Main Subject - Business

"I'm feeling a lot better now that I've given up all hope."

That humorous quote came from one of my lieutenant's. He was reporting on the morning ch

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

ange update by my boss. Our company had been working on change forever. Unfortunately, it was coming off like Alfred E. Newman once said, "Just becau

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

Examples of combination products may in

e everything is different doesn’t mean anything changed." We were burning cash and not a single thing was really happening.

At the time we were work

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

ng for Houston's other rocket, Compaq. We were changing a lot just by virtue of our growth. We were growing at about a 40% rate our first two years 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

th the company so that alone was a blur. On top of that the head of operations was ‘driving change’ and the whole thing became a comical episode of m

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

Combination pro

smanagement.

I didn’t go to the morning meeting, I thought they'd just be reviewing how far we were off track so why waste my morning. I mean this p

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

oject was so far gone Spiderman wasn’t going to be saving this day. But to everyone’s surprise there was an announcement to be made. Yet another grou

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

p of consultants were now taking over the failing project.

So get this ... the project started with Anderson, now Accenture after they wiped the egg

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

off their face at Enron. After them came the vaunted McKinsey. They rode into town with a busload of kids after the sharp guys made the sale. You got

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

a’ give it to them for efficiency though. After they unloaded the kids they used that bus to backhaul the cash they were carrying out of the place. B

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

t in spite of the big guys, still nothing was, well, different. But the new announcement in the meeting would surely change all of that. We’ll need a

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

Following aspects would a

drum roll please, this is too good. Yet, another new consulting outfit, this time from Vegas. We'd never heard of these guys before, which honestly c

dd to the challenges in developing combination products:

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

uld have been a good thing.

One thing you must remember as a change leader. Every time you change leadership on the project, be it a consulting hous

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

as in this example or an individual, you are tossing gas on the fire of cynicism. Everyone loses hope like my guy did. You just can't do it. If some

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

thing forces you to make changes, then communicate it and the reasons why or you lose.

What drove my guy to come out of there and mumble, "I'm feeli

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

g a lot better now that I've given up all hope?"

Well, the new consulting guys opened the meeting and wanted to prove that the days of McKinsey’s no

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

Professional from academic institutions, pharmaceutical industries, health care indust

sense were over.

The guy said, "You will never see us using overheads or Power Point."

That proved to be true. They whipped out brown butcher paper

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

and covered the walls and began immediately recreating the wheel we'd just been riding on for months. They were killing trees with brown butcher pape

.

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

for months to come. That was different, but nothing else was, nothing changed.

I'll bet you can hear the blub, blub, blub of the water leaking in y

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

Companies that provide selfless information through particip

ur project boat right now. Yep, you're right. That ship went down.

Keep steady leadership and you'll do your part to keep cynicism at bay.

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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When you learn something new like accounting concepts and terms, it helps to create links between what you know and what you are trying to learn. In some ways, it is like learning a second language and decoding the new word is part of the learning process.

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