Forum on Drug Discovery, Development, and Translation: 2013 Annual Report (2014)

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Reflecting Back Forum Activities in 2013 Forum Meetings The Forum membership met three times in 2013. Discussions at these meet- ings focused on diverse topics relating to the Forum’s priorities, including grand challenges in drug discovery, development, and translation; reproduc- ibility issues confronted in therapeutics development; harnessing informa- tion science; clinical trial data transparency and sharing; and policy devel- opments and needs in the landscape of the bioinnovation ecosystem. In addition, the Forum convened public workshops and collaborative meetings, described below. The Global Crisis of Drug-Resistant Tuberculosis and Leadership of China and the BRICS: Challenges and Opportunities—Workshop (January 2013) The Forum convened a multiyear international initiative on multidrug- resistant tuberculosis (MDR TB), which began with a foundational work- shop in Washington, DC, in 2008, and international workshops in the high- burden countries of South Africa (2010), Russia (2010), India (2011), and China (2013). The final workshop in the MDR TB series was held in Beijing, China, in January 2013 in collaboration with the Institute of Microbiology, Chinese Academy of Sciences (IMCAS). This workshop addressed the cur- rent status of drug-resistant (DR) TB in China and across the globe; high- lighted key challenges to controlling the spread of DR strains; and discussed innovative strategies to advance and harmonize local and international efforts to prevent and treat DR TB. The meeting focused on various aspects of DR TB, including epidemiology, diagnostics and preventive therapies, treatment, transmission and infection control, pediatric TB, innovative approaches to TB control, and drug procurement and supply issues. FORUM ACTIVITIES TIMELINE 2000–2004 2005 Clinical Research Roundtable, predecessor to the Drug Forum 

Reflecting Back: Forum Activities in 2013 MDR TB in China and the BRICS Workshop co-chairs Gail Cassell and Barry Bloom with speakers and IMCAS staff International Regulatory Harmonization Amid Globalization of Biomedical Research and Medical Product Development—Workshop (February 2013) The last several decades have seen a rapid globalization of commerce, includ- ing within the medical product and technology sectors. Investigational studies for products intended for use in U.S. populations are increasingly being con- ducted outside the United States, often in countries with limited regulatory March 23–24 June 29–30 September 8–9 Forum Meeting #1 Forum Meeting #2 Forum Meeting #3 

capacity. Moreover, biopharmaceutical companies seeking global markets for a single product face requirements for regulatory submissions in numerous interna- tional jurisdictions that could introduce scientific requirements that are discordant with U.S. standards. Discordant data requirements could result in additional clini- cal trials and animal studies, exposing more patients to experimental drugs and increasing the use of laboratory animals. There is a need for globally harmonized, science-based standards for the development and evaluation of safety, quality, and efficacy of medical products—both to enhance the efficiency and clarity of the drug development and evaluation process and ultimately to promote and enhance Lawrence Tabak speaking to the Forum about NIH reproducibility efforts, pictured with James Shannon, GlaxoSmithKline; Kathy Hudson, NIH; and Rusty Kelley, Burroughs Wellcome Fund 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 2013 product quality and the public’s health. There is also need for har- monization of standards for ongo- ing safety and quality surveillance of marketed biomedical products. This public workshop identified needs for international harmoni- zation of regulatory standards to support the development, evalu- ation and surveillance of bio- medical products. The workshop identified principles and potential approaches to the development or evolution of more harmonized International Regulatory Harmonization Workshop speaker Peter regulatory standards. Honig, AstraZeneca Developing a National Accreditation System to Improve Clinical Trial Performance—Action Collaborative (August 2013) The Forum continued to devote time and attention to issues around clinical trials, convening an Action Collaborative to foster develop- ment of a national accreditation system for clinical trial sites. The Action Collaborative, a convening activity under the auspices of the Forum, provides a venue for joint and collaborative activities among participants to advance development of standards or a system to improve clinical trial 2007 June 27–28 October 24–25 Forum Meeting #5 Forum Meeting #6 

Forum Director Anne Claiborne with, from left to right: Jeffrey Drazen (Forum co-chair), Steven Galson (Forum co-chair), Paul Seligman, Bernard Munos, and Rusty Kelley performance through accreditation of clinical trial sites. Participants, who are drawn from multiple sectors and disciplines, met for the second time on August 21, 2013, and convened working groups to discuss their perspectives on a process for standards development, and on the establishment of a mechanism to facilitate coordination of an experimental approach to develop and implement standards reporting and monitoring. 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