Answers - Finance

This is a true story, I had a man walk in my office one day and ask where the dentist was. I asked what was the dentist’s name, he did not

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

know. I asked what was the address, he thought it was around here someplace. I asked if he had the phone number, no. The man actually said

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

Examples of combination products may in

o me, “I cannot believe you don’t know where the dentist is”. I asked if he could call someone else who could tell him anything about the d

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

ntist, "yes" his wife. He called his wife and we found the dentist's office was about a mile away!

All the women are saying typical man. N

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

t so fast I have a few similar stories about women looking for offices and having no clue where they were. These people just figured they w

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

Combination pro

uld go out and just look around and ask someone where it was, thinking others would have all the directions memorized for them. But they di

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

not have any information to help in finding what they where looking for. It just boggles the imagination.

People just start driving and d

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

not know where they are going, they think the dentist is over in that section of town and just hope for the best. What do you think the ch

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

nces of these people finding their destinations are? They barely have an idea where the office was, they don’t know the name of the owner o

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

business, no phone number and no clear directions.

This situation is very common in many areas of people’s lives. I choose to talk about

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

eople’s financial life, but we could talk about their failure in relationships just as easily. If you want to get somewhere easily, safely

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

Following aspects would a

and in good time you need to know where you are going and have a good idea on how you are going to get there. If on your way, there is some

dd to the challenges in developing combination products:

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

construction then you take a detour and get back on your selected path. The trick is you have a fairly clear plan on where you are, where y

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

u are going and how you are going to get there.

If you take this example and apply it to your financial life you will retire rich. Get an

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

ssessment of where you are. It does not matter how broke you are, or what your personal financial situation is. If you were in Seattle and

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

anted to get to LA could you do it? Would it matter if next time you were in Florida and wanting to get to LA, no, you just need to know wh

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

Professional from academic institutions, pharmaceutical industries, health care indust

re you are and that’s it.

Okay, lets say you are in debt, $40K, and you want to be worth $2 million one day. You know your start and finis

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

line, get a route between those two points and start the work required to do it. It may seem like a long way but if you just keep driving

.

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

nd stay on the right road, eventually you will get there. The key is know where you are, where you want to go and use the map along the way

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

Companies that provide selfless information through particip

You can look for some of our other articles for specific help on different ways to reach your financial goals, good luck and safe driving

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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