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I live in Massachusetts and formerly worked for a high-tech company, so I witnessed first hand the ben

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

efits of the dot com boom. It was unbelievable as start-ups with nothing more than Power Point slides

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

Examples of combination products may in

and a recognized technologist on staff were receiving multi-million dollar investments from the ventu

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 capital community. It would have been a great time to be invested in limousines as the parking lots

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

of these companies were filled with deal makers. Towards the end of 2000 the excitement disappeared

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

Combination pro

nd the Venture Capitalist (VC) where nowhere to be found. Over the next 6 years, start-ups were few a

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

nd far between. Power Point was no longer good enough, the companies needed proven technology with re

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

al customer commitments in hand.

My friends and I would often wonder where did the VCs go? Well wonde

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

no more - according to a recent edition of The Economist the money is going into “Green” technologies

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

. One estimate puts the total investments going into clean energy at $63 billion up from $49 billion

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

n 2005 and $30 billion in 2004. That represents almost a tenth of America’s venture capital. A group

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

Following aspects would a

of Silicon Valley “deep pockets” in June invested $100 million in Nanosolar, a firm which hopes to cu

dd to the challenges in developing combination products:

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

t the cost of producing solar panels dramatically. Sun Power, the solar subsidiary of Cypress Semicon

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

uctor, is now worth almost as much as its chipmaking parent company. Green is definitely in.

Although

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

much hope is in clean energy, there is a significant price gap between energy generated by fossil fue

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

s and alternatives. Coal, the dirtiest of all energy sources, is by far the cheapest. Therefore almo

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

Professional from academic institutions, pharmaceutical industries, health care indust

st all clean energy relies on government subsidies to compete with fossil fuels. Governments are beco

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

ming fed up with their dependence on unstable and hostile countries for oil and gas, so maybe the poli

.

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

icians will seriously promote greater use of alternatives.

I have casually been watching the Power Sh

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

Companies that provide selfless information through particip

ares WilderHIll Clean Energy ETF (PBW). I think that I will bump it up a few notches on my watch list

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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