What Preclinical Work Has to Show
That the candidate acts as intended in models relevant to the disease; that it can be given at doses that work without unacceptable harm; how it is absorbed, distributed and cleared; and that it can be made consistently. The studies that matter most differ for small molecules, biologics, cell therapies and gene therapies.
Planning Backward From the Clinic
Regulators set expectations for what supports a first-in-human study. Planning from those expectations, and from early conversations with agencies where they help, tells a company which exploratory studies can be lean and which must meet formal quality standards.
Milestones Investors Recognize
We design milestone-driven programs that generate the evidence needed to de-risk a technology and attract follow-on investment, and we manage the labs, vendors and timelines that carry them out.
