Cases - Business

How good are you at standing up for yourself?

Do you run the other way when done an injustice or when someone steps on your proverbial toes?

How do you react?

Now’s the time to s

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

peak up and stand your ground! If you’ve never done this, you need to master this skill.

How many of you watched the “The Apprentice?” While the show is not the ultimate mirror o

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

Examples of combination products may in

corporate life or a guide on how to be promoted, my clients have cited specific show episodes to highlight weaknesses they’d like to improve.

In the “Apprentice” episode during wh

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

ich Jessie was fired, she remained silent in the boardroom while her team members were putting her down. Her reticence was THE reason that Trump fired her. She was timid, and her

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

nability to defend herself made it appear that she agreed with her detractors.

Have you declined to take a stand when you could have? How was that perceived?

Here’s a reality chec

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

Combination pro

for deciding whether or not to speak up:

Fact #1:
If you are silent when others are accusing you or impugning your words or deeds, you run the risk of appearing to agree.<

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

/b>

Fact #2:
If you are silent when someone is making a move into your areas of responsibility, it will seem that you don’t care.

Fact #3:
If you are silent

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

ecause of fear of reprisal or worry about unleashing your temper, you will have lost an opportunity to defend and advance what you believe.

Fact #4:
Not speaking up is

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

worse than making a case but not succeeding.

Here’s how this plays out in the workplace:

If a new co-worker or competitor infringes upon your established area of respo

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

nsibility and you say nothing, you run the risk of losing the business or job! Better to acknowledge the salvo and decide the best course of action.

If it’s a co-worker, you could

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

almly confront the person and re-establish your territory and/or educate him/her on the best way to work with you.

If it’s a competitor, ask your client if the account is in play.

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

Following aspects would a

ou might find that the competitor has put in an unsolicited bid for the business! You could then reinforce your position with the client by underscoring your loyalty to the team a

dd to the challenges in developing combination products:

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

nd how you’ve contributed to its success.

Now for a specific example of the positive results of speaking up:

When I worked in the HR department of a large corporation, my boss, th

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

HR Director, received a poor performance appraisal. After his unsatisfactory review, he proceeded to demean and blame his staff, making snide remarks within earshot of the pers

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

n he was singling out. This went on for several weeks until I couldn’t stand it anymore. I told the VP – HR, and he relocated the Director to another floor for the remainder of hi

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 time with the company.

This experience resulted in the removal of a person who was demoralizing the entire HR department. Further, I was offered the HR Director job on an interim

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

Professional from academic institutions, pharmaceutical industries, health care indust

basis, which became permanent several months later.

More importantly, I believe the VP-HR was impressed with my willingness to take a stand. The assertiveness I demonstrated was

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

trait that he valued and it established my ability to function successfully in a male-dominated department.

Finally, speaking up serves a threefold purpose. It allows you to convi

.

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

ncingly articulate your “case.” It provides a platform to exhibit a quality that your boss may highly prize. And if you succeed, it gives you the confidence to use your newfound

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

Companies that provide selfless information through particip

“voice” in other areas of your life.

The next time you want to speak up, role play your “case” ahead of time with a trusted friend or coach. You may have more to gain than you know

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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Cases - Speak Up: Your Job Is At Stake!

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