Digg It - Business

Time, time, time. Consider these numbers: the average executive spends 22 percent writing and reading memos, reports, letters. That equals eleven

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

workweeks. And they are spending over 50 percent of their time either reading your communication or responding to it! So if you want the big chees

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

Examples of combination products may in

to read your report, make certain that your executive summary—written for that decision maker—sings. Here are the details.

Executive Summary

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.

is stand-alone document is a synopsis of information in a report. A restatement of the most relevant points, it contains enough detail to inform t

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

e reader but concise enough to cover the topic's significance.

Though this is usually written last, it is placed before the report's introduction

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

Combination pro

and summarizes the major points of the report. The executive summary can be five sentences or a page but usually no longer. Keep the image of a o

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

e-legged interview—meaning, equate how long you can stand on one leg to how long you can hold your reader's attention—in the back of your brain. O

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

r use the recommendation from The Handbook of Technical Writing, by Brusaw, Alred and Oliu: the summary's length should be no more than ten-percen

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

of the length of the report. Consider bullets and lists to help the reader quickly skim major points.

Most executive summaries contain four key

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

sections: overview; methods; results and recommendations; and the conclusion. The order of the sections usually mirrors the sequence of the larger

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

report. All executive summaries address readers' needs for clarity about:

• Key problems or concerns

• Specific recommendations or solutions

•

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

Following aspects would a

Benefits to their business, customers or bottom line Use the chart below to guide the planning for your next executive summary:

WHO is my reader

dd to the challenges in developing combination products:

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

Key question: What do I know about my reader’s business and concerns?

WHY was the report written or why did the even take place? Key question: H

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

ow can I briefly summarize the purpose of the report?

WHAT main points need to be included in the following areas?

• Actions

• Results or findi

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

gs

• Recommendations

• Benefits Key Question: Which aspects/details are essential to help my reader understand my ideas?

WHEN should recommen

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

dations be carried out? Key question: What timeframe can I suggest? OR What’s the best order for implementing the recommendations?

HOW do my reco

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

Professional from academic institutions, pharmaceutical industries, health care indust

mendations directly benefit my reader? Key question: Have I anticipated my reader’s needs, questions, and concerns?

Even though e-mail is the co

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

mmunication vehicle in business today, professionals still need to deliver key information to senior management. An old standby—the executive summ

.

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

ry—still remains an important document. What can be difficult is writing the darn thing. These tips should help you. One last task, once you finis

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

Companies that provide selfless information through particip

h drafting the executive summary, revise, revise, revise!

This is an excerpt from Dr. Julie Miller’s fourth edition, Business Writing That Counts

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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According to a recent poll of HR professionals, only ten percent of managers are fully prepared for the next level. One of the most important qualities of a good leader is the ability and desire to develop their employees. By following these tips, you can prepare your employees for success at the next level.

One way to raise money for your concept or invention is to scour the trade journals for folks in the industry such as consultants, who have boatloads of contacts and may have a perfect corporate partner who needs what you have. Trade Journals have all sorts of interesting tidbits, often in stories you see quotes from Investment Bankers on something they have funded. Call them. Check the online Ezines in your industry too.

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