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2020 PDA Pre Filled-1988x680

2020 PDA Universe of Pre-Filled Syringes and Injection Devices

Commercialization of Combination Products from Best Practices to Innovative Technology

Oct 05 - Oct 08, 2020
Eastern Standard Time | Online
  • Virtual
  • Conference
  • Online

Overview

Virtual Buyer's Guide

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.

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Introducing Virtual Braindates - A whole new way to network

At this year's event, Braindate will help you connect through meaningful conversations with other event attendees.

What is a Braindate

Agenda

  • Day 1
  • Day 2
  • Day 3
  • Day 4
  • MONDAY, 05 OCTOBER

    8:00 a.m. – 10:00 a.m. | Braindates

    10:00 a.m. – 11:00 a.m. | P1: Opening Plenary  
    Co-Moderators: Roman Mathaes, Head Pharmaceutical Services, Lonza and Olivia A. Henderson, PhD, Principal Engineer, Amgen Inc.

    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.

    10:00 a.m. | Welcome and Opening Remarks from PDA Leadership and Conference Co-Chairs
    Richard M. Johnson, MSc, President and CEO, PDA
    Roman Mathaes, Head Pharmaceutical Services, Lonza
    Olivia A. Henderson, PhD, Principal Engineer, Amgen Inc.

    10:05 a.m. | The Patient Experience: As Told by A Fellow Colleague
    Siva Paramanandam, Senior Manager, Amgen Inc.

    10:25 a.m. | Personalized Health: A Comprehensive Approach to Transform Pharmaceutical Products to Products-Services Ecosystem
    Sujit K. Basu, PhD, Vice President & Head, Medical Devices Center of Excellence, Takeda

    10:45 a.m. | Q&A

    11:00 a.m. – 12:15 p.m. | Tech Talks 1-7

    11:00 a.m. – 11:15 a.m. | Tech Talk 1: Addressing the Evolving Needs of Complex or Variable Drug Delivery Regimens
    Christian Sandmann, R&D Associate Director, BD Medical - Pharmaceutical Systems
    Faced with a changing healthcare landscape and transition of care out of traditional clinical settings to alternative sites such as patients’ homes, a trend that may be augmented by global coronavirus concerns, delivery technologies that enable patient treatments in home settings are increasingly attractive. Designed as a programmable system capable of continuous, episodic, or delayed subcutaneous delivery of up to 3 mL dose volumes for up to a 3-day wear period, BD Evolve™ on-body injector may facilitate convenient at-home medication delivery.

    11:15 a.m. – 11:25 a.m. | Tech Talk 2: Ypsomed Platform Update
    Ian M. Thompson, MSc, MBA, Vice President Business Development, Ypsomed Delivery Systems
    Ypsomed’s Tech Talk summarises our latest platform developments and new product approvals including YpsoMate 2.25 for Teva’s Ajovy. We introduce SmartPilot for UnoPen and provide updates on SmartPilot for YpsoMate and the YpsoDose patch injector clinical programme. Finally, join us on the journey to carbon free emissions with YpsoMate Zero.

    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
    Philippe Lauwers, Director Technology Development, Terumo
    With the rise of large molecules comes the challenge of mitigating the risk of pre-fillable syringe (PFS) components adversely interacting with sensitive biodrugs. In this presentation Philippe Lauwers, Director Technology Development at Terumo Pharmaceutical Solutions, will explain how PLAJEX can mitigate some of these technical challenges. The audience will learn how a silicone oil-free, tungsten-free polymer PFS can eliminate the risk of protein aggregation and protein oxidation through a system approach. Selecting the appropriate materials as well as sterilization method will further help to build a low-extractable syringe system.

    11:35 a.m. – 11:45 a.m. | Tech Talk 4: Prefilled Syringe Elastomer Components - High Quality Solutions for Sensitive Molecules
    Christa Jansen-Otten, Director Global Product Management Prefilled Systems & Delivery, West Pharmaceutical Services, Inc.
    Increasing demands on quality, stringent regulations, trends towards home care treatments by using innovative device technology, and the development of specialized, high value treatments present challenges to companies looking for unique solutions. We will discuss a new elastomer component leading with innovation excellence that was developed to address the ever-increasing demands and challenges of the pharmaceutical industry driven towards components being essentially free of particulate and meeting customer demand for consistency by assuring dimensional stability.

