Advice Pool - Business

It's becoming more and more difficult to sift the nuggets of true knowledge from the mou

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

ntains of data thrown at us from all directions. Of course, we do this to ourselves to a

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

Examples of combination products may in

certain extent, because in this age of unlimited access to information through the Inter

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

et as well as all the traditional sources, most of us try to take in just too much. No w

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

nder we feel overwhelmed.

But if you are an executive or manager, there's one way you can

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

Combination pro

cut down on this data dump: stop the flow you get from your own people in the form of e-

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

ail messages, memos, reports and presentations.

I'm not suggesting you refuse to accept

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

any information from your people, but honestly, haven't you ever received a half-inch-th

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

ck written report when you only wanted the salient facts or the main figures?

Have you

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

ver sat through a monthly financial presentation in which your people stood in front of

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

slide covered in figures, turned around and read them out, and then --- just in case yo

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

Following aspects would a

missed anything --- gave you a copy of the slide as a handout? The message of these pre

dd to the challenges in developing combination products:

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

entations generally is, "Here's what the budget said we would do, here's what we actuall

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

did, so here's the shortfall or surplus."

Just think of all the time this took, both for

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

the people who laboured mightily to put it together (sweating bullets as they did becaus

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

they dread the presentation to much), and also for you to listen to it. And did it real

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

Professional from academic institutions, pharmaceutical industries, health care indust

y help you? Or did it simply add more data to the dump?

Fixing this universal problem n

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

t only saves companies money, but it also has the potential to cut down on workplace str

.

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

ss at all levels. But it won't fix itself. If you don't speak up, you'll listen to these

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

Companies that provide selfless information through particip

presentations and read those long-winded reports every month till the end of your career

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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Advice Pool - Information Overload: Don't Let Them Overwhelm You

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