Appendix A
Study Methods and Public Agendas
At the request of the U.S. Congress, the National Academies of Sciences, Engineering, and Medicine (the National Academies) convened the Committee on Security of America’s Medical Product Supply Chain to examine the security of America’s medical product supply chains and provide recommendations to improve the resilience of medical product supply chains. The sponsor of this report was the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR).
COMMITTEE EXPERTISE
The National Academies formed a committee of 13 experts to deliberate on and respond to the statement of task for the study (Box 1-1). 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. Appendix E provides biographical information for each committee member.
MEETINGS AND INFORMATION-GATHERING ACTIVITIES
The committee held five virtual full committee meetings from September 2020 to September 2021. The committee held six meetings that in-
cluded portions open to the public as well as one virtual, public workshop. A summary of this workshop is captured in a Proceedings of a Workshop—In Brief.1 The agendas for these six open sessions are included at the end of this appendix.
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. All written information provided to the committee from external sources is available by request through the National Academies’ Public Access Records Office.
Literature Search Strategy
Search Parameters:
- Date Parameters: All
- English only
- Peer-reviewed articles
- Trade publications
- Opinion publications
- Comments
- Editorial
- Reviews
- Proceedings
- Geographic region: International with a subset for the U.S.
- Humans research only
Databases:
- PubMed
- Cogress.gov
- Legistorm
Search Strategy:
Part I: Essential drugs/equipment AND supply chains
Database: PubMed
Date of Search: 09/08/2020
Filters: Humans, English
___________________
1 See https://www.nap.edu/catalog/26137/the-security-of-americas-medical-product-supplychain-considerations-for.
Results before deduplication:
International: 98
U.S.: 21
| # | Query |
| 1 | “critical devices”[Title/Abstract] OR “critical drugs”[Title/Abstract] OR “critical medication”[Title/Abstract] OR “critical medicine”[Title/Abstract] OR “priority medical devices”[Title/Abstract] |
| 2 | “drugs, essential”[MeSH Terms] |
| 3 | “active pharmaceutical ingredient”[Title/Abstract] OR “finished dosage form”[Title/Abstract] OR “health commodities”[Title/Abstract] OR “medical commodities”[Title/Abstract] OR “medical devices”[Title/Abstract] OR “medical products”[Title/Abstract] OR “drug products”[Title/Abstract] |
| 4 | #3 AND #2 |
| 5 | #1 OR #2 OR #4 |
| 6 | “equipment and supplies/supply and distribution”[MeSH Terms] OR “prescription drugs/supply and distribution”[MeSH Terms] |
| 7 | “domestic manufacturing”[Title/Abstract] OR “supply chain”[Title/Abstract] OR “supply chain capacity”[Title/Abstract] OR “supply chain contingency planning”[Title/Abstract] OR “supply chain information gaps”[Title/Abstract] OR “supply chain redundancy”[Title/Abstract] OR “supply chain sustainability”[Title/Abstract] OR “drug industry/organization and administration”[MeSH Terms] |
| 8 | “drug shortage”[Title/Abstract] OR “manufacturing disruption”[Title/Abstract] OR “supply chain disruption”[Title/Abstract] OR “supply chain information gaps”[Title/Abstract] OR “supply chain vulnerability”[Title/Abstract] |
| 9 | #6 OR #7 OR #8 |
| 10 | #9 AND #5 |
| 11 | “economic impact”[Title/Abstract] OR “trade impact”[Title/Abstract] OR “socioeconomic factors”[MeSH Terms] |
| 12 | #11 AND #9 |
| 13 | #12 AND #5 |
| 14 | “disease outbreaks”[MeSH Terms] OR “epidemics”[MeSH Terms] OR “pandemics”[MeSH Terms] OR “public health”[MeSH Terms] OR “health security”[Title/Abstract] OR “national security”[Title/Abstract] |
| 15 | “disaster medicine/organization and administration”[MeSH Terms] OR “disaster planning/organization and administration”[MeSH Terms] OR “disaster planning/trends”[MeSH Terms] OR “emergency medicine/organization and administration”[MeSH Terms] OR “emergency medicine/standards”[MeSH Terms] OR “emergency medicine/trends”[MeSH Terms] OR “risk management/organization and administration”[MeSH Terms] |
