Fortrea & Emery Pharma Announce Strategic Collaboration to Deliver FDA Compliant Drug-Drug-Interaction Studies Using Rifampin
Fortrea (Nasdaq: FTRE) has announced a strategic collaboration with Emery Pharma to provide rapid lot-by-lot MNP testing of rifampin for drug-drug interaction (DDI) studies. The partnership ensures rifampin impurities remain below FDA's Acceptable Intake Limit.
The collaboration enables sponsors to use rifampin, the preferred agent for DDI studies, by addressing previous concerns about nitrosamine impurity levels. This follows FDA's 2023 guidance updating acceptable MNP limits for rifampin, after their 2021 finding that all tested batches exceeded previous limits.
Through this partnership, Fortrea combines its clinical conduct capabilities with Emery Pharma's GLP and GMP testing expertise to enhance early-phase trial safety and efficiency.
Fortrea (Nasdaq: FTRE) ha annunciato una collaborazione strategica con Emery Pharma per offrire test rapidi MNP lotto per lotto della rifampicina, destinati agli studi di interazione tra farmaci (DDI). La partnership garantisce che le impurità di rifampicina rimangano al di sotto del limite di assunzione accettabile stabilito dalla FDA.
Questa collaborazione consente agli sponsor di utilizzare la rifampicina, agente preferito per gli studi DDI, affrontando le precedenti preoccupazioni riguardanti i livelli di impurità di nitrosammine. Ciò segue la guida della FDA del 2023 che ha aggiornato i limiti accettabili di MNP per la rifampicina, dopo la scoperta del 2021 che tutti i lotti testati superavano i limiti precedenti.
Attraverso questa partnership, Fortrea unisce le sue capacità di conduzione clinica con l'expertise di Emery Pharma nei test GLP e GMP per migliorare la sicurezza e l'efficienza delle sperimentazioni in fase iniziale.
Fortrea (Nasdaq: FTRE) ha anunciado una colaboración estratégica con Emery Pharma para proporcionar pruebas rápidas MNP lote por lote de rifampicina para estudios de interacción entre medicamentos (DDI). La asociación garantiza que las impurezas de rifampicina se mantengan por debajo del Límite de Ingesta Aceptable de la FDA.
La colaboración permite a los patrocinadores usar rifampicina, el agente preferido para estudios DDI, abordando preocupaciones previas sobre los niveles de impurezas de nitrosaminas. Esto sigue a la guía de la FDA de 2023 que actualizó los límites aceptables de MNP para rifampicina, tras el hallazgo de 2021 de que todos los lotes analizados superaban los límites previos.
A través de esta asociación, Fortrea combina sus capacidades de conducción clínica con la experiencia en pruebas GLP y GMP de Emery Pharma para mejorar la seguridad y eficiencia en ensayos en fases tempranas.
Fortrea (나스닥: FTRE)는 Emery Pharma와 전략적 협력을 발표하여 약물 상호작용(DDI) 연구를 위한 리팜핀의 MNP 로트별 신속 테스트를 제공합니다. 이 파트너십은 리팜핀 불순물이 FDA의 허용 섭취 한도 이하로 유지되도록 보장합니다.
이번 협력은 DDI 연구에 선호되는 리팜핀을 이전의 니트로사민 불순물 수준에 대한 우려를 해소하며 사용할 수 있게 합니다. 이는 2021년 모든 테스트 배치가 이전 한도를 초과했다는 FDA의 발견 이후 2023년 FDA가 리팜핀의 허용 가능한 MNP 한도를 업데이트한 지침을 따른 것입니다.
이 파트너십을 통해 Fortrea는 임상 수행 능력과 Emery Pharma의 GLP 및 GMP 테스트 전문성을 결합하여 초기 단계 시험의 안전성과 효율성을 향상시킵니다.
Fortrea (Nasdaq : FTRE) a annoncé une collaboration stratégique avec Emery Pharma pour fournir des tests rapides MNP lot par lot de la rifampicine pour les études d'interaction médicamenteuse (DDI). Ce partenariat garantit que les impuretés de rifampicine restent en dessous de la limite d'apport acceptable fixée par la FDA.
