Main Subject - Business

Alice’s prepaid telephone calling card said ‘Expires August 31, 2001’ on the bac

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

k.

She decided to use the remaining value of the card at 8:00 pm on August 31.

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

Examples of combination products may in

Unfortunately, the card had already been terminated when she tried to make a cal

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

. There was no value remaining. She held a worthless piece of plastic.

The tele

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

hone company had terminated her phone card’s value on the very first minute of t

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

Combination pro

e listed expiration date (12:01 am), rather than the very last minute as Alice h

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

ad expected (11:59 pm).

The company may be technically right, but commercially

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

hey are dead wrong.

When you see an expiration date, don’t you assume the produ

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

t is valid until the end of that date? Isn’t that how your credit card works? Is

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

’t that how a food expiration date works? Isn’t that how your telephone calling

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

ard should work, too?

Key Learning Point
--------------------------

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

Following aspects would a

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

When setting p

dd to the challenges in developing combination products:

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

licies and procedures, make every effort to see the world from your customer's p

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

int of view. Make their view, your view.

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

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

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

Ca

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

efully review all recent customer complaints. Look for cases where customers com

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

Professional from academic institutions, pharmaceutical industries, health care indust

plain that your policies are too narrow, your processes too slow or your procedu

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

es too bureaucratic. Revisit the source of these complaints. Is there another

.

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

ay to see the situation? Do your customers have a point you should consider? Sta

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

Companies that provide selfless information through particip

t making changes. Keep on improving until their views and your views are aligned

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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