Sessions

Analytics, Data and IT Tech Solutions: An Overview of Best Practices and Technology
Changing the Cell Therapy Landscape with In-Vivo Therapies: Is this a Viable Alternative for Point of Care Therapeutics?
Achieving Best Practice in Quality Control and Assurance
Implementing New and Enabling Technologies into Existing Processes for Improved Commercial Outcomes
Implementing New and Enabling Technologies into Existing Processes for Improved Commercial Outcomes
Delivery Solutions, Improvements and Alternatives for Gene & Cell Therapy
Industry 4.0 Approaches Transforming Cell and Gene Therapy
Accelerating the Digitalisation Revolution in Cell and Gene Therapy Development
Viral Vector Development: Safe and Effective Viral Vectors for Therapeutic Success

Analytics, Data and IT Tech Solutions: An Overview of Best Practices and Technology

27 Jan 2022
15:30
SPONSORED BY
Cytovance Biologics
Körber

15:30 Chairperson’s Opening
Jeff Buck, Vice President, Business Optimisation, Lash Group, AmerisourceBergen

15:35 Early Development of Data Strategies Prepares A Program for Success (Live Stream)

  • Data strategy design must encompass payor needs as well as regulatory requirements
  • Data strategies should shape the clinical trial design
  • Robust strategies are required for long term follow-up to minimize data gaps

George Smith, Vice President, Cell Therapy Operations, Turnstone Bio

15:50 Optimising a Scalable pDNA Manufacturing Process

Addressing challenges in pDNA manufacturing with:

  • Strain selection, plasmid optimization, media composition, and fermentation conditions necessary to produce high quality supercoiled plasmid DNA
  • Platform processes to address bottlenecks in purification
  • Integrated analytics to assess pDNA throughout the process appropriate for the various grades needed for gene therapy

Christa Feasley, Senior Analytical Development Scientist, Cytovance

16:05 Developing an Analytical Characterization Plan for Gene Therapy Products

  • Advantages of early extensive analytical testing of GT products
  • Main drivers for CDMO/CRO selection for Analytical development and testing
  • Learnings from SparingVision’s outsourcing model

Pierre-Axel Vinot, Associate Director, CMC Portfolio Management, Sparing Vision

16:20 How to Streamline CGT / ATMP Therapies’ Lifecycle

  • Obtain the relevant process data over the whole therapy lifecycle
  • Perform data analytic workflows in order to save experiment costs and accelerate product commercialization
  • Support process characterization and validation by providing the relevant data

Judith Koliwer, Principal Consultant, Körber

16:35 Speaker Q&A and Panel Discussion

Speakers

Jeff Buck
Vice President, Business Optimization Lash Group
AmerisourceBergen
George Smith
Vice President, Cell Therapy Operations
Turnstone Bio
Pierre Axel Vinot
Associate Director, CMC Portfolio Management
Sparing Vision
Judith Koliwer
Principal Consultant, Cell and Gene Therapy
Körber