On Demand 2020 PDA Universe of Pre-Filled Syringes and Injection Devices
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Program Highlights
The 2020 PDA Universe of Pre-Filled Syringes and Injection Devices is now available for on-demand viewing.
When you register, you will gain access to all session recordings, including talks and Q&A. These sessions will be available until Tuesday, Nov. 3, 2020.
Here's what's included in your registration:
- Browse the Exhibitor Booths, download information sheets and FAQs, and watch videos. Reach out to Exhibitors for additional information!
- Watch the recorded Conference sessions, including all concurrent tracks and moderated Q&A sessions with speakers, at your own speed.
- View all the Poster Presentations featuring case studies, new research, and industry insights.
Did you already register for the Universe of Pre-Filled Syringes and Injection Devices? Use your same login information to access the on-demand sessions through Tuesday, Nov. 3, 2020.
This year's program will be held virtually and will continue to build on the reputation of past events while bringing to light the latest advances in the field. Exploring the future of the pharmaceutical devices as rapid technological advances push the industry ahead. This event will bring together industry experts to share their experiences, new developments, regulatory considerations, challenges and industry trends in this exciting area.
Continued advances in materials of construction, manufacturing processes, injection processes and safety devices, and other technology improvements create a dynamic environment in the drug delivery device arena. Regulatory requirements, industry experience and evolving market trends are critical considerations to ensure a complete understanding of the application of pre-filled syringes or other pre-filled containers and injection devices to drug delivery. The challenges of new product introduction and support of existing products require that companies be aware of new developments.
At the completion of this conference, attendees will:
- Discuss the market benefits of pre-filled syringes and injection devices
- Identify critical attributes of end-user friendly devices
- Explain how innovation is helping patients to have a positive experience in managing their therapies and assuring compliance to dose regime
- Summarize manufacturing requirements of pre-filled syringes, injection devices, safety devices, and final drug/device combo products
- Discuss quality standards, regulatory and compliance concerns
- List insights through case studies presented by industry experts
- Discuss market, industry trends and new technologies
- Share experience in working in combined/integrated solutions that includes the primary packaging characterization (product stability), design and development of the container closure together with the device and automatization focus on flexibility (same device for different products or different devices for different products in the same industrial set up
- Overcoming challenges of delivering complex drug formulations
- Discuss patient preferences where multiple device formats are available on a commercial drug product.
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Standard Pricing
Standard Member Price
$1,676StudentMember Only
$248
Non-Member
$1,955
Day 1
MONDAY, 05 OCTOBER
8:00 a.m. – 10:00 a.m. | Braindates
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10:00 a.m. – 11:00 a.m. | P1: Opening Plenary Patient friendly and safe combination products require and integrated and holistic development strategy. This opening plenary session will link patient centric product design with the manufacturing of combination products. The speakers will discuss findings during the Q&A panel discussion which will bring together patients, scientists, and regulations. The FDA will join the Q&A session to discuss the latest trends in the combination product ecosystem. |
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10:00 a.m. | Welcome and Opening Remarks from PDA Leadership and Conference Co-Chairs 10:05 a.m. | The Patient Experience: As Told by A Fellow Colleague 10:25 a.m. | Personalized Health: A Comprehensive Approach to Transform Pharmaceutical Products to Products-Services Ecosystem |
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11:00 a.m. – 12:15 p.m. | Tech Talks 1-7 |
