Best & Brightest ATMP & Biotechnology Content from the 2021 Conferences
62 Presentations Featuring 29+ Hours of Content
No need to miss out on valuable knowledge-sharing! ISPE has gone through all of our conference presentations from 2021, hand-selected the absolute best and brightest ATMP & Biotechnology presentations and packaged them into the ISPE Best of Pharma Series. Access the most premier presentations offering compelling insights, strategies, and best practices from experts representing global health authorities and leading pharma organizations.
Sneak Peek of What to Expect
Watch this short clip from Peter Walters and Matthew Hewitt presenting ATMP Facilities: Sterile Manufacturing in the Multi-Modal for a glimpse of the kind of content you’ll engage within the ISPE Best of Pharma Series: Aseptic.
Presentations in this Package
Intersection of ATMPs and New Technologies
Speakers:
- Michael G. Higgins, Senior Compliance Advisor, Roche/Genentech
- Leslie Southam, QA Manager, Projects, Oxford Biomedica;
- James L. Drinkwater, PE, Head of GMP Compliance, F. Ziel GmbH, Chair, Annex 1 Focus Group, PHSS, F. Ziel GmbH;
- Marco Fadda, ATMP Solutions Manager, Comecer, SPA;
- Rob Roman, Head of Quality Systems & Compliance, Roche / Genentech
Duration: 60 min
Tech Transfer of ATMP Applications from Cleanroom to Isolator
Speaker:
- Marco Fadda, ATMP Solutions Manager, Comecer, SPA
Duration: 15 min
Combined Formulation-Fill-Finish of ATMPs: Lentiviral Vector – Oxbox Case Study Revisited – One Year Out
Speakers:
- Les Southam, QA Manager, Vector Product Operations, Oxford Biomedica
- James L Drinkwater, P.E., Head of GMP Compliance, F. Ziel GmbH, Chair, Annex 1 Focus Group, Pharmaceutical & Healthcare Sciences Society
Duration: 15 min
ATMP Facilities: Sterile Manufacturing in the Multi-Modal
Speakers:
- Peter A. Walters, Director, Advanced Therapies, CRB
- Matthew Hewitt, Head of Clinical Development; Head of R&D, Lonza
Duration: 10 min
Decontamination 5.0: From ATMPs and Aging Facilities to our “COVIDed” Office Room
Speaker:
- Ken Nagai, MBA, Director, New Business Development, Airex Co., Ltd
Duration: 15 min
Regulatory View on ATMPs and Make vs. Buy
Speakers:
- Richard Denk, Senior Consultant Aseptic Processing & Containment, SKAN AG
- Parla Hoelter, Senior Consultant, Project Farma;
- Daniel Foody, Senior Manager, Project Farma;
- Francesco Cicirello, Director, Quality Assurance, Evelo Biosciences;
- Alyce Maksoud, Team Leader Inspection Section, PIC/S Chair, Tissue & Cells , Australian Government Department of Health (TGA)
Duration: 60 min
Make vs. Buy in the Gene and Cell Therapy Space
Speakers:
- Parla Hoelter, Senior Consultant, Project Farma
- Daniel Foody, Senior Manager, Project Farma
Duration: 15 min
Update PIC/S Annex 2A Draft for ATMPs Revision
Speakers:
- Alyce Maksoud, Team Leader Inspection Section, PIC/S Chair, Tissue & Cells , Australian Government Department of Health (TGA)
- Francesco Cicirello, Director, Quality Assurance, Evelo Biosciences
Duration: 30 min
Development of Cell and Gene Therapies During COVID-19 Pandemic
Speaker:
- Wilson W. Bryan, M.D., Director, Office of Tissues and Advanced Therapies, CBER/FDA
Duration: 30 min
Implementation of Electronic Batch Records in Cell Therapy: Positives and Challenges
Speaker:
- Jessica Beyer, Director, Cell Therapy Manufacturing, Bristol Myers Squibb
Duration: 45 min
Cellular and Gene Therapy Products: A CMC Regulatory Perspective
Speaker:
- Carolyn Laurencot, Associate Director for Regulatory Science and Review, Division of Cellular & G, FDA (US Food and Drug Administration)
Duration: 30 min
Manufacturing an Adenovirus-Vectored Covid-19 Vaccine: From Bench to Millions of Doses in Months
Speaker:
- Sandy Douglas, Academic Clinician, University of Oxford
Duration: 30 min
Workshop 1: Control Strategy, Technology Transfer, CMC, Computer-based Modeling (EL Article)
