Alexander Tester

Project Manager - Pixel Perfect

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Amelia Clark

Head of Regulatory Policy Europe - ClientCare Inc.

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Ava Martinez

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

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Benjamin Wilson

Head of Biology - Secure Tech

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Charlotte Anderson

Director - Pharmacology - Skyline Solutions

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Chloe Nelson

CSO COO - Prime Marketing

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Daniel Smith

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

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David Adams

Director Alliance Management - Cloud Solutions

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Ella Allen

Professor - Thoracic & Cardiovascular Surgery - Digital Growth

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Emily Carter

Chief Executive Officer - Bright Solutions

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Day 3

7.00 Check In & Morning Coffee

Speaker

7.50 Workshop A

Optimising Non-Viral mRNA-Loaded Formulations to Improve Immunogenicity & Route of Administration

Drug delivery remains the biggest challenge to truly unlocking mRNA potential, yet the current delivery systems in the market do not offer effective targeting, reduced immunogenic responses and ultimately not enough clinical validation for new therapies and vaccines. With the rise of creative LNP formulations, modifications and structures along with novel carriers from peptides and…

Speakers

9.50 Morning Break & Networking

10.10 Workshop B

De-LIVER – Solving Extra-Hepatic Targeting Bottlenecks With Delivery to Combat Rare Diseases

Recent advances in mRNA technology and its delivery have enabled mRNA-based therapeutics to enter a new era in medicine with unlimited potential. The rapid, potent, and transient nature of mRNA-encoded proteins, without the need to enter the nucleus or the risk of genomic integration, makes them desirable tools for treatment of a range of diseases.…

Speakers

  • Ethan Taylor

    Ethan Taylor
    Chief Executive Officer - Global IT Solutions

  • Isabella Miller

    Isabella Miller
    Executive Director - Technology Development, Chemistry, Manufacturing, & Controls - Creative Minds

11.40 Lunch Break & Networking

12.40 Workshop C

mRNA & Gene Editing – Delineating the Convergence of mRNA’s Potential as a Tool to Treat Genetic Diseases

With the UK approval of the world’s first gene-editing treatment for blood cancer, the race is now on to develop next-generation gene editing technologies leveraging mRNA technology with the mission to develop curative therapies for some of the most challenging genetic diseases. With a convergence of academic and industry collaborations to focus on bringing these…

Speaker

2.10 Afternoon Break & Networking

2.30 Workshop D

High Quality mRNA at Low Cost – Improving the Process to Design & Produce mRNA Efficiently Karthi Test

With the rise in discovery tools, sequence optimization and process advancements to accelerate and economise drug development, the mRNA field is undergoing a radical transformation to improve mRNA vaccine and therapeutic production. However, there remain significant challenges to adopt and translate this knowledge into real-world applications and to leverage these platforms with the potential to…

Speaker

4:42 pm

4.45 EXPERT Workshop

Unlocking the Potential of mRNA within a Collaborative European Ecosystem

YOUR ROADMAP TO EUROPEAN PARTNERSHIPS The EU is actively building an ecosystem to support the development and commercialisation of RNA therapeutics through various initiatives, funding opportunities, public-private collaborations, infrastructure support and expert networks. Health biotechnology or biopharmaceutical R&I is supported substantially by the EU R&I Framework Programmes, with over 1,250 Horizon 2020 and nearly 600…

Speakers

6.45 End of mRNA Technology & Innovation Day

Day 1

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

  • Amelia Clark

    Amelia Clark
    Head of Regulatory Policy Europe - ClientCare Inc.

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

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

  • David Adams

    David Adams
    Director Alliance Management - Cloud Solutions

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

Day 2

7.00 Morning Coffee & Networking

7:50 am

Chair’s Opening Remarks

Advancing mRNA Vaccines & Therapies Towards the First Approval With Breaking First-InHuman Clinical Progress Data from Leaders in the Clinic

8:00 am

Safety, Tolerability, Pharmacokinetics & Target Engagement of ETH47 in Healthy Subjects

Showcasing nasal administration of ETH47 development for the prevention of virusdriven exacerbation in patients with asthma Demonstrating data on safety and well tolerated and not systemically bioavailable in healthy trial participants Overall, results present a dose-dependent local target protein induction

8:30 am

Technical & Clinical Progress in mRNA Therapeutics Beyond COVID-19 Vaccine

Demonstrating Abogen’s unique mRNA and LNP platform Clinical progress of mRNA cancer vaccine Future perspectives of mRNA therapeutics

Speaker

9:00 am

An mRNA Knowledge Library: Deep Profiling of Wild Type & Modified T7 Polymerases & Their Impacts on IVT Performance

