Pre-Conference Workshop Day

*All times listed are Central European Time (CET)*

Tuesday, 25th January

Workshop A - Achieving Individualised Treatments with Patient Specific mRNA-Based Vaccines & Therapies

The breakthrough of synthetic mRNA- based vaccines for COVID-19 has marked the limitless opportunity for synthetic mRNA technology. With increasing investment within the biopharmaceutical industry on mRNA platforms, this opens novel avenues and directions, with focus now being turned to address the potential of individualised treatments for patient specific synthetic mRNA- based vaccines and therapies. This workshop will elevate the challenges, opportunities and innovative ideas, determined to disrupt the current applications of mRNA- based vaccines and therapies towards better precision and individualisation.

Key topics include:

• How to better leverage genetic profiles to stratify patient subpopulations for tailored mRNA- based vaccines and therapeutics

• How to design clinical studies to validate an individualised treatments for regulatory approval

• How to address development, scalability, and applicability challenges of individualised mRNA- based vaccines and therapeutics towards commercial viability

• How to broaden the horizon of individualisation of mRNA -based vaccines and therapies to address unmet clinical needs

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Workshop B - Considerations for Analytical & Bioanalytical Characterisation of mRNA- Based Vaccines & Therapeutics to Improve Quality

With the successful expansion of mRNA- based therapeutic applications to prophylactic vaccines at an accelerated pace during the COVID-19 pandemic, this was the global and historical breakthrough of this new technology. However, there is now a larger necessity to characterise mRNA to better understand its mechanisms of action and the corresponding performance systems also in other therapeutic areas beyond the infectious diseases area. A deeper understanding of the impact of the delivery mechanisms and platforms is needed. Novel analytical approaches, specifically within formulation, purification and high throughput automation needs to be developed to identify the corresponding attributes helping to address, test and analyse such (future) systems. Phase appropriate analytical- and incremental product development is needed for the adequate selection of the analytical methods for mRNA- based therapeutics to improve quality control and individualisation.

A deeper focus is needed and will be explored in this workshop to combat the challenges and provide solutions for the future of analytical technology.

Key topics include:

• mRNA and DNA based therapeutics - similarities and differences from CMC Analytics perspective?

• Success of prophylactic mRNA, what is missing in the case of therapeutic mRNA?

• How to better characterize and analyse mRNA to assess drug product or drug substance quality and efficacy?

• How to develop and improve quantitative, robust, and rapid analytical testing for mRNA- based therapeutics?

• How to address challenge of individualisation of mRNA- based therapeutics through analytical processes?

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Roland Pach
Global Expert Cell
& Gene Therapy
Analytics
Roche Pharmaceuticals

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Elaine Peters
Director - Analytical Lead
Genentech