Cette collaboration permet aux sponsors d'utiliser la rifampicine, l'agent privilégié pour les études DDI, en répondant aux préoccupations antérieures concernant les niveaux d'impuretés de nitrosamines. Cela fait suite aux directives de la FDA de 2023 qui ont mis à jour les limites acceptables de MNP pour la rifampicine, après leur constatation en 2021 que tous les lots testés dépassaient les limites précédentes.
Grâce à ce partenariat, Fortrea associe ses capacités de conduite clinique à l'expertise d'Emery Pharma en tests GLP et GMP afin d'améliorer la sécurité et l'efficacité des essais en phase précoce.
Fortrea (Nasdaq: FTRE) hat eine strategische Zusammenarbeit mit Emery Pharma angekündigt, um schnelle MNP-Tests von Rifampin Chargenweise für Studien zu Arzneimittel-Wechselwirkungen (DDI) anzubieten. Die Partnerschaft stellt sicher, dass Rifampin-Verunreinigungen unter dem von der FDA akzeptierten Aufnahmelimit bleiben.
Die Zusammenarbeit ermöglicht es Sponsoren, Rifampin, den bevorzugten Wirkstoff für DDI-Studien, zu verwenden, indem frühere Bedenken bezüglich der Nitrosamin-Verunreinigungswerte ausgeräumt werden. Dies folgt auf die FDA-Richtlinie von 2023, die die akzeptablen MNP-Grenzwerte für Rifampin aktualisiert hat, nachdem 2021 festgestellt wurde, dass alle getesteten Chargen die vorherigen Grenzwerte überschritten hatten.
Durch diese Partnerschaft kombiniert Fortrea seine klinischen Durchführungskapazitäten mit Emery Pharmas GLP- und GMP-Testexpertise, um die Sicherheit und Effizienz von Studien in frühen Phasen zu verbessern.
- Partnership enables use of rifampin, the preferred and safer DDI study agent
- Collaboration helps sponsors de-risk early-phase trials and accelerate timelines
- Service addresses FDA compliance requirements for drug-drug interaction studies
- Combines Fortrea's clinical expertise with Emery's analytical capabilities
- None.
Insights
Fortrea's collaboration with Emery Pharma solves FDA rifampin concerns, strengthening its competitive position in early-phase drug development.
This strategic collaboration between Fortrea and Emery Pharma addresses a significant regulatory challenge that has been impacting drug development timelines since 2021. The partnership enables testing of 1-methyl-4-nitrosopiperazine (MNP) in rifampin, allowing its continued use in critical drug-drug interaction (DDI) studies despite previous FDA concerns about nitrosamine impurities.
The arrangement offers tangible competitive advantages for Fortrea in the contract research organization (CRO) market. By enabling sponsors to use rifampin—which has superior induction properties for CYP3A4 enzyme studies compared to alternatives—Fortrea can now offer more efficient and potentially more reliable clinical pharmacology services. This addresses a specific pain point for pharmaceutical developers who have been forced to use less optimal alternatives with safety concerns and slower activation times.
From a business perspective, this collaboration strategically positions Fortrea to capture more early-phase clinical trial work, particularly the mandatory DDI studies required for virtually all new drug applications. The ability to offer rifampin-based studies with FDA-compliant impurity testing represents a specialized service that could attract pharmaceutical sponsors looking to accelerate development timelines while maintaining regulatory compliance. By leveraging Emery Pharma's analytical expertise alongside their own clinical capabilities, Fortrea has effectively created a differentiated offering in the competitive CRO landscape that directly addresses an industry-wide challenge.
Collaboration enables testing of nitrosamine impurities, allowing sponsors to demonstrate acceptable use of rifampin in drug-drug interaction studies
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, media@fortrea.com
Kate Dillon (Media) – 646-818-9115, kdillon@prosek.com
Hima Inguva (Investors) – 877-495-0816, hima.inguva@fortrea.com
Emery Pharma Contacts:
Chris Purcell (Business Development) – 510-929-9262, cpurcell@emerypharma.com
FAQ
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