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

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Reflecting Back Forum Activities in 2010 Forum Meetings The Forum met three times in 2010. Discussions at these meetings focused on a diverse array of topics, including the needs for streamlining administra- tive inefficiencies and harmonizing regulatory responsibilities in the conduct of clinical trials and exploration of approaches to address societal and policy concerns about conflicts of interest in science and medicine. In addition, the Forum convened public workshops, described in detail below. The Public Health Emergency Medical Countermeasures Enterprise— Workshop (February 2010) During public health emergencies such as pandemic influenza outbreaks or terrorist attacks, effective vaccines, drugs, diagnostics, and other medical countermeasures are essential to protecting national security and the well- being of the public. The Public Health Emergency Medical Countermeasures Enterprise (PHEMCE)—a partnership among federal, state, and local governments; industry; and academia—is at the forefront of the effort to develop these countermeasures. At the request of the Secretary of the U.S. Department of Health and Human Services (HHS) and the Assistant Secretary for Preparedness and Response, the Drug Forum and the IOM’s Forum on Medical and Public Health Preparedness for Catastrophic Events collaborated to host a workshop, held February 22–24, 2010, to address challenges facing the PHEMCE. Workshop participants discussed federal policies and procedures affecting the research, development, and approval of medical countermeasures (MCMs) and explored opportunities to improve the process and protect Americans’ safety and health. The discussion at the workshop and workshop summary report helped inform the HHS Public Health Emergency Medical Countermeasures Enterprise Review, released in August 2010. FORUM ACTIVITIES TIMELINE 2000–2004 2005 Clinical Research Roundtable, predecessor to the Drug Forum 

Reflecting Back: Forum Activities in 2010 Building a National Framework for the Establishment of Regulatory Science for Drug Development—Workshop (February 2010) In its 2007 report, The Future of Drug Safety: Promoting and Protecting the Health of the Public, the IOM identified the need for an improved science base for drug evaluation within FDA, including both internal resources and extramural funding for collaboration with academia. In that same year, the FDA Science Board, at the request of Congress, reported on the agency’s need for an enhanced science base, including infrastructure development, multisector collaboration, and an expanded workforce capable of address- ing the rapidly evolving science of drug discovery and development. In 2008, the Forum held a public workshop to explore the science of drug regulation, focusing on the gap between leading-edge technologies of drug development and FDA’s capacity to adapt its process of regulatory evaluation to these technologies. Together, the results of these efforts suggest a widening gap between scientific developments in areas relevant to FDA’s mission and its ability to address these innovations, as well as a lack of understanding among the public, policy makers, and the agency of what is required to fill this gap. To address these concerns, the Forum convened a public workshop, held February 26, 2010, to examine the state of the science of drug regulation and consider approaches for enhancing the scientific basis of regulatory decision making. The workshop provided an opportunity to explore the concept of regulatory science, examine how it can be used to improve regulatory deci- sion making, and consider alternative mechanisms and institutional frame- works for its development and application. March 23–24 June 29–30 September 8–9 Forum Meeting #1 Forum Meeting #2 Forum Meeting #3 

Multidrug-Resistant Tuberculosis (MDR TB) The Forum’s initiative on multidrug-resistant tuberculosis (MDR TB) includes a series of workshops that have gained international attention. The first workshops— held in the United States in 2008 and 2009—highlighted new data in conducting a realistic assessment of the magnitude of the problem and the gaps needed to address the rapid spread of drug-resistant TB. These meetings led to the develop- ment of workshops to take place in the four highest burden countries—South Africa, Russia, India, and China. The Forum collaborated with the National Institute of Allergy and Infectious Diseases (NIAID) of NIH to develop coordinated MDR TB-related research meetings in both Russia and South Africa, and that collabora- tion is continuing in 2011 as the Forum plans its next workshop in New Delhi, India. The NIH meetings focus on science and opportunities for scientific collaboration, while the IOM meetings address health care delivery, drug access, public health, and other policy issues. The Emerging Threat of Drug-Resistant Tuberculosis in Southern Africa: Global and Local Challenges and Solutions—Workshop (March 2010) The first meeting in the workshop series on MDR TB was held in Pretoria, South Africa on March 3–4, 2010. The Forum partnered with the Academy of Science of South Africa (ASSAf ) to convene the two-day workshop, which brought together disease experts, community leaders, and policymakers to examine the state of MDR TB in the South Africa region, to learn from the experiences of the South African public health community in its fight against MDR TB, and to draw lessons regarding best practices and novel approaches that can be applied both within and beyond the region. The South Africa meeting focused on various aspects of MDR TB, including epidemiology, diagnostics and preventive therapies, treatment, transmission and infection control, pediatric MDR TB, and public policy issues. November 3–4 June 13 Workshop: Adverse Drug Event March 28–29 Workshop: Addressing Reporting: The Roles of Consumers Forum Meeting #4 the Barriers to Pediatric and Health-Care Professionals Drug Development 2006 May 30–31 Workshop: Understanding the Benefits and Risks of Pharmaceuticals 

Reflecting Back: Forum Activities in 2010 The New Profile of Drug-Resistant Tuberculosis in Russia: A Global And Local Perspective—Workshop (May 2010) The second meeting in the workshop series on MDR TB was held in Moscow, Russia on May 26–27, 2010. The workshop was mentioned as one of the first activities in the Statement of Intent under a Memorandum of Understanding between the Academies, NIH, and the Russian Academy of Sciences signed during President Obama’s visit to Moscow in 2009. The Forum partnered with the Russian Academy of Medical Sciences to convene the two-day workshop, which brought together disease experts, community leaders, and policymakers. FDA Commissioner Dr. Margaret Hamburg and Dr. Paul Farmer of Partners In Health delivered speeches and participated in session discussions. Like the South Africa meeting, the meeting focused on various aspects of MDR TB (including epidemiology, diagnostics and preven- tive therapies, treatment, transmission and infection control, pediatric TB, and public policy issues). The meeting objectives were to examine the state of MDR TB in Russia, to learn from the experiences of the Russian and inter- national public health community in its fight against MDR TB, and to draw lessons regarding best practices and novel approaches that can be applied both within and beyond the region. 2007 June 27–28 October 24–25 Forum Meeting #5 Forum Meeting #6