Speakers:
- Thomas Zahel, PhD, Head of Innovation, Körber Pharma, Werum IT Solutions GmbH
- Christoph Herwig, PhD, Professor, Vienna University of Technology
Duration: 90 min
Digitalisation for Construction Management of Large Biopharmaceutical Plants - Case Study
Speaker:
- Marick Paris-Cadet, Pharmaceutical Project Engineer, Technip Energies
Duration: 20 min
Digital Transformation in Biomanufacturing: A Risk and Compliance Perspective
Speaker:
- Francisca Folque Gouveia, MS&T Senior Process Expert, Novartis Pharma S.A.S. Manufacturing Science and Technology (MS&T)
Duration: 20 min
Machine Learning-Assisted Downstream Process Development - Case Studies
Speaker:
- Robin Schiemer, PhD Candidate, Karlsruhe Institute of Technology
Duration: 15 min
Gene Expression Dynamics Under Simulated Fluctuating Substrate Conditions Derived from a Scale-Down Reactor
Speaker:
- Julia Walther, MS&T Engineer, VTU Engineering Deutschland GmbH
Duration: 15 min
Panel Discussion with Speakers in "Track 1: Pharma 4.0™ in Biotechnology Accelerated by Digitalisation" and Closing Remarks
Speakers:
- Thomas Zahel, PhD, Head of Innovation, Körber Pharma, Werum IT Solutions GmbH
- Francisca Folque Gouveia, MS&T Senior Process Expert, Novartis Pharma S.A.S. Manufacturing Science and Technology (MS&T)
- Robin Schiemer, PhD Candidate, Karlsruhe Institute of Technology
- Marco Kunzelmann, Senior Statistician, Boehringer Ingelheim Pharma GmbH & Co. KG
- Julia Walther, MS&T Engineer, VTU Engineering Deutschland GmbH
- Robert W. Landertinger Forero, Head of QA in Drug Product, Sanofi-Aventis Pharma Deutschland GmbH
- Marick Paris-Cadet, Pharmaceutical Project Engineer, Technip Energies
Duration: 30 min
Operational Excellence in the Pharmaceutical Industry - From Innocence to World Leading
Speakers:
- 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)
Duration: 20 min
Operation Readiness
Speaker:
- Charlie Maher, BS, MBA, Senior Director, Capital Projects, Validation and Operational Readiness, Resilience
Duration: 15 min
Designing for Operation Readiness
Speaker:
- Charlie Maher, BS, MBA, Senior Director, Capital Projects, Validation and Operational Readiness, Resilience
Duration: 20 min
Panel Discussion with Speakers in "Track 2: Operations Readiness, Technology Transfer and Risk based Case Studies" and Closing Remarks
Speakers:
- Charlie Maher, BS, MBA, Senior Director, Capital Projects, Validation and Operational Readiness, Resilience
- Fiona Madden, Senior Scientist / Manager, Janssen Biologics (Ireland);Mark Grothkopp, Research Associate & PhD Candidate, University of St. Gallen (Switzerland)
- Kimberly-Anne Mattia, Process Technology Scientific Leader, GSK
- Thomas Friedli, PhD, Professor of Production Management, Director ITEM, Division Production Managemen, University of St. Gallen (Switzerland)
Duration: 40 min
Track 3: Cell and Gene Therapy Products, ATMPs, Projects, Commercial Manufacturing
Speakers:
- 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
Duration: 35 min
CAR-T Manufacturing, a Fast Evolution Through Challenges and Opportunities
Speaker:
- Alessandro Linciano, Project Director, Stein Cell & Gene Therapy, Novartis Technical Operation
Duration: 20 min
Modular and Flexible Manufacturing for Cell and Gene Therapies
Speaker:
-
Angel Alvarez-Mangual, Senior Manager, Process Sciences, Cellectis; Leslie M. Edwards, MSE, Vice President, Technology & Business Development, Skan US
Duration: 20 min
Individualised Neo-Antigen-Specific Therapies: Unique CMC Challenges and a Novel Regulatory Framework
Speaker:
- Amy Hardwick, Technical Regulatory Program Associate Director, INeST, Genentech
Duration: 20 min
Establishing Supply Chain Capabilities for Individualised Therapies
Speaker:
- J. Andrew Case, Head of Clinical Supply Chain - Individualized Therapies, Genentech
Duration: 20 min
