3. You have just obtained a job at a small biotech company that specializes in d

Question

3. You have just obtained a job at a small biotech company that specializes in developing technologies for skin replacement due to burns or other traumatic injury and for cosmetic purposes due to aging. The methods are still in laboratory-phase research, and the two lead technologies are (a) development of skin cells from induced pluripotent stem cells (iPSCs) and (c) gene therapy to stimulate normal skin stem cells to become regular mature skin cells. The technology, discuss the pros and cons in 2-3 sentences, based on your knowledge of the FDA's Critical Pathway Initiative, FDA regulations, chemical engineering, cell biology, immunology industrial production of bioproducts, etc. (12 points; well-justified answers based on principles discussed in class are most valuable)

Explanation / Answer

Nowadays, CPI is secondary investigation schemes crossways the Agency, mainly finished companies that comprise other Federal activities, academe, manufacturing, and other community health-related governments. CPI smears teamwork, data organization, discipline, and values expansion, amongst other tackles, all sideways the dangerous track of medicinal creation growth, assessment, production, and use to:

-Classify and succeed biomarkers that can initial therapy and make scientific ranges well-organized and harmless

-Help grow new diagnostics and actions

-Smear cutting advantage excellence by design approaches in medicinal manufacturing

-Present data skills into medical creation growth and post marketplace shadowing CPI's goalmouth is well-organized medicinal product growth and assessment as well as better excellence, care, and efficiency of the crops FDA controls.

This scheme is producing empirical indication about the present U.S. scheme for journalism thoughtful adverse actions (SAEs) to sleuths under a new new drug submission. The goalmouth is to deliberate potential scheme alterations that more professionally and efficiently inform detectives of such proceedings. The scheme comprises five subprojects:

-Article the variety of guarantor practices for journalism unforeseen SAEs to detectives and for mistake of produce safety

-Count detective time spent getting, understanding, and interactive separate accelerated intelligences and measuring apparent value to detectives of separate accelerated intelligences in informing a product’s risk outline

-Liken the current repetition of succumbing separate SAEs to another approach founded on a European Commission’s leadership

-Education patient prospects about observing and interactive product care throughout the behavior of a clinical experiment

-Assemble skilled collection to mix consequences and endorse habits to enhance SAE reportage to investigators and safeguard subject guard.

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