| 16 | #14 OR #15 |
| 17 | #16 AND #5 |
| 18 | (“united states”[MeSH Terms] OR “united states”[Title] OR “u.s.”[Title] OR “american”[Title] OR “america”[Title] OR “united states”[Title/Abstract] OR “u.s.”[Title/Abstract] OR “u.s.a.”[Title/Abstract]) NOT (“americas”[Title/Abstract] OR “latin america”[Title/Abstract] OR “south america”[Title/Abstract] OR “central america”[Title/Abstract] OR “latin america”[MeSH Terms] OR “south america”[MeSH Terms] OR “central america”[MeSH Terms]) |
| 19 | #10 OR #13 OR #17 |
| 20 | #19 AND #18 |
| 21 | “ambulatory”[Title] OR “animal model”[Title] OR “biological assay”[Title] OR “blood”[Title] OR “cbrn exposure”[Title] OR “dose-response”[Title] OR “drills”[Title] OR “eye care”[Title] OR “gain of function”[Title] OR “glucose”[Title] OR “licensure”[Title] OR “liver injury”[Title] OR “mass dispensing”[Title] OR “mass vaccination”[Title] OR “meter”[Title] OR “mice”[Title] OR “mouse”[Title] OR “neglected disease”[Title] OR “one health”[Title] OR “pathophysiology”[Title] OR “points of dispensing”[Title] OR “post-exposure”[Title] OR “schools”[Title] OR “transfusion”[Title] OR “veterinary”[Title] |
| 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] OR “critical medication”[Title/Abstract] OR “critical medicine”[Title/Abstract] OR “priority medical devices”[Title/Abstract] |
| 2 | “drugs, essential”[MeSH Terms] |
| 3 | “active pharmaceutical ingredient”[Title/Abstract] OR “finished dosage form”[Title/Abstract] OR “health commodities”[Title/Abstract] OR “medical commodities”[Title/Abstract] OR “medical devices”[Title/Abstract] OR “medical products”[Title/Abstract] OR “drug products”[Title/Abstract] |
| 4 | #3 AND #2 |
| 5 | #1 OR #2 OR #4 |
| 6 | (“crisis”[Title/Abstract] OR “crises” [Title/Abstract]) AND “standards of care”[Title/Abstract] |
| 7 | “critical care”[Title/Abstract] OR “emergency care”[Title/Abstract] OR “emergency management”[Title/Abstract] OR “risk management”[Title/Abstract] |
| 8 | “standard of care”[MeSH Terms] OR “delivery of health care/standards”[MeSH Terms] |
| 9 | #6 OR #7 OR #8 |
| 10 | #9 AND #5 |
| 11 | (“united states”[MeSH Terms] OR “united states”[Title] OR “u.s.”[Title] OR “american”[Title] OR “america”[Title] OR “united states”[Title/Abstract] OR “u.s.”[Title/Abstract] OR “u.s.a.”[Title/Abstract]) NOT (“americas”[Title/Abstract] OR “latin america”[Title/Abstract] OR “south america”[Title/Abstract] OR “central america”[Title/Abstract] OR “latin america”[MeSH Terms] OR “south america”[MeSH Terms] OR “central america”[MeSH Terms]) |
| 12 | #10 AND #11 |
| 13 | “ambulatory”[Title] OR “animal model”[Title] OR “biological assay”[Title] OR “blood”[Title] OR “cbrn exposure”[Title] OR “dose-response”[Title] OR “drills”[Title] OR “eye care”[Title] OR “gain of function”[Title] OR “glucose”[Title] OR “licensure”[Title] OR “liver injury”[Title] OR “mass dispensing”[Title] OR “mass vaccination”[Title] OR “meter”[Title] OR “mice”[Title] OR “mouse”[Title] OR “neglected disease”[Title] OR “one health”[Title] OR “pathophysiology”[Title] OR “points of dispensing”[Title] OR “post-exposure”[Title] OR “schools”[Title] OR “transfusion”[Title] OR “veterinary”[Title] |
| 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
| # | Query |
| 1 | “critical devices”[Title/Abstract] OR “critical drugs”[Title/Abstract] OR “critical medication”[Title/Abstract] OR “critical medicine”[Title/Abstract] OR “essential medicines”[Title/Abstract] OR “medical countermeasures”[Title/Abstract] OR “priority medical devices”[Title/Abstract] |
| 2 | “drugs, essential”[MeSH Terms] |
| 3 | “active pharmaceutical ingredient”[Title/Abstract] OR “finished dosage form”[Title/Abstract] OR “health commodities”[Title/Abstract] OR “medical commodities”[Title/Abstract] OR “medical devices”[Title/Abstract] OR “medical products”[Title/Abstract] OR “drug products”[Title/Abstract] |
| 4 | #3 AND #2 |
| 5 | #1 OR #2 OR #4 |
| 6 | “access to health care”[Title/Abstract] OR “accessibility”[Title/Abstract] OR “accessibility of health services”[Title/Abstract] OR “distribution”[Title/Abstract] OR “equity”[Title/Abstract] OR “health care delivery”[Title/Abstract] |
