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E-Folder - Entrepreneurship - Do You Have What It Takes?
Fully one in ten adults in the United States today is an entrepreneur.
This phenomenon is by no means restricted to North America. The
leading country for entrepreneurship is Brazil with one in eight adults
an entrepreneur. Australia is not far behind the U.S. with one in twelve.
These countries - Brazil, the United States and Australia - lead the
way. Contrast, for example, Germany (one in 25), the United Kingdom
(one in 33), Finland and Sweden (one in 50) and Ireland and Japan
(less than one in 100). (Source: Global Entrepreneurship Monitor
2000.)
ENTREPRENEURSHI
ENTREPRENEURSHI
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
P DEFINED
The Global Entrepreneurship Monitor 1999 defined entrepreneurship as "any attempt at new business or new venture creation, such as self-employment, a new business organization, or the expansion of an existing business, by an individual, a team of individuals, or an established business."
ENTREPRENEURIAL ACTIVITY - AN HISTORICAL PERSPECTIVE
Entrepreneurship is a major contributing factor to the economic well-being of a country both in terms of economic growth and job creation. Traditionally, entrepreneurial ability tended to focus on the following four attribut
The Global Entrepreneurship Monitor 1999 defined entrepreneurship as "any attempt at new business or new venture creation, such as self-employment, a new business organization, or the expansion of an existing business, by an individual, a team of individuals, or an established business."
ENTREPRENEURIAL ACTIVITY - AN HISTORICAL PERSPECTIVE
Entrepreneurship is a major contributing factor to the economic well-being of a country both in terms of economic growth and job creation. Traditionally, entrepreneurial ability tended to focus on the following four attribut
; 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
es:
=> Initiative - the entrepreneur takes the initiative to bring together the economic resources of land, labor and capital to produce a commodity (whether a good or a service) with the hope that such production will create a profitable business venture.
=> Decision-making - the entrepreneur makes the basic business policy decisions for the business, thereby setting the course of the enterprise.
=> Innovation - the entrepreneur is an innovator, attempting to introduce new products and new ways of doing things.
=> Risk-taker - the entrepreneur risks his or her time, eff
=> Initiative - the entrepreneur takes the initiative to bring together the economic resources of land, labor and capital to produce a commodity (whether a good or a service) with the hope that such production will create a profitable business venture.
=> Decision-making - the entrepreneur makes the basic business policy decisions for the business, thereby setting the course of the enterprise.
=> Innovation - the entrepreneur is an innovator, attempting to introduce new products and new ways of doing things.
=> Risk-taker - the entrepreneur risks his or her time, eff
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ort,
business reputation and invested funds in the entrepreneurial
venture.
THE MODERN ENTREPRENEUR
Until recently, the above attributes, especially innovation and risk-taking, were the dominant factors that defined the characteristics of those who chose to become entrepreneurs.
Now, however, with corporate downsizing being a fact of life, many entrepreneurs find themselves thrust into the role by default.
The question for anyone either finding themselves in this position involuntarily or thinking about leaving corporate life for the heady world of entrepreneurship
THE MODERN ENTREPRENEUR
Until recently, the above attributes, especially innovation and risk-taking, were the dominant factors that defined the characteristics of those who chose to become entrepreneurs.
Now, however, with corporate downsizing being a fact of life, many entrepreneurs find themselves thrust into the role by default.
The question for anyone either finding themselves in this position involuntarily or thinking about leaving corporate life for the heady world of entrepreneurship
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 whether you have what it takes to be
successful ... the "right stuff" in other words. Some people do, in
spades. Others simply don't. If you're one of the ones who just
doesn't, either resign yourself to working for someone else or
cultivate in yourself the qualities that successful entrepreneurs
share. Believe it or not, entrepreneurs are not just "born". Well,
some, of course, seem to be natural-born entrepreneurs, but
for the rest of us, the qualities of entrepreneurship can definitely
be acquired by hard work and application.
COMMON ISSUES
The "common denomin
COMMON ISSUES
The "common denomin
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ator" issues facing all entrepreneurs
are planning, finance and implementation.
=> Planning
All entrepreneurs face the challenge of starting a new business, be it through innovation (inventing something new or doing something a different way), finding the right opportunity to get into, or buying a franchise. Whichever road you choose, it will involve serious planning.
=> Financing
Unless you have ready funds at your disposal, getting finance is the next major challenge and cannot be attempted until your business plan is in place. You will need to prepare funding pr
=> Planning
All entrepreneurs face the challenge of starting a new business, be it through innovation (inventing something new or doing something a different way), finding the right opportunity to get into, or buying a franchise. Whichever road you choose, it will involve serious planning.
=> Financing
Unless you have ready funds at your disposal, getting finance is the next major challenge and cannot be attempted until your business plan is in place. You will need to prepare funding pr
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
oposals and applications for loans, venture capital,
and funds from angel investors.
