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
• 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