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Lowell Schiller, JD
Nonresident Senior Scholar, USC Schaeffer Institute
Former Principal Associate Commissioner for Policy, US FDA
Former Acting Chief Counsel, US FDA
Biography
Lowell Schiller is a Nonresident Senior Scholar at the USC Schaeffer Institute and a private consultant specializing in FDA policy matters.
He has held senior leadership roles in both the public and private sectors. Most recently, he was the Chief Legal and Regulatory Officer at Aetion, a health technology company focused on turning real-world data into evidence. He also serves on the board of directors of the Real-World Evidence Alliance, a coalition of real-world data and analytics organizations with a common interest in advancing the use of real-world evidence to inform regulatory decision making.
Previously, he served in senior roles at the FDA, most recently as the Principal Associate Commissioner for Policy. In this role, Lowell led FDA’s Office of Policy, oversaw the agency-wide development of regulations and guidance, and provided policy leadership on cross-cutting and high-profile issues across FDA’s jurisdiction. Earlier in his time at FDA, Lowell served as FDA’s Acting Chief Counsel and as the Senior Counselor to the Commissioner.
Prior to joining FDA, Lowell served as Senior Counsel to Chairman Lamar Alexander on the U.S. Senate Committee on Health, Education, Labor, and Pensions (HELP). In this role, Lowell helped conduct congressional oversight and advance legislation including the 21st Century Cures Act. Earlier in his career, Lowell was a litigator at Sidley Austin LLP, specializing in appeals, dispositive motions, and disputes involving federal agencies.
Lowell clerked for the Honorable Jane R. Roth of the U.S. Court of Appeals for the Third Circuit. He earned his law degree from Harvard Law School and his undergraduate degree from Princeton University.
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Axios
Schiller says China’s rise in drug development could upend U.S. R&D models
Featured Experts: Lowell Schiller
Axios
Schiller discusses opportunities to strengthen U.S. competitiveness in early-phase clinical research
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The Wall Street Journal
Many firms producing knockoff weight-loss drugs are “pushing the envelope” on legal requirements for compounders, Schiller says
Featured Experts: Lowell Schiller