30 Presentations Featuring 11+ Hours of Content
No need to miss out on valuable knowledge-sharing! ISPE has gone through all of our conference presentations from 2020, hand-selected the absolute best and brightest regulatory 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 Hari Kamaraju presenting Process Validation Considerations for CAR-T Therapies for a glimpse of the kind of content you’ll engage with in the ISPE Best of Pharma Series: Cell & Gene Therapy.
Presentations in this Package
A Multidisciplinary Approach for the Quality of Cell-Based Products
Speaker:
- Axel Stahlbom, Subject Matter Expert ATMP, ProPharma Group
Duration: 33 min
Advanced Therapeutics Manufacturing Strategy: Make vs. Buy
Speaker:
- Tony Khoury, Vice President of Client Services, Project Farma
Duration: 24 min
Advanced Therapy Medicinal Products (ATMP) Overview
Speakers:
- Peter Walters, ATMP Director, CRB
- Edward Domanico, P.E., Program Director, Bayer U.S. LLC
Duration: 18 min
Advancing ATMPs in Cellicon Valley
Speaker:
- Sumit Verma, Senior VP Commercial Manufacturing, Iovance Biotherapeutics, Inc.
Duration: 16 min
Advancing ATMPs in the City of Brotherly Love
Speaker:
- Ryan McDonough, P.E., Senior Vice President, Project Operations, DPS Group
Duration: 11 min
Applying Phase Appropriate GMPs to Develop and Deliver of ATMPs
Speakers:
- Michael Gorman, Principal Consultant, DPS Group
- Andrew Stober, Chief Manufacturing Officer, Encoded Therapeutics
- Aidan Harrington, PhD, Principal Consultant, DPS Group
Duration: 41 min
ATMP Facility Scale-up to Production using Isolator Technology
Speaker:
- Michael Hennessy, Head of Global Sales, ProSys Group
Duration: 29 min
Building Flexibility for Multiple Cell Therapy Processes
Speaker:
- Daniel Swanson, Senior Project Engineer, IPS
Duration: 30 min
Case Study for Fully Automated Robotic Filling of ATMPs
Speakers:
- Shailesh Shah, Associate Director, Manufacturing Sciences & Technologies, Janssen Cilag AG
- Thomas Thurn, Director Drug Product Clinical Supply Chain, Janssen Cilag AG
Duration: 24 min
Case Study: Commercialise ATMPs and Provide Sterility During the Whole Process
Speaker:
- Koji Ushioda, CEO, SKAN Japan
Duration: 24 min
Cell / Gene Therapy Supply Chain Considerations
Speaker:
- Raj Vora, Life Sciences Core Market Lead, DPR Construction
Duration: 11 min
Cell/Gene Therapy Market Development’s Effect on Manufacturing Supply Chain
Speaker:
- Becky Cap, CEO, Gencure
Duration: 9 min
Challenges for GMPs for ATMPs: European Perspective
Speaker:
- Lina Ertle, Head of External Relations EMEA and Japan, Roche
Duration: 24 min
Considerations For Global Cell Supply Chain Consistency
Speaker:
- Dominic Clarke, PhD, Global Head of Cell Therapy, HemaCare
Duration: 13 min
Considerations for Multi-product facilities in CGT--What we’ve learned by examining how to “do it all” in one building
Speaker:
- Charlotte Cooper Holmes, Associate Director MSAT, bluebird bio
Duration: 13 min
Design and Operational Considerations for ATMP Manufacturing Facilities
Speaker:
- Nicholas Casale, VP Technical Operations, Amicus Therapeutics
Duration: 23 min
Enabling Automation and Pharma 4.0 in Cell Therapy
Speakers:
- Shin Kawamata, Director of R&D Centre for Cell Therapy, Foundation for Biomedical Research and Innovation (FBRI)
- David Margetts, CEO, Factorytalk, Co. Ltd.
Duration: 25 min
Enabling Viral Vector Manufacturing in a Traditional Biopharmaceutical Pilot Plant
Speaker:
- Edward Stevens, Manager of Capital Projects, Biopharmaceutical Pilot Plant, GlaxoSmithKline
Duration: 13 min
ISPE Baseline Guide on ATMPs, Content and Progress
Speaker:
- Jeff Odum, VP of Life Sciences & Chemicals, Exyt
Duration: 21 min
Leveraging Operational Simulations for Gene Therapy Facilities
Speaker:
- Niranjan Kulkarni, PhD, Director, Operations Improvement, CRB
Duration: 31 min
Process Validation Considerations for CAR-T (or Autologous Cell) Therapies
Speaker:
- Hari Kamaraju, Director, Head of Manufacturing Excellence, Johnson & Johnson
Duration: 20 min
Process Validation of Suspension Lentiviral Vector Process
Speaker:
- Li Chen, Process Engineer II, bluebird bio
Duration: 19 min
Project Management Best Practices in Delivering Cell and Gene Therapy Facilities
Speaker:
- Byron Lindros, Director Capital Projects, Kite Pharma Scott Bertch, Sr. Director, AveXis Inc. (A Novartis Company)
Duration: 74 min
PV Lifecycle Stage 1 (Development) Challenges for AAV Gene Therapy Products for Rare Diseases
Speaker:
- Mark Galbraith, Head of Quality Control & Analytical Sciences, Spark Therapeutics Katherine Giacoletti, Partner, SynoloStats LLC
Duration: 17 min
Quality Considerations for Cell & Gene Therapy
Speaker:
- Luciana Mansolelli, Head Quality Strategic Planning, Cell & Gene Technical Development and Manufacturing, Novartis
Duration: 20 min
Rapid Vaccine/Viral Vector Deployment Using Flexible Biomanufacturing Platforms
Speaker:
- Yasser Kehail, Single Use & Enterprise Business Development Leader, Cytiva
Duration: 23 min
Regulatory and Quality Considerations for mRNA-based Medicinal Products
Speaker:
- Andreas Kuhn, Senior Vice President RNA Biochemistry & Manufacturing, BioNTech RNA Pharmaceuticals GmbH
Duration: 23 min
Re-thinking Comparability Assessments for Individualized Therapeutics
Speaker:
- Kathy Francissen, PhD, Senior Director, Pharma Technical Regulatory, Genentech, A Member of the Roche Group
Duration: 23 min
Update on PIC`S Annex 2 for ATMPs
Speakers:
- Richard Denk, SKAN AG
- Francesco Cicirello, TGA, Head of PIC`s Annex 2
Duration: 29 min
Working with CDMOs to Develop a CMC Strategy for Gene Therapy: Challenges for MAA
Speaker:
- Catherine Cancian, VP Pharmaceutical Operations, GenSight Biologics