Answers - Business

Losing my job in the last recession of the last century, I discovered first hand the p

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

ower of creating your own luck. A week later, I decided to locate an interim position while I looked for a "real” one. Accepting a temporary position at minimum

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

Examples of combination products may in

age in an industry I knew little about, I decided the way to enjoy the position was to learn everything I could and contribution all that I could. I poured over

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

anuals in my down time, developed processes to expedite the work, trained new employees, volunteered for additional assignments, and did anything that needed to

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

e done. Four weeks into a ten week job, I was unexpectedly offered my first management position.

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

Combination pro

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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

N: 0in 0in 0pt">If I had listened to my friends cautioning me that taking a minimum wage position was career suicide, if I had been conc

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

rned about accepting a job "beneath” my education or experience level, or if I had only done what was expected, I would have missed an opportunity that led to fi

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

e promotions in the next seven years.

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

s=MsoPlainText style="MARGIN: 0in 0in 0pt">It has been my experience over the years, while climbing the corporate ladder to Vice Preside

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

t of a multi-billion dollar company, that opportunity is everywhere and anywhere. Often, it’s in unexpected places for those who differentiate themselves in the

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

Following aspects would a

orkplace. People who do what is expected of them, do it very well, "and then some” have opportunities arise that others never do. And people who set their ego as

dd to the challenges in developing combination products:

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

de, contributing everything they can to the task at hand, often create their own luck. That’s because initiative is a powerful commodity in the workplace.

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

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

ONT face="Courier New">People offering to do extra work only if they get paid for it, or take on extra responsibility only if their salary is increased first, ha

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

e it backwards in my book. My advice: do the work, do it well, and then do it even better. Higher pay, greater responsibilities and increased opportunities follo

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

Professional from academic institutions, pharmaceutical industries, health care indust

individuals who are contributors. Anytime I looked to hire people, offer permanent positions to temporary employees or interns, start up new departments or busi

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

esses, or promote individuals, I looked for people doing their job well ..."and then some.”

.

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

(c) 2004 Nan S. Russell.elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

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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