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School systems across the country have just a couple of things on their plate: charter schools, budgets, magnet schools, pension plans, pre-K and dropout rates- to

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

name a few. Houston Schools are no different, and Magnet and Early Childhood programs appear to be at the top of the list.

The cream of the Houston School syste

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

Examples of combination products may in

m’s crop are the Gifted and Talented students. Currently, 25,000 students are identified as gifted and talented. Beginning next school year (’07-’08), students i

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

dentified as such will all attend “Vanguard” programs. The programs themselves will not change, but the name will consolidate programs throughout Houston Schools.

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

Houston Schools identify students for Vanguard programs by using an “identification matrix”. This includes test scores from the Stanford/Aprenza exam and the Na

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

Combination pro

lieri Nonverbal Ability Test. Report-card points and teacher recommendations are also taken into account. Houston Schools’ students who have limited English prof

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

iciency, are enrolled in special education, have low socioeconomic status are also considered. Vanguard schools are continuously monitored to help ensure that high

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

-quality; more-rigorous instruction is provided in all classrooms. Students are expected to score above grade-level on the Stanford test. In addition, any of Houst

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

on Schools’ high-school students who are enrolled in a Vanguard school are required to take a minimum of two advanced-academic courses (ex: Advanced Placement, Int

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

ernational Baccalaureate, or dual-credit). “I am excited about the improvements in the Vanguard programs,” said Superintendent of Houston Schools Abelardo Saavedra

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

“It means more students will benefit from the rigor and high expectations of the programs, and it helps in our efforts to create a college-bound culture.” The Ho

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

Following aspects would a

uston Schools’ system has 20 Vanguard magnet schools that enroll gifted/talented students from all over the district. All students may apply to Vanguard schools, r

dd to the challenges in developing combination products:

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

egardless of their sub districts, of which there are 10. Students who are zoned to a school that is a Vanguard magnet will automatically get to attend that school

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

; they will no longer have their names put into the magnet lottery system.

Another program that Houston Schools Board of Education and Superintendent Saavedra are

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

committed to expanding is the district’s Early Childhood programs. Early childhood education has been recognized as extremely important to future academic succes

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

. Houston Schools now offers prekindergarten to all students on a tuition basis, and some students can attend for free. To qualify for free PreK at Houston School

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

Professional from academic institutions, pharmaceutical industries, health care indust

s, a student must meet one or more of the following criteria: unable to speak and comprehend the English language, economically disadvantaged, homeless, a child o

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

f an active-duty member of the armed forces, or a child of an armed-forces member who was injured, killed, or missing-in-action while serving on active duty. Begi

.

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

nning with the ’07-’08 school year, parents may enroll their four-year-old child (who turned four on or before September 1, 2007) in a full-day, 10-month program a

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

Companies that provide selfless information through particip

t participating Houston Schools for a state-set fee of $405 per month. 16 elementaries in the Houston Schools offer PreK, one of which is also a Montessori magnet

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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