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Digg It - Choices: Lessons from Prison - Consequences from Ethical Choices: A Daily Memoir-October 3rd
With over ten years behind me since I walked into Federal Prison, I can clearly see the effects of the choices we make. We can wander in the illusion of life and think that we have eluded the consequences of our cho
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
ices, but those consequences are inescapable. Whether in our personal life or in business, the choices we make on a daily basis will always have a consequence.
Don’t mistake, however, the word – consequence. Conse
Don’t mistake, however, the word – consequence. Conse
; 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
quence doesn’t carry with it an emotional outcome of good or bad. Consequence is just the outcome. Whether it is good or bad depends on the choice made and how the recipient feels about the consequence. Let me giv
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
you an example from a perspective that looks back over some time.
The day I walked through those prison doors was clearly one of the worst days of my life. I can’t begin to describe how low, unworthy, and valueles
The day I walked through those prison doors was clearly one of the worst days of my life. I can’t begin to describe how low, unworthy, and valueles
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
s I felt as I took on my new identity. I went from being what some folks would describe as “somebody” to being what most would call a “nobody.” I was effectively the lowest of low in our society. Yet, looking back
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
over my life since then, I found that this was one of the most valuable experiences of my life. Not only did I learn many valuable lessons that have been life changing, I’ve also found that sharing these lessons ha
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
e been beneficial to others.
One of the greatest gifts we can give to others is to help them along their journey. Afterall we are souls having a human experience.
The following is my journal from the first day aft
One of the greatest gifts we can give to others is to help them along their journey. Afterall we are souls having a human experience.
The following is my journal from the first day aft
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
er my admission into Federal Prison. Perhaps the insight will help others. Read it and see where it takes you.
October 3, 1995.
I've been here less than 24 hours and understand that I will have time for reflectio
October 3, 1995.
I've been here less than 24 hours and understand that I will have time for reflectio
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
n. I also now appreciate a good mattress! Sleeping on a 4-inch thick plastic mattress stretched across metal bars is not very comfortable. Should I expect more? This is prison.
As a new inmate there is nothing t
As a new inmate there is nothing t
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
do. I need to concern myself with something, but what -- I have no idea. For now, I'm writing to my children. My first letter from prison, and I feel sad. I know will be amazing how much they will grow during my
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
absence. It's clear to me, that no amount of money can replace the loss that I feel right now.
It's been less than 24 hours and I have never had so much time to do what I want and the lack of freedom to do it. Wha
It's been less than 24 hours and I have never had so much time to do what I want and the lack of freedom to do it. Wha
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
t I want is what I can't have.
It's 9:10 p.m. My cellmate, Buck, and I have just had an interesting conversation. It took some time for Buck to ask me what I was in for. Still being concerned about self-preservati
It's 9:10 p.m. My cellmate, Buck, and I have just had an interesting conversation. It took some time for Buck to ask me what I was in for. Still being concerned about self-preservati
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
n, I told him I was a thief. He asked me what I stole? I said, “money.” He asked, “how much?” And a sternly as I could muster a response, I responded, “Is it really important how much?" We both seemed to underst
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
and that we were here, for reasons beyond what appeared on the surface. The amount was irrelevant. What was significant was what we did with the time we were given.
As we experience life daily, know that we are al
As we experience life daily, know that we are al
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
l more than what we seem and that each experience that we encounter in life has a purpose and meaning. We may not know at the moment what the meaning is or what value it brings. Make no mistake, meaning is there, w
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
just have to look deep to find it.
As you read these articles, which include Lessons from Prison, you may find that you want to know more. Two specific results, which came from this experience, are the establishme
As you read these articles, which include Lessons from Prison, you may find that you want to know more. Two specific results, which came from this experience, are the establishme
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
nt of the Choices Foundation, a non-profit organization and a book that will be published in the late spring of 2007 – Success Beyond Illusion. The Choices Foundation funds educational scholarships for underprivileg
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ed youth and speaking to youth in High Schools, Churches and Universities about the effects of the Choices we make. If you would like to schedule a presentation for your organization, contact Chuck Gallagher at www
.
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
huckgallagher.com.
Whether the choice you make deals with your spouse, your family, business associates or people seemingly unknown to you, you do have an impact and your choices do have a consequence. In today’s s
Whether the choice you make deals with your spouse, your family, business associates or people seemingly unknown to you, you do have an impact and your choices do have a consequence. In today’s s
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
ociety we seem bombarded with the effects of ethical choices and are reminded that bad choices = negative consequences. For information on how this message can be shared with your group go to www.chuckgallagher.com
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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