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Donna has been telling people for years that she wants to start her own business. She has dreamed about it since she was in high school but instead of taking st

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

eps towards following her dream, she has spent her days in the corporate world. When asked, Donna will say she doesn't know what she wants to do for a career.

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

Examples of combination products may in

ll she knows is that she is burned out with what she is doing. Yet, everyone around her knows the dream that has been following her – the dream of being her own

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

boss.

Many of us have dreams that are following us around while we desperately try to ignore them! Think for a minute. Have you heard yourself saying things

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

ike..."I'd love to turn this hobby into a career but..." or "I've always wanted to be my own boss but..." or "What I really wanted to do was _______ but now it

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

Combination pro

is too late." ? If this sounds like you then it is time to turn around and look those dreams right in the face. They hold clues to what your passion-filled ca

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

eer change can be.

What keeps us running from our dreams? One of the most common reasons I have seen as a Life Coach is that we think it is too late to live a

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

dream. Most of the time that is absolutely false! We give up on our dreams way too fast. I remember reading about a woman who always dreamed of being a doctor

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

She was 60 years old when she went back to college to pursue that dream. Many people asked her, "Do you realize that you will be almost 70 years old by the ti

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

me you get out of school and begin your career?" Her answer was always, "I can be 70 and a doctor or 70 and not a doctor. Either way I'll turn 70. I would muc

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

rather be 70 and a doctor!" She went on to achieve her MD and is still enjoying her thriving career. Are you giving up too soon?

I'll admit (although relucta

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

Following aspects would a

tly) that sometimes it might be too late to accomplish certain dreams. For example becoming a professional athlete in your 60's might not happen. Although I rea

dd to the challenges in developing combination products:

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

lly hate to say that because of a man called Banana George. He begin barefooting at the age of 46. He now holds 4 world records and is a professional barefoote

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

. To top that off when George turned 75 he learned how to snowboard! Be very careful before you decide your dream is "impossible"! But if you really, really

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

believe that the dream you have is impossible for you to reach then take a look at the essence of your dream. What is it that you wanted most from it? If you w

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

nted to be a professional dancer then what attracted you to that career? Was it the movement? If so you can have a career around movement . Was it the music?

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

Professional from academic institutions, pharmaceutical industries, health care indust

Was it the thrill of performing on stage? The challenge of mastering something and being known for it? Whatever you loved about that dream you can have in man

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

different careers. Take the essence of that dream and find a career to meet that essence.

The next time you hear yourself saying, "I have no idea what I am pa

.

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

ssionate about or what I want to do for a career change." take a quick peek behind you. Do you have a dream that is stalking you? If you do look it in the eye

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

Companies that provide selfless information through particip

nd start taking it seriously. I have been amazed over and over again at how well those clingy dreams lead people to exciting, passionate, and meaningful careers

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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