Panel Discussion with Speakers in "Track 3: Cell and Gene Therapy Products, ATMPs, Projects, Commercial Manufacturing" and Closing Remarks
Speakers:
- Jennifer Cheung, Vice President Quality Assurance and Regulatory Affairs, WuXi Advanced Therapies
- Leslie M. Edwards, MSE, Vice President, Technology & Business Development, Skan US
- Alessandro Linciano, Project Director, Stein Cell & Gene Therapy, Novartis Technical Operation
- Amy Hardwick, Technical Regulatory Program Associate Director, INeST, Genentech
- J. Andrew Case, Head of Clinical Supply Chain - Individualized Therapies, Genentech
- Angel Alvarez-Mangual, Senior Manager, Process Sciences, Cellectis
Duration: 40 min
Terminal Sterilisation of Oligonucleotides: Insights and Recommendations
Speaker:
- Daniel P. DeCollibus, Sr. Scientist, Process Development, Amgen
Duration: 20 min
Current Regulatory Trends for Synthetic Oligonucleotides
Speaker:
- René Thürmer, Quality Assessor, BfArm
Duration: 20 min
Cell Therapies Going Off-the-Shelf: The Beauty of Cord Blood Stem Cell-Derived Natural Killer Cells
Speaker:
- Volker Huppert, Chief Development Officer, Glycostem Therapeutics
Duration: 20 min
Panel Discussion with Speakers in "Track 4: Cell and Gene Therapy, ATMPs, Data Science Research and Development" and Closing Remarks
Speakers:
- Francesco Cicirello, Director, Quality Assurance, Evelo Biosciences
- Volker Huppert, Chief Development Officer, Glycostem Therapeutics
- René Thürmer, Quality Assessor, BfArm
- Daniel P. DeCollibus, Sr. Scientist, Process Development, Amgen
- Richard Denk, Senior Consultant Aseptic Processing & Containment, SKAN AG
- Giuseppina Sandri, Associate Professor, University of Pavia
- Alyce Maksoud, Team Leader Inspection Section, PIC/S Chair, Tissue & Cells , Australian Government Department of Health (TGA)
Duration: 25 min
Track 5: COVID-19 Vaccines: Development, Manufacturing, Distribution, Vaccination, Impact, Current Situation
Speakers:
- 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
Duration: 150 min
Making the Impossible Possible
Speaker:
- Luke Kimmel, Global Director, Engineering Biotech, Pfizer
Duration: 25 min
Immediate Supply to COVID-19 Vaccines Manufacturers
Speaker:
- Joerg Heinrich, Head Operations Separations Technologies, Sartorius Stedim Biotech
Duration: 25 min
Accelarating the Moderna COVID-19 Vaccine to Commercial Supply
Speaker:
- Paul Granadillo, Senior Vice President Global Supply Chain, Moderna
Duration: 25 min
Track 6: mABs: Continuous BioManufacturing, Technology Enablers & Rationalisation
Speakers:
- 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
Duration: 160 min
Advancing PAT & Automation for Advanced Therapeutic Modalities
Speaker:
- Jens Tränkle, Head PAT Biotechnology, Bayer AG
Duration: 20 min
Downstream Continuous BioManufacturing: Membrane Chromatography in mAbs Manufacturing
Speaker:
- Cristiana Boi, Associate Professor, Department of Civil, Chemical, Environmental & Materials, University of Bologna
Duration: 20 min
Large Molecule Drug Substance Process Intensification at Janssen Pharmaceuticals
Speaker:
- Barry J. McCarthy, Senior Director API Development, Janssen R&D
Duration: 20 min
Concept of Real Time Quality & Release Advanced Analytics for CM
Speaker:
- Olav Lyngberg, Sr. Scientific Fellow, Advanced Technology, Technical Operations, Janssen
Duration: 20 min
Harmonizing Rapid Contamination Detection Across the Biomanufacturing Process Through ATP Bioluminescence
Speaker:
- Ulrich Herber, Senior Director of Technology & Market Development, Charles River MS Germany GmbH
Duration: 20 min
ASTM International Consensus Standards: Facilitating Productivity in Bioprocessing
Speaker:
- Jeffrey Carter, PhD, Consumables Product Strategy Leader, Cytiva
Duration: 20 min
Panel Discussion with Regulators and Closing Remarks
Speakers:
