Overview
Holly Peay collaborates with clients on matters related to patient-focused drug development (PFDD), patient engagement and patient-focused research. She brings clients a sophisticated ability to generate meaningful, fit-for-purpose patient experience and preference data and systematically integrates the patient voice into the life cycle of drug and device development. She has experience in rigorous patient, community and invested party engagement to inform ethical and acceptable clinical research and product development.
Holly is a respected scientist with experience leading clinical and public health research; decision support; patient experience; and ethical, legal and social impact studies. Her clinical and research areas of focus have included rare and common disorders, genomic sequencing and other genomic and genetic technologies, public health, decision support tools, and empirical bioethics.
Patient-Focused Drug Development
Holly collaborates with patient advocacy organizations, pharmaceutical and medical device companies, government agencies, and professional societies to obtain rigorous qualitative and quantitative data to assess patient experience, determine priorities and inform patient-focused drug development. She is expert at survey and instrument development, data collection and analysis, and qualitative and quantitative interpretation. Data from her studies are used to understand symptom impact, treatment priorities, meaningful and valid outcome measures, acceptable and meaningful benefits, and risk and burden tolerance. She works with clients to use data to generate feasible and acceptable research protocols that are patient-centered, decision aids and shared decision making tools, and education and consent materials. She brings skill in engagement and collaboration across rare and common disorder communities, including transdisciplinary engagement as well as professional and community experience.
Prior Experience
In her decade-long prior role as a senior research scientist at RTI International, Holly developed and led work for industry, research and advocacy groups, as well as the Food and Drug Administration and other government agencies, related to common and rare health disorders, with a focus on genetic disorders, newborn screening, and gene therapy and gene editing. Holly led patient preference and experience studies, clinical research, studies that explored the ethical use of emerging technologies, research to inform the disclosure of research results to participants, and decision support and informed-consent tools. She also conducted community-engaged research in which Holly ensured that diverse perspectives were included in study planning, implementation, reporting, and the development of recommendations and guidance.
Previous to RTI, Holly was senior VP of community research at Parent Project Muscular Dystrophy (PPMD). She has also been an intramural researcher and associate graduate program director at the National Human Genome Research Institute; a senior project director and principal investigator at the National Coalition for Health Professional Education in Genetics (NCHPEG); a genetic counselor at Greater Baltimore Medical Center; and a genetic counselor at Johns Hopkins’ Epidemiology and Genetics Program in the Department of Psychiatry.
Personal Interests
In her free time, Holly enjoys spending time with family and friends, traveling, swimming, running, and reading.Related Legal Services
Related Policy, Advocacy & Consulting Services
Related Industries
Credentials
Certifications
American Board of Genetic Counseling — Certified Genetic Counselor (CGC),1999-2024
Education
Leiden University
Ph.D. in Medicine (2015)
University of South Carolina School of Medicine
M.S. in Genetic Counseling (1997)
University of Virginia
B.A. in Interdisciplinary Studies in Biomedical Ethics (1995)
Insights & Events
Latest
News
Other Perspectives
Holly has published more than 110 peer-reviewed articles, as well as a book, five book chapters, and numerous reports, blogs and other grey-literature resources. Selected examples follow.
