Main Subject - Business

Perhaps I'm just getting crochety. Then again, maybe not.

First, I'm hardly old enough to be in the "crochety" class. And secondly, I've been feeling this way for about 30 years.

My complaint? Delivering the goods. Or the lack there

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

of.

Growing up, one of the things stressed in my family had to do with keeping your word. When you said you would do something, promised to make good on something, you did it. Or made every good effort to do so. Mostly, you deliver

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

Examples of combination products may in

ed the goods. You showed up on time. Made the return phone call. Produced what you'd promised. Kept your word.

Occasionally, circumstances simply worked totally against you and it turned out that what you'd promised wasn't possib

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

e. Still, you did all you could to bring about the pledged result.

And if you didn't?

FEELING BADLY AND YOUR PERSONAL INTEGRITY

You felt badly, really badly. Not keeping your word was a very serious thing. Not because

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

others thought so, but because it was the essence of your own personal integrity.

And what is integrity? It means "wholeness," something complete in itself. And having it and living by it means that you become trusted by othe

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

Combination pro

s. They can count on you. They know you'll deliver the goods.

So when you truly were not able to do so, despite every effort you made to keep your word, you were personally wounded. It wasn't so much that you'd let others down; yo

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

u'd let yourself down. You felt badly, sometimes for a long while in serious cases. You didn't just forget it and prate on about your self esteem or how tough things were. You knew you'd screwed up.

DIFFERENT FISH

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

And today?

Today is a very different kettle of fish, I'm sad to say. Nowadays, delivering the goods all too often deals with written contracts and getting away with only what is written down...if that. It seems to be about cutting

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

corners, avoiding any commitment, personal or otherwise, finding ways to deliver less than what was promised, fooling the other guy. And laughing when you get away with it.

NOT GIVING A DAMN

It's about not caring about the o

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

her side of the contract and the effects you create when you don't keep your word. It's about irresponsibility, a casual attitude and a sense that too many people simply don't give a damn.

Does any of this sound familiar? Met too m

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

any folks like this lately? Been screwed in some deals? Didn't get what you paid for? Discovered there had been some surprises in the small print?

CHANGE IS COMING

Probably won't make you feel a whole lot better, but the

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

Following aspects would a

times they are 'achangin. We're beginning to see the return of that older version of ethics and integrity.

Why?

The internet.

"How come?" you might ask.

Because of both distance and anonymity. What we're seeing in the way of busi

dd to the challenges in developing combination products:

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

ess on the internet today is an unbelievably tiny increment of what is to come. Eventually, Trillions (yep, with a big "T") of business will be done this way. Already you're dealing with people whom you've never - and will never -

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

see, with whom you don't actually speak, in many instances. They may be in other cities, other territories and, often, in other countries. Those who will prosper will be those who deliver the goods, keep their word, make good on

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

heir promises. The others will quickly lose their lustre. The internet is quick to let you know when a phony is running around, when quality is poor, when the "deal" isn't being kept.

And personally?

Relationships are being built

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

in a new way. People in chat rooms and in email are often revealing more to people whom they've never met than they would have, in past years, to spouses.

Does it work?

Sometimes. Apparently, some good relationships are being cr

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

Professional from academic institutions, pharmaceutical industries, health care indust

ated, marriages taking place, perhaps families being raised. Too soon to tell how this may work.

EVEN HERE THE LIES CONTINUE

But already I've seen signs of the lack of delivering the goods, even in this area. Dates are made.

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

One person doesn't show up. Photos are exchanged. One person sends a friend's photo, perhaps someone more attractive. It's lying. Failing to keep one's word.

It won't do.

THE WORLD'S GLUE

The civilized world is held tog

.

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

ther with concepts. These are expressed by words and deeds. As one writer, living in a small town in France, said, "Most of life is governed, not by laws written by legislatures, but by invisible rules of order. They are written

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

Companies that provide selfless information through particip

down nowhere, but respected almost universally."

If your words and deeds don't deliver the goods, you will eventually be shunned. No matter the wealth or station in life you attain, you'll be known by whether you deliver the goods

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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