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:
- PHARMACOLOGY
- TOXICOLOGY
- CHEMICAL
- MANUFACTURING AND CONTROL
- DMPK
- CLINICAL STUDIES
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 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.