Today, Sally Okun, who has served as CTTI’s Executive Director since October 2021, is retiring after five decades in healthcare.  

“On behalf of the entire CTTI community, we congratulate Sally on her exceptional career and on her retirement,” said CTTI’s incoming executive director, Morgan Hanger. “Sally’s tenacity and gift for storytelling have had a remarkable impact on bringing person-centered research and care into the mainstream. As we move into a phase of AI-driven innovation, her vision for ethical, patient-led data stewardship is providing an invaluable foundation for CTTI. We are so grateful for her 50 years of contributions to healthcare and to the success of this organization.”  

During her 20 years as a nurse and palliative care specialist in the community setting, Sally worked with hundreds of patients and caregivers. At the online patient research network PatientsLikeMe, where she served in a variety of roles for 12 years including as vice president of policy and ethics, she led the national conversation on patient centricity and created an evidence base to support expanded use of patient-generated health data. More recently at CTTI, Sally has initiated enterprise-wide measurement, expanded our commitment to diversity in clinical trials, and empowered the team to be independent and creative.  

When Sally announced her retirement in August, she committed to ensuring a seamless transition to her successor. In October, CTTI announced Morgan Hanger’s promotion to Executive Director upon Sally’s retirement, and over the past two months they have doubled down on that commitment. With the support and guidance of the CTTI Executive Committee Chairs and team, Sally and Morgan have relied on their shared values of connection, openness, and integrity to stay focused on what matters: the health and growth of our team; exciting, relevant work; and partnership with our members and the FDA.  

“It has been a wonderful experience working with entire CTTI team in preparation for my retirement,” said Okun. “I am confident that the organization will flourish through the leadership of my dear friend and colleague Morgan Hanger.” 

Please join us in thanking Sally for her service to CTTI and wishing her well in her retirement. 

Throughout this year, we’ve had the pleasure of crossing paths with many of you at diverse locations around the world – from San Francisco and Boston, to the nation’s capital and the Big Apple, to Montreal and Riyadh. We shared our work at more than two dozen meetings, conferences, and events, and it’s been truly gratifying to see our community actively engaged in our work on a global level. 

In 2023, CTTI has redefined possibilities around some of the clinical trials enterprise’s most pressing challenges and made strides toward creating a more effective and efficient research process. We’re proud to share the results of those efforts in our 2023 CTTI Annual Report. 

As we usher in a new year with CTTI’s next generation of leadership, our strategy is to build on CTTI’s key strengths by offering new engagement and implementation opportunities with our members that are focused, flexible, and poised for impactful change, including: 

• Last Mile Implementation: CTTI is well-known for launching products and recommendations to improve the quality and efficiency of clinical trials. Yet, we recognize that more is needed to drive sustainable and scalable change. Therefore, we will test innovative approaches to make CTTI recommendations easier to implement in a range of settings, including our website. 
• Engagement Diversification: CTTI’s flagship multi-year project archetype is important and we appreciate that in-depth learning and meaningful multi-stakeholder consensus takes time. We are eager to forge different modes of engaging, including more dynamic conversations with members and with the FDA. With the increased accessibility of powerful AI tools, research is changing rapidly, presenting interesting opportunities to learn together by convening in new and interesting ways. 
• Dynamic Collaborations: There’s growing attention from private and public sectors as the U.S. government (including OSTP, NIH, ARPA-H and the FDA) intensifies its focus on clinical trials modernization and readiness. We’re delighted by the new and growing initiatives from digital platform companies to bring the research experience closer to patients wherever they are. CTTI has a crucial role to play, and we’ll continue to partner with our members, related efforts, and organizations around the world to harness these moments for impact.  

To our CTTI community, we thank you. While we all come from different parts of this complex enterprise, our collective culture is strong and our commitment steadfast. As our organization transitions from one leader to the next, we will carry CTTI’s legacy forward together by building on the work of leaders and members, past and present, to shape the future of clinical trials that we all want for ourselves and our loved ones.  

As we set our sights on 2024 and beyond, look to CTTI to pick up the pace of innovation and transformation in respect to our mission. We wish you a wonderful holiday season and a prosperous new year! 

A recording of the virtual public meeting “Mitigating Clinical Study Disruptions During Disasters and Public Health Emergencies (PHEs),” convened by the U.S. Food and Drug Administration (FDA) and Clinical Trials Transformation Initiative (CTTI) held October 18th and 19th, is now available.  

