Forum on Drug Discovery, Development, and Translation: Annual Report 2009 (2010)

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Fostering Collabo rative Rese Fostering a robust research environment through collaboration In April, the Forum held a public meeting to explore ways to streamline the process by which universi- ties, industry, and government negotiate agreements for research collaboration. The Forum commis- sioned a paper, which resulted in the development of material transfer agreement (MTA) and clinical trial agreement (CTA) templates that could be used to facilitate such negotiations. The NIH Nation- al Center for Research Resources has disseminated these documents for use by collaborating institutions. In another initiative, the Forum established a precompetitive collaboration to better understand drug failures, explore standards for data collection and analysis, and to ultimately foster improved decision- making with respect to research and investments in drug development. Member companies have begun to share and analyze information on late-stage attrition. Lastly, following the IOM’s report on conflict of interest, the Forum began plans for a workshop in 2010 that will explore approaches to imple- menting the conflict of interest guidelines in a way that promotes an open and fair exchange among arch academic and commercial partners to advance human health. February – Discussion Series Meeting June – Workshop on Breakthrough on Comparative Effectiveness Business Models for Drug Development 2008 April – Discussion Series June – Drug Failures  on Science at the FDA Workgroup launched 

Fostering Collabo rative Rese Material Transfer and Clinical Trial Agreements In an effort to streamline the process of negotiations between universi- ties, industry, and government, the Forum explored the use of mate- rial transfer agreement/clinical trial agreement (MTA/CTA) templates during a workshop in April 2009. A paper commissioned by the Forum resulted in a set of templates that have been widely-disseminated by NIH and others. They can be downloaded from the Forum website (www.iom.edu/CTA-MTA). Forum Member Barbara Alving, NCRR arch Susan Ehringhouse, AAMC, and Bernie Lo, UCSF July – Jeff Drazen October – Workshop on Accelerating the appointed co-chair Development of Biomarkers for Drug Safety August 3 – Psychiatric drug November – Workshop Series on the Threat development papers are published of Multidrug-Resistant Tuberculosis launched