Conference Day 1

Wednesday 6th December 2023

8:00 am
Registration & Morning Coffee

8:50 am
Chair’s Opening Remarks

Examining Potency Assays to Accurately Interpret Biological Activity for Better Understanding of mRNA Drugs

9:00 am Considerations for mRNA Potency Assay Development for Gene Editing Products

  • Benjamin Hall Senior Scientist, Analytical Development, Tessera Therapeutics


  • Overview of matrix approach for potency assay development
  • Review of available regulatory guidances and expectations for phased-based approach to potency assay development
  • Tools and considerations when measuring biological cascade of mRNA delivery in-vitro
  • Challenges associated with potency assay development for gene editing products

9:30 am Roundtable: Trailblazing Potency Assays for a Fine-Tuned Approach to Meeting Specifications & Ensuring the Correct Response is Elicited

  • Benjamin Hall Senior Scientist, Analytical Development, Tessera Therapeutics
  • Rebecca Malott Senior Scientist, Providence Therapeutics


  • How is the field aligning potency assays which are used to show that mRNA expresses the protein?
  • Assessing which assays can be used to show whether the drug product elicits the correct response
  • What is the most reliable combination of potency assays to carry out?
  • Are robust potency assays needed for both drug substances and drug products?

10:45 am Morning Break & Speed Networking


  • As the mRNA assay development community comes together, this valuable session will ensure you can reconnect with your peers in the room to make new and lasting connections. All attendees will have the opportunity to meet and network with their academic and industry colleagues!

Optimizing Bioanalytical Methods to Investigate Mechanism of Action & Determine Quantitation for Robust Translation

11:45 am Bioanalytical Strategies for Advancing mRNA Therapeutics

  • Harkewal Singh Director, Head of Bioanalytics – Nonclinical Sciences, Moderna


  • Lipid Nanoparticle quantitation
  • RT-qPCR vs bDNA for mRNA quantitation
  • Approaches for protein and Anti-Protein Antibody quantitation

12:15 pm Illuminating the Mechanism of Action for LNP/mRNA-Based Vaccines by Employing Fluorescent Based Assays

  • Alisa Zhilin-Roth Senior Scientist, Discovery Biology - In-vitro and Mechanism, Sanofi


  • Fluorescent-based assays to explore the Mechanism of Action for LNP/mRNA-Based Vaccines
  • Determining cellular LNP internalization, trafficking, and RNA cargo release by High content confocal microscopy
  • Assess the translation of released mRNAs by fluorescent microscopy assays

12:45 pm
Networking Lunch Break

Shining a Spotlight on Advances in mRNA Quality Assessment Tools to Improve Drug Efficacy

1:45 pm Digital PCR for Analysis of RNA Quality Parameters


  • Introducing dPCR technology for quality control analytics
  • Analysis of identity and ratio of RNA mixtures
  • Correlation of dPCR RNA quality data with classic capillary electrophoresis method

2:15 pm Development of Analytical Methods for Endless RNA (eRNA)

  • Dinesh Manvar Associate Director, Analytical development, Sail Biomedicines


  • Overview of endless RNA (eRNA)
  • Key structural differences between mRNA and eRNA  
  • Development of a platform-based HPLC purity method 

Increasing Assay Sensitivity to Accurately Assess mRNA Expression for Improved Safety & Efficacy

2:45 pm Methods to Assess Functional Protein Expression & Biodistribution for Development of Inhaled mRNA Therapeutics


  • What methods can you use to ensure that functional protein is being expressed in vitro and in vivo preclinical models?
  • Methods to confirm expression of your protein in the desired target cells/tissues
  • Sensitive tools to look for expression of your protein in non-target organs

3:15 pm
Chairs Closing Remarks & End of Conference Day One

  • Shilpi Mahajan Associate Director, Head of Bioanalytics, Switch Therapeutics