Cases - Business

At some point in every professional or managerial career, there is a t

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

ime when one start thinking: Is it time to move on or do something el

; 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? However, before you quit your job and take a fling at something el

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

se, realistically evaluate your career and potential options by asking

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

yourself these ten career success questions:

Do I really li

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

Combination pro

e my work or am I hanging on marking time?

Am I promotable o

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

r am I seen as a disposable commodity?

Am I visible to poten

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

ial employers, as well as my current boss?

Am I growing or s

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

agnating or just standing still waiting for the next wave of change?

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

l1>

How smooth are my interpersonal relationships with my boss a

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

d co-workers?

Am I being rewarded at my true worth?

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

Following aspects would a

i>Have I recently checked out my value in the marketplace?

dd to the challenges in developing combination products:

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

ow valued and diversified are my skills and competencies?

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

can I distinguish myself from competitors?

What will it tak

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

to get where I want to go from the place I am right now?

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

While setting distinct goals is a critical factor in career advanceme

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

Professional from academic institutions, pharmaceutical industries, health care indust

t, remaining flexible is important too. Climbing the career ladder wi

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

h blinders on could mean missed opportunity. Career success involves

.

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

staying open, staying flexible and making sure you’re using your tale

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

Companies that provide selfless information through particip

ts to the fullest. Remember, control your destiny or someone else will

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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