Main Subject - Business

As convenient as instant messaging is -- and in the corporate world, Lotus Sametime is the standard -- using it has been the downfall of many of

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

fice workers. Within the same company, policies regarding the use of instant messaging differ from one department to another. If you transfer wi

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

Examples of combination products may in

hin the company, you may discover the pitfalls the hard way, so for your own sake, be wary.

For example, the following differences apply at the

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

leading edge company where I work:

a number of departments are completely forbidden to use the Sametime that is automatically

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

installed by the IT people on every employee's PC.

Manager-friends in still other departments say Sametime's use is limited to manage

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

Combination pro

ment. Period. Non-managers caught sending instant messages are reprimanded, and may be "written up," if such use occurs again.

In our

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

epartment, we are often inundated with instant messages from all status levels, all day long. We are not allowed to be off-line, since only high

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

er-ups can announce they do not want to be disturbed. None of us mind the occasional, lighthearted inquiry from a co-worker.

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

It helps us get through the day. However, many interruptions tend to be unnecessary and often annoying. You answer a message, "they" answer back

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

, you answer them, they answer back, and on and on.

Sametiming a nearby co-worker definitely beats yelling across the office at him or her, but

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

look first to see if the person can truly be interrupted. Are they on a conference call, with headset on? Have they even said a word to anyone s

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

Following aspects would a

nce they got in?

If a technical question is urgent, due to an imminent release date, or a knock-down, drag-out fight is looming, then Sametime

dd to the challenges in developing combination products:

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

is the highly useful tool it was intended to be. No, you don't have to answer an instant message rightaway, and if you're away from your desk on

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

a research question or other errand, you won't answer rightaway. Ignore the message too long, of course, and your phone will ring.

Even

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

so, when I'm focused on a problem of my own, the last thing I need is a pop-up window that asks "We had a salesman in here about 16 months ago,

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

emo-ing Widget Zappers. Why didn't we buy his software? Whose decision was that?" Darned if I know, and right now isn't a good time for me to lo

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

Professional from academic institutions, pharmaceutical industries, health care indust

ok it up either.

Red Alert!

When the volume of messages is high, invariably there are days when at least two or three IM windows will s

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

ay open for more than a few minutes. Rare is the employee who has not made an inappropriate answer in one window that was intended for another!

.

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

The results are sometimes harmless and funny. Believe me though, you'll hear about it, when an offended person is truly angry. It can cost you a

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

Companies that provide selfless information through particip

merit increase, a promotion, or even your job. So, watch your step, especially when multiple message windows are open.

© 2006 Shirley Ann Parke

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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