A high throughput screening (HTS) workflow was developed to enable comprehensive evaluation of T7 polymerase as a critical raw material in mRNA production Total 4 of wild type and 16 of modified T7 polymerases were systematically evaluated via DOE based IVT optimizations and subsequently mRNA analytics  A ranking system including mRNA production performance, supply chain,…

9.30 Morning Networking Break

Turbocharging Antigen Selection & Design to Optimise mRNA Vaccine Safety & Tolerability for Emerging Infectious Diseases

Scale & Transfer – Leveraging Sustainable Platforms to Produce mRNA Products Effectively & Affordably for LMICs

10:00 am

Development of a Gonorrhea Vaccine Using the mRNA Platform Established at Afrigen

Overview of mRNA platform established in Afrigen Platform for sustainability with pipeline of disease targets Showcasing mRNA Gonorrhea vaccine as one of the pipeline targets, and early preclinical results

10:00 am

Techno-Economic Modelling for Sustainable, Low Cost & Scalable mRNA Medicines Manufacturing for LMICs

Techno-economic comparison of batch vs continuous mRNA manufacturing Techno-economic comparison of single use consumable vs multi-use equipment-based mRNA manufacturing The impact of automation on financially sustaining mRNA medicines manufacturing capacity during non-outbreak periods

Speaker

10:30 am

Session Reserved for: Immagina Biotechnology

10:30 am

Session Reserved for: Merck

11:00 am

Development of mRNA Vaccine Candidates for Pandemic Influenza

Optimising design of different HA candidates Unravelling in vivo proof of concept data for an mRNA influenza vaccine Demonstrating scaling up and process development methods

11:00 am

Towards Global Access & Equity for mRNA Technology: An Update from Afrigen Biologics

Unlocking mRNA vaccine design, development and production geared to enable LMICs to produce mRNA products Establishing a “green fields” mRNA end to end commercial production process Product innovations for effective, affordable and accessible mRNA vaccines for neglected diseases suitable for LMICs and relevance to pandemic preparedness

11.30 Lunch Break & Networking

Achieving Effective Cell & Tissue Targeting, Distribution & Translatability with Novel LNP Formulations

12:30 pm

Development of a Diversity-Oriented Lipid Library to Fight Diseases

A platform approach for LNP screening LNPs targeted for liver delivery LNPs targeted for immune cell delivery

OPPORTUNITY FOR PARTNERSHIP

TRACK A: DISCOVERY & PRE-CLINICAL DEVELOPMENT

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

1:30 pm

Unlocking mRNA Therapies Through Spatial Delivery

Demonstrating mRNA delivery to lung – case study lessons from mice to non-human primates Showcasing mRNA delivery to the spleen Presenting alternatives to current LNP systems for intramuscular vaccination 

2.00 Afternoon Break & Networking

Disruptive Companies Unlocking Diseases of Tomorrow With New Models Systems & Bioinformatic Approaches

Showcasing the emergence of new European Biotechs breaking through the mRNA industry and ready to present their exciting preclincal research

2:35 pm

IL-35 mRNA Therapeutic Local Expression in the Liver Suppresses Autoimmune Hepatitis

IL35 is a potent immunosuppressive cytokine regulating innate and adaptive immunity IL35 mRNA local expression in the liver reverses acute hepatitis IL35 mRNA therapeutics inhibits specifically auto-antibodies in chronic autoimmune hepatitis

3:00 pm

mRNA Therapeutic Vaccine Targeting Human IL-4 & IL-13 Protects Against Asthma

Showcasing first-in-class mRNA therapeutic product for asthma Presenting pre-clinical data in humanized mice Highlighting CMC and clinical programs

Speaker

3:25 pm

A First-In-Class Technology for mRNA Delivery

Demonstrating first-in-class mRNA delivery technology at Nuntius Therapeutics Utilising novel machine learning guided discovery techniques Sharing case-study examples of tissue targeting carriers

4:00 pm

End of 4th mRNA-Based Therapeutics Summit Europe 2025

6:15 pm

Chair’s Closing Remarks

Speaker

  • Amelia Clark

    Amelia Clark
    Head of Regulatory Policy Europe - ClientCare Inc.

