A paperweight sits on my desk, etched in silver the message: Life isn't always black and white. It serves as a reminder there are
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
few absolutes at work (or in life). Yet, it would be easier if there were; if good ideas from bad, trustworthy people from non-trustworthy, and right paths from the wrong ones could easily be discerned. I've lear
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
ned in twenty years in management that increasing one's perspective increases the grey, as words like always and never become obsolete for describing most situations and most people.
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
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here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
But early in my career, I was convinced there were right ways and wrong ways to do things at work. Of course, my way being right and someone else's wrong. Dug-in positions that at the time
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
seemed immensely important strike me now as limited in knowledge, understanding or perspective.
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
Now, I'm as convinced there are often many ways to accomplish the same goal and many right answers to the same problem. Certainly some ap
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
proaches may be better than others, but whose interpretation defines better? It is a subjective workplace and a matter of judgment if an idea is a good one, a performance rating accurate, or a decision correct. So
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
metimes that interpretation is based on quarterly profits, employee morale, company goals, personal filters, necessity, or a passionate champion embracing a challenge.
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
le="MARGIN: 0in 0in 0pt">
But here's the thing. That subjective element often frustrates us.
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
We think there should be a play book we understand or a standard method to judge an outcome so we can agree whether it's good or bad. Yet we have differing vantage points, information and criteria depending on ou
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
r roles. There may be big picture, long-term, short-term, temporary, personal, best, best of the worst, and a long list of considerations.
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
>
I learned this concept as I debated my boss over a decision he was about to implement. As a Hum
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
an Resources Director, I was concerned the decision would impact morale. HR was the filter by which I judged the world at the time. He gently closed the discussion agreeing with my view point, "Yes, it's true empl
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
oyees will be unhappy. But they'll be unhappier if there are layoffs next year. My job is to make sure everyone has a job."
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
urier New">
Absolute thinking limits perspective, causes mistakes in judgment, misunderstandings, disappoints, conflicts,
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
and frustration in the workplace. Most work issues are not black or white, right or wrong, win or lose. They are varying shades of grey. If you want to be winning at working, you need to adjust your eyes to see mo
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
re grey and adjust your beliefs to understand, for the most part, people are doing what they believe to be right, for reasons they believe are right. If we could stand behind them and see what they see, we might e
.
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
ven come to the same conclusion.
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
ourier New">(c) 2004 Nan S. Russell.
All rights reserved.
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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