| 7 | “delivery of health care”[MeSH Terms] OR “health equity”[MeSH Terms] OR “health services accessibility”[MeSH Terms] |
| 8 | #6 OR #7 |
| 9 | #8 AND #5 |
| 10 | (“united states”[MeSH Terms] OR “united states”[Title] OR “u.s.”[Title] OR “american”[Title] OR “america”[Title] OR “united states”[Title/Abstract] OR “u.s.”[Title/Abstract] OR “u.s.a.”[Title/Abstract]) NOT (“americas”[Title/Abstract] OR “latin america”[Title/Abstract] OR “south america”[Title/Abstract] OR “central america”[Title/Abstract] OR “latin america”[MeSH Terms] OR “south america”[MeSH Terms] OR “central america”[MeSH Terms]) |
| 11 | #9 AND #10 |
| 12 | “ambulatory”[Title] OR “animal model”[Title] OR “biological assay”[Title] OR “blood”[Title] OR “cbrn exposure”[Title] OR “dose-response”[Title] OR “drills”[Title] OR “eye care”[Title] OR “gain of function”[Title] OR “glucose”[Title] OR “licensure”[Title] OR “liver injury”[Title] OR “mass dispensing”[Title] OR “mass vaccination”[Title] OR “meter”[Title] OR “mice”[Title] OR “mouse”[Title] OR “neglected disease”[Title] OR “one health”[Title] OR “pathophysiology”[Title] OR “points of dispensing”[Title] OR “post-exposure”[Title] OR “schools”[Title] OR “transfusion”[Title] OR “veterinary”[Title] |
| 13 | #11 NOT #12 |
| 14 | #9 NOT #12 |
Part IV: Medical countermeasure/Stockpile AND Supply
Database: PubMed
Date of Search: 09/08/2020
Filters: Humans, English
Results before deduplication:
International: 19
U.S.: 18
| # | Query |
| 1 | “medical countermeasures”[Title/Abstract] OR “stockpile”[Title/Abstract] OR “strategic stockpile”[Title/Abstract] |
| 2 | “strategic stockpile”[MeSH Terms] OR “strategic stockpile/organization and administration”[MeSH Terms] OR “strategic stockpile/trends”[MeSH Terms] |
| 3 | #1 OR #2 |
| 4 | “domestic manufacturing”[Title/Abstract] OR “supply chain”[Title/Abstract] OR “supply chain capacity”[Title/Abstract] OR “supply chain contingency planning”[Title/Abstract] OR “supply chain information gaps”[Title/Abstract] OR “supply chain redundancy”[Title/Abstract] OR “supply chain sustainability”[Title/Abstract] OR “drug industry/organization and administration”[MeSH Terms] |
| 5 | “equipment and supplies/supply and distribution”[MeSH Terms] OR “prescription drugs/supply and distribution”[MeSH Terms] |
| 6 | #4 OR #5 |
| 7 | #3 AND #6 |
| 8 | (“united states”[MeSH Terms] OR “united states”[Title] OR “u.s.”[Title] OR “american”[Title] OR “america”[Title] OR “united states”[Title/Abstract] OR “u.s.”[Title/Abstract] OR “u.s.a.”[Title/Abstract]) NOT (“americas”[Title/Abstract] OR “latin america”[Title/Abstract] OR “south america”[Title/Abstract] OR “central america”[Title/Abstract] OR “latin america”[MeSH Terms] OR “south america”[MeSH Terms] OR “central america”[MeSH Terms]) |
| 9 | #7 AND #8 |
| 10 | “ambulatory”[Title] OR “animal model”[Title] OR “biological assay”[Title] OR “blood”[Title] OR “cbrn exposure”[Title] OR “dose-response”[Title] OR “drills”[Title] OR “eye care”[Title] OR “gain of function”[Title] OR “glucose”[Title] OR “licensure”[Title] OR “liver injury”[Title] OR “mass dispensing”[Title] OR “mass vaccination”[Title] OR “meter”[Title] OR “mice”[Title] OR “mouse”[Title] OR “neglected disease”[Title] OR “one health”[Title] OR “pathophysiology”[Title] OR “points of dispensing”[Title] OR “post-exposure”[Title] OR “schools”[Title] OR “transfusion”[Title] OR “veterinary”[Title] |
| 11 | #9 NOT #10 |
| 12 | #7 NOT #10 |
Part IV: Legislation from the U.S. Congress (both House and Senate), 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. |
Welcome and Introductions WALLACE HOPP, Committee Chair Distinguished University Professor of Business and Engineering The University of Michigan |
| 11:10 a.m. |
Sponsor Perspective on Charge to the Committee DAVID (CHRIS) HASSELL, Study Sponsor Acting Principal Deputy Assistant Secretary Office of the Assistant Secretary for Preparedness and Response U.S. Department of Health and Human Services |
|
LAURA (KWINN) WOLF, Study Sponsor
Director, Division of Critical Infrastructure Protection Office of the Assistant Secretary for Preparedness and Response U.S. Department of Health and Human Services |
|
| 11:25 a.m. |
