FDA Update on Draft Guidance for Digital Health Technologies in Clinical Trials

Beth Kunkoski currently works in the FDA’s Center for Drug Evaluation and Research (CDER), Office of Medical Policy (OMP). She oversees several projects involving decentralized clinical trials, digital health technologies and electronic records and storage in clinical investigations (Part 11). She worked for 15 years in the Center for Devices and Radiological Health (CDRH) in guidance document development and as a branch chief overseeing the review of orthopedic devices. She earned a Master’s Degree in Biomedical Engineering and a Bachelor’s Degree in Chemical Engineering from the University of Michigan.

Lauren Oliva is a Director, Global Regulatory Policy, and Lead for Digital Health Regulatory Policy at Biogen. She oversees the development and execution of Biogen’s digital health policy roadmap to enable Biogen’s neuroscience portfolio. She is passionate about patient centric drug development and the impact of multi-stakeholder initiatives to advance the adoption of new technologies. Dr Oliva is actively engaged with the Critical Path Institute, DIA (Drug Information Association), Clinical Trials Transformation Initiative, and the National Academies’ Drug Forum. Dr Oliva has over 10 years of experience in the pharmaceutical industry. In her time at Biogen, she’s held regulatory policy and strategy roles and launched a widely used regulatory intelligence platform.Dr Oliva received her PharmD from Rutgers University, Ernest Mario School of Pharmacy and has previously served as adjunct faculty and lecturer at MCPHS University in Boston, MA.

Leonard Sacks, MD received his medical education in South Africa, moving to the USA in 1987, where he completed fellowships in immunopathology and Infectious Diseases. He worked as an attending physician in Washington DC and South Africa and he joined the FDA in 1998 as medical reviewer in the Office of New Drugs. Subsequent positions included acting director of the Office of Critical Path Programs and associate director for clinical methodology in the Office of Medical Policy in the Center for Drug Evaluation and Research. In this capacity he has led efforts to support the use of electronic technology in clinical drug development. Besides his involvement in the design and analysis of clinical trials, he maintains a special interest in tuberculosis and other tropical diseases and has published and presented extensively on these topics. He  holds academic appointments as Associate Clinical Professor of Medicine at George Washington University, and at the Uniformed Services University of the Health Sciences.

Anindita (Annie) Saha is the Assistant Director for the Digital Health Center of Excellence (DHCoE) at the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH). Ms Saha is leading the development of partnerships, regulatory science, strategic planning and operations for the newly formed DHCoE to empower stakeholders to empower digital health stakeholders in advancing healthcare. Additionally, Ms Saha helped incubate and continues to support CDRH’s patient science and engagement efforts to advance the science and adoption of patient input as evidence, including patient preference information (PPI), clinical outcome assessments (COAs) including patient-reported outcomes (PROs) and patient-generated health data (PGHD). These efforts include researching the use of digital health technologies to capture the patient perspective. Previously, Ms Saha was the Director of Partnerships to Advance Innovation and Regulatory Science (PAIRS) where she oversaw a broad program portfolio, supporting a number of strategic partnership and regulatory science programs for CDRH. This included relationships with the Medical Device Innovation Consortium and other public-private partnerships, Network of Experts, Critical Path and technology transfer. Ms Saha began her FDA career as a researcher in the CDRH’s Office of Science and Engineering Laboratories in the Division of Imaging and Applied Mathematics in the area of imaging display technologies before moving to EEP to coordinate Critical Path and Regulatory Science activities for the Center. Ms Saha has a Bachelor of Science in Bioengineering and a Minor in History from the University of Pittsburgh. She was a student researcher at the McGowan Institute for Regenerative Medicine working in tissue engineering and wound healing.