Main Subject - Business

I was recently invited as a guest on a 4-day cruise boarding a ”True” Luxury Liner. Every room was a suite. I knew via their website we had a bathroom bigger t

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

han the one in my home, a sitting room, bedroom, mini-bar and balcony. I knew I needed a break and kept saying I did. It came just before I was due for foot s

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

Examples of combination products may in

urgery. In my heart I know when we continue to say what we want and believe, it comes to us bigger than what we expect.

I had also wanted to fly home and se

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

e my mother who is in an assisted living home. I knew I wouldn’t be seeing her for some time due to my foot surgery coming up and really wanted to get home.

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

So I asked. On our return flight we were able to stop to see my mom for a couple of days. The timing was amazing but I believed.

The day after returning hom

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

Combination pro

e I went into surgery. Before I went in I had a concern that I would lose momentum in my business with a 12-week recovery period. As I looked at what I had a

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

ccomplished and believed there was a great downtime opportunity to create, I KNEW I wouldn’t have any problem. I believed everything would be all right. The

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

second I woke up from my surgery I KNEW I would continue to achieve my goals. It’s the first thing I thought about when I opened my eyes. It was like a gift

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

that came in the form of a thought. Through the next 3 weeks my laptop was attached to my hip with ideas just BURSTING. (in-between naps from the painkillers)

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 was a painful time and an inspiring time.

Here’s something else I had in place. I had come across some great products about Belief and Truth. During my

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

first month of recovery time I continued to learn about myself, my business, what was right for me and where I shouldn’t go.

I was like a sponge and one day

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

Following aspects would a

something really hit me. A BIG AHA! BELIEF! I’ve had it all along but something was different now. It had a deeper meaning and it played a much bigger role

dd to the challenges in developing combination products:

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

. Not just for me but for all solo-entrepreneurs.

The BIG AHA is coming up soon. The foundation with cornerstones that I work from and I know a lot of us do

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

when we have a business is, Belief, Trust, Passion, Business Process and Marketing. Another big piece is only doing what I LOVE. That would be included in Pa

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

ssion. Feel free to fill in any pieces that are different for your foundation.

Here’s the BIG AHA! Belief is the entire foundation. In fact, if I were to c

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

reate a business model it would look something like this. Picture a triangle. On the left side of the triangle is Business; Right side is Marketing; top is Tr

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

Professional from academic institutions, pharmaceutical industries, health care indust

ust; Within the triangle is Passion; and Belief is the entire foundation.

I KNOW what I have and BELIEF has carried me to where I am now and where I will go.

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

Do you know what you have? You have something magnificent! You have something that no one else has because you are unique and that’s what you bring to your

.

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

business. If you have a dream, go after it. If you have a business, make it a GREAT one. In either case don’t deprive others of your gifts. They are in nee

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

Companies that provide selfless information through particip

d of you and it’s up to you (and your support system) to make it happen.

Have the BEST day and keep Believing!

Copyright 2006 Marketing On The Playground (TM

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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In order to make sure that your business is running smoothly, you have to keep good financial records. This is one of the issues with which businesses are most concerned because they want to make sure that they are turning a profit and at the same time paying the appropriate taxes to the government. When a business files an income tax return, it has to have all its I's dotted and t's crossed if it doesn't want to undergo a tax audit. That is why all income and expenses have to be carefully documented and all receipts kept.

Virtual assistants, the online equivalent of office administrative assistants, are becoming more popular as affordable staffing solutions.

What is involved in shipping internationally? Each country has its own set of regulations with respect to what is allowed to enter the country. Read about the typical documentation required to get your package through customs.

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Main Subject - Do You Really Believe You'll Be A Success?

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