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Remember being 10 years old again? Coming home from school and getting your first piece of mail. WOW! What a rush! "Someone sent me something!". What was it? Junk 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

course, but we did not know any better. We were so excited just to get something in "the mail". How cool was that. But, of course, reality sets in when we fast-forward 2

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

Examples of combination products may in

0 or more years. The mailman (or woman) comes by and delivers the mail and we have no excitement whatsoever. Mostly bills and junk mail every single day. Our minds sort

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

through it in seconds. We are trained to not even open most of the junk, unless of course "they" try a new tactic to make something look like "real" mail. We may let one

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

slip by, which really means that we open it and then throw it out. Our minds make adjustments as we struggle with what’s important and what’s not important in our lives.

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

Combination pro

This same trend has happened with our email inboxes. Some call it junk mail still, but we have coined a new term, “SPAM”. We all got our first email accounts over the pas

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

t 10 years or so. Most of us have even more than one account now. I remember getting my first email account when I was an Undergraduate at Rutgers University. It really

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

was a similar feeling to being 10 years old again. If I got ten emails in a week, that was a lot. Not because I had no friends, but because our generation could still com

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

municate face-to-face. Now, we get so many spam emails everyday. Somehow all of our accounts get spammed eventually. We even have sophisticated software to help protect 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

ur accounts and to help us sort through what is “real” and what is “junk”, just like we used to do by hand years ago.

So, how much attention to we pay to our regular mail

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

and our inboxes on a daily basis. Not much, I think. Not much at all. We have been so conditioned that the story gets worse. We have to get through so much more in our

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

Following aspects would a

daily lives that we can’t waste time on worthless tasks. If our brains can recognize emails that don’t need as much attention, then we can save time. Saving time always h

dd to the challenges in developing combination products:

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

elps out in our daily lives. Time and money drive our world. This trend has taken over our way of life so much that our email accounts have suffered. Email is such a pow

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

erful communication tool. But, too many emails from one source and our minds start to compartmentalize that source as something we need to get through quickly. It could e

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

ven be your boss. If he or she sends too many emails all the time, we tend to skim them and not pay much attention to them. We snooze through them. Everyone has a friend

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

that sends forwarded messages all the time. We barely even skim them anymore. So, what happens when that same person has something important to tell us? I hope we are p

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

Professional from academic institutions, pharmaceutical industries, health care indust

aying attention. Our attention has been so lost, that now we have little icons attached to the emails to let us know it is important. The program I use has different colo

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

red exclamation points. Honestly, I don’t even see them anymore. That’s how my mind works, and yours does too, I know it. We’re all in this together.

So what’s next? I

.

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

can’t see the future, so I am the wrong person to ask. All I know is that everyone is jostling for our time. Whether it’s our boss or the multitude of advertisements we

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

Companies that provide selfless information through particip

see on TV, billboards, at entertainment events or in the newspaper, our time equals someone else’s money. For that, “they” will keep trying and “we” will keep prioritizing

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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