    11:50 a.m. – 12:05 p.m. | Tech Talk 6: Driving Production Efficiency and Quality in Manufacturing through Container Traceability
    Tod R. Urquhart, Core Team Leader, Stevanato Group
    Traceability at the individual container level can drive quality and production efficiency by preventing product mix-up and improvements in machine utilization, thanks to collected data about rejections. This presentation will discuss the approach, process steps, and initial test results of how these improvements can be achieved today.

    12:05 p.m. – 12:15p.m. | Tech Talk 7: Diving Miniaturization to the Next Level
    Aaron Johnson, Vice President of Marketing & Customer Strategy, Accumold
    With the pressure on design engineers to deliver smaller, lighter and more cost-effective components many are turning to micro injection molding for support. Through a series of case studies this presentation will explore the advantages micro injection molding can provide. Case study examples include: pushing the limits with size, high-volume with high-quality, and an exploration of overmolded/insert molded components (including metal, mesh, fabric, glass and other fine media).

    11:15 a.m. – 12:15 p.m. | Concurrent Sessions

    A1: Integrated Device Development/Holistic Development Strategies
    Co-Moderators: Manfred Maeder, Head Device Dev. and Commercialization, Device Dev/Commercialization, Novartis Pharma AG and Sherri Biondi, PhD, Senior Director Device Development, AstraZeneca

    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.

    11:15 a.m. | Bringing a PFS Immunoglobulin Drug Successfully to the Market
    Tom Van Ginneken, Global Product Manager SCHOTT TOPPAC, SCHOTT
    Frank Bamberg, Associate Director of Primary Packaging and Medical Devices, CSL Behring

    11:35 a.m. | Self-Administration of Highly Viscous or Higher Volume (Up To 2ml) Biologics with Ergonomic, Syringe-Based Manual Subcutaneous Injections
    Tzvetelina Chevolleau, PhD,
    Clinical and Human Factor Program Leader, BD Medical - Pharmaceutical Systems, BD

    11:55 a.m. | Q&A

    B1: Manufacturing Science
    Co-Moderators: Laurent Jeanmart, PhD, Head for Packaging and Medical Devices, GlaxoSmithKline and Markus Bauss, Director Business Development, SHL Medical AG

    This session will focus on different track and trace technologies contributing PFS to improve fill and finish process, line performance, reduce the risk of mix-up allowing full PFS finish product traceability from production to end user-What are the key challenges and real benefits of proposed technologies also preparing the future.

    11:15 a.m. | Drug Product Identification of Pre-Filled Syringes with Integrated Radio-Frequency Identification (RFID) Technology
    Gabriel J. Anderson, BS, Device & Packaging Technical Transfer Lead, Novartis

    11:35 a.m. | New Smart Container Syringe for Drug Product Traceability Improving Manufacturing Efficiency
    Diana Löber, Global Product Manager, SCHOTT AG

    11:55 a.m. | Q&A

    C1: Susatinability
    Moderator: Karthik Vaideeswaran, PhD, MBA, Senior Director, Drug Delivery Platform Technologies & Portfolio Management, Eli Lilly and Company and Ian M. Thompson, MSc, MBA, Vice President Business Development, Ypsomed Delivery Systems

    This session will look at the relevant topic of sustainability as it pertains to the ever-expanding world of drug delivery devices – what are the current approaches and how is the industry addressing the challenge of reducing their environmental impact.

    11:15 a.m. | Drug Delivery: The Challenges and Practical Routes to Reduce Impact of Regulations on Construction Materials
    Stephen J. Duckworth, Global Head of Medical & Pharmaceuticals, Avient Corporation

    11:35 a.m. | Materials Engineering Considerations for Medical Devices and Drug Delivery Systems
    Naresh K. Budhavaram, PhD, Senior Consultant Engineer, Eli Lilly and Company

    11:55 a.m. | Q&A

    12:15 p.m. – 2:30 p.m. | Attendee Engagement with Exhibits, Posters, and Braindates

    The following posters will be presented each day from 12:15 p.m. - 2:30 p.m.

