Building Resilience into the Nation's Medical Product Supply Chains (2022) / Chapter Skim
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Appendix A: Study Methods and Public Agendas
Appendix A: Study Methods and Public Agendas
Pages 239-260
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From page 239... ...
. The committee comprised members with expertise in crisis standards of care, emergency and critical care medicine, drug and device development and manufacturing, drug shortages, regulatory policy, health economics, medical logistics, supply chain management, risk and emergency management, operations research, public health preparedness and response, and state and local public health.
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To inform its deliberations, the committee gathered information through a variety of mechanisms including reviews of the literature on medical product supply chains and medical product shortages. Targeted literature reviews were conducted as novel issues arose throughout the committee's deliberations.
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OR "supply chain contingency planning"[Title/Abstract] OR "supply chain information gaps"[Title/Abstract]
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22 #20 NOT #21 23 #10 OR #17 24 #23 NOT #21 Part II: Essential drugs/equipment AND Standards of care Database: PubMed Date of Search: 09/08/2020 Filters: Humans, English Results before deduplication: International: 21 U.S.: 1 # Query 1 "critical devices"[Title/Abstract] OR "critical drugs"[Title/Abstract]
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14 #12 NOT #13 15 #10 NOT #13 Part III: Essential drugs/equipment AND Accessibility/Equity Database: PubMed Date of Search: 09/08/2020 Filters: Humans, English Results before deduplication: International: 716 U.S.: 72
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OR "medical devices"[Title/Abstract] OR "medical products"[Title/Abstract]
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OR "supply chain information gaps"[Title/Abstract] OR "supply chain redundancy"[Title/Abstract]
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, Government Accountability Office, the Executive Office (Executive Orders) , and Congressional Research Service Database: Congress.gov AND Legistorm Date: April-May 2021 Results: U.S.:19 1 "medical" AND "supply chain" 2 "medical supply chain" AND "data sharing" 3 "medical supply chain" AND "medical devices" 4 "medical supply chain" AND "PPE" 5 "medical supply chain" AND "Personal Protective Equipment" 6 "medical supply chain" AND "drug shortages" PUBLIC AGENDAS AGENDA Monday, September 21, 2020 Zoom Webinar SESSION I DISCUSSION ON THE SCOPE AND CONTEXT OF THE STUDY CHARGE Session I Objective: To hear from the sponsor of the study regarding their perspectives on the charge to the committee 11:00 a.m.
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Food and Drug Administration Linda Ricci Director Division of All Hazard Response, Science and Strategic Partnerships Office of Strategic Partnerships and Technology Innovation Center for Devices and Radiological Health U.S. Food and Drug Administration Martin Vantrieste President & CEO Civica Rx William (Bill)
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12:00 p.m. Welcome and Introductions Wallace Hopp, Committee Chair Distinguished University Professor of Business and Engineering University of Michigan SESSION I KEY CONSIDERATIONS FOR ESTABLISHING A FRAMEWORK FOR CRITICAL MEDICAL PRODUCTS Session I Objectives: To discuss key considerations for the formulation of a unified list of critical medical products as it relates to this study; discuss how these considerations relate to • Demand surge and supply shocks; • The severity of effects on an individual affected by a shortage ver sus the number of people potentially affected by a shortage;
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12:15 p.m. Key Considerations for Establishing a Framework Stephen Schondelmeyer Professor, Department of Pharmaceutical Care and Health Systems College of Pharmacy Co-Principal Investigator, Resilient Drug Supply Project Center for Infectious Disease Research and Policy University of Minnesota Nathaniel Hupert Associate Professor of Population Health Sciences and of Medicine Weill Medical College, Cornell University Co-Director, Cornell Institute for Disease and Disaster Preparedness Khatereh Calleja President and CEO Healthcare Supply Chain Association James Lawler Associate Professor, Department of Internal Medicine Director, International Programs and Innovation, Global Center for Health Security Director, Clinical and Biodefense Research, National Strategic Research Institute University of Nebraska Medical Center Chris Liu Director, Department of Enterprise Services Washington State 12:45 p.m.
