This function is comprised of activities that will support the development of a comprehensive business plan for a new TB vaccine candidate up to new product launch. Several areas of expertise are gathered in this function, including business, legal and intellectual property (IP). Overall, their aim is to build and refine the business and economic rationale during the entire development path of a new TB vaccine candidate, according to the objectives stated in the Target Product Profile (see for more information on TPP, function ‘Project management’).
More specifically, the objective of this function is to develop a business plan based on an analysis of the competitive landscape (see function ‘Market, Access and Implementation’), business and financial considerations (in particular R&D investments, manufacturing and commercial costs), and organisational resources, including potential partnerships. Adhering to best financial practices, funding of each stage should be secured before it is initiated. The legal activities consist of establishing contracts and legal agreements with external partners. The objective of IP is to secure a solid intellectual property position, build a portfolio of patents, and ensure freedom to operate during product development and for commercialisation.
The economic rationale and underlying business plan are crucial for the development of novel TB vaccines, given the high global impact of TB on public health and the uncertain return on investment.
Intellectual Property (IP) is an important element in a project. At this early stage the IP status of the technology and the vaccine candidate(s) should be analysed. This includes a review of the ‘state of the art’, what is known and published, and the status of own patents versus competition. Submission of patent applications to create an early patent position is important. Obstacles due to competing IP should be identified, and an initial mitigation plan established. The IP situation and strategy for resolution (of e.g. existing prior patents, uncertain freedom to operate) are defined at this stage and become part of the Product Development Plan (for more information on PDP, see function ‘Project Management’). Particular attention should be paid to IP in highly competitive fields such as formulation and adjuvants, vectors, and nucleic acid-based vaccines.
Adhering to best financial practices, funding of all activities leading to pre-clinical evaluation should be secured. The developer should consider if a partner will be needed in the near-term to assist and support the development of the vaccine candidate.
The developer could consider a formal evaluation by a patent attorney of the freedom to operate, with an opinion on risks. The analysis of IP should further confirm or solidify what would be an acceptable intellectual property position, and IP strategy. Further patent applications should be filed as appropriate based on emerging data. Follow-up of applications already submitted and evaluation of patents in the field is needed.
A first business plan (see definition here) should be developed, based on the TPP and PDP (see Project Management) as the project advances towards the clinic. The business plan will rely on several elements, including market assessment (see Market, Access and Implementation, stage D), estimates of Cost of Goods (see function ‘Production Process’) and potential partnerships. The strategic value of potential partners to support early development is carefully evaluated and partnerships are established as needed. The business plan is used to convince potential investors and partners.
Adhering to best financial practices, funding for activities covering the whole stage should be secured. In particular, funding should be available to cover Phase 1 before the start of the trial.
As the project enters clinical development, the business plan will be refined according to emerging data and project needs. Potential partnerships, in particular for clinical development and commercial aspects should be further evaluated.
The IP position and strategy should be further refined, owned IP filings should be pursued and potentially supplemented. The patent landscape should be monitored on an ongoing basis.
Funding for activities covering the whole stage should be secured. In particular, funding should be available to cover Phase 2 before the start of the trial.
As the project progresses further in clinical development (Phase 2), the business plan is reviewed. This includes a first market forecast (see function ‘Market, Access and Implementation’) and a calculation of CoGs (see function ‘Production Process’). The business plan may be used to facilitate discussions with potential partners for further product development and commercialisation.
Funding for activities covering the whole stage should be secured. In particular, funding should be available to cover the Phase 2b before the start of the trial.
The own IP position is further consolidated and the patent landscape continues to be monitored. The status of IP to support commercialisation is confirmed.
The business plan is reviewed. An initial plan of supply versus demand is developed, based upon latest market assessment and forecasts (see Market, Access and Implementation). The business plan is used to secure additional funds internally or with external investors and partners.
Funding for activities covering the whole stage should be secured. In particular, funding should be available to cover the Phase 3 before the start of the study.
As the vaccine candidate progresses to Phase 3, the IP strategy is revised as required. This includes a thorough review of the own IP position, the overall landscape and potential need for acquisition of third-party IP.
The business plan is consolidated, integrating the latest market assessment and forecasts, refined Cost of Goods assumptions and an initial pricing approach (see function ‘Market, Access and Implementation’ and function ‘Production Process’).
The IP position is further strengthened.
Funding for activities covering the whole stage should be secured.
The analysis of the current business situation is updated, and opportunities re-evaluated.
The analysis of supply versus demand is performed in more detail, with input from functions ‘Production Process’, ‘Clinical Development and Operations’ and ‘Market, Access and Implementation’. The business plan is updated with validated market assessments, forecasts and pricing from Market, Access and Implementation.
The business plan is used to communicate with investors, public bodies and partners. All aspects of commercialisation are looked at, with partnerships and operations implemented as needed. Consider increasing capacity and capabilities for manufacturing, commercialisation and distribution.
The business strategy is confirmed and implemented with a detailed operational plan.
Funding for activities covering the whole stage should be secured. In particular, funding should be available to cover the Phase 4 before the start of the study.
The implementation of the business plan is closely monitored with input from Market, Access and Implementation. Launch in early adopter countries is closely followed up from a business perspective.
Demand (from ‘Market, Access and Implementation’) and supply (from ‘Production Process’) are validated, considering the sequence of launch in the early adopter countries, where recommendation and funding may be granted.
Opportunities to expand the business is constantly considered, in particular with partners involved in manufacturing and distribution.