Day 1 of the virtual public meeting opened with welcoming remarks from Janet Woodcock, FDA’s Principal Deputy Commissioner. Following the opening remarks, Jacqueline Corrigan-Curay of the FDA’s Center for Drug Evaluation and Research (CDER) provided an overview of the FDA’s activities and responses to address the COVID-19 public health emergency and clinical trial conduct disruptions. Following the presentations, three panel sessions were held and panelists discussed various topics related to clinical trial disruptions during COVID-19. The first day concluded with closing remarks from CTTI Executive Director Sally Okun.    

Day 2 of the meeting began with opening remarks from Celia Witten of the FDA’s Center for Biologics Evaluation and Research (CBER). Following the opening remarks, panel discussions were held on federal partners’ experience related to trial disruptions and strategies for emergency preparedness in clinical studies. The second and final day of the meeting concluded with closing remarks from M. Khair ElZarrad of the Office of Medical Policy at CDER. 

View the full slide deck to learn more about methods to mitigate clinical study disruptions during disasters and public health emergencies. 

For additional information on the FDA guidance on conduct of clinical trials of medical products during the COVID-19 public health emergency, please see the updated final guidance document. This meeting fulfilled a requirement under section 3605 of the Food and Drug Omnibus Reform Act of 2022 (FDORA).  

Please join us on November 29 and 30, 2023, for another FDORA virtual public workshop on enhancing clinical study diversity. Registration information and a full workshop agenda can be found here.  

Today, CTTI proudly announced Morgan Hanger as its next Executive Director.  

“CTTI has been at the center of advancing clinical trial transformation through public-private collaboration, and that leadership will continue under Morgan Hanger,” said Dr. Mark McClellan, CTTI Executive Committee Chair, and Founding Director, Duke-Margolis Center for Health Policy. “Combined with Sally Okun’s lasting contributions, a thoughtful transition plan, and a strong team, CTTI is uniquely positioned—at critical time—to identify and support innovative strategies to speed the development of better clinical evidence to help more patients at a lower cost.” 

Serving as CTTI’s Director of Strategic Programs since January 2022, Hanger has collaborated on strategic initiatives related to the organization’s Transforming Trials 2030 vision and led the early-stage activities of CTTI’s newest project, Measuring Trials Transformation. Prior to CTTI, she spent three years as an independent consultant advising health technology companies and innovators on the development of new products. Previously, she served as vice president of the online patient research network PatientsLikeMe (PLM), where she led programs utilizing patient-generated health data in life sciences and regulatory settings. Hanger’s earlier work provided consulting and advisory services to leading pharma, biotech companies, and professional societies to create more effective research strategies. She also held positions within the Health Outcomes Group at Memorial Sloan Kettering Cancer Center and the Congressional Budget Office. 

“I am excited and honored to lead CTTI at such an exciting moment in its trajectory,” Hanger said. “We have terrific members, partners, and a highly adaptive and talented team, all of whom are eager to drive change across the clinical trials enterprise. We will continue to lean into the transformation part of our directive by deepening our implementation resources, focusing on enterprise-wide measurement, and supporting the FDA as they anticipate and facilitate the evolution of trials with modernized designs, data, and capabilities.”  

“I know I speak for the entire CTTI team in celebrating Morgan’s promotion to the Executive Director position,” said Sally Okun, CTTI’s current Executive Director, who is retiring at the end of this year. “Over the past two years, Morgan’s unique combination of innovative thinking, operational skills, and inclusive engagement have guided the development of an impactful and measurable strategic plan. It is a rare privilege to have a person of Morgan’s caliber so well positioned to seamlessly continue advancing CTTI towards its transformational 2030 vision.”  

Hanger, who assumes her new role in January 2024, will work closely over the next several months with Okun to ensure a smooth transition. Both Hanger and Okun are working with Executive Committee leadership – Chair Mark McClellan, Duke Co-chair John Alexander, and FDA Co-chair Khair ElZarrad – on a thoughtful succession plan that ensures the highest level of team and organizational integrity. In addition, the CTTI team is actively involved in this transition process – one that considers their voices and reflects their perspectives about the next generation of CTTI leadership and its strategy moving forward.