Top Adding - Computers and Technology

When someone sends you an email, when should they expect a reply? Within an hour? A day? It is a simple question, but the answer (and you can send them to me via email if you'd like) isn't.

I

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

think most of us try to respond within a business day, and if we get the email early enough, by the close of that day too. It is a pretty good rule of thumb.

But then some of us expect a respo

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

Examples of combination products may in

se even quicker, and get annoyed or impatient of the delay. To me, this represents something out of balance, like some scenes from the movie Koyaanisqatsi. (Little ironies department: I now liv

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

about a mile from the former site of Pruitt-Igoe made famous in the movie.)

I was talking to a colleague yesterday about how she often replies to her emails late at night, after her husband h

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

s gone to sleep. It made me think about how often I reply to emails in the early morning, before my own wife awakes.

And how many of us can't leave the laptop home when we go on vacation for f

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

Combination pro

ar of the massive email pile-up that will await us upon our return? Or who can't help ourselves but "multitask" during meetings and clear our inboxes when we are supposed to be part of the meet

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

ng itself?

There are some that are hyperactive email responders, carrying BlackBerries and being reachable 24x7. You know who you are.

Is this healthy? I am beginning to wonder.

The irony is

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

that I have come full circle on email responsiveness. Back in the early days of my own email use, I tried to respond to every email that I received within a few hours. This is the early 1980s,

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

hen the Internet was still a DoD science project, and few people had the ability to send messages between corporations, let alone across the world. It was still a novelty then.

In the early 19

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

0s, I had an Internet-reachable email address, actually several. When I started Network Computing magazine, we were one of the first magazines to include email addresses of the authors for each

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

article, which was also novel concept then. Now you can find them for the bylines in my local paper. I was also an early user of the BlackBerry precursor, called Radiomail. I remember one time

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

Following aspects would a

ulling over at one toll plaza on the Garden State Parkway to answer some emails. A curious copy came over and was wondering what I was doing.

Back when Computer Associates (now called just CA)

dd to the challenges in developing combination products:

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

first implemented their email network, they actually turned the system off for several hours during the workday because they wanted their staff to get work done. This was before various executi

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

es were caught cooking the books, so I guess it worked too well. They eventually stopped doing this, and now email is available 24x7, just like everywhere else.

The email landscape sure has ch

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

nged since then and what was novel is now de rigueur. Today most of us think nothing about emailing people that are halfway around the world, and of course now I get spam in about a dozen diffe

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

ent languages, if I could figure out the character sets that come into my inbox.

The trick to being successful with email can be summed up with one word: balance. Or getting back into email ba

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

Professional from academic institutions, pharmaceutical industries, health care indust

ance.

"I do however still get a chuckle by those who complain they can’t get work done at the office, yet are sending personal emails out all day long," says Rich DiGirolamo, who writes a very

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

amusing email newsletter and is a professional keynote speaker. "Some of us make every effort to answer every email within twenty-four hours, but at times we need to prioritize them. Yours just

.

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

may not be as important to me as you think it is. But it will get answered, I promise."

I think that is a great strategy. I recommend setting aside some time every day to read your emails, and

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

Companies that provide selfless information through particip

perhaps a separate time to write replies. But don't let it bleed into the entire day.

Maybe we need an email rehab center in Malibu to help those that need to get their lives back into balance

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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