ISPE Best of Pharma Series: Cell & Gene Therapy

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.

ISPE Best of Pharma Series: Cell & Gene Therapy Rates

ON DEMAND ACCESS FOR 6 MONTHS

Member $199
Nonmember   $299 

Buy Now


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

Partner Solutions

A Multidisciplinary Approach for the Quality of Cell-Based Products

Speaker: 

  • Axel Stahlbom, Subject Matter Expert ATMP, ProPharma Group
Duration: 33 min

Partner Solutions

Advanced Therapeutics Manufacturing Strategy: Make vs. Buy

Speaker: 

  • Tony Khoury, Vice President of Client Services, Project Farma
Duration: 24 min

Partner Solutions

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

Partner Solutions

Advancing ATMPs in Cellicon Valley

Speaker: 

  • Sumit Verma, Senior VP Commercial Manufacturing, Iovance Biotherapeutics, Inc.
Duration: 16 min

Partner Solutions

Advancing ATMPs in the City of Brotherly Love

Speaker: 

  • Ryan McDonough, P.E., Senior Vice President, Project Operations, DPS Group
Duration: 11 min

Partner Solutions

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

Partner Solutions

ATMP Facility Scale-up to Production using Isolator Technology

Speaker: 

  • Michael Hennessy, Head of Global Sales, ProSys Group
Duration: 29 min

Partner Solutions

Building Flexibility for Multiple Cell Therapy Processes

Speaker: 

  • Daniel Swanson, Senior Project Engineer, IPS
Duration: 30 min

Partner Solutions

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

Partner Solutions

Case Study: Commercialise ATMPs and Provide Sterility During the Whole Process

Speaker: 

  • Koji Ushioda, CEO, SKAN Japan
Duration: 24 min

Partner Solutions

Cell / Gene Therapy Supply Chain Considerations

Speaker: 

  • Raj Vora, Life Sciences Core Market Lead, DPR Construction
Duration: 11 min

Partner Solutions

Cell/Gene Therapy Market Development’s Effect on Manufacturing Supply Chain

Speaker: 

  • Becky Cap, CEO, Gencure
Duration: 9 min

Partner Solutions

Challenges for GMPs for ATMPs: European Perspective

Speaker: 

  • Lina Ertle, Head of External Relations EMEA and Japan, Roche
Duration: 24 min

Partner Solutions

Considerations For Global Cell Supply Chain Consistency

Speaker: 

  • Dominic Clarke, PhD, Global Head of Cell Therapy, HemaCare
Duration: 13 min

Partner Solutions

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

Partner Solutions

Design and Operational Considerations for ATMP Manufacturing Facilities

Speaker: 

  • Nicholas Casale, VP Technical Operations, Amicus Therapeutics
Duration: 23 min

Partner Solutions

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

Partner Solutions

Enabling Viral Vector Manufacturing in a Traditional Biopharmaceutical Pilot Plant

Speaker: 

  • Edward Stevens, Manager of Capital Projects, Biopharmaceutical Pilot Plant, GlaxoSmithKline
Duration: 13 min

Partner Solutions

ISPE Baseline Guide on ATMPs, Content and Progress

Speaker: 

  • Jeff Odum, VP of Life Sciences & Chemicals, Exyt
Duration: 21 min

Partner Solutions

Leveraging Operational Simulations for Gene Therapy Facilities

Speaker: 

  • Niranjan Kulkarni, PhD, Director, Operations Improvement, CRB
Duration: 31 min

Partner Solutions

Process Validation Considerations for CAR-T (or Autologous Cell) Therapies

Speaker: 

  • Hari Kamaraju, Director, Head of Manufacturing Excellence, Johnson & Johnson
Duration: 20 min

Partner Solutions

Process Validation of Suspension Lentiviral Vector Process

Speaker: 

  • Li Chen, Process Engineer II, bluebird bio
Duration: 19 min

Partner Solutions

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

Partner Solutions

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

Partner Solutions

Quality Considerations for Cell & Gene Therapy

Speaker: 

  • Luciana Mansolelli, Head Quality Strategic Planning, Cell & Gene Technical Development and Manufacturing, Novartis
Duration: 20 min

Partner Solutions

Rapid Vaccine/Viral Vector Deployment Using Flexible Biomanufacturing Platforms

Speaker: 

  • Yasser Kehail, Single Use & Enterprise Business Development Leader, Cytiva
Duration: 23 min

Partner Solutions

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

Partner Solutions

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

Partner Solutions

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

Partner Solutions

Working with CDMOs to Develop a CMC Strategy for Gene Therapy: Challenges for MAA

Speaker: 

  • Catherine Cancian, VP Pharmaceutical Operations, GenSight Biologics
Duration: 24 min

ISPE Best of Pharma Series: Cell & Gene Therapy Rates

ON DEMAND ACCESS FOR 6 MONTHS

Member $199
Nonmember   $299 

Buy Now

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