Meet The Team

Sarah Marking, MS
Managing Partner, Regulatory Science and Strategy

Sarah is the Managing Partner, Regulatory Science and Strategy with Consilium Sciences.

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 also supports preparation for Tobacco Products Scientific Advisory Committee (TPSAC) meetings.

Sarah supports clients in implementing rigorous quality management systems and production processes
to ensure effective manufacturing controls, while establishing compliance with the proposed
requirements for tobacco product manufacturing practices (TPMPs). This work serves as the foundation
for a successful regulatory submission on which additional nonclinical and clinical evidence is built.
Sarah also specializes in developing approaches to assess switching behaviors among adult smokers and
monitor the prevalence of awareness and use among youth to form the basis of FDA’s determination of
whether a product is APPH for the population on the whole.

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.
In addition to leading submissions to FDA’s Center for Tobacco Products (CTP), Sarah works with clients
to explore product submissions through both the NDA and ANDA pathways as the regulatory landscape
continues to evolve.

Prior to joining Consilium, Sarah worked in the medical device and diagnostics industry where she gained
expensive experience integrating science, quality processes, and business goals in a regulated
environment. In this role, she honed her ability to develop resilient, cross-functional teams and
champion complex projects across diverse groups of stakeholders. Sarah received her MS in Biology
from the University of Maryland Baltimore County.