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You've been working up the nerve to get started in real estate investing for some time. You've had all the conversations with your rich u

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

ncle and your obscenely successful friends. You've read the how-to books. And now you've finally found the right property. It looks right

; 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 the deal ’smells’ right to you. The location seems like a sure bet.

But before you jump right in, take a step back and crunch

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

the numbers. Forget about the back-of-the-napkin analyses your heroes may tell you about. If you're spending this much of your hard-earne

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

money, you owe it to yourself to do some thorough due diligence. There's a good reason for it:

The financial analysis process

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

Combination pro

forces you to take a good look at the entire picture, not just the parts which appeal to you. You are forced to think things through, whi

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

h in and of itself reduces the risk that you’ll overlook something critical.

Analysis can be an objective exercise, very dif

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

erent from the emotion-laden, and subjective, process of negotiating and getting caught up in deal-frenzy. Especially when it's your firs

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

time out, you don't want to rush into one of those projects which turns out to be one where you would later say (with regret) 'it seemed

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

like a good idea at the time.’

There are a few other very solid reasons to perform thorough financial analysis on your deal:

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

Techniques such as discount cash flow analysis will project the ultimate potential gain or loss of your investment. This will help y

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

Following aspects would a

ou to get from 'it seems like a great deal' to 'it has the potential to net me $200,000 over 5 years.'

Preparing detailed finan

dd to the challenges in developing combination products:

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

ial projections is the hallmark of the professional. Doing your homework in this way will improve your attractiveness to bankers, potenti

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

lly aiding you in attracting financing for your deal.

Financial analysis can't see the future- you should not expect to be abl

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

to accurately predict the end results. However, through financial analysis, you can generate best- and worst-case scenarios in order to

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

reate a range of projected results. This will help you to approximate the maximum and minimum amounts you stand to gain or lose, as well

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

Professional from academic institutions, pharmaceutical industries, health care indust

s what you believe to be the most-likely gain or loss.

Investing is all about risk mitigation. Through this process, you ca

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

avoid deals which exceed your risk threshold, as well as deals which do not offer an adequate upside to balance against the potential do

.

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

nside. Never pursue an investment where you aren’t comfortable with the risks. That's what we call 'gambling.' Nor should you pursue inve

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

Companies that provide selfless information through particip

tments where the best-case scenario doesn’t meet your minimum return.
Don’t leap before you look. Run the numbers and be prepared

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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I am not suggesting that every decision made in an organization, department, division or group should involve every employee’s concerns, attitudes, problems, wants, issues or needs. I am, however, suggesting that...

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