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 in and perhaps you have had preliminary discussions with the FDA.

So many questions remain

Do you have enough study drug?

• Have you already produced enough study drug for your research and toxicology studies?
• Do you have enough drug for your first in human studies?
• Will you manufacture your own drug or contract this out?

Who will lead your scientific efforts?

• Who is on your team that will guide you in this highly regulated area of developing new drugs?
• Do you have a scientist who has relevant drug development experience to expedite validation of the target and lead the necessary laboratory studies to move drug development forward?

Medical and clinical leadership?

• Do you have a physician with extensive pharmaceutical industry experience in the area of clinical development?
• If not, does that physician have extensive experience in the science and conduct of 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 or is it better to bring a clinical operations manager on board first?

How will you deal with drug safety?

• Should you build your own department or should you outsource this function?

What role will a contract research organization (CRO) play?

• Should a CRO provide all of the services of a clinical department (and safety department}?
• Should you hire your own clinical department or just a few critical people to oversee the CRO?
• If you do work with a CRO, which one would be good fit for a startup company such as yours?

The above questions and many others may still need answers as you move forward.

You need answers

In the area of clinical development, we have answers.

Contact us

For questions and to explore further, contact us.