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Looking Forward Forum Activities in 2012 Forum Meetings The Forum membership will meet in March, June, and October 2012 to continue its discussions of key problems and strategies in the discovery, development, and translation of drugs. The March meeting will include a discussion organized by the Forumâs innovation working group, which is exploring potentially breakthrough ideas to advance âdisruptive innovationâ to break out of the current crisis in R&D productivity, as well as a discussion with the leadership of the new FDA-supported academic Centers of Excellence in Regulatory Science. Forum working groups are convening to discuss and explore potential workshop topics in the areas of clinical research data sharing, benefit-risk assessment, international drug regulatory har- monization, and clinical trials informatics. In addition, the Forum is convening a number of public meetings, described below. Maximizing the Goals of the Cures Acceleration Network (CAN) to Accelerate the Development of New Drugs and DiagnosticsâWorkshop (June 2012) Recent years have seen both extraordinary opportunity and complex challenges in pharmaceutical innovation. New biomedical technology platforms are creating novel avenues for research and new opportunities for the discovery and clinical development of innovative diagnostics and therapies. Yet despite these advances, the pathway from basic science to new therapeutics faces challenges on many fronts. Bringing a new diagnostic, drug, or biologic product to market has become increasingly expensive and risky: the scientific challenges in finding novel drug October 24 November 5 March 13 Workshop: Assessing and Workshop: Addressing the Threat Discussion Series: FDA Community Accelerating Development of of Drug-Resistant TB: A Realistic Update on Personalized Medicine and Biomarkers for Drug Safety Assessment of the Challenge the Genetic Basis of Adverse Events 2009 February 23 November 3 Capitol Hill Briefing: Growing Forum Meeting #11 Threat of Drug-Resistant TB
Looking Forward: Forum Activities in 2012 targets are profound; the pharmaceutical business model and acquisition of capi- tal are challenged; and the nurturing and collaborative research environment necessary for a robust biomedical research enterprise has eroded. New collabora- tive approaches within the federal agencies, academia, and industry are directing focused attention on the advancement of the drug development enterprise. The leadership at both NIH and FDA have established dedicated efforts to promote innovation in regulatory science and translational medicine, including establishment of a FDA-NIH Joint Leadership Council that is charged with identifying critical areas where cross-agency collaborative action can be taken, and the establishment of NCATS at NIH. In response to a request from NCATS, the Forum will convene a public workshop that will explore ways to maximize the usefulness and impact of CAN in order to advance translational sciences. The workshop will include con- sideration of the effective use of CAN authorities for the development of new tools and methods to enhance the development and testing of therapies and diagnostics to patients. In addition to providing suggestions to NCATS, the workshop is, in part, in response to congressional interest in CAN expressed in the FY 2012 appropria- tions act conference report. The workshop will inform NIH/NCATS in its efforts to implement CAN and advance translational sciences, and will also inform the public, policy community, and other stakeholders as all of these parties continue to work to enhance the development and testing of therapies and diagnostics to patients. The summary will be provided to NCATS and the newly established CAN Board to help it identify ways to accelerate and expand the number of cures. A summary of this workshop will be prepared and made available on the Forum website. April 27 September 2 Workshop: Streamlining Discussion Series: FDA October 15â16 Clinical Trial and Material Community Update on Forum Meeting #14 Transfer Negotiations Post-Market Drug Safety July 10 Symposium: Drug Regulation with October 7â8 April 27â28 FDA Commissioner, Peggy Hamburg Workshop: Transforming Clinical Forum Meeting #12 (Forum Meeting #13) Research in the United States
Addressing the Global Supply Chain for Second-Line Anti-TB Drugsâ Workshop (Summer 2012) To effectively treat patients diagnosed with DR TB, and protect the population from further transmission of this disease, an uninterrupted supply of quality-assured second-line anti-TB drugs (SLDs) is necessary. When SLDs are unavailable to the National Tuberculosis Control Program (NTP) and medical providers, patients miss critical doses of medicine or never start treatmentârisking the escalation of disease/amplification of drug-resistance, enhanced infectivity and transmission of disease to others, and death. Ensuring a reliable and affordable supply of high- quality SLDs is a complex public health intervention that, thus far, has not been organized or implemented in a way that allows all providers and patients access to SLDs when they are needed. Although some MDR TB patients without access to SLDs through a Green Light Committeeâapproved program may receive appropri- ate treatment through a government-run or other quality assurance program, it is estimated that approximately 90 percent of patients with DR TB are not receiving treatment through a government-run or quality-assured program. In other words, these patients are likely receiving treatment from sources of unknown quality or no treatment at all. The global supply chain for SLDs faces a number of challenges: (1) the overall market for SLDs is relatively small due to limited diagnostic capacity at the country level; (2) demand-forecasting mechanisms do not fully capture patient needs for SLDs; (3) markets are opaque, with high barriers to entry that may deter February 26 March 3â4 Workshop: Building a National South Africa Workshop: The Framework for the Establishment Emerging Threat of Multidrug- of Regulatory Science for Resistant Tuberculosis April 29â30 Drug Development Forum Meeting #15 2010 February 22-24 May 26â27 Workshop: The Public Health Emergency Medical Countermeasures Russia Workshop: The New Profile Enterprise (in collaboration with the Medical Preparedness Forum) of Drug-Resistant Tuberculosis
Looking Forward: Forum Activities in 2012 manufacturers; (4) drugs carry high prices; and (5) there are lengthy timelines for countries to receive drugs. The workshop will be convened by the Forum to provide a format for establishing a specific agenda to address the needs and opportunities for a global supply chain for TB SLDs. An international supply chain expert was commissioned to prepare a paper examining gaps in the global TB SLD supply chain and identifying potential solutions to those gaps. A summary of this workshop will be prepared and made available on the Forum website. Drug-Resistant Tuberculosis in ChinaâWorkshop (January 2013) The final workshop in the Forumâs international workshop series on MDR TB will be held in China in January 2013 in collaboration with the Chinese Academy of Sciences. This workshop will address the current status of DR TB in China and across the globe; highlight key challenges to controlling the spread of DR strains; and discuss innovative strategies to advance and harmonize local and international efforts to prevent and treat DR TB. The meeting will focus on various aspects of DR TB, including epidemiology, diagnostics and preventive therapies, treatment, transmission and infection control, pediatric TB, innovative approaches to TB con- trol, and drug procurement and supply issues. A summary of this workshop will be prepared and made available on the Forum website. August 5â6 April 18â19 Discussion Series: India Workshop: Facing the Conflict of Interest Reality of Multidrug-Resistant (Forum Meeting #16) March 28 Tuberculosis Forum Meeting #18 2011 October 29 March 29â30 Discussion Series: Administrative and Regulatory Workshop: Advancing Regulatory Science Inefficiencies in Clinical Trials (Forum Meeting #17) for Medical Countermeasure Development