Increased cost and length of development Increased resource drain associated with maintaining marketed products
Demand
Realistic product profile, production & presentation Realistic assessment of development costs and timelines Clear vision of future demand, price and financing Realistic assessment of public-health value, in the context of other preventive measures
Political Will
Shared commitment to need, priorities, demand, price and cost
Partnerships
Risk sharing Leveraging resources and expertise
Post-license activities
Identification of target antigens Understanding of pathologies Natural history of disease Done mostly outside of the Big Pharma
Phase I Phase II a Phase III Safety Dose finding Large scale Initial Dose/schedule safety immunogenicity finding + Immunogenicity Lot to lot consistency Phase II b + Early POC Non inferiority (combos) or Efficacy
Industrial Investment
7
10
Phases of CDP:
Phase I Phase IIa Phase IIb Phase III
11
Defining investment milestones Challenges with increasingly complex partnerships Strict traditional industry development paradigm is insufficient
12
Regulatory strategy
Clinical supply Approaches to access
13
14