    A Novel Silicone Oil-Free System for Pre-Filled Syringes with 1mL Long GORE® IMPROJECT™ Plunge
    Sonja Hartinger, Primary Packaging Engineer, Boehringer Ingelheim Pharma GmbH & Co. KG, Germany

    An Inclusive Approach to the Development of a Platform Medical Device When the Intended Therapy Area is Not Yet Known
    Finola Austin, Human Factors Engineering Manager, Owen Mumford Limited

    Aseptic Filling of Dry Powder and LIquid in Dual Chamber Syringes
    Frederic Dietrich, Managing Director, Dietrich Engineering Consultants

    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.
    Bjarne Sørensen, Director, Front End Innovation, Phillips-Medisize

    Autoinjectors – The Next 20 Years
    Iain Simpson, Director, Front-End Innovation, Phillips-Medisize

    Case Study: Adding Connectivity to a Range of Auto-Injectors
    Benjamin Cox, Head of Digital Design, Team Consulting and Alastair Willoughby, Development Manager, Bespak

    Delivering a True ‘Platform’ Autoinjector: Customisable vs Configurable vs Adaptive: A Case Study
    Rob Jordan, Design Engineer, Owen Mumford

    Development of a Synthetic Skin Model to Perform Subcutaneous Injection Tests and Study the Associated Key Parameters
    Pascal Dugand, Technology Product Manager, Nemera

    Digital Health Devices-Benefits to Pharmaceutical Companies, Patients, and Healthcare Providers
    Bill Guilliouma, Marketing Manager, Noble International

    Evaluating the Impact of Sterilization Methods on Plunger Stopper Performances: A Comparative Study by BD Medical – Pharmaceutical Systems
    Eloïse Perrin, R&D Engineer, BD Medical - Pharmaceutical Systems

    Evolving Component Technologies to Meet the Needs of Cartridge-Based Drug Delivery
    Simon Côté, Director of Technical Customer Support, West Pharmaceutical Services, Inc.

    Exploring the Digital Needs of People Using Injectable Treatments to Treat Chronic Conditions, with a Local Patient-Centered Innovation Community
    Emmanuelle Bensaude, PhD, Strategic Innovation Specialist, BDM-Pharmaceutical Systems

    Generating Value through Injection Pen Data Collection: A Case Study of InsulCheck CONNECT
    Dean Minnock, CEO, Innovation Zed

    High-Viscosity Formulations Present Challenges to the Delivery System in That Injection through a Needle Requires Extremely High Forces: Forces That Break Glass Syringes
    Andrew Donnelly, Vice President, Innovation, Bespak

    Human Clinical Patterns of Large Volume Subcutaneous Injection Tissue Effects, Depot Location and Pain-Based on Gender, Body Mass Index, Injection Site and Modality
    Wendy Woodley, Staff Scientist, BD Technologies and Innovation

    Identifying Target Product Profiles and Establishing Critical Quality Attributes to Support Lyophilized Product Specifications in Dual Chamber Pre-Filled Cartridge or Syringe
    Denise Miller, Quality Assurance Compliance Specialist, Lyophilization Technology, Inc.

    Improving Subcutaneous Chronic Drug Delivery and The Patient Injection Experience with Shorter 8mm Needles Combined with Thinner Wall Cannula Technology
    Aurélie Pager, Clinical and Human Factors Program Leader –Medical Affairs, BD Medical - Pharmaceutical Systems

    Injecting High Viscous Drugs: Interaction of the Needle and Its Features
    Carlos Navarro, Product Management – Syringes, Components & SG Lab, Stevanato Group

    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
    Julie Suman, President, Next Breath, an Aptar Pharma Company

    Particle Load in Syringes Used for Ophthalmic Applications
    Olga Laskina, Senior Technical Account Specialist, West Pharmaceutical Services, Inc.

    Quality by Design and Design Control Roadmap for Combination Products
    Ana Ladino, Senior Business Development Manager, West Pharmaceutical Services, Inc.

