Remembering Dr. Dionne Price and Her Contributions to Public Health and the Statistical Community

Adrian Coles (Biogen), Shanti Gomatam (FDA)

Introduction

Esteemed author and poet Maya Angelou once shared a bit of wisdom about an essential component of healthy interpersonal relationships, “I’ve learned that people will forget what you said, people will forget what you did, but people will never forget how you made them feel.” Well, in the case of Dr. Dionne Price, people remember what she said, what she did, and how she made them feel! Her broad impact on public health and her strong leadership within the statistical community were the subjects of a special commemorative session of the 2024 Regulatory-Industry Statistics Workshop. It was an informative, inspiring and heartwarming time of reflection and learning. The well-attended session was held on September 26, 2024, and it was organized by Adrian Coles (Biogen) and Shanti Gomatam (FDA). It featured multiple speakers and panelists from industry and FDA, each of whom had much to say about Dionne’s impact. The session was opened by Shanti, and she shared some of Dionne’s background. Having graduated with a bachelor’s degree in applied mathematics from Norfolk University, she went on to obtain a master’s degree in biostatistics from University of North Carolina, Chapel Hill and a Ph.D. from Emory University. She joined the Office of Biostatistics in FDA’s Center for Drug Research and Evaluation (CDER) in 2001 and remained with the Office till her passing. She made many impactful contributions at the FDA – as a Reviewer, a Team Lead, a Division Director, and the Deputy Office Director. In addition, she took on various roles at the American Statistical Association (ASA) and served as its first African American President in 2023.

Reflections from Karen Price and John Scott

Karen Price (Lilly) and John Scott (FDA) reflected on Dionne’s efforts to drive innovation in drug development via the FDA’s Complex Innovative Design (CID) program. Karen and John both shared that Dionne was a strong advocate for improving drug development in the United States through innovation. Karen highlighted the benefit of the CID program to pharmaceutical companies like Lilly, and, ultimately, to patients. Her description of her interactions with Dionne highlighted that she believed in establishing strong partnerships between the FDA and sponsors for the benefit of patients. John discussed his collaboration with Dionne on the CID initiative and the positive impression she left on him as a colleague. The two have published thoughts and findings on the impact of the CID program on drug development. John also reflected on Dionne’s ability to get difficult things done through effective leadership and her peerless diplomacy, commitment, curiosity, and deep passion for public health. She advocated strongly for the continuation of the CID program and personally negotiated for its renewal in Prescription Drug User Fee Act (PDUFA) VII. This was a great example of how the combination of technical competency, emotional intelligence, and leadership leads to increased influence, which when used wisely, leads to broad impact.

Reflections from Greg Levin and John Farley

Greg and John reflected on Dionne’s other contributions to public health. Greg touched on some of her impactful contributions – her statistical expertise and leadership in dealing with the public health concern about antibiotic-resistant infections and the lack of new safe and effective antibiotics, her role in the innovative design and analyses approaches to dealing with the West African outbreak of Ebola virus disease in 2014, and her leadership of statistical support for drug development for COVID-19. Throughout it all her passion for the FDA mission of promoting public health and focus on what was best for society was clear, as was her dedication, hard-work, leadership and supportive and encouraging personality. She was always positive, good at handling difficult conversations, and quiet and effective. Greg offered many heartfelt reflections about Dionne as a colleague and leader within CDER.

John presented a clinician’s perspective on Dionne’s contributions to public health. He collaborated with her on multiple initiatives, including work done to address Hepatitis C therapeutics, where she helped support a move from a 24-week to a 12-week endpoint and highlighted the importance of diversity in clinical trials. He described her contributions to addressing statistical challenges for anti-bacterial clinical trials and her contributions to the guidance for antibacterial therapies for patients with unmet medical need, that helped change the standard of care for patients with some of these infections. He also discussed her contributions to the development of therapeutics during the Ebola outbreak that demonstrated that randomized control trials can be done in the midst of an outbreak. He highlighted her strong technical skills as well as her ability to communicate with non-statisticians, a key trait for statisticians who aspire to maximize their impact as drug developers.

Panel Discussion

The objective of the panel discussion was to highlight Dionne’s impact as a leader and mentor beyond her technical contributions. Panelists included Donna LaLonde (ASA), Mark Levenson (FDA), and Therri Usher (FDA). Therri was one of Dionne’s mentees, and she described her relationship with Dionne as encouraging and very supportive, and through this relationship she learned first-hand the difference between mentorship and sponsorship. It was a good reminder for us to be intentional about helping to positively shape the careers and lives of those following in our footsteps. Donna worked closely with Dionne during her time as the 2023 ASA President. When asked what made her effective as a leader of a large professional society, she shared that above all else, Dr. Price valued people, and this value was reflected in her strong listening skills, compassion for others, and her love for our profession. Mark also reflected on traits that made Dionne an effective leader. In addition to the points made by others, he highlighted her ability to inspire others to connect to a vision, her strong work ethic, and her reputation for being firm but fair.

Conclusion

Dionne had a strong and positive impact on the people with whom she interacted, on the advancement of drug development and on the statistical community. As shared by participants in the session, she loved her work and our discipline. She was dedicated to helping patients gain access to safe and effective drugs and making a positive impact on the lives she touched through her daily interactions. Dionne was equally concerned about drug development as a service to society and about the people who participate in this enterprise. This combination of concerns contributed to many observable traits that enabled her to be effective as a leader and drug developer. The descriptions of her work and professional life were truly inspiring to all who attended the session. Dr. Price lived her life well, and she is an example from which all those who aspire to broaden their positive impact in our society can learn.