PhInc. Modeling offers consultancy and operational management services to bridge the gap between therapeutic lead identification to the clinical stage and to the patient PoC. We optimize your early drug development (EDD) by using an integrated 3-step strategy.
1. Defining the drug development strategy and deployment plan
Associated with your internal teams, our experts can bring their thorough understanding of the EDD to assess project potential, design development strategies and deliver effective project management.
2. Implementing Model Informed Drug Development
Modeling & Simulation (M&S) is a powerful approach to predict results with reasonable certainty and minimize the number of clinical studies, when applying a “predict, learn and confirm” principle in an iterative way throughout all development phases of the development process.
Innovative approaches, including PopPK models, PKPD modeling, simulations and PBPK models can help to progress from preclinical studies to phase I/II clinical studies, rapidly and efficiently. This multidisciplinary approach is a real benefit: results are considered globally, making your drug development more efficient.
3. Bringing value to your Investigational Medicinal Product (IMP)
The key to success is to bring robust answers on the critical issues affecting the biopharmaceutical industry to evaluate drug candidates, in particular during a due diligence process.
Throughout the early development, our concern is to keep focus on what will bring value to your IMP by the end:
- Deep knowledge of the safety profile and address the main attrition risk (e.g. QT prolongation)
- Full characterization of the PK profile and PK interactions of your IMP
- First indication of pharmacological effect through biomarker and PD in order to define the range of your therapeutic dose.