Advice You - Business

Thirty years ago, Jerry Harvey, a professor at George Washington University told a true story about an incident that occurred when he and his wife visited his in-laws in Texas one summer.

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

On a scorching August afternoon, they were enjoying a game of dominoes and cold lemonade on a shady porch when Professor Harvey’s father-in-law suggested that they drive to Abilene and

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

Examples of combination products may in

have lunch in the cafeteria. Harvey later explained that he thought it was a crazy idea, but he didn’t want to spoil everyone’s fun, especially since his wife and mother-in-law wanted to

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

go. The four of them climbed in an un-air-conditioned Buick and drove 53 miles to Abilene, with temperatures soaring to 104 degrees. After arriving at the cafeteria, they ate a mediocr

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 lunch before heading home. Exhausted, hot and unhappy with the experience, they gratefully crawled into the chairs that dotted the porch.

Only after they returned home did they discov

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

Combination pro

er that none of them had actually wanted to go to Abilene. Harvey’s father-in-law was just making conversation, certain that no one would take him up on his offer. None of the others wa

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

nted to drive that far on dusty roads, but not one of them offered an objection. They each assumed that the others wanted to make the trip.

Does anything about that story sound familiar

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

? Do decisions sometimes get made in your office (or at home) because you make assumptions about what you think other people want?

What kind of a decision maker are you? Have you tak

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

en corporate rabbit trails to Abilene? When you’re sitting in a meeting, do you fail to communicate your desires, your ideas, your beliefs? Do you make assumptions about what you think

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

others want?

Here are 5 tips for developing your decision making skills:

• Gather as much information as you can. Too often we make decisions based on incomplete information. Take the

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

time to really understand the problem or opportunity and be comfortable choosing from your options, or consider waiting.

• Know yourself. Are you the type of person who focuses primari

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

Following aspects would a

ly on the task at hand, or is your focus on the people involved? If you know yourself, you can pull in people with strong points where you are weak.

• Find out other people’s opinions..

dd to the challenges in developing combination products:

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

Professor Harvey’s father-in-law could have been more direct by telling the group what he was thinking. He could also have checked what everyone else thought about the idea.

• Questi

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

on assumptions. Question your own assumptions as well as those of others. Ask yourself what assumptions you’re making about others in the group.

• Learn from your mistakes. Don’t let

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

past mistakes prevent you from being actively involved in making new decisions. Use your mistakes to help you learn more about the advantages and disadvantages of the decision you’re fa

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

cing.

In Peter Senge’s book The Fifth Discipline Fieldbook, he describes a protocol for making decisions mindfully.

1) Pay attention to your intentions. Ask yourself, “What do I want t

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

Professional from academic institutions, pharmaceutical industries, health care indust

o happen?”

2) Balance advocacy with inquiry. Listen to each other’s positions as well as share your own ideas.

3) Build shared meanings of words. Words have different meanings for peo

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

ple. Check the meanings with one another so you don’t walk away with ambiguous understandings of who meant what and who will do what.

4) Use self-awareness as a resource. Ask yourself,

.

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

“What am I thinking? What am I feeling? What do I want at this moment?”

5) Explore impasses. Ask, “What do we agree on and what do we disagree on?” Pinpoint the source of the disagr

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

Companies that provide selfless information through particip

eement.

I hope these ideas will be helpful enough that you won’t take a metaphorical trip to corporate Abilene, but will instead make success your final destination.

© 2005 Julane Borth

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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Machiavelli advocated that a Prince should live in the new territory he has annexed to control the situation on ground and gain respect of the people.

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