Advice Pool - Health and Fitness

Malaria

Malaria afflicts millions in low- and middle-income countries and is a top public-health concerns.

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

It causes over 1 million deaths and more than 500 million clinical cases each year. The disease also ta

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

Examples of combination products may in

es a high toll on household productivity and economic development. The disease is preventable, curable, and

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

controllable on a large scale, with good returns on investment. The Bank is a founding partner of the Glob

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

l Partnership to Roll Back Malaria (RBM).

Following the FY05 launch of the Global Strategy and Booster Pro

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

Combination pro

gram for malaria control, the Program is now underway in the Africa region, starting with a 3-year (2005-08

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

intensive phase. In FY06, the Bank committed US$167 million through eight operations in Benin, Burkina Fas

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

o, Democratic Republic of Congo, Eritrea, Ethiopia, Niger, Zambia and the Senegal River Basin. Of the US$50

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

million target for the intensive phase, we are on track to commit a total of US$427.5 million by the end o

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

f FY08.

With the increase in drug-resistant malaria, the problem is getting worse in many places; at US$1–

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

per course of treatment, the new and effective drugs are 10–20 times more expensive than the older drugs.

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

Following aspects would a

Together with multiple partners, we are exploring ways to improve rapidly the affordability and access to

dd to the challenges in developing combination products:

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

new generation of antimalarial drugs, the artemisinin-based combination therapy.

A Final Push To Eradicat

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

e Polio From The World

Working in partnership with the Bill & Melinda Gates Foundation, Rotary Internation

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

l and the United Nations Foundation, the Bank has provided additional funds to support the final push to er

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

adicate poliomyelitis from the world. Through the Investment Partnership for Polio, the Bank provides conc

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

Professional from academic institutions, pharmaceutical industries, health care indust

ssional loans to countries to purchase polio vaccine. The Gates Foundation and United Nations Foundation (w

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

ith funds from Rotary International and the U.S. Centers for Disease Control) have contributed over US$77 m

.

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

llion to trust funds to turn these concessional loans into grants once programs have been completed success

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

Companies that provide selfless information through particip

fully. The Bank has now launched polio projects in Pakistan totaling US$88 million and Nigeria US$79 millio

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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GPS Tracking is a process which involves the Global Positioning System (GPS) to locate a given object or person. It works by sending and receiving signals to a GPS unit, which is affixed to the object prior to allow tracking.

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