Advice Pool - Business

So much has been written on this subject; Team Work, it’s almost hard to ad

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

d any thing at this point. T E A M; TOGETHER EVERYONE ACCOMPLISHES MORE. Th

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

Examples of combination products may in

at is really easy to say and it makes for a great acronym. It seems it has

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

even hit corporate America. They have integrated it into TQM “Total Quality

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

Management”. They call it “team building”. They talk about quality. They t

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

Combination pro

lk about communication. They talk about goal setting. They talk about produ

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

ctivity. They talk about this; they talk about that. That’s the problem; i

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’s all talk. The real problem is that you can’t talk about team building a

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

nd downsizing in the same sentence. Building means growing, expanding, plan

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

ning, etc. Downsizing is tearing down, discharging, shrinking. Which is it?

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

Either you are building a winning team or you are starting over. If they ar

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

Following aspects would a

e going to do both, they should downsize first and then team build second.

dd to the challenges in developing combination products:

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

Otherwise, you can talk all you want because no one is listening. The peopl

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

e are: either laid off, fearful of their job or not interested in the B.S.

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

anymore

When we say teamwork, we must mean it. We are not should not stro

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

e you and tell you “You are wonderful.” We expect performance from you. Jus

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

Professional from academic institutions, pharmaceutical industries, health care indust

t like you expect performance from your team captains and employers. Remem

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

ber a chain is only as strong as its weakest link.

Team work is an importa

.

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

nt concept, perhaps the most important part of any business. You need to as

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

Companies that provide selfless information through particip

k yourself and your team; Are we in it to Win it? Yes or No. Think about 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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