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CTTI Receives Innovations in Regulatory Science Award from Reagan-Udall Foundation

The Reagan-Udall Foundation for the FDA presented CTTI with the Innovations in Regulatory Science Award on Tues., Dec. 4, in recognition of its achievements and continued contributions to regulatory science. CTTI was one of three recipients of the annual award.

CTTI Wins Reagan-Udall Award

“This great honor caps off a momentous year for CTTI,” said Pamela Tenaerts, CTTI executive director. “We celebrated our 10-year anniversary at the beginning of 2018, so this award affirms that our efforts over the last decade have led to meaningful positive change in the quality and efficiency of clinical research.”


The Reagan-Udall Foundation for the FDA is an independent nonprofit organization created by Congress for the purpose of advancing regulatory science that is critical to the FDA’s mission.


“We are pleased to give CTTI proper recognition for advancing public health by streamlining and improving clinical research,” said Garry Neil, MD, awards committee chair and chief scientific officer for Aevi Genomic Medicine. “CTTI not only identifies the most critical areas that need to be addressed in order to achieve better and more efficient clinical trials—it also provides actionable road maps to help stakeholders realize this vision.”


Many agencies and organizations have applied CTTI’s more than 20 existing recommendations and associated resources to make better clinical trials a reality. A few examples include:

  • CTTI’s Quality by Design work has been cited in FDA and EMA guidance and incorporated into Good Clinical Practice (GCP) guidelines.
  • Its Single IRB recommendations and resources have been used by organizations such as Northwell Health and the National Institute of Neurological Disorders and Stroke.
  • The Duke Clinical Research Institute (DCRI) developed a new program for engaging patients in the research process based on CTTI’s Patient Groups & Clinical Trials work.

CTTI joined other awardees Richard Pazdur, MD, director of FDA’s Oncology Center of Excellence (OCE), and Robert O’Neill, PhD, former senior statistical advisor in the Office of Translational Sciences at the FDA’s Center for Drug Evaluation and Research.

The awards dinner took place at the Kaiser Permanente Center for Total Health in Washington, D.C.