Covance establishes new global unit for biologic drug development

This team brings together Covance’s operational expertise in flow cytometry, immunoassays and cell-based assays with its scientific expertise in immunotoxicology study design, direction and operation to provide a more comprehensive offering for large-molecule drugs.

Covance CEO John Ratliff said: “With the formation of this team, we continue to demonstrate Covance’s commitment to strengthening our biologics solutions with key investments in scientific staff, technology and facilities.

“Biologics make up more than one-third of biopharma’s pipeline. 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, which helps our clients bring cutting-edge new drugs to patients faster.”

Covance’s immunology and immunotoxicology experts, overseen by Shawn Heidel, D.V.M., Ph.D., vice president and global head, Safety Assessment, Metabolism and Lead Optimization, support and advise in the development of biologic projects from pre-clinical evaluation to new drug regulatory submission and clinical study sample analysis.

The new I&I unit’s comprehensive offering also includes a seamless bridge to bioanalysis for use in regulatory submissions and to Covance Phase I clinical research units for first-in-human and first-in-patient studies.

As studies progress, the I&I team can complete its unique set of solutions by drawing on additional expertise from Covance’s clinical development and commercialization, translational biomarker, immuno-oncology and central laboratory teams, as well as LabCorp’s specialist scientific and technical capabilities.

The formation of Covance’s I&I unit illustrates LabCorp’s continued focus on biologics, which extends through LabCorp Diagnostics’ expanding suite of biologic therapeutic drug monitoring tests.

Covance’s initial investment in I&I capabilities focused on increasing global capacity by expanding dedicated laboratory space, state-of-the-art instrumentation and scientific and operations teams.

In 2017 alone, Covance more than doubled its I&I laboratory footprint, including additional space in three locations and establishing a new innovation laboratory for method development and validation.

Staff size has also doubled, driven by an increase in the number of scientists with advanced degrees.

Covance’s recent investments in technology and innovation capabilities have enabled the business to further scale production, as well as support the development and implementation of new services within the rapidly growing biologics market.

Covance Early Development senior vice president Steve Street said: “Our growing I&I team is capitalizing on the global experience of our established facilities in the U.S., Germany and the U.K. to deliver comprehensive support for large-molecule development, from innovative testing methods to insightful data analysis and interpretation.”

“In addition to study design, development and direction, the global innovation team within our I&I unit will focus on new assay development and validation, keeping Covance at the forefront of biologic research and development.”