BURLINGTON LabCorphas introduced a suite of cell and gene therapy development services fromCovance, its drug development business, to help biopharmaceutical companies develop cell and gene therapies for cancer and other diseases.

With approximately one-third of biopharmas pipeline focused on precision medicines, it becomes even more critical to find innovative ways to help our customers speed these transformational therapies to the patients who need them, said Paul Kirchgraber, M.D., chief executive officer of Covance.

The coordinated services cover the full range of therapy development: pre-clinical, clinical and post-approval.

Pre-clinical services include pharmacology and safety assessment, biodistribution testing and services, and vector and cell characterization and qualification.

Clinical services include clinical trials with focused expertise in oncology, rare diseases and specific therapeutic areas; bioanalysis testing and services; biomarkers, including companion diagnostics; central laboratory services; and regulatory and strategic product development consultation, including clinical development and commercialization strategy.

Post-approval services include long-term follow-up studies, real-world evidence, pharmacovigilance, post-marketing commitments support, regulatory consulting and commercialization.

Cell and gene therapies, categorized as advanced therapy medicinal products (ATMPs), are more complex and specialized than traditional drugs. They typically involve correcting or replacing genetic information to restore the correct function of cells or genes for many conditions, including cancer and rare genetic diseases.

ATMPs have the potential to offer a durable, life-changing therapeutic response, possibly with a single administration, for patients who may have few or no alternative treatment options, according to the Alliance for Regenerative Medicine in Washington.

About 950 companies worldwide are developing ATMPs, and 1,052 clinical trials were under way by the end of the third quarter of 2018, according to the Alliance. Most of those trials 650 were for oncology indications.

Covance has more than 20 years of experience in supporting advanced therapies. The company said its coordinated approach to services uniquely positions it to partner with sponsor organizations to address complexity, reduce cost and risk, and accelerate timelines of their novel therapies.

In the last four years, Covance has conducted more than 300 preclinical studies and more than 40 clinical trials for cell and gene therapies globally, said Steve Anderson, Ph.D., chief scientific officer at Covance.

Covance is uniquely positioned to provide scientific and technical expertise to support the rapid growth in development of cell and gene therapies and the introduction of new regulatory pathways for these products, Anderson said. Our knowledge and experience from discovery through post-approval are significant, as demonstrated by our support of recent approvals in both cell and gene-based therapies.

Kirchgraber said Covance has made ongoing investments in people, processes and technologies targeting cell and gene therapies. The company has also grown its capabilities and capacity by forming strategic partnerships and making key acquisitions, such as the purchase in early 2019 of MI Bioresearch, a contract research organization specializing in nonclinical oncology testing, with a focus on immunotherapies and adoptive T-cell therapeutic approaches, he said.

LabCorp was established in 1969 as Biomedical Laboratories, a small pathology lab located in a hospital basement in Burlington, N.C. Over the last 50 years it has become a dominant life sciences company through mergers, acquisitions and organic growth.

LabCorp provides diagnostic, drug development and technology-enabled solutions for more than 120 million patient encounters per year. The company typically processes tests on more than 2.5 million patient specimens per week and supports clinical trial activity in about 100 countries through its central laboratory business, generating more drug safety and efficacy data than any other company.

LabCorp employs about 3,600 people in Alamance County, where it is the largest private employer, and about 7,300 across North Carolina. Its global workforce includes nearly 61,000 employees.

The company reported revenue of more than $11 billion in 2018. It announced today that it willannounce its 2019 financial resultson February 13. Its shares are traded on the New York Stock Exchange.

(C) N.C. Biotech Center

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LabCorp, Covance launch new effort focusing on gene therapies - WRAL Tech Wire

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