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Drug Quality Issues in the US and Health System Engagement to Address Them

Join us on September 19, 2024, for a thought-provoking in-person event focused on pharmaceutical drug quality and solutions. Our experts will discuss the underlying issues and their approach. This event is invitation only. Doors open at 11:15 a.m. for networking. Program and lunch service will begin promptly at 11:30 a.m.

There is growing concern over drug quality and safety, as evidenced by rampant drug shortages, approximately 76% of which are due to manufacturer quality problems, roughly 3 drug recalls per day in the United States, often related to dangerous impurities, and a growing number of studies and physician reports of patient harm. A growing number of health systems have taken action to help address these issues for improving healthcare delivery for their patients and to improve their own supply resilience of critical medicines. In this talk we will delve into the root causes of these problems and some promising solutions and health system engagements that are broadly applicable. 

David Light, Co-Founder and President of Valisure, is a biotech entrepreneur and scientist with over 16 years of broad experience in the field. A graduate of Yale University, David studied molecular biology and has worked in various scientific and business roles at start-ups like Synthetic Genomics, Ion Torrent, and Valisure.

At Ion Torrent, David developed core 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 a Founder and President of Valisure, an independent laboratory and partner for quality that chemically analyzes and certifies the chemical composition of medications and healthcare products before they reach consumers, David helped fund and invent the core technology and led its entry and impact into the market. David is named inventor on numerous patents, published in journals including Nature, Journal of the American Pharmacist Association and American Heart Association's Journal Circulation and has been invited to testify at congressional hearings and speak at The White House.

David was appointed an Affiliate Professor at Long Island University, has lectured at Yale University for the past decade, and was invited to present at Stanford University Medicine Grand Rounds. He has been quoted in numerous publications, including Bloomberg, The New York Times, The Wall Street Journal, The Washington Post, CBS News, NPR, and Forbes, to name a few.

Vic Suarez, Colonel (Ret), US Army, MS, PMP, CMRP, is the Founder and Principal Growth Partner of Blu Zone Bioscience & Supply Chain Solutions, LLC. Blu Zone Bio assists biotechnology and life science supply chain organizations in accelerating growth and expanding domestic biomanufacturing through effective public and private partnerships, strategic alliances, and business development. Vic served over 27 years of active duty as a Biotechnology Advanced Developer and Health Care Supply Chain senior leader. He recently was the Senior Medical Acquisition Consultant at the U.S. Army Medical Research and Development Command’s Tech Transfer, IP/Patent, and Business Development Office at Fort Detrick, MD. He also served as the Commander of the 6th Medical Logistics Management Center, a globally deployed healthcare supply chain, information systems, and biomedical maintenance solutions organization. His unique dual background has enabled him to lead highly complex biotechnology and supply chain programs and organizations. In 2020-2021, he served as the lead Vaccine Program Manager for the Moderna COVID-19 Vaccine at Operation Warp Speed/BARDA and has served in the U.S. Army for nearly three decades in worldwide operational, healthcare supply chain, acquisition, and product development roles, including two combat tours in the Middle East as a medical company and battalion commander.

Vic is a former Chief of Staff of the Walter Reed Army Institute of Research (WRAIR), DOD’s largest biomedical research laboratory headquartered in Silver Spring, MD, and was the Joint Product Manager of the Joint Vaccine Acquisition Program (JVAP). In this biodefense advanced development vaccine program, he played critical roles in the advanced development and delivery of the FDA-licensed Ebola and MPOX vaccines. In 2016-2017, Vic was an Army War College Fellow at the Milken Institute School of Public Health at GWU, Washington, DC.

He is a globally and nationally sought-after keynote and panel speaker at life science, supply chain, and national security conferences. He is often asked to chair tracks or moderate high-level panel discussions from highly technical life science areas to global trade and security matters. He has been featured in media, such as Bloomberg News, National Public Radio, Yahoo! News, Military Times, and multiple podcasts. Vic has testified as an expert witness in the U.S. Senate and has advised many C-Suite leaders, high-level policymakers, and Congressional and White House staff on critical healthcare supply chain, biosecurity, and pharmaceutical policy matters. He is also a visiting Senior Fellow at the Council on Strategic Risks, a DC-based, non-partisan national security-focused think tank.

Vic is a board advisor for several life science, technology commercialization, and healthcare supply chain organizations. He is a Certified Materials & Resource Professional (CMRP®) and Project Management Professional (PMP) and holds a BS and MS from UCLA and Central Michigan University, respectively.