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Useful Advices - Business Ethics 101
Sometimes life provides us with character-defining opportunities that remain with us forever. If we're lucky, that is. These events, which occur in both our professional and our personal lives, are significant not for their particulars, but for what they say about who we are and who we are not. It is who we become as a result of the
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
se experiences-not the experiences themselves-that is most important. This is because these "choice points" articulate our values, clarify our character, and define our integrity.
I had one such experience many years ago when I first relocated to Seattle. It's an experience that has stayed with me because it was so profound and bec
I had one such experience many years ago when I first relocated to Seattle. It's an experience that has stayed with me because it was so profound and bec
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
use, to this day, I am still both humbled and humiliated by it. I had had business cards printed, and there was an error. I called the owner of the print shop and she agreed to reprint them right away. But I never returned to the printer. My finances were very tight and I'd decided it was "better" to distribute the "bad" ones rather
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
than pay the several hundred dollars I owed her for the new version.
My tainted integrity nagged at me for more than a year before I finally phoned the woman to apologize. I never got that far. Oh, she remembered me all right. So clearly, in fact, that during our brief conversation she recounted the entire ordeal and then concluded
My tainted integrity nagged at me for more than a year before I finally phoned the woman to apologize. I never got that far. Oh, she remembered me all right. So clearly, in fact, that during our brief conversation she recounted the entire ordeal and then concluded
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
by telling me (with not a trace of anger, I might add): "Now I'm going to hang up because I'm not going to do business with you again." Click.
I remember putting the phone back in the cradle and staring at it, mouth agape, for quite some time. The sting of her words was minor compared to the swell of respect and admiration I felt f
I remember putting the phone back in the cradle and staring at it, mouth agape, for quite some time. The sting of her words was minor compared to the swell of respect and admiration I felt f
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
r this woman who so succinctly, so effortlessly, demonstrated who she was and how she stood in her business. She had no reason to prove herself. She had no need for a well-polished mission statement, a finely crafted public relations summary, or a perfectly rehearsed elevator speech. Her actions neatly defined her. When she hung up,
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
we both knew who she was.
Author and educator Benjamin Shield once said, "We vote with our actions." I would add that it is ultimately our intentions behind those actions, not the actions themselves, that announce to the world whether we are courageous or cowardly, whether we are leaders or merely the boss, and whether we will make
Author and educator Benjamin Shield once said, "We vote with our actions." I would add that it is ultimately our intentions behind those actions, not the actions themselves, that announce to the world whether we are courageous or cowardly, whether we are leaders or merely the boss, and whether we will make
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
a positive impact or simply take up space.
If we're going to "do the right thing" in business, we need to ask ourselves exactly and precisely why we're doing what we're doing-what our intended outcome is. Is it to win, to look good, or maybe to decimate the competition? Or is it to redefine excellence, showcase exceptional skills,
If we're going to "do the right thing" in business, we need to ask ourselves exactly and precisely why we're doing what we're doing-what our intended outcome is. Is it to win, to look good, or maybe to decimate the competition? Or is it to redefine excellence, showcase exceptional skills,
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
r create positive change? Are we trying to prove who we are, or demonstrate it? The former will result in ego-minded banter while the latter will produce camaraderie, pride, and outstanding performance. Doing the right thing requires that we permanently disengage the "autopilot" in our businesses while recommitting to the core value
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
of our decision-making processes.
The ethics scandals that have peppered the papers for the past few years have pitted the "little guy" against the "big, bad corporations." It's easy for us to forget that those corporations are made up of individuals just like you and me. Had I not shared my business card story, then I'd be able t
The ethics scandals that have peppered the papers for the past few years have pitted the "little guy" against the "big, bad corporations." It's easy for us to forget that those corporations are made up of individuals just like you and me. Had I not shared my business card story, then I'd be able t
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
tell you that I'd never do anything like commit insider trading, manipulate my accounting books, or lie to my employees. Of course now you won't believe me. If I could avoid paying a debt, you ask, then what else am I capable of?
Truth be told, it is likely that we are all just one little circumstance away from doing anything. Wit
Truth be told, it is likely that we are all just one little circumstance away from doing anything. Wit
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
h money dangling before us (or a promotion, or a big break, or adulation), it's easy to forget who we are, to discreetly shift the line between right and wrong, and to make some shortsighted decision because the sheer pleasure (joy, greed, ego) of it looks too delicious to pass up. The question is, "Is it the right thing?"
A few we
A few we
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
ks ago one of my coaching clients, a senior executive with one of the country's premier retailers, told me that her company, following an enormously profitable year, decided to distribute raises and bonuses to almost all of its employees. The only people in her group not to receive additional cash were the receptionists-perhaps the
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
eople who needed it most. The reason? Under a technicality the company didn't have to give them the funds.
My client loudly protested this travesty for two reasons: a) it was the wrong thing to do, and b) the bonuses would amount to a whopping total of $6,000-a mere 0.0024% of the company's $250 million budget. But why risk the wra
My client loudly protested this travesty for two reasons: a) it was the wrong thing to do, and b) the bonuses would amount to a whopping total of $6,000-a mere 0.0024% of the company's $250 million budget. But why risk the wra
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
h of her colleagues? Why jeopardize the celebratory climate of the executive offices? Because it's the only thing this leader could do and be able to look at herself in the mirror the next day. Because it was the right thing to do and she knew it. And so do you.
What does doing the right thing have to do with doing business, you as
What does doing the right thing have to do with doing business, you as
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
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
? "Everything," I answer. Doing the right thing defies-no, ignores-the status quo. Unless you have a seriously deteriorated character, you know when you're doing things just because you can vs. because they're the right thing to do.
So what does it take to do the right thing? It takes courage-the ability to do something different,
So what does it take to do the right thing? It takes courage-the ability to do something different,
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
omething outrageous, something that's outstanding. It takes self-trust-the ability to hear and respond to your executive intuition-to lead from the inside out because, to date, your gut reaction has never led you down the wrong path. It takes chutzpah-the ability to jump and earn your stripes on the way down. It takes character-the
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
hing you know you have because you have never, even once, questioned whether or not you do.
So, the choices have been made, the decisions decided, the outcome awaited. Now, how do we know if we've done the right thing? It's simple. It feels good. We're proud of ourselves. Our heads are held a bit higher, our shoulders a bit straigh
So, the choices have been made, the decisions decided, the outcome awaited. Now, how do we know if we've done the right thing? It's simple. It feels good. We're proud of ourselves. Our heads are held a bit higher, our shoulders a bit straigh
.
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
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
er, our step a bit lighter. When we've done the right thing, we offer others explanations, not excuses, for the decisions we've made. When we've done the right thing, we don't get defensive and look for someone else to blame. When we've done the right thing, our minds are free of embarrassment, humiliation, shame, and regret. When w
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
've done the right thing, we don't have to ask ourselves if we've done the right thing. We just know it.
By the way, if you know the printer who taught me that lesson in Business Ethics 101, please tell her how grateful I remain and that I said thank you. Whatever price I paid wasn't enough.
Copyright (c) 2007 Nancy D. Solomon, LL
By the way, if you know the printer who taught me that lesson in Business Ethics 101, please tell her how grateful I remain and that I said thank you. Whatever price I paid wasn't enough.
Copyright (c) 2007 Nancy D. Solomon, LL
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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