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I waited until the last minute to start thinking about the traditional New Year’s Day activities - reflecting and making resolutions. I have no resolu

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

tions, no regrets, but maybe some new goals.

It seems contradictory but I am a person who plans and prepares, but I am also open to changes. I can’t

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

Examples of combination products may in

imagine any other way to be. People are often surprised by how rigid I am about certain things. The same people have seen me become more flexible. M

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

only explanation is that I have learned to follow the path that leads to the best outcome. When the path leads to nowhere, I shall not be moved. Whe

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

n the path leads to bigger and better things, I don’t mind if it is unpredictable. I guess 2005 was about learning the difference between the two path

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

Combination pro

s.

I have several mentors in my life. Each one of them has an understanding of one or more of my goals. They monitor me as closely as I allow. Ever

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

one of them told me the same thing in 2005. Stop preparing and start doing! How do you know you can do something unless you try?

One of the mentors

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

was my professor when I studied for my doctorate. Have you ever known someone who was always right? Not someone who thinks that they are always righ

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

t or want to always be right, but someone who really is right all of the time? Well, he is that person in my life. I used to frustrate him while I wa

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

at Cornell and I frustrate him now. He knew the difference between the things that would make a difference and the things that wouldn’t. He has neve

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

r steered me wrong about anything. In fact, I learned humility or “how to eat crow” while working with him almost ten years ago. He can tell when I

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

Following aspects would a

am ready for something long before I feel ready. Feeling ready and being ready are very different. I got a much better understanding about that life

dd to the challenges in developing combination products:

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

lesson in 2005. In 2006, I will trust myself more.

Another one of my mentors is an accountant who consults for small businesses. He taught me that t

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

he flow of money says a lot about your priorities. It seems so obvious, but there is no better wake up call than a spreadsheet that tells you where yo

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

u have been, what you did, and what you wanted for the last year. I highly recommend a blunt talking accountant to anybody who feels any type of confu

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

ion in their life. Numbers tell stories with a clarity that you just not get with words! At the end of 2006, my spreadsheet will reflect the life of

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

Professional from academic institutions, pharmaceutical industries, health care indust

a more determined person.

My final mentor is also called my “lifestyle sensei” because I don’t know anyone who enjoys life as much as he does. We be

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

came friends very quickly and have remained so despite all of the changes that happen between young adulthood and middle age. He is such a great frien

.

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

. In 2005, I realized that being a good friend is something that requires thoughtful discipline. My friend has contagious optimism and the ability to

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

Companies that provide selfless information through particip

express it in ways that make people want to be around him. I think I can conjure up some of that energy for 2006 and be a great friend to more people

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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