Order ID:89JHGSJE83839 | Style:APA/MLA/Harvard/Chicago | Pages:5-10 |
Instructions:
regulating the MAPK/ERK signaling pathway
Cotellic Essay
Assignment: Cobimetinib (Cotellic) is an inhibitor of the mitogen-activated protein kinase (MAPK)/extracellular signal regulated kinase 1 (MEK1) and MEK2. These proteins are upstream regulators of the extracellular signal-related kinase (ERK) pathway, which promotes cellular proliferation. BRAF is a member of the Raf kinase family of growth signal transduction protein kinases. This protein plays a role in regulating the MAPK/ERK signaling pathway, which affects cell division. In patients with melanoma containing BRAF V600E or BRAF V600K mutations, the ERK pathway is constitutively activated, resulting in promotion of tumor growth. Background Information: On November 10, 2015, FDA issued an Approval Letter allowing Genentech, Inc. to market the kinase inhibitor, Cotellic (cobimetinib), for use in combination with vemurafenib for the treatment of patients with BRAFV600E/K mutation positive unresectable or metastatic melanoma. Cobimetinib is an inhibitor of MEK1 and MEK, which are ubiquitously expressed proteins that participate in the MAPK/ERK signal transduction cascade.
MEK proteins propagate signals between the small GTPase Ras, its downstream immediate effector Raf and the ERK1/2. Cobimetinib is a kinase inhibitor, consistent with the established pharmaceutical class for other drugs with this type of activity. Prompt: Drugs@fda.gov is a valuable resource for Regulatory Affairs personnel in the pharmaceutical industry.
Aside from new drug Approval Letters and Labeling Revisions, FDA summaries of nonclinical, medical, chemistry, statistical, clinical, and biopharmaceutics reviews are made publically available following marketing approval. Reviewing FDA approval decisions and the drug development programs associated with such decisions may provide insight and precedence to other pharmaceutical companies targeting the same indication or mechanism of action for their drug candidates.
Regulatory Affairs personnel may use this information to contribute to a corporate strategy shaped with regulatory input. Using Drugs@fda.gov, provide a broad, 2-3 page overview of the nonclinical studies Genentech Pharmaceuticals carried out for Cotellic prior to receiving marketing approval. Please include brief descriptions of carcinogenicity, genotoxicity, reproductive, pharmacokinetic, and pharmacology studies performed.
For each type of study, explain the potential timeframe during drug development when that study may have been carried out (for example, whether that study would need to be completed prior to starting clinical trials, or could be performed while clinical trials are ongoing), as well as its major objective. Include an overview of Cotellic and melanoma with BRAF V600E/K mutations in the introductory paragraph, and discuss the goals of nonclinical development and adequacy of the nonclinical development program for Catelli in the conclusion.
regulating the MAPK/ERK signaling pathway
RUBRIC |
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Excellent Quality 95-100%
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Introduction
45-41 points The background and significance of the problem and a clear statement of the research purpose is provided. The search history is mentioned. |
Literature Support 91-84 points The background and significance of the problem and a clear statement of the research purpose is provided. The search history is mentioned. |
Methodology 58-53 points Content is well-organized with headings for each slide and bulleted lists to group related material as needed. Use of font, color, graphics, effects, etc. to enhance readability and presentation content is excellent. Length requirements of 10 slides/pages or less is met. |
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Average Score 50-85% |
40-38 points More depth/detail for the background and significance is needed, or the research detail is not clear. No search history information is provided. |
83-76 points Review of relevant theoretical literature is evident, but there is little integration of studies into concepts related to problem. Review is partially focused and organized. Supporting and opposing research are included. Summary of information presented is included. Conclusion may not contain a biblical integration. |
52-49 points Content is somewhat organized, but no structure is apparent. The use of font, color, graphics, effects, etc. is occasionally detracting to the presentation content. Length requirements may not be met. |
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Poor Quality 0-45% |
37-1 points The background and/or significance are missing. No search history information is provided. |
75-1 points Review of relevant theoretical literature is evident, but there is no integration of studies into concepts related to problem. Review is partially focused and organized. Supporting and opposing research are not included in the summary of information presented. Conclusion does not contain a biblical integration. |
48-1 points There is no clear or logical organizational structure. No logical sequence is apparent. The use of font, color, graphics, effects etc. is often detracting to the presentation content. Length requirements may not be met |
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regulating the MAPK/ERK signaling pathway |
regulating the MAPK/ERK signaling pathway