Measurement science and regulatory strategy expert to lead global patient-focused endpoint initiatives.
TUCSON, Ariz., September 24, 2026 — Critical Path Institute® (C-Path) today announced the appointment of Elizabeth (Nicki) Bush as Vice President of its Clinical Outcome Assessment (COA) Program. Bringing more than 20 years of scientific and leadership experience to the role, Bush will drive the strategic vision for incorporating precise patient perspectives into drug development. She brings extensive industry experience to the role, most recently serving as Executive Director at OPEN Health, heading the Endpoint Strategy and COA Measurement consultancy capabilities. Her background also includes serving as Senior Director of Endpoints and Measurement Strategy at Johnson & Johnson Innovative Medicine and over a decade at Eli Lilly and Company, where she built and led the company’s Patient-Focused Endpoints and Measurement Center of Expertise.
Bush’s professional history includes a multi-year term serving as Industry Co-Director of C-Path’s Patient-Centered Evidence Consortium (formally Patient Reported Outcomes Consortium), establishing a strong foundation of collaborative success with the organization.
“We are honored and excited that Nicki will be carrying C-Path’s mission forward and leading our COA program,” said Klaus Romero, M.D., M.S., FCP. “She partnered with C-Path as we saw her build the patient-focused endpoints center at Eli Lilly, and our collaborations benefited greatly from having her as a collaborator over the years. Now at C-Path, it is a privilege to work alongside a leader who helps shape the measurement standards that change so much of how we understand the lived experience. I am filled with optimism about what we can achieve in the years to come, and I am so happy to know that the most talented people in measurement and regulatory science are here at C-Path, determined to be part of something bigger than any one of us.”
“Using robust methods incorporating patients’ lived experiences into medical product development has been my life’s work,” Bush said. “Having collaborated closely with C-Path for years, I know firsthand the power of bringing regulators, industry leaders, patient advocates, academia and other stakeholders to the same table. We have a profound responsibility to create tools that are meaningful and interpretable so that we capture the true reality of a disease. Being part of this organization is an absolute privilege, and I look forward to continuing to work with the global community that will shape the future of measurement science.”
Academic achievements for Bush include a master’s degree in infectious disease epidemiology from Johns Hopkins University’s Bloomberg School of Public Health, and a B.A. in philosophy and the history of mathematics and science from St. John’s College. Publishing extensively on topics related to clinical outcome assessments, she consistently champions best research practices across the healthcare spectrum. She currently co-leads an expert task force developing standards for the assessment of performance-related outcomes in clinical trials.
Taking the helm of the COA Program, Bush will oversee collaborative efforts to develop and qualify novel clinical outcome assessments. Partnering closely with global regulatory bodies ensures these measurement tools meet rigorous standards for evaluating treatment efficacy. Her leadership will directly support C-Path’s broader portfolio of consortia by providing strategic guidance on patient-reported, clinician-reported, and performance-based outcomes.
About Critical Path Institute
Critical Path Institute (C-Path) is an independent, nonprofit established in 2005 as a public-private partnership, in response to the FDA’s Critical Path Initiative. C-Path’s mission is to lead collaborations that advance better treatments for people worldwide. Globally recognized as a pioneer in accelerating drug development, C-Path has established numerous international consortia, programs and initiatives that currently include more than 1,600 scientists and representatives from government and regulatory agencies, academia, patient organizations, disease foundations and pharmaceutical and biotech companies. With dedicated team members located throughout the world, C-Path’s global headquarters is located in Tucson, Arizona and C-Path’s Europe subsidiary is headquartered in Amsterdam, Netherlands. For more information, visit c-path.org.
Media Contacts:
Roxan Triolo Olivas
C-Path
520.954.1634
rolivas@c-path.org
Kissy Black
C-Path
615.310.1894
kblack@c-path.org
