Specialized Expertise, Coordinated Capabilities and Targeted Investments Designed to Accelerate Development and Reduce Risk for Sponsors
BURLINGTON, N.C.–(BUSINESS WIRE)–LabCorp® (NYSE:LH), a leading global life sciences company that is deeply integrated in guiding patient care, today introduced its focused and coordinated suite of cell and gene therapy development solutions from Covance, its drug development business. These solutions are designed to reduce time and risk for sponsors at each phase and across the full continuum of their therapy development needs in one of the industry’s fastest-growing segments.
With more than 20 years of experience in delivering development solutions for advanced therapies, such as cell and gene therapy products, Covance provides a unique offering of specialized expertise and coordinated capabilities, combined with focused investments supporting the preclinical, clinical and post-approval phases of development. By offering a coordinated approach to scientific and program consultation, biomarker and companion diagnostic development, study management, regulatory and commercialization support capabilities, Covance is uniquely positioned to partner with sponsor organizations to address complexity, reduce cost and risk, and effectively accelerate timelines of their novel therapies.
“With approximately one-third of biopharma’s 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., Covance chief executive officer. “Covance has made ongoing investments in people, processes and technologies targeting cell and gene therapies. We are also growing our capabilities and capacity by forming strategic partnerships and making key acquisitions, such as our purchase in early 2019 of MI Bioresearch, a contract research organization (CRO) specializing in nonclinical oncology testing, with a focus on immunotherapies and adoptive T-cell therapeutic approaches.”
Cell and gene therapies, which fit into the general category of advanced therapy medicinal products, are more complex and specialized than traditional drugs. They can involve correcting or replacing genetic information and engineering the correct functionality of cells or genes for many conditions, including cancer and rare diseases with a genetic basis.
“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,” said Steve Anderson, Ph.D., Covance chief scientific officer. “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. In the past four years, Covance has conducted more than 300 preclinical studies and more than 40 clinical trials for cell and gene therapies globally.”
Covance Cell and Gene Therapy Solutions
Pharmacology and safety assessment
Biodistribution testing and services
Vector and cell characterization and qualification
Clinical trials, with focused expertise in oncology, rare diseases and specific therapeutic areas
Bioanalysis testing and services
Biomarkers, including companion diagnostics
Central laboratory services
Regulatory and strategic product development consultation, including clinical development and commercialization strategy
Long-term follow-up studies
Post-marketing commitments support
LabCorp (NYSE:LH), an S&P 500 company, is a leading global life sciences company that is deeply integrated in guiding patient care, providing comprehensive clinical laboratory and end-to-end drug development services. With a mission to improve health and improve lives, LabCorp delivers world-class diagnostic solutions, brings innovative medicines to patients faster, and uses technology to improve the delivery of care. LabCorp reported revenue of more than $11 billion in 2018.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements, including but not limited to statements with respect to the Company’s future operations, expansion of offerings and capabilities, and opportunities for future growth. Each of the forward-looking statements is subject to change based on various important factors, many of which are beyond the Company’s control, including without limitation, competitive actions and other unforeseen changes and general uncertainties in the marketplace, changes in government regulations, including healthcare reform, customer purchasing decisions, including changes in payer regulations or policies, other adverse actions of governmental and third-party payers, changes in testing guidelines or recommendations, the effect of public opinion on the Company’s reputation, adverse results in material litigation matters, failure to maintain or develop customer relationships, our ability to develop or acquire new products and adapt to technological changes, failure in information technology, systems or data security, and employee relations. These factors, in some cases, have affected and in the future (together with other factors) could affect the Company’s ability to implement the Company’s business strategy and actual results could differ materially from those suggested by these forward-looking statements. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements. The Company has no obligation to provide any updates to these forward-looking statements even if its expectations change. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Further information on potential factors, risks and uncertainties that could affect operating and financial results is included in the Company’s most recent Annual Report on Form 10-K and subsequent Forms 10-Q, including in each case under the heading RISK FACTORS, and in the Company’s other filings with the SEC.
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