By Theresa Wizeman, Sally Robinson, Robert Giffin, Development, and Translation Forum on Drug Discovery, Institute of Medicine

The method for constructing new drug and biologic items is very dear and time-consuming. even supposing huge pharmaceutical businesses are able to come up with the money for the price of improvement simply because they could anticipate a wide go back on funding, agencies constructing medicines to regard infrequent and ignored ailments are not able to depend upon such returns. On June 23, 2008, the Institute of Medicine's discussion board on Drug Discovery, improvement, and Translation held a public workshop, "Breakthrough enterprise types: Drug improvement for infrequent and overlooked illnesses and Individualized Therapies," which sought to discover new and leading edge concepts for constructing medicinal drugs for infrequent and missed ailments.

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The last 50 years has seen very limited development of anti-infective drugs for the developing world. However, with the passage of the Food and Drug Administration Amendments Act (FDAAA) of 2007 and the establishment of the priority review voucher, this situation could finally change. The priority review voucher uses current market forces to create new development incentives. Prior to FDAAA, once FDA had approved a new orphan drug to treat a tropical disease, the sponsor found itself in the difficult position of having a lifesaving new drug that it could not sell since the people who needed it could not afford it.

After the development agreement with a sponsor is in place, CFFT functions as an external expert advisor, enabling, facilitating, and troubleshooting. For example, CFFT can save a business partner 6 months on the learning curve by having validated assays available at contract research organizations or by providing access to positive control compounds or cellular, antibody, or protein reagents. CFFT can also facilitate collaborations between a sponsor and academic partners, as well as access to intellectual property.

More than onethird of childhood deaths occur in the neonatal period. , 2005). These statistics were striking and unacceptable to Dr. Hale, and inspired her to found the Institute for OneWorld Health, a not-for-profit pharmaceutical company focused on neglected diseases in the developing world. , Founder and Chair of the Board of Directors, Institute for OneWorld Health. 19 20 BREAKTHROUGH BUSINESS MODELS BOX 4-1 Examples of Business Models for Funding the Development of Drugs to Treat Rare and Neglected Diseases INSTITUTE FOR ONEWORLD HEALTH (IOWH) Business Model Not-for-profit pharmaceutical company Structure A small team of pharmaceutical company experts, founded in 2000 with seed funding from the Bill and Melinda Gates Foundation.

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