Conference Day Two

7.00 Morning Coffee & Networking

7:30 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

Synopsis

  • 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

  • Bo Ying Chief Executive Officer, Abogen Biosciences

Synopsis

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

9:00 am An mRNA Knowledge Library: Deep Profiling of Wild Type & Modified T7 Polymerases & Their Impacts on IVT Performance

  • Jing Zhu Vice President & Head of Process Development, ReciBioPharm

Synopsis

  • 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

TRACK A: DISCOVERY & PRE-CLINICAL DEVELOPMENT

Synopsis

Chair: Adèle Schmitt, Expert Scientist, GSK

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

10:15 am Development of a Gonorrhea Vaccine Using the mRNA Platform Established at Afrigen

  • Caryn Fenner Executive manager: mRNA Hub, Afrigen Biologics

Synopsis

  • 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

10:45 am Session Reserved for:

Synopsis

Immagina Biotechnology

11:15 am Development of mRNA Vaccine Candidates for Pandemic Influenza

Synopsis

  • 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

TRACK B: CLINICAL DEVELOPMENT & MANUFACTURING

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

10:15 am Techno-Economic Modelling for Sustainable, Low Cost & Scalable mRNA Medicines Manufacturing for LMICs

  • Zoltán Kis Associate Professor – Department of Chemical & Biological Engineering, University of Sheffield

Synopsis

  • 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

10:45 am Opportunity for Partnership

11:15 am Towards Global Access & Equity for mRNA Technology: An Update from Afrigen Biologics

  • Amin Khan Chief Science Advisor, WHO MRNA Program, Afrigen Biologics

Synopsis

  • 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

11.45 Lunch Break & Networking

TRACK A: DISCOVERY & PRE-CLINICAL DEVELOPMENT

Synopsis

Chair: Adèle Schmitt, Expert Scientist, GSK

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

12:45 pm Development of a Diversity-Oriented Lipid Library to Fight Diseases

Synopsis

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

1:15 pm Unlocking mRNA Therapies Through Spatial Delivery

Synopsis

  • 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 

TRACK B: CLINICAL DEVELOPMENT & MANUFACTURING

Assessing Safety, Measures & Pandemic Preparedness to Minimise Future Risks & Accelerate Response to Health Threats & Patient-Centric Decision Making

12:45 pm Uncovering Key Critical Safety Requirements for Clinical & Post-Authorisation Measures for mRNA Vaccines & Therapeutics

  • Marie Caby-Tosi European Economic Area/ United Kingdom Qualified Person for Pharmacovigilance, Moderna

Synopsis

  • Leveraging case study examples on safety and pharmacovigilance for mRNA-based vaccines for COVID-19 and RSV
  • Establishing regulatory measures for emerging safety concerns and restrictions, with patient and healthcare professionals in mind
  • Shaping a risk management plan for pharmacovigilance, post authorization studies, and risk minimization measures for future mRNA vaccines and therapeutics

1:15 pm Fireside Discussion: mRNA Pandemic Preparedness – Ensuring Speed, Manufacturability & Supply of mRNA Drugs With Coordinated Global Efforts to Ensure Benefit for All

Synopsis

  • What is required to ensure mRNA vaccine development at speed with a coordinated effort? 
  • How to accelerate mRNA vaccine process manufacturing to combat future pandemics?
  • How can we apply learnings to promote global access to mRNA technology that will be key for pandemic preparedness?

1.45 Afternoon Break & Networking

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

Synopsis

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

2:30 pm IL-35 mRNA Therapeutic Local Expression in the Liver Suppresses Autoimmune Hepatitis

Synopsis

  • 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

2:55 pm mRNA Therapeutic Vaccine Targeting Human IL-4 & IL-13 Protects Against Asthma

Synopsis

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

3:20 pm A First-In-Class Technology for mRNA Delivery

  • Albert Kwok Co-Founder & Chief Scientific Officer, Nuntius Therapeutics

Synopsis

  • 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

3:45 pm Chair’s Closing Remarks

4:00 pm End of 4th mRNA-Based Therapeutics Summit Europe 2025