Stakeholders that directly influence the adoption of our brands, eg, payers and KOLs developing treatment guidelines are increasingly focusing on value demonstration. Value demonstration is a term often defined as a brand's incremental clinical benefit/s over standard treatments in a specific population, at the right price – or put another way 'value-based pricing'. 

If we are to address this shift towards value-based pricing in early drug development, R&D functions involved in drug development must have a clear and detailed understanding of the changing pharmaceutical landscape. But this responsibility must not be put solely on the shoulders of R&D. Marketing has a responsibility to develop a closer working relationship with their R&D colleagues, in order to keep them informed of how brand value has been redefined in recent years and how it will continue to evolve over time.

The model of R&D developing a new drug with a unique mode of action or with improved drug delivery can no longer be justified as 'innovation', if external stakeholders do not understand the 'added value' of this innovation, ie, meaningful patient benefit/s at a price that justifies this benefit/s.

It is therefore crucial that marketing collaborates with R&D during the early stages of drug development. The ideal place to start is the Target Product Profile (TPP), ie, the optimal product profile that is required for regulatory approval, pricing and reimbursement. How often have we seen a TPP being proposed because we have the 'know how' within R&D, and we have done it that way before.

A TPP must be commercially driven if it is to reflect the changing market needs. This may require both R&D and marketing to go outside their comfort zone and identify new, and possibly untested, methods for generating clinical and health economic data, even if as a result timelines are delayed. As the saying goes: 'fail to prepare, prepare to fail'.

Stakeholders implementing the strategy, eg, CMC, clinical development, regulatory, etc, must understand the rationale behind it or we risk the strategy being questioned.

Develop your TPP with the relevant stakeholders and ensure they understand the rationale behind the profile that marketing is proposing. This is also the stage where marketing must define the Target Product Claims (TPCs), ie, what claims or key selling messages would be needed if the brand is to be reimbursed and seen as a clinical alternative to standard treatments.

One way to think about this is to define the brand's sales story flow. Imagine you were attending a dinner party and had to quickly explain the clinical and economic benefits of the brand, what would you say? This would probably consist of an overarching story and number of key selling messages that would enable you to elaborate on your story. It is crucial that the story and the messages are defendable and evidenced based. 

It's highly likely that when you present your recommendation for the TPP and TPCs, your analytical and evidence-based driven colleagues in R&D will challenge your proposal. With R&D budgets shrinking, your clinical development colleagues will need to be convinced the trials required to deliver the TPP and TPCs are truly needed and will offer the best ROI.

Marketing must be assertive and ensure it has a 'seat at the table' during early drug development. In a nutshell, there is no point spending millions of euros developing a new product and implementing a clinical development programme, if it will not gain access to the market because its brand value cannot be proven or understood by external stakeholders.