Main Subject - Business

“I didn’t have 3000 pairs of shoes. I had only 1600 pairs.” Imelda Marcos

Everything’s relative. A million dollars sounds like a lot of money to someo

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

ne who makes an average salary, but it’s a drop in the bucket to a Warren Buffett or a Bill Gates. Running a hundred metres in a few seconds seems

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

Examples of combination products may in

ike a miracle to ordinary mortals, but a track and field athlete will work hard to shave even more off that time.

Yet presenters often quote stati

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

tics without benchmarks, so the audience doesn’t know how to evaluate them. Is $10,000 a lot of money? Well it is for a bicycle. It’s not much for

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

house, unless that house is in a small village in a third world country, where it might be exorbitant. If you quote numbers this way, you will lose

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

Combination pro

the audience while they try to decide whether $125,000 is good, bad or indifferent in this context. Your statistics lose their power.

In a present

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

tion skills workshop for a group of lawyers, one participant was practicing his delivery of an address to the jury in an upcoming trial. He was askin

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

for damages in the amount of $750,000, and hoped the jury would consider it reasonable. It’s quite a large sum, and most ordinary folks think of t

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

at kind of cash as a lottery win. He needed to put it in context for them.

He might, for example, ask the jury to suppose they were thirty-five year

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

s old and earning a salary of $40,000 a year. By the time they reached the age of sixty-five, allowing for reasonable increases, they could expect

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

o have earned a certain amount. (He would do the arithmetic and insert the actual sum.) That amount would be what is called their “expected lifetim

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

Following aspects would a

income”. However, if they were involved in an accident and suddenly unable to work any more, that amount now represents their “forfeited lifetime

dd to the challenges in developing combination products:

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

ncome”. That is what happened to this claimant, and the amount he would have lost was $750,000. So in fact, counsel was asking no more than the amo

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

unt the man would have earned, had he not met with this unfortunate accident.

Don’t you think the jury is more likely to agree when given this backg

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

ound explanation?

Here are three ways to put figures in context for your audience.

1. Compare them to something to which they can personally relate

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

as in the courtroom example.

2. Compare them to a similar situation. If a new manufacturing process takes fifteen minutes, mention that the old o

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

Professional from academic institutions, pharmaceutical industries, health care indust

e took two hours, so we save 1-3/4 hours.

For even more effect, tell them how much time this will save in an average shift or on a certain number

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

of product units. Go further and translate that time into money and the statistic will now be a strong argument for change.

3. Create vivid word pic

.

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

ures to illustrate size: That’s the equivalent of five football fields. That’s enough to fill ten Olympic-size swimming pools. If laid end-to-end t

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

Companies that provide selfless information through particip

ey would stretch from New York to L.A. and back again.

Statistics can be great persuaders, but only when the audience has the means to evaluate them

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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Main Subject - Present Statistics In Context

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