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All organizations deal in some way or the other with change. A government is to follow the changes that take place in the world and that affect its citizens. A company also fol

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

lows most of the time changes in the same way by canalizing the effects of different causes. A third category of companies (institutions) however deal with change in a differen

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

Examples of combination products may in

way; they are more in the lead of change. They could be pictured as change leaders; empowering others to move into a new direction.

Sometimes things just happen...Unless ther

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

e is someone who interferes -- the intervention as it is called in change management terminology -- with development that might need some (serious) attention. Awareness to star

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

with. Recently Greenpeace signaled the massive constructional development on the Spanish coasts.

All of us who deal with change can learn from organization like Greenpeace th

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

Combination pro

at are to deal with resistance all the time.

The style of Greenpeace is influenced by thoughts of Margaret Mead:

"Never doubt that a small group of thoughtful, commi

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

ted citizens can change the world. Indeed, it is the only thing that ever has."

Greenpeace itself has also dealt with change over the years. Those who have followed

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

this organization will remember that.

In 1971, motivated by their vision of a green and peaceful world, a small team of activists set sail from Vancouver, Canada, in an old

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

fishing boat. These activists, the founders of Greenpeace, believed a few individuals could make a difference.

Their mission was to "bear witness" to US underground nuclear te

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

sting at Amchitka, a tiny island off the West Coast of Alaska, which is one of the world's most earthquake-prone regions. Amchitka was the last refuge for 3000 endangered sea o

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

ters, and home to bald eagles, peregrine falcons and other wildlife. Even though their old boat, the Phyllis Cormack, was intercepted before it got to Amchitka, the journey spa

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

Following aspects would a

ked a flurry of public interest. The US still detonated the bomb, but the voice of reason had been heard. Nuclear testing on Amchitka ended that same year, and the island was l

dd to the challenges in developing combination products:

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

ater declared a bird sanctuary. (www.greenpeace.com)

The spirit of the time we live in are quite different than those in the seventies and much of these alterations have i

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

fluenced this organization. Yet another change is the growth of the institution itself.

Today, Greenpeace is an international organization that prioritizes global environme

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

ntal campaigns. Based in Amsterdam, the Netherlands, Greenpeace has 2.8 million supporters worldwide, and national as well as regional offices in 41 countries.

And this is

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

common practice for nearly most of the organizations; when they grow their style will change. If we remember Greenpeace in the beginning its style was predominant "against" and

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

Professional from academic institutions, pharmaceutical industries, health care indust

confrontational leading to an increase of resistance that did undermine its guest for change. Today -- where the organization has its own research institution and presence in

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

41 countries, it has moved into the direction of helping and supporting; this is less innovative than in the seventies but much more effective.

Change is about dealing with re

.

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

sistance. And if you really want a credible change you should stay approximate to the majority that you want to affect and influence. This can only be done by lowering the wall

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

Companies that provide selfless information through particip

and barriers between your team or organization and the ones you want to influence. In such a way that your thoughts can be accepted or at least be negotiated.

© 2006 Hans Boo

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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