Compliant v. Compatible: Understanding FDA 21 CFR Part 11
It’s not always easy to figure out whether your software is 21 CFR Part 11 compliant or compatible. Regulations for 21 CFR Part 11 state that electronic records,...
PerkinElmer's Phenoptics™ quantitative pathology research system recently helped prominent researchers solve a mystery about why some patients with Merkel cell cancer respond and some not when treated with new anti-PD1 immuno-therapy drugs. Janis Taube, M.D., at Johns Hopkins University, used PerkinElmer's innovative multispectral imaging system to reveal specific cell-to-cell interactions occurring between the immune system and the invasive cancer, revealing a pattern that correlated with response. Other more common approaches to look for differences, such as convention IHC and sequencing, were not helpful in distinguishing responders from non-responders. PerkinElmer's approach could potentially serve as the basis for future predictive biomarkers for cancer immunotherapies.
This rare form of skin cancer affects some 1,500 mostly older Americans each year. First appearing as a bluish-red nodule on the face, head, or neck, the cancer spreads rapidly to impact nearby lymph nodes, the brain, liver, and lungs. Surgery, radiation, and chemotherapy are the traditional treatments. Once metastasized, however, the cancer is difficult to eradicate and life expectancy is about 50% after five years of diagnosis.
In the course of their research, Dr. Taube's team used PerkinElmer's Phenoptics multicolor immunohistochemistry (IHC) platform to reveal immuno-biology interactions consistent with an anti-PD-1 therapy method-of-action. Specifically, in pre-treatment samples, the Phenoptics system revealed lymphocytes expressing the PD-1 protein were directly in contact with tumor cells and other immune cells expressing PD-L1. This observation confirmed the hypothesis that if Anti-PD-1 therapies can interfere with this pathway, there is a potential for exposing the cancer to attack by the immune system. After treatment, the Phenoptics system showed absence of tumor cells and abundance of immune cells, suggesting that the treatment had activated an immune response that eliminated the tumor.
Results like this help verify that PerkinElmer's Phenoptics quantitative pathology system provides a new and very important capability to decipher or unravel the biology that drives response. Combining the multispectral imaging system with the multicolor immunohistochemistry (IHC) and advanced image analysis capabilities enables researchers to explore the underlying biology of immuno-therapy drugs that promise to advance substantially our ability to fight aggressive and previously untreatable metatastic cancers like Merkel cell carcinoma.
"A study of this nature demonstrates how cancer researchers can use our innovative technologies to gain valuable insights about cancer biology that may enable breakthroughs in future clinical applications," says Brian Kim, President, Life Sciences & Technology, PerkinElmer. "In cancer immunology, our quantitative pathology solutions play a critical role in understanding a tumor's immune profile and provide the data needed to advance the exciting and paradigm-shifting area of immuno-oncology research."
It’s not always easy to figure out whether your software is 21 CFR Part 11 compliant or compatible. Regulations for 21 CFR Part 11 state that electronic records,...
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