Clinical research and development rely heavily on translational medicine. It is a multidisciplinary discipline that involves researchers, clinicians, and patients in an endeavor to move discoveries from the research phase to the human clinical development phase and to supplement fundamental research with clinical research findings.
Fabien Schmidlin, Director of Translational Medicine at Servier, shares his thoughts.
Translational medicine exists at the intersection of fundamental research, which seeks to understand disease causes, and clinical research, which seeks to examine the efficacy and safety of novel therapies for patients.
This collaborative discipline is critical for converting scientific breakthroughs into innovative medicines that enhance patient health. Translational medicine brings together the expertise of researchers, pharmacologists, and clinicians to assess potential therapies and, eventually, to speed all phases of drug development. It applies to all disorders.
Translational medicine accelerates the hunt for novel compounds by expediting their assessment in patients, “Bedside-to-Bedside,” beginning with clinical observations and patient medical requirements.
Facilitate decision-making and hasten the delivery of a medicine to the market for the benefit of patients by creating an efficient transition between research and clinical development.
“Previously, a significant gap existed between the worlds of laboratory research and clinical drug development,” writes Fabien Schmidlin. Today, translational medicine more closely combines research and treatment, which eventually speeds up decision-making for medication introduction.”
Determine and select patient subpopulations that will benefit from tailored therapy. The therapies are then tailored to the patient’s traits and conditions.
“Previously, we tried to treat all cancers with a single molecule,” Fabien Schmidlin says. “Today, we are attempting to identify which patient subpopulations will respond effectively to treatment very early on.” This is known as individualized medicine. Today, we have targeted medicines with a response rate of almost 90% for certain tumors.”
Reduce Phase I and II clinical risks to increase the likelihood of success at various phases of development.
Select the appropriate dosage for the optimum medication tolerance and efficiency.
Servier’s Translational Medicine
Servier established a translational medicine branch in 2020.
Its goal is to facilitate an efficient and rapid transition of the Group’s molecule portfolio from the preclinical phase (in which a molecule is evaluated in vitro in cell culture and in vivo in animals) to the FIM phase (“first in man”: first dose given to humans), which is the first step in clinical trials.
In close coordination with other R&D departments, this department streamlines the new medication development process, resulting in a faster market authorisation to assist patients.
“The patient is at the heart of the process and plays a fundamental role in the discovery of new treatments,” Fabien Schmidlin adds. “Patient participation enables the collection of biological samples and associated clinical data, which are critical for identifying and offering new therapeutic solutions.”
Biomarkers are at the center of translational medicine.
What function do they play in drug development?
Biomarkers are critical components of the drug development process. They are making it easier to make decisions at every step of growth. Biomarkers allow for the monitoring and prediction of product effectiveness and safety throughout development, as well as the selection of patients who are likely to react.
Biomarker development is critical to translational medicine projects. There are numerous kinds for diverse purposes:
- To comprehend a disease’s phases and development
- To show that a proposed medication has reached its therapeutic target and is exerting therapeutic benefits in a patient.
- To assess molecular toxicity and achieve a good benefit/risk ratio
- Understanding illness heterogeneity and identifying patient subpopulations most likely to benefit from a treatment