Sarah Marking
Co-Founder and Chief Strategy Officer
Sanova

Sarah Marking is the Co-Founder and Chief Strategy Officer at Sanova. Sarah has broad experience serving pharma, medical device, and consumer products industries, with a focus on integrating science, quality processes, and business goals in a regulated environment. She has a proven ability to develop resilient, cross-functional teams and champion complex projects across diverse groups of stakeholders.

Sarah works closely with clients to plan and submit premarket tobacco product applications (PMTAs) and modified risk tobacco product applications (MRTPAs) across various nicotine product categories, including novel, emerging delivery systems. She combines her extensive industry experience, scientific expertise, and business acumen to navigate the rapidly evolving regulatory landscape and provide practical solutions to regulatory challenges. Sarah supports regulatory strategy across all scientific areas including product design and development, manufacturing, and nonclinical and clinical study programs.

She specializes in helping clients create and navigate multi-product regulatory strategies and product line extensions. These strategies leverage existing scientific evidence through use of supplemental PMTAs (sPMTAs) and tobacco product master files (TPMFs) to minimize regulatory costs and timelines. She also supports preparation for Tobacco Products Scientific Advisory Committee (TPSAC) meetings.

Sessions with Sarah Marking

Panel
VA, United States, 22202
Exploring Recent FDA Memoranda
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