Main Subject - Business

There used to be a time when outstanding performance on the job was reinforced, recognized and rewarded by employers. Nowadays

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

, employees are expected to perform “above the line” in terms of their performance. The reward, if any, is the employer’s expe

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

Examples of combination products may in

tation that the employee should be glad to have a job at all. Sounds pretty cynical doesn’t it?

Think about it. Oftenti

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

es, good work is rewarded by more work or not rewarded at all. It’s been shown that the reason why most employees quit their j

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

b has less to do with money and more because they (employees)perceive their sense of value within the organization is not bein

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

Combination pro

recognized.

Doing a good job and building a reputation as being competent at something means that anytime a similar pr

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

ject surfaces within the organization, you are the one being called. Instead of cultivating others, employers continually “go

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

ack to the same well” when it comes to recognizing talent.

Consider also the employer who professes their selection of

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

roject managers is based upon the level to which the employee will be “challenged to grow” by leading the assignment. What a 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

ock! One of the biggest detriments in today’s business practices is the failure of organizations to build in any type of succe

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

sion plan. More often than not, the employee is being selected because the supervisor has too few others to select from. The d

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

Following aspects would a

cision is not based on the right person for the job, but the one who is perceived by the supervisor as being the most availabl

dd to the challenges in developing combination products:

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

(or the one who will do the least amount of damage if things go wrong) is the one often selected. Another basis for selection

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

is the “likeability” factor, which I will deal with at another time.

So what does this mean to the employee who aspires

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

to grow within the organization and to further develop their skills? The answer is: you have to let everyone know your (

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

ositive) results and outcomes. Don’t rely upon anyone other than yourself to keep the real movers-and-shakers within the organ

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

Professional from academic institutions, pharmaceutical industries, health care indust

zation informed of your value. It’s also a good idea to make sure others outside your organization who are in your fie

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

d are also aware of your accomplishments. This can be done by conducting informational interviews, arranging lunches with key

.

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

nfluencers, attending and presenting at meetings and conferences, and brainstorming / collaborating with others.

Rememb

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

Companies that provide selfless information through particip

r: your career is your responsibility. Others may help you along the way, but it’s up to you as to how far you may actually go

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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Main Subject - If You Don't Toot Your Own Horn, Then There's No Music

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