Advice Pool - Reference and Education

Founded in 1842, the Detroit Schools are one of the nation’s largest public school systems. The Detroit Schools’ system is a district of choice, and is open to children who live

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

outside the city. The district offers numerous academic and career/ technical programs. Among these programs are: the Foreign Language Immersion and Cultural Studies School (

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

he only one of its kind in Michigan), Davis Aerospace (one of only a handful of schools in the country where students can obtain a pilot’s license), multiple award winning perfor

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

ing arts high schools, Detroit School of the Arts, and Crockett Technical High School (is a digital technology school).

The Detroit Schools consist of 232 schools; 147 elementar

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

schools, 31 middle schools, 28 high schools, 12 special education schools, 10 adult education schools, and 4 vocational education schools. Approximately 143,490 students attend

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

Detroit Schools. Student/teacher ratio in grades K-3 is 17:1. Detroit Schools have a “minority-majority” population; 91% of students are African American, 5% are Hispanic, 3% a

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

e White, 0.8% are Asian, and 0.3% are Native American. The Detroit Schools cover a geographical area that is 138.8 square miles and serves a city population of 951,270 people.

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

everal issues are currently being debated in the Detroit Schools. Among them are student achievement, as measured by the Michigan Educations Assessment Program, or MEAP, debate

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

ver lifting the Charter School cap, and shrinking student populations.

A recent study on how the Detroit Schools’ students are doing show that students have improved their readi

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

g and math scores since a federal program (No Child Left Behind) began pushing for academic progress. The report found that students’ performance in Detroit Schools increased in

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

reading and math at both the elementary and middle school levels. More students showed a higher proficiency in reading than in math. The study examined 5 years of test, race, p

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

overty and other student data.

Debate over charter schools is hot. Proponents of the schools, such as Daniel L. Quisenberry, president of the Michigan Association of Public Sch

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

ol Academies, said that “students make significant progress academically once they enroll in a charter school.” Detroit Schools’ District Interim Superintendent Lamont Satchel r

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

cently issued the following statement regarding a proposal to bring 25 new charter schools to Detroit: “The Detroit Public Schools system remains the best educational option for

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

children in this city. We offer a richer variety of academic and extra-curricular options than both charter schools and neighboring public school systems. Above all, we vastly ou

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

perform charter schools in the city on standardized examinations.” The rich variety of Detroit Schools includes many different programs, ranging from performing arts, technology,

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

media arts, commerce, finance, and, aviation.

Another issue that Detroit Schools are facing is a shrinking student population. Over the past 10 years, the district has lost mor

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

than 60,000 students. Much of this loss is due to the city’s declining population and shrinking birth rates, but a lot has been attributed to “poaching” from charter schools an

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

neighboring public school systems. “This is a critical year for the [Detroit School] District,” said Lamont Satchel, Esq. “While we continue to face declining enrollment we mu

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

t also confront the possibility of cuts in per pupil funding. …But we know that these problems are not insurmountable. We can overcome these challenges. And we shall overcome.

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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