    Relationship between Protein Adsorption and Protein Aggregation in Syringes
    Saki Yoneda, PhD Student, Department of Biotechnology, Graduate School of Engineering, Osaka University

    Simplifying the Transition from Vials to PFS with Very Low Leachable, No Delamination, and Silicone-Free Glass PFS System
    Benjamin Heiz, Product Engineer, SCHOTT AG

    Simulating Ocean Freight Shipping Conditions to Challenge Delivery Performance of Pre-Filled Syringes
    Russell Hornung, Business Development, W.L. Gore & Associates

    Stability of Pharmaceutical Proteins in Syringe Made of Cyclo Olefin Polymer (COP)
    Yosuke Harauchi, Reseacher, Zeon Corporation

    Sterilization Impacts of Gamma Irradiation on Rubber Components for Parenteral Drug Packaging
    Roman Ventura, Manager Material Applications Healthcare, Datwyler

    Sterilization of DPTE-BetaBag® Tyvek® Containing Loads: Proper Procedures Can Reduce the Risk of Non-Compliance during Autoclaving
    Dave Milligan, Sales Director – Transfer Systems – Americas – Getinge, Getinge USA Sales

    Stopper Movement During High Altitude Shipping: A Novel Solution
    Matthew Dobson, Senior Design Engineer, Owen Mumford

    The Impact of Physiochemical Excipients-Packaging Interactions on Prefilled Syringe Functionality
    Liang Fang, Fellow Scientist/Technical Director, West Pharmaceutical Services, Inc. and Tingting Wang, Senior Research Scientist, Eli Lilly and Company

    The Importance and Benefits of End-to-End Risk Management
    Oli Gould, Design Team Manager, Owen Mumford

    UV Disinfection Technology for Prefilled and Preloaded Wearable Drug Delivery Devices
    Andrei Yosef, CEO, Sorrel Medical

     

    1:00 p.m. – 1:50 p.m. | Tech Talks 8-12

    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
    Larry Atupem, Jr., BS ChemE, Senior Business Development Specialist, Zeon Specialty Materials
    COP polymers (ZEONEX®, ZEONOR®) were commercialized in 1990 and have found increasing use in medical and life science applications especially for Pre-Filled Syringes. COP's unique properties have led it to be a great glass alternative for protein-based biologics. This tech talk will explore COP's unique characteristics while also examining case studies comparing COP syringes to glass syringes in the areas of delamination, protein adsorption/aggregation, and its effect on immunogenicity.

    1:10 p.m. – 1:20 p.m. | Tech Talk 9: Shortening Time to Market with Sorrel's Wearable Drug Delivery Platform
    Andrei Yosef, CEO, Sorrel
    Dr. Andrei Yosef, Sorrel Medical’s CEO, will speak about how the Sorrel wearable drug delivery platform can be used to de-risk the development process and shorten timelines to clinical and commercial readiness. Leveraging the platform design approach and using both vial and cartridge-based devices, ensures fast time to market with Sorrel’s pre-filled and pre-loaded device configurations.

    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
    Pamela Barton, Senior Manager, Manufacturing Technology, Catalent Biologics
    As a pharma company looks to make the transition from a traditional pre-filled syringe (PFS) to an auto-injector, they may heavily rely on the experience of their manufacturing partner. It’s imperative that the two companies work together to meet product, device, quality, manufacturing, and packaging requirements. When experienced partners understand lifecycle management and anticipate equipment and process needs, the product can be transitioned from PFS to auto-injector more quickly. In this webinar, we will share:

    • How product characteristics and formulation determine the type of auto-injector best suited for your product
    • How the chosen auto-injector affects manufacturing and packaging of the finished product
    • What quality considerations are necessary as a product transitions to auto-injector
    • How the above coupled with integrated PFS manufacturing and auto-injector assembly can create an accelerated timeline to market

    1:40 p.m. – 1:50 p.m. | Tech Talk 12: Enhancing COC Syringes with Functional Labels
    Christian Liebl, Senior Innovations and Process Manager, Schreiner MediPharm
    Injection-molded syringes made out of COC are offering a lot of advantages. Schreiner MediPharm developed customized label solutions to further enhance the special characteristics of these primary containers by added functionalities.

  • TUESDAY, 06 OCTOBER

    8:00 a.m. – 10:00 a.m. | Braindates

    10:00 a.m. – 11:00 a.m. | P2: Regulatory
    Co-Moderators: Olivia A. Henderson, PhD, Principal Engineer, Amgen Inc. and Lee H. Leichter, MBA, RAC, President, P/L Biomedical

    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
    Megan K. Doyle, JD, MPH, Director, Global Regulatory and R&D Policy Amgen Inc.

