Drug Development, Patient Data and Clinical Trials
Debra is an industry leader in regulatory and science policy. She has spearheaded a highly effective collaboration to secure passage of legislation to create and fund the Advanced Research Project Agency for Health, or ARPA0H. She leads initiatives for patient engagement in drug development and the development of value models for payment and coverage determinations. She advises on new tools and collaborations to deliver patient data and insights to inform clinical trial design, endpoint confirmation, regulatory submissions, and labeling, and on the development of patient-led real world evidence platforms. She is active in advancing policies to protect and strengthen pathways for expedited approval of therapies addressing high, unmet needs. 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 as a member of the Board of Research!America for more than a decade.