Main Subject - Business

I was passing through Kuala Lumpur International Airport (KLIA) in Malaysia, returning from a live web-cast presentation on a new e-learning channel.

One

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

of my small indulgences after a good presentation is the soft chocolate-and-vanilla swirled ice cream available at the quick service restaurant just befo

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

Examples of combination products may in

re Immigration at KLIA.

A young staff member was at the ice-cream machine. I asked her for the vanilla-and-chocolate swirl in an ice-cream sundae cup wit

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

h a squirt of chocolate syrup on top. (I don’t have this very often, but when I do, I enjoy it.)

She said that I could only have the sundae with vanilla

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

ice cream, not the vanilla and chocolate swirl. The three small nozzles for dispensing vanilla, chocolate and vanilla-and-chocolate were located side by s

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

Combination pro

ide.

I asked again, very nicely, for her to use the vanilla-and-chocolate nozzle instead of the plain vanilla. Again, she declined. ‘The sundae comes wit

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

h vanilla,’ she said, ‘not with vanilla-and-chocolate.’

I’d had the sundae with vanilla-and-chocolate in the very same restaurant a few months earlier. I

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

explained this to her and asked once more. Once again, she declined.

The store manager agreed with the staff: vanilla-and-chocolate ice cream was defini

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

tely not part of the sundae.

I pressed for a win–win solution. The manager said, ‘You can buy the large ice cream cone in vanilla-and-chocolate, and then

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

we can give you a plastic cup to put it in to make a sundae.’

‘But what will I do with the ice-cream cone?’ I wondered out loud.

Without a moment’s pau

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

se she replied, ‘You can throw it away.’

And that is exactly what we did.

I bought the large vanilla-and-chocolate ice-cream cone and the manager gave m

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

Following aspects would a

e the plastic cup for a sundae. I turned the vanilla-and-chocolate ice cream out of the cone and into the cup, and threw away the cone.

Then the young st

dd to the challenges in developing combination products:

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

aff member politely put a squirt of chocolate syrup on top – exactly what I had wanted from the beginning.

But there was a bonus: the price of a sundae w

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

as $2.50, while the price of the large cone was only $1.60. They insisted on charging me only for the price of the large cone. Since they couldn’t figure

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

out what else to do, the plastic cup and squirt of chocolate syrup were free.

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

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

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In a world where customer choice is only a nozzle away, staff must be given the authority and responsibili

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

Professional from academic institutions, pharmaceutical industries, health care indust

ty to make obvious decisions in favor of the customer, and the company. Rigid policies that limit choice and force staff into bizarre situations are the p

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

roblem, not the staff, nor the cone, nor the nozzles.

Action Steps
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.

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

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What policies do you have in place that make your customers laugh (or cry)? What standards do your staff routinely run around? Is tighte

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

Companies that provide selfless information through particip

r adherence to standards and controls the best or only answer? It's a vanilla and chocolate world out there _ make sure your staff and your policies adapt

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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Business security is extremely important in this new era of increasing crime and is considered as a valued investment.

What does a board moderator do? With so many people making social connections online-I wondered what do this brave people do? With that in mind, I hunted one up who was kind enough to fill me in.

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