Clinical Development Plans

A major decision in compiling a Clinical Development Plan involves picking among different candidates the one to move forward. We work with our partners to characterize the Benefit/Risk ratio of each candidate and use that as the basis of selection.
 

For example, among candidates with similar efficacy in animal models, pick the one that is predicted to have a lower Risk profile. We use such analyses and approaches to compile the CDP to any depth required.

Risk Mitigation Plans

Our team members have extensive experience in compiling Risk Mitigation Plans.
 

We offer novel value added by our Derisking technology and workflow that enhances the direction of RMPs. We can develop the RPMs to whatever depth required.

In/Out Licensing Due Diligence

When you are very busy with due diligence of a compound, how do you know the best use of the compound, or its possible risks? Typically, you rely on the data you are given by the Licensor, plus your own internal and external experts. Your process will involve agreeing or disagreeing with the claims made by the Licensor.

 
Biovista provides an independent, uniform, standardized way of characterizing the Benefit/Risk profile of any compound, no matter what the claims for it are or who is making these claims.
 

Instead of simply agreeing or disagreeing with Licensor claims, Biovista offers new potential indications or risk assessments for a compound. For example, the Licensor may be claiming that their compound is excellent for prostate cancer. Biovista can show that the compound could also be used in psoriasis with a much lower risk profile than in prostate cancer. This could help focus the due diligence and negotiation. In addition, when out-licensing a program, our technology and work can help identify “hidden” value in your compounds that you may use to find new potential Licensees for your out-licensing programs. For example, you may be out-licensing a compound for chronic congestive heart failure, and we may show how your compound could be used in seasonal allergies, too. This gives you more options to stratify the market.

 
Biovista provides this data in actionable format in 30-45 days, which is a major advantage when you are in due-diligence mode. 

For mor information on any of these services please contact us.