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Picture your life as a trip to a global amusement park. The opportunities surrounding you in life are the “rides.” At any popular amusement park, there is often a line at almost every rid

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

e or event, your learning curve. How do you handle the waiting?

Every ride or opportunity has a fantastic appeal. You ultimately want to ride everything in an amusement park, except ride

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

Examples of combination products may in

you may think are too risky or too boring. Imagine yourself in line waiting for the ride you came upon first. In line you have progressed forward some and have a long time more to wait.

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

You look up and see right over there is another ride that looks even more exciting so you go over there and get in line for it. You move forward a little in that line and just outside the

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

que you notice the most exciting show! There’s not too much of a line for it yet so you can be near the front and get in fast, “ground level.” That is when you notice show time arrives in

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

Combination pro

about 30 minutes. While you’re waiting for show time you have lots of time to think. You realize you have just spent a few hours at the park already and have not ridden even one ride.

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

ou decide it was a mistake to leave the first one and change so you go back to the first one. While you are in the first line again, you realize why you changed to the other line in the fi

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

rst place and you really wanted to ride the other ride more so you change “just this once more.”

Can you see how with a strategy like that you will never get to ride any ride? You could h

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

ve ridden EVERY ride if you would have just seen the first one through, then had gone to the next one and the next. When you entered the park you were probably handed a map. If you had th

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 patience to sit down and create a plan, connecting the dots for velocity of doing all or in order of favorites and stuck to that plan, you would have had time to do every single thing in

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

he park and with no stress or frustration. You would have certainty that you would get around to each. Then, as you went along, if you did notice one ride taking way too long because of i

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

Following aspects would a

ts popularity, you could have skipped it if necessary to get the most variety or you could stay all day in that one line if it were worth it.

Opportunity is like that. You MUST look aroun

dd to the challenges in developing combination products:

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

you and see the niches available. And you MUST know the niches that match your deepest core passion. If you’re like me, you can see something you like in just about any opportunity. But

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

does that opportunity match your core passion? The first opportunity or “ride” you take on must be the one that is the most deeply matching you to make sure you are fulfilled by the end o

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

the “ride,” the results. Having done this first, you will be able to ride the less compelling fun rides as well and with more joy since you are fulfilled in your deepest core of who yo

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

u are.

There are people who just seem to know themselves well and know what they want very early in life. Most people don’t. They graduate from high school and even go on to college havi

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

Professional from academic institutions, pharmaceutical industries, health care indust

g no idea what they want their lives to be about. Are you one of those people? If so, you could wait in a lot of long lines getting almost to the mark and then falling short because you s

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

kipped the basic step of knowing yourself . Then how to move through the line with the most velocity possible to the result. You may not even know for sure what “ride” or opportunity you

.

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

ven want in the sea of opportunities available.

Find the one key element to who you are first and then find the opportunity that most quickly gives you an access for expressing yourself.

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

Companies that provide selfless information through particip

Then, you will save many years of “waiting” and will live a life of untold joy and wealth if you wish from this point forward. You are your own guarantee.

Copyright 2005 Juanita Bellavanc

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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