2021 ISPE Biotechnology Conference & Workshop

Sep 22, 2021 ‐ Sep 24, 2021



Sessions

Welcome and Introduction and Keynotes

Sep 22, 2021 1:00pm ‐ Sep 22, 2021 6:00pm

Speaker(s):

Workshop 1: Control Strategy, Technology Transfer, CMC, Computer-based Modeling (EL Article)

Sep 22, 2021 6:00pm ‐ Sep 22, 2021 7:30pm

Workshop 1: Control Strategy, Technology Transfer, CMC, Computer-based Modeling (EL Article)|

Speaker(s):

Track 1: Pharma 4.0™ in Biotechnology Accelerated by Digitalisation

Sep 23, 2021 1:00pm ‐ Sep 23, 2021 4:00pm

Speaker(s):

Track 2: Operations Readiness, Technology Transfer and Risk based Case Studies

Sep 23, 2021 1:00pm ‐ Sep 23, 2021 4:00pm

Speaker(s):
  • Mark Grothkopp, Research Associate & PhD Candidate, University of St. Gallen (Switzerland)
  • Thomas Friedli, PhD, Professor of Production Management, Director ITEM, Division Production Managemen, University of St. Gallen (Switzerland)
  • Kimberly-Anne Mattia, Process Technology Scientific Leader, GSK
  • Fiona Madden, Senior Scientist / Manager, Janssen Biologics (Ireland)
  • Charlie Maher, BS, MBA, Senior Director, Capital Projects, Validation and Operational Readiness, Resilience

Track 3: Cell and Gene Therapy Products, ATMPs, Projects, Commercial Manufacturing

Sep 23, 2021 1:00pm ‐ Sep 23, 2021 4:00pm

Speaker(s):

Workshop 2: Work-stream - ATMPs, Facility Design, GXP Compliance

Sep 23, 2021 4:30pm ‐ Sep 23, 2021 6:00pm

Workshop 2: Work-stream - ATMPs, Facility Design, GXP Compliance|

Speaker(s):
  • Jean-Francois Duliere, Pharmaceutical Senior Expert, Consultant, Chair ISPE France Affiliate
  • Richard Denk, Senior Consultant Aseptic Processing & Containment, SKAN AG
  • Prudence Edwards, Double Degree Engineering Student (University of Queensland/Centrale Marseille)

Track 4: Cell and Gene Therapy, ATMPs, Data Science Research and Development

Sep 24, 2021 1:00pm ‐ Sep 24, 2021 4:15pm

Speaker(s):

Track 5: COVID-19 Vaccines: Development, Manufacturing, Distribution, Vaccination, Impact, Current Situation

Sep 24, 2021 1:00pm ‐ Sep 24, 2021 4:15pm

Speaker(s):

Track 6: mABs: Continuous BioManufacturing, Technology Enablers & Rationalisation

Sep 24, 2021 1:00pm ‐ Sep 24, 2021 4:15pm

Speaker(s):
  • Jens Tränkle, Head PAT Biotechnology, Bayer AG
  • Cristiana Boi, Associate Professor, Department of Civil, Chemical, Environmental & Materials, University of Bologna
  • Barry J. McCarthy, Senior Director API Development, Janssen R&D
  • Olav Lyngberg, Sr. Scientific Fellow, Advanced Technology, Technical Operations, Janssen
  • Jean-Marc Bielser, Associate Director - Head of BPS Process Technologies, Merck
  • Ulrich Herber, Senior Director of Technology & Market Development, Charles River MS Germany GmbH
  • Jeffrey Carter, PhD, Consumables Product Strategy Leader, Cytiva

Panel Discussion with Regulators and Closing Remarks

Sep 24, 2021 4:20pm ‐ Sep 24, 2021 5:00pm

Speaker(s):