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How many times a day do you hear something to this effect: "We need to meet to discus

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

s this." I would venture to say that it is quite a bit. However, what follows is an

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

Examples of combination products may in

mail chain like the following:

"Ok, what time is good for you?"
"Hmm, whenever,

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

'm pretty open."
"Me too, do you have a time that you prefer?"
"Not really,

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

hatever works for you."
"Ok, how about 3:00?"

The last sentence

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

Combination pro

is emphasized because it's the most important of the entire conversation: The setting

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

of the meeting time. If you take a look at the first four sentences, they really don'

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

t do anything for the meeting other than waste time. If the last sentence was just th

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

first sentence, it would have been resolved a lot quicker. This brings me to my main

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

point: When scheduling a meeting, be the first one to suggest a time. This accomplis

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

es two main things:

You are more likely to get the meeting time you want.
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a
i>
You save time because the meeting is setup from the get go.

In re

dd to the challenges in developing combination products:

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

ards to the first point, I've found that most people will go along with a meeting time

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

as long as they have no drastic conflicts. All you have to do is suggest it, and you

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

can usually get the time you want or close to it. Even more important is the second p

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

int, because you would be surprised how much time is actually spent settling on a meet

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

Professional from academic institutions, pharmaceutical industries, health care indust

ng time. I would wager that it can even exceed the length of the meetings on some occ

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

sions. Even if it doesn't, you'll definitely save both time and trouble if you just t

.

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

y and set the meeting time in the beginning.

This line of thinking can lead the above

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

Companies that provide selfless information through particip

conversation to look like this:

"Ok, how about 3:00?"

"Sounds good."

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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Digg It - The Importance of Setting the Meeting Time

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