles, improved reliability, and streamlined regulatory submissions, ultimately reducing time-to-market. This poster will provide practical insights into how simulation-driven design verification is transforming drug delivery device development and how companies can incorporate these advanced tools into their R&D workflows.

      Please list and/or describe the objectives of this abstract.: • Explain how digital twin technology can optimize the design verification of autoinjector retention clips.
      • Demonstrate how computer simulation reduces physical testing time while ensuring compliance with medical device regulations.
      • Highlight cost savings, efficiency gains, risk reduction, and enhanced reliability can be achieved through in-silico validation.
      • Provide insights into real-world applications and success stories from the medical device industry.

    • Advancing RTU Tub Innovations

    • AI in Automated Visual Inspection of Prefilled Cartridges: Success Stories

    • Assessing Plunger Stopper Movement under Low Pressure and Variable Temperature Conditions

      Abstract: The sterility and performance of prefilled syringes (PFS) is critical for maintaining drug stability and device function. Plunger stopper movement (PSM) during storage and transport can lead to leakage, contamination, or changes in drug concentration. This study aims to develop a test methodology to evaluate PSM in PFS under low-pressure conditions while exposed to extreme temperatures, which is increasingly relevant for biologics and temperature-sensitive pharmaceuticals. A controlled experimental setup was designed to simulate low-pressure environments encountered during air transport and storage. Syringes were subjected to defined pressure differentials in a temperature-controlled chamber, replicating high or low temperature conditions. High-resolution image analysis techniques were used to measure plunger-stopper movement, assessing both absolute displacement and rate of movement. This study presents a novel methodology for evaluating plunger-stopper movement under defined storage conditions, offering a framework for assessing syringe performance and drug stability in real-world scenarios. The findings can inform regulatory strategies and manufacturing decisions to enhance the reliability of prefilled syringes for temperature-sensitive therapeutics.

      Please list and/or describe the objectives of this abstract.: Develop a test methodology to assess Plunger Stopper Movement at variable temperature conditions Evaluate the effect of high and low temperatures to assess the absolute displacement and rate of Plunger Stopper Movement

    • Development and Use of an Innovative Methodology for Analyzing Visible Particulates

    • Development of a Portable Indenter Device for Assessing Tissue Stiffness at Injection Sites

    • Ebeam Technology – Transfer Technology For Pre-Sterilized RTU Components

    • Exploring Opportunities for Large Volume Subcutaneous (LVSC) Injections for Acute Illness Treatment from Both Patient and Healthcare Perspectives

      Abstract: Whilst initial anti-infective treatment is intended to be delivered in a hospital setting by healthcare professionals, from a patient perspective there is an overarching ambition: to transfer the care currently provided in hospital settings to home environments. However, the feasible, systematic and user-centred considerations that surround this ambition are not yet understood. These are split into; Delivery Training Monitoring Our study has been to explore the HCP perspectives using different investigational tools such as; 'Contextual inquiry', to understand the existing practices, workarounds and protocols better. Identifying potential challenges and risks associated with administering treatment at home. 'Remote interview', To support the contextual inquiry sessions, a series of remote semi-structured interviews aim to build a holistic understanding of both the opportunities and potential barriers. Remote interviews introduce the potential to access specialists across the US, as recruitment is not constrained to a single location.

      Please list and/or describe the objectives of this abstract.: To gain real world insight into potential barriers and considerations into delivering large volume sub-q at home.

    • Identification of Foreign Particulate Matter in Assembled Autoinjectors Through Long-Time Tracking of Individual Particles’ Trajectories

    • Impact of Injection Stress and Collection Methods on Drug Quality of Autoinjector

      Abstract: Autoinjectors have greatly improved the precision and convenience of therapeutic administration. However, their widespread use requires careful evaluation of drug quality after ejection, as the injection process can alter important physicochemical properties crucial for regulatory compliance and patient safety. Two key factors must be considered when comparing ejected drugs to those in their original packaging. (1) Mechanical stresses during high-speed injection driven. The fast movement of the plunger can peel off more silicone oil from prefilled syringe. And shear stress occurs as the drug moves through the syringe and fine needles, causing high shear stress on the product. (2) The method of sample collection, especially the stand-off distance (the gap between the needle tip and the collection container), is critical. If the distance is too short, the high-velocity impact of the drug on container surfaces can cause mechanical stress, leading to particle formation or changes in molecular structure. Improper collection practices risk generating artifactual data, leading to false conclusions about drug stability during characterization studies. This study systematically evaluates these factors under controlled flow rates and stand-off distances, aiming to establish an optimized comparison method for autoinjector performance testing, promoting analytical accuracy and quality-by-design principles in drug development.

      Please list and/or describe the objectives of this abstract.: 1. To share our techinical findings with EU centric audience. 2. Assess the Impact of Mechanical Stresses on Drug Quality 3. Optimize Sample Collection Methodology

    • Impact Of Tolerable Injection Conditions And Interindividual Sample Geometry Variability On Tissue Backpressure, Its Variability, And Formulation Spreading, Resulting From Subcutaneous Injections

      Abstract: Hypothesis about mechanical phenomena occurring in tissue during subcutaneous injections are only based on injections of small volumes and viscosities. Unfortunately, it is known that injections of larger volumes and/or viscosities induce larger tissue backpressures. Other mechanical phenomena could thus be activated in tissue during such injections, impacting tissue backpressure reached and formulation spreading. Also, tolerable subcutaneous injection condition extremums are up to now unknow, as the origin of the tissue backpressure variability for injections presenting same injection conditions. In this context, Nemera decided to carry out contrast absorption X-ray microtomography scans of swine samples before injections, in which cannulas were yet positioned. Such scans allowed the determination of sample geometry specificities, and distances of given microstructures with the injection point. Injections of placebos containing a radiopaque agent were then carried out in those same samples, measuring tissue backpressure. Another scan of each sample was also carried out post-injection, to observe formulation spreading. Contrast agent depots were then segmented, and orthogonal projections carried out. Injection conditions used have been chosen based on a first estimation of the tolerable injection condition extremums. The eventual existence of relations between injection conditions, sample geometry, formulation spreading, backpressure and its variability were then studied.

      Please list and/or describe the objectives of this abstract.: These results focus on subcutaneous injections of large volumes and/or viscosities, and more specifically on their resulting tissue backpressure and formulation spreading by: - Generating hypothesis about mechanical phenomena occurring in subcutaneous tissue during injections - Establishing differences between depots induced by different injection conditions, covering their tolerable extremums, and taking into consideration interindividual sample geometry variations - Furnish phenomenology required to generate numerical models able to predict backpressure at the injection point and data allowing their validation - To take into consideration tissue backpressure for device dimensioning

    • Insights of Human Factor Considerations that may Influence User Experience in Drug-Device Combination Products Design

    • Mastering Novel Combination Product Transfer to Commercial Manufacturing

      Abstract: In the rapidly evolving field of drug delivery, shortening the time to market for novel combination products is of paramount importance. On one hand, one might be tempted to progress serially to reduce risk and address the design, testing, and manufacturing of novel combination products in separate serial phases, which leads to long development times and delayed design transfers. On another hand, one might be tempted to skip intermediate stages and move directly from design straight into commercial Manufacturing. While this approach seems the shortest, the inherent high development risk due to a lack of design maturity will lead to costly and lengthy iterations in the commercial production phase, ultimately leading to long commercialization timelines. In this poster, we review the benefits of a development model based on a balanced process that requires simultaneous increase in maturity on the design, testing, and manufacturing approaches (i.e., as the product evolves so do the test methods and the assembly processes). We will review the processes and infrastructure required to enable such a model that relies on a careful balance of risk and knowledge.

