Stacey plays a leadership role at the FNIH, helping to lead many public-private partnerships, such as Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) the PPP that evaluated hundreds of available therapeutic agents with potential application for COVID-19, prioritized them, and designed and launched multiple master protocols to test them. Stacey oversees the Cancer, Metabolic Diseases and Clinical COVID Research portfolios at the Foundation for the National Institute of Health (FNIH). Beyond ACTIV other major partnerships under her guidance include the two steering committees of the Biomarkers Consortium and their projects, Partnership for Accelerating Cancer Therapies (PACT), and the Lung Master protocol (Lung-MAP) clinical trial. Prior to FNIH, she was a Manager at Deloitte Consulting within the Federal Life Sciences and Healthcare Strategy. She received her PhD at Duke and postdoctoral training at Stanford.
Agent Selection and Master Protocols for Evaluation of Candidate COVID-19 Therapeutics and Lessons Learned for Future Pandemics
Working in an unprecedented timeframe, the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership rapidly designed a unique therapeutic agent intake and assessment process for multiple types of candidate treatments (preclinical and clinical antivirals, immune modulators, SARS-CoV-2 neutralizing antibodies, and organ supportive) for COVID-19, reviewing over 800 and advancing over 30 agents to trials for testing. ACTIV also developed and launched ten master protocols between April 2020 and August 2021 to allow for the coordinated and efficient evaluation of these over 30 investigational therapeutic agents. The ACTIV master protocols were designed with a portfolio approach to serve multiple patient populations with COVID-19: outpatient mild to moderately ill, inpatient moderately ill, and inpatient critically ill and designed to test the spectrum of the disease pathophysiology. Each protocol, either adaptive or pragmatic, was designed to efficiently select those treatments that provide benefit to patients while rapidly eliminating those that were either not effective or safe. For both the agent prioritization and master protocol development ACTIV has captured lessons learned that may be useful in meeting the challenges of a future pandemic.
The COVID-19 pandemic is driving the unprecedented transformation of the global medical research ecosystem through the search for effective new therapeutics that can help ease symptoms and prevent death among COVID-19 patients.