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

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Looking Forward Looking Forward: Forum Activities in 2014 Forum Activities in 2014 Forum Meetings The Forum membership will meet in March, June, and October 2014 to continue its discussions of key problems and strategies in the discovery, development, and translation of drugs. Forum working groups are convening to discuss and explore potential research, publication, and workshop topics in the areas of envisioning and characterizing transformation and disruptive innovation in the drug development enterprise, strengthening the effectiveness and impact of collaboration, advancing pharmaceutical safety monitoring, and supporting a translational science work- force. In addition, the Forum is convening the public workshops and collaborative meetings described below. Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products—Workshop (February and May 2014) There is increasing attention to the need for enhancing the evaluation and commu- nication of the benefits and risks associated with pharmaceutical products, thereby increasing the predictability, transparency, and efficiency of pharmaceutical regula- tory decision making. In 2006, the IOM’s Forum on Drug Discovery, Development, and Translation held a workshop to explore the complex tradeoff between drug benefits and risks and examine approaches for better quantifying this balance and informing the public and the medical community. Since that time, FDA has worked to develop an enhanced structured approach to the assessment of benefits and risks in drug regulatory decision making to better communicate this aspect of the human drug review process. An extensive body of evidence informs regulatory decisions on 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) 

Clinical Trial Site Accreditation Action Collaborative meeting, August 2013 the safety and efficacy of a proposed product, but in many cases, FDA must draw con- clusions from imperfect data. This two-part public workshop series is being convened at the request of FDA to address the opportunity to advance the development of more systematic and structured approaches to characterize and communicate: (a) the sources October 24 November 5 March 13 Workshop: Assessing and Workshop: Addressing the Threat Discussion Series: FDA Community Accelerating Development of of Drug-Resistant Tuberculosis: A Update on Personalized Medicine and Biomarkers for Drug Safety Realistic 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 Tuberculosis 

Looking Forward: Forum Activities in 2014 of uncertainty in the assessment of benefits and risks, and (b) their implications for pharmaceutical regulatory decisions. Specifically, the workshops will explore potential analytical and communication approaches and identify key considerations on their development, evaluation, and incorporation into the assessment of benefits and risks in pharmaceuticals. Developing a National Accreditation System to Improve Clinical Trial Performance—Action Collaborative (March 2014) The members of the Clinical Trial Site Accreditation Action Collaborative will meet for the third time on March 11, 2014, to discuss the findings of the working groups on a process for standards development, and on the establishment of a mechanism to facilitate a process to align and improve clinical trial site standards. Participants are preparing a Perspective paper to be published by the IOM. April 27 September 2 Workshop: Streamlining Discussion Series: FDA October 15–16 Clinical Trial and Material Community Update on Forum Meeting #14 Transfer Negotiations Post-Market Drug Safety July 10 Symposium: Drug Regulation with October 7–8 April 27–28 FDA Commissioner Peggy Hamburg Workshop: Transforming Clinical Forum Meeting #12 (Forum Meeting #13) Research in the United States