Advice You - Business

Do you feel like one in a million at work – and not in a good way? When you run into your boss in the hallway, do you get the impression she isn’t sure who you a

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

re? Are the juicy projects always going to someone else?

If you answered “yes” to any of these questions, you need to raise your work profile. Here are some tip

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

Examples of combination products may in

s to get you started.

1. Listen more than you talk. If you offer an opinion, suggestion, comment or question at every opportunity, soon people will run away whe

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

n they see you coming. Remember when you were in college and there was always one smart-aleck who, when the class was asked, “Are there any more questions?” woul

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

d shoot his hand in the air and hold the class up? Don’t be that student in the boardroom. If you listen carefully and confine yourself to intelligent and to the

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

Combination pro

-point remarks, you’ll end up looking smarter than most of the people in the room. And when you do have something to say, everyone will listen.

2. Meetings aren

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

’t for airing dirty laundry. If you have a problem or gripe with someone, bring it to his or her attention privately. When you point fingers or air departmental

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

problems in a group setting, you (a) blindside the person you’re complaining about, and (b) have just about ruined your chances for a peaceful resolution. Beside

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

s, the next time you make a mistake, that person will fall all over himself to make sure to bring it up in a large meeting just to watch you squirm.

3. Try to c

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

atch people doing something right. Whether boss, co-worker or subordinate, people love to be told they’re doing a good job. You don’t have to turn into Eddie Has

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

kell to be aware of opportunities to compliment someone. Keep it short, low-key and honest. It’s even better if you can pass the compliment to someone else. “Hey

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

Following aspects would a

, boss, Jim was a huge help to us on the Acme project – he made some suggestions that should save us $20,000.” What are the chances that the boss is going to men

dd to the challenges in developing combination products:

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

tion it to Jim the next time he sees him? Pretty good.

4. Know when to hold ‘em and know when to fold ‘em. Pick your battles. If you’ve made the best case you c

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

an for doing something a certain way and the boss decides to do it Sally’s way, smile and go along (unless doing it Sally’s way is going to send you to jail). If

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

your way really is better, people will remember that when Sally folds like a cheap card table. When you do decide to keep fighting to do it your way, make sure

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

it’s something worth fighting for and not just because you can’t stand to lose. If you only start a war when the stakes are high you have a better chance of comi

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

Professional from academic institutions, pharmaceutical industries, health care indust

ng out on top than if you try to fight every low-level skirmish like Sherman going through Atlanta.

5. Don’t hide your mistakes. As soon as it becomes apparent

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

that something has gone wrong, take it to your boss and be upfront about what happened. Have a plan laid out to correct the problem and limit the fallout. You sh

.

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

ould be able to tell the boss that you’ve already put the recovery in motion and exactly what the final outcome will be. The key here is to accept the blame with

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

Companies that provide selfless information through particip

out hand wringing or whining and pointing fingers at your subordinates or other departments. You take the responsibility, and then you take the lead in fixing it

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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