Fortrea teams with Emery for rifampin testing for drug-drug interaction studies

Fortrea has partnered with Emery Pharma to offer testing services for key components in drug-drug interaction studies.

The collaboration will see Emery look for impurities that are sometimes present in batches of rifampin, an antibiotic that is commonly used in drug-drug interaction (DDI) studies. Financial terms of the deal were not disclosed.

Fortrea chief medical officer Oren Cohen said, “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,” he added.

Ron Najafi, Emery CEO, was similarly enthusiastic, commenting, “Our team’s strength lies in solving complex analytical challenges and ensuring studies meet the highest regulatory and scientific standards.”

DDI testing

A DDI study is used to determine whether a candidate medicine’s efficacy, safety, or pharmacokinetics will be altered if it is given with other drugs that the target patient population may also be taking.

Rifampin has been used for DDI studies for decades because it induces enzymes involved in drug transport and metabolism including CYP3A4 isoenzyme, which is known to break down therapeutic compounds.

However, this role has been a topic of debate in recent years. In 2021, a US FDA team found batches of the drug containing higher than expected levels of the impurity 1-methyl-4-nitrosopiperazine (MNP), which is a potential carcinogen.

This discovery prompted efforts to find alternatives, but no universally accepted candidates emerged. So, in 2023, the FDA updated its guidance, raising the acceptable MNP limit for rifampin.

According to a recent report, the global drug interaction testing service market was valued at $1 billion in 2024 and is expected to generate $1.11 billion this year. By 2033, the market is forecast to be worth $2.34 billion, with a projected CAGR of 11.4%.

DepositPhotos/maxkabakov