      Please list and/or describe the objectives of this abstract.: Communicate to the audience that there is an optimal development pathway that will lead to the shortest commercialization timeline that relies on calculated risks and a simultaneous development of the novel combination product design, test methods, and manufacturing processes. Such optimal timeline is achieved through a careful use of development and manufacturing capabilities limiting the number of intermediate transfers until the actual design transfer to commercial manufacturing.

    • Mental Models and User Interface Design Considerations for Large-Volume Subcutaneous Infusion Devices

      Abstract: High-dose biotherapeutics have spurred the need for large-volume subcutaneous (LVSC) delivery devices. At-home, self-administration with these devices has the potential to reduce cost of care and improve patient convenience. However, LVSC infusion devices require intuitive indicators to communicate critical status information to patients, particularly during extended-duration administrations. We conducted a mixed-methods study of n=7 patients with primary immunodeficiency diseases currently self-administering subcutaneous immunoglobulin by LVSC infusion at home. Patients completed a narrated card sort exercise comprising 16 indicator objectives (i.e., patient-centered goals, abstracted from the indicator or device itself). Our results suggest that patients fall into two distinct groups: a sedentary group primarily interested in end-of-dose alerts, and a mobile group requiring more comprehensive information to fit infusions into their schedules. Both groups had shared mental models for how they interpret their device indicators, and these findings provide design guidance for new and existing LVSC devices to enhance user experience. Overall, effective LVSC device indicators must provide easily interpreted in-progress feedback that can be monitored at a glance, include distinct end-of-dose notification with both alert and visual distinction, offer meaningful progress indicators calibrated to extended-duration administrations, and incorporate regimen sequencing information in a hierarchical design that avoids overwhelming users.

      Please list and/or describe the objectives of this abstract.: Present findings on device indicators and user interface design to fit large-volume subcutaneous (LVSC) patients’ existing mental models and preferences. Identify how patients handle and interact with their current devices to understand how existing indicator systems are impacted by patients’ behavior and environment. Provide design guidance for new and existing LVSC devices to enhance user experience and therapy adherence.

    • Mitigating Risk in ANDA Submissions: A Case Study on Leveraging Human Factors Data During Generic GLP-1 Combination Product Development

      Abstract: As GLP-1 drugs approach patent expiration in the US, generic development is expected to rapidly accelerate. Navigating the ANDA submission process can be complex with many hurdles needing to be overcome. When submitting a generic drug-device combination product in the US, pharmaceutical companies must follow the FDA guidance “Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry”. As part of this guidance, a threshold analysis is performed to assess the differences between the Reference Listed Drug (RLD) and the generic device. Generic manufacturers must carefully consider the design of the user interface and seek to minimize differences from the user interface of the RLD. Identified differences may necessitate a comparative use human factors (CUHF) study to prove the non-inferiority between the two products. To help prevent challenges from arising during regulatory review, generic manufacturers should consider implementing a comprehensive pre-ANDA strategy. During this presentation, a case study will show how a drug device developer performed a comparative analysis (part of threshold analysis) and formative CUHF study to help inform pharmaceutical companies’ final CUHF and de-risk their combination product ANDA submission.

      Please list and/or describe the objectives of this abstract.: - Explore threshold analysis requirements for generic combination product ANDA submissions - Share insights into the role that comprehensive human factor strategies play in the development of biosimilar and generic combination product - Learn how formative comparative use human factors (CUHF) studies can inform methodological decisions for final CUHF studies

    • Navigating Biocompatibility For Combination Products

    • Optimizing Drug Delivery For At-Home Use

    • Preclinical Evaluation on the Functionality and Usability of a High-Volume Auto-Injector (HVAI) as an Off-Body Injector Enabled by Recombinant Human Hyaluronidase PH20 (rHuPH20)

    • Predicting Creep Performance of Spring-Loaded Parts in Injection Devices

    • Push-to-Activate vs Button-Activated? A Self-Injection Device Interchangeability Study

    • Quantification of Silicone oil in Primary Packaging Materials using HPLC

      Abstract: The siliconization of primary packaging containers, such as syringes and cartridges, is crucial for their functionality. To examine the amount of silicone oil within a container, a time-efficient quantification method with a low limit of quantification (LOQ) is needed. A silicone oil extraction method for syringes, cartridges and stoppers and a subsequent automated quantification method based on HPLC using a size exclusion column (SEC) and a charged aerosol detector (CAD) was developed. The method was utilized to support several development activities. Spray-coated syringes with different amounts of silicone oil were analyzed and the results were compared with functionality tests of filled syringes with a drug solution. Additionally, the batch-to-batch variation of the silicone oil amount in the syringes was monitored. The silicone oil amount in cartridges was analyzed prior and after the bake-on process in a dry heat tunnel of a commercial production plant. Moreover, free and cross-linked silicone oil on the surface of rubber stoppers was quantified and distinguished on the basis of the molecular weight. This showed diverse applications of the method in the pharmaceutical development.

      Please list and/or describe the objectives of this abstract.: Quantification of silicone oil, functionality of syringes, processing of cartridges

    • Reducing Product Carbon Footprint – Design Impact

    • Size Matters? Patient Insights from a Wearability Study on Large-Volume OBDS

      Abstract: As on-body delivery systems (OBDS) evolve to accommodate large-volume drugs, device size becomes a critical factor influencing patient perception and acceptance. While larger devices may initially seem intimidating, real-world wearability assessments provide deeper insights into the actual patient experience. This poster presents findings from a wearability study assessing patient perceptions of a modular OBDS designed for large-volume drug delivery. After outlining the study’s scope and design, we will explore how patients perceived the device at various time points, from first impressions to extended use. Key observations will highlight how initial perceptions regarding comfort, ease of wear, and overall acceptability evolve as patients become more familiar with the device over time.

      Please list and/or describe the objectives of this abstract.: • Explore the impact of device size on patient perceptions in large-volume OBDS, focusing on how initial impressions evolve with extended use. • Present Stevanato Group’s wearability study, highlighting the study’s methodology and key findings derived from patient feedback.

    • Sustainability in Subcutaneous Drug Delivery: Collaborative Opportunities from the SC Consortium Benchmarking Initiative

      Abstract: The Subcutaneous Consortium's Sustainability Benchmarking Initiative led a comprehensive study examining organizational commitments, priorities, and efforts toward sustainability in subcutaneous drug delivery systems. The initiative engaged 12 member organizations representing major pharmaceutical companies and device manufacturers, collecting both quantitative data and qualitative insights through interviews with 29 subject matter experts across environmental sustainability, device development, and packaging functions. The research revealed a significant gap between high-level corporate sustainability commitments and actual implementation. While member organizations demonstrate strong strategic commitment to sustainability, the incorporation of sustainable practices in product development remains moderate with investments often not matching stated ambitions. The benchmarking identified several critical barriers to sustainable transitions: competing priorities, regulatory uncertainties, challenges in material selection, and limitations of current take-back and recycling programs. Despite these challenges, the study revealed significant opportunities for industry collaboration, particularly in standardizing approaches to circularity, developing industry-wide take-back programs, and creating common specifications for sustainable materials. The findings emphasize that sustainability in pharmaceutical delivery systems is not an area for competitive differentiation, but rather an opportunity for pre-competitive collaboration to establish new industry standards and practices. As regulatory pressures increase globally, this collaborative approach will be essential for meeting both sustainability goals and patient needs.

