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Well last week my thoughts were mostly success bound as I was finishing off reading a great autobiography from one of the

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

leading, current day entrepreneurs from here in the UK. Most of you in Britain will know of Duncan Bannetyne from the TV s

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

Examples of combination products may in

ries, Dragons Den. In his biography he shares with his readers how an underachiever at school became a high achiever in bu

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

iness! It is a truly remarkable story and a must read for anyone.

In this article I want to talk briefly about beliefs an

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

about 1 million pounds!

So first let’s get on to beliefs. Beliefs are strange things that steer us in different directio

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

Combination pro

s. They even let us know what we are capable of and worst still – what we are not capable of. Beliefs are great things to

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

ave as long as you are in control of them. For instance if you where on a tall cliff with only a map and a compass then th

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

belief that humans can’t fly would be a good one to have – as to stop you from taking the fastest route to the beach belo

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

.

Now I want to get onto the 1 million pounds. This is a nice round figure. If you earned ?20408.16 per month from the ag

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

of 16 until you were 65 you will have made it! However you probably would have just about spent it as well on living expe

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

ses. Too many, it seems like an unachievable goal and to others, 1 million pounds is a drop in the ocean. So why is this?

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

Following aspects would a

Why do so many see fortunes as being unreachable? Well this comes back to beliefs.

The way we look at what one million po

dd to the challenges in developing combination products:

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

nds is, is important as if we see it as something that it is not, or even as something more than it is then we move it eve

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

further from our reach.

Now I propose an experiment. How easy would I be for you to take ?1 and double it within a week?

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

What Ideas could you come up with that could make that shiny little one pound coin turn into two shiny little one pound co

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

ns? If this is so easy then would it not also be achievable to take ?500,000.00 and double it and turn it into a million?

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

Professional from academic institutions, pharmaceutical industries, health care indust

guess you are seeing where I am going – but where would you get half a million in the first place to turn into that 1 mil

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

ion pound goal?

Easy! If you take the one pound from the original experiment and double it every week for 21 weeks you wi

.

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

l have reached your 1 million pound goal! Now I bet that has made you look at what one million pounds is differently.

So

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

Companies that provide selfless information through particip

here you have it! If you cut your big goals down into smaller ones you will achieve them quicker and easier than you think

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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For business, non-profit or association managers like yourself, survival pretty much depends on whether you achieve, or fail to achieve your department, division or subsidiary objectives. Which stro...

The loss of a few files can be a bad experience for most individuals, but it can mean serious trouble when this loss affects entire companies and businesses that may be depending on those files to help them carry on with business as usual.

Safety is a prime concern in many organizations, especially those involved in manufacturing and production. A lot of accidents, mishandling, and unfortunate incidents in the factory occur almost every day, but they could have been averted if proper safety measures had been taken. It is for this reason that safety leadership training is given to managers and leaders of such organizations so that they can drive the message of optimum safety down to the lowest possible levels of the organization.

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