=> Implementation
This is make or break time. Many people think just getting started is the hard part - and it is hard. But where many businesses stumble is not in the planning and financing stages but in implementing their business plan. Why this is so is not certain. There are various hypotheses including the idea that ideas people and implementation people are two very different breeds and it is highly unusual to find one person who can do both. More likely though, is the simple
=> Implementation
This is make or break time. Many people think just getting started is the hard part - and it is hard. But where many businesses stumble is not in the planning and financing stages but in implementing their business plan. Why this is so is not certain. There are various hypotheses including the idea that ideas people and implementation people are two very different breeds and it is highly unusual to find one person who can do both. More likely though, is the simple
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
fact that
implementation requires such a broad range of skills that
no one person can possibly be adept at all of them.
The real challenge and skill of the entrepreneur, then, is to recognize what you do well and then appoint employees or subcontractors to do the rest. Of course, if you're running a business on a shoestring, this simply may not be possible! So be brutally honest and objective in assessing your particular strengths and weaknesses BEFORE you cash in your day job and your 401K.
The areas to think about in terms of implementation are the same as those enc
The real challenge and skill of the entrepreneur, then, is to recognize what you do well and then appoint employees or subcontractors to do the rest. Of course, if you're running a business on a shoestring, this simply may not be possible! So be brutally honest and objective in assessing your particular strengths and weaknesses BEFORE you cash in your day job and your 401K.
The areas to think about in terms of implementation are the same as those enc
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
mpassed by a broad definition of
management: promotion (marketing and advertising), public
relations, sales, employees, communications, legal issues,
plant and equipment, risk management, disaster planning,
crisis management, insurance, technology, computer systems,
taxes, bookkeeping, finance, and the internet.
PERSONAL QUALITIES
Equally important as the common issues shared by all entrepreneurs are the personal qualities of the entrepreneur him or herself. To start you thinking about whether you have the right stuff to make a success of an entrepreneurial ventur
PERSONAL QUALITIES
Equally important as the common issues shared by all entrepreneurs are the personal qualities of the entrepreneur him or herself. To start you thinking about whether you have the right stuff to make a success of an entrepreneurial ventur
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
e, here's a list of character traits and work ethics
common to successful entrepreneurs. Although it is not
necessary that you possess all of them, you should possess
most:
=> Passion - entrepreneurs have a strong passion for their idea or concept, so much so that their work is their play. If you don't like what you do, you won't stick it out when challenges come along, as they inevitably will.
=> Curiosity - entrepreneurs need to understand how things work. They ask a lot of questions. Curiosity therefore triggers innovation.
=> Sponges - entrepreneurs are sponges
=> Passion - entrepreneurs have a strong passion for their idea or concept, so much so that their work is their play. If you don't like what you do, you won't stick it out when challenges come along, as they inevitably will.
=> Curiosity - entrepreneurs need to understand how things work. They ask a lot of questions. Curiosity therefore triggers innovation.
=> Sponges - entrepreneurs are sponges
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
. They devour
information about their industry and are always current on
new and emerging trends and technologies, not only in
their specific industry but in closely related industries. This
habit of scanning their environment is a rich source of
discovery of new opportunities. Entrepreneurs are ALWAYS
looking for new markets, applications, products or twists on
an old concept.
=> Optimism - entrepreneurs think of problems as opportunities for improvements and new ideas.
=> Forward looking - entrepreneurs are never satisfied with the status quo and are always proact
=> Optimism - entrepreneurs think of problems as opportunities for improvements and new ideas.
=> Forward looking - entrepreneurs are never satisfied with the status quo and are always proact
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
ively carving out their future.
=> Careful about money - entrepreneurs are careful with money and have a firm grasp on what things cost and their value to the business. This allows them to recognize a true bargain when they see one.
=> Started earning at a young age - entrepreneurs commonly displayed entrepreneurial leanings as a teenager seeking out entrepreneurial activities such as babysitting, lawnmowing and lemonade stands.
=> Competitive - entrepreneurs are naturally competitive and don't let the grass grow under their feet.
=> Time conscious - entrepreneurs know
=> Careful about money - entrepreneurs are careful with money and have a firm grasp on what things cost and their value to the business. This allows them to recognize a true bargain when they see one.
=> Started earning at a young age - entrepreneurs commonly displayed entrepreneurial leanings as a teenager seeking out entrepreneurial activities such as babysitting, lawnmowing and lemonade stands.
=> Competitive - entrepreneurs are naturally competitive and don't let the grass grow under their feet.
=> Time conscious - entrepreneurs know
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
he value of time and
how to make the best use of it. You won't find entrepreneurs
spending much time on nonproductive activities. That said,
entrepreneurs typically also recognize the value of downtime and
time with family and will factor these activities into their schedule.
=> Risk takers - entrepreneurs are not afraid of taking calculated risks. They typically trust their hunches and act on them.
=> Usually loners - entrepreneurs generally prefer a solitary work environment as opposed to teamwork.
=> Professional - entrepreneurs are professional in their approach
=> Risk takers - entrepreneurs are not afraid of taking calculated risks. They typically trust their hunches and act on them.
=> Usually loners - entrepreneurs generally prefer a solitary work environment as opposed to teamwork.
