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Agenda

Agenda

05 - 06 October | Online

 

Agenda

As of 05 August 2021 | All times listed are Central Europe Summer Time (UTC +2)

  • Agenda at a Glance

    Tuesday, 5 October

    • Opening Plenary, PDA Welcome Remarks

      11:00am CEST
    • 2021 PDA Drug Delivery Innovation Awards

    • Day 1 Opening Plenary: Keynotes

    • Regulatory & Industry Updates

    • Session 1

      • Regulatory Trends
      • Novel Developments in Manufacturing
      • Business Development and Marketing
    • Tech Talks, Meet & Greet the Presenters

    • Session 2

      • Hospital & Patient Needs
      • Advances in Components, Application Systems and Devices
      • New Delivery Needs - Large Volume & Intra-Vitreal
      • 21:00h CEST

    Wednesday, 6 October

    • Day 2 Opening Plenary Keynotes

      11:00am CEST
    • Sars-CoV-2: Learnings & How the Industry Came Together

    • Break, Poster Session & Exhibition

    • Session 3

      • Sustainability & Green Technologies
      • Smart Devices, Smart Packaging and Digital Health Applications
      • Deep Cold Storage and Processing
    • Closing Plenary Keynotes

    • Closing Panel Discussion

    • LIVE Conference Summary by the 2021 Conference Chairs

    • Conference Closing, PDA Farewell

      21:00h CEST
  • Daily Schedule

    Tuesday, 5 October

    Virtual Conference Platform Opens: Browse Exhibition & Scientific Poster Session
    Conference Opening, PDA Welcome Remarks
    2021 PDA Drug Delivery Innovation Awards
    LIVE Conference Opening: Conference Chairs’ Welcome

    Brigitte Reutter-Haerle, Vetter
    Laurent Jeanmart, GSK Vaccines

    Day 1 Opening Plenary: Keynotes
    Regulatory & Industry Updates

    European Regulatory Update
    Speaker invited, European Medicines Agency

    My Lifelong Patient Journey as an IBD Patient: Insights from an Industry Insider
    Mathias Romacker, ex-PfizerConsultant

    Break, Poster Session & Exhibition
    Industry Tech Talks, Meet & Greet the Presenters
    Regulatory & Industry Updates

    How to Improve Medication Adherence and Treatment Outcomes Using Integrated Device-And-Digital Therapeutic Solutions
    Andreas Schneider, Ypsomed

    Un-Tethering Drug Delivery: How On-Body Injectors Can Widen Access at Lower Cost to Society
    Oliver Gazeley, Hoffmann-La Roche

    Panel Discussion, Q&A
    Break, Poster Session & Exhibition
    Industry Tech Talks, Meet & Greet the Presenters
    Virtual Networking Lounge
    Session 1
    Track A
    Regulatory Trends

    MDR, Notified Body Consultations
    Juan Carriquiry, Novartis

    Reinventing Design Control to Accelerate Combination Product Through Agile and Digitalized Methods
    Guido Drees, F. Hoffmann-La Roche

    Strategies for Achieving ‘Five Nines’ Reliability
    Chris Hurlstone, Team Consulting

    Track B
    Novel Developments in Manufacturing

    Improving Dose Accuracy for Auto-Injector Products by Applying Optimized Manufacturing Settings and Choosing Enhanced Release Test Methodology
    Imad Sallit,
    Anja Doerfler, Novartis

    Proof of Processability for New Coated Stopper on Filling and Assembly Lines – A Collaborative Study by Bausch+Ströbel and BD Medical
    Camille Maury, Becton Dickinson
    Edgar Bauer, Bausch+Ströbel

    Scaling Up, A Case Study – Applying a Lifecycle Approach to Streamlining Automated Production Utilizing a Digitally Enabled Control Strategy
    Jonathan Kearns, SHL Medical
    Ed Halili, Amgen

    Track C
    Business Development & Marketing

    Subcutaneous Delivery of Oncology Drugs - Enhancing Breakthrough Therapies with a New Route of Administration
    Philip Green, ex-MerckConsultant

    Strategies and Approaches for Integrating Multi-Sourced Syringe Components Into Combination Product CMC Development
    Pete Sargent, Eli Lilly & Co.

