Main Subject - Business

Imagine you are the most amazing figure skater who ever lived. When rehearsing in a peaceful, empty rink, you demonstrate the ultimate in athleticism and artistry. You defy the laws of gravity as you le

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

ap in the air, landing with flawless precision. You spin with effortless grace and power; you execute jumps other skaters only dream about. On that ice, you are in your element, doing what you love to d

; 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 and doing it perfectly.

In rehearsal, that is.

The next day, you enter the same rink for the big competition. When you look into the stands, you see thousands of eyeballs on you. As you begin your p

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

rogram, you skate self-consciously, hesitantly. You stumble on moves you usually don't even have to think about. You forget what comes next. You wobble and bobble and barely get through the program on y

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

ur feet.

Now, consider this: Your frustrated coach barrels up to you and bellows, "That's it! From now on, we're spending two extra hours a day in rehearsal until you get this right in competition!" Qu

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

Combination pro

estion: Will that tactic solve the problem? Of course not, because the problem is not in the realm of the skating. (Remember, you skated the program perfectly 24 hours ago.) The problem is in the realm

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

of the EYEBALLS. You can skate until your feet fall off, but until you make peace with those eyeballs, you will continue to stumble in the spotlight.

So It Is With Public Speaking

Most people say, "On

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

-on-one I'm fine. It's only when I'm in front of a group that I get nervous." If you can speak confidently and clearly one-on-one, it means you already know the content and can convey it well (like skat

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

ing perfectly in rehearsal). The problem comes when a speech coach says, "OK, we're going to have you rehearse the speech five more times in the conference room to make sure you get it right when you pr

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

esent in front of the Board." Emphasizing the content and delivery has limited value because it attacks the problem from the realm of the SPEAKING. But where most people suffer most is in the realm of t

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

e EYEBALLS.

Sure, you're more likely to withstand the eyeballs if you feel confident in your material, but the discomfort will still be there. Techniques and gimmicks (like "picture the audience naked"

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

Following aspects would a

or "start with a joke" or "look at the back wall if you're too nervous to make eye contact") won't help either. These tricks just put up a barrier; they don't solve the problem.

So what is the answer?

dd to the challenges in developing combination products:

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

Realize that the problem is not that you don't know how to speak; it's that you're not used to being THE CENTER OF ATTENTION. You see those eyeballs and suddenly you're thrust outside of your comfortab

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

le anonymity into the shocking realization that someone is actually paying attention. You shy away from the attention, the intense energy. But ironically, the energy in those eyeballs can energize and c

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

mfort you-once you let it in.

Yes, eyeballs almost always have positive energy behind them because listeners want you to succeed. Even if you face grouches in the crowd, you can count at least a few po

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

sitive eyeball vibes coming toward you. Soak in the positive energy and send it back out in the form of genuine warmth and concern for your listeners. Seeing that concern invites even more positive ener

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

Professional from academic institutions, pharmaceutical industries, health care indust

gy, which keeps the cycle going.

Far-Fetched Idea?

It may seem far-fetched at first. But the only way to make peace with those eyeballs is to stop avoiding them and explore them instead. Seek them out

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

Peer back with your own eyeballs and see what's really there. It takes practice, of course. To get started, seek out a positive setting such as a SPEAKING CIRCLE* or supportive group of friends. Rememb

.

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

er, you're already a speaker. You're just not accustomed to being a recipient of listening-a skill that can only be mastered in the mysterious, wondrous, scary, exciting realm of eyeballs.

* The SPEAKI

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

Companies that provide selfless information through particip

NG CIRCLE(R) methodology is a revolutionary new approach for building speaking skill and power. It's based on the book Be Heard Now by Lee Glickstein. For more information, go to www.speakingcircles.com

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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Expense report forms are the formats to be filled out by an employee for claiming reimbursement of expenses of official or personal visit. Every organization will have its own format. It is advisable to use an expense report form rather than simply listing out all the expenses in an Excel sheet and submit that. Through the form, both the employee and the employer are in a position to have a clear-cut idea as to how much money is involved in the form of expenses so that reimbursement will be quickened. Thus, the process of expense reporting starts with filling out the expense report form. Some organizations have online versions of these expense reports in which the employees need to enter all the data and send it to the Accounting Department.

There are many kinds of businesses that flood the market today aside from owning your own business, meaning you run and finance it, there are others which are also businesses in their own way. All of these are businesses and each has their own advantages and disadvantages as you try to work them out. Should you wish to enter these ventures, it is good to have some knowledge of what you are getting into.

Although your business has become a fixture of the community that serves it well, you may never have been able to get out from under the accumulation of business related debt. Regardless of the reason, the business cash flow is not equal to the monthly bills, which are beginning to fall behind. With each payment that isn't made, the interest on the business debt continues to accrue, make the debt larger and more difficult to pay. Each missed payment results in a stiff late fee or missed payment charge that adds to the debt mess.

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