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Improving the Safety, Security, Robustness, and Resilience of the Nation’s Drug Supply Chain

October 6 12-2pm ET

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Led by the U.S. Department of Health and Human Services, one of the Biden Administration’s supply chain reviews released in June 2021 assessed pharmaceuticals and active pharmaceutical ingredients. The review found that the pharmaceutical supply chain is complex, global, and vulnerable to disruptions. The review argued that a robust pharmaceutical supply chain is able to consistently manufacture high-quality products; is geographically-diversified; has redundancy; and has the flexibility to change volumes and products in response to changes in supply and demand. This panel will summarize and discuss the results of the HHS-led assessment, from one end of the supply chain (doctor/patient) to the other (key starting materials/active pharmaceutical ingredients).

Moderator: John Gray, Professor, Operations and Business Analytics Department, Fisher College of Business, Ohio State University

Administration Presenter: Elisabeth Reynolds, Special Assistant to the President for Manufacturing and Economic Development, National Economic Council

Discussants:

Elisabeth Reynolds is Special Assistant to the President for Manufacturing and Economic Development at the National Economic Council. In this role, she oversees the Administration’s domestic policy agenda for manufacturing and industrial strategy, supply chain resilience and regional economic development. She was formerly the executive director of the MIT Industrial Performance Center and the MIT Task Force on the Work of the Future as well as a lecturer in MIT’s Department of Urban Studies and Planning. Before MIT, Reynolds was the director of the City Advisory Practice at the Initiative for a Competitive Inner City (ICIC), a non-profit focused on job and business growth in urban areas. Reynolds has an AB from Harvard in government, an MSc from the University of Montreal in economics and a PhD from MIT in Urban and Regional Studies.

>https://workofthefuture.mit.edu/people/elisabeth-b-reynolds<

>https://ipc.mit.edu/people/elisabeth-b-reynolds<


Harry M. Lever, MD was the Medical Director of the Hypertrophic Cardiomyopathy Clinic and a staff cardiologist in the Section of Cardiovascular imaging of the Robert and Suzanne Tomsich Department of Cardiovascular Medicine at the Sydell and Arnold Miller Family Heart and Vascular Institute at the Cleveland Clinic until September of 2020.  He now continues as retired Contract Staff.  He specializes in echocardiography and hypertrophic cardiomyopathy. Dr. Lever who is board-certified in internal medicine and cardiovascular disease, is a Fellow of the American College of Physicians, the American College of Cardiology, the American College of Chest Physicians and the American Heart Association. A graduate of the University of Pittsburgh School of Medicine, he completed his residency at Montefiore Hospital in Pittsburgh and his fellowship in cardiology at the University of Rochester in New York.  He has authored or co-authored 100 papers in cardiology with the majority pertaining to hypertrophic cardiomyopathy and is an advisor to the Hypertrophic Cardiomyopathy Association, a support group for patients with the disease. He has developed a deep interest in drug quality and safety.  Dr. Lever was the subject of a chapter in Katherine Eban’s book, Bottle of Lies.  He was coined the “Sheriff” of generic drugs in an article published by Medscape and recognized among The Best Physicians of 2019.

David Light, Founder and CEO of Valisure, is a biotech entrepreneur and scientist with over 15 years of broad experience in the field. A graduate of Yale University, David studied molecular biology and has worked in a variety of scientific and business roles at start-ups like Synthetic Genomics, Ion Torrent, and Valisure. At Ion Torrent, David developed key technologies that directly led to the semiconductor DNA sequencing company's acquisition by Life Technologies and ran its flagship technology programs through development and global commercialization into the #2 sequencing technology in the world. As Founder and CEO of Valisure, an independent laboratory that checks and certifies the chemical composition of medications and healthcare products before they reach consumers, David helped fund and invent the core technology along with leading the company’s entry and impact into the market. David is named inventor on numerous patents, published in journals including Nature and the cover of Electrophoresis, has been invited to submit testimony at congressional hearings as well as speak at the U.S. Capitol  Building. David has been quoted in numerous publications including Bloomberg, The New York Times, The Wall Street Journal, The Washington Post, and CBS News. He also sits on the boards of non-profits bolstering the local community and is very passionate about entrepreneurship and improving public health.

Dr. Eric Edwards is co-founder and chief executive officer of Phlow Corp., a pioneering public benefit pharmaceutical corporation. As CEO, Dr. Edwards has assembled a world-class team committed to providing a solution to the broken essential medicines supply chain and over-reliance on foreign manufacturers for our Nation’s highest priority medicines. Dr. Edwards was previously co-founder of Kaléo, Inc. a pharmaceutical company in Richmond, VA. During his 16 years at Kaléo, he held several executive management positions including Chief Science Officer where he was responsible for overall scientific strategy and all pharmaceutical development programs; Chief Medical Officer responsible for developing a medical affairs team and capability while operationalizing the Company’s clinical program strategy; and Vice President – Innovation, overseeing Kaleo’s research and development pipeline and overall new product strategy. Dr. Edwards is the co-inventor of multiple marketed products, including AUVI-Q, epinephrine auto-injector for the treatment of allergic emergencies (anaphylaxis), is named on over 215 issued and patent-pending applications, and is a published author on numerous scientific publications. Dr. Edwards also continues to serve his community by volunteering on a local rescue squad, including responding to 911 calls and training paramedics in pre-hospital emergency care. Dr. Edwards. obtained his B.S. in Biology, Ph.D. in the Pharmaceutical Sciences, and Doctor of Medicine degrees at Virginia Commonwealth University/Medical College of Virginia.