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I was 22 when I told my Dad I was getting married. He just looked up at me while getting a cup of coffee and said …

"Just remember, it's for a helluva’ long time".

Whe

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

n you're managing a change project, hopefully it’ll be for a helluva’ long time?

We hear a lot today about how difficult change is on people and how they fight it, and

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

Examples of combination products may in

hey do. But does it have to be that way for everyone? I don’t think so. If you recognize a couple of key things about people, your change efforts will move along like m

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

elting snow instead of inching along at glacier speed. Change isn’t easy but it can work better than it does in most organizations.

The first thing to recognize is that

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

people are used to change. It’s happening all around them every single day. The seasons changes, our neighbors are moving, even time changes twice a year. It isn’t the c

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

Combination pro

hange that gets us, it's the uncertainty that change brings. That's not just a play on Webster's words, it’s a fact. Changes that people don’t understand will give you t

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

ouble. For most people, the lack of understanding drives their resistance, not the changes.

To help people move through change you have to start with honesty. You have

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

to lay it on the line, in a respectful and kind way, but lay the truth out there. You have let them know what’s happening, how it impacts them, or doesn’t; and you have

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

o continue to tell them the truth throughout the project. You have to help them see the situation as it relates to them.

Once you've told them you have to reinforce the

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

fact that they are responsible, individually, to make their choice in how to respond to the changes. But they have to know, beyond a doubt, that the organization is cha

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

ging. It will hopefully with them rather than without them, but it is changing.

In extreme and hopefully exceptional cases, you need to help them understand that they m

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

Following aspects would a

ght have to make a choice. That choice is to stay or go. That is the first choice in coping with change. Do I stay or do I go? If you go, then you focus on finding a new

dd to the challenges in developing combination products:

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

career. If you stay, by virtue of that decision you become part of the solution and you are looking forward within your organization.

Coping only becomes hard for peop

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

e who stay when they don’t become part of the solution. It’s when they sit in the streets of change and disrupt traffic. That is when their anxiety grows and over time t

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

hey become miserable. You have to deal with those people privately, one-on-one. You have to help them understand the need to make the 'stay or go' decision. You owe them

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

that honesty.

After being an atheist for most of my life I became a Christian at around 29. It had been a rocky road, so I was sure my Mother would be happy with the ch

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

Professional from academic institutions, pharmaceutical industries, health care indust

anges that took place in the years following my conversion. I was talking with her one day about my new life when she laid a great one on me. She said, "I think religio

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

is a good thing, as long as you don’t let it interfere with your life".

Unfortunately for many people, change is viewed with about as much logic as Mom used on me that

.

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

day. You have to manage people’s reaction to change. You have to be honest in your communications and most will ‘get it’. For those that don’t you’ll have to help them

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

Companies that provide selfless information through particip

ee the reality of the situation. Only then can they make the right decisions for them and therefore for you.

Show them the facts and let reality be the judge.

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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