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Question: I have been going over this opprortunity for a long time. Should I freelance and work from home? But the answer, the logical answer, always

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

wins. Can I survive? And the funny thing is that…I always think that I can’t. I am a single mom. If I fail, my kids fail with me. And we eat nothing

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

Examples of combination products may in

. So?

Abby

Dear Abby,

I am glad you asked this question because this was the very same question I asked myself 7 years back. I had a needy 1-month

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

old child then (now I have 2) and I knew that if I leaped into the freelance world (which was something I REALLY wanted to do), it would spell either

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

success or…FAILURE. And I can’t take failure for an answer.

I know every one of us is different. Our situation is different and the circumstances s

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

Combination pro

rrounding our decision is different but…one thing is the same. The passion to move out of the corporate confines.

Good questions to ask yourself:

D

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

o YOU want to freelance?
Do YOU want to have more freedom?
Do YOU want to answer to no one?
Do YOU feel that you could earn more money

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

from a business on your own…over time?
Do YOU want to have CONTROL over your life?
Will YOU be willing to learn everything there is to lea

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

n about making it in the freelance world?
Would YOU be willing to do anything to survive if you were thrown into the business world?
Are YO

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

U willing to learn, make mistakes, make amends and make deals?
Can YOU negotiate with people?
Can YOU admit that you’ve made a mistake and

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

make amends?
Are YOU flexible?
Are YOU willing to learn technology? As in internet…of course.
Are YOU willing to discard with conventi

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

Following aspects would a

onal ways of doing business?
Are YOU trustable?

If you’ve noticed, the questions are all YOU questions. Because of one reason…the decision is y

dd to the challenges in developing combination products:

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

ours to make, no one else. I can’t help you make the decision because I am not you…and I am not in your position and situation.

Now, before you jump

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

into my bandwagon (the freelancing bandwagon), you’d have to consider whether you have enough financial reserves for the beginning months of freelanc

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

ing (very important if you want to make sure your kids have something to eat throughout the day). You need to consider, before you start freelancing,

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

if you have the support of your friends and family members (they can crush your dreams within a day!). Are you willing to walk that extra mile to tur

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

Professional from academic institutions, pharmaceutical industries, health care indust

n your dream into a reality?

It takes a whole damn lot to be freelancing…to make that jump. You’re standing at the edge of the cliff, wondering and

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

pondering, while the rest of the world just evolves.

Listen to your heart, Abby. If your heart tells you you should, go ahead and your head will fol

.

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

ow. Communicate and learn from your mistakes (and other people’s mistakes, as well) and you’ll do just fine.

If six months down the road and you’re

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

Companies that provide selfless information through particip

not making a single cent, go back to employment. If you’re making $150 a month, I say trudge on.

Believe in yourself. Good luck, Abby.

Yours, Marsh

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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