Biomedical Field
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Drawing on this week’s readings and lectures, submit a reflection addressing the following:
In preparation for viewing this week’s lectures, please read the following:
• Biomarkers and Beyond (SCRIP Executive Briefing)(upload)
• Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests: Workshop Summary (Beachy, et al.) Note: This article is
available as a free download from The National Academies Press. You will be asked to create a free MyNAP account if you don’t already have one. (link)
https://www.nap.edu/catalog/18617/refining-processes-for-the-co-development-of-genome-based-therapeutics-and-companion-diagnostic-tests
• FDA approves first cancer treatment for any solid tumor with a specific genetic feature (FDA Press Annoucement). (link)
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm560167.htm
• 2014 Pharma Profile (upload)
• Precision Medicine and Companion Diagnostics: Recent Trends and Accomplishments (Sakul) (upload)
Writer please answer the following completely. I do tip well for quality and no need for revision.
Response 1 (3 pages) 2 reference, may include provide info
Assume that you are Head of Oncology Companion Diagnostics at MEGA pharma ($14 billion in revenue and you need a companion diagnostics to launch your exciting new drug
with a potential market of $2 billion. A relatively small but profitable Diagnostic company owns a unique but not yet patented (in prosecution) technology that your
medical and scientific team believes is best for your relevant biomarker you need to measure. What deal terms and operational requirements would you impose on your
companion diagnostic partner? Explain your rationale.
Response 2 (2 pages) 1 reference
“The U.S. Food and Drug Administration granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature (biomarker). This is the
first time the agency has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated.” What are the
implications of this decision for diagnostic companies and for the drug developers? Discuss at least one for each industry.