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11:00 a.m. – 11:15 a.m. | Tech Talk 1: Addressing the Evolving Needs of Complex or Variable Drug Delivery Regimens 11:15 a.m. – 11:25 a.m. | Tech Talk 2: Ypsomed Platform Update 11:25 a.m. – 11:35 a.m. | Tech Talk 3: Polymer-Based Pre-Fillable Syringes Designed to Minimize the Aggregation Risk of Sensitive Biodrugs 11:35 a.m. – 11:45 a.m. | Tech Talk 4: Prefilled Syringe Elastomer Components - High Quality Solutions for Sensitive Molecules 11:50 a.m. – 12:05 p.m. | Tech Talk 6: Driving Production Efficiency and Quality in Manufacturing through Container Traceability 12:05 p.m. – 12:15p.m. | Tech Talk 7: Diving Miniaturization to the Next Level |
11:15 a.m. – 12:15 p.m. | Concurrent Sessions
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A1: Integrated Device Development/Holistic Development Strategies During this session we will receive insights on the development process for a specific Drug and the application of the platform principle during development of combination products. The enhancements and improvement of efficiency is being discussed. |
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11:15 a.m. | Bringing a PFS Immunoglobulin Drug Successfully to the Market 11:35 a.m. | Self-Administration of Highly Viscous or Higher Volume (Up To 2ml) Biologics with Ergonomic, Syringe-Based Manual Subcutaneous Injections |
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B1: Manufacturing Science |
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11:15 a.m. | Drug Product Identification of Pre-Filled Syringes with Integrated Radio-Frequency Identification (RFID) Technology 11:35 a.m. | New Smart Container Syringe for Drug Product Traceability Improving Manufacturing Efficiency |
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C1: Susatinability |
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11:15 a.m. | Drug Delivery: The Challenges and Practical Routes to Reduce Impact of Regulations on Construction Materials 11:35 a.m. | Materials Engineering Considerations for Medical Devices and Drug Delivery Systems |
12:15 p.m. – 2:30 p.m. | Attendee Engagement with Exhibits, Posters, and Braindates
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The following posters will be presented each day from 12:15 p.m. - 2:30 p.m. |
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A Novel Silicone Oil-Free System for Pre-Filled Syringes with 1mL Long GORE® IMPROJECT™ Plunge An Inclusive Approach to the Development of a Platform Medical Device When the Intended Therapy Area is Not Yet Known Aseptic Filling of Dry Powder and LIquid in Dual Chamber Syringes Assessing the Environmental Impact of Autoinjectors - Is there a case for reusable devices? In the current study, an LCA comparison is being made between reusable and disposable autoinjectors. Autoinjectors – The Next 20 Years Case Study: Adding Connectivity to a Range of Auto-Injectors Delivering a True ‘Platform’ Autoinjector: Customisable vs Configurable vs Adaptive: A Case Study Development of a Synthetic Skin Model to Perform Subcutaneous Injection Tests and Study the Associated Key Parameters Digital Health Devices-Benefits to Pharmaceutical Companies, Patients, and Healthcare Providers Evaluating the Impact of Sterilization Methods on Plunger Stopper Performances: A Comparative Study by BD Medical – Pharmaceutical Systems Evolving Component Technologies to Meet the Needs of Cartridge-Based Drug Delivery Exploring the Digital Needs of People Using Injectable Treatments to Treat Chronic Conditions, with a Local Patient-Centered Innovation Community Generating Value through Injection Pen Data Collection: A Case Study of InsulCheck CONNECT High-Viscosity Formulations Present Challenges to the Delivery System in That Injection through a Needle Requires Extremely High Forces: Forces That Break Glass Syringes Human Clinical Patterns of Large Volume Subcutaneous Injection Tissue Effects, Depot Location and Pain-Based on Gender, Body Mass Index, Injection Site and Modality Identifying Target Product Profiles and Establishing Critical Quality Attributes to Support Lyophilized Product Specifications in Dual Chamber Pre-Filled Cartridge or Syringe Improving Subcutaneous Chronic Drug Delivery and The Patient Injection Experience with Shorter 8mm Needles Combined with Thinner Wall Cannula Technology Injecting High Viscous Drugs: Interaction of the Needle and Its Features Migration Study to Evaluate the Impact of Steam vs. Gamma Irradiation in Ready-To-Use (RTU) Uncoated Stoppers, PremiumCoat Stoppers, and Other Fluorinated Film Coated Stoppers Particle Load in Syringes Used for Ophthalmic Applications Quality by Design and Design Control Roadmap for Combination Products Relationship between Protein Adsorption and Protein Aggregation in Syringes Simplifying the Transition from Vials to PFS with Very Low Leachable, No Delamination, and Silicone-Free Glass PFS System Simulating Ocean Freight Shipping Conditions to Challenge Delivery Performance of Pre-Filled Syringes Stability of Pharmaceutical Proteins in Syringe Made of Cyclo Olefin Polymer (COP) Sterilization Impacts of Gamma Irradiation on Rubber Components for Parenteral Drug Packaging Sterilization of DPTE-BetaBag® Tyvek® Containing Loads: Proper Procedures Can Reduce the Risk of Non-Compliance during Autoclaving Stopper Movement During High Altitude Shipping: A Novel Solution The Impact of Physiochemical Excipients-Packaging Interactions on Prefilled Syringe Functionality The Importance and Benefits of End-to-End Risk Management UV Disinfection Technology for Prefilled and Preloaded Wearable Drug Delivery Devices |
