Useful Advices - Business

You walk into your local grocery or market, looking for apples. You see the displays. They are bursting with apples of many varieties. To your left you notice a sea of yellow and red apples – the sign says they

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

are Jonathans. To your right you see bright, green Granny Smiths. But straight ahead, you see the biggest, reddest Red Delicious apples you have ever seen. You are drawn to the display knowing that is what you w

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

Examples of combination products may in

ant. As you walk closer you can see that the merchant has polished every one.

You pick up a bag and start to select a few of the red marvels. Usually in this process you sort through looking for the fruit with n

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

blemishes or soft spots. Today, though, each of these beauties is perfect. It is as if the merchant has already done the work for you. As you hold each apple in your hand you notice that each one could be used

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

in a picture postcard or an advertisement.

You smile as you carry your paper bag of apples to the cashier. In your brief, pleasant conversation with the cashier you mention how great the apples look. He smiles a

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

Combination pro

d assures you that they taste even better. He mentions he had one on his break and he thought it was the best apple he had ever eaten.

When you get to your car and close the door, suddenly all you can smell are a

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

pples! Between the sight, touch and conversation about the apples you were already hungry. But once you get the smell, you can wait no longer. Before you even start your car you pick up one of those big red apple

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

and take a bite. The taste is incredibly sweet, and it is so firm that you hear that satisfying snap when you complete the bite and pull the apple from your lips.

So tell me . . . Are you hungry for an apple?

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

Can you almost taste the imaginary apple in this short story?

If you can, there is a reason: Our minds can’t tell the difference between something real and something vividly imagined. If this story create

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

a vivid mental image for you, you are likely wondering where you can find an apple.

And in this story of the apple lies the keys to creating a powerful vision for a project team (or any team for that matter).

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

>The Keys

A vision must be real. This story was more real for you if you buy apples, have a car and most importantly if you like apples (especially Red Delicious). When we make a vision for a project

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

Following aspects would a

real for people – something that they can see happening and seems within the scope of the “possible” (even if it is a stretch) – we will make the vision much more powerful.

A vision must be personal. Notic

dd to the challenges in developing combination products:

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

I talked about the market you go to and your car. I tried to make the story as personal to you as I could. And, as you read it, you likely were embellishing the story yourself. Seeing the market you shop in – w

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

hether a Farmer’s Market, roadside stand or your favorite grocery store. We must make the vision of project success personal. People need to see how they will be impacted and how the work and its outcomes will ha

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

e meaning from them. When we do that, we have a created a more motivating vision.

A vision must be desired. Again, if you connected with this story, you probably like big, juicy, red, crisp apples. If no

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

t, this story isn’t very desirable to you and therefore the vision won’t be that compelling. If you don’t like apples (or if you have never eaten an apple) this might not work very well for you. This is important

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

Professional from academic institutions, pharmaceutical industries, health care indust

Often the vision is desired by the leader or the people who start the project (they really like apples) but for that vision to be compelling to others, the others must want to achieve that vision as well.

A v

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

ision can be expressed powerfully in a story. Hopefully I’ve illustrated this for you. And, when we can help people create the story (rather than telling it to them as I had to do in this situation) the visio

.

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

becomes even more powerful.

Now What?

You have the four keys now, and you have a story to help you put the keys together. Now it is time to create a vision for your project. Maybe the project is halfway

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

Companies that provide selfless information through particip

done or maybe it starts next week. Regardless the stage in your project’s lifecycle, you can use these keys to your advantage for the ultimate success of your project and its team members.

Now, go get your apple

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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Food trends are certain to stay. There's no doubt about food sticking to the basic because it's already set to improve. Give extra attention to this area of concern because it's what your customers' target.

In any business entity, the type of business determines the income tax return form to be filed. In other words, the business structure determines the legal and tax considerations. S Corporation is one of the most common forms of business structure with a limited number of shareholders that is treated as a partnership for tax purposes.

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