      Please list and/or describe the objectives of this abstract.: • Present findings from the SC Consortium's Sustainability Benchmarking Initiative involving 12 member organizations and 29 subject matter experts across pharmaceutical and device manufacturing companies • Identify gaps between corporate sustainability commitments and actual implementation in subcutaneous delivery systems • Highlight opportunities for industry-wide collaboration on circularity, take-back programs, and sustainable material selection • Provide a framework for pre-competitive collaboration to establish new sustainability standards in the industry

    • Sustainable Drug Delivery Devices: A Whole Value Chain Approach

    • The Big Misunderstandard: On the Application of ISO 2859-1 for Drug Delivery Device Lot Inspection

      Abstract: In this presentation, we focus on the application of ISO 2859-1Sampling Procedures for Inspection by Attributes to lot acceptance of auto-injector devices. The presentation goes over the statistical basis of the standard rules to provide a solid understanding of their applicability. It points out the pitfalls and nuances of certain elements and provides a maturity-based strategy that leverages the strengths of the standard rules. Examples are provided for a hypothetical auto-injector device along with a proposed methodology to derive appropriate acceptance quality limits (AQL) for different critical attributes. The presentation concludes with an overview of an automated software application to implement the standard within a manufacturing workflow.

      Please list and/or describe the objectives of this abstract.: Provide an understanding of the standard beyond the procedural adherence to its tables and rules. Point out common misunderstandings of certain details of the standard Present a user-friendly software package to implement the standard within a manufacturing workflow

    • Transforming Sterile Manufacturing For Syringes

      Abstract: Oncomed implemented new PFS Filling and automatic Syntegon inspection lines. Our presentation will highlight challenges and key breakthroughs in deploying the isolator line, showcasing Oncomed’s commitment to innovation, operational excellence, and sustainable pharmaceutical production. Through agile engineering and cross-functional collaboration, we successfully validated a GMP-compliant aseptic facility within 3.5 years, producing 3 million syringes across 10 strengths in 1 mL Long syringe bodies. The dual filling system (TPF and peristaltic) runs at 30,000 syringes/hour, reaching 100 million syringes annually after 81 APS/PQ/PPQ runs in six months. We will discuss Annex 1 compliance, including cleanroom classification, sterile filtration (PUPSIT), and sterilization/cleaning approaches validated through qualification studies. The validation program, managed by 11 teams, covered isolator mock-up, RA, DQ, FAT, installation, SAT, IQ, OQ, VHP cycle validation, product process development, and full PPQ and cleaning validation. Additionally, we will detail the development and optimization of an automatic optical inspection machine with 23 high-resolution cameras and HVLD for container closure integrity. Beyond production expansion, modernization efforts include a centralized compounding and weighing area, optimizing material flow, reducing cross-contamination, and enabling seamless handling of highly potent APIs (OEB 3–OEB 6).

      Please list and/or describe the objectives of this abstract.: Analyze – Examine rising global demand for injectable oncology treatments and its manufacturing impact. Design – Develop a high-speed syringe production line for efficiency, safety, and sustainability. Implement – Integrate advanced filling systems for precision and sterility. Evaluate – Ensure Annex 1 compliance and assess automated inspection effectiveness. Optimize – Enhance material flow and minimize contamination risks. Reduce – Shorten project timelines through parallel design, build, and validation. Innovate – Highlight agile engineering and cross-functional collaboration. Compare – Assess operational efficiency before and after modernization. Summarize – Key outcomes, GMP compliance, and future readiness.

    • Understanding Engagement With Sustainable Injection Devices Through Behavioural Science

    • Unlock Key Insights for Robust Method Validation in Design Verification and Manufacturing of Medical Devices

  • Opening Session Part II

    Hall D

    The second part of the opening plenary will present pharma company perspectives on going all the way from molecule to the patient, covering the development of combination products and their integration into a pharma company’s patient offering. Expect to hear fresh perspectives and to learn more about the opportunities and challenges both in obesity treatment and in taking combination product development to the next level!

  • Networking Lunch Break, Poster Session & Exhibition

    Foyer X2-X3

  • Tech Talks

    Foyer X3

  • Session 1, Track A

    Hall D

    Real-world data on device performance informs future device development. This session will provide case studies and strategies leveraging prior art and market product experience to develop new devices with improved safety and functionality efficiently.

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

      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.

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

      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.

    • Advancing Platform Technologies for Combination Products

      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.

    • Session 1, Track A: Q&A, Discussion

  • Session 1, Track B

    Hall G

    This track explores innovative strategies to enhance home care by addressing stakeholder needs, fostering patient engagement, and strengthening support systems, ranging from oncology nursing perspectives to digital tools that drive adherence and improve outcomes.

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

      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.

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

      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.

    • B-COMPASS: Designing to improve Patient Experience, Adherence and Outcomes

      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.

    • Session 1, Track B: Q&A, Discussion

  • Session 1, Track C

    Hall K

    Ensuring the integrity of prefilled syringes (PFS) and autoinjectors is more critical than ever as delivery systems become increasingly complex and demands on storage, performance, and safety grow. This session explores cutting-edge strategies and novel imaging techniques that are redefining how we evaluate the robustness of these drug delivery systems.

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

      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.

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

      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.

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

      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.

    • Session 1, Track C: Q&A, Discussion

  • Networking Coffee Break, Exhibition and Guided Poster Walk

    Foyer X2-X3

  • Tech Talks

    Foyer X3

  • Guided Poster Walk Part II

    Foyer X3

  • Session 2, Track A

    Hall D

    Explore how innovative delivery systems are transforming the administration of complex biologics—from dual-liquid co-formulations to automated reconstitution of lyophilized drugs. Learn how smart adaptations to standard platforms and redefined device specs can accelerate development, improve patient outcomes, and sustainability.

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

      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.

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

      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

    • Challenging Design Requirements to Unlock Innovation and Improve Sustainability

      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.

    • Session 2, Track A: Q&A, Discussion

  • Session 2, Track B

    Hall G

    Immerse yourself in the revolutionary world of autoinjectors, where patient centricity, intuitive design, and sustainability are transforming drug delivery. This session explores breakthrough research on reusable devices, usability in GLP-1 therapies for high-BMI patients, and the art of crafting epinephrine autoinjectors. Discover how cutting-edge insights are driving adoption and improving outcomes. Don’t miss this exciting look into the future of user-centered innovation.

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

      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.

    • 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

      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.

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

      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.

    • Session 2, Track B: Q&A, Discussion

  • Session 2, Track C

    Hall K

    Join us to review some examples of cross-industry collaboration and continuous improvement processes applied during the lifecycle of primary packaging materials and how predictive analysis and artificial intelligence can reduce complexity and increase flexibility during the automatic visual inspection in large-scale manufacturing.

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

      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.

    • Minimizing Particulate Matter in Intravitreal PFS by Improving Syringe Manufacturing Process

      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.

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

      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

    • Session 2, Track C: Q&A, Discussion

  • 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.
Wednesday, 22 October

CEST Daylight Time (UTC +2:00)

Posters

A Holistic Approach to De-Risking and Accelerating Subcutaneous Formulations Development
  • Sigrid Saaler-Reinhardt

A New Form of Protein Aggregates: An Early Warning Sign for Polysorbate Degradation
  • Laura Philips

A Strategic Approach to Design Control in Large Volume Ready-to-Use Cartridges
  • Alessia Mocci, Product Design Developer, Stevanato Group

Accelerating Autoinjector Clip Design Verification with Digital Twin Technology
  • Jack Dunkley, CEng MIMechE, Engineering Director, Haughton Design

Advancing RTU Tub Innovations
  • Sophie Ruddick

AI in Automated Visual Inspection of Prefilled Cartridges: Success Stories
  • Federico Scattolin

AI-Driven Injection Molding & Assembly Optimization in MedTech
  • Felix Müller

Assessing Plunger Stopper Movement under Low Pressure and Variable Temperature Conditions
  • Charlotte Utting, BSc, Laboratory Supervisor, Smithers Medical Device Testing Division

