As novel large-molecule drugs are being developed, Covance has formed an immunology and immunotoxicology unit dedicated to biologic drug research. The CRO hopes to attract more programs by offering streamlined services.
The new team brings together Covance’s existing operational expertise in flow cytometry, immunoassays and cell-based assays with the scientific know-how in immunotoxicology.
The company expects that the unit can help biologic programs in preclinical evaluation and clinical study sample analysis, and can also offer seamless interaction with bioanalysis for regulatory submissions or to its clinical research teams for first-in-human studies. Additional help from Covance’s clinical development and commercialization, translational biomarker, immuno-oncology and central laboratory teams, as well as parent company LabCorp’s expertise, can also be integrated.
“Biologics make up more than one-third of biopharma’s pipeline,” said Covance CEO John Ratliff in a statement. “Integrating our scientific and operational know-how into a seamless group allows us to deliver even richer scientific insights and faster cycle times for clients’ biologic programs.”
According to biopharma intelligence firm EvaluatePharma’s “World Preview 2017, Outlook to 2022” report released last June, in 2022, biologics will surpass chemicals to constitute over half of the world’s top 100 drug sales.
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Covance offers I&I services for both small molecules and biologics through the Safety Assessment, Metabolism and Lead Optimization organization, and that’s not changed; but “as a percentage of the drug-development pipeline, many fewer small molecules impact immune-system function directly, and biologics often require more individualized development plans,” so the company decided to form a new I&I unit specifically for biologics, LabCorp spokeswoman Sue Maynard told FierceCRO.
Covance has conducted more than a thousand large-molecule studies over the past few years and has assisted in the submission of more than 40 integrated IND/CTA-enabling packages for biologics in the last four years, according to Maynard.
After expanding its laboratory footprint and doubling its staff size in 2017, currently more than 70 full-time members run the I&I services in five Covance sites globally, in Madison, Wisconsin, and Greenfield, Indiana in the U.S.; Harrogate, the U.K.; Muenster, Germany; and Shanghai. Maynard said the company expects to grow its footprint and team further in the next two years.
Formation of the I&I team comes as Covance is still in the process of a restructuring. LabCorp expanded its LaunchPad business improvement project to include Covance last April. The plan is to “align people and capabilities with client and business demand, utilize automation and new information technology platforms to create efficiencies, and enhance customers’ experience with [Covance] through investments in commercial and operational processes,” said LabCorp in its 2017 SEC filing. The goal is to achieve net savings of $130 million through the three-year period ending in 2020.