- Wilson W. Bryan, M.D., Director, Office of Tissues and Advanced Therapies, CBER/FDA
- Matthew JH 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
Duration: 40 min
ElevateBio BaseCamp – Enabling the Next Generation of Cell and Gene Therapies
Speaker:
- Mario Miele, Vice President Facilities and Engineering, ElevateBio
Duration: 15 min
Build of innovative MAbs Drug Substance Facility Providing Positive Societal Impact
Speaker:
- Maneesh Ghildyal, Vice President & Global Head Projects & Engineering, Biocon Biologics Limited
Duration: 15 min
Vaccines for the World - Insights into a BSL2 fill-finish Facility
Speakers:
- Laura Moody, PhD, Product Manager, Syntegon Pharma Technology
- Thomas O’Sullivan, Director of Aseptic Technology, IPS
Duration: 30 min
Agile Turnaround & Cleaning: Supporting Sustainable Drug Supply
Speakers:
- Kenneth W. Pierce, B.Sc. Ph.D., Cleaning Validation Specialist, Engineer III, Hyde Engineering + Consulting Europe Ltd
- Geraldine Murray, Associate Director, Strategic Services, Astellas Ireland Ltd
Duration: 20 min
Single-Use Standardization in Pandemic Times
Speakers:
- Tyler C. Underhill, Biologics & Cell / Gene Therapies SME, PM Group
- Juerg Brechbuehler, Bio Future TechOps Program Engineer, Novartis
Duration: 20 min
Plug and Play Automation for Single Use Biopharma Equipment
Speaker:
- Clay Schaeffer, PE, Principal Engineer / Automation, Biogen
Duration: 20 min
Flexible Universal CAR-T Manufacturing in Isolators
Speakers:
- Steven H. Doares, PhD, Senior Vice President & Site Head, US Manufacturing, Cellectis
- Leslie M. Edwards, MSE, Vice President, Technology & Business Development, Skan US
Duration: 20 min
A Scalable and Flexible Future for Gene Therapy Production
Speakers:
- Carissa Marak, Architect, CRB
- Branden Salinas, PhD, Senior Director, Manufacturing Science and Technology, Umoja Biopharma
Duration: 20 min
Looking Beyond Autologous – Transitioning to Allogeneic
Speakers:
- Tom Bannon, Biopharma & Advanced Therapies SME, PM Group
- Arantxa Lera, Principal Architect, PM Group Ireland
Duration: 20 min
Concurrent Session: Innovations in Supply Chain and CGT Operations
Speaker:
- Aaron Weinstein, Senior Director, Validation Services, IPS-Integrated Project Services, LLC
Duration: 20 min
Decentralized Supply and Demand Signalling System (DS)2
Speaker:
- James Canterbury, Principal, Consulting, Ernst & Young LLP
Duration: 30 min
Disruptive Innovations: Key to CGT’s Growth & Maturity
Speakers:
- Komal Hatti, Director, Process Architect, IPS
- Marcia Steger, Senior Manager of External Manufacturing, Drug Product, Moderna
Duration: 30 min
Car-T Facility Design - Autologous vs. Allogeneic
Speakers:
- Michael J. Lennon, RA NCARB, Senior Process Architect, IPS
- Christian Estes, PE, Lead Process Engineer, IPS
Duration: 20 min
Cell and Gene Therapy Regulatory and Commercial Challenges
Speaker:
- Peter G. Millili, PhD, Director, Manufacturing Science and Technology, Bristol-Myers Squibb
Duration: 20 min
Impact of New Drug Therapies on Manufacturing
Speaker:
- Parikshit Sanghavi, Supply Chain & Manufacturing Leader for North America, Cognizant Life Science Manufacturing
Duration: 20 min
Perspectives on a Hybrid Continuous Peptide Manufacturing Scale-up
Speakers:
- Darragh Mcdonagh, Program Leader, Eli Lilly Kinsale Limited
- Kevin Seibert, PhD, Engineering Fellow, Synthetic Molecule Design and Development, Eli Lilly and Co
Duration: 20 min
Implementation of Continuous Manufacturing for Monoclonal Antibodies
Speaker:
- Thomas C. Ransohoff, M.S., Technical Head, Biologics Franchise, National Resilience, Inc.
Duration: 20 min
On-Demand Manufacturing of Pharmaceuticals
Speaker:
- Stephen Born, PhD, Director of Scientific Affairs, CONTINUUS Pharmaceuticals
Duration: 20 min
AI: The Core Foundation to Control of Biomanufacturing Processes
Speaker:
- Andy Alasso, Senior Vice President, Product Management, Aizon