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This is a story about a man and three dogs.

I walk a lot - usually for about half to three-quar

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

ters of an hour most mornings. I see a guy with two dogs quite a lot. We chat a little occasionally.

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

Examples of combination products may in

f the two dogs (I know I said three, so hold on a bit), one is a light brown lurcher and is quite friendly an

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

d the other is a beautiful black labrador. He is 'nippy' as my co-walker tells me, so I have been a b

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

t careful of him, but I always try to stroke him too. Whilst I have always been cautious of dogs, I ha

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

Combination pro

ve always tried my best to make friends with them, wherever I have gone (and no, I don't have a dog, and yes,

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 probably would like one!)

My friend has now gained a third dog - another black labrador; a bit young

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

er than the other two. So as I'm walking down the road this morning, I see all four of them coming down the r

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

ad towards me. I'm not sure which black labrador is which, so I try to pick out the 'nippy' one (he sometimes

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

nips you, to clarify!).

One of the black labradors seems to be 'smiling', the other not, if you get m

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

drift. I guess right, say my 'hellos' safely, we pass pleasantries and I walk on. As I go on, I hear the man

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

Following aspects would a

say to the nippy labrador, 'I've no biscuits left', as he is pestered.

I'm a little sad for the dog.

dd to the challenges in developing combination products:

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

is master doesn't know why he is temperamental, but he is. It's also interesting that he's the first t

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

o pester for a biscuit.

Questions

Why has the 'nippy' dog got a different

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

temperament to the other two?

How does this translate to us humans and more specifically, to you an

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

d people you work with?

What can we learn from this and apply in our day to day business re

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

Professional from academic institutions, pharmaceutical industries, health care indust

ationships?By considering the answers to each of these questions carefully and applying the thinking to

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

the relationships we have with our people in the workplace, we will do much to leverage our people's p

.

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

rformance. And forging the relationships, individualised; personalised, one-by-one with our people, we will g

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

Companies that provide selfless information through particip

et the very best from their individual talents.

And, of course help our businesses grow

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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