Spotlight Series – In Record Time: COVID-19 Vaccines and FDA Expedited Timelines


This lecture will focus on two areas: the first, on the regulatory context of Operation Warp Speed and a corresponding “snapshot” of the COVID-19 therapeutic clinical trials from the Clinical Research Organizations (CRO’s) that run them. COVID-19 vaccines have been developed in record time. Despite this, the process has ensured that they meet the quality, safety, and efficacy standards that the public have come to expect from prophylactic vaccines given to healthy people. Two mRNA vaccines received Emergency Use Authorization in December 2020, and more are on the horizon.

The second part of this lecture will bring into context the pivotal strategic thinking of C-level executives in the biotechnology and the CRO industry when faced with a global pandemic and the decision-making process considering the critical need of FDA expedited timelines, potential need for expanded access for emergency use, and clinical site expansion to meet the endpoints of the registered clinical study. This analysis will incorporate two commercial case studies in the public domain, Humanigen (NASDAQ: HGEN) based in Burlingame, California, USA as well as DURECT (NASDAQ: DRRX) in Cupertino, California, USA. Current research being conducted at Humanigen has a focus on acute respiratory distress syndrome (ARDS) while DURECT seeks to understand multi-organ failure resulting from COVID-19.

Nate Hughes, MPH ‘12, MPP, M.Phil, has been working in the life science industry for almost two decades, and is a writer and public speaker. From 2015-2016, he served as a board member on the Corporate Governance Roundtable for the American College of Preventive Medicine. In 2018, he facilitated the instalment of Real-Time Scheduling for Kymriah for NOVARTIS in Morris Plains, NJ site, the very first US approved CAR-T therapy, among other global deals. In March, 2020, Hughes facilitated the Humanigen Covid-19 mAb Phase 3 study (including site expansion to LATAM), and facilitated the BD side of several deals in the CRO space, including in cell & gene therapy, rare renal, and rare liver disease. He received his Bachelor’s degree from The University of California at Berkeley, his M. Phil degree from Trinity College, Dublin, a MPP from The UCLA Luskin School, and a MPH from The Johns Hopkins Bloomberg School of Public Health.

Peter Marks received his graduate degree in cell and molecular biology and his medical degree at New York University and completed Internal Medicine residency and Hematology/Medical Oncology training at Brigham and Women’s Hospital in Boston. He has worked in academic settings teaching and caring for patients and in industry on drug development. He joined the FDA in 2012 as Deputy Center Director for CBER and became Center Director in January 2016.

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