ETFOptimize | High-performance ETF-based Investment Strategies

Quantitative strategies, Wall Street-caliber research, and insightful market analysis since 1998.


ETFOptimize | HOME
Close Window

Fortrea & Emery Pharma Announce Strategic Collaboration to Deliver FDA Compliant Drug-Drug-Interaction Studies Using Rifampin

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


Primary Logo

Stock Quote API & Stock News API supplied by www.cloudquote.io
Quotes delayed at least 20 minutes.
By accessing this page, you agree to the following
Privacy Policy and Terms Of Service.


 

IntelligentValue Home
Close Window

DISCLAIMER

All content herein is issued solely for informational purposes and is not to be construed as an offer to sell or the solicitation of an offer to buy, nor should it be interpreted as a recommendation to buy, hold or sell (short or otherwise) any security.  All opinions, analyses, and information included herein are based on sources believed to be reliable, but no representation or warranty of any kind, expressed or implied, is made including but not limited to any representation or warranty concerning accuracy, completeness, correctness, timeliness or appropriateness. We undertake no obligation to update such opinions, analysis or information. You should independently verify all information contained on this website. Some information is based on analysis of past performance or hypothetical performance results, which have inherent limitations. We make no representation that any particular equity or strategy will or is likely to achieve profits or losses similar to those shown. Shareholders, employees, writers, contractors, and affiliates associated with ETFOptimize.com may have ownership positions in the securities that are mentioned. If you are not sure if ETFs, algorithmic investing, or a particular investment is right for you, you are urged to consult with a Registered Investment Advisor (RIA). Neither this website nor anyone associated with producing its content are Registered Investment Advisors, and no attempt is made herein to substitute for personalized, professional investment advice. Neither ETFOptimize.com, Global Alpha Investments, Inc., nor its employees, service providers, associates, or affiliates are responsible for any investment losses you may incur as a result of using the information provided herein. Remember that past investment returns may not be indicative of future returns.

Copyright © 1998-2017 ETFOptimize.com, a publication of Optimized Investments, Inc. All rights reserved.