    More Sustainable Waste Management for Patients Taking at-home Injectable Medications
    Marion Briggs, HealthBeacon

    Panel Discussion, Q&A
    Break, Poster Session & Exhibition
    Industry Tech Talks, Meet & Greet the Presenters
    Virtual Networking Lounge
    Session 2
    Track A
    Hospital & Patient Needs

    Push or Patch? Understanding Patient Preferences for Pre-Filled Autoinjectors Versus Large-Volume On-Body Injectors
    Jakob Lange, Ypsomed

    Preclinical Evaluation of Investigational On-Body Injector Ambulatory Wear
    Wendy D Woodley, BD

    Creating Market Differentiation in Self Injection by Addressing Emerging Needs – What We Have Learned from Recent Autoinjector User Studies
    Bob Scrase, Phillips Medisize

    Track B
    Advances in Components, Application Systems & Devices

    Silicone-Aggressive Drugs in Pre-Fillable Syringes: A Comparative Study Between Silicone Oil and Novel Coating Technology
    Enrico Barichello, Stevanato Group

    Integrating Voice-Activated User Interfaces into Drug Delivery Devices
    Salvatore Forte, Flex

    Safety and Subject Preference of a 2.0 mL Needle-free Injection: Results of the PIONEER Trial
    Bart E. Burgess, Portal Instruments

    Track C
    New Delivery Needs - Large Volume & Intra-Vitreal Injections

    Ocular Delivery, the Importance of Devices Validated for Intravitreal Injection(IVT)
    Vincent Cazanave, F. Hoffmann-La Roche

    Intravitreal Injection Risks, Failure Modes and New Solutions for Patients and Physicians
    Susan Dounce, WEST Pharmaceutical Services

    Assessment of a High-Volume (10 mL) Auto-Injector to Subcutaneously Administer a Macromolecule with Recombinant Human Hyaluronidase in a Miniature Pig Model
    David Kang, Halozyme Therapeutics
    Michael Roe, Kaléo

    Wednesday, 6 October

    Virtual Conference Platform Opens: Browse Exhibition & Scientific Poster Session
    Day 2 Opening Plenary: Keynotes
    Sars-CoV-2: Learnings & How the Industry Came Together

    Pfizer’s Project Lightspeed- Rapid Development of the COVID-19 Vaccine
    Advait Badkar, Pfizer

    Two Sides of a Coin: Pharma and Supplier’s Perspective of mRNA COVID-19 Vaccine - From Vial to Pre-filled Syringe
    Tom Van Ginneken, SCHOTT & GSK Speaker, invited

    Panel Discussion, Q&A
    Break, Poster Session & Exhibition
    Industry Tech Talks Meet & Greet the Presenters
    Session 3
    Track A
    Sustainability & Green Technologies

    Practical Measures Now for Improving Sustainability and Reducing the Carbon Footprint of Injection Systems
    Brennan Miles, Team Consulting

    Improve Sustainability of Injection Devices – A Case Study Within Device & Packaging Development
    Tonio Hoche, F. Hoffmann-La Roche

    Assessing the Environmental Impact of Autoinjectors - Is there a case for reusable devices?
    Bjarne Sorensen,
    Emil Fraenkel, Phillips-Medisize

    Track B
    Smart Devices, Smart Packaging & Digital Health Applications

    Adding Connectivity to Platform Devices – Challenges And Insights
    Uri Baruch, Cambridge Design Partnership
    Hans Jensen, Bespak by Recipharm

    Connected Injection Devices in Clinical Operations
    Rebecca Beck, Becton Dickinson

    Smart Packaging for Smart Devices: How to Design a Good User Experience
    Paul Greenhalgh, Team Consulting

    Track C
    Deep Cold Storage & Supply Chain Challenges and Solutions

    Impact of Deep Cold Storage (-80°C) on Glass PFS Performance
    Guillaume Lehee, Becton Dickinson

    A Feasibility Study on Storage Performance of Modern Therapeutic Drugs in Pre-filled Glass and COP Syringes at Ultra Low Temperatures
    Wenzel Novak, Gerresheimer Bünde

    Double-Chamber Syringes and Freeze-Dried Products
    Javier Alonso, Dara Pharmaceutical Equipment

    Break, Poster Session & Exhibition
    Industry Tech Talks, Meet & Greet the Presenters
    Virtual Networking Lounge
    Closing Plenary Keynotes
    Future Perspectives: Industry Updates

    Bypassing the Blood/Brain Barrier With Drug Delivery Devices
    Joshua D. Horvath, Genentech

    EPIWatch Wearable Auto Injector in a Smart Watch
    Amber Witteman, Ebenroth B.V. - EPIWatch

    Break, Poster Session & Exhibition
    Industry Tech Talks, Meet & Greet the Presenters

    Next Generation of Automated Filling Equipment for Small Scale Injectable Production
    Klaus Ullherr, Syntegon
    Ute Schleyer, Vetter

    Collaborating with Frontline Healthcare Providers to Develop Efficient and Resilient Vaccine Formulations for Mass Vaccination Campaigns
    Rachel Poker, AstraZeneca
    Nick Carrara, Matchstick

    Closing Panel Discussion
    Collaboration and Simplification to Accelerate Device Development and Drug Delivery
    LIVE Conference Summary by the 2021 Conference Chairs

    Brigitte Reutter-Haerle, Vetter
    Laurent Jeanmart, GSK Vaccines

    Conference Closing, PDA Farewell