2021 ISPE Best of Pharma Series: ATMP & Biotechnology

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.

ISPE Best of Pharma Series: 2021 ISPE Best of Pharma Series: ATMP & Biotechnology

ON DEMAND ACCESS FOR 6 MONTHS

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Nonmember   $299 

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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

Partner Solutions

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

Partner Solutions

Tech Transfer of ATMP Applications from Cleanroom to Isolator

Speaker: 

  • Marco Fadda, ATMP Solutions Manager, Comecer, SPA
Duration: 15 min

Partner Solutions

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

Partner Solutions

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

Partner Solutions

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

Partner Solutions

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

Partner Solutions

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

Partner Solutions

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

Partner Solutions

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

Partner Solutions

Implementation of Electronic Batch Records in Cell Therapy: Positives and Challenges

Speaker: 

  • Jessica Beyer, Director, Cell Therapy Manufacturing, Bristol Myers Squibb
Duration: 45 min

Partner Solutions

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

Partner Solutions

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

Partner Solutions

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

Partner Solutions

Digitalisation for Construction Management of Large Biopharmaceutical Plants - Case Study

Speaker: 

  • Marick Paris-Cadet, Pharmaceutical Project Engineer, Technip Energies
Duration: 20 min

Partner Solutions

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

Partner Solutions

Machine Learning-Assisted Downstream Process Development - Case Studies

Speaker: 

  • Robin Schiemer, PhD Candidate, Karlsruhe Institute of Technology
Duration: 15 min

Partner Solutions

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

Partner Solutions

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

Partner Solutions

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

Partner Solutions

Operation Readiness

Speaker: 

  • Charlie Maher, BS, MBA, Senior Director, Capital Projects, Validation and Operational Readiness, Resilience
Duration: 15 min

Partner Solutions

Designing for Operation Readiness

Speaker: 

  • Charlie Maher, BS, MBA, Senior Director, Capital Projects, Validation and Operational Readiness, Resilience
Duration: 20 min

Partner Solutions

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

Partner Solutions

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

Partner Solutions

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

Partner Solutions

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

Partner Solutions

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

Partner Solutions

Establishing Supply Chain Capabilities for Individualised Therapies

Speaker: 

  • J. Andrew Case, Head of Clinical Supply Chain - Individualized Therapies, Genentech
Duration: 20 min

Partner Solutions

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

Partner Solutions

Terminal Sterilisation of Oligonucleotides: Insights and Recommendations

Speaker: 

  • Daniel P. DeCollibus, Sr. Scientist, Process Development, Amgen
Duration: 20 min

Partner Solutions

Current Regulatory Trends for Synthetic Oligonucleotides

Speaker: 

  • René Thürmer, Quality Assessor, BfArm
Duration: 20 min

Partner Solutions

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

Partner Solutions

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

Partner Solutions

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

Partner Solutions

Making the Impossible Possible

Speaker: 

  • Luke Kimmel, Global Director, Engineering Biotech, Pfizer
Duration: 25 min

Partner Solutions

Immediate Supply to COVID-19 Vaccines Manufacturers

Speaker: 

  • Joerg Heinrich, Head Operations Separations Technologies, Sartorius Stedim Biotech
Duration: 25 min

Partner Solutions

Accelarating the Moderna COVID-19 Vaccine to Commercial Supply

Speaker: 

  • Paul Granadillo, Senior Vice President Global Supply Chain, Moderna
Duration: 25 min

Partner Solutions

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

Partner Solutions

Advancing PAT & Automation for Advanced Therapeutic Modalities

Speaker: 

  • Jens Tränkle, Head PAT Biotechnology, Bayer AG
Duration: 20 min

Partner Solutions

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

Partner Solutions

Large Molecule Drug Substance Process Intensification at Janssen Pharmaceuticals

Speaker: 

  • Barry J. McCarthy, Senior Director API Development, Janssen R&D
Duration: 20 min

Partner Solutions

Concept of Real Time Quality & Release Advanced Analytics for CM

Speaker: 

  • Olav Lyngberg, Sr. Scientific Fellow, Advanced Technology, Technical Operations, Janssen
Duration: 20 min

Partner Solutions

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

Partner Solutions

ASTM International Consensus Standards: Facilitating Productivity in Bioprocessing

Speaker: 

  • Jeffrey Carter, PhD, Consumables Product Strategy Leader, Cytiva
Duration: 20 min

Partner Solutions

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

Partner Solutions

ElevateBio BaseCamp – Enabling the Next Generation of Cell and Gene Therapies

Speaker: 

  • Mario Miele, Vice President Facilities and Engineering, ElevateBio
Duration: 15 min

Partner Solutions

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

Partner Solutions

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

Partner Solutions

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

Partner Solutions

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

Partner Solutions

Plug and Play Automation for Single Use Biopharma Equipment

Speaker: 

  • Clay Schaeffer, PE, Principal Engineer / Automation, Biogen
Duration: 20 min

Partner Solutions

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

Partner Solutions

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

Partner Solutions

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

Partner Solutions

Concurrent Session: Innovations in Supply Chain and CGT Operations

Speaker: 

  • Aaron Weinstein, Senior Director, Validation Services, IPS-Integrated Project Services, LLC
Duration: 20 min

Partner Solutions

Decentralized Supply and Demand Signalling System (DS)2

Speaker: 

  • James Canterbury, Principal, Consulting, Ernst & Young LLP
Duration: 30 min

Partner Solutions

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

Partner Solutions

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

Partner Solutions

Cell and Gene Therapy Regulatory and Commercial Challenges

Speaker: 

  • Peter G. Millili, PhD, Director, Manufacturing Science and Technology, Bristol-Myers Squibb
Duration: 20 min

Partner Solutions

Impact of New Drug Therapies on Manufacturing

Speaker: 

  • Parikshit Sanghavi, Supply Chain & Manufacturing Leader for North America, Cognizant Life Science Manufacturing
Duration: 20 min

Partner Solutions

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

Partner Solutions

Implementation of Continuous Manufacturing for Monoclonal Antibodies

Speaker: 

  • Thomas C. Ransohoff, M.S., Technical Head, Biologics Franchise, National Resilience, Inc.
Duration: 20 min

Partner Solutions

On-Demand Manufacturing of Pharmaceuticals

Speaker: 

  • Stephen Born, PhD, Director of Scientific Affairs, CONTINUUS Pharmaceuticals
Duration: 20 min

Partner Solutions

AI: The Core Foundation to Control of Biomanufacturing Processes

Speaker: 

  • Andy Alasso, Senior Vice President, Product Management, Aizon
Duration: 20 min

ISPE Best of Pharma Series:  ATMP & Biotechnology

ON DEMAND ACCESS FOR 6 MONTHS

Member $199
Nonmember   $299 

Buy Now

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