• Understanding how AI is being used end-to-end for vaccine discovery, development, manufacturing, regulatory, clinical trials, and licensure 
• Streamlining antigen discovery and design e.g., identifying T cell epitopes, optimizing noncoding RNA vaccine sequences
• Clinical trials: Could AI have a place in protocol writing and patient communication?
• Expanding the role of in silico tools in vaccine CMC e.g., digital twin technology for process optimization, automated viral infectivity assays
• Advances in bioinformatics models for pandemic preparedness

• Updates on RNA vaccine R&D in key areas e.g., flu, RSV, and combinations
• Opportunities and challenges for novel nucleic acid vaccine platforms e.g., saRNA, circRNA
• Innovative cap analogs for improved stability and reduced immunogenicity
• Improved delivery systems – next-gen LNPs and LNP alternatives
• Addressing IP challenges in mRNA-LNP development
  
  
  
  
  
  
  
  
  
  
  
  

• Achieving a resilient raw materials supply chain
• Developing digital tools to effectively model and manage the supply chain
• Flexibility and modular manufacturing to maintain supply chains during shortages
• Improving the environmental sustainability of the vaccine supply chain
• Maintaining cold chain worldwide with advanced freezer technology and real-time digital monitoring
• Ensuring more efficient delivery with improvements in formulation, alterative delivery methods, and logistics 
  
  
  
  
  
  
  
  
  
  

NEW!
Manufacturing: improving efficiency

• Integrating Pharma 4.0 principles in vaccine manufacturing
• Automated manufacturing of diverse vaccine platforms, from protein to viral vector 
• Reducing wastage and improving sustainability of single-use systems
• Achieving more efficient purification 
• Overcoming bottlenecks in continuous manufacturing e.g.,  continuous ultra/diafiltration, single-pass tangential flow filtration (SPTFF), fixed bed bioreactors
• Bringing down the high costs of GMP facilities and raw materials 
• Overcoming downstream bottlenecks in products with high upstream titers e.g., in mRNA and viral vector vaccines

• Developing and validating robust analytical methods for product characterization, batch release, and stability studies 
• Applying quality by design and statistical tools to expedite release of batches
• Implementing the appropriate process analytical technology and real-time monitoring to optimize workflow while remaining cost effective
• Multiplex assays for analysis of complex/combination vaccines
• Will cell-based assays be replaced with newer technologies e.g., HPLC, LCMS, NGS?
• Regulatory challenges for platform pre-qualification

• Replacing animal models with robust in vitro models (e.g., organoids) for early phase development and potency determination
• Exploring new technologies in single cell analysis and high-throughput screening e.g., mass cytometry, high-throughput microscopy
• Improving prediction of reactogenicity before human trials e.g., cytokine release studies
• Validating and standardization complex bioassays, e.g., T cell assays
• Multiplex approaches to antigen selection and design 
• New directions in vaccine research e.g., autoimmune conditions, antibiotic-resistance pathogens, new platforms

RNA: manufacturing and analytics

• Progress in synthetic (plasmid-free) manufacturing of mRNA
• Developing alternative natural and engineered RNA polymerases to improve IVT performance and reduce impurities
• Overcoming scale-up challenges with advances in automated and/or continuous manufacturing of RNA
• Common quality hurdles in RNA production
• Development of real-time batch release tools for small batch sizes
• Long-read sequencing and LC-MS to assess RNA integrity and modifications

NEW!
Manufacturing: technological advances in upstream and downstream processing

• Cell-free systems for production of recombinant protein vaccines
• Advances in mammalian cell expression systems for protein-based vaccines
• Continuous perfusion manufacturing processes for vaccines
• Improvements in closed cell bank process equipment
• Modular manufacturing systems for vaccines
• End-to-end software for data logging, management, and analysis
  Advanced purification equipment, including new chromatography chemistries and columns, to lower impurities and increase yield

• Measuring and directing specific immune responses to vaccines
• Identifying better correlates of protection
• Driving optimal isotype antibody responses
• Profiling T cell responses 
• Harnessing advanced flow cytometry and sequencing tools
• Understanding nonspecific vaccine effects

• Expanding applications beyond oncology to include autoimmune, infectious, and neurological diseases
• Designing conditionally active constructs to minimize systemic exposure and enhance safety
• Developing bi- and multi-specific scaffolds to improve targeting breadth and therapeutic potential
• Creating long-circulating conjugates with reduced clearance for chronic conditions
• Establishing new regulatory endpoints tailored to non-oncology indications
• Incorporating companion diagnostics and theranostics to guide treatment and validate targets