BioPharma Services Completes Its 1st Year Of A 5 Year Phase 1 Program With The U.S. FDA
Published: Sep 25, 2017
TORONTO--(BUSINESS WIRE)--BioPharma Services, Inc. (BioPharma) is proud to announce that it 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.
Dr. Janice Faulknor, Chief Medical Director at BioPharma Services, Inc. added: "We are thrilled that our capabilities of conducting complex Phase I programs including abuse deterrent studies will assist the FDA in approving safe and effective pharmaceuticals.”
The statements in this press release are solely made by BioPharma and does not represent the official views of the FDA.
About BioPharma Services Inc.
BioPharma Services Inc. is a fullservice Contract Research Organization (CRO) specializing in the conduct of Phase I/IIa and Bioequivalence clinical trials for international pharmaceutical companies worldwide. BioPharma has clinical facilities both in the USA and Canada with a total capacity of 300 beds with access to healthy volunteers and special populations. Headquartered in Toronto, Canada, BioPharma’s comprehensive services also include Bioanalysis at our GLP Certified Laboratory, Scientific and Regulatory Affairs, Biostatistics and Safety Data Analysis (CDISC), Medical Writing and Data Management.
BioPharma Services, Inc.
Ms. Anna Taylor
Executive, Vice-President, Business Development