Advice You - Business

In today’s fast paced world there are few people that are enjoying prosperity. I mean true prosperity. I am talking about those people who wake up when they are done sleeping. They are people who can go on a vacation whenever they want to. Peopl

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

e who when they shop for a car, they go with the intention of buying a new Ferrari or Porsche. 95 % of the people in this country do not have that kind of lifestyle. Most will fall in to one of the categories below. See which one you fit into, a

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

Examples of combination products may in

d if you fit into category 3, then congratulations you are truly prosperous.

Group 1- People with No Financial Security

Most people are working harder for less real money. Many are living paycheck-to-paycheck just be able to rent movies for th

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

weekend until Monday rolls around so they can grind out another week. Some may even be working 2 or 3 jobs just to make ends meet. Corporate layoffs, downsizing, corporate accounting scandals are abundant. The cost of benefits and cost of livin

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

go up faster then your annual raise, and in 90% of the cases the cost of living increase is higher than your raise. That’s not progress, that’s a lack mindset. Think to yourself, where will I be in my current job in 20 years. Will I have the fi

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

Combination pro

ancial security I need to provide for my retirement? The United States has record year after record year of personal bankruptcies. We have the highest consumer debt & lowest personal savings in history. The majorities are in credit card prison.

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

he social security benefits are dwindling every year. You may be used to living on $25,000 a year only to find out at retirement that you must now subsist on $600 or $700 a month. The Government cannot realistically provide for your retirement,

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

edicare has been changing drastically just in the last 2 years.

Group 2 -People Winning the Rat Race, but Living Like Rats

These are people with high incomes, but are still trading hours for money. Many still are paying someone else to raise t

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

eir children. This lifestyle has a high toll on marriage and relationships. Some of these people may appear to be living their Dream Lifestyle. They have a great income, but don’t have time or freedom to enjoy what they are putting in 60 hours a

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

week for. I was one of those people; I worked in a Level One Trauma Center, working many 60 or 70-hour weeks. Never seeing my wife, never enjoying my time off because all of my free time was spent doing chores. I worked so much that my friends s

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

opped calling me, as I was never around to meet with them. I hadn’t been on a vacation for nearly 3 years, always being told, “We can’t do without you for 2 weeks, we need you here, we are short staffed.” or any number of other excuses. Now what

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

Following aspects would a

if there were a business that could offer you an escape from these last 2 categories. How much would it be worth to you? Can you see the opportunity, if there was a business that offered people lifestyle, residual income, and freedom from the R

dd to the challenges in developing combination products:

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

t Race?

Group 3 – People Living Their Dream Lifestyle

We all have dreams, many of us had a belief as children that we would be doing something different or living a different way. There are about 5% of the people in this category. They are liv

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

ng their dreams, driving their dream car, or living in the home they always wanted. Not worrying day to day whether they will be out of a job the next day. These are the truly prosperous people. You see them from time to time driving their new V

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

per or Mercedes 500. You see them on the lake in huge yachts and fancy boats pulling up to their dock on the lake. Which is of course attached to their $800,000 summer home on the lake. They never lost their dream and it wasn’t luck or inheritan

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 that got 99% of them to that position. It was their own personal belief system, and confidence that they could do it.

If you find yourself in one of the first two groups, it is highly advisable that you do something now to change it. I was in

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

Professional from academic institutions, pharmaceutical industries, health care indust

group 2, realizing this I did what many of you are now thinking about doing. I opened a home business. Opening a home business for me was the answer to my problems of time and freedom. It afforded me the opportunity to work with people who I wan

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

ed to work with. It gave me tax benefits beyond anything I could find at a traditional job. I could work it part time. It was a minimal investment with a huge possible return. I have travel opportunities that my business pays for. The best part

.

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

owever is that it is Residual Income, which means that I don’t have to trade my hours for an even trade of money. My business is in 41 countries and 24 time zones. I get paid even while I am sleeping. Now that is living…If your contemplating a h

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

Companies that provide selfless information through particip

me based business for yourself, I would only advise one thing. Find out “Why” you want a home based business and then just do it. If your why is because you fall into one of the first two categories, then do something quickly before its too late

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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This practical article is for people who take minutes in meetings of any size and any type. It re-focuses your thinking on minutes from traditional narrative minutes to modern business oriented and results oriented minutes. The article is also very useful for people who chair modern meetings and people who attend them as well.

Unless companies adopt an holistic approach to security that focuses on building and fostering a culture of honesty and integrity, GAP's will appear in their defenses and in their ability to perform their mission; selling their products and services. Once GAP's are exposed, they can be exploited for the personal gain of the individual(s) exposing them.

Power Teams work well when there is an element of trust and integrity. Holding the information for a project is certainly one of those areas where trust is prominent.

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Advice You - 3 Groups of People in the World

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