Advice Pool - Self Improvement

The myth of Sisyphus has always been always a favourite of mine. Sisyphus was condemned by the gods to spend eternity rolling a huge stone to the top of the mountain. No sooner

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

would he reach the top than the stone would fall down and he’d have to start all over again. It was, I guess, the Ancient Greek equivalent of housework.

Once upon a time, my 'ex

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

Examples of combination products may in

stentialist' - aka depressive - leanings led me to interpret Sisyphus’s richly deserved punishment as a metaphor of the human condition. I didn’t know he was actually an all roun

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

d bad egg, who debauched, tortured and killed his fellow human beings, blamed his wife for his wrongdoing, and lied to the gods… Nor did I know that espousing beliefs of this kin

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

led to a rather bleak experience of the human condition.

Still the image of the uphill struggle with a giant boulder is a powerful one. It relates closely to the way a lot of p

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

Combination pro

eople view change: change is the huge boulder that we try to shift with our puny human forces.

Like Sisyphus we strain every muscle and sinew in our attempts to shift the immova

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

le rock, but our efforts are virtually predestined to fail. So we conclude that change is just too hard to do. (Although we see some people achieve it.)

In reality, it is the w

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

ay that we go about change that is wrong. How To Do Change is -like How To Build Successful Relationships and How To Believe In Your Own Worth – one of the many useful things tha

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

nobody ever teaches you in school.

The old adage that no teacher would ever tell you: “It at first you don’t succeed, try something different’ holds the key.

Because it is well

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

nigh impossible to achieve change through brute force, it makes sense to try a different approach; namely, leverage.

If our burdens, baggage, blocks and problems are, indeed, li

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

e a giant boulder, then it makes sense to ease the end of a plank under that solid mass, so as to destabilize it and start it moving. The thing to do is focus on the end result

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

Following aspects would a

ou want – shifting the boulder – rather than becoming fixated on the amount of force you need to deploy in order to do so.

Sisyphus had to roll his boulder up a mountain, but he

dd to the challenges in developing combination products:

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

deserved that because he was a vicious, devious, dead snit. The rest of us only have to get our boulder moving. We can choose whether we roll it uphill (why???), along level grou

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

d, or downhill into the nearest lake or tip. Once it is moving the whole process becomes simple anyway.

So what do you use for a plank? Anything that serves to destabilize even

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

one belief that crushes your spirit will do it. Just challenging one destructive belief, by repeatedly affirming a positive one, either out loud or in writing, is enough to set

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

he boulder rolling.

It’s not Formula 1 racing. You needn’t expect the boulder to go from 0-60 in 4.2 seconds. That won’t happen, at first. Given its size you can expect it to

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

Professional from academic institutions, pharmaceutical industries, health care indust

gather momentum slowly. But gather momentum it will.

And it doesn’t even matter which destructive belief you start with. Leverage is leverage. The laws of physics apply. Peri

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

d.

So where will you start? If you’re not sure, you could always start with that hoary old chestnut: “I deserve better”. That typifies the old approach of trying to displace th

.

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

e boulder with main force. “I deserve the best”, on the other hand, provides the leverage to move the boulder.

Even better, using leverage leaves you with heaps of energy you ca

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

Companies that provide selfless information through particip

profitably dedicate to other areas of your life.

What do you want to do, that you’re not doing now, with all the energy you will free up through leverage?

(C) 2006 Annie Kaszin

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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