Welcome and Introduction and Keynotes
Sep 22, 2021 12:00pm ‐ Sep 22, 2021 5:00pm
Speaker(s):
- Thomas B. Hartman, President and CEO, ISPE
- Antonio R. Moreira, PhD, Vice Provost, Academic Affairs, University of Maryland
- Wilson W. Bryan, M.D., Director, Office of Tissues and Advanced Therapies, CBER/FDA
- Mr. Francesco Cicirello, Senior Director, Quality Assurance, Evelo Biosciences
- Richard DENK, Senior Consultant Aseptic Processing & Containment, SKAN AG
- Matthew J. Davis, Senior GMP Inspector, Therapeutic Goods Administration
- Rino Rappuoli, Chief Scientist and Head External R&D, GSK Vaccines
- Jessica Beyer, Director, Cell Therapy Manufacturing, Bristol Myers Squibb
- Carolyn Laurencot, Associate Director for Regulatory Science and Review, Division of Cellular & G, FDA (US Food and Drug Administration)
- Oliver Hennig, PhD, Senior Vice President Operations, BioNTech SE
- Sandy Douglas, Academic Clinician, University of Oxford
Workshop 1: Control Strategy, Technology Transfer, CMC, Computer-based Modeling (EL Article)
Sep 22, 2021 5:00pm ‐ Sep 22, 2021 6:30pm
Workshop 1: Control Strategy, Technology Transfer, CMC, Computer-based Modeling (EL Article)|
Speaker(s):
- Thomas Zahel, PhD, Head of Innovation, Körber Pharma Austria GmbH
- Christoph Herwig, PhD, Professor, Vienna University of Technology
Track 1: Pharma 4.0™ in Biotechnology Accelerated by Digitalisation
Sep 23, 2021 12:00pm ‐ Sep 23, 2021 3:00pm
Speaker(s):
- Thomas Zahel, PhD, Head of Innovation, Körber Pharma Austria GmbH
- Robert W. Landertinger Forero, Head of QA in Drug Product, Sanofi-Aventis Pharma Deutschland GmbH
- Marco Kunzelmann, Senior Statistician, Boehringer Ingelheim Pharma GmbH & Co. KG
- Marick Paris-Cadet, Pharmaceutical Project Engineer, Technip Energies
- Francisca F. Gouveia, MS&T Senior Process Expert, Novartis Pharma S.A.S. Manufacturing Science and Technology (MS&T)
- Amy Hardwick, Technical Regulatory Program Associate Director, INeST, Genentech
- Robin Schiemer, PhD Candidate, Karlsruhe Institute of Technology
- Julia Walther, MS&T Engineer, VTU Engineering Deutschland GmbH
Track 2: Operations Readiness, Technology Transfer and Risk based Case Studies
Sep 23, 2021 12:00pm ‐ Sep 23, 2021 3:00pm
Speaker(s):
- Mark Grothkopp, Research Associate & PhD Candidate, University of St.Gallen
- Prof. Thomas Friedli, PhD, Professor and Director, University of St.Gallen
- Kimberly-Anne Mattia, Process Technology Scientific Leader, GSK
- Fiona Madden, Senior Scientist / Manager, Janssen Biologics (Ireland)
- Mr. 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 12:00pm ‐ Sep 23, 2021 3:00pm
Speaker(s):
- Alessandro Linciano, Project Director, Stein Cell & Gene Therapy, Novartis Technical Operation
- Angel Alvarez-Mangual, Senior Manager, Process Sciences, Cellectis
- Leslie M. Edwards, MSE, Vice President, Technology & Business Development, Skan US
- Jennifer Cheung, Vice President Quality Assurance and Regulatory Affairs, WuXi Advanced Therapies
- Amy Hardwick, Technical Regulatory Program Associate Director, INeST, Genentech
- J. Andrew Case, Head of Clinical Supply Chain - Individualized Therapies, Genentech
Workshop 2: Work-stream - ATMPs, Facility Design, GXP Compliance
Sep 23, 2021 3:30pm ‐ Sep 23, 2021 5:00pm
Workshop 2: Work-stream - ATMPs, Facility Design, GXP Compliance|
Speaker(s):
- Jean Francois Duliere, Reg Advisor, ISPE
- Prudence Edwards, Operational Excellence Specialist, Thermo Fisher Scientific Brisbane, Australia
- Richard DENK, Senior Consultant Aseptic Processing & Containment, SKAN AG
Track 4: Cell and Gene Therapy, ATMPs, Data Science Research and Development
Sep 24, 2021 12:00pm ‐ Sep 24, 2021 3:15pm
Speaker(s):
- Daniel P. DeCollibus, Sr. Scientist, Process Development, Amgen
- René Thürmer, Quality Assessor, BfArm
- Giuseppina Sandri, Associate Professor, University of Pavia
- Olav Lyngberg, Sr. Scientific Fellow, Advanced Technology, Technical Operations, Janssen
- Volker Huppert, Chief Development Officer, Glycostem Therapeutics
- Alyce Maksoud, Team Leader Inspection Section, PIC/S Chair, Tissue & Cells , Australian Government Department of Health (TGA)
- Mr. Francesco Cicirello, Senior Director, Quality Assurance, Evelo Biosciences
- Richard DENK, Senior Consultant Aseptic Processing & Containment, SKAN AG
Track 5: COVID-19 Vaccines: Development, Manufacturing, Distribution, Vaccination, Impact, Current Situation
Sep 24, 2021 12:00pm ‐ Sep 24, 2021 3:15pm
Speaker(s):
- Ulrich Blaschke, Vice President Technical Development, BioNTech SE
- Luke Kimmel, Global Director, Engineering Biotech, Pfizer
- Joerg Heinrich, Head Operations Separations Technologies, Sartorius Stedim Biotech
- John O'Hara, North American Supply Chain Lead for COVID-19, Janssen
- Paul Granadillo, Senior Vice President Global Supply Chain, Moderna
Track 6: mABs: Continuous BioManufacturing, Technology Enablers & Rationalisation
Sep 24, 2021 12:00pm ‐ Sep 24, 2021 3:15pm
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 3:20pm ‐ Sep 24, 2021 4:00pm
Speaker(s):
- Wilson W. Bryan, M.D., Director, Office of Tissues and Advanced Therapies, CBER/FDA
- Matthew J. Davis, Senior GMP Inspector, Therapeutic Goods Administration
- Alyce Maksoud, Team Leader Inspection Section, PIC/S Chair, Tissue & Cells , Australian Government Department of Health (TGA)
- René Thürmer, Quality Assessor, BfArm
- Thomas B. Hartman, President and CEO, ISPE