Tuberculosis is one of the leading causes of death in the world today, with 4,500 people dying from the disease every day. Many cases of TB can be cured by available antibiotics, but some TB is resistant to multiple drugs-a major and growing threat worldwide. The Institute of Medicine's Forum on Drug Discovery, Development, and Translation hosted a workshop on November 5, 2008, to address the mounting concern of drug-resistant TB. The session brought together a wide range of international experts to discuss what is known and not known about this growing threat, and to explore possible solutions. Table of Contents Front Matter Summary 1 Introduction 2 The Global Spread of Multidrug-Resistant and Extensively Drug-Resistant Tuberculosis 3 MDR TB Transmission, HIV Coinfection, and Transmission Control 4 Diagnosis 5 Infrastructure and Health Care Delivery Systems 6 Global Systems for the Purchase and Delivery of TB Drugs 7 Research on the Global Control of TB: Understanding the Role of Drugs, Vaccines, and Funding 8 Strategies for Confronting the Global MDR and XDR TB Crisis References Appendix A: Agenda Appendix B: Participant Biographies Appendix C: Partners In Health White Paper - Stemming the Tide of Multidrug-Resistant Tuberculosis: Major Barriers to Addressing the Growing Epidemic

Biomarkers can be defined as indicators of any biologic state, and they are central to the future of medicine. As the cost of developing drugs has risen in recent years, reducing the number of new drugs approved for use, biomarker development may be a way to cut costs, enhance safety, and provide a more focused and rational pathway to drug development.
On October 24, 2008, the IOM's Forum on Drug Discovery, Development, and Translation held "Assessing and Accelerating Development of Biomarkers for Drug Safety," a one-day workshop, summarized in this volume, on the value of biomarkers in helping to determine drug safety during development.

The process for developing new drug and biologic products is extraordinarily expensive and time-consuming. Although large pharmaceutical companies may be able to afford the cost of development because they can expect a large return on investment, organizations developing drugs to treat rare and neglected diseases are unable to rely on such returns. On June 23, 2008, the Institute of Medicine's Forum on Drug Discovery, Development, and Translation held a public workshop, "Breakthrough Business Models: Drug Development for Rare and Neglected Diseases and Individualized Therapies," which sought to explore new and innovative strategies for developing drugs for rare and neglected diseases. Table of Contents Front Matter 1 Introduction and Overview 2 Current Model for Financing Drug Development: From Concept Through Approval 3 The Food and Drug Administration's Orphan Drug Program 4 Diverse Funding Models 5 Strategies for Facilitating Sharing of Research Materials and Data 6 Strategies for Navigating Intellectual Property 7 Strategies for Facilitating Clinical Trials 8 Summary References Appendix A: Agenda Appendix B: Speaker Biographies Appendix C: Resources