Case Study – Start Up

The Valley of Death:

Background:

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.

Scope:

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.

Vendor Selection:

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.

Program Management:

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.