Ford transitioned from auto to ventilator production with guidance from Hogan Lovells and Blake Wilson L’12
In April, as the COVID-19 crisis grew, the Ford Motor Company found itself in unfamiliar territory, agreeing to switch gears and produce 50,000 ventilators by early July.
This was a huge challenge for a multinational accustomed to rolling automobiles off assembly lines.
How would they get FDA approval for this new product in an ever-shifting regulatory landscape? How about distribution and market clearance? And exposure and liability?
For answers to these questions, Ford turned for legal advice to the Hogan Lovells’ FDA group and Blake Wilson L’12, a member of the legal team.
“The COVID-19 pandemic has been a unique time for us (Hogan Lovells),” Wilson said. “What we’ve seen are a lot of companies very eager to share the burden and help the country. Some have experience while others are new to the space, but everyone recognizes there are shifting variables in play. It’s been very exciting to shepherd companies through the process.”
The Ford Motor Company formalized a collaboration with GE Healthcare in early April, contributing to a federal effort to produce 100,000 ventilators in 100 days. GE Healthcare licensed the ventilator from Airon Corp., a small company specializing in high-tech pneumatic life support products. The ventilator is designed for quick setup, making it easy for healthcare workers to use. It can be deployed in emergency rooms and intensive care units. On May 21, President Trump visited the Ford plant in Michigan that is making the ventilators.
In another project, Wilson and Hogan Lovells teamed with regulatory consultant Wanda Henry Co. to advise Sansure Biotech, Inc., which filed for an Emergency Use Authorization (EUA) to produce molecular diagnostic test kits for COVID-19. The FDA granted the EUA in early May, following earlier approvals in China and the European Union. Sansure aims to produce between 750,000 and one million tests per day.
Wilson comes to this work with a background in both medical research and the law. Before coming to Penn Law, Wilson was a lead research assistant in Brown University’s Center for Alcohol and Addiction Studies, where he managed Phase II clinical trials.
Passionate about patient care and clinical research, he said he went to law school because he wanted to understand the legal and policy considerations that undergird health care in preparation for his career.
At the Law School, Wilson was vice president of the Penn Health Law Group, which fostered interdisciplinary discussion of health law and policy. He was also an executive editor of the Journal of International Law. Wilson noted that two key life events were connected with his involvement on the Journal. He published a student comment about the use of foreign clinical trials in FDA’s drug and marketing approval process, which sparked his decision to switch from corporate to FDA law. He also met his future wife, Elisa Solomon L’13, a Journal colleague. The two started dating after Wilson stole a dance with her at the Barrister’s Ball; they married in May 2017.
Today, Wilson combines his interest in law and life sciences as senior associate in Hogan Lovells’ FDA/Medical Device group. His practice focuses on FDA’s premarket approval process for medical devices, drugs, and biologics, as well as oversight of clinical investigations. A member of the Innovation Council at Children’s Hospital of Philadelphia, Wilson is also completing a master’s degree in biostatistics at Columbia University’s Mailman School of Public Health; he delayed graduating this Spring in order to devote his efforts to the pandemic response.
Even before the COVID-19 public health crisis, Wilson contributed his legal expertise on a range of novel, and sometimes revolutionary, medical devices, like the first medical device for treatment of pediatric ADHD and the first percutaneous catheter for creation of vascular access in dialysis patients.
Wilson said it has been challenging adapting to the new pandemic framework, which seems to change on the fly. It requires almost 24-7 vigilance to regular updates. In this environment he’s been learning – and teaching others – how to bring products to market quickly and still meet stringent performance standards. At the end of the day, he loves combining the rigors of the life sciences with the law.
“You’re right on the cutting edge of science,” Wilson said. “It’s an amazing space to be in.”