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1:00 p.m. – 1:50 p.m. | Tech Talks 8-12 |
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1:00 p.m. – 1:10 p.m. | Tech Talk 8: A Comparison of ZEONEX® and ZEONOR®, Cyclo Olefin Polymer (COP) vs Glass for Pre-Filled Syringes 1:10 p.m. – 1:20 p.m. | Tech Talk 9: Shortening Time to Market with Sorrel's Wearable Drug Delivery Platform 1:20 p.m. – 1:40 p.m. | Tech Talk 10: The Faster Path to Self-Administration: Moving from Pre-Filled Syringe to Auto-Injector
1:40 p.m. – 1:50 p.m. | Tech Talk 12: Enhancing COC Syringes with Functional Labels |
Day 2
TUESDAY, 06 OCTOBER
8:00 a.m. – 10:00 a.m. | Braindates
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10:00 a.m. – 11:00 a.m. | P2: Regulatory |
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10:00 a.m. | How A Platform Approach to Combination Product Reviews Can Enhance Regulatory Efficiency and Patient Access in the Era of COVID-19 10:20 a.m. | ASTM Combination Products Standard Progress Report |
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11:00 a.m. – 12:05 p.m. | Tech Talks 14-19 |
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11:00 a.m. – 11:15 a.m. | Tech Talk 14: Customizing Platform Devices: A Review of Molly’s Flexible Design and Development Model 11:15 a.m. – 11:25 a.m. | Tech Talk 15: It’s All Connected – Some Key Challenges and Opportunities in Development of Connected Drug Delivery Devices 11:25 a.m. – 11:35 a.m. | Tech Talk 16: Holistic Cleanroom Concept: Reaching Higher Quality and Greater Flexibility 11:35 a.m. – 11:45 a.m. | Tech Talk 17: Key Considerations for Automated Visual Inspection of Pre-filled Syringes 11:55 a.m. – 12:05 p.m. | Tech Talk 19: OXYCAPT Multilayer Plastic Vial & Syringe with Excellent Oxygen and UV Barrier |
11:15 a.m. – 12:15 p.m. | Concurrent Sessions
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A2: Combination Product Design Control Effective design control is critical to ensuring the suitability, safety, and performance of combination products. Navigating design control whilst combining the approaches and cultures of the pharmaceutical and device supplier worlds to produce a combination product can be challenging. Here, we highlight illustrative examples of key watch-outs, lessons learned, and improved approaches. |
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11:15 a.m. | Use of Clinical and Nonclinical Data in Combination Product Risk Management: An Overview and Case Study 11:35 a.m. | Bridging from Application-Specific Requirements for a Combination Product to Design Inputs/Outputs for the Integrated Delivery System and its Constituent Components |
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B2: Industry Standards and Trends The development of novel injectable drug products is on the up, and ensuring patient safety, highest quality and improved outcomes are essential for success in the market. No Touch Transfer (NTT) Methodology has been characterized as an alternative method to introduce pre-sterilized containers into filling line Grade A zones, which typically require an in-process outer packaging surface bio-decontamination step. Significant refinements of methodology and development of the associated qualification approach (considering the full NTT process combining equipment and RTU components) will be presented. There are growing applications with a need for dose flexibility and require new drug delivery technologies that are fit for intended use. Current Industry trends, such as needs for individualized dosing, advantages for clinical trial dose flexibility and Real World Evidence (RWE) will be presented for development considerations. |
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11:15 a.m. | No Touch Transfer (NTT) Methodology: Challenges and Developments in Supplying RTU Containers into the Filling Area 11:35 a.m. | Importance of Dosing Flexibility for Combination Product Development 11:55 a.m. | Q&A |
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C2: Emerging Technologies |
