CCRB UPDATES AND INTRODUCTION TO CCRB SECTION LEADERS

By: Mary Smolskis, BSN, MA, Operations and Strategy Management Section Chief | Stephen Migueles, M.D., CCRB Science Section Chief

As of June 2023, the Office of Planning and Operations Support (OPOS) merged with the Collaborative Clinical Research Branch (CCRB) within the Division of Clinical Research (DCR). In this unification, the CCRB has introduced two new sections: the Science Section and the Operations and Strategy Management Section. The Science Section is dedicated to providing scientific guidance and oversight and establishing working relationships with host country government ministries and partners. Meanwhile, the Operations and Strategy Management Section will act as a resource for operations, logistics, and training for clinical trials/studies from the early stage of protocol development through the lifecycle of protocols. This includes the identification and coordination of all resources required across special projects, developing innovative approaches to operational challenges while remaining within budget requirements, maintaining the availability and offering of relevant training programs across special projects, and keeping strategic management in alignment with the DCR and special projects’ strategy planning, all while coordinating closely with the CCRB Science Section.

Mary Smolskis has been with the National Institute of Allergy and Infectious Diseases (NIAID) since 1987. She became the new Director of the Office of Planning and Operations Support as of January 2023. Prior to this role, she served as a Clinical Research Oversight Manager in the DCR for 15 years. Ms. Smolskis officially transitioned as the new Section Chief in June 2023. Her years of profound expertise in clinical research support initiatives in the Division of Clinical Research at NIAID. Her leadership guides the team’s ceaseless endeavors in pioneering result-driven research in ever-changing times. Notably, her role in PREVAIL, LaRed, and DCR ICC operations co-lead are examples of the multifaceted areas of focus in CCRB and DCR’s research and development.

Dr. Migueles will head the Science Section in the CCRB. He joined the National Institute of Allergy and Infectious Diseases in 1997 as a Clinical Associate in the Laboratory of Immunoregulation and was commissioned as a Medical Officer in the U.S. Public Health Service (USPHS). He became a Staff Clinician in 2005, was promoted to CAPT (O-6) in the USPHS in 2010, and became a Senior Research Physician in 2017. He maintains active certification in Internal Medicine and Infectious Diseases. Currently, Dr. Migueles is the head of the Cellular Immune Response Unit, with a research focus on the cellular response to HIV, SARS-CoV-2, mechanisms of durable immunologic control of HIV in patients, immunology of vaccine-induced responses, and a cohort of people living with HIV infection in West Africa (Liberia). He will officially transition to his new role in the CCRB in February 2024. The Collaborative Clinical Research Branch is thrilled to have Dr. Migueles and Ms. Smolskis in their new leadership appointments and looks forward to their role in promoting the mission and vision of the branch.

DCR Special Projects Smartsheets is an exciting source with access to information across special projects. INA-RESPOND has a dashboard available full of analytics in protocol timelines, enrollment summaries, publications, and much more. For more details, user access, and questions, please contact Katie Watkins at katie.watkins@nih.gov or Kristine Nagales at kristine.nagales@nih.gov.

NIAID DCR CCRB recently refreshed its web pages with up-to-date information. Rich with resources and information, worldwide partnerships and the latest studies can be found at https://www.niaid.nih.gov/about/collaborative-clinical research-branch and INA-RESPOND’s network at https://www.niaid.nih.gov/research/ina-respondnetwork.
Please contact Kristine Nagales for details and questions at kristine.nagales@nih.gov.