Celgene Research relies on ENAC accreditation to provide the best guarantees for its pharmacodynamics testing
ENAC has recently granted accreditation to Celgene Research, belonging to the multinational pharmaceutical Bristol Myers Squibb (BMS), for its Centre for Innovation and Translational Research in Europe (CITRE). Accreditation has been granted for the quantification of biomarkers in leukocyte and lymphocyte subpopulations using flow cytometry. These trials fall within the scope of pharmacodynamics, that is, how drugs affect the patient's body.
The accredited laboratory, located in Seville, is the multinational's only research and development centre outside the United States. Debora Pons, the company's Head of Quality, in this interview addresses the reasons that led CITRE to request accreditation for this type of testing.
What trials has CITRE's internal laboratory been accredited for? Why did the company decide to rely on accreditation for these particular analyses?
The accredited trials are Bristol Myers Squibb's pharmacodynamic tests applied in clinical trials. Pharmacodynamic results, which relate the concentration of the drug with its biological effect in defined biomarkers, contribute decisively to the scaling phase and clinical concept confirmation in early development clinical trials.
BMS is a company committed to demonstrating ethics, integrity, and quality in everything it does for patients. From the moment we started the first trial we always had in mind that we wanted to demonstrate the technical competence of our staff and the reliability of our analytical results.
What advantages do you think having an accredited internal laboratory brings to the multinational BMS?
The pride of demonstrating its commitment to scientific excellence and the peace of mind of knowing that a drug's development will be based on reliable, robust, and reproducible results. In order to use these results for supporting clinical decisions and relations with regulatory agencies, this accreditation provides external validation of our quality assurances.
How can the accreditation you have just obtained benefit the patients who use the company's services?
Patients who participate in our clinical trials will be assured that for us their samples are invaluable and irreplaceable, and that they will be treated and analyzed with the highest quality standards.
Since BMS is a biopharmaceutical company operating internationally, do you think accreditation can help your global going-to-market processes?
Although the ENAC-accredited trials are part of the RDI phase and not the commercialization phase, if one of the compounds we have analyzed becomes commercialized, without a doubt, we at CITRE will have done our bit in the drug reaching those who need it, something that fills us with pride and drives us to continue researching to ensure that our science continues to transforming the lives of patients.
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