    10:20 a.m. | ASTM Combination Products Standard Progress Report
    Manfred Maeder, Head Device Dev. and Commercialization, Device Dev/Commercialization, Novartis Pharma AG

    10:40 a.m. – 11:00 a.m. | Q&A

    11:00 a.m. – 12:05 p.m. | Tech Talks 14-19

    11:00 a.m. – 11:15 a.m. | Tech Talk 14: Customizing Platform Devices: A Review of Molly’s Flexible Design and Development Model
    Josh Gonzalez, Chief Commercial Officer, SHL Medical
    Design constraints in platform-based devices often pose challenges to customization requests for drug, branding, or usability purposes. SHL’s Molly® autoinjector is built upon a modular platform where integral front and rear subassembly components form a robust core technology that enables an appreciable level of freedom for design customization and manufacturing scalability, all the while maintaining the benefits associated with platform device models.

    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
    Malcolm Boyd, Senior Sector Manager: Medical and Scientific, DCA
    Following a round table discussion with senior members of DCA’s medical, human factors, electronics hardware and software teams, this short talk summarises key challenges and opportunities in the development of effective connected drug delivery devices. The talk focuses on deciding what a connected drug delivery device should do, designing for a coin cell, direct cellular connection, and antenna design.

    11:25 a.m. – 11:35 a.m. | Tech Talk 16: Holistic Cleanroom Concept: Reaching Higher Quality and Greater Flexibility
    Ute Schleyer, PhD, Project Manager Site and Plant Development, Vetter Pharma-Fertigung GmbH & Co. KG
    Pharmaceutical service provider will require increased flexibility and face more stringent requirements for microbial and particulate contamination control. Consequently, this will increase the demand for production technologies that can meet the stringent quality and safety requirements as well as sufficient built-in versatility to anticipate future format, packaging, and manufacturing needs. New approaches like Vetter's V-CRT© create manufacturing processes meet the ever-evolving demands of the world’s dynamic healthcare market. 

    11:35 a.m. – 11:45 a.m. | Tech Talk 17: Key Considerations for Automated Visual Inspection of Pre-filled Syringes
    Michael Kerbaugh, Reional Sales Manager, Syntegon
    This tech talk explores the technical aspects of automated visual inspection of pre-filled syringes. Key considerations learned from over 40 years of automated visual inspection equipment manufacturing are discussed. A preview into advanced visual inspection techniques, including application of AI (deep learning) is provided, along with description of a fully integrated line layout with the option of no glass to glass contact for a modern inspection line.

    11:55 a.m. – 12:05 p.m. | Tech Talk 19: OXYCAPT Multilayer Plastic Vial & Syringe with Excellent Oxygen and UV Barrier
    Tomohiro Suzuki, Associate General Manager, Mitsubishi Gas Company
    Mitsubishi Gas Company (MGC) will show some basic and latest data of OXYCAPT Multilayer Plastic Vial & Syringe.

    11:15 a.m. – 12:15 p.m. | Concurrent Sessions

    A2: Combination Product Design Control
    Moderator: Co-Moderators: Theresa E. Bankston, PhD, Director, Combination Product Science & Technology, BD and Thomas W. Burns, Director, Process Engineering, Product Care and Design Verification, Genentech

    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.

    11:15 a.m. | Use of Clinical and Nonclinical Data in Combination Product Risk Management: An Overview and Case Study
    Tara A. Feuerstein, MS, Head of Device Quality Risk and Usability, Takeda
    Sarah Esterquest, Manager, CMC Regulatory, Takeda

    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
    Susan M. Dounce, PhD, Director Commercial Technology Development, West Pharmaceutical Services, Inc.

    11:55 a.m. | Q&A

    B2: Industry Standards and Trends
    Moderator: Co-Moderators: Tibor M. Hlobik, Senior Director Product Management, West Pharmaceutical Services, Inc. and Philippe Lauwers, Director Technology Development, Terumo

    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.

