Useful Advices - Business

Almost every day, I hear the same question, over and over,

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

from motivated, well-meaning financial planners who want

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

Examples of combination products may in

to use publicity in their marketing mix. It goes something

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

like this:

“Who do you know in the media? (Or, sometimes

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

they frame it as, “Who do I need to know in the media?”) C

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

Combination pro

an you get me publicity?”

My answer is always the same. W

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

o you know in the media is only half the game. And it’s 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

e easier half.

I'm a former newspaper reporter, and am on

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

a first name basis with plenty of newspaper reporters. An

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

here’s what you get from knowing someone in the media:

I

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

t gets them to take your phone call, or your e-mail. Perio

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

Following aspects would a

d. That’s it.

But it’s what you know – your unique expert

dd to the challenges in developing combination products:

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

se and experience - and how you serve it up to those hungr

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

y media folks that determines whether you’ll become a medi

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

a star.

When they know you (or your publicist), they’ll 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

adly give you 30 seconds on the phone to make your pitch.

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

Professional from academic institutions, pharmaceutical industries, health care indust

But – and this is the harsh truth – for you to get into pr

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

int or on the air, they must make the cold, calculated jud

.

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

ment that what you’ve got is newsworthy. Not even the stro

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

Companies that provide selfless information through particip

ngest relationships or friendships can bend this iron rule

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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Useful Advices - Marketing-Minded Financial Planners, It's Not Who You Know But What You Know

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