Summary - Relationships

Part of the beauty and the frustration of any partnership is the difference. The different way

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

s your partner and you:

-View the world

-Make decisions

-Respond to stress

-Start a projec

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

Examples of combination products may in

-Squeeze the toothpaste.

Most of the time we see the gifts these differences bring. We appr

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

eciate how they complement our work and/or our life. There are times however, when we just w

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

sh our partner did it "right", namely our way. It's natural to feel like this periodically and

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

Combination pro

there is no great harm in it. After fussing and feuding, giving and taking we get it squared a

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

way and move on.

However, if this feeling [to change and control] gets to be the norm then th

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

relationship is headed for trouble. A vicious cycle of attempted control ensues that leads to

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

nothing but frustration and eventual relationship breakdown.

Here are a few do's and

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

b>don'ts...

- DO pay attention to what's going on with you [are you feeling out of sorts,

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

i.e. stressed, over looked, stepped on, tired, ill, etc.]

- DO revisit how this difference th

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

Following aspects would a

at is now frustrating you was an asset to your relationship in the past

- DO stop and think w

dd to the challenges in developing combination products:

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

y this difference is causing you a problem right now [ask yourself, "What has changed for me?"

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

]

- DON'T immediately see your partner's approach as negative [unless it is blatantly abusive

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

or destructive]

- DON'T jump in and try to control your partner's feelings or actions in publ

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

c [if it is critical that your partner makes changes discuss it in private]

- DO layout a pla

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

Professional from academic institutions, pharmaceutical industries, health care indust

n of approach that has both your best interests at heart

Remember, many relationship adjustme

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

ts begin with ME not THEE.

Most are best worked out together via open and honest dialogue.

<

.

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

i>[Please note: This course of action outlined here does NOT apply to abusive or destructive r

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

Companies that provide selfless information through particip

lationships - both life and business]

Life is too short for strife - resolve it and ENJOY

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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Summary - I Cannot Control Thee, Alas Only Me!

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