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Spinning like a top the minds of the members of the Online Think Tank are in constant motion discussing issues from aroun

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

d the Globe and with more energy then the older gentlemen with the slower minds in Davos. It is amazing that the Patent P

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

Examples of combination products may in

iracy and International Intellectual Insidious Insanity continues to go on to this day, as technology in many nations is

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

stolen and products suddenly appear on slow boats from foreign shores.

Do I blame the Chinese for trying to steal our st

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

uff? Yes and no. But I know the detriment it causes in places like Silicon Valley where the artificial microeconomics got

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

Combination pro

out of hand and now this is enough to really sink the ship. I see the same thing around Washington DC, as the money flow

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

is 2 times that of a Federal Reserve City, where the money flow is substantial for bankers, capitalists, entrepreneurs,

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

professional parasites and those who stand in the flow making the deals.

The default answer is linear and easily predict

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

ed with humans; It is to protect what they got (human instinct) like the monkey who will not let go of the nut in the tre

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

e trunk and therefore is captured and loses his head over it. But my point is an "Expanded Pie" is the best for all conce

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

rned; WIN/WIN.

Protectionism is a tough row to hoe when the incentive for those who want is so great. I am certain there

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

Following aspects would a

is a Chinese Proverb for that too. Unbalanced money flows left unchecked tear down nations and build others. Do I blame

dd to the challenges in developing combination products:

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

the US for trying to protect their high-cost innovations, R and D or lab work, Absolutely not.

Do I blame the Chinese fo

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

r not instituting better patent protections for the US benefit? No, it doesn't serve them. Do I blame China for not addin

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

g the bureaucracy regulations to slow their economy down to match the mess the US has made here so we can compete? No, wh

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

y should they, we proved that doesn't work. Anyway, Just thinking out loud here; and thoughts on thoughts, as it is all o

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

Professional from academic institutions, pharmaceutical industries, health care indust

ne and inter-related. Of course this is my personal opinion after my last online session at the Online Think Tank.

The s

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

ubject came up after one gentleman mentioned the future of the "Knowledge Society" and if taken to mean "Intellectual Eco

.

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

nomy," in this case then there needs some strategic planning and reorganizing of thought there. I hope you enjoyed today’

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

Companies that provide selfless information through particip

s discussion. I had fun thinking about it and perhaps this tid bit might assist you in your quest to be the best in 2007.

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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