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Fortrea & Emery Pharma Announce Strategic Collaboration to Deliver FDA Compliant Drug-Drug-Interaction Studies Using Rifampin
Collaboration enables testing of nitrosamine impurities, allowing sponsors to demonstrate acceptable use of rifampin in drug-drug interaction studies DURHAM,
About this update from Fortrea Holdings Inc.
[{"type":"text","content":"Collaboration enables testing of nitrosamine impurities, allowing sponsors to demonstrate acceptable use of rifampin in drug-drug interaction studies\nDURHAM, N.C., June 24, 2025 (GLOBE NEWSWIRE) -- Fortrea (Nasdaq: FTRE) (the “Company”), a leading global contract research organization (CRO), today announced a strategic collaboration with Emery Pharma, a leading analytical and bioanalytical CRO providing testing services under current Good Manufacturing Practice (cGMP) and Good Laboratory Practice (GLP), to provide rapid lot-by-lot, 1-methyl-4-nitrosopiperazine (MNP) testing of rifampin, the preferred drug for drug-drug interaction (DDI) studies, to certify impurities are below the Acceptable Intake (AI) Limit set by U.S. Food and Drug Administration (FDA) guidelines. Fortrea has selected Emery Pharma due to its strong capabilities in analytical and bioanalytical testing in support of Fortrea’s global clinical programs. Emery Pharma’s expertise in this area supports Fortrea’s ability to offer rifampin as an agent for inducing the CYP3A4 isoenzyme in DDI studies. The collaboration announced today allows sponsors to conduct DDI assessments using rifampin, which is frequently named as the preferred agent in these studies, due to its safety and tolerability profile. “This collaboration reflects our shared commitment to smarter study design and greater participant safety,” said Oren Cohen, M.D., chief medical officer and president of Clinical Pharmacology Services at Fortrea. “By enabling use of rifampin through our collaboration with Emery Pharma, we’re helping sponsors de-risk early-phase trials, accelerate timelines and enhance data quality. Emery Pharma’s deep expertise in bioanalytical sciences, coupled with their GLP and GMP capabilities, combined with Fortrea’s industry-leading clinical conduct capabilities makes this an ideal collaboration for the testing of rifampin for use in our DDI studies. The collaboration strengthens our ability to generate high-quality data that will benefit patients worldwide.” Ron Najafi, Ph.D., chief executive officer of Emery Pharma, added, “We’re honored to partner with Fortrea in advancing critical early-phase studies. Our team’s strength lies in solving complex analytical challenges and ensuring studies meet the highest regulatory and scientific standards. We’re excited to contribute to safer, ...