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Competent, educated and in prison – I would never have considered that this is where I would be some 11 years ago. But, there are consequences to every choice we

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

make and though one might think that we can avoid the consequences – we can’t. They are unavoidable and certain. We just don’t know how or when we will face the

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

Examples of combination products may in

inevitable.

As a former CPA who, through a series of choices, became a white-collar criminal, I now take the time to review my time in prison and write about that

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

experience so that others may gain benefit from my experience. Some of us learn lessons the hard way. Yet, through sharing the experience of my incarceration, o

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

thers have stated that they’ve been able to look at their choices in a different and more productive way.

While the prison experience was painful, as the followin

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

Combination pro

excerpt from my memoirs shows, it provided a foundation for an incredible opportunity for growth. Likewise, through the prison experience I found numerous ways t

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

help others.

My journal dated - October 6, 1995 reads as follows:

“8:37 a.m. -- Reading this morning brought up feelings of sadness, once again. I understand I

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

'm here to be punished, and being away from my children and the things I hold dear is punishment.

4:00 p.m. -- Its time for mail call and stand up count time. I

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

ive for this time. Being cut off from society is difficult. I hope each day that someone cares enough to send me a letter.

9:40 p.m. -- At dinner tonight I had

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

revelation, I need to talk to high school children and college kids, about the effects of the choices they make. 70% or more of the people here are here for drug

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

related crimes. It's sad to see the educational level of most of the inmates. How can anyone expect to ever break the cycle of poverty and crime, if they don't h

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

Following aspects would a

ave the education to do so? I don't know my role now, but hopefully someday I can make a difference.”

Now, some eleven years later, I find that the personal grow

dd to the challenges in developing combination products:

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

h from the prison experience provided a foundation for help to others. The revelation to speak to high school and college students has manifested through the esta

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

lishment of the Choices Foundation, which provides a forum to educate young people on the effects of the choices they make.

It’s extremely powerful to see and hea

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

r how young people react to the message of choice and consequence. All too often they don’t experience the direct consequence of the choices they make. The detri

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

ent of youth is you haven’t lived long enough to see the link between choice and outcome. Likewise, many youth, other than perhaps those extremely disadvantaged,

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

Professional from academic institutions, pharmaceutical industries, health care indust

ave no connection with anyone who has been incarcerated for their actions. Therefore, being exposed, in a direct way, to someone who has made unethical choices an

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

d faced the consequences, to some is profound.

All too often we find that “ethics” and “ethical choices” dominate our media through new events of what has been do

.

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

e wrong. In order to change our focus, we must create an awareness of what should be done right. Ethics and ethical thoughts must begin with an understanding tha

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

Companies that provide selfless information through particip

one cannot escape the consequences of their personal choices.

For a free report on the five most common corporate ethics violations, 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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Assuming that about half the people in your area use the local YP Internet vehicle versus the print product, you now have only half the potential customers to deal with. What are you planning to do about it?

If you are a job seeker looking for a new challenge, where do you start your search? If you are recruiting in a Niche Market and you chose your consultancy well you should gain access to your key candidate at speed.

Discussion of pharmaceutical sales careers and the different job positions that can be possible. A pharmaceutical sales career is a very rewarding one. Not many other careers offer the same types of perks and benefits along with a fairly high paying job as pharmaceutical sales position. The role of helping well educated health professionals treat their patients better is special indeed. I've even had the pleasure of being introduced to actual patients by some of my doctors. These patients were prescribed on my drugs and the treatments made a big difference in their lives. This is just one of the many intangible benefits of the job.

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