Day One Agenda

8:00am - 5:00pm | London, UK

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8:00 am Registration Open & Coffee Networking

8:50 am Chair’s Opening Remarks

9:00 am Panel Discussion: Assessing Common Challenges & Opportunities in Analytical Development for Cell Therapy Products

Synopsis

  •  Looking at the evolution of analytical development in cell therapy over the past decade, what did we learn?
  • With a lack of standardized methods, how do we define our own best practices?
  •  With the speed of evolution, what new tools are emerging to help us solve these challenges?

10:00 am Morning Break

11:15 am Expertise in Assessing Cell Therapy Efficacy using Potency or Surrogate Assays

Synopsis

  • Selecting an external analytical continuity partner able to support the qualification and validation of analytical methods in a phase-dependent manner
  • Supporting safety and efficacy assessment for multiple-site clinical trails all the way to commercial batch release for top notch cell therapy communities
  • Discussing several case studies on how we have become a partner of choice for developing potency as well as surrogate assays to assess cell therapy efficacy

Regulatory Experience Case Studies to Avoid Regulatory Pushback

11:30 am Industry Considerations to Hit Regulatory Guidelines & Reduce Delays to Acceptance

  • Eesha Vyas Regulatory Affairs Manager, Oncology, GlaxoSmithKline

Synopsis

  • Exploring how to approach submitting filings with regulatory bodie
  • Defining the strategy to get seamless acceptance of analytical protocols for a cell therapy product
  • Sharing experience of common questions from regulatory boards and explaining how these were addressed

12:00 pm Case Study: What are the Regulatory, Analytical & Process Development Considerations for Decentralised Point of Care?

  • Chaya Mazouz Vice President, Quality (IL) & Global Regulatory Affairs, Orgenesis

Synopsis

  • Reviewing the importance of decentralised point of care manufacturing in autologous cell therapies
  •  Navigating the regulatory environment – suggested regulatory path
  •  Exploring the subsequent analytical and process development considerations

12.30 pm Lunch Break & Networking

Reference Standards for State-of-the-Art Analytical Development

1:30 pm Producing Reference Materials for Cell Therapies

  • Katherine Cornish Senior Stem Cell Biologist, Head of Cell Therapy, UK Stem Cell Bank, NIBSC

Synopsis

  • Developing flow cytometry reference reagents for cell therapies
  • Reviewing the first WHO collaborative study on MSCs and cell types comparison study
  • Exploring the future work of the NIBSC and the WH

2:00 pm T2Evolve IMI Consortium: Harmonising Analytical Methods for Engineered T Cells From Leukapheresis to Immunomonitoring

  • Hélène Negre EPFIA Project Leader, T2Evolve IMI Consortium, Servier

Synopsis

  • Vision of T2Evolve IMI consortium
  • Mapping of current analytical practices through a European survey
  • Process for the elaboration of Gold Analytical Standards

2:30 pm Roundtable Session: Addressing the Lack of Standards

  • Assegid Oumie Principal Scientist, Analytical Development Lead, Enara Bio

Synopsis

  • What are the challenges for cell therapy reference standards that you are facing?
  • What product attribute is important to calibrate against a reference standard? How best do we measure cell product attribute?
  • Are there any unique considerations for evaluating stability of cell therapy reference standards? How are acceptance criteria established?

3.00 pm Afternoon Break & Poster Session

Best-in-Class Characterisation & Analysis of Cell Therapies

4:00 pm Final Product Characterisation of Autologous Cell Therapy: How Much is Really Needed?

Synopsis

  • What characterisation is needed and at what stages?
  • Review what the characterisation can be used for
  • Discussion of aligned characterisation and analysis of starting material, final product, and clinical samples

4:30 pm Methods to Characterise NK Cells for Best-in-Class Cellular Therapeutics

  • Yvet Noordman Head of Analytical Development, Bioanalytics Genomic Medicine, Sanofi

Synopsis

  • Sanofi off-the-shelf NK-cell platform is based on NK-cells from a unique universal donor, expanded and activated ex vivo using the PM21 particle technology
  • Outlining approaches on characterisation of expanded NK cells
  • Addressing how to overcome challenges with measuring low levels of cellular impurities

5:00 pm Chair’s Closing Remarks & End of Day One