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I've been watching my local basketball team, the Dallas Mavericks, struggling in their first round of the playoffs, hoping this is the

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

year they take it all. I still have confidence that they can win, but an interesting thing occurred to me during last night's game.

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

Examples of combination products may in

I was talking out loud to the TV as I often do during ball games (I think it is a guy thing) and many times I would shout something l

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

ike "That looked like goal tending to me!", or "That wasn't Charging!".

My wife patiently read her book as all of this was going on b

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

ut finally she looked up from her book and said "How do you know all these rules?" It made me take a moment and think as to why some

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

Combination pro

people know the rules better than others, not only in basketball, but in all sports. I examined my own knowledge level of sporting ru

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

les and quickly determined that even though I may watch all kinds of sports, baseball, football, golf, Hockey, etc., there are some sp

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

orts in which I understand the rules better than in others.

I tried to think about why that was so, and eventually I came to the conc

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

lusion that the sports that I actually participated in as a youngster were the ones in which I had the most knowledge of the rules. I

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

believe this is probably true with most people. If you have ever played baseball you probably understand what an infield fly rule is

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

all about and why it exists. If you have never played golf you probably don't completely understand when and where you can take a no

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

Following aspects would a

n penalized drop or how it is done.

I believe this is true in the business world as well. Those of us who have gone through the tria

dd to the challenges in developing combination products:

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

ls and tribulations of running a business have made enough mistakes that we are quite familiar with what will work and what will not w

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

ork, the rules so to speak. Just because we might have an advanced business degree doesn't mean that we know all of the rules. A deg

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

ree by itself is probably similar to watching the sport but never playing it.

This brings me to the point of this article; never unde

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

restimate the value an experienced advisor can bring to the table. Many business people will fail simply because they did not know th

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

Professional from academic institutions, pharmaceutical industries, health care indust

e rules they were playing under. Keep your business advisor close and consult with him/her frequently. Their EXPERIENCE
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
i> will make a significant and positive impact on your success. You'll soon be playing the game of business with a high level
.

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
of knowledge. It is a lot more fun when you understand the rules.

The last thing you want is to hear the referee blowing his whistl
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
e, pointing at you, and slapping a penalty on you because you did not understand the "3 seconds in the paint" rule!

To Your Success -

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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E-Folder - Do You Know the Rules?

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