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Is it possible for a global CRO to improve – and even reshape – today’s drug development industry? We think so. We work with people like you to offer unique perspectives at every stage of development – from early phase development to clinical trials and commercialization.

Transforming pharmacovigilance with technology and automation

Pharmaceutical customers today are challenging pharmacovigilance service providers to deliver greater value for the funding they provide. Not surprisingly, service providers are addressing this need by investing in technology and automation tools that are poised to increase both the efficiency and quality of pharmacovigilance operations.

Designing a comprehensive self-administration drug abuse liability study | Part II

Regulatory agencies require that any drug (parent or major metabolite) that penetrates the brain and has CNS activity, regardless of its therapeutic indication, be assessed for that drug’s abuse potential. In this series on Assessing Potential Drug Abuse, we are sharing how the team designs and setup accurate and valid nonclinical GLP abuse liability assessment study types required by regulatory agencies: self-administration, drug discrimination and physical dependency studies. For the first in this series, we will explore how to design and develop a comprehensive self-administration study to test for a drug’s potential abusive or addictive nature. 

Emerging immuno-oncology therapies: life after checkpoint inhibitors

The clinical approval of biological therapeutics inhibiting CTLA-4 (ipilimumab), PD-1 (nivolumab, pembrolizumab) and PD-L1 (atezolizumab, avelumab, durvalumab) has ushered in a revolution in the field of cancer immunotherapy. Thus far, the approvals have occurred in a small number of cancer histotypes including melanoma, non-small cell lung cancer and urothelial cancers, but over 2000 active clinical trials of these drugs are ongoing. The common mechanism of action that links these agents together is that they target T cell checkpoint pathways. The role of T cell checkpoint receptors is to down-regulate T cell proliferation and effector function after these processes have been initiated by stimulation of T cells via the T cell receptor (TCR) and CD28, the primary T cell costimulatory receptor.

evaluation of immune response following treatment with Anti-CTLA-4 antibody, radiation therapy, or combination in murine model of breast cancer

Breast cancers are considered poorly immunogenic tumors, however, several approaches utilizing immunotherapies are being undertaken in the clinic to evaluate their potential for improving outcomes. Radiation therapy (RT) is a highly utilized clinical treatment modality in breast cancer. Radiation is known to modify the tumor microenvironment, induce cytokines and chemokines, and has been shown to potentially synergize with immunotherapies.During AACR’s Annual Meeting 2016, Maryland Franklin, PhD, Vice President, Scientific Development, presented her poster session on this subject. The aim of the work was to evaluate the possible synergy between RT and anti‐CTLA‐4 therapy in a murine model of breast cancer.Please use the link below to download the entire poster. You can also contact us for more information or to set up your next study.

Flow cytometry based functional assays essential for characterizing biological significance

The efficacy of immune-modulating anti-cancer therapeutic antibodies that have been FDA-approved in recent years, such as anti-CTLA-4 and anti-PD-1, has driven growing interest in methods that provide a mechanistic understanding of drug function. Development of new mono and combination therapies with immune-modulatory effects requires more powerful immunophenotyping techniques capable of in depth cell characterization. Flow-cytometry-based functional assays can be essential for elucidating the mechanism of a drug. While standard flow cytometry can identify immune subsets and their relative abundance within a sample, functional assays allow for the characterization of the biological significance of these populations including suppressive capability or activation status of a target population.

Labcorp expands drug development solutions with acquisition of Sciformix

BURLINGTON, N.C.–(BUSINESS WIRE)–Jun. 11, 2018– Labcorp® (NYSE: LH), a leading global life sciences company, announced today that it has acquired Sciformix Corporation, a scientific process outsourcing company focused on pharmacovigilance and regulatory solutions for biopharmaceutical and medical devices clients. Sciformix will become part of LabCorp’s drug development business.

Pharmacovigilance & risk management for biosimilars: unique challenges & possible solutions

Biological medicines (biologics) have made substantial contributions to the treatment of many chronic and serious diseases such as cancers, chronic inflammatory diseases and some rare genetic disorders, and are expected to provide significant therapeutic benefits to many patients who would otherwise have had limited treatment options.

Cancer testis antigen burden (CTAB): a novel biomarker of tumor‑associated antigens in lung cancer

Technology & automation drive operational efficiencies across the PV continuum

We are all aware that what we know of Pharmacovigilance today will radically transform in the future with the use of automation and technology tools. Companies that implement these tools in their PV operations can experience greatly improved efficiency, compliance and quality.