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11:15 a.m. | Combination Product Development: scPharmaceuticals and West Case Study 11:35 a.m. | Human Factors in Emerging Technologies: Considerations and Lessons Learned from On-Body Injection Device Development 11:55 a.m. | Q&A |
12:15 p.m. – 2:30 p.m. | Attendee Engagement with Exhibits, Posters, and Braindates
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1:00 p.m. – 1:20 p.m. | Tech Talks 21-22 |
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1:00 p.m. – 1:10 p.m. | Tech Talk 21: RFID-Based Smart Labeling Solutions for Injection Devices: Benefits and Challenges in Real World Applications 1:10 p.m. – 1:20 p.m. | Tech Talk 22: Creating Connectivity Modules to Enable Low-cost Smart Syringes |
Day 3
WEDNESDAY, 07 OCTOBER
8:00 a.m. – 10:00 a.m. | Braindates
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10:00 a.m. – 11:00 a.m. | P3: Creativity and Flexibility: Essential Elements in Combination Product Development As markets evolve, creativity and flexibility are pivotal to developing successful combination products and delivery systems that effectively meet the needs of pharmaceutical manufacturer and patients. Attend this session and learn through case studies how creative problem solving and flexibility in design allowed to build a platform combination product for an existing delivery device and how a Large Volume Injector (LVI) for biologics was successfully designed to meet the needs of a variety of stakeholders in a non-clinical setting, in particular, patient safety and ease of use. |
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10:00 a.m. | An Exploration into Platform Combination Product Device Design 10:20 a.m. | Development of Large Volume Injectors for Biologics 10:40 a.m. | Q&A |
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11:00 a.m. – 12:05 p.m. | Tech Talks 27-32 |
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11:00 a.m. – 11:15 a.m. | Tech Talk 27: The Role of an Integrated Approach from Design to Final Device Assembly 11:35 a.m. – 11:45 a.m. | Tech Talk 30: Fill/Finish of Syringes for Aseptic and High Potent Applications 11:55 a.m. – 12:05 p.m. | Tech Talk 32: Innovation in PFS Components for Biotech and Associated Services |
11:15 a.m. – 12:15 p.m. | Concurrent Sessions
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A3: Technical Challenges and Hot Topics Simplifying drug delivery through optimizing the primary packaging and device interaction, leads to developing and implementing of new technologies and products. As more innovation happens, more reliable data has to be created. This session will show the detailed interaction established along the value chain from idea to a commercial product, adding all keyholders in the relevant phases. The final product needs to be characterized to fulfill the markets needs on regulatory and confidence in a stable product. The case study will highlight the efforts taken to give the requested confidence in a product. |
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11:15 a.m. | Case Study: Collaboration between a Biotech, a Device Manufacturer, and a CDMO to Advance Innovation in Dual Chamber Drug Delivery Technology Towards the Clinic 11:35 a.m. | Characterization of a Novel Mini Bag Primary Packaging Technology 11:55 a.m. | Q&A |
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B3: Clinical Study Approaches and Outcomes Clinical study designs and outcomes are of paramount importance to the successful development and evaluation of a drug or combination product. Recent developments, advances, and case studies in pre-clinical or clinical study design and execution and associated key findings related to pharmacokinetics, bioavailability/bioequivalence, and/or tissue effects and pain perception will be highlighted. |
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11:15 a.m. | Novel Method to Predict In Vivo Delivery Times for Autoinjectors Given Viscosity and Device Features 11:35 a.m. | Early Feasibility Clinical Evaluation of An Investigational 5ml Wearable Injector in Healthy Human Subjects 11:55 a.m. | Q&A |
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C3: Digitalization In times of the Covid-19 pandemic outbreak digital technology has changed the way we communicate. The established way of supporting patients in their therapies as well as organizing clinical trials for new drug development is challenged. Whereas you currently just see a few connected injectable drug delivery systems in the market, one question is, how to enable the variety of currently existing drug delivery systems, such as pre-filled syringes and other injection devices to become “smart”. A question that will be discussed in the presentations in this session is also the topic how to include software into a Connected Therapeutics package – providing an all-inclusive platform - Drug-Device-Data-Delivery - for different therapies. |
