BioPharma Services has successfully completed its first year of collaboration with the Center for Drug Evaluation and Research (CDER), a division of the US Food and Drug Administration (FDA). The first year program involved the use of a smart pill technology to investigate in vivo PK on a generic drug product in a drug-drug interaction bioequivalence study. The final cohort of this Phase 1 study is set to be completed in October of 2017. Planning and discussions are underway with the FDA for follow up studies as part of BioPharma’s 5 year contract term.
"We are very proud to work with the FDA in support of their early stage research needs. We are truly excited and honored to be continuing our collaboration with new programs for 2018.” said Renzo DiCarlo, CEO at BioPharma Services, Inc.
The FDA studies conducted by BioPharma will allow CDER to proactively address scientific questions in developing approval standards and ensure postmarket safety and efficacy of approved drug products. Ultimately, the outcome of these studies will help improve the generic drug review practice within CDER. As part of this contract, BioPharma will provide the FDA with a full service offering from protocol development, clinical conduct, and bioanalysis to final report.