Clinical Development

Clinical development begins with the end in mind.

Once the Research department has identified a new molecule with the potential for development the Clinical department can get involved.

What are the potential safety issues?

Based on the mechanism of action what would the likely indications be?

What is the unmet medical need?

What is the addressable population for this treatment?

How will the treatment be administered?

What is the target product profile?

What clinical studies will need to be done?

Are there validated endpoints or outcome measures for efficacy trials?

Who will pay for the drug?

What will be required to get the medicine approved by regulatory authorities as a treatment?

For a startup company, such ruminations may seem excessive; there is great urgency to do standard animal and toxicology studies and to move as quickly as possible to a Phase 1 “first in man” study.  In large, established pharmaceutical companies, there may a tendency to go through an extensive and grueling analysis involving many individuals and committees.  A balance between extensive planning and rapid action is important.