=> Professional - entrepreneurs are professional in their approach
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
to work. They operate as they would in a corporate environment
and don't allow themselves to be distracted by outside influences.
=> High energy - entrepreneurs have a plan and a vision and they work it. Entrepreneurs are often health-conscious too, recognizing that the fitter they are, the better their minds work. So entrepreneurs will take time from their schedule to work out and eat well.
=> Flexible - entrepreneurs are nothing if not responsive to change. Although they appreciate the importance of having a plan and working that plan, they allow themselves room
=> High energy - entrepreneurs have a plan and a vision and they work it. Entrepreneurs are often health-conscious too, recognizing that the fitter they are, the better their minds work. So entrepreneurs will take time from their schedule to work out and eat well.
=> Flexible - entrepreneurs are nothing if not responsive to change. Although they appreciate the importance of having a plan and working that plan, they allow themselves room
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
to react and respond to
opportunities that may suddenly reveal themselves.
=> Nurture entrepreneurial spirit - entrepreneurs seek out and nurture the entrepreneurial spirit in their employees and reward them accordingly.
=> Confident goal-setters - entrepreneurs are confident and set long-term goals, both for themselves personally and their businesses. They view money and financial security as a measure of accomplishment and a source of peace of mind.
=> Persistent - entrepreneurs never give up. They persist until they succeed.
=> Learn from failure - entrepreneurs
=> Nurture entrepreneurial spirit - entrepreneurs seek out and nurture the entrepreneurial spirit in their employees and reward them accordingly.
=> Confident goal-setters - entrepreneurs are confident and set long-term goals, both for themselves personally and their businesses. They view money and financial security as a measure of accomplishment and a source of peace of mind.
=> Persistent - entrepreneurs never give up. They persist until they succeed.
=> Learn from failure - entrepreneurs
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
learn from their failures and those
of others. Failure to an entrepreneur is nothing more than an opportunity
waiting to be discovered.
=> Self responsibility - entrepreneurs take the initiative and personal responsibility for their success or failure (which is always a merely temporary state).
=> Resource utilization - entrepreneurs utilize ALL of their available resources.
=> Internal locus of control - entrepreneurs don't believe in luck. They firmly believe that success and failure lies within their personal control or influence.
THE FUTURE OF ENTREPRENEURSHIP
As
=> Self responsibility - entrepreneurs take the initiative and personal responsibility for their success or failure (which is always a merely temporary state).
=> Resource utilization - entrepreneurs utilize ALL of their available resources.
=> Internal locus of control - entrepreneurs don't believe in luck. They firmly believe that success and failure lies within their personal control or influence.
THE FUTURE OF ENTREPRENEURSHIP
As
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
e all know, increasing numbers of people are electing to work
from home either through telecommuting or running home businesses.
While this trend has commonly been attributed to the growth in the
number of working women wanting to be home for their children, over
half of all people now working from home are men.
A recent Purdue University study concluded a number of factors seem to favor continued high rates of new firm formation:
1. Continuing high rates of change (change creates opportunities for new firms).
2. Continued growth of the service sector (the highest
A recent Purdue University study concluded a number of factors seem to favor continued high rates of new firm formation:
1. Continuing high rates of change (change creates opportunities for new firms).
2. Continued growth of the service sector (the highest
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
growth area for
new firm formation).
3. Increasing number of virtual corporations in which firms outsource their functions, creating opportunities for entrepreneurs.
4. Positive climate for small business - a general perception that small business is a positive influence on the economic wellbeing of the country giving entrepreneurs legitimacy and respect.
5. Growth in international business opportunities.
With the traditional corporate-employment track seemingly on the decline, the trend of forming strategic alliances with other businesses that are closel
3. Increasing number of virtual corporations in which firms outsource their functions, creating opportunities for entrepreneurs.
4. Positive climate for small business - a general perception that small business is a positive influence on the economic wellbeing of the country giving entrepreneurs legitimacy and respect.
5. Growth in international business opportunities.
With the traditional corporate-employment track seemingly on the decline, the trend of forming strategic alliances with other businesses that are closel
.
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
y aligned with yours or with someone who can add value
to your product is emerging. In fact, futurists envision a return to
extended community living with shared resources but individual living
and working relationships with entrepreneurial activities being the basis
of these communities. Strategic alliances are a first step along this
path.
So, if you have determined entrepreneurship is for you, you can be confident that you are part of the wave of the future. But understand what it will demand of you and whether you are prepared to give what it will take. The all
So, if you have determined entrepreneurship is for you, you can be confident that you are part of the wave of the future. But understand what it will demand of you and whether you are prepared to give what it will take. The all
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
ure of entrepreneurship is undeniably strong for many
but make sure you're going into it for the right reasons. Being miserable
in your job does not automatically make starting your own business the
best idea in the world. In fact, it could be the worst reason of all to get
into business for yourself. The right choice may instead be to find another
job that you won't be miserable in. But if, taking into account everything
that's been said above, you're adamant that you have what it takes,
by all means take the bull by the horns and create something
absolutely fabulous
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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