Remarks from Congressional Staff MAX KANNER Health Policy Advisor Office of Sen. Dick Durbin (D-IL) |
| 11:30 a.m. | Discussion with Committee |
| 12:15 p.m. | Break (30 mins) |
| SESSION II | ADDITIONAL CONTEXT FOR THE STUDY |
Session II Objective: To hear from the sponsor of the study regarding their perspectives on the charge to the committee
| 12:45 p.m. |
Stakeholder and Regulatory Perspectives Panel STELIOS C. TSINONTIDES Office of Pharmaceutical Manufacturing Assessment Office of Pharmaceutical Quality Center for Drug Evaluation and Research U.S. 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) HAWKINS Senior Advisor EW Healthcare Partners |
| 1:15 p.m. | Discussion with Committee |
| 2:00 p.m. | ADJOURN |
AGENDA
Monday, December 1–2, 2020
Zoom Webinar
Day 1: December 1, 2020 (12:00 p.m.–3:30 p.m. ET)
| 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 versus the number of people potentially affected by a shortage;
- Outcome measures that matter to end users; and
- Products that are most at risk (e.g., difficulty of manufacturing).
| 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. | Discussion with Committee |
| 1:30 p.m. | Break (45 minutes) |
| SESSION II | CRITICAL/ESSENTIAL MEDICAL PRODUCTS LISTS |
Session II Objectives: To examine current lists of critical/essential medical products with attention to how these lists were developed and how they are currently being used to inform decisions; discuss lessons learned and/or generalizable approaches for the formulation of a unified list of critical medical products for purposes of this study.
| 2:15 p.m. |
Current Critical/Essential Medical Product Lists FDA’s List of Essential Medicines, Medical Countermeasures, and Critical Inputs 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 |
|
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 |
| 2:45 p.m. | Discussion with Committee |
| 3:30 p.m. | ADJOURN WORKSHOP DAY 1 |
DAY 2: DECEMBER 2, 2020 (11:30 A.M.–3:30 P.M. ET)
| 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 | PRACTICAL 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.
| 11:45 a.m. |
Lessons Learned and Practical/Tactical Approaches HEATHER WALL Chief Commercial Officer Civica Rx |
|
DAN KISTNER
Group Senior Vice President of Pharmacy Service Vizient |
|
|
CRAIG KENNEDY
Senior Vice President, Global Supply Chain Management Merck |
|
|
BILL MURRAY
Medical Device Specialist Executive Deloitte Consulting |
|
NICOLE LURIE
Strategic Advisor to the CEO and Response Lead Coalition for Epidemic Preparedness Innovations Senior Lecturer, Harvard Medical School Former Assistant Secretary for Preparedness and Response U.S. Department of Health and Human Services |
|
| 12:15 p.m. | Discussion with Committee |
| 1:00 p.m. | Break (45 minutes) |
| 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) when it comes to
- What makes a medical product critical;
- Outcome measures that matter to end users when it comes to supply chain resilience and success.
| 1:45 p.m. |
End User Perspectives Panel SUZANNE SCHRANDT Founder and CEO ExPPect |
|
CHRISTOPHER NEWTON
Director, Trauma Care Co-Director, Neuroscience Center UCSF Benioff Children’s Hospital Oakland |
|
|
RYAN MAVES
Faculty Physician Naval Medical Center San Diego |
|
|
SALLY WATKINS
Executive Director Washington State Nurses Association |
|
|
MICHAEL GANIO
Director, Pharmacy Practice and Quality American Society of Hospital Pharmacists |
|
MICHAEL SCHILLER
Senior Director Association for Health Care Resource and Materials Management American Hospital Association |
|
| 2:30 p.m. | Discussion with Committee |
| 3:15 p.m. |
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
| 12:30 p.m. |
Welcome and Introductions WALLACE HOPP, Committee Chair Distinguished University Professor of Business and Engineering University of Michigan |
| SESSION I | INNOVATION AND TECHNOLOGY CONSIDERATIONS |
Session I Objective: To gather information on innovation and technology (e.g., blockchain, artificial intelligence, continuous manufacturing) applications that can improve transparency, risk assessments, and manufacturing capacity, and ultimately improve the resilience of medical product supply chains.
