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In any job, as time goes on, it can feel like you are being pulled from every direction. You are doing the best you can and seems like it is still not enough.

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

It’s easy to feel like you are falling behind and will never catch up. And if you do catch up, there will be no keeping up, let alone make time availab

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

Examples of combination products may in

e to truly excel.

It is easy to get overwhelmed with things big and small, lose perspective on what’s important and let the proverbial straw break your back. After the

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

20th email, the tenth phone call, the 4th “IM” and the sixth decision you are asked to make today, it can feel like meltdown-time. At that point, you are not exactly poised to do your b

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

st work…

Some of the best performers I know have thoughts like this under these circumstances:

Am I pulling my weight?

Is this going to impact my performance rating?

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

Combination pro
>Am I going to get fired?
Am I putting myself at risk of getting laid off?

Is my boss going to hold this against me?

Know what success looks like for your position,

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

nd then deliver.

It’s tempting to get caught up in others’, sometime unrealistic, expectations of us. Often we get caught up before we know it. And then we end up running ourselves i

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

nto the ground, or into the hospital, trying to meet all those expectations.

It’s times like this when it’s imperative to simplify. Remind yourself of the baseline
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

ng> for what is expected of your position. Take some time to take a breath and check out whose expectations you are trying to meet and look at them objectively. Only then, with a clearer mind, can you make
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

ong>realistic choices about how you are going to choose to enhance your performance in a way that works for you and your employer.

What’s your job? Boil it down.

When

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

I get particularly overwhelmed with both stated and assumed expectations, I always try to go back to asking myself, “What is the bottom line that I need to deliver?”

Recently I agreed to teach m

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

Following aspects would a

first course to college students. I had lots of experiencing designing and conducting training and facilitation in corporations and thought I had what it took to make this a great experience for everyone, right

dd to the challenges in developing combination products:

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

off the bat. I had all of these grand ideas about what it could be, what I wanted it to be, for me and them both… only to get brought back to reality very quickly. I had to remind myself:

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

ockquote>My job as an instructor is to deliver on the course objectives on the syllabus. I make students aware of the ground-rules and expectations of the class. I use a va

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

riety of ways to familiarize students with the required material so they can have a realistic opportunity to make a passing grade. I test the students on the material required,

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

and return objective, helpful grades and feedback. I deliver thoughtful assessments and final grades at the end of the semester, on time.

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

Professional from academic institutions, pharmaceutical industries, health care indust

Now, these objectives can be met in effective ways, that are either good-enough, or energy-draining. If I have the time and energy to design something more fun or

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

elegant, great. And I’m not suggesting that quality be sacrificed. Putting what’s expected of you in these simple terms helps you be objective 1) when you're stressing and 2) when someone see

.

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

ms to be expecting more.

So, can you describe the core of your job in 100 words or less? Include those adjectives that are important to you and the job, but keep it concise. Think about it a

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

Companies that provide selfless information through particip

if this were the annual objective that would be considered a no-brainer for your job, and you’ll be on your way to a clearer brain in no time.

Copyright 2004-2006, Mary C. Schaefer, all rights reserved

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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