Programme Schedule

  • Day 1
    Thursday, 20 September
       
    0800–0830 Speaker Breakfast and Speaker Update
    0830–0845 Welcome, Chairs
    0845–0925 Janssen`s Technology Strategy in Sight of Industry 4.0
    Timo Simmen, Director Parenteral Technology Innovation & Standardisation, J&J
    0925–1005 Integrated Drug Substance-Drug Product Development for the Next Generation of Biologics
    Hitto Kaufmann, Global Vice President Biopharmaceutics Development and Platform Innovation, Sanofi
    1005–1045 Networking Break in the Exhibition Area
     

    The 2018 ISPE Europe Biotechnology Conference programme is a multiple track conference, with two sessions running concurrently. Attendees are able to move between all of the tracks to create a customised education experience. Explore the tracks below to see what topics will be discussed and who will be presenting.

    • Track 1:  Industrialising Next Generation Products: Gene & Cell Therapy & ADCs
      1045–1115 Designing a Robust and Cost-Effective “Off-the-Shelf” Supply Chain for Osteoblastic Cell Therapy: A QbD Approach to Filling and Cryopreservation for Large-scale Allogeneic Osteoblastic Cells Production
      Benoît Champluvier, Chief Technology and Manufacturing Office, Bone Therapeutics S.A.
      1115–1145 Flexible Facilities for Next Generation Therapeutics
      Ahmed Farouk, Pharma Process Specialist, PM Group
      1145–1215 Large-scale Manufacturing of AAV Vectors: Scale-up and Technical Transfer of an AAV8 Production Process
      Matthias Hebben, Head of Bioprocess Development, Genethon
      1215–1300 Networking Lunch
      1300–1345 Cell Therapies and Their GMP Requirements
      Kasia Averall, Head Of Quality Assurance, Cell Therapy Catapult (CTC)
      1345–1430 IADC Scale-up and Industrialisation
      Matthias Brun, ADC Program Manager, Lonza AG
      1430–1500 Panel Discussion
      All Speakers from Track
    • Track 2:  Integrated Processing and Novel Development Strategies (Predictive Models, PAT, Continuous Processing, Single-use Systems)
      1045–1115 Process Intensification of mAb Platform Processing
      Paul Kaschutnig, Process Development Scientist, Merck Group
      1115–1145 State-of-the-Art Biopharma Factory
      John Hyde, Chairman and Founder, Hyde Engineering and Consulting, Inc., Hyde Consulting
      1145–1215 Scalable Technologies and Advanced Process Control for the Intensified Facilities of the Future
      Gerben Zijlstra, Platform Marketing Manager Continuous BioManufacturing, Sartorius-Stedim Integrated Solutions
      1215–1300 Networking Lunch
      1300–1345 Making Large-Scale Processes Transparent - More Relible Design and Scale-Up by Experimental Analysis of a 15,000 L Glass Reactor
      Thomas Wucherpfennig, Scientist, Cell Culture Development, Boehringer Ingelheim
      1345–1430 Development of HPLC and Raman-based PAT Solutions for Biopharmaceutical Production Process Monitoring
      Pierre-Damien Martinet, Global Head of Data Sciences, Sanofi Pasteur
      1430–1500 Panel Discussion
      All Speakers from Track
       
    1500–1530 Networking in the Exhibition Area
     
    • Track 3:  Impact of New Regulations on Biologics
      1530–1600 Aspects of Validation in Context of ICH Q 12
      Steffen Gross, Head of Section Monoclonal and Polyclonal Antibodies, Paul-Ehrlich-Institut
      1600–1630 Bio-Manufacturing: Knowledge, Documentation and Training - Three Key Elements to Consider in Your “Human Errors Reduction Journey"
      Olivier Michel, Specialist Life Sciences, Altran World Class Center Life Sciences & Process Excellence
      1630–1700 ICH Q 12 Product Life Cycle Management for Biologics
      Georges France, VP LOCs Global Quality Lead, GSK
    • Track 4:  Converting Data to information, Information to Knowledge, Knowledge to Intelligence
      1530–1600 Industrial Lab Automation
      Peter Boogaard, CEO, Industrial Lab Automation
      1600–1630 Data and Information: The Main Product of Bioprocess Development
      Stefan Buziol, Group Leader Process Development Fermentation, Roche Diagnostics GmbH
      1630–1700 A CMOs Perspective on Process Control Strategy
      Denes Zalai, Team Lead USP Manufacturing, Richter-Helm BioLogics
       
    1700–2000 Welcome Reception
    2000–2300 Networking Dinner
  • Day 2
    Friday, 21 September
     

    The 2018 ISPE Europe Biotechnology Conference programme is a multiple track conference, with two sessions running concurrently. Attendees are able to move between all of the tracks to create a customised education experience. Explore the tracks below to see what topics will be discussed and who will be presenting.

    • Track 3: Impact of New Regulations on Biologics
      0830–0900 Annex 1 and Impact on Biotechnologies Processes
      ISPE Commenting Group
      0900–0930 Continuous Process Verification
      Andre Walker, Biopharm Consultant - Engineering, Manufacturing, Compliance, Andre Walker Consulting, BPOG
      0930-1000 Panel Discussion
      All Speakers from Track
    • Track 4: Converting Data to Information, Information to Knowledge, Knowledge to Intelligence
      0830–0900 Prior Knowledge Harvest in the Age of ICH Q 12
      José Cardoso de Menezes, Full Professor, Technical University of Lisbon, CEO, 4Tune Engineering
      0900–0930 Knowledge Management and Workforce 4.0
      Antonio Moreira, Vice Provost for Academic Affairs, University of Maryland, Baltimore County (UMBC)
      0930-1000

      Panel Discussion
      All Speakers from Track

       
    1000-1030 Networking Break in the Exhibition Area
    1030–1100 GMP for Biologics
    Tom Cosgrove, Partner in Food, Drug and Device Group, Covington & Burling LLP
    1100-1130 Current Industry Perspective on the Management of Pharmaceutical Incoming Material
    Philippe Ronse, Head Quality Shared Services, GSK
    1130–1200 Value-adding Potential of Cultural Change in Frame of Future Challenges
    Renato Wirthner, Executive Vice President, Quality Management, Celonic
    1200–1215 How ISPE Addresses  European Needs?
    John Bournas, President & CEO, ISPE
    1215–1300 Pharmapolitical Environment for Production in Europe
    Nathalie Moll, Director General, European Federation of Pharmaceutical Industry Associations (EFPIA)
    1300–1400 Networking Lunch
    1400–1700 Site Visits at Manufacturers

Exhibit Hall

Attend the Exhibits

Benefits

  • Attendees will find answers to their questions and solutions in the Europe Biotechnology Conference Exhibit Hall
  • Daily schedules provide opportunities to have meaningful conversations with exhibitors during breaks and lunch
  • Companies have information on:
    • Analytical Equipment & Services
    • Architecture/Engineering/Construction
    • Contract Services
    • Packaging Machinery
    • Process and Manufacturing
    • Manufacturing Software
    • Validation Support
  • You will take away ideas and recommendations that can have measurable benefits for your company

 


Exhibit Hall Hours

  • 20 September from 0700 – 0830 set-up
  • 20 September from 0830 – 1900
  • 21 September from 0830 – 1330
  • 21 September from 1330 – 1500 dismantling

Find Event Exhibitors