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.
Reflecting Back Forum Activities in 2011 Forum Meetings The Forum membership met three times in 2011. Discussions at these meet- ings focused on diverse topics relating to the Forumâs priorities, including observational drug safety monitoring; addressing quality in clinical trials and international efforts to harmonize regulation of medical research; drug development for rare and neglected diseases; and policy developments related to drug discovery, development, and translation. In addition, the Forum convened public workshops, described and grouped according to Forum priority topics below. Strengthening the Scientific Basis of Drug Regulation Advancing Regulatory Science for Medical Countermeasure Developmentâ Workshop (March 2011) During public health emergencies such as pandemic influenza outbreaks or terrorism attacks, effective vaccines, drugs, diagnostics, and other medical countermeasures (MCMs) are essential to protecting national security and the well-being of the public. The August 2010 Department of Health and Human Services (HHS) Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Review made numerous recommendations to trans- form the PHEMCE to increase its speed, agility, capacity, and success rate, including the promotion of regulatory innovation and investment in regula- tory science at FDA. To promote regulatory innovation and investment in regulatory science, FDA has established an MCM initiative. In March 2011, the Forum collaborated with the IOMâs Forum on Medical and Public Health Preparedness for Catastrophic Events to conduct, at the request of FDA, a workshop that examined ways to advance regulatory science for MCM development and regulatory evaluation; identified scientific opportunities to improve, simplify, or speed MCM development; and identified tools and methods to improve the predictability and success rate of candidate MCMs. FORUM ACTIVITIES TIMELINE 2000â2004 2005 Clinical Research Roundtable, predecessor to the Drug Forum
Reflecting Back: Forum Activities in 2011 Regulatory Science Workforce Workshop co-chairs Regulatory Science Workforce Workshop panel from left to right: Elaine Gallin and Barry Coller Carl Peck, Alastair Wood, Steven Galson, Elaine Gallin, and Barry Coller Strengthening a Workforce for Innovative Regulatory Science in Therapeutics DevelopmentâWorkshop (September 2011) A number of gaps in the regulatory science discipline and infrastructure have been identified. They include workforce and resource constraints; cultural differences and systematic barriers to collaboration and exchange; and deficiencies in the network and infrastructure necessary to forge the collaboration and communication needed to advance regulatory science. In September 2011, the Forum held a workshop that considered opportu- nities and needs for advancing innovation in the discipline of regulatory science for therapeutics development through an interdisciplinary regula- tory science workforce. The workshop focused closely on the core compo- nents of a robust discipline of regulatory science; deliberated on the key competencies for a regulatory science workforce; and examined needs and opportunities to promote training, career development, and collaborative approaches to sustain and nurture a workforce in innovative regulatory sci- ence. The workshop was held at the request of Forum sponsor Burroughs Wellcome Fund (BWF) and was a follow-up to the regulatory science work- shop held in February 2010. March 23â24 June 29â30 September 8â9 Forum Meeting #1 Forum Meeting #2 Forum Meeting #3
Transforming Research and Fostering Collaborative Research and Promoting Public Understanding of Drug Development Public Engagement and Clinical Trials: New Models and Disruptive Technologiesâ Workshop (June 2011) In June 2011, the Forum collaborated with the Mount Sinai School of Medicine Department of Health Evidence and Policy and Conduits, the Institutes for Translational Sciences at Mount Sinai, to convene a public workshop that explored systemic, cultural, and methodological issues underlying the problem of insufficient public engagement in the clinical trials enterprise, and considered models, methods, and messages for enhancing and supporting clinical research in the United States. Discussions at the workshop included consideration of the structures and culture of health care systems and delivery organizations that fail to support or engage with the clinical trials enterprise; how academic medical centers can create successful community partnerships to improve public engagement in clinical trials; models, methods, and messages for communication and engagement with the public; and novel clinical trial designs (such as adaptive clinical trial designs) that minimize enrollment needs and address treatment assignment concerns of physicians and their patients. This workshop was conducted as part of the Forumâs clinical trials initiative to improve the clinical trials enterprise in the United States, including promotion of public understanding of and support for clinical trials and the drug development enterprise. Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020âWorkshop (November 2011) Since 2009, the Forum has been engaged in a focused effort to address challenges facing the U.S. clinical trials enterprise and to engage stakeholders in an open November 3â4 June 13 Workshop: Adverse Drug Event March 28â29 Workshop: Addressing Reporting: The Roles of Consumers Forum Meeting #4 the Barriers to Pediatric and Health-Care Professionals Drug Development 2006 May 30â31 Workshop: Understanding the Benefits and Risks of Pharmaceuticals
