Investment decision-making is a core function of any drug development group. Developing drugs demands highly innovative thinking while, at the same time, development plans are strictly regulated.
The development process has a number of well-defined technical milestones, alongside key investment decision or inflexion points.
It is critical, at project inception, to make an informed view of the profile of a successful product at the time of launch
Of course, it is almost impossible to second guess which development candidates will pass or fail clinical hurdles, but it is important to define what we mean by ‘success’. In addition, it is important to understand the global picture – the impact of emerging markets and trends within established ones; the shifting treatment paradigms and disease prevalence patterns – as all markets are different and are often receptive to different product profiles.
It is also naïve to dismiss future pricing, reimbursement and market access considerations for an early-stage asset – too many products are progressed without early insight to the likely acceptance of a product within the market – not from a regulatory perspective, but relating to likely pricing and access barriers.
Of course, emerging Biotech Companies need to ensure that their programmes are satisfactory for investors and Pharma licensees, as well as regulators and payers. However, it is a misconception that a biotech can ignore market access considerations, because they are looking for an exit by phase II. Ultimately, the drug has to be saleable – having activity against a target is not enough.
Successful decision making is driven by ensuring an appropriate balance throughout the discovery and development programme. Targets should be selected on the basis of sound strategy and this should be driven by techno-commercial foresight. It is a myth to assume that, ‘if a product works, it will sell’. Good products fail because of poor alignment to commercial factors due to a lack of early, clear direction and consideration.
Hence, commercial leadership should exist right at the start, followed by strong representation from clinical, technical and commercial functions throughout the whole process, ensuring viable early stage discovery targets, development of clinical programmes that marry with marketable opportunities and into late-stage clinical positioning and pricing – although the balance shifts as a drug is progressed through development stages, the commercial role can never be down-played.
Of course, there are many issues that can interfere with this alignment and it’s easy to point the finger of blame at leadership when things go wrong. In the ideal world, individuals and valuation teams need a blend of commercial acumen with scientific understanding. Without this, a drug can still be commercially successful, but it’s likely to be by chance!