Fortrea collaborates with Emery Pharma for rapid rifampin impurity testing in drug-drug interaction studies, enhancing participant safety and data quality.
Quiver AI Summary
Fortrea, a global contract research organization, has announced a strategic partnership with Emery Pharma to provide rapid testing of rifampin for impurities, specifically 1-methyl-4-nitrosopiperazine (MNP), in compliance with FDA guidelines. This collaboration enhances Fortrea's ability to conduct drug-drug interaction (DDI) studies using rifampin, which is often preferred for its safety profile. The partnership aims to streamline early-phase trials, improve data quality, and ensure participant safety. This initiative follows regulatory changes from the FDA that raised allowable MNP limits in rifampin, addressing safety concerns that emerged from previous findings. Both companies emphasize their dedication to advancing regulatory-compliant drug development and improving health outcomes globally.
Potential Positives
- Strategic collaboration with Emery Pharma enhances Fortrea's capabilities in offering timely and compliant DDI studies utilizing rifampin, a preferred drug in clinical trials.
- This partnership aims to accelerate trial timelines and improve data quality, which may lead to more effective drug development and greater participant safety.
- The collaboration underlines Fortrea's commitment to addressing industry challenges related to impurity testing and regulatory compliance, aligning with updated FDA guidelines.
- Fortrea’s expanded service offerings through this collaboration position the company favorably within the competitive landscape of clinical research organizations.
Potential Negatives
- The press release highlights concerns about the nitrosamine impurity MNP found in rifampin, which has previously led to FDA scrutiny and calls for alternative drugs.
- The collaboration's emphasis on new testing for impurities may imply previous inadequacies in safety measures for rifampin, potentially affecting the company's reputation.
- By addressing FDA limits and scrutiny, the release may inadvertently signal underlying issues with the safety and reliability of existing therapies, raising concerns among stakeholders.
FAQ
What is the purpose of Fortrea's collaboration with Emery Pharma?
The collaboration aims to provide rapid testing of rifampin for drug-drug interaction studies, ensuring impurity levels meet FDA standards.
Why was rifampin chosen for drug-drug interaction studies?
Rifampin is preferred due to its safety profile and its role in inducing the CYP3A4 isoenzyme in DDI assessments.
How does Emery Pharma support Fortrea's clinical programs?
Emery Pharma offers strong analytical and bioanalytical testing capabilities that enhance Fortrea's data quality and trial safety.
What recent FDA changes affect rifampin testing?
The FDA updated its guidance, raising the acceptable impurity limit for rifampin, allowing for more flexible study designs.
What technologies does Emery Pharma utilize for impurity analysis?
Emery Pharma employs advanced technologies like liquid chromatography-mass spectrometry (LC-MS/MS) for precise quantification of nitrosamine impurities.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
DURHAM, 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, faster and more effective drug development.”
DDI studies are a cornerstone in the development of new therapeutics. Rifampin, a widely used antibiotic and traditionally a key tool in DDI studies, has faced scrutiny due to the discovery of MNP, a nitrosamine impurity. In 2021, the FDA found that all tested rifampin batches contained MNP levels exceeding previously accepted limits, prompting researchers to explore alternative drugs. However, these substitutes come with safety concerns and slower activation times. In 2023, the FDA updated its guidance , raising the acceptable MNP limit for rifampin.
This innovative approach of testing rifampin impurity levels is now available to Fortrea customers conducting clinical pharmacology trials, with flexible study designs that meet FDA requirements.
About Fortrea
Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, biotechnology, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients. Fortrea provides phase I-IV clinical trial management, clinical pharmacology and consulting services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team working in about 100 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com and follow us on LinkedIn and X (formerly Twitter).
About Emery Pharma
Emery Pharma is a leading analytical and bioanalytical contract research organization based in Alameda, California, recognized for its scientific leadership in impurity analysis and regulatory compliance. Specializing in GLP- and cGMP-compliant analytical testing, the company provides a comprehensive suite of services that support every stage of drug development—from early discovery through clinical trials and commercialization.
A pioneer in the development and validation of sensitive and specific assays for nitrosamine detection, Emery Pharma has played a key role in helping pharmaceutical sponsors and manufacturers navigate evolving FDA and ICH guidelines. The company’s cutting-edge capabilities in liquid chromatography-mass spectrometry (LC-MS/MS) and high-resolution mass spectrometry (HRMS) enable the precise quantification of trace-level nitrosamine impurities, including NDSRIs, NDMA and MNP, in complex matrices.
Emery Pharma also offers antibiotic screening, robust stability testing programs for both research-stage and commercial products, along with advanced analytical platforms such as nuclear magnetic resonance (NMR) and gas chromatography-mass spectrometry (GC-MS). Its team of interdisciplinary scientists delivers problem-solving, method development and investigational services with a strong focus on regulatory readiness and data integrity.
Driven by a commitment to scientific excellence and public health, Emery Pharma continues to advance the field of impurity profiling—ensuring safer medicines and contributing to industry-wide efforts to mitigate the risks associated with nitrosamines and other genotoxic contaminants.
For more information, visit us at emerypharma.com and follow us on LinkedIn .
Fortrea Contacts:
Galen Wilson (Media) – 703-298-0802,
[email protected]
Kate Dillon (Media) – 646-818-9115,
[email protected]
Hima Inguva (Investors) – 877-495-0816,
[email protected]
Emery Pharma Contacts:
Chris Purcell (Business Development) – 510-929-9262, [email protected]
