Drug Development, Patient Data and Clinical Trials
Debra has special expertise in regulatory science, where she leads initiatives for patient engagement in drug development and in the generation of value models for payment and coverage determinations. She advises on new tools and collaborations to deliver patient data and patient insights to inform and enable clinical development and access, including: clinical trial design, endpoint confirmation, regulatory submissions and labeling, development of real world evidence, and benefit design. Drawing upon her understanding of health agency trends, law, ethics and practical funding challenges, Debra delivers advice and creative solutions that position clients to take advantage of the “future state” in the federal enterprise.
Debra facilitates scientific meetings, bringing an ability to translate and synthesize complex scientific information for diverse audiences and to elicit collective and balanced input. She is respected and trusted by senior leaders across the nation’s health agencies, having served on advisory boards to the directors of both the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC), as President of the Council for American Medical Innovation, and continuing today as a member of the Board of Research!America.
Debra serves clients of Faegre Baker Daniels Consulting as a consulting professional, and does not act as a lawyer for those clients. Learn more.