Main Subject - Business

Times of cost cutting and downsizing has dramatically impacted the way employee

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

s look at their careers. Employees at all levels now know better than ever tha

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

Examples of combination products may in

t job security is no longer something they can count on. They've been required

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

to think bigger, look at other options and do whatever it takes to prepare the

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

mselves for the future. In essence, they have let go of their corporate commit

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

Combination pro

ment and become "free agents" in search of the best opportunity available.

"Re

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

tention of talent" has become a key strategy for the largest corporations aroun

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

d the world. Some are looking at things like building new fitness centers. Oth

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

ers have gone deeper and are looking to their leaders to become more competent

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

"retention managers".

Take time now to start talking to your people, really li

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

stening to their responses and taking action to change what needs to be changed

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

Following aspects would a

. Here are a few questions to get you started:

What would make your

dd to the challenges in developing combination products:

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

work more meaningful and satisfying?

What conditions would cause you to s

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

eek employment elsewhere?

What is it that keeps you from seeking other emp

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

loyment?

What changes need to be made in your work environment?

How d

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

o you like to be rewarded and acknowledged for a good job?

What is your gr

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

Professional from academic institutions, pharmaceutical industries, health care indust

eatest challenge or roadblock?

What makes you feel like a valuable contrib

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

utor?

What support, tools/resources, skills or empowerment do you need 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

be more effective?

What strengths or talents do you have that aren't being

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

Companies that provide selfless information through particip

utilized?

What de-motivates you?

What else needs to be asked?

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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