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During 1967-1970 a virtual conflagration, in the form of the most heated debate ever, raged uncontrollably across Britain concerning the need for a long distance study centre, a university of the air. It was a time for petty prejudices to push themselves to the surface as

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

the pros and cons struggled for supremacy in the war of words which developed, particularly among the privileged, well-educated, middle class elite.

Its purpose and value were minutely dissected on one hand by the enthusiastic visionaries who saw it as the new saviour o

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

Examples of combination products may in

the masses, especially those who had been unable to take advantage of full time higher education. The academic champions, on the other hand, most of them armed with the benefits of an Oxbridge education, went almost ballistic at the thought of a university which would be

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

welcoming people without any prior qualifications. The idea was too preposterous to contemplate, as snobbishness ran rampant. They were absolutely certain it would not only lower the standard of degrees to unacceptable levels, but the thought of so many thousands of forme

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

ly unqualified people actually ending up with degrees was more than any 'properly' educated man could stomach.

Watching uncertainly from the middle of this debate, and listening intently, were the future students if this educational utopia, like me. With inadequat

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

Combination pro

GCEs, a one year old son and a part-time job, the Open University seemed so right, manna from heaven, in fact, and I hesitantly became its first Black graduate. I knew there was no way my current qualifications would have gotten me into Oxford or Cambridge and the though

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

of studying at home for a degree, with all my domestic responsibilities, was too unreal to consider. Initially, I sided with the doubters. It would never work, I told myself often, too scared to believe it and the possibilities. Too good to be true, I thought. But I want

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

d it to succeed so badly, the dramatic change in my family life (and great personal sacrifice which would ensue) seemed so insignificant then. By registration day, my doubts had largely evaporated. I was now certain it would work and willed it with all my heart.

Many oth

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

rs, particularly with the power to affect the OU's development, did not have our belief in its success and did not want to be convinced either. Feeling comfortable with their narrow experience of what a 'real' university should be, they felt threatened by the OU's revolut

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

onary concepts of a veritable free-for-all and closed their eyes to its advantages, preferring to concentrate on all the negative aspects, the bits they were sure would go wrong.

Academic Success
Perhaps because of such widespread scepticism, Britain's

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

first university of the air set out to prove them wrong with great tenacity and skill. Starting off in an almost low-key, conformist way, it has been revolutionary in its impact. Rapidly approaching it's 38th birthday, and unmatched in research, new initiatives and ideas,

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

Following aspects would a

the Open University occupies a unique place in British history. It has unremittingly changed the face of higher education, not only in Britain, but worldwide, with its byword of 'credits' and flexibility of study having become an integral part of the education language. O

dd to the challenges in developing combination products:

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

er 350,000 graduates have already passed through its doors. It's academic success, particularly in education and research, and the way it has dramatically changed people's lives, perceptions and achievements, have been phenomenal, not least for one of its graduates - me.

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

hrough it, I finally did get into Cambridge University. Not a bad feat for someone with hardly any qualifications.

This story springs readily to mind on the eve of its anniversary and in the face of our general unwillingness to step into the unknown and embrace change. N

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

w initiatives tend to bring out the worst fears for our future, and the worst reaction, making us needlessly defensive of our territory while firing our natural instinct to protect the status quo at all cost.

It seems that accepting any form of change depends primarily o

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

the personal perception of our individual situation; our vision of how we could be affected by something new; our degree of readiness for a different experience; how much we perceive we have to lose and our level of confidence in dealing with the unexpected. Havin

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

Professional from academic institutions, pharmaceutical industries, health care indust

no vision means we can only see through a narrow tube of familiarity which usually gives us just a tiny part of the whole picture. This keeps us firmly where we are, without letting in any more light, while detaching us gradually from both reality and the action. In this

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

way we continue to have a distorted, jaundiced view of the potential effects of anything new in our environment and to the detriment of our development.

For instance, if you were to play blind and deaf from today and move to an uninhabited island, you would learn nothing

.

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

else about the world you left behind, you would meet no one else and probably do nothing more than the basics. Ten years from now, you may be an expert on plant life, or on how to survive on very little, but you would be technologically ignorant and trapped in a time warp

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

Companies that provide selfless information through particip

while the world would have moved on at a cracking pace. There are many of us like that in life who miss out on new developments, and benefits which are rightfully ours, because we lack the courage to overcome one main confidence killer: a preoccupation with the past

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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Just Other Articles - The BEST Way to Face Up To Change (1)

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