Advice You - Business

The federal, state and local government agencies throughout the United States are looking to do business with women-owned firms like never before. One of the key reason

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

s is that women-owned firms in the U.S. are growing like never before.

The federal government, along with many states and local government agencies, maintain goals reg

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

Examples of combination products may in

rding the contracts they target for women-owned businesses. The federal government’s goal is 5% of the more than $300 billion in federal contracts which amounts to $15

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

billion in business opportunities that should be won by women-owned firms. This is both good news and bad news. The bad news is that this goal has never been reached. 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 good news is that there is a greater opportunity now than ever before for women-owned firms to tackle and win contracts in the government market.

This is a time of g

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

Combination pro

olden opportunity because the SBA has finally issued the proposed regulations to implement the formal women's federal procurement program which was approved as law over

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

five years ago, but never enacted. This important program provides a targeted option to enable federal contracting officers to "set-aside" certain procurements for wome

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

n-owned businesses. This creates an unprecedented opportunity for qualified women-owned firms to jump-start their government contracting business.

Can women-owned busi

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

ess handle these opportunities? The answer is a resounding yes. A recent report by the Office of Advocacy of the U.S. Small Business Administration (SBA) states that wo

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

men-owned firms increased nearly 20 percent over the latest period studied. During the five years between 1997 and 2002, women-owned firms grew by 19.8 percent while a

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

l U.S. firms grew by seven percent.

The report uses newly released U.S. Census and other data to describe women’s contributions to the economy. Statistics documented

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

Following aspects would a

in the report include:

* In 2002, women owned 6.5 million or 28.2 percent of nonfarm U.S. firms. More than 14 percent of these women-owned firms were employers, with

dd to the challenges in developing combination products:

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

7.1 million workers and $173.7 billion in annual payroll.

* According to 2002 data, significant proportions of women-owned businesses were in professional, scientific

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

, and technical services, and in health care and social assistance.

Another fascinating statistic from a different organization, the Center for Women’s Business Resear

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

h states that:

* Businesses majority-owned by women of color have grown six times faster than all U.S. firms between 1997-2004. The number of firms increased by more

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

than half (55%), number of employees increased by nearly two-thirds (62%), and annual sales revenue increased by almost three quarters (74%).

Firms owned by women have

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

Professional from academic institutions, pharmaceutical industries, health care indust

the knowledge and capacity to perform well in the government market. Generally their biggest hurdles are learning how to break into the market and working within govern

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

ment processes, rules and regulations. There are a number of organizations that are poised to help women-business owners tackle this profitable market such as the SBA a

.

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

d the National Women’s Business Council. It is a complicated maze, but one worth tackling!

Gloria Berthold is President of TargetGov, a national firm specializing in h

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

Companies that provide selfless information through particip

elping companies win government contracts in federal, state and local governments. She can be reached through the web site: www.targetgov.com or by calling 866-579-1346

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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