Forum on Drug Discovery, Development, and Translation: 2010 Annual Report (2011)

Below is the uncorrected machine-read text of this chapter, intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text of each book. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Looking Forward Forum Activities in 2011 Forum Meetings The Forum plans to meet in March, June, and October 2011 to identify and discuss key problems and strategies in the discovery, development, and translation of drugs. In addition, the Forum is organizing a number of public meetings, described below. Advancing Regulatory Science for Medical Countermeasure Development— An Institute of Medicine Workshop (March 2011) The Drug Forum will again collaborate with the IOM’s Forum on Medical and Public Health Preparedness for Catastrophic Events to organize a workshop that focuses on advancing regulatory science for MCM development. The workshop will examine ways to advance regulatory science for MCM development for chemical, biological, radiological/nuclear, and emerging infectious disease threats and iden- tify scientific opportunities to improve, simplify, or speed MCM development and improve the predictability and success rate of candidate MCMs. The Global Threat of Multidrug-Resistant Tuberculosis (India and China) In April 2011, the Forum will hold an MDR TB workshop in New Delhi, India. The workshop, which represents a continuation of the Forum’s international workshop series, will bring together local and global experts, as well as government leaders, to continue the dialogue on overcoming the rising threat of MDR TB. The Forum also plans to travel to China to hold its fourth workshop in the series in late 2011 or early 2012. April 23–24 Workshop: Emerging Safety October 15–16 Science, FDA (Forum Meeting #7) Forum Meeting #8 March 12 September 14 Symposium: The Future of Drug Discussion Series: From Patient Safety: Challenges for the FDA Needs to New Drug Therapies 

Looking Forward: Forum Activities in 2011 Members from left to right: Les Benet, Janet Woodcock Steven Galson, Annalisa Jenkins, and Jack Keene Envisioning a Transformed U.S. Clinical Trial Enterprise In 2011, the Forum will continue its attention to how clinical trials can be improved to enhance feedback to a learning health care system, leading to a major workshop to be held in fall 2011. The meeting will examine the need for a national infrastruc- ture for clinical trials that will help to close the gap between clinical research and clinical practice by convening stakeholders to describe the core components of, and to set the agenda for, a transformed clinical trial enterprise. Through discussions and papers submitted to the meeting, the workshop will consider strategies for improving the organization and design of clinical trials across different settings and clinical areas. An additional meeting addressing approaches for enhanced public engagement in the clinical trial enterprise is also planned for 2011. June 23 April 21 Workshop: Breakthrough November 30 Discussion Series: Business Models: Drug Discussion Series: A Conversation Science at FDA: Challenges Development for Rare with Tony Fauci and Opportunities and Neglected Diseases 2008 February 20–21 June 23–24 Discussion Series: Comparative Symposium: Diseases and Individualized Effectiveness (Forum Meeting #9) Therapies (Forum Meeting #10)