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Remember the story of the Pied Piper?

One day a piper came to the village of Hamelen. He offered, for a fee, to rid the town of its mice and rats. Since the village had been overrun

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

with such vermin for quite some time, the town council eagerly accepted the piper's offer.

So the piper began to play a melody on his pipe. It was an eerie melody that enchanted the

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

Examples of combination products may in

mice and rats, and they followed the piper to the river where they drowned.

Once the little animals were gone, the villagers immediately forgot how terribly bothersome the little cre

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

atures had been. They regretted having promised so much money to the piper.

So when the piper came to collect his fee, the town council refused to pay.

The piper put up no fuss. He

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

simply played a new melody on his pipe, one sweet and playful. One that enchanted the children of the town. And the piper led the children into the mountains where they were never see

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

Combination pro

n again.

While the story of the Pied Piper is for children (though it's hard to imagine that this disturbing little story suits children), the Pied Piper illustrates a very important

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

aspect of mortgages, one I call the "pay me now or pay me later" principle.

The most drastic application of the principle happens when people default on their loan. When people "hir

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

e" the services of the mortgage company -- the service of "renting money" -- they agree to pay the company for its service. If at some point they fail to pay "now" with regular monthl

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

y payments, the mortgage company will force them to pay "later" through a foreclosure.

But there are other applications of this principle that are far less troublesome and far more a

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

ppealing (and they may not even keep you awake at night). Let's look at one.

When a mortgage company loan representative quotes you the costs for taking out a mortgage, the quote inc

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

ludes two parts:

1. The interest rate

2. An additional cost called points.

The interest rate specifies how much of each month's payment goes to pay for your rental of the borrowed

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

Following aspects would a

money. The amount you pay in a year is roughly equal to your outstanding loan balance at the start of the year multiplied by the interest rate. This calculation is only approximate, b

dd to the challenges in developing combination products:

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

ecause your outstanding loan balance goes down a little each month with each payment you make.

On the other hand points are an amount you pay when you first get a loan. Like the inte

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

rest you pay, points are just another cost of borrowing the money.

Really the only difference between points and interest is the time frame in which you pay the money. Points are pai

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

d upfront; interest is paid throughout the load period.

What some people don't realize is that, when you apply for a mortgage, you can get a different interest rate by varying the po

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

ints you pay. As points increase the interest rate decreases, and vice versa.

This relationships between interest rate and points nicely illustrates the pay me now or pay me later pr

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

Professional from academic institutions, pharmaceutical industries, health care indust

inciple. By paying additional money (as points at the start of your loan) you can pay less later (as interest with each monthly payment). Or you can pay less to start and have a highe

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

r monthly payment. The principle applies to many aspects of mortgages.

When you purchase a mortgage, you sign up for a huge commitment. Taking the time to choose your mortgage carefu

.

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

lly is time well-spent. As you consider different loans, think of them in terms of the pay me now or pay me later principle. This will help you figure out which is the better deal. If

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

Companies that provide selfless information through particip

your upfront costs seem low, look for higher future costs. If your future costs seem low, you must be paying high upfront costs. Remember -- the Piper gets paid one way or the other.

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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