Dr. Liu is a renowned expert in regulatory strategy development and nonclinical studies for tobacco harm reduction products. She brings nearly a decade of technical and management experience in toxicology and risk assessment at R.J. Reynolds, JUUL Labs, and RELX International. With nearly 20 years of prior experience in human health risk assessment at U.S. Environmental Protection Agency Superfund sites, Dr. Liu was one of the pioneers in applying quantitative risk assessment (QRA) to evaluate the relative health risks of tobacco products for regulatory submissions over a decade ago.
Dr. Liu has successfully developed QRA frameworks and methodologies for Premarket Tobacco Product Applications (PMTAs) for Electronic Nicotine Delivery Systems (ENDS) and oral nicotine pouches, as well as substantial equivalence (SE) filings for smokeless tobacco products. Her work has influenced the FDA to adopt QRA as a key component in evaluating toxicological risk in ENDS PMTAs for regulatory decisions on Appropriate for the Protection of Public Health (APPH).
Dr. Liu founded Riskwise Solution, a consulting firm providing expertise in nonclinical science, including gap analysis, product development, specification and manufacturing compliance, chemical characterization, stability and toxicology testing design, risk assessment, regulatory submissions, and deficiency letter responses. Riskwise helps clients navigate the evolving PMTA regulatory landscape by developing and executing successful regulatory strategies to ensure compliance with FDA and global regulations and bring innovative nicotine products to market.
Dr. Liu has authored over 50 abstracts and peer-reviewed publications on the toxicology and risk assessment of tobacco products, as well as the human health risk assessment of chemicals at contaminated sites.
