Useful Advices - Business

In the HBS Digest, we discussed getting a business up and running. We took a couple of steps a month and by the end of the year we had our grand opening for our business. In this article we will discuss nine succinct steps to put you on the path to success

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

with your own business start up.

First, you need to make up a plan and then pick out a couple of things to accomplish each month. Second, you need to define your short term goals. Yes long term goals are important too, however, remember you want to do

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

Examples of combination products may in

this in a years’ time so for now let’s break your goals down into things to do each week and by the end of each month. Also, when you accomplish your goals for the month, be sure to reward yourself with something you like to do. Shopping, movies, hiking,

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

you name it, be sure to reward yourself. Remember, however, as we discussed when setting up our mock business, you must be sure that your goals are realistic. If you take on too many things to do each month, you will overwhelm yourself, which will eventua

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

lly lead tofailure. A great analogy here is losing weight. So many people set themselves up for failure bysetting unrealistic weight goals, e.g. I want to lose 80 lbs in 4 months. Not going to happen. So be sure you don’t do the same with your business.

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

Combination pro

Third, and most important is to write your goals down on 3 x 5 cards and place them prominently where you will see them every day. It is very important that you reinforce to yourself on a daily basis what you are trying to do. Make it a part of your life

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

. Remember, our motto, “YOU MAKE IT HAPPEN”. But YOU have to WORK at it!

Next is to be sure that you surround yourself with support, and I don’t mean family. Family is only good as a support system if they are in favor of what you are trying to do. We h

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

ave found over the years that most family members will try to talk you out of it. Why? Because you make them look bad, and they have negative karma, which is certainly not something you need. Dieters are very familiar with this type of sabotage! Instead, g

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

o to on-line forums/boards which concentrate on new business start ups, and get help and support from people who are working towards the same goals as you are.

One of the best ways to keep yourself motivated and going strong is to visualize what your li

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

fe will be like once your business is up and running. Picture yourself in your dream office, with yourself at the helm, making a difference, making money, whatever makes you happy. Again, this is a very powerful tool for people who quit smoking and those w

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

ho are trying to lose weight. For many weight watchers they pick out a piece of clothing they want to fit into. Or smokers will reward themselves with a trip, vacation, or a special present for themselves with all themoney they saved. So be sure you use th

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

Following aspects would a

is visualization technique to picture yourself at the end of the year. It is also very powerful for long term goals also. To picture yourself in the future with a new home, car, etc. Whatever is important to you. For many of us who run our own business it

dd to the challenges in developing combination products:

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

is FREEDOM to come and go as we please, take days off, make decisions without goingthrough channels. To do business with whom we want and don’t do business with those we don’t want to. Not having someone to answer to!

Yes, doing this is sometimes hard a

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

nd you will need someone to push you. Which is why we suggest getting on boards and forums. When you feel you can’t do it, and need some encouragement, get on the boards and ask for help. Also, and this is something Chuck and I have emphasized on too many

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

occasions to count, read, read, and read some more. Educate yourself, keep up to date with what is going on in your business. If there is something you don’t know how to do, ask for help! Go buy some educational materials on the subject, take a class, but

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

do something.

Also, be sure that just because you are trying to get a business up and running you don’t forego doing the other things you love. If you do, getting the business up and running is no longer fun and exciting, but just another thing on your

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

Professional from academic institutions, pharmaceutical industries, health care indust

“To Do” list. It just becomes another job to you, and that is not going to keep you motivated towards success. So be sure you keep doing the fun things you like.

Step number eight is “NO EXCUSES”. None of the following excuses and any others you com

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

e up with are allowed: I am tired. This is too much work. This is not going to work, so why am I even bothering to try. I don’t have enough time. I don’t have the money. It won’t work for me. The list goes on and on.

There should be no excuses made. The

.

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

re is no reason why you can’t find time, energy and motivation to do a couple of things each month. This is to make a better life for yourself. Or for yourself and your family. So for every excuse you come up with do your visualization and keep that dream

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

Companies that provide selfless information through particip

strong.

Last but not least is finally realizing your dream. Give yourself a big hug, pat on the back, and whatever else you have decided on when you got to the end of the road. You certainly deserve KUDOS from all!

Copyright 2004 DeFiore Enterprises

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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When you read the glossies have you ever wondered how these real-life effects are produced? It is the result of technology, digital printing to be precise. Digital printing is a process which uses electronic files to create prints with laser or inkjet printers.

Business in the UK’s freight shipping industry has been booming over recent months. The port of Belfast is experiencing one of the busiest periods in its 400 year history. And now figures from the country's leading sea freight lines show that freight shipping volumes increased by 8% between 2004 and 2005.

Now Government wants to eliminate LIFO. LIFO stands for Last In, First Out. It is an inventory costing methodology. The last in, first out, or LIFO method, selects the most recent purchases whose quantities add up to the total number of items sold during the year. The last in, or most recent purchases, are the first charged out to expense. The primary theory of the LIFO method is that products sold have to be replaced to continue in business and that the most recent (i.e., the last in) costs are the closest to the costs of replacing the products sold. From a tax standpoint, LIFO minimizes tax consequences by using the highest cost of inventory which reduces reported profit.

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