- Clinician Perspectives of Gene Therapy as a Treatment Option for Duchenne Muscular Dystrophy
Senior Author, Journal of Neuromuscular Diseases, Vol. 11, Issue 5 (July 2024) - Prioritizing Research Needs and Opportunities at the Intersection of Implementation Science and Engagement Science
Senior Author, Implementation Science Communications, Vol. 5, Article 78 (July 2024) - Return of Participant-Level Clinical Trial Results to Participants: Pilot of a Simplified Centralised Approach
Co-author, BMJ Open, Vol. 14, Issue 3 (March 2024) - Parent Perspectives Following Newborn Screening Resulting in Diagnoses of Fragile X Syndrome or Fragile X Premutation
Senior Author, Research in Developmental Disabilities, Vol. 148 (May 2024) - Role Preferences in Medical Decision Making: Relevance and Implications for Health Preference Research
Co-author, The Patient, Vol. 17, Issue 1 (Jan. 2024) - HIV Remission Trial Investigators’ Attitudes Towards Risk and Risk Mitigation in Trials That Include Treatment Interruption
Senior Author, Journal of Virus Eradication, Vol. 9, Issue 2 (June 2023) - The Essential Need for Trust When Transmission Risk Cannot Be Eliminated in HIV-Remission Trials
Senior Author, Ethics and Human Research, Vol. 45, Issue 4 (July-Aug. 2023) - Defining Critical Educational Components of Informed Consent for Genetic Testing: Views of US-Based Genetic Counselors and Medical Geneticists
Co-author, European Journal of Human Genetics, Vol. 31, Issue 10 (Oct. 2023) - A Mixed-Method Study Exploring Patient-Experienced and Caregiver-Reported Benefits and Side Effects of Corticosteroid Use in Duchenne Muscular Dystrophy
Senior Author, Journal of Neuromuscular Diseases, Vol. 10, Issue 4 (May 2023) - Development of a Novel Shared Decision Making Aid for Primary Immunodeficiency Diseases
Co-author, Immunotherapy, Vol. 15, Issue 9 (June 2023) - Adaptation of the WOMAC for Use in a Patient Preference Study
Co-author, Therapeutic Innovation and Regulatory Science, Vol. 57, Issue 4 (July 2023) - GM1-Gangliosidosis: The Caregivers’ Assessments of Symptom Impact and Most Important Symptoms to Treat
Senior Author, American Journal of Medical Genetics, Part A, Vol. 191, Issue 2 (Feb. 2023) - Education and Consent for Population-Based DNA Screening: A Mixed-Methods Evaluation of the Early Check Newborn Screening Pilot Study
First Author, Frontiers in Genetics, Vol. 13 (May 11, 2022) - Caregivers’ Assessment of Meaningful and Relevant Clinical Outcome Assessments for Sanfilippo Syndrome
Senior Author, Journal of Patient-Reported Outcomes, Vol. 6, Issue 1 (April 2022) - Preparing Newborn Screening for the Future: A Collaborative Stakeholder Engagement Exploring Challenges and Opportunities to Modernizing the Newborn Screening System
Senior Author, BMC Pediatrics, Vol. 22, Article 90 (Feb. 2022) - Parent Clinical Trial Priorities for Fragile X Syndrome: A Best-Worst Scaling
Co-author, European Journal of Human Genetics, Vol. 29, Issue 8 (Aug. 2021) - Patients’ and Caregivers’ Maximum Acceptable Risk of Death for Non-curative Gene Therapy to Treat Duchenne Muscular Dystrophy
First Author, Molecular Genetics and Genomic Medicine, Vol. 9, Issue 5 (May 2021) - Parent Experiences of Sanfilippo Syndrome Impact and Unmet Treatment Needs: A Qualitative Assessment
Senior Author, Neurology and Therapy, Vol. 10, Issue 1 (June 2021) - Recommendations From Thai Stakeholders About Protecting HIV Remission (‘Cure’) Trial Participants: Report From a Participatory Workshop
First Author, International Health, Vol. 12, No. 6 (Nov. 2020) - Reporting Formative Qualitative Research to Support the Development of Quantitative Preference Study Protocols and Corresponding Survey Instruments: Guidelines for Authors and Reviewers
Senior Author, The Patient, Vol. 13, Issue 1 (Feb. 2020) - Priorities When Deciding on Participation in Early-Phase Gene Therapy Trials for Duchenne Muscular Dystrophy: A Best-Worst Scaling Experiment in Caregivers and Adult Patients
Senior Author, Orphanet Journal of Rare Diseases, Vol. 14, Issue 1 (May 2019) - How Do Members of the Duchenne and Becker Muscular Dystrophy Community Perceive a Discrete-Choice Experiment Incorporating Uncertain Treatment Benefit? An Application of Research as an Event
Senior Author, The Patient, Vol. 12, No. 2 (April 2019) - Developing a Patient-Centered Benefit-Risk Survey: A Community-Engaged Process
Senior Author, Value in Health, Vol. 19, Issue 2016, Issue 6 (Sep-Oct 2016)
Leadership & Community
Pro Bono
- National Human Genome Research Institute — Genomics and Society Working Group, 2022-present
- Frontiers in Genetics — “ELSI in Science and Genetics” Section, Associate Editor, 2021-present
- The Patient: Patient-Centered Outcomes Research — Editorial Board, 2016-present
- International Consortium of Newborn Sequencing — Steering Committee, 2023-25
- National Institutes of Health’s All of Us Research Program — Ethical, Legal and Social Implications (ELSI) Brain Trust Committee, 2022-25
Professional Associations
- International Society for Pharmacoeconomics and Outcomes Research — Stated-Preference Methods Special Interest Group
- Society for Medical Decision Making
- American College of Medical Genetics