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Let's say you have a pipeline 10 feet in height, 10 feet in width, and a mile long. What most people do is p

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

ut one or two people into the entrance, get all excited, run to the other end of the pipeline, expend a lot

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

Examples of combination products may in

of energy, and anxiously wait to see what happens. They don't yet realize that they have no control over wha

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

t happens with that person after they have been introduced to the business. They might have fallen, gone on

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

mental vacation, or turned back and left the tunnel. So you have wasted your energy and thoughts on one or

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

Combination pro

two people; instead you should put as many prospects as you can into the tunnel, and by the laws of nature,

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

people will start getting pushed out from the other side.

Let's work on not getting emotional about whether

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

someone joins your business or not. That is the roller-coaster way of building your business and will soon

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

ake the fun out it.

There are three different types of pipelines: a pipeline of leads; a pipeline of qualif

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

ied leads with future appointments to show the plan to; and a pipeline of people already exposed to the busi

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

ness and in a decision-making process.

It is equally important to have each of these pipelines at least som

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

Following aspects would a

ewhat full on a consistent basis. This is the only way to catch the dynamic of momentum.

When you have enou

dd to the challenges in developing combination products:

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

h people in your pipeline, you can always quickly replace a person who, for instance, didn't show up to ther

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

e appointment. Let's say it's five minutes before the conference call; you call Joe and he is a no show. Oka

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

y, no problem: you start going through your file and decide to call Mary, who's a qualified prospect but did

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

n't show up for her appointment a few nights ago. You say,

"Hi, Mary. I realize you missed your appointment

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

Professional from academic institutions, pharmaceutical industries, health care indust

a few nights ago, I'm sure something equally important must have come up. The great news is that we happen t

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

o have another call right now and I can simply take you to this call, so you can get some great information

.

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

regarding making that $5000 per month you're looking for. How does that sound?" They usually say okay. Then

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

Companies that provide selfless information through particip

you take the next step. This is one of the benefits of having a moderately full pipeline.

See You At The To

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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