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Collaboration, strategic alliance and partnering are business terms not to be taken lightly as they represent more power than you realize in helping your busine

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

ss to grow.

In the August 2005 issue of Industry Week, there was an article titled, Collaborating To Grow. Mentioned in the article, was a March 2005 survey of

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

Examples of combination products may in

U.S. executives taken by KPMG LLP. It appears that sixty-four percent of the responding executives plan to increase the use of strategic alliances during the n

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

ext two years. What was not covered was how they were going to make these intended alliances successful.

Through my work with alliances, I have discovered 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

there are basically three key activities necessary for achieving successful alliances:

1. Finding others with whom you can create mutually beneficial value.

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

Combination pro

2. Delivering that value to one another.

3. Communicating to your partner the value you delivered.

While I realize you might be think the above is too simplis

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

tic, understand that a number of people spend their entire careers working on the fine details.

Finding others with whom you can create mutually beneficial val

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

ue. Too many organizations never get past this first activity. In searching for another organization with which to develop a strategic alliance there must be c

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

omplementary core competencies. This means that their circles of interest must overlap, as should their core capabilities. Inherent in the search for a compatib

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

le partner is the fear of having to give up a modicum of control. Giving up control is a huge hurdle for many executives.

Delivering that value to one another.

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

This would seem straightforward but the challenge is in understanding what your partner considers valuable. Too frequently, one partner delivers value to anoth

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

Following aspects would a

er that the second partner did not consider to be of value. Guess what? The perception from the second partner's point of view is that no value has been deliver

dd to the challenges in developing combination products:

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

ed in this situation.

Communicating to your partner the value you delivered. Through my work in the area of alliances, I have discovered that about fifty perc

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

ent of the alliances created are not successful. The primary reason for the lack of success in most cases was ineffective communication. There are a number of p

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

ossibilities from basic to complex. Many of the successful communication methods are electronic centric.

Additionally, many follow up and feedback methods use

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

the 360-team evaluation style of response mechanism. This allows perceptions of alliance performance in both the macro and micro to be known by all. Once challe

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

Professional from academic institutions, pharmaceutical industries, health care indust

nges are discovered, repair strategies and tactics can be put into place.

To offer you a bit of help in the first area--selecting a partner, I will provide you

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

with the first chapter of my book titled, Developing Strategic Alliances. This chapter will give you an idea of the possible types of successful allianc

.

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

es and the reasons for creating them. To access this and other helpful additional information at no charge, please visit elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

ee.com/downloadaccess.htm">www.rigsbee.com/downloadaccess.htm.

I wish you the best in your definitive actions of developing alliances to grow your business

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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