    11:15 a.m. | No Touch Transfer (NTT) Methodology: Challenges and Developments in Supplying RTU Containers into the Filling Area
    Holger Kranenburg, Aseptic Containment Lead and GMP Training Manager, Franz Ziel GmbH
    Philipp Hörner, Product Manager, Bausch+Ströbel Maschinenfabrik Ilshofen GmbH & Co. KG

    11:35 a.m. | Importance of Dosing Flexibility for Combination Product Development
    Min Wei, PhD, Director/Fellow, AstraZeneca

    11:55 a.m. | Q&A

    C2: Emerging Technologies
    Co-Moderator: Mathias J. Romacker, Principal, Romacker Injection Device Strategy LLC and Ian M. Thompson, MSc, MBA, Vice President Business Development, Ypsomed Delivery Systems

    11:15 a.m. | Combination Product Development:  scPharmaceuticals and West Case Study
    Michael Hassman, SVP Technical Operations, scPharmaceuticals
    Liat Shochat, Platform Director, Delivery Systems, I&T, West Pharmaceutical Services Inc.

    11:35 a.m. | Human Factors in Emerging Technologies: Considerations and Lessons Learned from On-Body Injection Device Development
    David Staub, Project Manager, Sonceboz SA

    11:55 a.m. | Q&A

    12:15 p.m. – 2:30 p.m. | Attendee Engagement with Exhibits, Posters, and Braindates

    1:00 p.m. – 1:20 p.m. | Tech Talks 21-22

    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
    Christian Liebl, Senior Innovations and Process Manager, Schreiner MediPharm
    Connectivity is an exciting megatrend when it comes to parenteral drug delivery systems. How can label-integrated RFID chips withstand the challenging conditions during pharmaceutical manufacturing processes to ensure reliable functionality? Join us to explore our unique solution and real-life applications.

    1:10 p.m. – 1:20 p.m. | Tech Talk 22: Creating Connectivity Modules to Enable Low-cost Smart Syringes
    Yossef Schvetz, Director, Industrial Design and Innovation, Flex
    In-depth analysis of a smart prefilled syringe platform, weighing the benefits of reliable data against the challenges related to renovate a well-consolidated drug delivery system. Includes how to develop an add-on connectivity module adaptable to existing PFSs, analysing the challenges, and proposed associated technological solutions.

  • WEDNESDAY, 07 OCTOBER

    8:00 a.m. – 10:00 a.m. | Braindates

    10:00 a.m. – 11:00 a.m. | P3: Creativity and Flexibility: Essential Elements in Combination Product Development
    Co-Moderators: Brigitte Reutter-Haerle, Vice President Product Management & Marketing, Vetter and Anil Kumar Busimi, MSc, MBA

    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.

    10:00 a.m. | An Exploration into Platform Combination Product Device Design
    Andrew T. Snow, MSc, Consultant Engineer, Eli Lilly and Co.

    10:20 a.m. | Development of Large Volume Injectors for Biologics
    Mehak Mehta, PhD, Scientist II, Parenteral Drug Product Development, Biogen

    10:40 a.m. | Q&A

    11:00 a.m. – 12:05 p.m. | Tech Talks 27-32

    11:00 a.m. – 11:15 a.m. | Tech Talk 27: The Role of an Integrated Approach from Design to Final Device Assembly
    Paolo Golfetto, Business Development Director, Stevanato Group
    In emergency situations, administering medications with an easy-to-use and safe auto-injector is critical. The perfect emergency auto-injector must incorporate enough fail-safe features to prevent any possible misuse or loss of a life-saving dose. Reliability of device functionality is also key in delivering the intended dose: this can only be achieved with controlled Manufacturing and Assembling Process capabilities. The exclusive Partnership between Stevanato Group and Duoject streamlines the auto-injector supply chain under one point of contact, coordinating from the optimization of the glass container to injection molding and final device assembly.

    11:35 a.m. – 11:45 a.m. | Tech Talk 30: Fill/Finish of Syringes for Aseptic and High Potent Applications
    Laura R. Moody, PhD, Product Manager – Primary Packaging and Pharma Liquid Packaging, North America, Syntegon Pharma Technology
    Syntegon has fill/finish technology that can address the demands of syringe filling for both aseptic and cytotoxic products. This presentation will discuss final fill solutions for nested syringes under a variety of product-specific conditions. 

