Clinical positioning and regulatory strategy

Clinical positioning analysis
and regulatory strategy

All projects should start either by:

  1. validation of a target involved in pathogenesis process or,
  2. identification of a group of patients where the mechanism of action (MoA) is expressed and functionally active.

From its own background BIOPHACT® helps and supports the project holder in the patient determination and stratification according to the MoA. At early stage, in silico datamining is one of the tools used by BIOPHACT® to select the right patient who will be eligible to the MoA modulation.

When available, guidelines drive the drug development. When guidances are lacking, BIOPHACT is able to activate its KOL network to guide the choice of evaluation criteria in studies. This kind of approach is always checked by the request of a scientific advice to competent authorities.






Genomic Database/
In silico datamining

Clinical studies


Clinical positioning


Drug development plan

Clinical positioning


Drug development pathway


KOL an Competent
Authorities check

Drug development project Management

Two kinds of studies need to be defined in order to reach the clinical trials stage:

  1. regulatory studies (pharmacology, DMPk, Toxicology, CMC),
  2. supportive studies (clinical rationale, medical need…).

The listing of the tasks costs and timelines, milestone determination and turning point are proposed to the partner, the deliverable is a clear flow chart (Gantt).

BIOPHACT® can support the partner in Competent Authorities questioning and meeting such as Pre-IND. By his own KOL network, BIOPHACT® helps his partner in the validation and consolidation of the drug development pathway.

BIOPHACT® can manage studies in CRO/CDMO and summarize the data by writing or reviewing the master documents such as IB, IND, IMPD.

As a qualified expert of the field, BIOPHACT® can also provide the rationale and the calculation for the choice of the first dose in Human based on pharmacology, DMPK and toxicology.

Support to scientific advice.

Project evaluation by KOL and clinical experts of the field.

Competitor landscape analysis

Competitor differentiation-driven approach improves the value of projects, first for patients and then for firms.

The drug development pathway and the clinical positioning of the project is fully linked to the class of the drug project. If the asset is a First In Class (FIC), it addresses an unmet medical need. In that case, the Standard Of Care (SOC) will shape the project. If the asset is a Best In Class (BIC) the analysis of the competitor landscape is mandatory to well design non-clinical and clinical strategies. A differentiation strategy is essential to strengthen and increase project value. BIOPHACT® supports and helps partners in this difficult differentiation plan building. Mainly based on selectivity, potency and safety, the asset must exhibit the best pharmacological profile when compared to standard of care or competitors.