Beyond App Fatigue:  Alternative Ways of Adherence Monitoring in Home Injections
  • David Christen

Capitalizing on ASME V&V40: Regulatory-Grade Modeling and Simulation as an Alternative to Testing
  • Peter Harley, MEng, PhD, FIMechE, Head of Technology, Crux Product Design

CCI Testing of High Viscosity Product in Pre-Filled Syringe
  • Guerney D.H Hunt, MS, Research Engineer 1, Packaging Technologies and Inspection

Determining the Oxygen Permeation Rate through Different Syringes
  • Marnix Wieffer

Development and Use of an Innovative Methodology for Analyzing Visible Particulates
  • Antoine Buonomo, MSc, R&D Analytical Development Engineer, Becton Dickinson

Development of a Portable Indenter Device for Assessing Tissue Stiffness at Injection Sites
  • Alexander Lyness

Development of High-Concentration PFS Combination Products: A Strategic Approach to Life-Cycle Management for a Biological Drug
  • Jing Liu

Development of Plungers for Pre-filled Syringe Systems
  • Christa Jansen-Otten, DI, Director Technical Product Development, West Pharmaceutical Services, Inc.

Device Attributes that Matter: Patient Preferences and Drivers of Treatment Migration in Immunoglobulin Therapy
  • Chris Franzese, PharmD, MHS, Principal & Clinical Leader, Matchstick LLC

Double-Sided 1.5 mL Fluoropolymer-Laminated Plunger for Low-Volume Cartridge Solutions
  • Amy Gindhart, Manager Scientific Communications, West Pharmaceutical Services

Dual-Chamber Device Holding Carrier Design Considerations
  • Michael S. Thomas, M.S. Pharmaceutics, Research Fellow, Lyophilization Technology Inc.

Ebeam Technology – Transfer Technology For Pre-Sterilized RTU Components
  • Manfred Holzer, Strategic Product Manager E-Beam Technology, SKAN AG

Enabling Conversion of IV Formulation Into SC Formulations
  • Byung Ha Lee

Evaluation of PLAJEX™ 1mL Long Luer Lock Pre-Fillable Syringe with NeoFlex™ Plunger Stopper after Deep Cold Storage
  • Jianxiu Zhao, PhD, Senior Technology Development Manager, Terumo

Exploring Opportunities for Large Volume Subcutaneous (LVSC) Injections for Acute Illness Treatment from Both Patient and Healthcare Perspectives
  • Simon Moss, Principal Huma Factors Engineer, Pfizer

Exploring Platform Synergies: Enabling High-Viscosity Biologic Delivery with SHL Medical's Molly® 2.25 mL Autoinjector and Stevanato Group’s Syringes
  • Enrico Barichello, Global Product Manager Syringe Platform, Stevanato Group
  • Nina Fetz

Faster and Safer Single-Use Technologies From Thaw to Final Fill
  • Lucie Clavel

From Flow to Blockage: The Dynamics of Needle Clogging in PFS
  • Fabiano Bonaventura, MSc, Expert Science & Technology, Novartis Pharmaceutical Manufacturing GmbH

Identification of Foreign Particulate Matter in Assembled Autoinjectors Through Long-Time Tracking of Individual Particles’ Trajectories
  • Matthias Kahl, Head of R&D and Lab Services, WILCO AG

Impact of Incomplete Plunger Rod Engagement on the Functionality of Prefilled Syringes
  • Wei Chen, PhD, Executive Director, WuXi Biologics

Impact of Injection Stress and Collection Methods on Drug Quality of Autoinjector
  • Wei Chen, PhD, Executive Director, WuXi Biologics

Impact Of Tolerable Injection Conditions And Interindividual Sample Geometry Variability On Tissue Backpressure, Its Variability, And Formulation Spreading, Resulting From Subcutaneous Injections
  • Aurélien Baquié, PhD candidate, Nemera and INSERM U1059 SAINBIOSE
  • Pascal Dugand, Technology Product Manager – Parenteral, Nemera

Impact of VH2O2 Sterilization as Established Category A Modality
  • Juha P. Mattila, MEng, Senior Manager, Technical Services, STERIS Life Sciences

Improved Design Robustness by Combining Injection Molding Software With Measuring Software
  • Glenn Svedberg, M.Sc, Group Sustainability & Technology Director, Nolato AB

Insights of Human Factor Considerations that may Influence User Experience in Drug-Device Combination Products Design
  • Jeremy Guo, PhD, SVP, Head of DPD and Clinical DP Manufacturing network, WuXi Biologics

Mastering Novel Combination Product Transfer to Commercial Manufacturing
  • Alexis Dechelette, Director, Design & Innovation, Kymanox

Mechanical Disturbances and Sterility Integrity in Pre-Filled Syringe Assembly: Evaluating Risks of Stopper Displacement and Rotation During Plunger Rod Installation
  • Jeremy Guo, PhD, SVP, Head of DPD and Clinical DP Manufacturing network, WuXi Biologics

Mental Models and User Interface Design Considerations for Large-Volume Subcutaneous Infusion Devices
  • Chris Franzese, PharmD, MHS, Principal & Clinical Leader, Matchstick LLC

Midazolam Needle-Free Auto Injector Demonstration of Intramuscular Injection by MRI and PBPK Modeling to Show No Impact of Subcutaneous Fraction on Midazolam Exposure
  • Don Zinn

Mitigating CCI Risks in PFS Under Deep Cold Storage: A Case Study Using Headspace Analysis
  • Francesca Caprioli, PhD, Laboratory Director, Lighthouse Instruments

Mitigating Risk in ANDA Submissions: A Case Study on Leveraging Human Factors Data During Generic GLP-1 Combination Product Development
  • Laurie Brunet-Manquat, MSc, Clinical & Human factors manager, Becton Dickinson

Navigating Biocompatibility For Combination Products
  • Soroosh Bagheriasl, PhD, Director, BioPhorum

Optimizing Drug Delivery For At-Home Use
  • Robert Lindner, PhD, Global Product Manager Bulk and Sterile Cartridges, SCHOTT Pharma

Patient Characterisation For Setting Design Constraints – A Case Study on Gathering Anthropometric Data
  • Kyle Berman, Principal Mechanical Engineer, Pfizer

Plunger Movement in Prefilled Syringes: An Altitude Simulation Study
  • Steven Malbon

Preclinical Evaluation on the Functionality and Usability of a High-Volume Auto-Injector (HVAI) as an Off-Body Injector Enabled by Recombinant Human Hyaluronidase PH20 (rHuPH20)
  • David Kang, Director, Drug Delivery & Innovation, Halozyme Therapeutics

Preclinical Investigation of Subcutaneous Delivery of an Antibody-Drug Conjugate (ADC) with Recombinant Human Hyaluronidase PH20 (rHuPH20) and a High-Volume Auto-Injector
  • David Kang, Director, Drug Delivery & Innovation, Halozyme Therapeutics

Predicting Creep Performance of Spring-Loaded Parts in Injection Devices
  • Ian Wands, Marketing Leader, Delrin

Push-to-Activate vs Button-Activated? A Self-Injection Device Interchangeability Study
  • Nenad Suknovic, PhD, Senior Research Lead – Usability Engineering, Global Product Development, SHL Medical

Quantification of Silicone oil in Primary Packaging Materials using HPLC
  • Tabea Koch, Scientist, Boehringer Ingelheim

Redefining The Sustainability Benchmark
  • Alex Fong

Reducing Product Carbon Footprint – Design Impact
  • David Cook

Risk Management For Sterilized Delivery System Components in Their Packaging: How to Define and Control The Risk of Post-Sterilization Contamination?
  • Maxime Haure

Size Matters? Patient Insights from a Wearability Study on Large-Volume OBDS
  • Carlo Valbonesi, Master Degree, Human Factors Engineer, Stevanato Group

Statistical Method for Classifying Abdominal Stiffness Behavior in a Human Factor Dataset
  • Alexander Lyness

Sustainability in Subcutaneous Drug Delivery: Collaborative Opportunities from the SC Consortium Benchmarking Initiative
  • Madeleine Anderson, Insights Manager, Matchstick

Sustainable Drug Delivery Devices: A Whole Value Chain Approach
  • Rich Harrison

The Big Misunderstandard: On the Application of ISO 2859-1 for Drug Delivery Device Lot Inspection
  • Basel Taha, PhD, President, Prossima Health Inc

Transforming Sterile Manufacturing For Syringes
  • Radek Fialka, MSc, MBA, Chief Business Officer & Member of the BOD, oncomed manufacturing a.s.

