SAN FRANCISCO--(BUSINESS WIRE)--Woebot Health today announced that it has appointed Robbert Zusterzeel, M.D., Ph.D., M.P.H., as Vice President of Regulatory Science and Strategy. Reporting to Founder and President Alison Darcy, Zusterzeel will lead the regulatory and scientific strategy for the company’s portfolio of behavioral health and regulated products to ensure they are founded on the highest standards of quality, safety and efficacy. Woebot Health’s products include: the behavioral health solution Woebot; WB001, an investigational digital therapeutic for postpartum depression that was granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) in 2021; and WB002, an investigational device intended for adolescent depression.
Darcy said the company’s range of products reflects a rapidly shifting, complex environment that is struggling to meet unprecedented demand for mental health services. “Software-based medical devices represent an important public health opportunity to reduce the burden of mental health challenges by making efficacious therapeutics accessible at scale,” said Darcy. “We believe in and have embraced regulation from the start and have expanded our science-based product organization, which makes it the perfect time to add deep expertise to accelerate the process toward clearance. Robbert’s unique mix of clinical, scientific and regulatory skills and passion for this emerging space will be instrumental in bringing our clinically-proven products to market.”
Zusterzeel’s expertise focuses on evidence generation across the entire product lifecycle, from computational modeling to adaptive clinical trials and real-world evidence generation. Before joining Woebot Health, he was Senior Director of U.S. Regulatory Science and Strategy at IQVIA, where he co-led, managed and operationalized the U.S. Regulatory Science and Strategy Team to build out evidence solutions for drug, device and biologics development lifecycles.
Before that, Zusterzeel joined the FDA as a Staff Fellow Medical Officer. He spent nearly 10 years at the agency serving as the lead investigator for multiple studies about the cardiac safety of drugs and co-investigator for multiple reviews of the safety and efficacy of medical device therapies. Zusterzeel obtained his M.D. and Ph.D. degrees at Maastricht University’s Faculty of Health, Medicine and Life Sciences in the Netherlands and completed his Master’s of Public Health in Epidemiology at Harvard University’s T.H. Chan School of Public Health. The author of dozens of peer-reviewed publications, book chapters and white papers, Zusterzeel has received numerous honors, awards and grants.
“I’ve always been interested in technology and passionate about the use of data to improve our understanding and the development of new treatment areas,” said Zusterzeel. “The opportunity at Woebot Health brings together my interests in medicine and technology, coupled with novel challenges in the regulatory arena. It’s a great opportunity to help push the field forward in an essential area.”
About Woebot Health
Woebot Health is the world’s first mental health ally for people and businesses that puts personal growth in people’s hands, wherever they are. Our pipeline of prescription digital therapeutics and behavioral health products combine artificial intelligence, decades of clinically-proven techniques and a relational agent called Woebot, which together form the foundation for mental health solutions that engage at scale and fit right into people’s lives. For more information, visit woebothealth.com or follow Woebot on Facebook, Twitter and LinkedIn.