Main Subject - Business

If you are like me, you are living some distance from the devastation wrought by Katrina. If you are like me you not physically impacted and can watch the plight of others on television in the comfort of your home. And if you are like me, you are won

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

dering what you can do.

I believe the answer to that question is an important one. It can help define who you are and what you have and choose to give to the world. The list that follows is not meant to stimulate your thinking. It is meant to stimu

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

Examples of combination products may in

late action. All of us can do all of these things. And in doing them we will not only be helping others, we will be helping ourselves deal with and grow from these events as well.

Give Resources. You have heard it and will hear it often. Th

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 resources required by these events will be unprecedented. Open your wallet and give. It doesn’t matter which charity you choose, just give. Pick a number, then add to it. Do a search on Katrina relief to find places to contribute. You can give mo

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

re than money though. Perhaps you have other resources that you could offer. Spare blankets or other supplies will inevitably be leaving from your community in the coming days. Watch for these announcements and donate. If you know someone affected,

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

Combination pro

or know someone who knows someone, perhaps you can provide a spare bedroom. You can even support relief efforts each time you search the internet. Go to http://allgive.com to search and learn more.

G

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

ive Yourself. If your situation allows, perhaps you feel drawn to go and help. If you are thinking about that and you can, go. Many of us won’t be able to go and lend a hand directly. You can still give of time and talents locally and have a dire

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

ct impact on efforts there. Organizations like The Salvation Army and The Red Cross will be spread thin for months. If you volunteer in your town, more physical resources can remain on the Gulf Coast longer.

Encourage Others to Give. This is

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

a way for you to give of your talents. Use the leadership and influence skills that you have to encourage others to give. If you own a business, match employee contributions to relief efforts. If you are involved in any sort of organization, start

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

a fund raising effort. A colleague of mine sent an email saying he would match any gifts given by those on his list up to a total of $500. Every person could do this. Ask yourself who you could influence and how you could personally help increase gi

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

ving. Get creative! And get started.

Say a Prayer. Regardless of your religious beliefs, or how you would state this, say a prayer. Say one for those who have lost family. For those who have lost their homes. For those who are sick or thir

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

Following aspects would a

sty or hungry. And say a special prayer those involved in rescue and recovery efforts - those giving of themselves to make things better for others.

Keep Your Perspective. It is sometimes hard to keep a healthy perspective as you watch the ev

dd to the challenges in developing combination products:

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

ents on television. It is easy to let the worry and concern become overwhelming. Do yourself a favor and don’t let these events overpower your life. Be grateful for your situation. Rethink how upset or frustrated you become at little inconveniences

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

or challenges, because these situations mean little in the bigger scheme of things, and the events of recent days should make this very clear to us.

Conserve. Our country is going to be dealing with the aftermath of Katrina for a long time.

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

There are other little things that we can do that will make a difference. Conserve fuel. Carpool to work. Combine your errands, or just stay home. Turn off your air conditioning and turn off the lights. Fossil fuels will be in short supply and eve

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

ry little bit helps. Plus every dollar you don’t spend on fuel, is another dollar you could choose to donate to relief efforts.

Give Again, Later. Many will give now, but agencies like The Red Cross will tell you that after the situation leav

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

Professional from academic institutions, pharmaceutical industries, health care indust

es most people’s conscious thoughts, the needs will still be great. Make a commitment now to make another contribution later in the year. One way to do this is to reduce your holiday spending and earmarking the difference for Katrina relief.

I’m sur

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

e there are many more things that you can do to help both yourself and others in the coming weeks. It matters less what you do than that you do something. That is my urging to you. You can make a difference, but only if you take action.

Special N

.

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

ote: One of the ways I am taking my own advice to “Encourage Others to Give” is by offering you (and anyone you know) a choice of a 6 month membership to our Powerquotes Plus service, a $30 value, or a seat in our tele-seminar, The Leader as a Coa

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

Companies that provide selfless information through particip

ch, a $49 value, if you simply let us know that you made any donation at all. Visit http://www.kevineikenberry.com/katrina.asp to learn more and contact us with your choice.

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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Why do some businesses take off that seem like terrible ideas? Why do businesses with all the right ingredients never get off the ground?

Most salespeople believe that quality means “best.” But quality REALLY means conformance to standards and expectations—your prospect’s standards and expectations. Quality means the right stuff—not the best stuff. If you understand this critical difference, you'll make more sales, at higher margins, even if you think you sell a commodity.

Being your own boss and owning your own business can be a lot of fun. For some they consider it part of their American Dream. Many people decide to be their own boss as solo-professionals and this makes sense, as you have no employees to deal with and if you need help you can contract with others in the industry and work on Team Projects.

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