Understanding Engagement With Sustainable Injection Devices Through Behavioural Science
  • Lara Zaki, MSc, Senior FEI Innovation ​& Strategy Consultant, Team Consulting

Unlock Key Insights for Robust Method Validation in Design Verification and Manufacturing of Medical Devices
  • Ying Wang, PhD, A.R. Fellow, Head of device development science, Pfizer UK

VH2O2 Sterilization Under Deep Vacuum conditions for PFS Containing a Thermosensitive Drug Product
  • Serena Carella

PDA Global GMP Expectations for Combination Products Workshop 2025
20 Oct

This workshop will take place before the PDA Universe of Pre-Filled Syringes and Injection Devices Conference 2025.

Learn More and Register
PDA Sustainability in Pharma Workshop 2025
20 Oct

This workshop will take place before the PDA Universe of Pre-Filled Syringes and Injection Devices Conference 2025.

Learn More and Register
PDA Unleashing the Power of Data Workshop 2025
20 Oct

This workshop will take place before the PDA Universe of Pre-Filled Syringes and Injection Devices Conference 2025.

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PDA Extractables and Leachables Training Course Fall Edition
23 Oct - 24 Oct
Learn More and Register
PDA Container Closure Integrity Testing - Basic Training Course Fall Edition
23 Oct - 24 Oct
Learn More and Register
PDA All About Pre-Filled Syringe Systems - Basic Training Course Fall Edition
23 Oct - 24 Oct
Learn More and Register
PDA Basics of an Environmental Monitoring Program Training Course
19 Nov - 20 Nov
Learn More and Register
PDA Fundamentals of Aseptic Processing Training Course
08 Jul - 09 Jul
Learn More and Register

Activities and Networking Opportunities

Connect and Collaborate with Purpose

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 a rockabilly band and waltz under the chandeliers.

Highlight of the Evening:

A costume competition that celebrates contrast and creativity!
It will take place at the legendary Volksgarten Club – a true Viennese institution located in the heart of the city, surrounded by historic buildings and the blooming Volksgarten park.

With roots dating back to 1822 and a rich history as both a dance café and iconic nightlife venue, it’s the perfect backdrop for a night where tradition and rebellion collide.

Also returning: the famous PDA Europe Band, ready to rock the stage and create another unforgettable fan moment.

Dress Code

Dress to impress: In your best vintage rockabilly attire or as a vision of Viennese sophistication. From leather jackets and swing dresses to ballgowns and tuxedos – let your outfit reflect the theme and embrace the contrast!

Travel to the venue is to be arranged individually.

Program Planning Committee

The Team Behind the Event's Agenda

  • Andrea Allmendinger, Prof Dr

    ten23 health

    Chief Scientific Officer

    Read Bio

  • Frank Bamberg, MA

    CSL Behring

    Head of Primary Packaging and Medical Devices - Product Care

    Read Bio

  • Theresa E. Bankston, PhD

    BD

    VP Combination Products & Capabilities

    Read Bio

  • Marion Briggs, MBA

    SLR

    Associate Director

    Read Bio

  • John Burke

    Team Consulting

    Managing Consultant – Drug Delivery

    Read Bio

  • Marco Eller

    Bausch+Stroebel SE +Co.KG

    Business Development Manager

    Read Bio

  • Flora Felsovalyi, PhD

    Lonza

    Associate Director

    Read Bio

  • Jeffrey Givand, PhD

    Merck

    Executive Director, Device and Combination Product Development

    Read Bio

  • Christian Helbig

    SCHOTT Pharma

    Vice President Glass Syringe Business

    Read Bio

  • Markus Hoerburger

    Vetter Pharma International GmbH

    Product & Service Manager

    Read Bio

  • Shirish Ingawale, PhD

    Takeda

    Director, Device & Combination Product Development

    Read Bio

  • Christa Jansen-Otten

    West

    Read Bio

  • Falk Klar, PhD

    Parenteral Drug Association

    General Manager, Vice President Europe

    Read Bio

  • Christian Kollecker

    Harro Höfliger

    Read Bio

  • Jakob Lange, PhD

    Ypsomed AG

    VP & Head of Account and Business Development

    Read Bio

  • Philippe Lauwers

    Terumo Pharmaceutical Solutions

    Technology Development Director

    Read Bio

  • Roman Mathaes, Dr.

    Clear Solutions Laboratories AG

    Chief Executive Officer

    Read Bio

  • Alessandro Morandotti

    Stevanato Group

    Director Product Development - Drug Containment Solutions

    Read Bio

  • Galen Shi, PhD

    Eli Lilly and Company

    Vice President of Engineering – Delivery Devices

    Read Bio

  • Courtney Nicholas Sutton

    SHL Medical

    Head of Portfolio Strategy

    Read Bio

  • Dominik Ziegler, MSc

    Novartis Pharma

    Executive Director Device Technology Solution Center

    Read Bio

Location and Travel

Venue Details and Accommodations

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Venue: Austria Center Vienna

Bruno-Kreisky-Platz 1
Vienna, Austria 1220
Reservation Instructions

The Austria Center Vienna is a premier venue for conferences and exhibitions, located in the heart of Vienna, Austria. Known for its state-of-the-art facilities and exceptional connectivity, the center offers an ideal setting for global events. With its modern infrastructure, spacious exhibition halls, and a reputation for hosting international gatherings, it provides attendees and exhibitors with a seamless and professional environment to network, exchange knowledge, and showcase innovations.

Welcome to Your Preferred Hotel Booking for the PDA Universe of Pre-Filled Syringes and Injection Devices Conference 2025

PDA Europe and our partner optiMICE secured the best rates at hotels conveniently located near the Austria Center Vienna, ensuring a comfortable and seamless stay.

As a conference attendee, you can enjoy exclusive hotel rates tailored specifically for this event. With our close partnerships, we offer competitive prices and prime accommodations to make your time in Vienna stress-free and enjoyable.

For any questions about your stay or booking assistance, please feel free to reach out to optiMice anytime to make your Vienna visit smooth and memorable.

Hotels Nearby

Click the link below to view the list of available hotels. The distance in kilometers next to each hotel name indicates how far it is from the Austria Center Vienna, the conference venue. For individual reservations less than five rooms please use the link below.

Make a Reservation Online

For Group Bookings for more than 5 rooms, please contact optiMice here:
optiMICE - Hotels for Events
email: pda-europe@opti-mice.eu
phone: +49 2243 923 9008

Please note: All hotel bookings will be managed through PDA's official hotel partner, optiMICE – Hotel for Events. For any questions or assistance, please contact optiMICE directly. Additional details can be found at the link above.

Travel in Style with Lufthansa Group Airlines

We are excited to partner with Lufthansa Group Airlines to offer discounted flights for attendees of the PDA Universe of Pre-Filled Syringes and Injection Devices Conference 2025!

