Expert Xchange: Pharma 4.0™: Transformation, Integration & Trends for the Future

Complimentary
Learning Level: Intermediate
Session Length: 3 hours


Take a deeper dive into the evolving landscape and future of Pharma 4.0™ showcases, the recent innovations and trends. Hear from subject matter experts who will discuss practical challenges and solutions form a technical, logistical and regulatory perspective. Participants will also have the opportunity to engage with industry leaders and peers through a 30 minute networking event.

First-hand Strategic Insights & Actionable Takeaways 

  1. Trends and updates on current industry understanding and application of Pharma 4.0™ concepts and projects
  2. Practical and innovative sample of how to commence the digitalisation journey by capitalising on current infrastructure and resources
  3. Concepts around the use of robotics in the aseptic fill-finish operation of sterile products to enhance prevention of contamination, increase flexibility and scalability with focus on digitalization from development to commercial
  4. Transformation strategies and concepts
Small group Discussions
Small Group Discussions
Technical Presentation
Technical Presentations
Case Studies
Case Studies
Problem-Solving
Problem-Solving

Don’t miss out on this next-generation virtual experience – ISPE Expert Xchange!


Agenda

Thursday 9 December 2021
  • 1500 – 1510 CET/0900 - 0910 ET
    Welcome & Introduction
    Yvonne Duckworth, PE
    Fellow - Digital Technology, Associate
    CRB
    Heike Roeder
    Director, Lead Digital Quality, Risk Advisory Life Science
  • 1510 – 1540 CET/0910 - 0940 ET
    Results of Pharma 4.0™ Industry Survey #5: Benefit and Progress with Pharma 4.0™
    Teresa Minero
    Founder & CEO
    LifeBee - Digitalizing Life Sciences
  • 1540 – 1600 CET/0940 - 1000 ET
    Setting the Scene - Artificial Intelligence Driven Manufacturing Understanding the process variability by means AI: from drug development to the patient needs
    Joeri Van Wijngaarden
    R&D Engineer
    Aizon

    Digital maturity and the road to Pharma 4.0 requires a digital transformation of information systems, internal resources and manufacturing processes. Together these create holistic value networks of interconnected systems across the enterprise, and artificial intelligence (AI) is a tool that shines under these conditions. In this talk I would like to go over a value proposition of AI for biotech and drug manufacturing with a patient-centric approach that focuses on quality and control. I'll discuss several applied use-cases for AI across the product's life cycle that impact how we can better manufacture pharmaceutical products. AI-driven manufacturing and drug-discovery help us understand the complex reality of process variability and enable more efficient processes operating under better control.

  • 1600 – 1620 CET/1000 - 1020 ET
    From Paper to Paperless: A Digitalization Roadmap from the 2021 Student and Emerging Leader Hackathon
    Nadin Osman
    Quality Manager
    Oxyphen GmbH Filtration Group
    Prudence Edwards
    Double Degree Engineering Student (University of Queensland/Centrale Marseille)

    Digitalisation’s potential to increase productivity and profitability is widely acknowledged, yet the journey towards a fully digitalised process can be a daunting one. This is especially the case for production plants on the lower end of the digital maturity scale. Therefore, to open the Pharma 4.0 Roadmap for Implementation track, the winning solution from the 2021 ISPE Student & Recent Graduate International Hackathon will be presented, providing a highly practical and innovative example of how to commence the digitalisation journey by capitalising on current infrastructure and resources.

    The 2021 ISPE Hackathon, with a problem statement provided by Bayer, required participants to propose a lean solution to convert paper-based batch record documentation into a digital, readable format, without relying on retrospective digitalisation. Strict constraints were also imposed, including covid restrictions, budget limitations and committed production volumes, hence eliminating solutions that would require a production shutdown. This presentation will also explain the priority areas for digitalisation identified in the solution, using the example of an OSD production process for contextualisation. This is then further developed into a comprehensive, high-level digitalisation roadmap, highlighting all the advantages of a fully digitalised process. The roadmap includes an implementation plan based on the principles of agile development, budget estimation, GMP and data integrity assessment, and review of technology requirements.

  • 1620 – 1700 CET/1020 - 1100 ET
    Networking Break
     
  • 1700 – 1720 CET/1100 - 1120 ET
    Smart Robotic Solutions and Real Time Monitoring in Aseptic Fill/Finish Operations - Where Are We Today
    Svenja Michaela Gutsche, PhD
    Head of Aseptic Production STE-1
    Bayer AG
    Petra Merker
    Biological Quality Control Expert
    Bayer AG

    One of the most critical and challenging operations within the Pharmaceutical Industry is the aseptic fill/finish operation of sterile products. The use of robotics in this area enhances prevention of contamination and will benefit flexibility, fast turn over, scalability from development to commercial and digitalization. In parallel to the development of smart robotic filling solutions, the need for modern, alternative viable monitoring methods like BFPCs (Biofluorescent Particle Counters) arises. Especially for closed robotic isolators with minimum human interventions or even completely gloveless, BFPCs are of great advantage compared to conventional monitoring methods by continuous, real-time monitoring and significantly minimizing particle generation and contamination risks. Looking back a few years we started talking about robotics and gloveless isolators. It was mostly based on smaller and innovating companies who saw the benefit and realized where Industry needed to go. Most of the well-known manufacturers weren’t in the position to believe in this trend. The Landscape has totally changed and with more and more companies going the route of smaller, personalized and CGT batches we as Pharmaceutical Manufacturers and in particular the patients will benefit greatly.

  • 1720 – 1740 CET/1120 - 1140 ET
    Transformation Strategies That Work: An Insider's Guide to Successful Pharma 4.0
    Thomas Lee Johnson, CEO
    CEO & Founder
    Agile Immersive

    • A. The neuroscience of unconscious behavior and why starting with cultural transformation is crucial
      1. Learning / Unlearning healthy thinking vs unhealthy thinking
      2. Human Reactions: Survival to Harmony to Overcoming
      3. Reaction: moving teams from Medulla Oblongata to Frontal Lobe
      4. The neuroscience of leadership: hunter-gatherer to hyper specialization
    • B. How does aligning on a shared purpose turn individuals into a team?
      1. Meaningful work makes meaningful moments makes authentic teams
      2. Distill mission statements into purpose statements that teams execute daily
      3. Prioritize like you mean it. There is only one number one priority.
    • C. The Insider's Guide: Top 20 Behaviors that indicate Pharma 4.0 success
  • 1740 – 1815 CET/1140 - 1215 ET
    Q&A - All Speakers
     

ISPE Expert Xchange Session Speakers

Yvonne Duckworth, PE
Fellow - Digital Technology, Associate
CRB
Prudence Edwards
Double Degree Engineering Student (University of Queensland/Centrale Marseille)
Svenja Michaela Gutsche, PhD
Head of Aseptic Production STE-1
Bayer AG
Thomas Lee Johnson, CEO
CEO & Founder
Agile Immersive
Petra Merker
Biological Quality Control Expert
Bayer AG
Teresa Minero
Founder & CEO
LifeBee - Digitalizing Life Sciences
Nadin Osman
Quality Manager
Oxyphen GmbH Filtration Group
Heike Roeder
Director, Lead Digital Quality, Risk Advisory Life Science
Joeri Van Wijngaarden
R&D Engineer
Aizon

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