Heather Stone

Health Science Policy Analyst @ FDA

About

With over a decade at FDA, my expertise in global health and epidemiology has been instrumental in advancing public health policies. The development of a repurposing database for FDA-approved products is a cornerstone of our efforts, addressing areas of high unmet medical need from emerging and neglected infectious diseases to cancer. My team's commitment to innovative clinical trial methodologies is enhancing drug development and treatment access. We are at the forefront of shaping healthcare for all those lacking adequate known treatments, driven by a collective mission to improve health outcomes and to help elucidate what helps and what doesn’t through real-world data and innovative clinical trial designs. In addition to my work on drug repurposing, I have co-lead the development of FDA guidance on embedding randomized trials into routine clinical practice. This is an opportunity to shape the future of clinical research merging the benefits of RCTs and real-world data.

Country

United States

City

Washington DC-Baltimore Area

Industry

Public Policy

Skill

Oncology, Registry Management, Cancer Registry, Web Content Creation, Mobile Testing, Mobile Application Design, Web Design, Web Development, Mobile Application Development, Emerging Infectious Diseases, Oncology Clinical Research, Grant Preparation, Grant Budgeting, Project Team Management, Project Implementation, Project Finance, Project Planning, Systematic Reviews, Data Entry, Data Collection

Experience

Health Science Policy Analyst

FDA

2018 - Present · 8 yrs

Silver Spring, Maryland, United States

Public Health Analyst, Office of Medical Policy, Center for Drug Evaluation and Research (CDER)

FDA

2013-6 - 2018 · 4 yrs

White Oak Campus, Silver Spring, MD

My primary work in CDER is focusing on the development of a repurposing database to capture information on the global experience of repurposing FDA-approved products for neglected tropical diseases and emerging threats. The project also examines how adult devices are repurposed for pediatric use, addressing an additional unmet medical need. In addition to the repurposing database, I am working on project related to clinical trial endpoints and methodologies.

Epidemiology Research Associate, ORISE Fellow

FDA

2012-8 - 2013-5 · 10 mos

Washington D.C. Metro Area

Research on patient reported outcomes and minimal clinically important difference related to orthopaedic surgical device implants.

Intern and Ongoing Volunteer, Tuberculosis

Lady Willingdon Hospital

2011-5 - 2012-8 · 1 yr 4 mos

Manali, Himachal Pradesh, India

MPH Internship in Epidemiology Contact Tracing for Tuberculosis I worked to develop and implement a protocol for contact tracing investigations of drug-resistant and relapse/failure TB cases. Designed interview questionnaires for index patients and their contacts Organized a database for the collection of information from the TB patients and their contacts Implemented the contact tracing investigations for priority index patients with extensively drug resistant and multi-drug resistant TB Lead Investigator Research conducted on Tuberculosis and the Prevalence of Multi-Drug Resistance (MDR-TB); Continuing work from U.S./India at present In collaboration with Lady Willingdon Hospital and Civil Government Hospital Manali, I have designed and executed an epidemiologic research study to examine the prevalence of tuberculosis and drug-resistant strains in the populations served by these two hospitals. Developed a comprehensive database of all tuberculosis patients seen by the two Manali hospitals between January 2008 and July 2011 Provided recommendations, based on analysis of the evidence collected, that will improve protocols for the follow-up of patients, with the goal of reducing the number of patients who default from treatment and/or relapse

Graduate Research Assistant

University of Maryland School of Public Health

2010-6 - 2012-6 · 2 yrs 1 mo

I worked initially as a graduate assistant for the College Park Scholars Program in Global Public Health. In 2011, I then accepted a position as a research assistant for epidemiologist, Dr. Maria Khan, assisting on research related to HIV risk in the U.S.

Intern, Access to Essential Medicines

Pan American Health Organization

2008-6 - 2009-1 · 8 mos

Washington D.C. Metro Area

At the Pan American Health Organization I conducted a complex systematic review of the literature to determine how governments in the Latin American and Caribbean region could utilize the concept of the right to health to improve access to essential medicines for neglected tropical diseases.