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"The reasonable man adapts himself to the world; the unreasonable one persists in trying to a

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

dapt the world to himself. Therefore, all progress depends on the unreasonable man." -- Geor

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

Examples of combination products may in

ge Bernard Shaw, Maxims for Revolutionists

It is probably the number two task of leadership --

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

asking. You ask people to do things, and when they do -- well, stuff happens.

But what really e

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

xtends your ability to make big things happen is asking for things that are "unreasonable."

Wha

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

Combination pro

t is unreasonable? Asking people for things you have no right to expect from them, which under o

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

rdinary circumstances, you would expect them to say, "no." But asking anyway.

The trick is to e

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

xpect them to say yes, and not worry about whether they do or they don’t.

Create a game in your

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

business. The game is for everyone to continually be unreasonable in what they ask of each othe

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

r. And not just internally -- externally as well. Include all your stakeholders in this game. (Y

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

ou choose whether or not to tell them about it the game.) Do you think this game could rocket yo

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

Following aspects would a

ur project forward?

If making requests is not a normal activity for most people in businesses,

dd to the challenges in developing combination products:

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

unreasonable requests are doubly abnormal. Most of us don’t want to risk rejection -- so we ask

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

for small things, easy things, wimpy things, and make it easy for people to say yes.

Keeping yo

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

ur requests small is a good strategy if you are no-o-phobic, but it limits your results.

The ac

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

tion in your business is moved forward in direct proportion to the size of your requests, so to

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

Professional from academic institutions, pharmaceutical industries, health care indust

move things along quickly, you have to ask big.

Think of what changes would make your requests

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

unreasonable. Whatever you were going to ask for, ask for more. Whenever you wanted it, ask for

.

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

it sooner. Whatever you were willing to pay or trade, ask for it for less, or free. You get the

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

Companies that provide selfless information through particip

idea.

Make your requests larger. Bigger. Faster. Cheaper. Outrageouser.

Make them unreasonable

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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