Dr. Charlene Liu
President and Chief Scientist
Riskwise Solution

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.

Sessions with Dr. Charlene Liu

Panel
VA, United States, 22202
15:45 - 16:45
In an effort to enhance transparency, FDA released a series of regulatory science policy memoranda outlining its latest thinking on toxicology assessments, excess lifetime cancer risk (ELCR) calculations, and other critical scientific evaluations in tobacco product applications. These memos provide valuable insights into the FDA’s evolving approach to reviewing PMTAs, shaping testing methodologies, and setting new regulatory expectations. Hear experts discuss these memos, exploring their impact on risk assessments, study design, and the overall PMTA process.

Moderators

Speakers

  • Dr. Jenna Guynn

    Senior Director, Scientific and Regulatory Affairs, Reynolds American

  • Dr. Matthew Holman

    Vice President and Chief Scientific and Regulatory Strategy Officer for the US, PMI

  • Dr. Don Kenkel

    Andrew Dickson White Professor, Jeb E. Brooks School of Public Policy at Cornell University

  • Dr. Charlene Liu

    President and Chief Scientist, Riskwise Solution