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Have you ever had the client from hell? The one who has been with you for some time, maybe from the beginning, that every time you do a project for them they put you through so much

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

grief that you feel like taking a flying leap from the top of a freeway overpass?

Well my friend, DON'T JUMP - FIRE THAT CLIENT!

It may sound like an unusual bit of advice, fire

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

Examples of combination products may in

a client, but let's take a look at what a very difficult client does to our business.

I know you are saying, but I make a lot of money from that guy - hang on there is an alternati

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

ve.

Yesterday I was working with a guy who was working on a project for a client. During the time I was there he received at least four calls with the client asking him to change t

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

his and tweak that. Each time he got off of the phone, he let fly with a tirade of reasons why this client was a pain in the neck.

So I asked him. "Well, why not fire that client?"

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

Combination pro

He looked at me as if I were crazy. He began to say that he had been with this guy for three years and blah, blah, blah. So I told him the following:

Look, you said that each proj

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

ect you work on with this client is a three hour project that turns into a three day project because of changes and follow up and approvals and the like. In three days I am guessing

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

that you could complete nine projects of the same size and value. Not only that, each time that phone rings, your stress level goes through the roof, so you have to re-adjust after

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

each call before you can even make the changes.

To which he replied:

Well, I know that this guy is a sure thing and will give me business every month. There have been times when

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

that business was there when I did not have any other stuff going on.

So I said:

OK then, if you do not want to fire the client, it is time to change the terms of the working rela

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

tionship. You could instead write or re-write a contract that states that after a specified amount of change that each additional change will incur an additional charge. At least th

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

Following aspects would a

en you would be compensated for the extra stress to a degree.

He agreed that he might need to do that. He said however, to present this client with a contract after three years wou

dd to the challenges in developing combination products:

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

ld not be acceptable. They had worked all of this time without one.

So my final answer was this:

You are faced with a decision of three items.

Item One: Fire the Client or contin

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

ue to go through the stress that it brings to continue to work with him.

Item Two: Re-define the relationship through contractual agreement that at least compensates you for the ex

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

tra time and grief

or

Item Three: Adjust your attitude to accept this client for the evil person that he is. Realize that no matter how stressed you get, he will not change. Feel

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

pity for him and each time the phone rings with yet another change, say to yourself " I am smart, I am good-looking, and people like me for who I am."

So I ask you, informed reader

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

Professional from academic institutions, pharmaceutical industries, health care indust

, which of those options would you choose?

In our world today, opportunity is everywhere. It is true that there will always be difficult clients, the question remains - if they bec

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

ome too difficult is it cost effective to keep working with them? I suggest that you look at your client list and ask youself is there someone on it whose time has come? If the answ

.

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

er to those questions is yes, then do the right thing and let them go.

I guarantee that your competitor is out there waiting to call on them and do some work for them, and while th

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

Companies that provide selfless information through particip

ey are dealing with all of the stress and issues, you have an opportunity to pitch the clients that they no longer are able to serve while they deal with their new client from hell.

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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