Discovery & preclinical

Scheduled: February, April, June, July, September, October, November  ·  7 issues

Discovery & immunology

• New directions in vaccine research, e.g., autoimmune conditions, antibiotic-resistant pathogens, new platforms
• AI/computational tools and multiplex approaches in antigen discovery and design, including partnership models
• Platform design and selection: matching the platform to the pathogen and the immune response needed
• Exploring new technologies in single cell analysis and high-throughput screening to map immune responses and identify target antigens
• Opportunities and challenges for novel nucleic acid vaccine platforms, e.g., saRNA, circRNA

Preclinical models & assays

• Identifying better correlates of protection
• Replacing animal models with robust in vitro and in silico models (e.g., organoids, human digital twins): how predictive are they for early phase development and potency determination?
• Improving the translational value of preclinical models
• Improving prediction of reactogenicity before human trials, e.g., cytokine release studies
• Harnessing advanced flow cytometry and sequencing tools
• Validating and standardizing complex bioassays, e.g., T cell assays

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Formulation, adjuvants & delivery

Scheduled: February, March, April, May, July, September, October, December  ·  8 issues

Adjuvants & formulation

• Optimizing formulation for improved shelf-life, stability, and immunogenicity
• Thermostable and single-dose vaccines, including reformulation of existing products
• New vaccine adjuvants, including mucosal adjuvants, and securing adjuvant raw material supply
• Ensuring thorough characterization of vaccine/adjuvant formulation
• Overcoming formulation challenges of combination and conjugate vaccines

Delivery

• Mucosal vaccination: intranasal and oral routes of administration
• Delivery devices beyond needle and syringe, e.g., microneedle patches, intradermal devices, nasal devices
• Improved RNA delivery systems: next-gen LNPs and alternatives, e.g., polymers, exosomes
• Innovative cap analogs for improved stability and reduced immunogenicity of RNA vaccines

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Clinical development

Scheduled: March, May, June, July, November, December  ·  6 issues

Discussion topics

• The future of vaccine trials: using AI, global evidence, pragmatic designs and decentralized testing to make trials faster and more affordable
• Defining Phase 3 populations and de-risking late-stage development
• Experimental medicine and controlled human infection models (CHIMs): balancing cost and de-risking
• Clinical development in LMICs
• Tailoring clinical research to specific populations, e.g., pediatric, maternal, older adults, rare disease
• Vaccine safety: pharmacovigilance and understanding the biological mechanisms of adverse events

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Manufacturing innovation

Scheduled: February, March, May, June, July, September, November, December  ·  8 issues

Discussion topics

• Innovation in upstream & downstream manufacturing of prophylactic and therapeutic vaccines
• Automated manufacturing of diverse vaccine platforms, from protein to viral vector
• Progress in synthetic (plasmid-free) manufacturing of RNA
• Overcoming bottlenecks in continuous manufacturing, e.g., continuous ultra/diafiltration, SPTFF, fixed bed bioreactors
• Cell-free systems for production of recombinant protein vaccines
• Digital twins and modeling in process development
• Manufacturability by design: platform selection for scale-up
• Rapid-response CMC platforms for outbreaks
• Sovereign and surge manufacturing capacity for biosecurity and pandemic response, including regional manufacturing in LMICs
• Reducing costs and improving sustainability of GMP facilities, raw materials, and single-use systems
• Next-gen purification equipment, including new chromatography chemistries and columns, to lower impurities and increase yield

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QC/QA/CMC

Scheduled: March, April, June, July, September, October, December  ·  7 issues

Discussion topics

• Developing and validating robust methods for product characterization, batch release, and stability studies
• Real-time batch release tools for small batch sizes of therapeutic vaccines
• Applying quality by design and statistical tools to expedite batch release
• Implementing the appropriate process analytical technology and real-time monitoring to optimize process workflows while remaining cost effective
• Multiplex assays for QA/QC of complex/combination vaccines
• Will cell-based potency assays be replaced with newer technologies, e.g., HPLC, LCMS, NGS?
• NGS for viral safety and adventitious agent testing
• AI in QC data review: balancing automation with human oversight
• Standardizing serology and reference standards

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Regulatory

Scheduled: February, March, May, July, October, December  ·  6 issues

Discussion topics

• How regulatory frameworks are evolving with new technologies, platforms, antigens, and adjuvants
• Regulatory use of CHIM data, correlates of protection, and AI/modeling-derived evidence
• Platform approaches: moving new candidates onto established platforms without repeating every step
• Regulatory pathways for medical countermeasures and emergency use
• Overcoming IP and regulatory hurdles for RNA vaccines, including implications of EMA’s “Guideline on the quality aspects of mRNA vaccines”
• Regulatory convergence: the prospect of global regulatory submissions
• How will therapeutic cancer vaccines be codified in current regulatory frameworks?

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Therapeutic vaccines

Scheduled: February, April, May, June, September, October, November  ·  7 issues

Discussion topics

• Advances in tumor profiling and antigen selection: the role of new analytical technology and AI in establishing a tumor-specific cytotoxic T cell response
• Progress in personalized cancer vaccines as late-stage data emerge
• Selecting an appropriate platform for cancer vaccines: nucleic acid, peptide, viral vector, etc.
• Adjuvants and immune modulators to strengthen therapeutic responses
• Improving translational models for therapeutic vaccines
• Delivery bottlenecks, dosage, and route of administration for optimal immune response
• Combining cancer vaccines with cell therapies, immune checkpoint inhibitors, and chemotherapy
• Cancer prevention and interception vaccines

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Biosecurity & pandemic preparedness

Scheduled: March, April, May, September, November  ·  5 issues

Discussion topics

• Biosecurity and medical countermeasures: preparing for deliberate and accidental biological threats
• Rapid-response and multi-platform readiness for priority pathogens and Disease X, e.g., the 100 Days Mission
• Biosurveillance and early warning, and how they link to vaccine response
• One Health: veterinary vaccine research and the drivers of zoonotic spillover
• Strengthening resilience to vector-borne disease
• New vaccines for respiratory diseases
• Applying the family-based approach to understanding and developing vaccines for pandemic threats
• Vaccines to address antimicrobial resistance
• Lessons from recent outbreak responses and AI-enabled outbreak analytics

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Access, policy & public trust

Scheduled: February, April, July, December  ·  4 issues

Discussion topics

• Overcoming vaccine hesitancy and misinformation, beyond pandemics
• Communicating vaccine safety: trusted community voices and public engagement
• Ensuring vaccine equity with improvements in formulation and logistics
• Bringing LMIC and smaller biotech voices into vaccine policy
• Sustainable research funding and continuity
• Vaccine economics and partnerships: demonstrating value and building access models

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