Special Offer Details:
Special Lufthansa Group Airlines Fares

Use the exclusive discount code: MCDE6232

Book Your Flight

Take advantage of reduced fares to make your travel to the conference both convenient and cost-effective. Don’t miss this opportunity to join us while enjoying a seamless travel experience!

How to Get Here
By Air Vienna International Airport (VIE): Located about 20 km from the Austria Center Vienna, the airport is well-connected to the city. How to Get There from the Airport: Take the City Airport Train (CAT) to Wien Mitte (16 minutes) and transfer to the U-Bahn (U1 line) heading to Kaisermühlen VIC station, directly adjacent to the Austria Center Vienna. Taxis and ride-share services are available, with a travel time of approximately 25 minutes.
Book Discounted Flights
By Car The Austria Center Vienna is easily accessible from major motorways. Use the following address for navigation: Bruno-Kreisky-Platz 1, 1220 Vienna, Austria. Parking is available on-site at the multi-story car park.
By Other Options Vienna’s public transport system is highly efficient and convenient: U-Bahn: Take the U1 line to Kaisermühlen VIC station. The Austria Center Vienna is a 5-minute walk away. Trams and Buses: Numerous lines stop at the nearby Kaisermühlen VIC hub.
Area Attractions
  • Explore the City’s Historical Sites: Visit Schönbrunn Palace, St. Stephen’s Cathedral, and the Vienna State Opera.
  • Enjoy World-Class Museums: Explore the Albertina Museum or the Natural History Museum.
  • Relax at the Danube River: Take a stroll or enjoy a river cruise close to the conference venue.
  • Sample Viennese Cuisine: Try Wiener Schnitzel, Sachertorte, or a coffee in a traditional Viennese café.

Did you know? Vienna is renowned for its exceptionally pure drinking water, sourced directly from alpine springs. The water quality is so high that it is considered among the best in the world and even powers small hydroelectric plants on its way to the city.

Registration

Pricing Options

Standard Registration

Member Price

€2,690

GovernmentMember Only

€1,350

Health AuthorityMember Only

€1,350

Early Career ProfessionalMember Only

€1,350

StudentMember Only

€1,350

AcademicMember Only

€1,350

Non-Member

€2,990

See Qualifying Criteria for Member Types.

ALL PRICES IN EURO (EUR), EXCLUDING VAT.

WAYS TO REGISTER: 1. Online Registration   2. registration-europe@pda.org

PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact registration-europe@pda.org before registering.

If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.

Presenters

Meet the Experts
  • Reza Abedian, PhD

    Reza Abedian, PhD

    Gerresheimer

    Senior Medical Affairs Manager

    Panelist
    Presenter
    Read Bio
  • Seda Aksel, PhD

    Seda Aksel, PhD

    SHL Medical AG

    Product Manager

    Co-Presenter
    Panelist
    Read Bio
  • Madeleine Anderson

    Madeleine Anderson

    Matchstick

    Insights Manager

    Poster Presenter
    Read Bio
  • Soroosh Bagheriasl, PhD

    Soroosh Bagheriasl, PhD

    BioPhorum

    Director

    Poster Presenter
    Read Bio

  • Aurélien Baquié

    Nemera and INSERM U1059 SAINBIOSE

    PhD candidate

    Poster Presenter
    Read Bio

  • Enrico Barichello

    Stevanato Group

    Global Product Manager Syringe Platform

    Poster Presenter
    Read Bio
  • Nicole M. Bergmann, PhD, MBA

    Nicole M. Bergmann, PhD, MBA

    Eli Lilly and Company

    Sr. Director - Device, Design and Connected Solutions

    Co-Presenter
    Panelist
    Read Bio
  • Kyle Berman

    Kyle Berman

    Pfizer

    Principal Mechanical Engineer

    Poster Presenter
    Read Bio
  • James Best

    James Best

    Flex

    Design Manager, Studio lead

    Panelist
    Presenter
    Read Bio
  • Gea Bianchi, MSc

    Gea Bianchi, MSc

    Politecnico di Milano

    Software Quality Senior Engineer | Cybersecurity Authority

    Tech Talk Presenter
    Read Bio
  • Fabiano Bonaventura, MSc

    Fabiano Bonaventura, MSc

    Novartis Pharmaceutical Manufacturing GmbH

    Expert Science & Technology

    Co-Presenter
    Panelist
    Poster Presenter
    Read Bio
  • Marion Briggs, MBA

    Marion Briggs, MBA

    SLR

    Associate Director

    Committee Member
    Panelist
    Presenter
    Read Bio
  • Laurie Brunet-Manquat, MSc

    Laurie Brunet-Manquat, MSc

    Becton Dickinson

    Clinical & Human factors manager

    Poster Presenter
    Read Bio

  • Antoine Buonomo, MSc

    Becton Dickinson

    R&D Analytical Development Engineer

    Poster Presenter
  • Anil Busimi, Msc, MBA

    Anil Busimi, Msc, MBA

    Terumo Pharmaceutical Solutions

    VP Strategy & Marketing

    Tech Talk Presenter
    Read Bio
  • Francesca Caprioli, PhD

    Francesca Caprioli, PhD

    Lighthouse Instruments

    Laboratory Director

    Poster Presenter
    Read Bio

  • Serena Carella

    Poster Presenter
  • Matthieu Charvin

    Matthieu Charvin

    BD Medical - Pharmaceutical Systems

    Senior Project Manager - New Product Development

    Panelist
    Presenter
    Read Bio
  • Wei Chen, PhD

    Wei Chen, PhD

    WuXi Biologics

    Executive Director

    Poster Presenter
    Read Bio

  • David Christen

    Poster Presenter

  • Lucie Clavel

    Poster Presenter

  • David Cook

    Poster Presenter
  • Sebastien Cordier, MS

    Sebastien Cordier, MS

    Aptar Pharma

    Technical Product Manager PFS

    Tech Talk Presenter
    Read Bio
  • Katie Cornish, PhD

    Katie Cornish, PhD

    AstraZeneca

    Senior Human Factors Engineer

    Co-Presenter
    Panelist
    Read Bio
  • Alexis Dechelette

    Alexis Dechelette

    Kymanox

    Director, Design & Innovation

    Poster Presenter
    Read Bio
  • Mehul Desai, PharmD, MBA

    Mehul Desai, PharmD, MBA

    Enable Injections

    Vice President, Medical Affairs

    Tech Talk Presenter
    Read Bio
  • David DeSalvo, MS, MBA

    David DeSalvo, MS, MBA

    Kindeva Drug Delivery

    Vice President, Combination Product Development

    Tech Talk Presenter
    Read Bio
  • Pascal Dugand

    Pascal Dugand

    Nemera

    Technology Product Manager – Parenteral

    Poster Presenter
    Read Bio

  • Jack Dunkley, CEng MIMechE

    Haughton Design

    Engineering Director

    Poster Presenter
    Read Bio
  • Corinna Endres, MSc

    Corinna Endres, MSc

    Schreiner MediPharm

    Product Manager

    Panelist
    Presenter
    Read Bio
  • Claire J. Everitt, MEng, BSc (Psych)

    Claire J. Everitt, MEng, BSc (Psych)

    Pfizer

    Design Engineering Lead - Medical Devices

    Panelist
    Presenter
    Read Bio

  • Gene Rhode Fensalida Pantig

    Tech Talk Presenter
  • Paolo Ferrigno

    Paolo Ferrigno

    Datwyler

    Product Manager, Prefilled Syringes & Cartridges

    Tech Talk Presenter
    Read Bio

  • Nina Fetz

    Poster Presenter
  • Radek Fialka, MSc, MBA

    Radek Fialka, MSc, MBA

    oncomed manufacturing a.s.

