Advice You - Business

Small and emerging companies often do not put together a board of advisors or board of directors fo

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

r many reasons. Some entrepreneurs believe that businessmen and women would not be willing to serv

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

Examples of combination products may in

on their board of advisors for the little or no compensation that the new company can afford. Ano

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

her reason small and emerging companies do not have boards of advisors is that often the entreprene

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 does not want advice from others. In some extreme cases, entrepreneurs believe they do not need

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

Combination pro

advice from others. GSI knows better.

GSI works with entrepreneurs, like Kelly O’Brien, President

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 TurningPointe Marketing, www.turningpointemarketing.com, who has hired our firm to assist her in

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

putting together a strong board of advisors to help her grow her company. Entrepreneurs like Kell

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

O’Brien are finding out that having a board of advisors for your company that meets regularly can

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

ay huge dividends.

Beginning with its first meeting on November 18, 2004, Turning Pointe Marketing

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

s board of advisors consisting of 6-12 members will meet quarterly for one year to help expand the

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

Following aspects would a

company’s business model. Currently the company provides intensive marketing clinics twice a month

dd to the challenges in developing combination products:

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

for its clients where Ms. O’Brien, in a classroom/boardroom environment, helps create marketing ap

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

roaches for each of the company’s clients.

In the future, the Turning Pointe Marketing will great

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

ly expand its use of technology, virtual classrooms and will be writing articles and books on marke

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

ing for a broad audience. The board of advisors will play an essential role in making this large-s

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

Professional from academic institutions, pharmaceutical industries, health care indust

ale expansion of the offerings and media used by the company a reality within two years.

For more

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

information on TurningPointe Marketing, contact Kelly O’Brien at kelly@turningpointemarketing.com.

.

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

For more information on the services that GSI provides to help organizations create and manage boar

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

Companies that provide selfless information through particip

s of advisors and boards of directors, please contact Herb Rubenstein at herb@growth-strategies.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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In the Truck Wash Industry we see many makers of truck wash equipment and personally I think many of these units are over priced and often under perform. In other words they do not get the whole truck clean you see? And whereas many manufacturers of truck wash equipment have good synergy and distributors around the country, I am not sure I trust their units to clean trucks.

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Advice You - The Role of Marketing for Boards of Directors

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