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Do you avoid engaging in conversations that might be difficult?

Are you paralyzed at the thought of having to take a stand that would not be received well?

If so, you are not alone.

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

You might wonder why otherwise savvy and smart professionals avoid confrontation like the plague.

Fear.

Fear of embarrassment.

Not wanting to rock the boat.

Or, because they’ve neve

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

Examples of combination products may in

had practice in successfully dealing with confrontation.

Avoiding confrontation certainly affects your entire life.

Let’s focus on how it affects your career…

If you are in a situat

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

ion in your job/career that you’re afraid won’t turn out well — whether it’s about money, project leadership or telling someone you won’t meet a deadline — waiting can make it ten times

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

worse.

First off, if you’re hoping that if you avoid the subject, it’ll go away, you’re wrong. Eventually, these situations come to light and you’ll have made it worse by not bringing

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

Combination pro

it up earlier.

Most bosses hate surprises. How do you think the boss will feel if you delay delivering the bad/difficult news?

The good news is that when you decide to have a conver

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

ation about a topic that could be challenging, you’re the one picking the time and place of the conversation. And you can prepare your “case.”

Oftentimes, when you wait and are confro

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

nted by a question you’re not prepared for, you’ll fumble for an answer and make excuses. In either case, you’ll be on the defensive.

When you’ll miss a deadline…

If you are p

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

oactive, and state your case in a matter-of-fact, confident tone, you’ll be much more likely to see a better outcome and you’ll feel better. Having the courage to face a difficult situa

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

tion head-on builds your self-esteem.

A note of caution: ensure that you have a clear, logical and substantiated case. Develop a fallback position: a course of action that you can su

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

gest to deal with and offset the missed deadline message you’re delivering. Getting into a difficult conversation without a well thought out plan is a recipe for failure.

When you w

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

Following aspects would a

ant a promotion…

One of the areas that women, especially, are reluctant to bring up is what they need to do to get promoted. It harkens back to the sense that if they do a really

dd to the challenges in developing combination products:

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

ood job and get on everyone’s good side, the “God of promotion” will hear them and it will magically happen. Okay, that’s a bit of an exaggeration, but not entirely.

Doing a really go

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

od job and having everyone like you is a simplistic approach. Being personable, establishing good relationships with those above, laterally and below you and doing a good job are just

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

he beginning. To get promoted you must know the specific criteria, skills and needs of your company and how you can answer that need.

Unless you ask and get specific answers to plug t

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

he holes in your background and experience, how can you possibly be a realistic candidate for promotion?

Having the “what do I need to do to be promoted?” conversation with your boss c

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

Professional from academic institutions, pharmaceutical industries, health care indust

n bring up issues of self-worth, rejection and a host of other 3 am-type monsters. However, avoiding the conversation does not get you closer to the insight you need and keeps you stu

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

ck and uninformed.

Instead, choose your time and prepare a script, one in which you start with a positive comment from your last performance review, i.e. “I know you’ve praised my abil

.

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

ty to write terrific copy.” Then follow that with a statement, such as: “I’d like to contribute at even a higher level; what would I need to learn, do, or take on, to make me a viable

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

Companies that provide selfless information through particip

candidate for promotion?”

So, rehearse your script and take it to your boss. You’ll find that asking for what you want and facing your fear of confrontation becomes easier over time

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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