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Food and Drug Administration Doug Throckmorton Deputy Director for Regulatory Programs Center for Drug Evaluation and Research U.S. Food and Drug Administration Resilient Drug Supply Project -- Critical Acute Drug List Stephen Schondelmeyer Professor, Department of Pharmaceutical Care & Health Systems College of Pharmacy Co-Principal Investigator, Resilient Drug Supply Project Center for Infectious Disease Research and Policy University of Minnesota WHO Essential Medicines List Lisa Hedman Group Lead, Supply and Access to Medicines World Health Organization Pernette Bourdillion Esteve Team Lead, Incidents and Substandard/Falsified Medical Products World Health Organization
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11:30 a.m. Welcome and Debrief of Day 1 Wallace Hopp, Committee Chair Distinguished University Professor of Business and Engineering University of Michigan SESSION III P RACTICAL AND TACTICAL APPROACHES FOR EXECUTING A FRAMEWORK FOR CRITICAL MEDICAL PRODUCTS Session III Objectives: To discuss generalizable lessons learned when it comes to implementing a resilient supply chain for critical medical products; consider practical and tactical approaches for executing a framework for critical medical products.
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SESSION IV END USER PERSPECTIVES: WHAT MAKES A MEDICAL PRODUCT CRITICAL? Session IV Objective: Consider on-the-ground perspectives from end users of the medical supply chain (e.g., patients, clinicians, health systems)
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Concluding Remarks Wallace Hopp, Committee Chair Distinguished University Professor of Business and Engineering University of Michigan 3:30 p.m. ADJOURN WORKSHOP DAY AGENDA Monday, April 23, 2020 Zoom Webinar Meeting Objective • To gather information on issues related to improving the re silience of medical product supply chains including: innova tion and technology; geopolitical risks and national security; and on-shoring 12:30 p.m.
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BLOCKCHAIN John Polowczyk Managing Director Ernst and Young James Canterbury Principal Ernst and Young ARTIFICIAL INTELLIGENCE Peter Swartz Chief Technology Officer Altana MANUFACTURING PROCESSES OF THE FUTURE Ryan Furnell Vice President Anklesaria Group, Inc.
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GEOPOLITICAL CONSIDERATIONS Yanzhong Huang Senior Fellow for Global Health Council on Foreign Relations Professor and Director of Global Health Studies School of Diplomacy and International Relations Seton Hall University Damien Bruckard Deputy Director, Trade and Investment International Chamber of Commerce NATIONAL SECURITY CONSIDERATIONS Colin Chinn Rear Admiral, U.S. Navy (Retired)
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Welcome and Introductions Wallace Hopp, Committee Chair Distinguished University Professor of Business and Engineering University of Michigan SESSION I MEDICAL DEVICE SUPPLY CHAIN CONSIDERATIONS Objective: • To gather information on medical device supply chains including, the current landscape, issues related to resilience (e.g., characteris tics of device shortages, the management of device shortages, the effects of device shortages, tools for preventing device shortages) , and similarities and differences between the drug and device sup ply chains.
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ET Zoom Webinar Meeting Objective • To gather information on current FDA and ASPR activities related to increasing the resilience of medical product supply chains 1:30 p.m. Welcome and Introductions Wallace Hopp, Committee Chair Distinguished University Professor of Business and Engineering University of Michigan
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ADJOURN OPEN SESSION AGENDA Wednesday, October 6, 2021 1:00 p.m.–3:00 p.m. ET Zoom Webinar Meeting Objectives • Open session to gather additional information on trade pol icy as it relates to º Restrictions on export bans of medical products; and º International information sharing on the details of medi cal product supply chains 1:00 p.m.
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Speaker Presentations and Q&A Discussion with Committee Jonathan Kimball Vice President, Trade and International Affairs Association for Accessible Medicines Scott Kominers MBA Class of 1960 Associate Professor of Business Administration Entrepreneurial Management Unit, Harvard Business School Chad Bown Reginald Jones Senior Fellow Peterson Institute for International Economics 3:00 p.m. Adjourn Meeting
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