Reflecting Back: Forum Activities in 2011 Forum member Janet Woodcock Forum co-chair Jeffrey Drazen discussion of potentially transformative strategies to improve the efficiency and effectiveness of clinical trials. Key themes considered throughout the ini- tiative included (1) regulation and infrastructure of clinical trials in the United States and (2) public engagement in the clinical trials enterprise. In November 2011, the Forum convened a major workshop to serve as a âcapstoneâ to this clinical trials workshop series, which established a vision and a framework for a transformed national clinical trials enterprise. The workshop was supported by and organized around a series of four discussion papers authored by collab- orative, cross-sector working groups of Forum members and outside experts. The workshop focused on core themes, including vision for a clinical trials enterprise in the health care system of 2020; clinical trials workforce devel- opment; alignment of cultural and financial incentives; and infrastructure to support a transformed clinical trials enterprise. Developing Drugs for Rare and Neglected Diseases and Addressing Urgent Global Health Problems Facing the Reality of Multidrug-Resistant Tuberculosis: Challenges and Potential Solutions in IndiaâWorkshop (April 2011) The Forumâs initiative on MDR TB includes a series of workshops that have gained international attention. The first workshopsâheld in the United 2007 June 27â28 October 24â25 Forum Meeting #5 Forum Meeting #6
Workshop delegation: MDR TB in India States in 2008 and 2009âhighlighted 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 (DR) TB. These meetings led to the development of workshops taking place in the four highest-burden countriesâSouth Africa, Russia, India, and China. The Forum collaborated with the National Institute of Allergy and Infectious Diseases (NIAID) of NIH to develop coordinated MDR TBârelated research meet- ings in South Africa, Russia, and India, and that collaboration is continuing in 2012 as the Forum plans its next workshop in Beijing, China. In April 2011, the Forum hosted the third workshop in its workshop series on MDR TB in New Delhi, India. The workshop was held in partnership with the Indian National Science Academy and the Indian Council of Medical Research, and took place at the Indian National Science Academy conference facility. The workshop addressed the current status of April 23â24 Workshop: Emerging Safety October 15â16 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
Reflecting Back: Forum Activities in 2011 DR TB in India and across the globe; highlighted key challenges to control- ling the spread of DR strains; and discussed innovative strategies to advance and harmonize local and international efforts to prevent and treat DR TB. In India, the NIH portion of the meeting focused on basic science and oppor- tunities for scientific collaboration in the discovery and development of TB drugs, while the IOM portion addressed health care delivery, drug procure- ment, public health, and policy issues. Also in 2011, the Forum extended dissemination of and engagement with its initiative on DR TB by convening two workshop summary report release events. In July 2011, in Durban, South Africa, the Forum partnered with the Academy of Science of South Africa to hold an official release event, which took place at the Nelson Mandela School of Medicine of the University of KwaZulu-Natal, in conjunction with the Groundbreaking Symposium of the new KwaZulu-Natal Research Institute for Tuberculosis and HIV (K-RITH), a collaboration between the Howard Hughes Medical Institute and the University of KwaZulu-Natal. In November 2011, in Moscow, Russia, the Forum partnered with the Russian Academy of Medical Sciences to hold an official release event, which was held in conjunction with a meeting hosted by the International Science and Technology Center addressing pediatric DR TB. The event immediately pre- ceded the convening of a major biomedical conference held as a collaborative forum among the Fogarty International Center, the Foundation for the NIH, the Russian Academy of Sciences, the Russian Academy of Medical Sciences, the National Academy of Sciences, and the IOM. 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 20â21 June 23â24 Discussion Series: Comparative Symposium: Diseases and Individualized Effectiveness (Forum Meeting #9) Therapies (Forum Meeting #10)