Agenda

7.20 Check In & Morning Coffee

8:20 am

Chair’s Opening Remarks

Speaker

  • Daniel Smith

    Daniel Smith
    Senior Vice President - Ribonucleic Acid Biochemistry & Chemistry Manufacturing & Controls Development - Tech Innovations

Visions for the Future of mRNA & Beyond: The Leadership Perspective

Speaker

9:15 am

Current Cancer Vaccine Strategies Including Initial Phase 1 Study Data of CVGBM, an Off-the-Shelf Cancer Vaccine in Glioblastoma

Cancer vaccines based on mRNA technologies have shown encouraging clinical data over the last couple of years Showcasing current strategies to develop cancer vaccines focus on either personalized cancer vaccines or off-the-shelf cancer vaccines Presenting CVGBM, an off-the-shelf cancer vaccine, that demonstrated encouraging immunogenicity in a phase 1 study in patients with GBM after tumor…

Speaker

  • Olivia Johnson

    Olivia Johnson
    Chief Executive Officer & Head of Translational Research & Alliance Management - People First Co.

10:15 Morning Break & Speed Networking

TRACK A: DISCOVERY & PRE-CLINICAL DEVELOPMENT

Chair: Nigel Horscroft, Chief Technology Officer, Stealth Mode mRNA Biotech

Speaker

Deciphering a Regulatory Framework & Guidance for Future mRNA Platforms to Harmonise Clinical & Manufacturing Development

Speaker

11:15 am

The Value of a Harmonised Regulatory Framework for mRNA Medicines

mRNA platform technology approaches supported by regulatory provisions Diverse regulatory understanding of platform technology from various perspectives Examples of platform technology – platform technology approaches today and in the future

Speaker

12:15 pm

Harnessing In Vivo Therapeutic Antibody Production Enabled by mRNA-LNP Technology

Outlining novel mRNA-LNP platform for mRNA therapeutic antibody production Exploring therapeutic antibody potential from discovery to pre-clinical development Overcoming key challenges of in vivo protein expression for successful translation of mRNA-based therapeutics

Speaker

12:15 pm

Swiss Regulatory Aspects & Evaluation for mRNABased Vaccines & Therapeutic Pathways to Approval

Exploring harmonisation regulatory challenges and expectations for new mRNA drugs applications and documentation Delineating the mRNA platform definition for vaccine, therapeutic and broader applications Highlighting regulatory progress in personalised mRNA cancer vaccines and manufacturing considerations

Speaker

12:45 pm

Session Reserved for: Tebu Bio

Speaker

  • Lily Baker

    Lily Baker
    Senior Product Manager - Advanced Therapeutics OEM - Talent Works

12:45 pm

Session Reserved for: Arcalis

Speaker

12.55 Lunch Break & Networking

Turbocharging new mRNA-LNP Programs to Expand Therapeutic Potential with European Research Initiatives & Collaborations

Forging New Commercial Partnerships to Ensure Smooth Transfer into Trials & Manufacturing at Scale

2:00 pm

REGeRNA Project: Identifying & Developing mRNAEncoded Proteins Towards Novel Therapeutics for Cardiac Tissue Regeneration

Establishing the need for new treatments of heart failure Deciphering a rationale for an mRNA-based strategy for reinducing proliferation of cardiomyocytes Showcasing first results and remaining challenges

Speaker

  • Ella Allen

    Ella Allen
    Professor - Thoracic & Cardiovascular Surgery - Digital Growth

2:30 pm

Multidimensional Characterisation of RNA-Based Vaccines & Therapies

Evaluate potency through the identification of ribosome stalls that reduce protein production Examine purity by discovering the sequences and structures that lead to dsRNA by-products Measure safety through studies of off-target changes in transcription and translation

4.00 Afternoon Break & Poster Session

As the landscape of innovation that is supercharging the next wave of efficacious mRNA vaccines and therapeutics, it is more important than ever to collaborate and learn for the growth of this field. Join our dedicated poster session to share your latest data and get the first look into what your peers are working on!

4:30 pm

Advancing RNA Therapeutics Development: Novel Reagents for DNA Template Production by Rolling Circle Amplification

The rolling circle amplification (RCA) is an isothermal amplification technique that shows promise for generating DNA template for in vitro transcription (IVT) reaction used in therapeutic RNA production. Compared to using bacterial plasmids as DNA templates, RCA offers several advantages as speed, simplicity and safety For mRNA therapeutics development the AOF (animal origin free) reagents…

Speaker

  • Lily Baker

    Lily Baker
    Senior Product Manager - Advanced Therapeutics OEM - Talent Works

5:30 pm

Panel Discussion – A European Industry & Regulatory Perspective on the Development & Approval of mRNA Medicines

Uncovering how regulatory provisions can support mRNA medicines’ approval Reducing the regulatory approval timeline through platform technology approaches Moving towards a harmonized approach for mRNA medicines for the benefit of patients

Speakers

  • Amelia Clark

    Amelia Clark
    Head of Regulatory Policy Europe - ClientCare Inc.

  • Ava Martinez

    Ava Martinez
    Vice President Global Regulatory Affairs & Pre-Clinical - Storyline Media

6:20 pm

End of Conference Day One