Advice You - Business

Curt and Justin were lifelong fishing buddies. Now, in their retirement, they had together taken up the art of do-it-yourself home-improvers. Curt decided to tackle wallpapering his living room. When he finished the job, he proudly called his friend over to see his handiwork. Justin

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

was very impressed. In fact, he liked it so much, he asked his buddy if he would mind if he got the same wallpaper for his living room. Their homes were practically identical in size and layout. Curt thought that was a great idea. So Justin asked him how many rolls of wallpaper he

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

Examples of combination products may in

bought for the job. Seven was the reply.

Justin went right to work and when he finished, called his buddy over to his house. “Ah, man, that looks really good”, said Curt. Then Justin said to his friend: “But you know, Curt, it’s a funny thing; our living rooms are the same size, bu

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

t I had two rolls of wallpaper left over! How come that?” To which Curt replied: “You, too? That’s exactly what I had left over!”

Poor Justin; he asked his friend the wrong question. What he should have asked was not how many rolls of wallpaper Curt bought for the job, but how many

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

rolls of wallpaper he had to use for the job.

Knowing the right questions to ask can have a dramatic effect on our success. Not having good information or not getting the answers we need in doing our jobs can make all the difference in the world. What is hard to realize is that th

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

Combination pro

is is often of our own doing. How many times have you been surprised to learn of a turn of events and then asked your employees “Why didn’t you tell me that?” only to have them reply “You didn’t ask me.” Since it is illegal to strangle them when they say something like that, the bes

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

t course is to figure out how to avoid such communication traps.

The secret weapon of power negotiators is being skilled in asking questions. Why? One of the reasons is that questions get the communication going and encourages the other party to talk, to share information with you.

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

And what you are always, always looking for is information, particularly something you do not know. Even when you think you know the answers, get in the habit of asking questions; at the least, it will confirm your knowledge. And if you have somehow missed asking the really right q

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

uestion, the answer you need will likely come out the more the other party is forced to talk and you are talking less.

Of course, we are not talking here about hard interrogation. There is a difference between asking relevant questions and the demanding, rat-a-tat-tat fire of inter

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

rogation, as if you were the chief of police. Such action can rank anywhere from offensive to intimidating. And you don’t want to put people on the defensive. Asking a question like “How could you possibly have made that mistake?” will solve nothing. The person will just feel compel

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

led to defend his actions. Something like “What do we need to do to avoid this happening again?” is more likely to get you the answers you need. Your goal is to make sure people are comfortable about opening up and communicating with you.

Train yourself to ask open-ended questions,

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

Following aspects would a

ones that can not be answered by just yes or no, but that require longer, more expansive answers. Questions that begin with Why or What or Who will tend to elicit more communication. And you will have more chance of getting all the information you need.

I have a question I try to

dd to the challenges in developing combination products:

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

remember to ask every time an associate discusses a situation with me. At the end of our discussion, I ask: “Is there anything else I need to know?” Or it may take the form of “Is there anything else we need to discuss?” It is the words “anything else” that are important here. Once

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

asked, I pause and wait for a reply. That is my fair warning of their obligation and their opportunity to tell me everything that is relevant to this situation. No surprises later. So get in the habit of performing this little routine. You will have fewer surprises and no one will e

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

ver again be able to hide behind the cloak of “well, you didn’t ask me” or “I didn’t know you wanted to know.”

Sometimes we don’t get the answers we need because we don’t listen. Learn to be a good listener. Be sensitive to the possibility that you may be asking your associates the

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

right questions, but not listening to them when they try to answer. Or maybe you are so fast and sure in your own thought process, that you interrupt and don’t give them the opportunity to finish what they are saying before you jump in. Or you finish their answer for them. Curb the

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

Professional from academic institutions, pharmaceutical industries, health care indust

se tendencies.

Listening is not passive; a good listener can take complete control of an exchange between people. When you listen well, you earn the trust of others. People come to you with their problems, and their opportunities, when they feel they can trust you to listen.

Your

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

ears may be the receptor for the sounds you hear when you are listening, but something else about you is equally important: your eyes. If you are not making good eye contact or are continually busy moving around, the other person will not “feel” listened to. They will know they have

.

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

not really been heard. Look directly at the person the whole time they are talking. If it is a particularly long dissertation, you can look away or look down to jot a note, but only for a second before looking right back at them. When you don’t maintain this direct eye focus, the p

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

Companies that provide selfless information through particip

erson will feel that you don’t think what they have to say is valuable to you anyway, so why bother fully answering your questions or coming to you with information.

Having good information is critical in business today. It’s yours for the (right) asking!

Copyright 2006, Liz Tahir

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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