PhinC is currently conducting a research project to develop and validate innovative modeling methodologies applied to the specific development of monoclonal antibodies (mAbs). The aim is to guide and support more efficiently the development of this type of drug candidates - from preclinical to clinical phases - using Model Informed Drug Development (MIDD). The MIDD approach is largely recognised and used for small molecules, whereas it is still lacking for large molecules such as mAbs.
The research project is focusing on the translational phases from inter-species scaling to the first studies in human. The targeted points are as follows:
- Development of models for mAbs lead candidate’s optimization
- Development of inter-species translational PK modeling to help the choice of the target PK in human.
- Development of inter-species translational PKPD modeling (efficacy and safety) to help the choice of the target dose and exposure in human.
- Development of PKPD models to support the dose escalation in Phase I study.
- Development of models to evaluate potential drug-drug interactions (DDIs) induced by mAbs.
The objective is to use our experience and knowledge to analyze retrospectively relevant data to consolidate existing models and develop new tools and solutions which could then be beneficial for the development of mAbs.
What we can offer
During the development, the sponsor must consolidate the different achievements and anticipate the key features of the candidates. Depending on the development phase, several problematics can arise, such as the lead choice or the PK and PKPD translation of the drug from animal to human. The figure below (figure 1) presents some of the aspects for which PK modeling and simulation can bring a valuable contribution.
How we can collaborate
PhinC Development proposes a fully collaborative partnership free of commercial interest and aiming at a mutual benefit. The interest for PhinC Development would be to improve the overall knowledge on mAbs development to better understand and anticipate go/no-go decisions in early phases using real case study data. One of our motivations is to be able to share these new approaches with the scientific community.
The advantages for collaborative partners would be:
- To gain a comprehensive hindsight analysis on their product with integrated PK modeling methodologies.
- To be able to consider new perspectives or solutions on the studied drug
- To use the retrospective analysis to better anticipate future drug projects
- To become a privilege partner of PhinC Development as a support for further studies.
In this partnership, a Confidential Disclosure Agreement will be established.
Figure 1 : Representation of four critical aspects of the development with their inherent questions and how PK modeling & simulation can contribute to bring new solutions and perspectives
Are you interested in this project? Please contact us at the following address: contact@phinc.fr
