Suggest - Self Improvement

If you are going to achieve what you have a passion for, you just may have to burn the boats.

Of course, this is a reference to explorer Hernan Cortez. In the early 1

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

500’s he set sail for Mexico with an army of 600 men. To keep the men from retreating he gave the order to burn the boats. They actually just beached the boats but 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

idea was that they had to be successful or they would have no way to get back to their homeland of Cuba.

So like Cortez, we need to burn our boats in terms of situat

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

ions that are not helping us achieve our goals. Let me give some specific examples of how this can work.

You may be in a job that you no longer enjoy. Or it may be a

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

relationship that has become unhealthy or unloving. It might be that where you live is not in a neighborhood or city that you want to live in forever. How do you get f

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

Combination pro

rom where you are to where you want to be? The first step is to burn the boats?

But wait, you’re thinking, do you mean that someone should quit their job, divorce the

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

ir spouse, and put up a for sale sign in the front yard of the family home? Not exactly…but close. Let me explain further.

Take your job, for example. Who says that y

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

ou must stay with a job that you have been in for many years? If the job no longer brings you joy you must leave it behind. You are not doing anyone a favor by staying

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

in a position that you do not want to be working at anymore. Furthermore, there is someone else who would love to do your job. It is all in how you think about your l

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

ife.

We constantly worry about what "they" would think if we did or did not do a particular thing. Just who exactly are they? They are the

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

ameless, faceless people that we allow to run our lives. Years later, after we have spent our time doing things we did not enjoy, where are these people? Nowhere to be

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

Following aspects would a

found. And if we could find them and remind them that they had encouraged us to do a certain thing I guarantee you that they would not even remember having said any s

dd to the challenges in developing combination products:

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

uch thing. So what is the answer?

Live your life doing the things that bring you happiness and joy. Work at a job that you look forward to doing. Forget about how muc

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

h something costs or something pays and live your life to the fullest. If you work towards joy the money will follow.

Observe small children and see how they understa

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

nd this so well. They do not care about what others say and they do not judge others for what they do. They live totally in the moment and enjoy each second. They brea

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

the deeply, laugh heartily, and sleep soundly. It is only after we get older that we begin to worry about what they will think if we do not do something their

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

Professional from academic institutions, pharmaceutical industries, health care indust

way.

When you wake up in the morning see how you feel. Your emotional guidance system will let you know if you are on the right path or not. If you feel good you are

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

moving towards a positive experience that will move you closer to where you want to be. If you feel bad you are moving in the wrong direction. We call this intuition,

.

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

but as we get older we tend to discount these basic feelings that tell us what is right for each of us as individuals. We are still concerned with what other people w

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

Companies that provide selfless information through particip

ill think.

Forget them! Burn the boats and live each minute as though it were your last. You will be happier and others will be attracted to your natural joy and ease

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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