    Chief Business Officer & Member of the BOD

    Poster Presenter
    Read Bio

  • Emilien Folzer

    Co-Presenter

  • Alex Fong

    Poster Presenter
  • Chris Franzese, PharmD, MHS

    Chris Franzese, PharmD, MHS

    Matchstick LLC

    Principal & Clinical Leader

    Poster Presenter
    Read Bio
  • Massimo Frasson

    Massimo Frasson

    Brevetti CEA

    CEO & General Manager

    Co-Presenter
    Panelist
    Read Bio

  • Daniela Geiger

    Tech Talk Presenter
  • Oliver Germershaus, PhD

    Oliver Germershaus, PhD

    University of Applied Sciences and Arts Northwestern Switzerland

    Professor for Pharmaceutical Technology of Macromolecular Drugs

    Academic Presenter
    Panelist
    Read Bio

  • Amy Gindhart

    West Pharmaceutical Services

    Manager Scientific Communications

    Poster Presenter
    Read Bio
  • Stephanie Göbel, Dipl-Ing FH

    Stephanie Göbel, Dipl-Ing FH

    Roche / Genentech

    Senior Regulatory Program Director PTR Device and Combination Products

    Panelist
    Presenter
    Read Bio
  • Thomas Grant, PhD

    Thomas Grant, PhD

    Team Consulting

    Senior Consultant – Digital Health

    Co-Presenter
    Panelist
    Read Bio
  • Robert CH Gresham, PhD

    Robert CH Gresham, PhD

    Gilead Sciences

    Post Doctoral Scientist

    Co-Presenter
    Panelist
    Read Bio
  • Michele Guasti

    Michele Guasti

    Terumo Europe

    Global Product Manager

    Co-Presenter
    Panelist
    Read Bio

  • Jeremy Guo, PhD

    WuXi Biologics

    SVP, Head of DPD and Clinical DP Manufacturing network

    Poster Presenter
    Read Bio

  • Ana Isabel Gutierrez

    Tech Talk Presenter

  • Byung Ha Lee

    Poster Presenter
  • Peter Harley, MEng, PhD, FIMechE

    Peter Harley, MEng, PhD, FIMechE

    Crux Product Design

    Head of Technology

    Poster Presenter
    Read Bio

  • Rich Harrison

    Poster Presenter

  • Maxime Haure

    Poster Presenter

  • Mark Hazel

    Delrin uk Ltd

    Application Development Engineer

    Poster Presenter
  • Manfred Holzer

    Manfred Holzer

    SKAN AG

    Strategic Product Manager E-Beam Technology

    Poster Presenter
    Tech Talk Presenter
    Read Bio
  • Guerney D.H Hunt, MS

    Guerney D.H Hunt, MS

    Packaging Technologies and Inspection

    Research Engineer 1

    Poster Presenter
    Read Bio
  • Patrik Ingvarsson, MSc

    Patrik Ingvarsson, MSc

    Nolato AB

    Technical Director

    Poster Presenter
    Read Bio
  • Christa Jansen-Otten, DI

    Christa Jansen-Otten, DI

    West Pharmaceutical Services, Inc.

    Director Technical Product Development

    Moderator
    Poster Presenter
    Read Bio
  • Theresa Jeary, MSc

    Theresa Jeary, MSc

    BSI

    Global Head - Medicinal & Biologics Team

    Panelist
    Presenter
    Read Bio
  • Reto Jost, MSc

    Reto Jost, MSc

    Ypsomed AG

    Director, Category Lead Large Volume Injectors

    Co-Presenter
    Panelist
    Read Bio
  • Matthias Kahl

    Matthias Kahl

    WILCO AG

    Head of R&D and Lab Services

    Panelist
    Poster Presenter
    Presenter
    Read Bio
  • David Kang

    David Kang

    Halozyme Therapeutics

    Director, Drug Delivery & Innovation

    Poster Presenter
    Tech Talk Presenter
    Read Bio
  • Fitore Kasumaj, PhD

    Fitore Kasumaj, PhD

    Johnson & Johnson Innovative Medicine

    MSAT Biotherapeutics DP Primary Packaging Principal Engineer

    Co-Presenter
    Panelist
    Read Bio
  • Kaylene Kau, MA

    Kaylene Kau, MA

    Phillips Medisize

    Sr. UX Designer

    Tech Talk Presenter
  • Hassan Khairat

    Hassan Khairat

    Novartis

    Associate Director Business Development CDMO

    Tech Talk Presenter
    Read Bio
  • Richard Kieran, MSc

    Richard Kieran, MSc

    West Pharmaceutical Services Inc.

    Director, Business Development

    Tech Talk Presenter
    Read Bio
  • Tabea Koch

    Tabea Koch

    Boehringer Ingelheim

    Scientist

    Poster Presenter
    Read Bio
  • Diana Koschel

    Diana Koschel

    BD

    Senior Manager R&D

    Tech Talk Presenter
    Read Bio
  • Robert Lindner, PhD

    Robert Lindner, PhD

    SCHOTT Pharma

    Global Product Manager Bulk and Sterile Cartridges

    Poster Presenter
    Read Bio

  • Jing Liu

    Poster Presenter
  • Scott Lovald, PhD, MBA, MEME

    Scott Lovald, PhD, MBA, MEME

    Exponent

    Senior Managing Engineer

    Panelist
    Presenter
    Read Bio
  • Bernhard Ludvik, MD

    Bernhard Ludvik, MD

    1st Medical Department, Landstrasse Clinic

    Head

    Panelist
    Read Bio

  • Alexander Lyness

    Poster Presenter
  • Durga Prasad Madhavapeddi, MTech, PMP

    Durga Prasad Madhavapeddi, MTech, PMP

    FUJIFILM Diosynth Biotechnologies

    Sr. Material Scientist

    Co-Presenter
    Panelist
    Read Bio
  • Hanns-Christian Mahler, PhD

    Hanns-Christian Mahler, PhD

    ten23 health

    CEO

    Panelist
    Presenter
    Read Bio

  • Steven Malbon

    Poster Presenter
  • Will Marsh

    Will Marsh

    DCA Design International

    Senior Sector Manager Medical & Scientific

    Panelist
    Presenter
    Read Bio
  • Roman Mathaes, Dr.

    Roman Mathaes, Dr.

    Clear Solutions Laboratories AG

    Chief Executive Officer

    Committee Member
    Co-Presenter
    Panelist
    Read Bio
  • Juha P. Mattila, MEng

    Juha P. Mattila, MEng

    STERIS Life Sciences

    Senior Manager, Technical Services

    Poster Presenter
    Tech Talk Presenter
    Read Bio

  • Michael Maust

    Noxilizer, Inc.

    Laboratory Manager for Customer Projects

    Tech Talk Presenter
  • John A Merhige, MEM

    John A Merhige, MEM

    Credence MedSystems, Inc.