    11:55 a.m. – 12:05 p.m. | Tech Talk 32: Innovation in PFS Components for Biotech and Associated Services
    Audrey Chardonnet, MD, Business Development Director PFS, Aptar Pharma
    Development of biologics products in PFS may present its own set of challenges. With a focus on PFS components, Aptar will discuss PFS platform for biotech developed to address auto-injector challenges, ensure drug stability, traceability and answer viscous drug injection, as well as services offer to derisk and accelerate biotech projects.

    11:15 a.m. – 12:15 p.m. | Concurrent Sessions

    A3: Technical Challenges and Hot Topics
    Co-Moderators: Wenzel Novak, Global Senior Director Business Development, Gerresheimer MDS and Alessandro Morandotti, Head of the Customer Technical & Quality Service, Stevanato Group

    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.

    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
    John A. Merhige, MEM, Chief Commercial Officer, Credence MedSystems, Inc.
    Evan R. Lewis, PhD, Senior Director of Pharmaceutical Development, Kezar Life Sciences

    11:35 a.m. | Characterization of a Novel Mini Bag Primary Packaging Technology
    Hans Peter Manser, Senior Director of Business Development, SHL Medical
    Christoph Egloff, Senior Manager of Innovation and Development, SHL Medical

    11:55 a.m. | Q&A

    B3: Clinical Study Approaches and Outcomes
    Co-Moderators: Theresa E. Bankston, PhD, Director, Combination Product Science & Technology, BD and Hanns-Christian Mahler, PhD, Head of Drug Product Services, Lonza AG

    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.

    11:15 a.m. | Novel Method to Predict In Vivo Delivery Times for Autoinjectors Given Viscosity and Device Features
    Rhea Sirkar, BSE, Associate Consultant Engineer, Eli Lilly and Company

    11:35 a.m. | Early Feasibility Clinical Evaluation of An Investigational 5ml Wearable Injector in Healthy Human Subjects
    Natasha G. Bolick, MEngSc, PMP, Associate Director, Parenteral Sciences Center of Excellence, BD

    11:55 a.m. | Q&A

    C3: Digitalization
    Co-Moderators: Markus Bauss, Director Business Development, SHL Medical AG and Ian M. Thompson, MSc, MBA, Vice President Business Development, Ypsomed Delivery Systems

    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.

    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
    David Daily, MSc, PhD,CEO & Founder, DALI Medical Devices

    11:35 a.m. | From Self-Administration to Self-Management: A Digital Health Reformulation for The Drug Delivery Industry
    Ramin Rafiei, PhD, Director of Digital Healthcare, SHL Medical
    Rasmus Renstad, PhD, Director Innovation, SHL Medical

    11:55 a.m. | Q&A

    12:15 p.m. – 2:30 p.m. | Attendee Engagement with Exhibits, Posters, and Braindates

  • THURSDAY, 08 OCTOBER

    8:00 a.m. – 10:00 a.m. | Braindates

    10:00 a.m. – 11:00 a.m. | P4: Innovation
    Co-Moderators: Markus Bauss, Director Business Development, SHL Medical AG and Mathias J. Romacker, Principal, Romacker Injection Device Strategy LLC

    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.

    10:00 a.m. | Case Study: Key Transformation Considerations for the Design, Development, and Manufacturing of Connected Devices
    Dewi Kodrat, Manager of Engineering Solutions, SHL Medical

    10:20 a.m. | Towards User-Driven Specification of Performance Requirements for Self-Injection Devices: Insights from Sensor-Augmented Simulated Use Studies
    Jakob Lange, PhD, Senior Director Delivery Systems, Ypsomed AG

    10:40 a.m. | Q&A

    11:00 a.m. – 11:25 a.m. | Tech Talks 40-41

    11:00 a.m. – 11:15 a.m. | Tech Talk 40: Systems Engineering Approaches for Injection Device Development
    Chris J. Hurlstone, MA, Director of Engineering, Team Consulting Limited
    Medical devices can be thought of as systems. This presentation will provide a high-level overview of the principles of systems engineering and highlight the benefits of applying them to the development of injection devices.

