COVID-19: how is the pandemic changing the vaccines space?
What have we learned from the past two years and how can we apply our experience going forward?

• New platforms: Following the rapid commercialization of mRNA and adenovirus COVID-19 vaccines, what’s next for these and other novel platforms?
• Regulation: Will streamlined regulatory processes be applied to future vaccine candidates?
• Supply chain: Overcoming shortages and strengthening weak links in the supply chain, from the availability of raw and starting materials to distribution of vaccines in LMIC
• Pandemic preparedness: Getting ready for the next “Disease X”
• Business: with smaller biotechs taking the lead on several COVID-19 vaccine candidates, will we see changes in the vaccine ecosystem?

Advances in formulation and administration 
How is formulation and administration of vaccines adapting to new technology and ongoing challenges? 

• Development of needle-free immunization as a priority for better acceptability, avoidance of needle-stick injuries, and enhanced thermostability
• Advances in alternative administration routes, including transdermal, intranasal, inhaled, and oral
• Optimum formulation of mRNA vaccines to improve stability and acceptability
• Deepening our understanding of adjuvant mechanisms and predicting the adjuvants of the future

New technology and strategies to accelerate translation of promising vaccine candidates

• Understanding immune responses to better predict immunogenicity of candidate vaccines at all ages
• Omics as an emerging tool for understanding early immune responses and optimizing regimes
• Computational modeling to accelerate vaccine development
• Correlates of protection: can it be used to license forthcoming vaccines?
• Improving the efficiency of clinical trials: what can we learn from COVID-19?
• Building clinical trial capacity in LMICs
• Planning for regulatory success

mRNA technology has great potential, but there is much work ahead to fully exploit its advantages and overcome technical and clinical hurdles.

• Exploring the potential for rapid (and localized?) vaccine production
  
• Tackling stability, immunogenicity, and cost of materials
  
• Self-amplifying mRNA vaccines as a promising approach for the future
  
• What are the alternatives to current lipid nanoparticle delivery technology?
  
• Will IP concerns hold back future mRNA vaccine development?
  
• What will the next generation of mRNA vaccines look like?

With new players entering the vaccines space and unprecedented global demand, CMC is more important than ever.

• Meeting evolving regulatory guidance at all stages of development
  
• Best practice in assay development - from immunogenicity to exposure and safety
  
• Moving from preclinical and early clinical to GMP production
  
• Extracting actionable information from large analytical data sets
  
• New and emerging analytical technologies, including advances in process analytical technology (PAT), to reduce time to market

What are the emerging trends in vaccine manufacturing today – and where are we headed?

• Overcoming manufacturing challenges of novel vaccine platforms
  
• Improving production efficiency with new platforms and tools, including continuous manufacturing, automation, and artificial intelligence
  
• Adherent vs suspension bioreactor systems
  
• Harnessing Quality by Design and Design of Experiments approaches for vaccine manufacture
  
• Localized and flexible vaccine manufacturing approaches to allow more efficient and equitable distribution
  
• Raw materials: sourcing quality raw and starting materials at a reasonable cost during the pandemic

What’s new and next for vaccine research? mRNA vaccines are in the spotlight, but what other platforms and approaches will make waves in the coming years?

• Scientific, regulatory, and manufacturing challenges of new and emerging platforms
  
• Matching technology to indication: what will be the role of viral vector, DNA, and antigen-presenting cell vaccines?
  
• Beyond antibody response: harnessing cytotoxic T cells and trained immunity
  
• New technology and approaches in cancer vaccines