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Lets put it this way; supposing you knew you needed to make a journey for your business and you had a gut feeling you should do it tomorrow. You get in you car, still not

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

knowing where you are going at a time that feels right. You drive to your first junction and think to yourself, “Shall I go left or right”? You choose right, because it

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

Examples of combination products may in

ooks the better option! You keep changing direction throughout the morning based on what feels or looks right, until you decide to stop and have a break.

“Am I here yet?

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

” you wonder to yourself sitting having your coffee and bacon sandwich. You look around, “no, I am sure this is not where I want to be” so on you go again. A little later

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

on you think to yourself, “Why am I here by myself? Should I have brought some of my colleagues with me?” “Never mind” you tell yourself, “its too late now, I will have t

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

Combination pro

get by”. Eventually the fuel light comes on and now you know you have to stop at the nearest garage. At the petrol station you ponder, “how much fuel should I put in?

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

I still don’t know how far I have got to go and I haven’t brought much money with me”. “It’s a good job I have an overdraft,” you tell yourself. You fill the tank to th

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

top and then continue on you journey. Eventually you become tired and weary and so make your way home, not really knowing if you got to where you wanted to go, or why

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

ou made the journey in the first place.

This seems like an extreme situation, but if you decide to run a business without a defined business plan, you business could end

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

up being just like this example of an “undefined journey”.

A business plan will help you define, where you are going, how long it will take you, why you are going there

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

who you should be going there with, how much it will cost you to get there, or even if you should make the journey in the first place.

This business map will save you m

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

Following aspects would a

ny times the money and time it took to create in the first place. There are many books available to help you put to paper your “recipe of success” and if you intend to r

dd to the challenges in developing combination products:

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

aise finance, it will be essential to have such a plan in place, professionally prepared.

The professional side of me says that you should always have a business plan th

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

t has been professionally prepared that follows a set structure of content and presentation. However the realist part of me says if the plan is purely for yourself and ma

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

be a few employees, then it doesn’t matter what format it is in. As long as it is clear, simple and covers all aspects of your business, from who should be doing what, ma

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

rketing, seasonality, sales, and what your company stands for etc. Much of my planning is on the wall in my office where I am forced to look at it everyday, to reinforce

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

Professional from academic institutions, pharmaceutical industries, health care indust

here I am going.

Don’t forget about change. Change will always happen and no matter how good your business plan is, there will come a time when a new revised one will ne

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

d to be rewritten, or at least parts of it. So if you are proud of your business plan you wrote 5 years ago search though the draws, blow off the dust and read it again t

.

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

o see if it still represents your business of today.

I will finish with a question. Supposing your business is in a race with a competitor and the business that can driv

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

Companies that provide selfless information through particip

to Southampton first, wins the prize. Who do you think will get win? Will it be the business that plans the route or the one that relies on gut feeling at every junction

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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