Drug Development Strategy

Work-Package and MILESTONES

Our core business is to build the development plan of new therapeutics either New Biological Entities or New Chemical Entities. BIOPHACT® suggests the design of all  experimental studies in:

  • DMPK

Whatever the development stage from Target validation to Phase 3.

Target>compounds>lead>optimized lead>candidate>PI ED>P2RD>P2b>P3

BIOPHACT® provides with  partners the main project deliverable such as IB/IMPDs/INDs. We can assist our partners in the Scientific Advice or other discussion  with competent authorities or IP strategy.

The key point is to define the experimental work-packages listing which are necessary and sufficient to reach the next development milestone in regulatory, logical and ethical compliance:

  • Target validation, expression of the MoA in patients, in silico studies, datamining
  • Hit selection
  • Lead selection according predefined quantitative developability criteria, competitor differentiation
  • Clinical candidate and back-up
  • Phase I or First in Man/First In Patient
  • Phase II or cohort extension at the chosen dose
  • Phase III or pivotal studies vs standard of care


drug development strategy

Drug Development Plan set-up

To define thoroughly the experimental packages of each line, it is mandatory to predefine the success criteria of each experimental step. BIOPHACT merged a lot of specific quantitative and qualitative performance criteria for each development stage which have been considered as successful in various drug development. This key-point is one of the BIOPHACT’s added value to your project: the Probabilities of Success are objectivized by quantitative parameters.

For instance, a lead-stage mAbmust exhibits a Ki of at least picomolar level toward its antigen.