Drug development today is characterised by promise and potential pitfall in almost equal measure, to an extent unprecedented in the past.
Each early stage asset has potential utility in multiple disease settings. The challenge is working out where to start, especially given the current level of intense competition from existing established and experimental approaches in pretty much every known indication. There is never only one way anymore, although there may still be a best way. Each potential development pathway for a new entrant has attendant scientific, clinical, regulatory, commercial and corporate strengths and weaknesses, often going in different and divergent directions.
Choosing the wrong indication can be a very costly mistake, especially as the right drug in the right setting can lead to initial regulatory approval at much earlier stages of development than in the past. Somehow, therefore, someone must make sense of it all and chart the best direction forwards for a promising new agent as well as its possibilities beyond the pill itself.
That’s where we come in. The ability to think strategically combined with years of experience of the shifting complexities of the therapeutic arena, allow us to critically appraise an asset in an objective and dispassionate manner that sometimes only an outsider can provide. We can then formulate several clinical development options for further review and subsequently interrogate the most promising through external validation. The result is a clear pathway forward, most importantly with a transparent set of underlying assumptions (including future market dynamic assessments, investment, roughly-right forecasting and business development) at the outset, which can be reviewed and refined on an ongoing basis to ensure their continued validity. That way, we avoid inadvertently veering off track along the way.
Our therapeutic experience is extensive. Most importantly, we bear battle scars gained from making mistakes in the past and learning from them, so that you don’t have to do the same.
Find out how we can help. Book a 15-minute call with us here!