Advice You - Business

Part One

The miss conception is that it is the billions of ideas that pops into peoples minds all over the g

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

lobe that make money. I don't want to be the bearer of bad news but very few ideas are worth the time it took

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

Examples of combination products may in

for the thought to manifest itself.

Most ideas are nothing more than fleeting 'sparks' of inspiration that g

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

o no place and are forgotten within minutes. Some may last until the next day if your lucky.

The unfortunate

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

truth is that most of the ideas that are very good, very few are followed up on and never see the light of da

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

Combination pro

y and so therefore never end up as a worthwhile development in the market place. So it comes as no surprise t

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

at a lot of great ides end up being squandered and theoretically flushed down the proverbial toilet pan.

Mos

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

t people are unfortunately not oriented to do anything about their ideas, meanwhile others believe it would t

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

ke too much of their time or money or leave them open to other's taking advantage of their original idea and

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

benefiting themselves.

You see some people come up with a good idea but fail to implement a proper business

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

lan, do the required research or secure enough funds in order to succeed and so therefore they fail and someo

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

Following aspects would a

e else usually comes along and ends up benefiting from there failures and more importantly there ideas.

Howe

dd to the challenges in developing combination products:

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

ver the situation is wide open for the person who can 'create' profitable ideas, and then follow through with

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

them and invest some quality time and money in following through with the idea to completion.

If you do deci

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

de that your going to try and come up with an idea then make sure you carry a pad and pencil everywhere you g

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

; and yes I mean everywhere, some of the greatest ideas have been thought up whilst sitting on the thrown.

A

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

Professional from academic institutions, pharmaceutical industries, health care indust

s you create ideas, remember to write them down immediately. Ask yourself how many times you have thought abo

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

t something that needed doing in your day to day tasks and how many times you have forgotten to do it.

Remem

.

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

ber the golden rule, 'ideas are only of use to you if you remember what they were in the first place'.

A goo

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

Companies that provide selfless information through particip

incentive to help you remember is that what you dream up can ultimately be your key to unbelievable wealth

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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