Conference Day Two

Thursday 31st August 2023

8:30 am
Registration Opens & Morning Coffee

9:20 am Chair’s Opening Remarks

Navigating Through the Regulatory Expectations & Genetic Profiling of mRNA Vaccines & Therapeutics

9:30 am Regulatory Expectations for mRNA Therapeutics and Vaccines

  • Francis Galaway Quality Assessor, Medicines & Healthcare Products Regulatory Agency (MHRA)

Synopsis

  • UK regulatory perspectives on marketing authorisation applications
  • What do regulators look for in the characterisation and manufacturing control of mRNA therapeutics?
  • Applying this information to your own licensing applications with the MHRA

10:00 am Exploring How We Can Narrow the Gap Between the In Vitro & In Vivo Genetic Profiles

Synopsis

  • Understanding the challenges with in vivo distribution of the mRNA and how it can be targeted to specific tissues
  • Tackling the bottlenecks with the misalignments of in vitro tests to in vivo animal model testing to accelerate the development of new treatments and improve patient outcomes

10:30 am A Comprehensive Overview of the Advancements of Using Next Generation Sequencing to Enhance mRNA Sequencing

Synopsis

  • Explore the latest advancements in this technology and how it has made sequencing faster, more accurate, and more accessible

11:00 am
Morning Break & Networking

12:00 pm Panel Discussion: Reviewing Standards & Regulatory Requirements of the Analytical Field of mRNA-based Therapeutics to Accelerate Approvals

  • George Dakwar Associate Director, Head of Drug Delivery & Formulation, VaxEquity Ltd.
  • Iulia Oita Chemistry, Manufacturing & Controls Manage, Ziphius Vaccines NV
  • Paolo Martini Chief Scientific Officer, Moderna
  • Camilla Foged Professor, University of Copenhagen

Synopsis

  • Delving into how to give evidence of a state of control and maintain regulatory compliance for your mRNA analytical techniques
  • Revealing how to integrate the new novel mRNA analytical technologies to align with GMP guidelines
  • Understanding how to standardise your mRNA analytical techniques to align to CQA’s & CPI’s to allow efficient and rapid approval

1:00 pm
Networking Lunch

Expanding the Analytical Toolbox to Support Process Development, Formulation & Manufacturing of saRNAs

2:00 pm Employing Advanced Analytical Techniques to Understand the Differences of LNP Interactions with mRNA vs. saRNA

  • George Dakwar Associate Director, Head of Drug Delivery & Formulation, VaxEquity Ltd.

Synopsis

  • Highlight the main differences between mRNA vs. saRNA
  • Impact of lipid composition, N/P ratios on encapsulation efficiency and percentage of loaded vs. unloaded LNPs

2:30 pm Exploring the Analytical Toolbox Supporting Early-Stage Development of Process & Product Development for saRNA Vaccines

  • Iulia Oita Chemistry, Manufacturing & Controls Manage, Ziphius Vaccines NV

Synopsis

  • Analytical tools needed to support process development of saRNA manufacturing
  • Looking into analytical tools needed for formulation development of saRNA LNPs

3:00 pm Exploring the Analytical Development & Optimization of Lipid Nanoparticles as mRNA Delivery Systems to Advance mRNA Therapeutics

Synopsis

  • Review of critical quality attributes and discuss the control strategy for lipid nanoparticles
  • Delving into the methods used to characterize lipid nanoparticles to understand their performance under different conditions 
  • Discuss analytical challenges and opportunities for lipid nanoparticles

3:30 pm
Chair’s Closing Remarks & End of Summit

CONFERENCE DAY ONE
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