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11:15 a.m. | Case Studies Presenting the Benefits of Smart Connectivity Solutions for Prefilled and Safety Syringes for Monitoring Patient Self-Injection at Home During Pandemic Outbreaks and Clinical Trials 11:35 a.m. | From Self-Administration to Self-Management: A Digital Health Reformulation for The Drug Delivery Industry 11:55 a.m. | Q&A |
12:15 p.m. – 2:30 p.m. | Attendee Engagement with Exhibits, Posters, and Braindates
Day 4
THURSDAY, 08 OCTOBER
8:00 a.m. – 10:00 a.m. | Braindates
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10:00 a.m. – 11:00 a.m. | P4: Innovation The digitalization presentation will demonstrate how an organization transformed from a mechanical device-focused organization to being able to successful deliver a connected medical device. Share the learning from the transformation, highlighting the major considerations, risks, challenges, and recommendations for companies that are considering similar transformation. The large volume injection presentation will shed light on how novel sensor-augmented research designs provide quantitative data on user handling forces and show how such data translate into specifications for different types of handling steps during injection device usage. It will highlight how user characteristics influence perceived ease of use and objectively measured force capabilities along with provide inputs on how to apply user-centered design to self-injection device systems. |
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10:00 a.m. | Case Study: Key Transformation Considerations for the Design, Development, and Manufacturing of Connected Devices 10:20 a.m. | Towards User-Driven Specification of Performance Requirements for Self-Injection Devices: Insights from Sensor-Augmented Simulated Use Studies 10:40 a.m. | Q&A |
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11:00 a.m. – 11:25 a.m. | Tech Talks 40-41 |
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11:00 a.m. – 11:15 a.m. | Tech Talk 40: Systems Engineering Approaches for Injection Device Development 11:15 a.m. – 11:25 a.m. | Tech Talk 41: Portal Instruments - Next Generation Needle-Free Injections |
11:15 a.m. – 12:15 p.m. | Concurrent Sessions
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A4: Life Cycle Management Why bother? A view on Life Cycle Management from companies that have explored the opportunity. What does it take and what is the value proposition? |
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11:15 a.m. | Product Innovation Through a Portfolio of Patient-Centric Self-Injection Devices for Certolizumab 11:35 a.m. | Self-Administration of Long-Acting Biologics: Motivation and Challenges for Developing an Auto-Injector 11:55 a.m. | Q&A with Additional Panelist |
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B4: Patient Preference In this session, we will address the role of user centricity in product design and development toward influencing patient preference. The nuances of how the patient interacts with a drug-device combination product as well as the patient on-boarding plans will also be covered. |
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11:15 a.m. | Improving Brand Performance by Leveraging Patient Insights and Training Strategies 11:35 a.m. | A Paradigm for New Combination Product Design: Integrating Container Closures with Device Development 11:55 a.m. | Q&A |
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C4: Patient Centric Design: Innovation Perspective Improving patient experience and outcomes are key value pillars for drug therapy adoption and success. For self-administered therapies in particular, these are achieved through patient-centric design, requiring a thorough understanding of the wide array of patient considerations from the physiological to the behavioral. In this session, we will highlight studies conducted to assess parameter and feature impact on patients and inform key design choices during product development. |
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11:15 a.m. | In Vivo Assessment of Pre-Filled Syringe Designs on 2.0 mL Large Volume Subcutaneous Auto-Injector Performance for High-Viscosity Solutions 11:35 a.m. | How Can They Get It Wrong? Why Injection-Experienced Users Approach New Devices Differently 11:55 a.m. | Q&A |
12:15 p.m. – 2:30 p.m. | Attendee Engagement with Exhibits, Posters, and Braindates
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