Mark Stewart

Regulatory Science Expert | Advancing Oncology Trials, Regulatory Pathways, and Data-Driven Insights

Washington, District of Columbia, United States

About

I work at the intersection of science, policy, and regulation to help bring better cancer treatments to patients. With over a decade of experience in oncology drug development and regulatory science, I’ve had the opportunity to collaborate with FDA, industry, academia, and patient advocates on projects that shape how clinical trials are designed and how new therapies reach people faster. My focus has been on creating practical solutions, whether that’s advancing novel endpoints like ctDNA, improving the use of real-world evidence in regulatory decision-making, or harmonizing diagnostic development. I’ve also been part of efforts to evaluate AI-driven tools and optimize trial designs in rare cancers, always with the goal of making drug development more efficient and reliable, while keeping patients at the center of regulatory science and ensuring innovation translates into meaningful outcomes in cancer care.

Experience

  • Friends of Cancer Research (10 yrs 6 mos)
    • Vice President, Science Policy
      Jul 2018 - Present · 8 yrs

    • Senior Science Policy Analyst
      May 2017 - Jul 2018 · 1 yr 3 mos

    • Science Policy Analyst
      Jan 2016 - May 2017 · 1 yr 5 mos

  • Associate Member Council at American Association for Cancer Research
    Apr 2013 - Apr 2017 · 4 yrs 1 mo

  • Research Associate at National Academies of Sciences, Engineering, and Medicine
    Oct 2014 - Jan 2016 · 1 yr 4 mos

  • Contributing Writer at American Society for Biochemistry and Molecular Biology
    Mar 2013 - Mar 2015 · 2 yrs 1 mo

  • Graduate Researcher at University of Alabama at Birmingham
    Aug 2009 - Oct 2014 · 5 yrs 3 mos