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Each of us needs a dream to keep us filled with hope and desire and often even alive. The worst thi

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

ng that can happen to anyone is that they lose their dream(s) and it doesn’t matter whether you are

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

Examples of combination products may in

3 or 67, male or female. I have seen the dull look in people’s eyes who no longer believe in the p

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

ossibility of their dreams.

They have given up. I have also seen the spark in people’s eyes even p

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

ople over 80 who are still living the pursuit of their dream. It isn’t about getting it, reaching i

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

Combination pro

or doing it – it is about having the dream, believing that it is possible and working toward it day

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

by day, little by little, until one day – poof – you are there, it is yours and you can celebrate k

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

owing that you never gave up or in to: the fears, frustrations, disappointments, discouraging words

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

rom others, the failures, the obstacles, the pain - you name it.

If you have a dream and are in pur

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

suit of it I guarantee that sooner or later you will experience roadblocks either internal or extern

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

l. And they know it won’t be easy.

The dreamers know that their dreams often take on a life of the

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

Following aspects would a

r own. They also know that the dream when realized, often looks a little different than what they im

dd to the challenges in developing combination products:

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

agined it would when reached or achieved.

-Have you given up?
-Are you in the process of g

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

ving up?
-Are you discouraged or frustrated?
-Are you feeling that no matter how hard you

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

ry, the world seems to plot against

you?
-Do you know someone who has given up?
-Are you

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

plugging ahead one minute, hour and day at a time – knowing and

believing that your day will come?

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

Professional from academic institutions, pharmaceutical industries, health care indust

That you success and your dream(s) will be

realized just around the next corner?

Everyone need

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

hope. Everyone needs a dream. Everyone needs something to look forward to. Everyone sooner or la

.

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

ter needs encouragement. Everyone wants to believe in the possibility of their dreams.

Dreams are

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

Companies that provide selfless information through particip

onderful. What are you DOING today, right now to move toward your dreams? Or are you just dreaming

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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