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If you run a company and you run it like a sports team or Navy Seals Special T

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

eam, well then you should be congratulated indeed. It is that level of commitm

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

Examples of combination products may in

nt, which can win markets in business thru streamlined efficiency in Managemen

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 at all levels and camaraderie at the front desk and line workers. We all kno

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

this is true, but how come when the team’s engine is firing on all cylinders

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

Combination pro

is it so obvious?

Well let us just call it the multiplier affect shall we and

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

to that point many of us have heard the Team Building Seminar Tapes or read in

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

books or perhaps have a “Successories” picture on the wall with a team of row

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

rs in a high-tech row boat which says; T.E.A.M. = Together Everyone Accomplish

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

es More.

Indeed and it is hard to deny such obvious logic, yet we see that ju

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

t by adding people to the team is no guarantee that the TEAM will accomplish m

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

Following aspects would a

re because a team is about individuals and their commitment to the end goal. I

dd to the challenges in developing combination products:

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

f the team members are not all in it to win it then you are and you have proba

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

ly also heard; Only as Strong as Your Weakest Link.

How do we insure each and

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

every member is truly in it to win it and not merely putting out half efforts

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

and enjoying the sweet fruits of victory? In other words how to we turn medioc

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

Professional from academic institutions, pharmaceutical industries, health care indust

rity into a dedication to drive to the goal line? Well we must all get on the

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

ame page and believe. You must Believe to Achieve and you must make sure that

.

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

everyone agrees to put forth their 110% effort and then you have indeed built

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

Companies that provide selfless information through particip

team willing to do whatever it takes, for as long as it takes, so help us God

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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