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It is interesting to listen to the commentary about the coaches in this years super bowl. What do you think they have in

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

common?

When I look at Tony Dungy I know he is the coach of the Indianapolis Colts and Lovie Smith is the coach of the

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

Examples of combination products may in

Chicago Bears. Everything I have read about them is they are good Christian men, who do not shout or disrespect the ath

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

letes on their team.

In fact, Dungy and Smith are the best of friends and wonderful people. After all, this is what all

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

men should strive to be and they are excellent role models for all people.

Do not get me wrong, the only thing I hear

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

Combination pro

from the media is that Dungy and Smith are African-American professional football coaches or black coaches. It is hilari

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

ous listening to the commentary, for example they say, "You know you are the first two black coaches to lead your teams

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

o the super bowl."

What is wrong with this media commentary? Cocahes Dungy and Smith do not have to be reminded of thei

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

r race, it is obvious what their ethnic background is. In fact, what the media should be saying is these two coaches are

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

great leaders, intelligent, and principled God fearing men.

What is truly interesting is the fact it took until 2007 f

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

or two outstanding men such as Dungy and Smith to coach in the super bowl. What does this mean?

It means the ownership

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

Following aspects would a

teams In Indianapolis and Chicago based their decision to hire Dungy and Smith to coach their teams based on their outst

dd to the challenges in developing combination products:

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

anding character, rather than color, race, or ethnicity.

So what took the Nationa Football League so long to hire based

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

on character? After all, the National Basketball Association experienced the leadership of two coaches who happended to

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

be African-American professional basketball coaches who coached for the NBA championship over 30 years ago.

Al Attles c

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

oached the Golden State Warriors and KC Jones coached the Boston Celtics. Why such a huge disparity of time and judgemen

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

Professional from academic institutions, pharmaceutical industries, health care indust

t about one's ability to coach?

Seems to me people are too hung up on race, rather than leadership ability and characte

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

r. Imagine how many other leaders and character people have been overlooked because of the color of their skin, race or

.

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

gender.

It is high time America begins to value character over race. Why? We are leaving too much talent on the sidelin

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

Companies that provide selfless information through particip

es at numerous companies and organizations. To remain viable we need all hands on deck, no matter the racial composition

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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