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They're real, but few survive. High risk investing is dangerous to your bank balance. The process toward extinction is that an angel risks money in one venture. It fail

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

s. Then, he joins a group of angels and risks money in another venture. It fails. At this point, the angel usually hands in his or her wings.

To be an angel, you must

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

Examples of combination products may in

have considerable discretionary income. This is why most angels are attorneys, accountants, medical doctors or successful small business people. Attorneys and accountan

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

ts often form angel groups from their client base. Their goal is to take the ride on the roller coaster without paying for the ticket. Their clients invest in the proje

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

ct and they get a piece of the action. Since the action is usually bad, all they get from the effort is a reduced client base.

Angels want to invest within fifty miles

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

Combination pro

of their location. This allows them to visit the office or plant of the investment on a regular basis. As the company starts to fail, the proximity card encourages the

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

angel to try to take over the business investment. This mistake is often made by successful small business people.

I'd defer to a study on the odds of attracting an a

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

ngel to your company. However, my experience suggests that an angel will invest in about one company out of every three hundred that send the angel their business plan.

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

My experience is based upon working with San Francisco Bay Area Venture Capital Clubs over a decade ago. Given the greater investment interest today, your odds may be

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

better than 1-in-300.

Eighty-five percent of small businesses fail. Among the 15% that succeed are franchises and professional offices. My guess is that an angel has a

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

bout one chance in ten of making money on a risk capital investment. The angels think they can beat the odds. They're wrong.

Most attorneys, accountants and medical do

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

Following aspects would a

ctors achieve their social position and income by believing what they read. As a student, if you question the data in a textbook, you are unlikely to pass the final exa

dd to the challenges in developing combination products:

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

m. This pattern of read and believe gets the student from first grade to medical school or law school. Believing what you read in a business plan is often a mistake. Pr

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

ofessionals tend to believe the written word. Doing so as the basis of a risk capital investment is fatal. As more than one professional has told me when they turned in

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

their wings, "I guess I'll have to raise my fees to offset my business loss." I've often wondered if barring professionals as angels wouldn't lower legal and medical c

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

osts.

Small business owners believe they are "smarter than the average bear." It's their ego that often clouds their judgment. If you don't believe that you've made a

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

Professional from academic institutions, pharmaceutical industries, health care indust

mistake, you'll dump more money into a black hole investment. It's this group that are most likely to turn in their wings as they file for Chapter 11. "There's a time t

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

o hold them and a time to fold them." Successful small business people don't believe in folding.

There are always angels coming into the Market. We live in boom times.

.

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

The population of angels is growing. If you can catch a nearby angel, do it. It's best to catch them before they see the financial fire that awaits most of them.

As w

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

Companies that provide selfless information through particip

ith buying lottery tickets, there are a few successful angels. I'd like to see a study of how long they last, if they beat the investment odds.

Published February 2000

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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