Experimental biology and medicine
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Exp. Biol. Med. (Maywood) · Feb 2018
ReviewThe FDA Oncology Center of Excellence and precision medicine.
In January 2017, the U. S. Food and Drug Administration (FDA) formally established the Oncology Center of Excellence (OCE) to streamline the development of cancer therapies by uniting experts from FDA product centers to conduct expedited review of drugs, biologics, and devices. ⋯ Food and Drug Administration's (FDA) first site-agnostic oncology drug approval, a landmark event in the history of cancer drug development. The role of the FDA's newly established Oncology Center of Excellence (OCE) in this approval is described, as are several OCE programs to advance excellence in regulatory science in the era of precision medicine. Also provided is an overview of FDA's expedited drug review programs, which are important to the continued acceleration of therapeutics development for patients with life-threatening diseases and few or no other treatment options.
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Exp. Biol. Med. (Maywood) · Feb 2018
ReviewBiomarkers: Delivering on the expectation of molecularly driven, quantitative health.
Biomarkers are the pillars of precision medicine and are delivering on expectations of molecular, quantitative health. These features have made clinical decisions more precise and personalized, but require a high bar for validation. Biomarkers have improved health outcomes in a few areas such as cancer, pharmacogenetics, and safety. ⋯ The successes in these cases suggest many more applications for biomarkers and a greater impact for precision medicine across the spectrum of human disease. The authors assess the status of biomarker-guided medical practice by analyzing themes for biomarker discovery, reviewing the impact of these markers in the clinic, and highlight future and ongoing challenges for biomarker discovery. This work is timely and relevant, as the molecular, quantitative approach of precision medicine is spreading to many disease indications.
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Exp. Biol. Med. (Maywood) · Jan 2018
ReviewGut reactions: How the blood-brain barrier connects the microbiome and the brain.
A growing body of evidence indicates that the microbiome interacts with the central nervous system (CNS) and can regulate many of its functions. One mechanism for this interaction is at the level of the blood-brain barriers (BBBs). In this minireview, we examine the several ways the microbiome is known to interact with the CNS barriers. ⋯ These metastatic bacterial factors can signal T-cells to become more CNS penetrant, thus providing a novel intervention for treating CNS disease. Studies in humans show the therapeutic effects of T-cell engineering for the treatment of leukemia, so perhaps a similar approach for CNS disease could prove effective. Future research should begin to define the bacterial species that can cause immune cells to differentiate and how these interactions vary amongst CNS disease models.
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Exp. Biol. Med. (Maywood) · Nov 2017
ReviewNext generation human skin constructs as advanced tools for drug development.
Many diseases, as well as side effects of drugs, manifest themselves through skin symptoms. Skin is a complex tissue that hosts various specialized cell types and performs many roles including physical barrier, immune and sensory functions. Therefore, modeling skin in vitro presents technical challenges for tissue engineering. ⋯ This paper provides an overview of the strategies to build complex human skin constructs that can faithfully recapitulate human skin and thus can be used in drug development targeting skin diseases. In particular, we discuss recent developments and remaining challenges in incorporating various skin components, availability of iPSC-derived skin cell types and in vitro skin disease models. In addition, we provide insights on the future integration of these complex skin models with other organs on microfluidic platforms as well as potential readout technologies for high-throughput drug screening.
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Exp. Biol. Med. (Maywood) · Sep 2017
Ultrasound-guided microwave ablation in the treatment of benign thyroid nodules in 435 patients.
The objective of the present study was to investigate the effectiveness and safety of ultrasound-guided microwave ablation in the treatment of benign thyroid nodules. A total of 474 benign thyroid nodules in 435 patients who underwent ultrasound-guided microwave ablation from September 2012 to August 2015 were included. Nodule volume and thyroid function were measured before treatment and at 1, 3, 6, and 12 months and subsequently after every 6 months. ⋯ Impact statement Ultrasound-guided MWA is an effective and safe technique for the treatment of benign thyroid nodules. It can significantly reduce the nodule volume, improve the patients' clinical symptoms, has less complication, guarantees quick recovery, meets patients' aesthetic needs, and shows less interference on the physiological and psychological aspects of the body. MWA should be a good complement to traditional open surgery and has potentials in clinical applications.