Translational Medicine and Epigenetics Program Consultation
Bridging the gap between pre-clinical and early clinical development
Translational medicine is a bridge between pre-clinical and early clinical development (from bench to bedside), creating the foundation for precision medicine in late clinical development. A translational medicine program includes the adopting biomarkers to mitigate clinical trial risk, identify patient subpopulations, facilitate decision-making, and accelerate a drug’s market approval.
Biomarkers are a routine part of drug development. Identifying and adopting biomarkers are especially valuable in rare diseases and precision medicine product development.
Model-based data integration, biomarker-guided trial designs, and artificial intelligence are critical data-driven tools for integrating mechanism-centric translational medicine and patient-centric precision medicine. Epigenetic biomarkers have significantly contributed to an improved understanding of the progression of the disease and have the potential for personalized medicine. The Epigenetic includes self-perpetuating, and post-translational modifications of DNA and nuclear proteins producing lasting alterations in chromatin structure and gene expression.
Dr. Claudio Carini, led translational medicine department at major pharmaceuticals.
The Translational Medicine and Biomarkers Program Consultation:
- Accelerate product development and approval
- Increase the success of the clinical trials
- Meet FDA and EMA high priority call for innovation in clinical research
Case Study
Biomarker Signature in Rheumatoid Arthritis MTX Responders
Challenge: One of the most critical questions in a treating physician’s mind is knowing which patient will respond to which drug in a given disease.
Solution: Retrospective study in patients with early rheumatoid arthritis to identify a signature able to differentiate responder from non-responder to methotrexate. Such a signature would allow for early treatment with biologics in patients unable to respond to first-line treatment. Data showed the first signature can predict responders from no-responders in RA patients. This work is a milestone in precision medicine for RA.
Results were published in Journal of Translational Medicine
Translational Research Article:
Chromosome conformation signatures define predictive markers of inadequate response to methotrexate in early rheumatoid arthritis
Our senior advisor, Dr. Claudio Carini, led the translational medicine department at major pharmaceutical companies.