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'Team' and 'I'. These two words are said not to fit together very well. Let's explore why and whether we

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

can't get value from both...

By definition, a 'team' is a group of people working together to a c

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

Examples of combination products may in

mmon goal. And from this definition has come the well worn phrase, pitched on noticeboards of staff rooms

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

in organisations all around the world:-

"There is no 'I' in team"

Partly based on the mnemonic:-

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

T ogether

E ach

A chieves

M ore

...which values the togetherness

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

Combination pro

f individuals, this well meaning adage is to emphasize that egos have no place in teams and that t

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

e generic direction of everyone is the same.

All true.

Focus on each helping each other out with no per

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

sonal distractions is the perfect way to success for any team.

Yet there is another level - a mor

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

mature level that leaders and team managers must exploit fully to the benefit of the team, the in

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

ividuals in it and the business or organisation as a whole.

Valuing the individual strength

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

, skills and experiences of every one of those in a team, can generate exceptional results.

Why?

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

Following aspects would a

Because a skilled leader can realise where best to focus key activities in their team.

Whilst it

dd to the challenges in developing combination products:

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

s vital to expand the capabilities of all the members of your team, it has no value to make someone strug

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

le in an area of activity where they truly have little ability.

Using individuals precisely where

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

they are strong in certain skills, will accelerate the performance of the team, though there is a

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

need to be capable of managing this well.

Using key people strategically for their strengths and finding

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

Professional from academic institutions, pharmaceutical industries, health care indust

ways for them to develop others in their field of operation, will strengthen the sustainability

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

/B> of great performance.

That can mean that instead of fire-fighting and panic measures when som

.

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

one leaves, you have strength in depth.

This values the individuals and uses the 'I' factor in a

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

Companies that provide selfless information through particip

onstructive and positive way.

There can indeed be value in accepting that there is an 'I' in TEAM

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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