Fortrea Collaborates with Emery Pharma to Ensure Rifampin Safety in Early-Phase Drug Studies

Emery and Fortrea Pharma’s Collaboration

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Announcement

Fortrea pharma, a known contract research organization (CRO), entered into a collaboration with Emery pharma, an analytical and bioanalytical CRO. The collaboration is initiated to deliver testing services under current good laboratory practice (GLP) and good manufacturing practice (GMP). Also, to enable 1-methyl-4-nitrosopiperazine (MNP) testing of rifampin, lot-by-lot, the preferred drug for drug-drug interaction (DDI) studies, and certify that impurities are below the acceptable intake (AI) limit measured under US Food and Drug Administration (FDA) guidelines.

What Attracts Fortrea to Collaborate with Emery Pharma?

Fortrea approached Emery Pharma due to its expertise in analytical and bioanalytical testing, supporting Fortrea’s global clinical programs. Emery Pharma is a professional in the area that Fortrea seeks an opportunity to provide rifampin as an agent for the leading CYP3A4 isoenzyme in DDI studies. The collaboration asked sponsors to initiate a DDI assessment using rifampin. Rifampin is commonly used as the most commonly used agent for studies because of its tolerability and safety profile.

DDI Studies

DD studies are a foundation for the development of new therapeutics. Rifampin is a most demanding traditional and antibiotic aspect of DD studies. It goes through scrutiny due to the introduction of nitrosamine impurity, an MNP. Around 2021, the FDA noticed that all tested rifampin sets had the highest MNP level above the previously accepted limit. This led researchers to find an alternative option to the drug. These substitutes are all safety-controlled and take less activation time. FDA upgraded its guidelines and set an acceptable MNP limit for rifampin. The current news for Fortrea customers is, the innovative initiative of testing the rifampin impurity level is available after the clinical pharmacology trials, with a well-designed study needed for FDA approval.

Views and Statements

MD, Chief Medical Officer and President of Clinical Pharmacology Services at Fortrea, Oren Cohen said, “The collaboration matched our commitment to smart study and participants' safety. The approach to rifampin through Emery Pharma is supporting sponsors in de-risking early-phase trials, improving data quality, and leveraging timelines. Emery Pharma’s deep learning in bioanalytical sciences, along with their GMP and GLP, and Fortrea’s capabilities, make this a valuable collaboration.”

PhD, Chief Executive Officer of Emery Pharma, Ron Najafi, said, “The company is honored with this partnership with Fortrea to introduce advancement in critical early-phase studies. Our team is capable of solving intricate analytical challenges and enabling studies to reach the peak of scientific and regulatory standards.”