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Rob hangs around when others are talking, always lingers a little after meetings, and just starts talking when people are working. His game is to get people talking whether they want to talk or not.

Once people are talking, he jumps in or says somethi

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

ng like, 'I could not help hearing what you were talking about.' Of course, he could help it. He made a point to hear. Nonetheless, he now expresses his opinion. Whatever the topic, he has an opinion.

His opinion is that things are a mess. He thinks t

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

Examples of combination products may in

hings should be handled better. In fact, the company is going to the dogs. Why? Everyone - except him - is incompetent and does not know what he/she is doing. Adding, 'I have said this before but….' is a master touch.

Here is the key to the technique.

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

If someone asks Rob for his opinion on something, he says, 'I have some strong opinions on this, but I want to hear your ideas first.' Notice he is clear about his having opinions - more than one - on the topic. No matter what the other person says, R

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

b is ready. He has managed to move back to a position from which to react to what others are saying. He is not one to let anyone get him out of position.

Management Tips:

Understanding the motivations of agitators is not too difficult if you look at

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

Combination pro

their behavior and then ask yourself why they are behaving that way. More to the point, what do they get out of it? Their motivations are in the payoff or what they get.

The agitator will say anything no matter who gets hurt or feels badly. What does

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

the player get? He/she gets a cheap moment in the spotlight, even if it is at the expense of a co-worker. Just keep in mind that the player will say anything about anyone, including you.

Agitators also get their kicks from complaining. They are again

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

n the spotlight. Of course, there is always a little more power in that position.

The player makes things seem bad, people seem incompetent, and everything appears worse than it is. The player gets attention, gets a little more power for a little whil

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

e, and is seen as someone who is in the know and on top of things. Experienced players do this in a way that is additive over time. They also take care not to overdo it. They are very good at not giving away their game.

Given the behavior, its varieti

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

es and its motivations, what does counter play look like? Listen to what the agitator has to say and then say, 'You are a trip. You can find more ways to look at things negatively than anyone I know.' The strategy is to call the player on the behavior

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

nd make it clear that you have no interest in what he/she says. There is no power reinforcement for the behavior.

In another example, a player is agitating. She says something negative about someone. The classy response is, 'I am surprised to hear you

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

Following aspects would a

say that. I do not think it is true.' The player will almost always press on with, 'It is true! I….' She goes on to say some more negative things.

Your response is, 'You probably would describe the tooth fairy as a thief.' Now comes the real trick. N

dd to the challenges in developing combination products:

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

o matter what the player says next, do not respond. The game is over.

As with most people who drive you up the wall, the trick to counter play with agitators is to do what needs to be done and then quit. Players of any type or variety can only play wi

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

th people who will play. For agitators, just be sure they get minimal attention and no additional power or status from you. Quietly and calmly call them on their behavior and then let it go. When others do not play, the game gradually stops.

Also when

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

agitating gets started in a group, it tends to be contagious. The play is hard to resist. People who just enjoy small talk - almost always about other people who are not there - inadvertently pick up the behavior. The play becomes a way to get status a

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

nd attention in the group. It works for the agitator so why not for others?

Given the contagion virility of the game, it is important to stop it as quickly and completely as possible.

Locate the most vocal agitator and then do two things. First, priv

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

Professional from academic institutions, pharmaceutical industries, health care indust

ately ask him to tell you what problems he sees or what concerns he has. If necessary, candidly share with him what you have learned he is saying or complaining about. Once the issues are on the table, you and he can go into a problem solving mode.

Ne

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

t, and this is the key, tell him that his agitating behavior is unacceptable. Let him know that you are always available to work on problems but will not tolerate agitating. He will undoubtedly act shocked and deny the behavior. Nonetheless, make your

.

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

point and do not argue with him.

If necessary and after giving problem solving a chance, say to the player, 'This behavior must stop. If not, I will call a meeting of the group. At that time, I will again say to you that your destructive behavior must

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

Companies that provide selfless information through particip

stop. I also will caution your associates not to follow your example.'

This is usually enough. You must not be bluffing, though. It may be necessary for you to follow through, especially with dyed-in-the-wool agitators.

Now you know and there you go

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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