Advice You - Business

When being polite and understanding gets you nowhere, you may be trying to cooperate with a bully. It simply won't work. Yo

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

u must start by giving him a reason to listen to you.

"He didn't refund my money. I've called three times and actually spo

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

Examples of combination products may in

ke to him once, and he agreed that I was entitled to a refund. He explained that his bookkeeper was on vacation and told me

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

she would issue the check when she returned. He has not respond to my emails at all since then and I have sent 5 or them i

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

n the last month. I don't know what I should do now."

After questioning this highly ethical, hard working professional, I

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

Combination pro

learned that the original payment had been made with a credit card.

"Have you thought about reporting the problem to the c

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

redit card company?"

"Oh, I couldn't do that. I don't want to get him into trouble. I would rather resolve the problem wit

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

h him directly."

She was determined to be nice about the situation. It did not occur to her that he apparently had no inte

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

ntion of refunding her money.

My client made the mistake of believing that everyone is as ethical and responsible as she i

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

s. She is using tactics that would work well to resolve a problem if someone asked her for a refund. Those tactics are obvi

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

ously not working here.

It's hard for her to imagine how differently someone else can approach the world. Some people play

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

Following aspects would a

by an entirely different set of rules.

Sharks, opportunists or bullies or whatever you choose to call them just don't car

dd to the challenges in developing combination products:

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

e about cooperating-that is they don't care about playing a game where everybody wins. What they care about is that they wi

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

n. It doesn't matter what happens to anyone else.

If they can manage to avoid you, they have no reason to solve a problem

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

with you-they don't even see it as their problem.

Mathematical research* shows that if you want to win, or at least not lo

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

se, with an opportunist, you must seize the initiative and command attention. Sometimes you need to use tactics that are di

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

Professional from academic institutions, pharmaceutical industries, health care indust

stasteful to you.

Once the bully experiences being confronted, s/he may start to behave cooperatively again. Then your ori

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

ginal tactics may work-but only AFTER the bully has shown evidence of cooperating.

The ethical professional recognized tha

.

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

t this bully had completely ignored her approaches. She decided that complaining to the credit card company might get his a

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

Companies that provide selfless information through particip

ttention and was her best current alternative.

*"The Evolution of Cooperation" Axelrod

Copyright 2006 Laurie Weiss, Ph.D.

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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Building a business is like constructing a house. You want to build your home on a solid foundation and then make it your own by personalizing it with your strengths, maybe interior design, painting or decorating, and outsource the areas that are your weaknesses, perhaps plumbing, roofing or electrical wiring. In the same way you want to build your business around your strengths and where you have weaknesses you should look into outsourcing work. So what areas are you strongest in? What are your business’s strengths? Sometime these two things start off being one and the same, but as you add more to the mix of your business than just you, the business develops its own strengths and the business should be built around those.

Skilled negotiators know that they must lead their opponents toward their goals in order to achieve a viable result. They bring passion to the negotiation to establish their conviction and commitment to the outcome.

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Advice You - You Can't Play Win-Win With A Bully Until

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