2018 FDA interns and organizing committee members

The Food and Drug Administration (FDA) held the Oak Ridge Institute for Science and Education (ORISE) Statistical Conference August 17 at its White Oak campus in Silver Spring, Maryland, to showcase the work of its summer interns.

ORISE is an educational and training program designed to provide students with opportunities to participate in project-specific research and developmental activities. It provides educational experiences and training in public health as a way to introduce highly motivated participants to public health careers. The program, for advanced doctoral candidates in biostatistics offers opportunities to explore statistical issues arising from review activities, guidance/policy development, and other FDA initiatives that use the skills of highly trained statisticians.

This year, 155 applications were received and 21 students were selected by the Office of Biostatistics. Also included was one student sponsored by Center for Drug Evaluation and Research’s (CDER) Office of New Drugs, three students sponsored by the Center for Devices and Radiological Health (CDRH), and one student sponsored by the Center for Veterinary Medicine (CVM).

The conference—which was co-sponsored by the FDA Statistical Association (FDASA), an internal organization including all FDA statisticians—attracted approximately 150 FDA scientists, researchers, and reviewers from various disciplines of pharmaceutical research and development. Chaired by Shein-Chung Chow and co-chaired by Mengdie Yuan and Julia Luan, the conference consisted of three general sessions (Innovative Methodology Development in Clinical Trials, Practical and Challenging Issues in Drug Development, and Practical and Challenging Issues in Generics/Biosimilars Studies) and one poster session led by William Koh and Andrew Potter. There were nine oral presentations, including three panel discussions and 17 posters. Janet Woodcock, CDER director; Malcolm Bertoni, FDA associate commissioner for planning; and Juan Ruiz, CDER/OTS deputy director for science, were invited as keynote speakers to give the opening remarks.

The award committee, led by Jason Schroeder, presented awards to Wenda Tu of the University of Iowa for her oral presentation and Philani Mpofu of Indiana University Purdue University Indianapolis and Dongyan Yan of the University of Missouri for their poster presentations. In addition, Guoxing Soon from the conference publication committee announced that 16–18 manuscripts from the conference will be invited for publication consideration in a special issue of the Journal of Biopharmaceutical Statistics (tentatively the first issue of 2019).