| 12:45 p.m. | Innovation and Technology Considerations (5–7 minutes each) |
| 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. |
|
| 1:05 p.m. | Discussion with Committee |
| 1:45 p.m. | Break (15 minutes) |
| SESSION II | GEOPOLITICAL, NATIONAL SECURITY, AND ON-SHORING CONSIDERATIONS |
Session II Objective: To gather information on the totality of geopolitical and national security risks to U.S. medical product supply chains and whether on-shoring manufacturing of critical drugs and devices would protect U.S. medical product supply chains.
| 2:00 p.m. | Geopolitical Risks and National Security Considerations (5–7 minutes each) |
|
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) Former Joint Staff Surgeon Former U.S. Pacific Command Surgeon |
|
| 2:15 p.m. | Brief Discussion with Committee |
| 2:30 p.m. |
On-Shoring Considerations (5–7 minutes each) ROSEMARY GIBSON Senior Advisor The Hastings Center |
|
CHAD BOWN
Reginald Jones Senior Fellow Peterson Institute for International Economics |
| 2:45 p.m. | Full Discussion with Committee Regarding Geopolitical Risks, National Security, and On-Shoring |
| 4:00 p.m. | ADJOURN OPEN SESSION |
AGENDA
Wednesday, June 9, 2021
2:30 p.m.–5:00 p.m. ET
Zoom Webinar
| 2:30 p.m. |
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., characteristics 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 supply chains.
| 2:45 p.m. | Medical Device Supply Chain Considerations (5–7 minutes each) MARK RUTKIEWICZ Vice President of Quality Innovize |
|
NOEL COLON
Senior Vice President, Chief Quality Officer Medtronic |
|
|
GREG SMITH
Executive Vice President, Supply Chain and Operations Medtronic |
|
| 3:00 p.m. | Discussion with Committee |
| 4:00 p.m. | Break (15 minutes) |
| SESSION II | UPDATE ON COMMISSIONED ECONOMIC ANALYSIS |
| 4:15 p.m. | Progress Update and Discussion on Commissioned Economic Analysis PHILIP ELLIS Ellis Health Policy |
| 4:30 p.m. | Discussion with Committee |
| 5:00 p.m. | ADJOURN OPEN SESSION |
AGENDA
Wednesday, August 18, 2021
1:30 p.m.–2:30 p.m. ET
Zoom Webinar
| 1:30 p.m. |
Welcome and Introductions WALLACE HOPP, Committee Chair Distinguished University Professor of Business and Engineering University of Michigan |
| SESSION I | FEDERAL UPDATES |
Objective: To gather information on current FDA and ASPR activities related to increasing the resilience of medical product supply chains
| 1:35 p.m. |
FDA Updates TAMMY BECKHAM Associate Director for Resilient Supply Chain Office of Strategic Partnerships and Technology Innovation Center for Devices and Radiological Health U.S. Food and Drug Administration |
| 1:45 p.m. |
ASPR Updates JOSEPH HAMEL Director, ASPR Program Office for Innovation and Industrial Base Expansion (IBx) HHS Office of the Assistant Secretary for Preparedness and Response |
| 1:55 p.m. | Discussion with Committee |
| 2:30 p.m. | ADJOURN OPEN SESSION |
AGENDA
Wednesday, October 6, 2021
1:00 p.m.–3:00 p.m. ET
Zoom Webinar
| 1:00 p.m. |
Welcome and Opening Remarks LEE BRANSTETTER, Committee Member Professor of Economics and Public Policy Carnegie Mellon University |
| 1:05 p.m. |
Speaker Presentations and Q&A Discussion with Committee MONICA GORMAN Deputy Assistant Secretary for Manufacturing, Industry and Analysis International Trade Administration U.S. Department of Commerce |
| CARTER WILBUR Economic Officer Office of Multilateral Trade Affairs U.S. Department of State |
|
| 1:50 p.m. |
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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