Top Adding - Finance

OK, I’ve been thinking. Not that I do much of it… but sometimes it’s worth something.

I’m going to tell you why most people yo

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

u know hate their job and will never do anything to improve their situation in life. Not only that, but why they would rather a

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

Examples of combination products may in

ccept mediocrity than success.

You heard me right… for the most part your friends would rather NOT succeed.

First of all, let

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

me start with this. Our north american school system TRAIN’S us to be the perfect middle class citizen. What do middle class ci

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

tizens do? Wake up at 6:00, eat breakfast, to work by 8:00 (after a 45 min commute) work, take a 15 mim break, work, take a 1/2

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

Combination pro

hour break, work, another 15 mim break, work, drive home through traffic (another 45 min commute at least) get home just in tim

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

e to sit in front of the TV to eat some over processed food micro-waved, wrapped in plastic and fall asleep dreaming of winning

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

the lottery so they don’t have to get up and do the same thing again every day for the next 40 years so they can retire on half

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

of what they make now.

Sound familiar?

School told us really early on “be here then, or you are in trouble, have this done b

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

then, sit here, move there, go home now, be back here tomorrow.” Sound familiar? We’ve been trained. Oh yes… we’ve been traine

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

d well.

So what is success? I believe that happiness is a great measure of success. I also believe that being able to write a

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

Following aspects would a

check for $1000 when I need to after I retire may be a good thing. (Did you know that writing a $500 check is a major struggle

dd to the challenges in developing combination products:

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

or 90% of our north american senior citizens?).

Back to the point. Your friends don’t want to succeed. It’s too much work, I d

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

on’t have time, I don’t have the money to invest, I have a itch, I can’t do it today… I’d rather win the lottery. But honestly…

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

why not? I’ll tell you right now. They don’t know how to. And we have been taught to reject failure. When I say failure, you pr

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

obably flinch! What happened when you got a D on your science paper in grade 9? I know for a fact that failure is one of our so

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

Professional from academic institutions, pharmaceutical industries, health care indust

ieties biggest fears along with public speaking and rubber chickens. Your friends are afraid of failure... but fail to recogniz

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

e that failure should be embraced. It is one of the ways that that we learn and grow… one of the most potent ways that we can e

.

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

pand and improve.

Learn to never fear failure and you will see opportunities to make money that you may have never seen before

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

Companies that provide selfless information through particip

. Learn to embrace failure and you will know what it means to respect success and strive for it.

All for now,
Jack Squatr

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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