Conference Day Two

Wednesday July 31, 2024

8:00 am Morning Check In & Coffee

8:20 am Chair’s Opening Remarks

De-Risking Your Pipelines with Guidance from Regulatory Experts to Realize the Promise of mRNA

8:30 am Discussing the Regulatory Expectations for mRNA-Based Therapeutics & Vaccines Against Infectious Diseases, Cancer & Rare Diseases

  • Peter Marks Director - Center for Biologics Evaluation & Research, US Food & Drug Administration (FDA)

9:00 am Session Reserved For:

Synopsis

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9:30 am Panel Discussion: Uniting Regulatory Experts from Industry & Agencies to Navigate the Complex Landscape for mRNA-Based Medicines

  • Peter Marks Director - Center for Biologics Evaluation & Research, US Food & Drug Administration (FDA)
  • Marco Cavaleri Head of Public Health Threats, European Medicines Agency
  • Emily English Senior Vice President, Head of Manufacturing Operations, Cartesian Therapeutics
  • Nitisha Pyndiah Global Director - Global Regulatory Affairs Lead, GlaxoSmithKline Plc
  • Carla Vinals Head Of Regulatory Affairs, Moderna
  • Ka-Wai Wan Senior Pharmaceutical Assessor, Medicines & Healthcare products Regulatory Agency

10:15 am Session Reserved For:

Synopsis

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10:45 am Morning Networking Break

Track 1: Discovery

Discovery

Chair: Denny Kraichely, Global Program Leader, Vaccine Development Management, Pfizer

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Accelerating the Development of Personalized & Prophylactic mRNA-Based Vaccines to Fight Infectious and Oncological Diseases 


11:15am Advancing Immunoinformatic Tools for Epitope Mapping to Supercharge Development of mRNA-Based Personalized Cancer Vaccines

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Guilhem Richard, Chief Scientific & Technology Officer, Epivax Therapeutics


11:45am Session Available for Partnership – Contact Us to Find Out More

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12:15pm Innovac’s End-To-End Approach to Capitalize on the mRNA Revolution in the Vaccine Industry

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Nicholas Valiante, Co-Founder & Chief Scientific Officer, Innovac Therapeutics New Company!


Track 2: Translation
Track 3: Clinical Development
Track 4: CMC

12:45 pm Lunch & Networking Break

Track 1: Discovery

Discovery


Elucidating the Fate of the mRNA Payload Inside the Cell for Increased Delivery Efficiency & Expression 


1:45pm Decoding the Dance: Unravelling the Moves of LNP-mRNA-based Vaccines

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Alisa Zhilin Roth, Senior Scientist, In vitro & Mechanism, Sanofi New Data!


2:15pm Roundtable: Measuring Cellular Uptake & Endosomal Escape Through Bespoke Assay Development to Turbocharge Delivery Efficiency

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2:45pm Radar Therapeutics: Pioneering Precision-Expressed mRNA Therapeutics

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Sophia Lugo, Chief Executive Officer, Radar Therapeutics New Company!


Track 2: Translation
Track 3: Clinical Development
Track 4: CMC

3:15 pm Afternoon Networking Break

Gearing up for 2025: Licensing, Partnership & Financial Considerations in the Dynamic mRNA Landscape

3:45 pm Wellcome Leap’s R3 Program: RNA Readiness & Response

4:15 pm Session Reserved For:

Synopsis

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4:45 pm A Perspective on Licensing, Partnership & Financial Evaluations in the Dynamic mRNA Landscape

  • Matthew Hawryluk Executive Vice President, Chief Business Officer & Head, Gritstone bio, Inc.

5:15 pm Planning for the Second Half of 2024: Investments, Partnerships & De-Risking Your mRNA Pipeline for 2025

  • Gad Berdugo Managing Partner, Explorium Capital LLC; Nutcracker Therapeutics New Company!

5:45 pm Chair’s Closing Remarks

6:00 pm End of 4th mRNA-Based Therapeutics Summit 2024