Koneksa CMO Speaks at FDA Workshop

Koneksa CMO John Wagner, MD, Ph.D. discussed the benefits and challenges of using biomarkers and translational science in clinical development programs at an FDA workshop hosted by the Duke-Margolis Center for Health Policy.

The meeting was titled “Translational Science in Drug Development,” and Dr. Wagner was a guest speaker in a session titled “Enhancing Clinical Development Programs by Leveraging Translational Science Throughout the Drug Development Lifecycle.”

The mission of the Center is to improve health, health equity, and the value of healthcare through practical, innovative, and evidence-based policy solutions.

Their workshop sought to:

• • Present efforts from FDA, NIH, academia, patient groups, and industry to support surrogate endpoint and other biomarker identification and development for use in therapeutic development and regulatory submissions.
  • Provide successful examples of using translational science in the development of therapeutics.
  • Identify current challenges and opportunities in developing innovative drug development tools and applying them in therapeutic development.
  • Foster interaction and discussion among the stakeholders who are developing these tools and implementing them in therapeutic development programs

And the purpose of Dr. Wagner’s session specifically, where he was joined by speakers from the FDA and the National Center for Advancing Translational Sciences, was to present points of view on the use of biomarkers and other translational science into clinical development programs.

Dr. Wagner began with a general introduction to what biomarkers and translational science are, how they’re used in drug development, and why. Next, he dug deeper, offering several vignettes, or case studies: biomarkers and surrogate endpoints, prognostic biomarkers, investigation into mechanisms of action, digital biomarkers for functional status, translational clinical models, and the role of reverse translation. There are numerous examples of biomarkers and translational science strategies with direct benefit to drug development. Finally, he finished his presentation with a discussion of challenges and potential solutions.

Materials from the meeting, including video, a discussion guide, the agenda, meeting slides for both days, and Dr. Wagner’s slides in particular, are all now available from Duke.