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

9:00 am TFF in RNA Workflow: Process Optimization for mRNA, saRNA, & LNP Manufacturing

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

  • Peter Marks Director, CBER FDA
  • Marco Cavaleri Head of Anti-Infectives & Vaccines, European Medicines Agency
  • Nitisha Pyndiah Global Regulatory Lead, GSK
  • Carla Vinals Vice President, Global Regulatory Product Strategy, Moderna
  • Ka-Wai Wan Senior Pharmaceutical Assessor, Medicines & Healthcare products Regulatory Agency

10:15 am Empowering the mRNA Industry with Nucleic Acid Therapeutics: Innovating for Success

  • Sara Henneman General Manager, Nucleic Acid , Thermo Fisher Scientific

Synopsis

This presentation offers an exploration of Thermo Fisher Scientific's unrivaled expertise in nucleic acid therapeutics, specifically tailored to support the mRNA industry. It provides a detailed overview of Thermo Fisher Scientific's extensive capabilities and offerings, highlighting their ability to deliver highly impactful solutions in this dynamic and rapidly evolving field. The presentation features an inspiring customer case study, showcasing Thermo Fisher Scientific's successful track record of supporting businesses in the mRNA industry. This real-life example serves as a testament to the effectiveness and reliability of Thermo Fisher Scientific's solutions and underscores their commitment to driving progress in the mRNA sector.

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 & Therapeutics to Fight Infectious & 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, Head of Innovation and Technology, EpiVax, Inc.


11:45am Radar Therapeutics: Pioneering Precision-Expressed mRNA Therapeutics

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Sophia Lugo, Chief Executive Officer, Radar Therapeutics


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!


 

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

2:15 pm Afternoon Networking Break

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

  • Jason Zhang Co-Founder & Chief Executive Officer, Zipcode Bio

3:15 pm Wellcome Leap’s R3 Program: RNA Readiness & Response

3:45 pm Robust mRNA Production with End-to-End In-Process Analytics

4:15 pm A Perspective on Licensing, Partnership & Financial Evaluations in the Dynamic mRNA Landscape

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

4:45 pm Planning for the Second Half of 2024: Investments, Partnerships & De-Risking Your mRNA Pipeline for 2025

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

5:15 pm Chair’s Closing Remarks

  • Jason Zhang Co-Founder & Chief Executive Officer, Zipcode Bio

5:30 pm End of 4th mRNA-Based Therapeutics Summit 2024