Debra R. Lappin

Principal - Science & Regulatory Policy - Faegre Drinker Consulting

Overview

Debra Lappin leads complex partnering and coalition strategies across the life sciences enterprise. She is a subject matter authority in the area of patient focused drug development and in the generation patient-centered value models for payment and coverage determinations. Debra also advises on new tools and collaborations to deliver patient data and patient insights to inform clinical trial design, endpoint selection and confirmation of clinically meaningful outcomes to support payment and beneficiary access.

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.

Strategic Communications

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.

 

 

Related Policy, Advocacy, and Consulting Services

Credentials

Bar Admissions

Colorado

Education

University of Denver Sturm College of Law
J.D. Order of St. Ives (1977)

University of Denver
B.A. magna cum laude (1972)

Insights & Events

Other Perspectives
  • Patient Engagement in Alzheimer’s Drug Development: Disruptive Innovation
    Alzheimer’s Association International Conference, Toronto, July 2016
  • Time = Lives: Resiliency – The Potent Ingredient in the Path to Better Health
    Milken Partnering for Cures, New York City, November 2015
  • The Role of the Indiana CTSI: Impacting the Life Sciences Sector, Translating Science Into Therapies
    Co-presenter, BioCrossroads Frameworx, Indianapolis, November 12, 2015

Leadership & Community

Professional Associations

  • Next Fifty Initiative — Secretary, Board of Trustees
  • Council for American Medical Innovation — Former President
  • Research!America — Former Board Member
  • Centers for Disease Control and Prevention (CDC) — Former Advisory Committee to the Director
  • National Institutes of Health (NIH) — Former Committee on Organizational Structure
  • Arthritis Foundation — Former National Chair and Trustee Emeritus
  • National Library of Medicine — Former PubMed Central Advisory Committee
  • National Institutes of Health Counsel of Public Representatives — Charter Member
  • National Academy of Sciences — Committee on National Immunization Policy and Data Sharing, Former Member; Committee on Organizational Structure of NIH, Former Member
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