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Leading change means making tough calls. There’s none tougher than making the calls regarding the scope, timing and resources of the project. One of the biggest mistakes leaders make is g

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

etting happy and caught up in the moment trying to impress the boss and making commitments you’re not able to keep.

The biggest problem I see is when otherwise good leaders and managers

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

Examples of combination products may in

each out and forecast what I call ‘heroism’. With the war in Iraq right now we read daily of the exploits of some of our soldiers and Marines. They do some extraordinary things. They are

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

eroes but heroism can’t be forecast, it just happens.

I wrote a book called Dead Center about the exploits of a Marine sniper team in Vietnam. A couple of years after it came out I was t

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

aveling on a consulting job in Ohio when one night in a motel I saw this PBS special on Medals of Honor winners. There before me was none other than one of my Drill Instructors from boot

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

Combination pro

amp in Parris Island. I remembered the event, I was actually nearby when it happened and this great Marine was later awarded the Medal of Honor. So I sent him one of my books.

A few mont

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

hs later I happened to be home one Friday morning and the phone rang and it was Sergeant McGuinty as I knew him. We had a great talk and he was relating to me the experiences of that day

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

n what was later known as Helicopter Valley. He was trapped with his men when four helicopters went down in the landing zone. There were fifty or so who survived the crash and they were s

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

rrounded and fought off 1500 enemy for three days. I was amazed by his exploits and said so. Then he said something I will never forget. He said, “Kugler, always remember when somebody ge

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

s a medal like this it is because somebody else screwed up”.

He explained that when the Recon teams selected the landing zone it was for one type of smaller chopper and three weeks later

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

when the assault came the Marine Corp had rolled out a new twin blade chopper and the rest is history as they say, they crashed blades together. The point being is that Sergeant McGuinty

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

Following aspects would a

is a true hero, but he didn’t plan it. He was a great leader who reacted to the events around him.

On three different occasions in the past eight years I have been called in to ‘bail out

dd to the challenges in developing combination products:

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

a change project going under. To many I was a hero for coming in and fixing the project. But that isn’t the problem. The problem is that the prior planning placed the project right in th

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

path of a train wreck because the leaders wouldn’t stand their ground on what they knew to be true.

When you start a project you start with the scope. Based on the scope, the work to be

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

done, you will need a certain amount of resources to complete the work in a certain amount of time. If someone wants to speed up the work then the scope must come down or the resources mu

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

t go up. It’s that simple.

Now I know it is often difficult if not impossible to get the Big Kahuna’s to understand this, I get it. But … if you proceed with ‘their’ plans and fail, whic

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

Professional from academic institutions, pharmaceutical industries, health care indust

h can be predicted, then your career is going blub, blub, blub, not your bosses. So speak up. Don’t forecast heroism because the hero will be the guy like me who is called in to clean up

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

he wreck.

It’s as common as the morning breeze to forecast heroism on change projects. Don’t let it be you. In one major company I worked for they called it ‘the Spirit’. If it was Acme,

.

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

they’d say we have the Acme Spirit and we can do anything. At another it was called their ‘magic’. We have the Acme Magic! In both instances colossal change projects were ran right down t

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

Companies that provide selfless information through particip

e tracks and crashed because of over commitments.

If you’re smart you will fight the good fight in the beginning, not after the wreck when your name is placed as the cause of the debacle

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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