Services of Biopharma Excellence related to vaccines

Vaccines – Development, Licensure, Marketing

Established vaccine companies:

  • Pharmaceutical, pre-clinical and clinical development programs
  • Life cycle management
  • Post marketing surveillance, pharmacovigilance plans, risk management plans
  • Inspections
  • Post Authorization safety and/or Efficacy Studies (PAES and PASS)
  • Clinical trial applications

Small and Medium Sized Enterprises (SMEs), start-up companies, academic institutions

  • Early development programs
  • Facilitating access to the European Medicines Agency’s Innovation Task Force and/or National Regulatory Agency’s Innovation Offices
  • Understanding the language of major regulatory agencies 

Pathways to licensure for non- EU vaccine manufacturers and developers, e.g. India, China, Latin America, etc.

  • Strategies to procure EU markets with urgently needed vaccines, e.g. Pa containing combination vaccines, monovalent vaccines (e.g. measles vaccines, rubella vaccines, D, T, Pa vaccines), BCG vaccines, etc. 

Adaptive pathways to vaccine licensure – integrative product development (benefit-risk, cost effectiveness, etc.)

  • Feasibility of human challenge trials
  • Development of biomarkers predicting vaccine safety and efficacy 

Platform technologies for vaccine production

  • Vaccines against emerging pathogens
  • Better influenza vaccines, how to improve licensed products
  • Universal influenza vaccines, criteria that need to be considered 

Pandemic preparedness/bio-preparedness

  • Considerations important for National Competent Authorities, governmental institutions, political decision makers, manufacturers
  • Organizing batch testing and release in the European Union, understanding EDQM procedures
  • Addressing WHO’s priorities for vaccine development (e.g. decade of vaccines, polio endgame, pandemic influenza preparedness (PIP program), research and development blueprint) 

Translational medicine

  • Mastering selection criteria for EU funded research and product development programs (e.g. IMI, Horizon 2020)