Advice You - Business

Congratulations. After much thought and research, you have discovered which career is right for you. The thought of it fills you with passion, enthusiasm, and inspiration. This career will give you the oppor

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

tunity to use your favorite and best talents to make a great contribution. This is the type of work that Joseph Campbell referred to when he said, “Follow your bliss.”

Ahead of the Pack

You’re ahead of many

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

Examples of combination products may in

thers who have not discovered their “bliss.” You feel grateful that you discovered your right livelihood, but now you face a dilemma. There are risks. Do you quit your present job or business and plunge ahea

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

d into your dream job or business? Will you be able to pay your bills? What will your family and friends think? Is this career practical?

Heart and Mind Conflict

Your heart says, “go for it.” Another part

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

of you is scared and urges caution. Fears you didn’t know you had start appearing. You wonder, “What if I fail?” When you listen to your heart or that part of the mind that says, “go for your dreams,” fears

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

Combination pro

often come up. The self-preservation part of your mind raises concerns. Both parts of yourself are attempting to support you. Both parts need to be heard and considered. Before making your final decision, y

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

u may experience intense inner conflict between these parts of your mind.

You may feel like a war or boxing match is going on inside of you. I once experienced this inner turmoil before I resigned from a secu

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

re job to begin full-time self-employment. I had a steady salary, excellent benefits, and was less than three years from receiving a retirement pension. Some of my friends and family cautioned me against leav

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

ng my job to follow my dreams. I decided that leaving was best for me.

The Choice Is Yours to Make

I am sharing my experience to let you know that I have experienced this dilemma, not to influence you to do

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

it the way I did. The ideal is to start a part-time business and build it before leaving your job, or to go from a job to a job. However, what is right for one may be wrong for another. Only you can decide w

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

en to leave your job and whether to do it slowly or quickly. It depends upon your personal makeup, circumstances, and finances.

Questions to Consider

How can you decide whether to pursue your passion? Here

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

Following aspects would a

are some questions that can help.

1. What will be the costs for you and your loved ones if you don’t pursue your dreams? What are the costs of leaving your current job or business?

2. What are the benefits o

dd to the challenges in developing combination products:

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

pursuing your passion? What benefits will you lose if you quit your present employment?

3. What if you fail? When you come to the end of your life, would you rather have tried and failed than to have never

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

tried?

4. What would you do if you knew you couldn’t fail?

5. How will you feel about yourself if you pursue this inner calling? What will your feelings of self-worth be if you don’t try?

Steps to Overcome

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

ear

Also consider the following:

1. Begin moving toward your goal, no matter how slowly. Start it as a hobby, or as volunteer work, or part-time employment. Take the first step even if it’s a small one. Em

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

erson told us, “Do the thing you fear and the death of fear is certain.” Action is powerful! According to Goethe, “Whatever you think you can do, or believe you can do, begin it. Action has magic, grace, and

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

Professional from academic institutions, pharmaceutical industries, health care indust

power in it.”

2. Read the biographies of others who took risks, overcame failures, and succeeded.

3. Place inspiring quotations and pictures in your home and office.

4. Listen to CDS that lift your spirit an

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

d motivate you.

5. Reflect deeply on how you want to live the rest of your life.

You were born for a purpose that you are worthy of fulfilling. The world needs your talents and contribution.

I leave you wit

.

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

a powerful quote by Helen Keller that had a positive impact on me when I was battling the fear of following my passion. I hope it will inspire you to pursue your dreams. “The marvelous richness of human expe

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

Companies that provide selfless information through particip

rience would lose something of rewarding joy if there were no limitations to overcome. The hilltop hour would not be half so wonderful if there were no dark valleys to traverse.”

Copyright 2007. Raymond Gerso

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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