You’re building the plane while flying it!
So many moving parts. You have at least one interesting molecule and good data that justified starting your company. You raised money and assembled your team. The pressure is on to move into first in human studies as soon as possible. Extensive discussion and planning activities are ongoing about what has to be completed to make the move. Pharmacology and toxicology studies in animals are about to start or are underway. Regulatory experts have weighed sin and perhaps you have had preliminary discussions with the FDA.
So many questions
Have you already produced enough study drug for your research and toxicology studies? Will you have enough drug for your first in human studies? Will you manufacture your own drug or contract this out?
Will you have a contract research organization (CRO) provide all of the services of a clinical department, or will you hire your own clinical department, or just a few critical people to oversee the CRO? Anyway, which CRO would be good for a startup company such as yours?
Who is on your team that will guide you in this highly regulated area of developing new drugs? Do you have a Ph.D. scientist? That will help with validation of the target and further laboratory studies.
Do you have a physician? Does that physician have extensive pharmaceutical industry experience in the area of clinical development? If not, does that physician have extensive experience in the science of clinical research or is this a physician who has done clinical research outside of an industry setting? Is this a physician who has run a prestigious research laboratory, while also seeing patients, but has no industry experience?
Should you hire a Chief Medical Officer? Is it better to start with a clinical operations manager first?
You need answers
In the area of clinical development, we have answers. We don’t know what you have done thus far, but otherwise have answers to the questions raised.
For questions and to explore further, contact us.