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A few years ago, when I was president of a state organization, I designed our first e-newsletter. A professional writer with a graduate degree in art, I w

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

as the logical choice for the job. Two questions were paramount in my mind: How will the content differ from our printed newsletter? What are the recurri

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

Examples of combination products may in

ng columns?

Talking with members helped me to answer these questions. Our printed newsletter would be external communication -- something we could give t

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

o prospective members and the press. Our e-newsletter would be internal communication for members. Since we are an affiliate organization I patterned our

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-newsletter after the parent organization's e-newsletter. This was a mistake.

From the get go our e-newsletter was too long. As the presidents changed

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

Combination pro

the design of the e-newsletter gradually changed. The writing style kept changing because we had no editorial guidelines. We are in the process of revamp

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

ing our e-newsletter and, as Communications Chair, I have been doing some research.

1. E-newsletters are the way to go. According to www.heartlandtechno

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

logies.com, electronic newsletters are "here to stay." We may as well take advantage of this trend.

2. E-newsletters drive traffic to Web sites. This,

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

again, from Heartland Technology solutions. E-newsletters are another element of the marketing mix, a way to stay in touch with members and clients.

3.

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

E-newsletters are fast. Chad Barr, President of CB Software Systems Incorporated, describes the efficiency of e-newsletters as "speed to market." Once yo

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

u have a new product or, in the case of an organization, hot news, "you are able to immediately announce it."

4. E-newsletters save money. Layout and pa

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

Following aspects would a

per costs are going up. You may have to pay someone to send your e-newsletter to a database, but it is still cheaper than printing newsletters. Plus, you

dd to the challenges in developing combination products:

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

can zap e-newsletters to prospective members and/or clients.

5. E-newsletters generate excitement. I thought this was an interesting point from www.mar

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

ketbuilding.com. Part of this excitement comes from the immediacy of electronic newsletters and colored photos.

How will our e-newslettter change?

It wi

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

ll be shorter, for one thing. We will publicize our revamped newsletter in our printed newsletter, spotlighting the features of the new design. I think w

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

e will do a better job of creating columns that meet our members' needs.

Though I am not certain, I think the columns will be Member News (personal stuff)

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

Professional from academic institutions, pharmaceutical industries, health care indust

, Helpful Info (Web site links), News Flash (news that needs immediate action) and Real Deals (free lunches, bulk rate discounts, prizes). Members may sug

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

gest other columns as well.

A photo is worth a thousand words and we will publish action photos to go with the recurring columns. Colored headings will f

.

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

lag the columns and, hopefully, keep people reading. All of these ideas must pass board review and, while I can't guarantee these changes, I think most pe

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

Companies that provide selfless information through particip

ople will agree with them. Just as people change with the times, e-newsletters must change with the times. We're ready!

Copyright 2007 by Harriet Hodgso

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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