Main Subject - Business

It is easier to walk through life with the attitude of Positive Intent.

Positive Intent means

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

you approach everything with the thought process in place that no matter what, there will be a

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

Examples of combination products may in

positive ending to whatever you are doing.

This is akin to stepping up to the plate with the t

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

ought process of “I am here to put the ball in play”.

You are assuming that putting the ball i

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

n play will start a positive chain of events. If the ball is hit on the ground, perhaps it will

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

Combination pro

scoot between two fielders and roll into the outfield for a hit. If the ball is hit in the ai

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

, perhaps it will travel between the reach of the outfielders and roll all the way to the wall

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

, maybe even resulting in an extra bases hit. Even if the ball is caught and the batter is thro

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

wn out, he still accomplished the basic thought, “put the ball in play.”

If the ball is not in

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

play, nothing else can happen. Base hits and good Service does not come from bad thought proces

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

ses.

Ever notice how you interact with one customer better than another? Every time you work w

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

Following aspects would a

ith this one particular customer everything is just right, you know, like the baby bears bed. N

dd to the challenges in developing combination products:

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

t too hard, not too soft, not too tall, not too short and it feels juuuussst right.

If you exa

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

mine your thought process you might find that you are working with an attitude of “Positive Int

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

ent.”

The next time you have an Ogre type customer, you might switch on your positive intent t

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

inking process, and see how much better your customer reacts and how much better you perform. Y

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

Professional from academic institutions, pharmaceutical industries, health care indust

ou might be surprised at the results.

What’s the worst that could happen? The customer will st

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

ill be the same and you will not have lost anything, right?

However, if you do switch it on, a

.

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

d the customer feeds on your projection of a Positive Intent, you might find yourself with a ne

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

Companies that provide selfless information through particip

w customer for life and on the way to more happy customers.

More importantly, a more happy you

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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The world’s unfair. Yes it is. Let’s look at it this way. Staying at home is considered an occupation not many would willingly consider because the following reasons:
• 24 hour work (especially right after birth of children)
• No leave
• No medical coverage
• No insurance coverage

There are some common barriers that get in our way of being the most productive learners in training: we are forced to be there, we don’t see the learning as relevant or valuable, and we feel like we already know the material. While these barriers are real, there are things we can do to jump over or break through these barriers – to make the time invested in these situations more valuable and useful to us.

Do your leaders ever force timelines on projects? Does the bear... well, you know what I mean. Leaders everywhere want to be macho and disguise leadership under a heavy coat of demands. Read on and see the cost of such demands in the Vietnam War and how it relates to your organization.

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