Main Subject - Finance

Community Outreach Program

The mission of the World Bank’s Community Outreach Program is to improve the quality of life of people in

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

the Washington metropolitan community. The Program aims to make a difference in the lives of local families and children in lasting,

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

Examples of combination products may in

sustainable ways – particularly in the areas of education and youth development.

The Program encourages Bank staff, whose daily work

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 focused on promoting economic development and reducing poverty in developing countries, to show their concern and generosity to 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 most disadvantaged populations of Washington.

Activities focus on four main areas: charitable giving, capacity building, staff vol

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

Combination pro

nteerism, and partnerships. Bank staff raise money annually for local nonprofits through a charitable giving campaign, and also for i

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

nternational disaster relief as the need arises. Staff volunteer with community groups, which can also benefit from donations of recy

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

led equipment, furniture and supplies. A grants program provides financial support to local nonprofits. Local high school students ar

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

e offered summer internships. A new program was launched in FY07 to provide capacity building support to nonprofits working in educat

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

on and youth development in Wards 6, 7 and 8 of Washington. Overview

Grants Program : The Grants Program awards small grants to non

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

rofits in the Washington area. In FY06, the Program awarded grants totaling $960,000 to 25 local charities and funding collaboratives

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

Following aspects would a

undertaking the following activities: education support programs in the District of Columbia’s public schools, after-school tutoring

dd to the challenges in developing combination products:

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

renovating low-income housing; HIV/AIDS prevention; skills training for unemployed workers; distribution of meals to street resident

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

s; Latino youth support; and prenatal and well-baby care. The Program is managed by a Grants Committee comprising both Bank staff and

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

representatives from local grantmakers such as the Community Foundation of the National Capital Region. The Grants Committee recently

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

narrowed its criteria to focus on supporting nonprofit organizations that work in education and youth development in Wards 6, 7 and 8

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

Professional from academic institutions, pharmaceutical industries, health care indust

of Washington.

Funding Collaboratives : The Outreach Program actively participates along with other local grantmakers in five local

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

funding collaboratives that are testing innovative approaches to addressing underlying social problems. A total of $230,000 has been

.

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

distributed to five collaboratives in FY07: DC Education Compact ($50,000); the Community Development Support Collaborative ($50,000)

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

Companies that provide selfless information through particip

the Washington AIDS Partnership ($50,000), the Washington Partnership for Immigrants ($50,000), and the Common Ground Fund ($30,000)

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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