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A large grocery store opened a new outlet in my neighborhood. A small baske

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

t of red apples sits by the cash register. The sign in the basket reads:

‘

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

Examples of combination products may in

ree apple if our staff at check-out did not greet you and say thank you.’

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

But the apple basket stays full. Not because the check-out staff are always

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

smiling (trust me), but because the act of taking an apple is tantamount to

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

Combination pro

‘catching the staff doing something wrong’! Who wants to irritate grocery c

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

heck-out staff when they’re ringing up your order?

To get the impact the s

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

ore really wants, the sign could be re-written like this:

‘Thank you for s

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

hopping with us. We want you to have a good shopping experience. If, at any

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

point, we are so busy serving you that we forget to greet you or say “Thank

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

you!”, please let one of these delicious apples put a smile upon your face.

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

Following aspects would a

We will smile back!’

The store would give away more apples with this sign

dd to the challenges in developing combination products:

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

but would gain more smiles, too. Better text, better impact.

Key Le

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

arning Point
--------------------------------------------------------

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

-----------------------

Follow your good ideas all the way from

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

oncept to detailed execution. Good ideas need great implementation to deliv

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

Professional from academic institutions, pharmaceutical industries, health care indust

er real results.

Action Steps
--------------------------------

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

-----------------------------------------------

Find where your

.

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

promotions and policies are actually seen and heard by your customers. Be s

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

Companies that provide selfless information through particip

re the message is as clear at point of contact as it was when first created

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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