Phospho-Flow Cytometry for the Screening of Intracellular Signaling Events in Cancer Cells and Immune Cells

Pre-clinical research on the development of small molecule inhibitors that block the activity of disease-associated kinases continues to be a major focus of cancer therapy. Therefore, robust platforms that can quantify the phosphorylation state of these kinases are valuable to drug development efforts. Using the MV-4-11 acute myeloid leukemia (AML) model, this update describes new in vitro and ex vivo phospho-flow services that measure phospho-kinase signaling with consistency and reproducibility. This platform uses fluorescence-labeled antibodies that recognize proteins only when phosphorylated on specific amino acid residues that regulate their function. Furthermore, we demonstrate how phospho-flow can integrate high throughput immunophenotyping with phospho-protein detection, which provides an advantage over ELISA-based and other conventional techniques.

The State of Modeling Preclinical Immuno-Oncology Pharmacology

The field of cancer immunology or immuno-oncology (I/O) dates back to the 1890’s with efforts by William Coley to treat malignancies by infection with certain bacterial strains.1 Fast forward 120 years, and we have observed the clinical success of multiple checkpoint inhibitor antibodies against cancer specific T cell negative regulatory pathways in multiple cancer types.2 Because of these clinical successes with antibodies targeting CTLA-4, PD-1, and PD-L1 (e.g., ipilimumab, nivolumab, pembrolizumab, atezolizumab, avelumab), vast resources in biotech and large pharma are being directed toward preclinical I/O research in an effort to develop novel immunotherapies.

A Practical Business Approach to Data Management for Clinical Trial Efficiency

Today’s clinical trials have become more complex and expensive, pressuring pharmaceutical companies to further improve their clinical trial operations. Clinical trial data management is one area where both sponsors and contract research organizations (CROs) can uncover new efficiencies, increase cost-saving measures and better meet diverse operational reporting needs across the clinical development cycle.

Pop Quiz: What’s Your Patient Centricity IQ?

What issues do patients cite as barriers to clinical study participation? How far are they willing to travel to participate in a study and how much more willing are they to participate knowing that their physician is aware of the study?

An Introduction to Immunohistochemistry

Immunohistochemistry (IHC) is an assay that utilizes the biological collaboration of Histology and Immunology. The biochemical interactions between an antibody and antigen permit visual distribution and localization of antibody–antigen interactions. This allows morphology, antigen intensity, and spatial relationships to be determined.

TDAR Assays for In Vivo Assessment and Testing

The immune system is the body’s main defense against foreign materials and biologic agents such as bacteria, viruses, chemicals, and foreign cells and tissues. The immune response includes specific action of lymphocytes (one type of white blood cell) and is facilitated by other white blood cells, including neutrophils, monocytes, macrophages, eosinophils and basophils. The immune system can be viewed as a system controlled by negative feedback, meaning that normally it must reduce the effects of disturbance or invaders through self-regulation.

Labcorp Announces 2023 Fourth Quarter and Full Year Results

Company Provides 2024 Guidance Results from Continuing Operations for the fourth quarter and full year versus last year: Revenue: Q4 of $3.03 billion vs $2.93 billion ; Full year of $12.16 billion vs $11.86 billion Diluted EPS: Q4 of $(1.95) vs $0.42 ; Full year of $4.33 vs $10.94 Adjusted EPS: Q4

Cell and Gene Therapy Answers: Top considerations for biomarkers in gene therapies

Gene therapies show great potential for addressing previously hard-to-treat diseases. However, optimizing their safety and efficacy requires careful analytical testing. Biomarkers can provide key insights into a gene therapy's effects and mechanisms. To learn more about the crucial role of biomarkers and analytical testing in gene therapy development, we spoke with Akanksha Gupta, PhD, executive director for cell and gene therapy at Labcorp. Here, she discusses the critical role of biomarkers and analytical testing within gene therapy, as well as important considerations for the adoption of a biomarker strategy to support development efforts.

Utilization of Radiation in the Preclinical Oncology Setting

The American Cancer Society estimates that in 2017 over 1.6 million people will be diagnosed with non-skin cancers in the United States. It is known that more than 50% of all cancer patients will receive some sort of radiation therapy as part of their treatment plan. Why is it then that preclinical evaluation of drugs in combination with radiation is not mainstay in the industry? In fact, in early 2017 the Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, within the US Food and Drug Administration, wrote a commentary in the International Journal of Radiation Oncology to address this point.1 In the commentary Walker, et al., indicate that, despite the high frequency of clinical radiation use resulting in both curative and palliative outcomes, there is a paucity of drug development efforts to capitalize on the potential synergies between targeted therapies and radiation therapy.

5 Things to Know About the Evolving Requirements For SEND

As our industry approaches the one year anniversary of the implementation of SEND (Standard for the Exchange of Nonclinical Data) datasets as required by the FDA for regulatory submissions, attention is shifting to the next set of requirements. From recent notices to upcoming compliance dates, we’ve compiled five key highlights for your information that will also help you proactively prepare for the changes.