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How many times have you sat in a conference room listening to your fearless leader drone on about one initiative or another and you wonder who put this bozo in charge? How many times have 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 walked by the guy who is perched up at his desk gloating over his latest promotion and you think someone put this bozo in charge?

Well, you are not alone. Many people who work in organiza

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

Examples of combination products may in

tions where the hierarchy is very organized can pick out quite a few characters who they think would be better off shoveling hay than leading any sort of team. As onlookers we tend to be rather cri

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

tical of others flaws and in many cases see us much more suited to the job than they are. After all, we went to a better school, had a better internship, have worked here longer, and are all around

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

a more likable person right?

But, if you really step back and look at what these bozos are doing and then do a comprehensive audit of yourself, you may find the reasons a bit more clear. So, if y

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

Combination pro

ou are one of those people who think your position in your company is someone else's fault or that someone else is to blame for the fact that you are not where you wanted to be, then I recommend ta

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

king the following steps to getting where you want to be.

1. Assess the big picture. Do you really like your job? The Company? Is your discontent over the fact that you are not where you wa

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

nt to be in the company or that you would really rather not be in the company at all? (If that is the case, you may have a lot more work to do) If you could have any position in the company, what w

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

ould it be? What qualities do you think a person in that position would need to be successful at the job? What type of person would you have to be to be able to do that job? Figure out exactly what

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

you want and then determine what it would take to achieve it.

2. Tell your managers or supervisors. A lot of times people are afraid to tell their managers or their boss that they have the

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

r sights set on greater things within the company. Perhaps you feel intimidated or you think your supervisor doesn't like you so you could be sabotaging your own efforts in the long run. If that is

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

Following aspects would a

the case, then choose someone else. Assess the company and determine what value you could add. Without sounding like you have all of the answers, present your ideas to a decision maker and tell th

dd to the challenges in developing combination products:

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

em what your goals are. Do not sit back and wait for them to notice you. Do something that is worth noticing and make your aspirations clear.

3. Stop worrying about what others are doing. O

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

ne of the most common complaints I hear from people working in office settings is that "so and so did such and such, and then I couldn't do what I was supposed do" etc. You can never control other

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

people but you can decide not to give them the energy and instead focus on what you are doing. Think about what you want and what you need to do to get there. That does not mean that you step on ev

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

eryone's toes to get there. It just means that you take responsibility for your own direction and do not let someone else decide for you. As long as their are offices there will be office politics.

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

Professional from academic institutions, pharmaceutical industries, health care indust

You have two choices - you can either focus on your work and stay true to your goal or if you can't do your work and you really hate it, get out of there.

4. Clarify your values. If you ar

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

e not able to express your most important values through your day to day work, eventually it is going to get to you. What is important to you? What values are so important that you MUST be able to

.

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

fulfill them at work. Figure out a way to do so if you are not. It can be the difference between misery and job satisfaction.

All of us have worked with people we think have no business being in p

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

Companies that provide selfless information through particip

ositions of leadership but it is a waste of out talent and energy to worry about them. If you see something you don't like, think about how you can make it better and then get busy making it better

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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