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Appendix A: Workshop Agenda
Pages 71-90

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From page 71... ... Campus White Oak, Maryland Background and Meeting Objectives There is increasing attention on the need for enhancing the evaluation and communication of the benefits and risks associated with pharmaceutical products, thereby increasing the predictability, transparency, and efficiency of pharmaceutical regulatory decision making. In 2006, the IOM's Forum on Drug Discovery, Development, and Translation held a workshop to explore the complex trade-off between drug benefits and risks and to examine approaches for better quantifying this balance and informing the public and the medical community. Read the entire page →
From page 72... ... • Identify potential systematic approaches to address uncertainty faced by regulators in the assessment of benefits and risks in phar maceuticals, drawing from various scientific and regulatory disci plines and domains. 1 FDA's structured approach to benefit–risk assessment in drug regulatory decision mak ing is outlined in the Draft PDUFA V Implementation Plan [February 2013] Read the entire page →
From page 73... ... First Workshop in the Series 9:00 a.m. Opening Remarks Baruch Fischhoff, Workshop Co-Chair Howard Heinz University Professor Department of Social and Decision Sciences Department of Engineering and Public Policy Carnegie Mellon University Robert Ratner, Workshop Co-Chair Chief Scientific and Medical Officer American Diabetes Association 9:15 a.m. Read the entire page →
From page 74... ... Baruch Fischhoff, Workshop Co-Chair Howard Heinz University Professor Department of Social and Decision Sciences Department of Engineering and Public Policy Carnegie Mellon University 9:35 a.m. Key Sources of Uncertainty in the Assessment of Benefits and Risks of Pharmaceuticals and Associated Challenges (15 min.) Read the entire page →
From page 75... ... Patrick Frey, Session Chair Director, Office of Program and Strategic Analysis Center for Drug Evaluation and Research U.S. Food and Drug Administration 11:15 a.m. Read the entire page →
From page 76... ... Discussion Moderator: Patrick Frey, Director, Office of Program and Strategic Analysis, Center for Drug Evaluation and Research, U.S. Food and Drug Administration 12:10 p.m. Read the entire page →
From page 77... ... Baruch Fischhoff, Workshop Co-Chair Howard Heinz University Professor Department of Social and Decision Sciences Department of Engineering and Public Policy Carnegie Mellon University 1:05 p.m. Methods to Characterize and Elicit Uncertainty (15 min.) Read the entire page →
From page 78... ... Baruch Fischhoff, Workshop Co-Chair Howard Heinz University Professor Department of Social and Decision Sciences Department of Engineering and Public Policy Carnegie Mellon University 2:45 p.m. Public Policy in an Uncertain World: Analysis and Decisions in Pharmaceutical Benefits and Risks (15 min.) Read the entire page →
From page 79... ... Baruch Fischhoff, Workshop Co-Chair Howard Heinz University Professor Department of Social and Decision Sciences Department of Engineering and Public Policy Carnegie Mellon University Read the entire page →
From page 80... ... Francesco Pignatti Oncology, Hematology, Diagnostics Section Scientific and Regulatory Management Department European Medicines Agency Kimby Barton Director, Bureau of Cardiology, Allergy, and Neurological Sciences Health Canada John Jenkins Director, Office of New Drugs Center for Drug Evaluation and Research U.S. Food and Drug Administration Ralph Horwitz Senior Vice President Clinical Sciences Evaluation GlaxoSmithKline Timothy McDaniels Faculty of Science Institute of Resources and Environment University of British Columbia Panel and Discussion Moderator: Baruch Fischhoff, Howard Heinz University Professor, Department of Social and Decision Sciences, Department of Engineering and Public Policy, Carnegie Mellon University 5:00 p.m. Read the entire page →
From page 81... ... Campus White Oak, Maryland Background and Meeting Objectives There is increasing attention on the need for enhancing the evaluation and communication of the benefits and risks associated with pharmaceutical products, thereby increasing the predictability, transparency, and efficiency of pharmaceutical regulatory decision making. In 2006, the IOM's Forum on Drug Discovery, Development, and Translation held a workshop to explore the complex trade-off between drug benefits and risks and to examine approaches for better quantifying this balance and informing the public and the medical community. Read the entire page →
From page 82... ... Welcome and Opening Remarks Baruch Fischhoff, Workshop Co-Chair Howard Heinz University Professor Department of Social and Decision Sciences Department of Engineering and Public Policy Carnegie Mellon University Robert Ratner, Workshop Co-Chair Chief Scientific and Medical Officer American Diabetes Association Read the entire page →
From page 83... ... § Discuss how lessons and observations from the first workshop could support the advancement of approaches to characterizing uncertainty in the assessment of benefits and risks and their impli cations for pharmaceutical regulatory decisions. Baruch Fischhoff, Workshop Co-Chair, Session Chair Howard Heinz University Professor Department of Social and Decision Sciences Department of Engineering and Public Policy Carnegie Mellon University 9:05 a.m. Read the entire page →
From page 84... ... Food and Drug Administration 10:30 a.m. FDA Patient-Focused Drug Development Initiative (15 min.) Read the entire page →
From page 85... ... SESSION III: COMMUNICATING UNCERTAINTY ABOUT BENEFIT AND RISK ASSESSMENTS Session Objectives: § Understand and consider the implications of the communication of uncertainty about benefit and risk assessments on the health care system beyond drug regulatory decision making. § Understand a patient perspective on what is important to patients in understanding the assessments of benefit and risk and how patients want to receive and share information about uncertainty. Read the entire page →
From page 86... ... Baruch Fischhoff, Workshop Co-Chair Howard Heinz University Professor Department of Social and Decision Sciences Department of Engineering and Public Policy Carnegie Mellon University 11:40 a.m. Risk Communication in the Context of Pharmaceuticals (15 min.) Read the entire page →
From page 87... ... Robert Temple Deputy Director for Clinical Science Acting Deputy Director, Office of Drug Evaluation I Center for Drug Evaluation and Research U.S. Food and Drug Administration 1:05 p.m. Read the entire page →
From page 88... ... Food and Drug Administration Cynthia Sitcov Patient Representative & Voting Member U.S. Food and Drug Administration, Central and Peripheral Systems Advisory Committee, 2005–Present Discussion Moderator: Gavin Huntley-Fenner, Human Factors and Safety Consultant, Huntley-Fenner Advisors 2:25 p.m. Read the entire page →
From page 89... ... Baruch Fischhoff, Workshop Co-Chair Howard Heinz University Professor Department of Social and Decision Sciences Department of Engineering and Public Policy Carnegie Mellon University Robert Ratner, Workshop Co-Chair Chief Scientific and Medical Officer American Diabetes Association 3:20 p.m. Brainstorming Discussion of Key Themes from the Workshop Series (80 min.) Read the entire page →
From page 90... ... Discussion Moderators: Workshop Co-Chairs, Baruch Fischhoff, Carnegie Mellon University; and Robert Ratner, American Diabetes Association 5:00 p.m. Adjourn Read the entire page →

From page 71...

... Campus White Oak, Maryland Background and Meeting Objectives There is increasing attention on the need for enhancing the evaluation and communication of the benefits and risks associated with pharmaceutical products, thereby increasing the predictability, transparency, and efficiency of pharmaceutical regulatory decision making. In 2006, the IOM's Forum on Drug Discovery, Development, and Translation held a workshop to explore the complex trade-off between drug benefits and risks and to examine approaches for better quantifying this balance and informing the public and the medical community.

Appendix A: Workshop Agenda Pages 71-90

Appendix A: Workshop Agenda
Pages 71-90