Main Subject - Business

You know that one. He’s the one in the office who puts out all the great ideas then steps out of the way while y

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

ou do the work, but comes back just in time to tell you how you did it all wrong. His interest gravitates only t

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

Examples of combination products may in

Power and Recognition. He isn’t interested in doing the work, actually participating in the project, or activel

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

becoming involved in the accomplishment. He only wants the glory of suggestion and the recognition of completio

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

.

Over the past several years’ one particular person has instigated several projects in a group I actively parti

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

Combination pro

ipate in. This person shows up suggests a project and disappears for the next several meetings, appearing often

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

enough to rip apart most anything that’s been accomplished toward the completion of any article, find fault with

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

ny work done on the project, and disappear again until the next round of complaints and judgmental condemnations

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

re ready.

Unfortunately, there are those members of the group who desire accomplishment enough to go the extra m

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

le and attempt to complete the projects in the face of this sorry individual who desires only the glory. Those m

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

mbers willingly commit their time and effort to the project and work hard to gain acceptable results, while inadv

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

Following aspects would a

ertently complying with the demanding coworker with the bad attitude.

There is a solution.

When the power hungr

dd to the challenges in developing combination products:

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

recognition monster rears its head on that occasional appearance, if the rest of the members suggest that person

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

get started on the project and agree to jump in and do their part after the original project is well started, the

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

power disappears. That person looses the control factor and becomes just another peon in the group. The project

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

in question is either activated by the instigator, or dies on the table. The power monger must either get into t

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

Professional from academic institutions, pharmaceutical industries, health care indust

he project or let it die the unnatural death of neglect.

So, the next time someone in your office or group comes

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

up with an incredible opportunity to accomplish something and you know for a fact they aren’t going to actively p

.

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

rticipate in the completion of the project, bow out gracefully by suggesting they get it started and offer to jum

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

Companies that provide selfless information through particip

in with your part when the project is actively ongoing. Otherwise let their own neglect of their project kill it

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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To accomplish this task there are several things to keep in mind. First you need to provide resources to be full time on the project to oversee your personnel and to be your advocate to the partner

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