    Chief Commercial Officer

    Tech Talk Presenter
    Read Bio
  • Alessia Mocci

    Alessia Mocci

    Stevanato Group

    Product Design Developer

    Poster Presenter

  • Simon Moss

    Pfizer

    Principal Huma Factors Engineer

    Poster Presenter
    Read Bio

  • Felix Müller

    Poster Presenter
  • Tobias Nemeth

    Tobias Nemeth

    Vetter

    Director DS Primary Packaging Service & Projects / Product & Service Manager

    Tech Talk Presenter
    Read Bio
  • Tyler A. Novak, PhD

    Tyler A. Novak, PhD

    Gilead Sciences

    Director of Drug Delivery Innovation

    Co-Presenter
    Panelist
    Read Bio
  • Vlad Novak, PhD

    Vlad Novak, PhD

    ANAXAM

    Group Leader

    Panelist
    Presenter
    Read Bio
  • Tom Osman, MEng (Hons) CEng

    Tom Osman, MEng (Hons) CEng

    University of Birmingham, UK

    Honorary Assistant Professor

    Tech Talk Presenter
    Read Bio

  • Aude Ouensanga, MPH

    Noble an Aptar Pharma company

    Head of Strategy and Patient Engagement

    Co-Presenter
    Panelist
    Read Bio

  • Nick Petersen

    bluesight

    VP, Corporate Development

    Co-Presenter
    Panelist
    Read Bio

  • Laura Philips

    Poster Presenter
  • Sven Pohle, PhD

    Sven Pohle, PhD

    SCHOTT Pharma

    Product Manager

    Co-Presenter
    Panelist
    Read Bio
  • Sylvine M. Raverdy-Wilson, MA, PhD

    Sylvine M. Raverdy-Wilson, MA, PhD

    Becton Dickinson

    Clinical and Human Factors Manager

    Panelist
  • Andrea Redd

    Andrea Redd

    Eli Lilly and Company

    Associate Vice President, Global Regulatory Affairs, Drug Device Delivery

    Panelist
    Read Bio
  • Joseph Reynolds, MS

    Joseph Reynolds, MS

    Noble International, LLC

    Director of User Experience Services

    Co-Presenter
    Read Bio
  • Marco Rigamonti

    Marco Rigamonti

    Flex

    General Manager, European Health Solutions Design

    Panelist
    Presenter
    Read Bio
  • Jessica Rocco, MD

    Jessica Rocco, MD

    Stevanato Group

    Technical Leader - Product Development DCS

    Co-Presenter
    Panelist
    Read Bio

  • Sophie Ruddick

    Poster Presenter

  • Brent Rutland

    Tech Talk Presenter

  • Sigrid Saaler-Reinhardt

    Poster Presenter

  • Federico Scattolin

    Poster Presenter
  • Stefan Scheler

    Stefan Scheler

    Novartis Pharmaceutical Manufacturing GmbH

    Associate Director Science & Technology

    Co-Presenter
    Panelist
    Read Bio
  • Christian A Scherer, Dipl.-Ing.

    Christian A Scherer, Dipl.-Ing.

    Körber Pharma

    Executive Vice President Sales

    Tech Talk Presenter
    Read Bio
  • Andreas Schneider, PhD

    Andreas Schneider, PhD

    Ypsomed AG

    Head Innovation Delivery Systems

    Panelist
    Presenter
    Read Bio

  • Stefano Selvatici

    Tech Talk Presenter
  • Galen Shi, PhD

    Galen Shi, PhD

    Eli Lilly and Company

    Vice President of Engineering – Delivery Devices

    Committee Member
    Moderator
    Panelist
    Presenter
    Read Bio
  • Sakiko Shimizu, MA

    Sakiko Shimizu, MA

    Terumo Corporation

    Chief Scientist, Pharmaceutical Solution Devision

    Co-Presenter
    Panelist
    Read Bio
  • Herve Soukiassian

    Herve Soukiassian

    BD

    Assoc. Director – Product Development

    Co-Presenter
    Read Bio
  • Chloé Stoll, PhD

    Chloé Stoll, PhD

    BD

    Clinical and Human Factors Senior Specialist

    Panelist
    Presenter
    Read Bio
  • Adam Stops

    Adam Stops

    Tech Talk Presenter
    Read Bio

  • Nenad Suknovic, PhD

    SHL Medical

    Senior Research Lead – Usability Engineering, Global Product Development

    Poster Presenter
    Read Bio
  • Glenn Svedberg, M.Sc

    Glenn Svedberg, M.Sc

    Nolato AB

    Group Sustainability & Technology Director

    Poster Presenter
    Read Bio

  • Basel Taha, PhD

    Prossima Health Inc

    President

    Poster Presenter
    Read Bio
  • Yuki Takeuchi, MS

    Yuki Takeuchi, MS

    Terumo Pharmaceutical Solutions

    Global Product Manager, PLAJEX

    Panelist
    Presenter
    Read Bio
  • Tobias Theiler, PhD

    Tobias Theiler, PhD

    Ypsomed AG

    Head of Science and Evidence

    Tech Talk Presenter
    Read Bio
  • Michael S. Thomas, M.S. Pharmaceutics

    Michael S. Thomas, M.S. Pharmaceutics

    Lyophilization Technology Inc.

    Research Fellow

    Co-Presenter
    Panelist
    Poster Presenter
    Read Bio
  • Thomas Thueer, PhD

    Thomas Thueer, PhD

    Haselmeier

    Program Lead

    Tech Talk Presenter
    Read Bio
  • Amanda Tilles, MS

    Amanda Tilles, MS

    Phillips Medisize

    Human Factors Engineering Manager

    Co-Presenter
    Panelist
    Tech Talk Presenter
    Read Bio
  • Charlotte Utting, BSc

    Charlotte Utting, BSc

    Smithers Medical Device Testing Division

    Laboratory Supervisor

    Poster Presenter
    Read Bio
  • Karthik Vaideeswaran, PhD, MBA

    Karthik Vaideeswaran, PhD, MBA

    Merck

    Associate Vice President and Head, Device Delivery and Technology

    Panelist
    Presenter
    Read Bio
  • Carlo Valbonesi, Master Degree

    Carlo Valbonesi, Master Degree

    Stevanato Group

    Human Factors Engineer

    Poster Presenter
    Read Bio

  • Ian Wands

    Delrin

    Marketing Leader

    Poster Presenter
  • Ying Wang, PhD

    Ying Wang, PhD

    Pfizer UK

    A.R. Fellow, Head of device development science

    Poster Presenter
    Read Bio

  • Michael Wecker

    Tech Talk Presenter

  • Daryl Wells

    Tech Talk Presenter

  • Marnix Wieffer

    Poster Presenter
  • Alastair Willoughby, MEng

    Alastair Willoughby, MEng

    Team Consulting

    Head of Mechanical Engineering

    Tech Talk Presenter
    Read Bio
  • Gemma Wood, MBA, CMgr

    Gemma Wood, MBA, CMgr

    Phillips Medisize

    Director, Platform Management

    Co-Presenter
    Panelist
    Read Bio
  • Fubin Wu, MS

    Fubin Wu, MS

    GessNet

    Co-founder & President

    Co-Presenter
    Panelist
    Read Bio
  • Massine Yanat

    Massine Yanat

    SGD Pharma

    Technical Support Service and Sustainability, North America

    Co-Presenter
    Panelist
    Read Bio
  • Mike Yang, Master’s degree

    Mike Yang, Master’s degree

    Sheng Zou

    Marketing Manager

    Tech Talk Presenter
    Read Bio
  • Andrei Yosef, PhD

    Andrei Yosef, PhD

    LTS Device Technologies

    General Manager and President

    Panelist
    Presenter
    Read Bio
  • Lara Zaki, MSc

    Lara Zaki, MSc

    Team Consulting

    Senior FEI Innovation ​& Strategy Consultant

    Poster Presenter
    Read Bio
  • Christoph Zauner

    Christoph Zauner

    Schott Pharma

    Head of product managment polymer solutions

    Co-Presenter
    Panelist
    Tech Talk Presenter
    Read Bio
  • Bernd Zeiss, Dipl.-Biol.

    Bernd Zeiss, Dipl.-Biol.

    Gerresheimer

    Head of Scientific Affairs and Application Technologies

    Tech Talk Presenter
    Read Bio
  • Jianxiu Zhao, PhD

    Jianxiu Zhao, PhD

    Terumo

    Senior Technology Development Manager

    Poster Presenter
    Read Bio

  • Don Zinn

    Poster Presenter

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