by Andrew Makin
There is no shame in admitting that sometimes we need help and advice, and that while we are really good at some things, there are others we are less good at. Maybe this sounds completely obvious, but often it either isn’t or it gets overlooked.
Over many years I have seen companies, particularly the smaller drug development and biotech companies, run into problems with their early development programmes because of lack of advice or because of poor advice. Particularly when you are selecting your lead candidate, or when you are taking your lead candidate into early studies, it is important that the design of those studies is as good as it can be so as to avoid performing unnecessary studies, or having to repeat studies, or making incorrect decisions based on inadequate data. Many of these problems can be avoided by seeking and taking good advice from experts; people who deal with such situations on an almost daily basis.
In the early phases of a programme, developing good data on kinetics or basic toxicity and understanding those data is very important. And understanding those data is critical. For example, your drug will be toxic at or above some or other dose. This is basic toxicology, but it shouldn’t frighten either you or your investors (many smaller companies want to have products with a “clean” profile because they think this will make them more attractive). But, everything is dependent on the context. A molecule that is toxic at 1 mg/kg is not a problem if the therapeutic dose is multiples lower than this. A molecule that is not toxic at 1 gram/kg is going to be somewhat of a problem for you because you will need to make enormous quantities to take it through the full preclinical and clinical programmes.
Furthermore, it is often the case that the first clinical studies are overlooked when designing the preclinical programme. There is no point in running the preclinical studies unless you know that they will be fit for purpose (and here I mean the designs; of course the results are rather more difficult to predict). Make the preclinical studies as predictive as possible to achieve the aims of the clinical studies.
The best way to improve your chances of success is to ask seasoned experts to advise you. Indeed, my advice is that you should enroll both experienced preclinical and clinical experts into your team at an early stage and let them help you to make the best of your project.
You can read more about Andrew here.