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“The sun rises in the east and sets in the west.” True or False? Answer: FALSE. I’ll explain.

If you get up tomorrow morning at sunrise and look for the sun, you’ll see it right where it always is, in the eastern sky. Then you can watch it move in an upward, west

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

ward motion. Come back this evening a little before sunset, and you can actually watch it disappear into the western horizon--- “setting”, if you will. This is REALITY. You can see it with your own eyes. But is it the TRUTH?

No.

The truth is that the sun doesn’t

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

Examples of combination products may in

ise and fall at all. But from Earth, it looks like it does because you’re standing still on a round planet that’s tilted on its axis and rotating at about 60 miles an hour. The sun is still. YOU’RE moving. And that’s the truth.

But how do you tell somebody that th

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

y don’t see what they’re looking at? They don’t feel the earth moving under their feet; gravity is holding them in place. They look up and see the large round object moving from one place to the other. For them it’s for REAL, which is where we get the word “reality

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

(real-ity).

There is a saying among smart people, “the perception IS the reality”. The rest of us respond, “Say what? Don’t make this hard for us. Just tell us if it IS or ISN’T.”

But it’s not that simple. It’s either/or, or BOTH, depending on who you’re talking

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

Combination pro

to and what you’re talking about. This is a puzzle that I try to solve in my work each day. Not in physics or in astronomy, but in MARKETING.

You see, I’m what’s called a NETWORK marketer, something that means different things to different people. Most people don’

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

know what it means at all. I get paid to do something that most people do for free.

If you buy something and like it, you naturally tell people. If they buy it too, you don’t make any money; you just have the satisfaction of sharing a good thing. I’m satisfied to

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

o, but I get paid for sharing. As a commission, I earn a portion of the sales made by my referrals. When somebody wants to learn how to do what I do, I can teach them. And when they make referrals that result in sales, they get paid, and I get paid some more.

HERE

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

S WHERE I FIGHT the truth/reality battle: some people think that what I do is bad, but it’s NOT. Like anything else, it CAN be done badly, but in and of itself, it’s good. The irony is, it pays more money than most people make who say that it’s bad! And I have more

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

control of my time as well as my income. If it’s raining tomorrow, I don’t have to brave the elements; I can work at home and watch the rain from the window. I can run my business from anywhere in the country with a phone and an Internet connection.

I don’t have a

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

job. I run a business of my own. The REALITY of that is scary. Reality says that 8 out of 10 businesses fail because they either don’t make enough money, or they mismanage the money they get. For me, the reality is that most network marketers fail because they eith

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

Following aspects would a

r don’t make enough of those referrals, or the business that supports them goes under.

The TRUTH is that things can be done to prevent those failures. But most people who want to work for themselves won’t even try because the reality scares them so much.

“80% OF

dd to the challenges in developing combination products:

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

LL BUSINESSES FAIL WITHIN 5 YEARS BECAUSE THEY EITHER RUN OUT OF MONEY, OR DON’T HAVE ENOUGH TO BEGIN WITH.”

Yikes!

Reality can sometimes make us irrational. But if we really want to do something, reality shouldn’t stop us. Let’s say someone likes fish and wants

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

o go fishing. But they pick up the paper and the headline reads,

“80% OF ALL FISHERMEN DROWN EVERY 5 YEARS BECAUSE THEY EITHER DON’T KNOW HOW TO SWIM, OR DON’T HAVE A LIFE JACKET”.

If that were the reality, a lot of people would stop fishing, eating fish, or both

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

. But that would be irrational, because fish is good. And so is fishing. The problem is in the part of the headline that reads,

“…because they either don’t know how to swim, or don’t have a life jacket.”

A lot of people would say,

“I don’t like fishing.”

Why? D

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

you ever go?

“No. I don’t even eat fish. Fish bad. Fishermen worse.”

I resent that, because I’m a fisherman and I love fish! What do you mean?

“Well, it’s nothing against you personally, it’s just that my daddy drowned while fishing. Just like most fishermen do

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

Professional from academic institutions, pharmaceutical industries, health care indust

You read the papers.”

Oh. I’m sorry. Did he know how to swim?

“No, he didn’t.”

Was he wearing a life jacket?

“Well, no… he didn’t even own a life jacket. Said he didn’t need it. But fishin’ killed my daddy, and I’ll be damned if it’s gonna kill me too! I won’t

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

even look at a fish!”

I’m sorry about Daddy. You must be devastated. But with all due respect, fishing didn’t kill Daddy. DROWNING DID.

You see, a lot more people could be successful in my kind of business, but they get into it without the skill and safety needed

.

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

to survive. When reality screws them up, they blame the business. What’s worse, they keep other people from trying by telling them the reality.

That’s where I go to work. I tell people the TRUTH so they won’t be confused by REALITY. The truth is that I CAN HELP YO

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

Companies that provide selfless information through particip

make up to $150,000 or more, part-time over the next three years--- and give you what it takes to be safe and successful.

Reality is that you can work on jobs for 40 years and in the end have nothing but bills to show for it.

So… what’ll it be, TRUTH, or REALITY

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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