Main Subject - Business

Just today my partner Russ and I sat down to hash out a nagging frustration. It took a little bantering back and forth [not without some rise in emotional tension I’ll have you know] until we got at the heart of the issue.

Unmet e

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

xpectations!

Stop and look back at the last time you were frustrated with your life or business partner. Odds are it was because he/she did not meet your expectations.

Expectations of…

Leaving the toilet seat up or dow

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

Examples of combination products may in

Making the bed

Meeting you at the restaurant on time

And so on.

These expectations can be small or large, simple or complex, pertinent or absurd; the point is that somewhere in your head you e

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

xpected something different to happen than what did happen.

So, most every time you find your level of frustration on the rise it is because your partner acted contrary to one of your myriad expectations. Now that you’ve become more o

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

re-aware of this what can you do about it…besides hoot and holler?

The first step is to identify what the expectation is

For example: My husband expects that we arrive at least 15 minutes early for meetings where we are the s

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

Combination pro

peakers, as he likes to greet attendees and take our position behind the podium in a timely manner. When for some reason I get caught talking with someone outside he gets perturbed.

Now before we had a dialog about this and how import

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

nt it is to him I didn’t have a clue. The same holds true for how he and I squeeze the toothpaste!

What are your expectations with your life partner regarding…

Taking out the trash [who does it and when, every day or

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

only when it reeks to high heaven?]

Being intimate

Raising your children

Getting the oil changed

Balancing the check book

Hanging out with members of the opposite sex

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

b>And with your business partner what are your expectations regarding…

Time and effort put forth
Taking time off
Doing the work neither of you much enjoy
And the list goes on.

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

Once you have identified which expectation is being stomped on address it with your partner [when you emotions are in check] and find out what his/her expectations are around the same issue. At times you’ll find that your partner does

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

’t care and readily does it your way, and other times he/she has opposing expectations [like the proverbial squeezing the toothpaste scenario]. If that is the case you have some work to do.

Where do our expectations come from?

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

Following aspects would a

Our expectations generally are spawned during our childhood years. I recall when our daughter was about five years old and she came home from visiting our neighbors rather concerned and said, “Jason’s mommy and daddy are mad and his da

dd to the challenges in developing combination products:

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

ddy went away. Mommies and daddies must stay together.” Her expectation was [and still is now that she is 26 and married] that couples work it out.

Take a moment to reflect on some of your expectations; you might just chuckle about w

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

ere some of them come from. Like the one about the ham…

Mother is teaching her daughter how to cook ham for a holiday dinner. “Mom, why do you cut off the ends of the ham before putting it in the casserole?” Mother stops to think f

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

or a moment then says, “Because that’s how grandma did it.” Fortunately Grandma is visiting and is sitting in the front room reading to her five year old grandson. “Grandma, why do you cut the ends off the ham?” Grandma smiles and sa

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

s, “Why child, because when your mother was young the pan was too small.”

Choose your battles

Depending on the expectation you may want to concede so that in another area your partner will agree to your preference. Determine w

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

Professional from academic institutions, pharmaceutical industries, health care indust

hich expectations are most important to you and which are most important to your partner. Be prepared for some give and take.

Find a better way.

When expectations are in conflict, it is frequently best to sit back and look at

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

hat is best for the situation or the relationship. Who takes out the trash may vary according to work schedule and availability. When to take out the trash may be determined by sanitary concerns. When individual expectations clash th

.

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

e fastest way to resolve the concern is to create a totally new expectation that fits you and your life or business partner best.

If you are a workaholic working 16 hours a day and your partner puts in 8hours you need to look at what y

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

Companies that provide selfless information through particip

ur business demands and set your expectations to line up with your business plan and goals.

In a partnership, life or business, remember that your expectations may need to be realigned so that they work for the good of the relationship

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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