Pre-Conference Workshop Day

Wednesday, November 6, 2024

8:00 am Check In & Morning Coffee

Workshop A

8:30 am Innovating Characterization Techniques to Fully Grasp the Lipid Nanoparticle Potential

Synopsis

Tessera Therapeutics continue to expand possibilities in genetic medicine, with lipid nanoparticles at the core of what they do. Dive deep into the art of thorough lipid nanoparticle characterization with Mohit, who will be outlining their unique techniques and how this can be applied across varying formulations

  • Outlining the impact of the method of particle concentration determination
  • Estimating the presence and quantity of empty LNPs
  • Quantifying the targeting moiety amount of LNPs

10:30 am Networking Break & Refreshments

Workshop B

11:00 am Navigating the Regulatory Frameworks To Spearhead the Drive for Increased LNP Approvals

  • Yun Liu Intellectual Property Counsel, Moderna

Synopsis

The LNP world will long celebrate the approval of Moderna’s COVID-19 vaccine – but how did they achieve such a feat?

Join representatives from Moderna to debunk the regulatory myths and share their pathway to success, in addition to fundamental lessons learnt which have been taken forward!

  • Sharing insights into regulatory interactions experienced when preparing submission of LNP drug products
  • Revealing the quantity and quality of data packages required to satisfy the regulatory bodies
  • Developing an analytical structure from early-stage development with regulatory guidelines at the forefront of design

1:00 pm Lunch & Networking

Workshop C

2:00 pm Implementing a Robust Analytical Strategy To Generate Characterization Datapoints Indicative of Functionality

Synopsis

Collaborate with esteemed LNP expert, as Carlo hosts an interactive deep dive into how to create a bulletproof analytical strategy.

Creation of an all-encompassing data package whilst ensuring efficiency of resources is paramount to LNP development success. How robust is your strategy?

  • Brainstorming analytical frameworks developed from early stage to late stage to optimize understanding of the LNP
  • Utilizing analytics to assist discovery of next-generation LNP formulations
  • Debunking the current analytical pitfalls to rationalize what is working and what requires updating

4:00 pm End of Pre-Conference Workshop Day