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These past few weeks on American Idol they have been auditioning singer from all around the country in search of the lucky finalist w

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

ho will have the awesome opportunity to go to Hollywood. I have watched many of the early tryouts and have heard some great and not so great singers. My hat is

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

Examples of combination products may in

off to these people who spend days in a long line hoping to ultimately perform for the three celebrity judges.

I like to hear the many stories th

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

y share of people who have met new friends while waiting in line for the big chance. One story in particular was about two young men pumped up, excited, suppor

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

ing one another and ready to demonstrate their originality to the judges only to be voted down, joining the long list of others who have failed to make the gra

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

Combination pro

de. The difference between these two individuals and the others who have met the same fate is that they were not only told they would not be going to Hollywood

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

but they were also laughed at and teased.

I understand that not everyone can win. If everyone won there would be no definition for lose

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

s. If everyone won there would be no room for improvement and growth. American Idol’s Simon Cowell crossed the line when he told the contestan

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

he “looked like a monkey.” To make matters worse the two other judges Randy and Paula just gigged and laughed like children supporting a bully on a playground

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

. Judges like referees have to have the freedom to make the calls to keep the game interesting. Not every call or opinion is to everyone’s liking but to say so

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

ething like that is crossing the line.

Each week I present my Anti-bullying/Anti-violence programs to hundreds of students, corporate staff and associa

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

Following aspects would a

ions. We discuss tolerance, respect and kindness, sharing tips and suggestions on how to end this kind of negative behavior at work, school or

dd to the challenges in developing combination products:

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

in the community. Then we turn on the Fox Network’s hottest show American Idol to observe a bully in action.
Bullying is “imbalance of power,”

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

rong> one person uses their power to hurt or verbally harm another individual. A victim is someone who is weaker or lacks social skills and the ability to defe

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

d themselves. In this situation there is an imbalance of power because we have a so-called celebrity teasing a weaker “regular” person. The regular individual

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

an’t defend himself because the celebrity has the ability to control not only the situation but also the final product air on the Fox Network.

The good

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

Professional from academic institutions, pharmaceutical industries, health care indust

ews is that in the days following the broadcast, people called into radio stations around the country and have joined in on the discussion asking that Simon ap

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

ologize to these individuals and for the Fox Network to not allow this kind of bullying behavior. Fox has listened to the concerns of their viewers and have ta

.

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

ed down the insults aired on American Idol. This proves that when we come together to stand up against the bully we can weaken their power.

It is my hop

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

Companies that provide selfless information through particip

that the bullies of the world aren’t using this program to validate their verbal/physical bullying and victims don’t use this as another excuse to stay silent

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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References - American Idol or American Bully?

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