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We sat in staff meeting awaiting the report out of yet another attempt by Houston's other Rocket to catch its nemesis over in Austin in the race to

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

build computers to order. Dell was so far out front in this race that the dust was settled by the time our horse reached the fourth turn. Everyone

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

Examples of combination products may in

on my staff clearly understood our manufacturing didn’t have the capability to be a contender in the ‘build to order’ race.

My guy walked in, sly

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

smile on his face, placed his slides on the table and began.

"It appears we'll start with BTO (build to order, it was a world of acronyms), but, w

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

'll do it in three levels. That will take us from where we are today, which we all know is NRBTO) (not really build to order) to where we want to g

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

Combination pro

o. Then, we’ll go on to CTO (configure to order). We will end up with RBTO (really build to order). I'll be handing out decoder rings at the end of

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

this presentation."

The sad thing about this story is that the actual plan really did include BTO, CTO and RTBO. The only one my guy made up was N

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

RBTO, or not really build to order. Our charade with building our computers to order, like Dell, had gone on for two years. It was a series of fals

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

starts that had driven hope out the back door. Everyone knew we were so far from that reality we couldn’t even dream it. Everyone that is, but our

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

illustrious leaders.

You see here was a change project that was launched after the three before it were scrapped because nothing happened. The CE

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

was irate that the young man from Houston, Michael Dell, was over in Austin kicking our butts with his build to order strategy. The senior VP of O

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

Following aspects would a

's, my boss, launched several ‘BTO’ projects to calm the CEO down. This one proved nothing more than a scud missile like Saddam used to use. It end

dd to the challenges in developing combination products:

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

ed with actual computer reports that showed we were building to order when in fact we weren’t, nothing had changed.

When you’re managing change yo

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

can't pretend. There is a true saying that goes … to change, you gotta' change. That simply means at the end of the day, something is different. T

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

he people in your organization know the difference. The case above was a complete farce and it was being managed by the vaunted boys from McKinsey.

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

It was a travesty. And it drove all hope from the building.

As the leader of change you have to make sure that the project you’re rolling out is r

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

Professional from academic institutions, pharmaceutical industries, health care indust

eal. You have to insure that it isn’t like Alfred E. Newman, yep, the one from Mad Magazine described when he said, “Just because everything’s diff

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

rent doesn’t mean anything’s changed”. You cannot permit the organization you represent to play charades. It destroys morale, wastes money and is d

.

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

ownright wrong. Sometimes the cost is even more than money.

When you're tempted to turn your head and think that it doesn’t matter, think about En

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

Companies that provide selfless information through particip

on. Think about how many lives were destroyed and dreams crushed because no one spoke up. Vow to never let it happen on your watch. Ever!

Ed Kugle

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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