Day 2

7.00 Morning Coffee & Networking

7:50 am

Chair’s Opening Remarks

Advancing mRNA Vaccines & Therapies Towards the First Approval With Breaking First-InHuman Clinical Progress Data from Leaders in the Clinic

8:00 am

Safety, Tolerability, Pharmacokinetics & Target Engagement of ETH47 in Healthy Subjects

  • Showcasing nasal administration of ETH47 development for the prevention of virusdriven exacerbation in patients with asthma
  • Demonstrating data on safety and well tolerated and not systemically bioavailable in healthy trial participants
  • Overall, results present a dose-dependent local target protein induction
8:30 am

Technical & Clinical Progress in mRNA Therapeutics Beyond COVID-19 Vaccine

  • Demonstrating Abogen’s unique mRNA and LNP platform
  • Clinical progress of mRNA cancer vaccine
  • Future perspectives of mRNA therapeutics

Speaker

9:00 am

An mRNA Knowledge Library: Deep Profiling of Wild Type & Modified T7 Polymerases & Their Impacts on IVT Performance

  • A high throughput screening (HTS) workflow was developed to enable comprehensive evaluation of T7 polymerase as a critical raw material in mRNA production
  • Total 4 of wild type and 16 of modified T7 polymerases were systematically evaluated via DOE based IVT optimizations and subsequently mRNA analytics 
  • A ranking system including mRNA production performance, supply chain, and cost analysis for each T7 polymerase was established to support RecBioPharm’s advanced mRNA technology platform

9.30 Morning Networking Break

Turbocharging Antigen Selection & Design to Optimise mRNA Vaccine Safety & Tolerability for Emerging Infectious Diseases

Scale & Transfer – Leveraging Sustainable Platforms to Produce mRNA Products Effectively & Affordably for LMICs

10:00 am

Development of a Gonorrhea Vaccine Using the mRNA Platform Established at Afrigen

  • Overview of mRNA platform established in Afrigen
  • Platform for sustainability with pipeline of disease targets
  • Showcasing mRNA Gonorrhea vaccine as one of the pipeline targets, and early preclinical results
10:00 am

Techno-Economic Modelling for Sustainable, Low Cost & Scalable mRNA Medicines Manufacturing for LMICs

  • Techno-economic comparison of batch vs continuous mRNA manufacturing
  • Techno-economic comparison of single use consumable vs multi-use equipment-based mRNA manufacturing
  • The impact of automation on financially sustaining mRNA medicines manufacturing capacity during non-outbreak periods

Speaker

10:30 am

Session Reserved for: Immagina Biotechnology

10:30 am

Session Reserved for: Merck

11:00 am

Development of mRNA Vaccine Candidates for Pandemic Influenza

  • Optimising design of different HA candidates
  • Unravelling in vivo proof of concept data for an mRNA influenza vaccine
  • Demonstrating scaling up and process development methods
11:00 am

Towards Global Access & Equity for mRNA Technology: An Update from Afrigen Biologics

  • Unlocking mRNA vaccine design, development and production geared to enable LMICs to produce mRNA products
  • Establishing a “green fields” mRNA end to end commercial production process
  • Product innovations for effective, affordable and accessible mRNA vaccines for neglected diseases suitable for LMICs and relevance to pandemic preparedness

11.30 Lunch Break & Networking

Achieving Effective Cell & Tissue Targeting, Distribution & Translatability with Novel LNP Formulations

12:30 pm

Development of a Diversity-Oriented Lipid Library to Fight Diseases

  • A platform approach for LNP screening
  • LNPs targeted for liver delivery
  • LNPs targeted for immune cell delivery

OPPORTUNITY FOR PARTNERSHIP

TRACK A: DISCOVERY & PRE-CLINICAL DEVELOPMENT

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

1:30 pm

Unlocking mRNA Therapies Through Spatial Delivery

  • Demonstrating mRNA delivery to lung – case study lessons from mice to non-human primates
  • Showcasing mRNA delivery to the spleen
  • Presenting alternatives to current LNP systems for intramuscular vaccination 

2.00 Afternoon Break & Networking

Disruptive Companies Unlocking Diseases of Tomorrow With New Models Systems & Bioinformatic Approaches

Showcasing the emergence of new European Biotechs breaking through the mRNA industry and ready to present their exciting preclincal research

2:35 pm

IL-35 mRNA Therapeutic Local Expression in the Liver Suppresses Autoimmune Hepatitis

  • IL35 is a potent immunosuppressive cytokine regulating innate and adaptive immunity
  • IL35 mRNA local expression in the liver reverses acute hepatitis
  • IL35 mRNA therapeutics inhibits specifically auto-antibodies in chronic autoimmune hepatitis
3:00 pm

mRNA Therapeutic Vaccine Targeting Human IL-4 & IL-13 Protects Against Asthma

  • Showcasing first-in-class mRNA therapeutic product for asthma
  • Presenting pre-clinical data in humanized mice
  • Highlighting CMC and clinical programs

Speaker

3:25 pm

A First-In-Class Technology for mRNA Delivery

  • Demonstrating first-in-class mRNA delivery technology at Nuntius Therapeutics
  • Utilising novel machine learning guided discovery techniques
  • Sharing case-study examples of tissue targeting carriers
4:00 pm

End of 4th mRNA-Based Therapeutics Summit Europe 2025

6:15 pm

Chair’s Closing Remarks

Speaker

Heading