There is a high clinical attrition rate for NCEs with only 8% of candidates successfully making it to launch, and the earliest establishment of efficacy and an acceptable safety and PK profile can lead to a substantial reduction of R&D costs. Aptuit's approach of Integrated Drug Development brings together experts at the cutting edge in understanding causes of attrition and applying the most advanced approaches to reduce it, in a ‘quick win, fast fail’ drug development paradigm.
More in detail, all starts with non-clinical assessment of safety (General and Genetic Toxicology & Safety Pharmacology studies) followed by the assessment of the translational pharmacodynamic potential (integrated meaningful PK-PD links from preclinical to clinical) and non-clinical assessment of the pharmacokinetic and metabolic profile. An integrated analysis of data from these studies permits realistic human dose predictions to be made and hence meaningful interpretation of the predicted dose in the context of the safety profile and technical feasibility.
To facilitate an efficient process, key activities contributing to the design of the most valuable and cost effective package in support of the clinical plan include:
- Rapid delivery of Active Pharmaceutical Ingredient, including optimization via customized approaches if required;
- The rational design and development of the dosage form for clinical use including integrated cGMP delivery (application of tactical formulations and processes in early phases for preclinical and clinical use);
- Comprehensive dosage form qualification including the early risk assessment and gap analysis of the proposed FIM product vs TPP;
- The appropriate scale manufacture of investigational products for clinical trials;
- Formulation refinement and optimization based on PK readouts and the TPP.
Finally, two further fundamental FIM enabling activities are the fully integrated risk assessment of impurities and the analytical controls for API.
The following disciplines support stand alone or integrated services for FIM Enabling Studies: