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Can leadership exist where there is no vision? For perspective, let us revie

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

w the Story of the Three Stonemasons.

Three stonemasons were busy at work wh

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

Examples of combination products may in

n a passerby asked them, “What are you doing?”

The first stonemason responde

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

, “Laying bricks, sir.”

The second mason answered, “Earning a living.”

But,

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

when asked by the passerby what he was doing, the third stonemason said, “I’m

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

Combination pro

building a cathedral.”

The third craftsperson had a vision and saw the great

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

er purpose of their labor. It was the third that recognized they would leave

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

lasting legacy.

Leadership without vision isn’t true leadership at all. It

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

is management. While management is both valuable and necessary, it is simply

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

not the stuff that takes people and organizations to new heights of achieveme

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

t.

For an organization to grow, to move boldly forward, the leader must know

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

Following aspects would a

where her organization is and where she wants it to go. She must have and c

dd to the challenges in developing combination products:

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

nvey a compelling vision, one powerful enough to call her constituents to act

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

on. Martin Luther King’s “I have a dream,” speech is a classic example of th

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

type of vision that inspires the passionate dedication of those who share in

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

it.

No less important than organizational vision is personal vision. Your v

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

Professional from academic institutions, pharmaceutical industries, health care indust

ision is your beacon, a clear and constant guide to the life of your choosing

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

“You’ve got to think about ‘big things’ while you do small things, so 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

ll the small things go in the right direction.” (Alvin Toffler)

What are the

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

Companies that provide selfless information through particip

‘big things’ in your world? What will be your legacy?

What’s your cathedral

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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In business, the blueprint for success has zero to do with gender and everything to do with characteristics. The number one reason most people don't start a business is not because of a lack of money but a conceptual fear. For one to operate a successful business, they must first define what success is in their own terms.

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