The Valley of Death:
A start-up is working on a small molecule and has access to data which were generated in an academic setting with limited background data. The company is currently assembling investors for a seed investment round.
The scope of the engagement is to generate a development plan that provides enough data to justify a full non-clinical development program – the deliverable is an investor slide deck!:
- KreaMedica assembles a streamlined plan with predefined GO / No-GO decision points:
- Scale up to synthesize sufficient material for the study
- API Characterization and dose formulation development
- DMPK including preliminary PK data
- Preliminary tox data
- Efficacy data in a well-established model using the intended route of administration with a suitable formulation.
Vendors will be selected who have relevant experience and the models established. They are prequalified in respect to their ability to deliver and fit the budget.
KreaMedica will manage the studies and monitor critical steps. All the decisions lie with the biotech partner. Where needed, technical expertise will be added by engaging consultants.