I love the atmosphere in very early startups.
The focus is still mainly on the Science and Proof-of-concept.
The possibilities are endless, and so is the promise.
Seed investments are considered as Dreams, and everyone is happy to embark on a new journey.
It is unfortunate that many such boats will encounter rough waters, and some will never make it through.
Among with the sunken hopes and costs, the real question that looms after each such event is- could have things been done differently?
Could we design the clinical trial in another way?
Was there another Candidate, just slightly similar to the one we selected, that WOULD show the promise?
Why was it so difficult to transfer or scale-up the manufacturing process?
Sometimes we never know, but sometimes we can avoid trouble by looking far enough ahead.
I urge startups at early R&D to use all the opportunities they get to validate the project’s direction with domain experts- they can be in the advisory board, the incubator's network, and even in other companies.
I offer myself as your guide for all Manufacturing-CMC and Regulatory Affairs related (As a reminder- you can meet me free of charge for occasional brainstorming- schedule here)
Either way- if you are the captain of this boat- do your best to look as farthest ahead as possible. It might not cost you anything at the early stages to steer your boat away from troubles, at least from the foreseen ones...