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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

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.

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 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
    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

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

    A1: Integrated Device Development/Holistic Development Strategies
    Moderator: Manfred Maeder

    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. | Industry Representative Invited

    11:55 a.m. | Q&A

    B1: Manufacturing Science
    Moderator: Laurent Jeanmart, PhD, Head for Packaging and Medical Devices, GlaxoSmithKline

    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

    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

    1:00 p.m. – 2:00 p.m. | Tech Talks

  • 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

    10:40 a.m. – 11:00 a.m. | Q&A

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

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

    A2: Combination Product Design Control
    Moderator: Theresa Bankston

    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: Tibor Hlobik

    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 Romacker 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. – 2:00 p.m. | Tech Talks

  • 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. – 12:15 p.m. | Tech Talks

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

    A3: Technical Challenges and Hot Topics
    Co-Moderators: Wenzel Novak 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
    Moderator: Theresa Bankston

    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
    Moderator: Markus Bauss, Director Business Development, SHL Medical AG

    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, SHL Medical

    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. – 2:00 p.m. | Tech Talks

  • THURSDAY, 08 OCTOBER

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

    10:00 a.m. – 11:00 a.m. | P4: Innovation
    Moderators: Markus Bauss, Director Business Development, SHL Medical AG and Mathias Romacker

    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. – 12:15 p.m. | Tech Talks

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

    A4: Life Cycle Management
    Moderator: Nic Bowman and Mathias Romacker

    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
    Moderator: Joel Cotton

    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
    Bill T. Guilliouma, MBA, Marketing Manager, Noble International

    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
    Moderator: Theresa Bankston

    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

    1:00 p.m. – 2:00 p.m. | Tech Talks

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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October 12-15 | Online

The 2020 PDA Combination Products Workshop will explore the unprecedented growth in both combination products and the regulations that govern them. Hear first-hand how this dramatic evolution is impacting the industry and take home practical guidance based on the real-life experiences of pharmaceutical and Medical Device professionals.

Learn more

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    Tel: +1 (301) 656-5900 ext. 132
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