The aim of these functions is to develop a business case and guide the development of the new TB vaccine. Indeed, an overall business model is crucial for TB vaccines, which have a high global impact but an un-validated commercial value which will vary depending upon the Target Product Profile (TPP).
A key objective of the business function is to develop the business approach for the TB vaccine candidate, to establish partnerships, and to mobilise resources. The objective of legal is typically to support negotiations during the establishment of partnerships, to manage intellectual property and to implement policies. The market function develops market analysis and assessment, monitors the competition, defines product positioning and the communication strategy.
Intellectual Property (IP) is an important element in business. If not done already, it is wise at this early stage to analyse the status of IP of the technology or vaccine. This includes a review of the ‘state of the art’, what is known and published, and the status of own patents versus competition. It is important to identify any obstacle due to IP. The IP situation and strategy for resolution (of e.g. existing prior patent, uncertain freedom to operate) is defined at this stage and becomes part of the Product Development Plan (PDP).
The developer should consider if a partner will be needed in the near- or long-term to assist and support the development of the vaccine candidate. If so, a strategy for establishing and management of partnerships should be developed and this becomes part of the PDP.
An early analysis of the market potential of the product and the countries where it would be used should be performed and summaries should be part of the PDP. This analysis is important for TB vaccines which have a high global impact but an unvalidated commercial value. Further information is provided in an AERAS and TBVI publication TB vaccine Research and Development, a Business Case for investment.
A Patent Attorney should evaluate the freedom to operate and provide an opinion on risk to further confirm/solidify an acceptable IP position.
Funding must be secured and available for the first-in-human (FIH)/Phase1 before the start of the study.
The decision to move the candidate(s) into clinic should trigger a more formal analysis and detailed analysis of the potential market and target countries are re-evaluated.
As the cost of development and the need for capacity increases, if necessary, potential partners to support mid and late clinical (CMC, scale-up validation) development are sought.
An initial forecasting and cost of goods (CoG) analysis for pricing parameters, scalability of process and product viability in targeted countries should be performed and the analysis integrated back into the TPP and PDP. An analysis of the IP situation should confirm that the IP status would support commercialisation.
As the product progresses to Phase 3, the IP situation is further analysed as needed. Performing a large Phase 3 efficacy study and anticipating registration and the potential market requires new business development, and a pathway to commercialisation is defined. It might include seeking partnership, obtaining support from principal investigators (PI) and key opinion leaders (KOL). The market assessments made in the previous Stages are updated in potential early adopters as first priority, in middle and late countries as second priority. The initial COGs, supply and demand plan are also fine-tuned.
The IP is updated. Any obstacles to commercialisation must be addressed. Budget and financial plan to licensure have been established and post-market commitments and funding have been secured. The plan between demand and supply is finalised.