Evolving the US Clinical Trial Infrastructure for Better Clinical Trials and Emergency Response

Dr Brian Anderson is chief digital health physician at MITRE, where he leads research and development efforts across major strategic initiatives in digital health alongside industry and the U. S. government. Dr Anderson is responsible for co-founding the Coalition for Health AI (CHAI), and the VCI™ coalition of more than 1,000 organizations assembled during the COVID-19 pandemic to work towards interoperable and verifiable clinical information; leading MITRE’s development of machine learning techniques to leverage real world health data; and linking genomic and clinical data to provide insight into the efficacy of therapeutics and vaccines. He also leads MITRE’s largest health R&D effort in oncology and personalized medicine. His team helps to architect, implement, and analyze health data and information systems for federal agencies, including HHS, CMS, the FDA, and VA.Dr Anderson is an internationally recognized author and expert in digital health, and is regularly engaged as a speaker on digital health innovation, health standards development, clinical decision support systems, and interoperability. He has been quoted in leading publications, including CBS News, CNN, Fast Company, Forbes, STAT, and USA Today. Prior to joining MITRE, Dr Anderson led the Informatics and Network Medicine Division at athenahealth, where he launched a new model of clinical decision support leveraging artificial intelligence. He has also served on several national health information technology committees in partnership with the Office of the National Coordinator.Dr Anderson completed his clinical training at Massachusetts General Hospital and practiced in Greater Lawrence (MA). He completed his BA and MD degrees at Harvard College and Harvard Medical School.

Amy Cramer draws on her experience as a cardiac critical care nurse, clinical research coordinator, certified healthcare quality professional and clinical research informaticist. Ms Cramer has worked in a community hospital, an independent academic medical center, and world class academic medical institution. She is currently Johnson & Johnson Innovative Medicine Clinical Innovation Focus Area Leader: Capitalizing on Data Assets. She has been the Director of eSource Implementation for Pfizer, Inc. Ms Cramer’s focus throughout her career has been determining improvements that provide better patient centric care, whether that be developing a visualization for a complex hypoglycemia protocol, developing a transplant quality program or optimizing the use of the electronic health record for clinical research. Ms Cramer’s current focus is on clinical trials solutions, which includes eSource; specifically the secondary use of EHR data for clinical research. Ms Cramer is Co-Chair of HL7 Clinical Interoperability Council, AMIA’s Scientific Panel Committee, a TransCelerate member and reviewer for many professional journals. Ms Cramer received a Master in Management of Clinical Informatics from Duke University School of Medicine and plans to continue her studies in Clinical Research Informatics at the University of Arkansas for Medical Sciences.

Dr Jennifer Roberts is the director of the Resilient Systems Office at the Advanced Research Projects Agency for Health (ARPA-H). Dr Roberts joined ARPA-H in February 2023 from the White House Office of Science and Technology Policy, where she was the assistant director of Health Technologies. She has a broad background in both engineering and computer science and has overseen research programs and strategy development on topics such as cyber security, healthcare data interoperability, artificial intelligence for synthetic biology, and information integrity.Before joining the White House, Dr Roberts worked for the Defense Advanced Research Projects Agency as deputy director of the Information Innovation Office. During this time, she received the prestigious Superior Public Service Medal for her contributions to the fields of artificial intelligence and cyber security. Dr Roberts has a PhD in computer science from MIT, which she attended as both a National Science Foundation and Hertz Foundation Fellow.

Grail Sipes, JD serves as Assistant Director for Biomedical Regulatory Policy at the White House Office of Science and Technology Policy (OSTP), where her portfolio includes clinical trial infrastructure, related preparedness issues, and other matters related to the development and marketing of medical products.  For ten years prior to her work at OSTP, Ms Sipes worked in a variety of roles at the FDA, most recently serving as Deputy Director for Regulatory Policy in FDA’s Center for Drug Evaluation and Research (CDER). Prior to that, she was a lawyer in private practice and a partner at Covington & Burling LLP. At FDA, Ms Sipes worked on a wide range of matters involving drugs and other FDA-regulated products, including reproductive health, drug pricing and access, drug shortages, digital health, and First Amendment challenges to regulation. At FDA and at OSTP, Ms Sipes role has been to develop effective public health strategies and policies in light of evolving science, differing stakeholder viewpoints, and various regulatory challenges.