    11:15 a.m. – 11:25 a.m. | Tech Talk 41: Portal Instruments - Next Generation Needle-Free Injections
    Bart Burgess, Associate Vice President, Product Management and Strategy, Portal Instruments
    Bart Burgess will provide an overview of Portal Instruments' needle-free injector and how it can enhance the patient experience to drive sales growth.

    11:15 a.m. – 12:15 p.m. | Concurrent Sessions

    A4: Life Cycle Management
    Co-Moderators: Nic J. Bowman, FIMechE, Head of Devices CoE, Pfizer and Mathias J. Romacker, Principal, Romacker Injection Device Strategy LLC

    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?

    11:15 a.m. | Product Innovation Through a Portfolio of Patient-Centric Self-Injection Devices for Certolizumab
    Serkan Oray, PhD, Vice President, Head of Device, Packaging, and Wearable Technologies, UCB Pharma

    11:35 a.m. | Self-Administration of Long-Acting Biologics: Motivation and Challenges for Developing an Auto-Injector
    Chirag Walawalkar, Associate Director, Combination Products and Devices R&D, Teva

    11:55 a.m. | Q&A with Additional Panelist
    David J. Harrison, MCIPS, Senior Director, Strategic Alliance Lead, External Manufacturing and Partnerships, UCB Pharma

    B4: Patient Preference
    Co-Moderators: Joel Cotton, Business Development Director, Aptar Pharma and Karthik Vaideeswaran, PhD, MBA, Senior Director, Drug Delivery Platform Technologies & Portfolio Management, Eli Lilly and Company

    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.

    11:15 a.m. | Improving Brand Performance by Leveraging Patient Insights and Training Strategies
    Tim McLeroy, Executive Director of Marketing and Patient Services, Noble International, LLC
    Joe Reynolds, Noble

    11:35 a.m. | A Paradigm for New Combination Product Design: Integrating Container Closures with Device Development
    Gavin M. McKeown, MSc, Senior Consultant Engineer, Eli Lilly and Company
    Akshay R. Kamdar, Director – Container Closure, Materials and Process Innovation, Eli Lilly and Company

    11:55 a.m. | Q&A

    C4: Patient Centric Design: Innovation Perspective
    Co-Moderators: Theresa E. Bankston, PhD, Director, Combination Product Science & Technology, BD and Thomas Seiffer, Dipl Ing, Director Research + Technology, Bausch Stroebel

    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.

    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
    Christopher J. Rini, MS, Associate Director-Biomedical Systems, BD Technologies and Innovation

    11:35 a.m. | How Can They Get It Wrong? Why Injection-Experienced Users Approach New Devices Differently
    Christoph Jordi, MSc, Director Usability & Human Factors, Ypsomed AG

    11:55 a.m. | Q&A

    12:15 p.m. – 2:30 p.m. | Attendee Engagement with Exhibits, Posters, and Braindates

Highlighted Speakers

Sujit K. Basu
Sujit K. Basu
Takeda
Megan K. Doyle
Megan K. Doyle
Amgen Inc.
Dewi Kodrat
Dewi Kodrat
SHL Medical
Jakob Lange
Jakob Lange
Ypsomed
Manfred Maeder
Manfred Maeder
Novartis Pharma AG
Mehak Mehta
Mehak Mehta
Biogen
Andrew T. Snow
Andrew T. Snow
Eli Lilly & Co.

Learning Objectives

At the completion of this conference, attendees will:

  1. Discuss the market benefits of pre-filled syringes and injection devices
  2. Identify critical attributes of end-user friendly devices
  3. Explain how innovation is helping patients to have a positive experience in managing their therapies and assuring compliance to dose regime
  4. Summarize manufacturing requirements of pre-filled syringes, injection devices, safety devices, and final drug/device combo products
  5. Discuss quality standards, regulatory and compliance concerns
  6. List insights through case studies presented by industry experts
  7. Discuss market, industry trends and new technologies
  8. 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
  9. Overcoming challenges of delivering complex drug formulations
  10. Discuss patient preferences where multiple device formats are available on a commercial drug product.

Registration Fees

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Registration Type Fee
Member $1,676
Non-member $1,955
Young Professional Member $838
Gov’t/Health Auth./Academic Member $560
Gov’t/Health Auth./Academic Non-member* $640
Student Member $248
Student Non-member* $224

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