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The senior manager of a large organization called me seeking help.

‘We are stiff and bureaucratic,’ he said, ‘but we want to be more open.

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

We are formal until it hurts but we’d like more innovation. Can you help us, Mr. Kaufman? Can you share a new perspective and bring some f

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

Examples of combination products may in

resh ideas?’

I accepted the assignment and found that what he said was true: they had an old culture of top-down control, suffocating auth

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

ority, miles of red tape and rigid ways of working.

With enthusiasm, I prepared a speech that opened many eyes. Laughter rolled through th

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

e audience, self-reflection mixed with humor. I saw skepticism and resignation, but also interest, possibility and a desire for new action.

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

Combination pro

The next day my telephone rang. Someone in the audience felt I had gone too far, was too provocative, had challenged too many sacrosanct

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

assumptions.

I was concerned, of course, but also began to wonder. Had I stayed within the safety zone of caution and consensus, would my

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

emarks have hit the spot at all; would my speech have made a difference?

My friend Chauncey Bell opened my eyes on this topic with a point

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

of view I found completely unexpected. He said, ‘There are two times when consensus is required. First, when there is fundamental distrust

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

in the group. Second, when you want to guarantee a lack of innovation.’

That statement caught my attention! I can understand why consensu

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

s works when distrust prevails within a group. After all, if everyone agrees on everything, then anyone will notice anything out of kilter.

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

Following aspects would a

It was the second half of Chauncey’s claim that made me think much harder. If we cherish consensus and complete agreement, where is the s

dd to the challenges in developing combination products:

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

pace for ‘out of the box’ new thinking and ‘off the wall’ ideas?

It is risky to try something new, change from one day to the next, do som

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

ething now you have never done before. But the world is changing day by day and innovation is all around us.

The most risky approach to yo

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

r group’s success may be trying to achieve consensus!

Key Learning Point
-----------------------------------------------------

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

---------------------------
To say you seek innovation - but also want consensus - can be a recipe for frustration and confusion.

`Do

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

Professional from academic institutions, pharmaceutical industries, health care indust

n't rock the boat' used to be the safest path to find the future and climb the company ladder. Today, a boat that won't rock is very likely

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

sinking!

Action Steps
--------------------------------------------------------------------------------
How open are you

.

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

and your organization to completely new ideas? How welcoming are you to diversity, controversy and well-intended provocation?

If there are

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

Companies that provide selfless information through particip

questions you cannot raise, issues you dare not discuss or items banned from your agenda, make the space and time to relook and reconsider

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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