Subjects - Business

Who are your role models? Your heroes? And do you even have any? I believe

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

one of the problems we have in society today is that we lack positive role mode

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

Examples of combination products may in

s who influence us in a healthy way. Just look at many of the successful peopl

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

e today in: sports, entertainment, politics, business and religion. You don’t

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

ave to look very far to find numerous examples of – negative role models. So w

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

Combination pro

y bother having a hero or role model? Role models can help us a great deal as

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

we move through our careers, relationships and lives. They can:

1. Offer us a

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

standard of behavior.
2. Show us how to maintain proper direction in our l

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

fe.
3. Help us avoid costly mistakes.
4. Teach us through their exper

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

iences.
5. Save us time.
6. Accelerate our careers.
7. Help us a

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

hieve our goals and life purpose.

I have numerous role models in my life – som

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

Following aspects would a

are still living and many passed away years ago. There are speakers, spiritual

dd to the challenges in developing combination products:

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

leaders, authors, actors, business and leaders – the list is endless. But I w

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

uld like to mention just a few:

-Will Rogers for his wit.
-Mark Twain for

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

his candor.
-Winston Churchill for his courage.
-Margaret Thatcher fo

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

r her purpose.
-George Burns for his humor.
-Jesus for his compassion

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

Professional from academic institutions, pharmaceutical industries, health care indust

as well as others.
-Neil Diamond for his staying power.

Why not take some

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

time and think about who you:

-respect
-relate to
-like
-believ

.

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

e in
-want to learn from

Then learn as much about them as you can so you

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

Companies that provide selfless information through particip

an develop a model for what you would like to learn from them, emulate or avoid

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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We are only kidding ourselves if we really believe that everything will be smooth sailing and will go exactly the way we want it to.

A useful approach when generating ideas is simply to ignore content. Evaluating content is a hindrance rather than an enhancer. If the people who wrote Red Riding Hood had realised the number of interpretations and analysis it was going to receive, they may have given up on the project.

As the smoke of battle clears, what these managers will have is a sound public relations strategy combined with effective communications tactics leading directly to the bottom line -- perception altered, behaviors modified, employer/client satisfied.

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Subjects - Who Are Your Role Models?

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