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Bankruptcy is a contentious word for a whole number of reasons. Firstly it relates to a situation whereby a Debtor not being able to satisfy or compound to his

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

Creditors a suitable amount has to turn to the Courts for protection and at the end of the day everyone loses out.

Let me repeat this last fact lest it passe

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

Examples of combination products may in

s some by. In a Bankruptcy situation no one wins. It is a “lose-lose” scenario. The Debtors by and large lose almost everything he or she owns (unless they are

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

very carefully advised) and the Creditors by and large lose their money because when the Courts, Bankruptcy Trustees etc take their cut there is usually only

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

dividend of mere pence in the pound at the end of the day.

I hope all petitioning solicitors and lawyers read this with care as they are the ones who are adv

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

Combination pro

ising all of their clients to sue people for bankruptcy. It is a bit like loading up pistols left right and centre for a “Russian Roulette Fest” it gets nobody

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

anywhere.

In fact having read the last paragraph in more detail I take back my comment about Bankruptcy being a lose-lose situation it’s not, the Lawyers and

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

Accountants make a fortune out of their fees, no one else does.

But there is a hidden cost to all of this that no one is prepared to acknowledge and this inc

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

udes the knock on cost of ill health brought about by the stress of Bankruptcy. It is the “sleeping elephant” (for want of a more suitable metaphor) in the cor

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

ner of the room that no one wants to acknowledge but it is certainly there all the same.

Let us analyse part of that “ill health” that we referred to above an

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

d that is the area of High Blood Pressure. It is one of the few natural growth phenomena of the late 20th and 21st Centuries and now is assuming almost epidemi

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

Following aspects would a

c proportions. The stress and elevated blood pressure brought about by the comings and goings of bankruptcy and all of the shenanigans that ensue can be lethal

dd to the challenges in developing combination products:

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

and in some cases lead to fatal consequences.

Our Society is so powered by the worship of all things financial that in the “heated blood lust of debt recovery

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

” we seldom stop to consider the hidden human cost to all of this. I have client who as well as his business career being well and truly finished (boy was he b

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

adly advised earlier on but that is another issue) but his health, or should I say ill-health, is such now that any job prospects he might have had are now wel

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

l and truly finished.

Now let us consider who well and truly gains by any of this? The answer? No one and if I can make just one final point it is a plea to a

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

Professional from academic institutions, pharmaceutical industries, health care indust

y Solicitors and Lawyers who may, just may be reading this article. When you advise clients to pursue matters to Bankruptcy, get your background research carri

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

ed out properly, do your due diligence well and get it right because at the end of the day as well as well and truly losing the majority of your clients money

.

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

(which statistics point out is most certainly the case) you also damage the health of the person at the end of the writ.

Do you know the sad thing abut the wh

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

Companies that provide selfless information through particip

ole side of this? I bet there is not a Solicitor or Layer who really cares, as long as they get their bonus and their fees, who gives a damn about anybody else

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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This article is about minipreneur. What is it? It is about part-time entrepreneur who start small business while having a day job with the eventuality of going in full time entrepreneurship.

Something is roaring into the business community’s depot that has been building momentum for years. I call it the Gray Train. On December 31, 2004, the last Baby Boomer turned 40, pushing that train to full throttle. Marketers are missing the obvious and not-so obvious opportunities to grow their businesses with this appealing audience.

For an online business to succeed the most important factor is traffic. Without traffic even the most expensive website is worthless. Having a website is like having a shop in a basement in a dark alley in a small town. So how can you generate traffic?

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