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Main Subject - Exit The Corporate World and Enter The Entrepreneurial World - It's Easier Than You Think
A few years ago I was sitting in my office at the hotel in which I worked wondering why it was 11:00 p.m. and I was still at work and not at home with my family. It was winter in Massachusetts – cold, dark and dreary. The Night Manager arrived about 11:30 p.m.
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
and I drove home on desolate streets and crawled into bed exhausted. I had missed saying goodnight to my young daughter and my husband was peacefully snoring. I realized the best part of my life was happening without me being present – my family.
The next day,
; 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
I gave my boss four weeks notice and quit. I had no idea what I was going to do, but I knew I was done making business decisions for someone else and making other people (mainly my superiors) successful.
Luckily, an opportunity landed in my lap that I couldn’t
Luckily, an opportunity landed in my lap that I couldn’t
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
pass up and I took the leap into entrepreneurship. I bought an in-home tutoring franchise. I cleared a spot in my hallway, set up a makeshift office and dove into the unknown. I was successful and owned my franchise for three years before I sold it. I gained
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
wonderful experience but disliked being associated with a franchise and paying monthly royalty fees. My family moved to California, I had another child and founded my own tutoring company.
Four years later, after establishing myself in my community and being ve
Four years later, after establishing myself in my community and being ve
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
y successful, I decided to mentor others who wanted to take the plunge and own their own company. I wrote a book, packaged it with a website, customized accounting software and marketing materials, found myself a wonderful publicist and began selling my business
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
packages via the internet. After only five months, I have surpassed my forecast of how many packages I would sell. I have been featured in a major women’s magazine and have five more articles lined up with other publications between now and April. Several yea
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
rs ago, I never thought I would be working from home, making excellent money and mentoring others on how to begin a home-based business.
The transition for me was easy, but it was a difficult decision. I gave up my medical benefits and the security of a full-ti
The transition for me was easy, but it was a difficult decision. I gave up my medical benefits and the security of a full-ti
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
e job and a regular paycheck. I gained financial independence and the ability to work from home and apply my twenty plus years in Corporate America to establishing two companies. When others call me about buying one of my business packages, these are the questi
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
ons I tell them to ask themselves:
1) Do you have enough financial security to survive for up to six months if you do not immediately make enough money to pay the mortgage and other expenses? 2) Is your business experience broad enough to enable you to make t
1) Do you have enough financial security to survive for up to six months if you do not immediately make enough money to pay the mortgage and other expenses? 2) Is your business experience broad enough to enable you to make t
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
e best decision as to what skills you have that will make you successful as an entrepreneur?
3) What type of business is the best match with your skill set?
4) Do you have the ability to network and sell yourself and your new company, product, idea, etc?
5)
3) What type of business is the best match with your skill set?
4) Do you have the ability to network and sell yourself and your new company, product, idea, etc?
5)
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
Can you except rejection well and not let it pull you down and discourage you from forging ahead with your business idea or purchase?
6) Do you have a good support system in place, i.e. do you have a good attorney, accountant, and mentor?
7) Are you willing
6) Do you have a good support system in place, i.e. do you have a good attorney, accountant, and mentor?
7) Are you willing
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
to take chances without the safety net of an employer? Can you think “out of the box” without constant reinforcement from co-workers or a “boss?”
8) Are you self-disciplined? Can you work independently, without set hours and not slip into an unhealthy routine
8) Are you self-disciplined? Can you work independently, without set hours and not slip into an unhealthy routine
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
f getting up late, floundering through the day and realizing you got nothing accomplished – are you a goal-setter?
9) Have you carefully thought about the realities of having some lean months and possibility not being able to afford the little luxuries that you
9) Have you carefully thought about the realities of having some lean months and possibility not being able to afford the little luxuries that you
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
once took for granted?
10) Will you miss the social aspects of working in an environment where you could easily interact with others?
Being an entrepreneur has some terrific benefits, but not everyone is well-suited for this type of lifestyle. Sometimes it ge
10) Will you miss the social aspects of working in an environment where you could easily interact with others?
Being an entrepreneur has some terrific benefits, but not everyone is well-suited for this type of lifestyle. Sometimes it ge
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
ts lonely working solo. There is no office gossip or grapevine to share stories about your co-workers. (In the beginning there are no co-workers) There are days when the phone doesn’t ring. That sale you thought was a sure thing falls through. Clients or cust
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
mers can be difficult and you are the customer service department, complaint department, accounting department and more. Sometimes it’s terrifying to think about what would happen if you failed. On the other hand, when you land a big client or make a big sale,
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
it is euphoric and extremely fulfilling.
I have experienced some very tough days and weeks when I questioned my decision to strike out on my own. However, I have never regretted my decision. I could not report to anyone again. When I feel discouraged, I go an
I have experienced some very tough days and weeks when I questioned my decision to strike out on my own. However, I have never regretted my decision. I could not report to anyone again. When I feel discouraged, I go an
.
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
sit in the lobby of a hotel and watch the managers running around like I did. I go on the weekend when I know I don’t have to work, but they do.
A great feeling of satisfaction settles over me, even if I’ve had a bad week. To me, nothing could be worse than h
A great feeling of satisfaction settles over me, even if I’ve had a bad week. To me, nothing could be worse than h
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
aving my time scheduled by someone else.
When I am consulting with a prospective buyer of one of my packages, I ask them the ten questions noted above. It is vital for an individual to do some real soul-searching before making a commitment to be an entrepreneur
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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