Advice You - Business

In the world today we see civil unrest, international terrorism, religious fundamen

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

talism and unnecessary human rights abuses and it seems most of these issues are be

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

Examples of combination products may in

ing caused by Nation States and third world or borderline third world nations. But

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

what if these nations indeed belonged to a higher-level grouping. I speak of a Worl

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

d Franchise System where these nations are franchisee members. And of course any sy

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

Combination pro

stem of this type must be simple. I am very practical and yes always KISS!

For thi

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

rd world nations joining the franchise system they need a stable foundation to buil

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

d on and we know the most important things for an emerging nation are;

1.) Clean W

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

ater, Food and Shelter and maintenance of those. (systems to insure they remain in

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

place-stability)

2.) Safety of the People

3.) Form of Government-ongoing and viab

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

e.

They need stability methods to be put in place to insure their on-going nature.

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

Following aspects would a

If they already have those things or a semi system in place, we move forward. It i

dd to the challenges in developing combination products:

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

s a progression. Just like it takes time to build a Kinder Care franchise. You must

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

start with the foundation, then the building and then train the staff; before you

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

can take care of the children.

Additionally, as you build it with their help (neve

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

r give a man a fish, teach them to fish motif), they will see the progress and work

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

Professional from academic institutions, pharmaceutical industries, health care indust

to make it great, they have a stake (real stakeholders, not NGO bogus buzzwords, w

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

here the last lying dictator wins and buys a private jet, guns and ammo with the Fo

.

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

od money). I think we should franchise the world and help these emerging nations do

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

Companies that provide selfless information through particip

better in their endeavors and in doing so everyone wins. Consider all this in 2006

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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Advice You - Nation State or Nation Franchise; Keeping it Simple

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