Grail Sipes, JD serves as Assistant Director for Biomedical Regulatory Policy at the White House Office of Science and Technology Policy (OSTP), where her portfolio includes clinical trial infrastructure, related preparedness issues, and other matters related to the development and marketing of medical products.  For ten years prior to her work at OSTP, Ms Sipes worked in a variety of roles at the FDA, most recently serving as Deputy Director for Regulatory Policy in FDA’s Center for Drug Evaluation and Research (CDER). Prior to that, she was a lawyer in private practice and a partner at Covington & Burling LLP. At FDA, Ms Sipes worked on a wide range of matters involving drugs and other FDA-regulated products, including reproductive health, drug pricing and access, drug shortages, digital health, and First Amendment challenges to regulation. At FDA and at OSTP, Ms Sipes role has been to develop effective public health strategies and policies in light of evolving science, differing stakeholder viewpoints, and various regulatory challenges.

Nick Slack, MBE, is the Chairman and CEO of The START Center for Cancer Research, bringing nearly two decades of leadership experience to the clinical research industry. He is a transformative healthcare executive with a proven track record of driving growth and innovation, all while focusing on the mission, vision, and values an organization delivers to the broader research community.

Most recently, Mr Slack served as an Executive in Residence at Warburg Pincus. During this time, he was a member of Warburg's Healthcare Team, where he worked on life sciences and pharma services strategy. In this role, he supported Warburg's portfolio companies as an advisor, contributing his extensive knowledge and experience to enhance their strategic initiatives and operational efficiencies.

Before joining Warburg Pincus, Mr Slack was the President of WCG Clinical. During his decade-long tenure, Mr Slack was responsible for developing and growing WCG’s relationships with the industry’s leading sponsors, CROs, and hospital systems. Mr Slack worked with partner-clients to design and implement solutions that accelerate the activation of clinical trials, eliminate the duplication of efforts in research, and promote the highest standards of safety for research subjects.

Throughout his career, Mr Slack has provided guidance to more than 150 sponsors, CROs, and sites. He was previously the director of consulting services for HRP Consulting Group and the Associate Director of Accreditation for AAHRPP. A trained ethicist, Mr Slack earned a master’s degree in bioethics from the University of Pennsylvania.

Sarah Small is interested in exploring opportunities that promote Patient Focused Drug Development. Ms Small is passionate about deploying patient centric solutions to advance drug discovery to bring new medicines to patients. She has experience in the Biotech and Pharmaceutical Industry with a breadth of knowledge in measuring what is clinically meaningful to patients, deploying digital health solutions, and ensuring through the use of patient centric solutions we can reduce the burden of clinical trials while improving quality of data. As an Associate Director of Patient Centricity at Moderna, her goal is to develop benchmarks through data visualization to identify metrics across the entire Moderna Portfolio globally while deploying patient centric solutions (DCTs) to better support engagement in Moderna’s clinical trials. She also serves the Clinical Development Transformation Enabler (CDO-TE) Lead for the Patient and Site experience team. The CDO-TE is an emerging leader’s peer led change management group responsible for implementing innovative work streams across the organization through advocacy, training, and coaching. Ms Small is the External Engagements Lead for Women in Science Driving Moderna (WISDM) ERG and has previously served as the Chapter Co-Lead for Biogen’s Women’s Innovation Network.

Dr Del Smith is passionate about health equity through inclusive research. Dr Smith is the co-founder and CEO of Acclinate, a trusted digital health company specializing empower communities to take actions for better health. Dr Smith has 20+ years of leadership experience in healthcare, IT, higher education, and government. His research has appeared in leading publications such as the Journal of Equity, Diversity, and Inclusion and the Journal of Business Research. Dr Smith earned his PhD in Management from the University of Alabama.

Jennifer Sozio has 25 years of Clinical Operations experience, the past 15 of which have been at Syneos Health. Ms Sozio started her career as a Clinical Research Associate (CRA) moving into Project Management leading global project delivery teams where she honed her project and people management skills. Prior to assuming her current role, she led the North America Clinical Monitoring Lead organization. She has been leading the North America FSP 360 Clinical Operations team at Syneos Health since October of 2019 responsible for the teams that support customers across a wide range of models and therapeutic areas. Ms Sozio serves as one of the Syneos Health Asian ERG executive sponsors, an advocate and ally for Syneos Health Employee Resource Groups and the McKinsey leadership programs with her team celebrating 7 graduates over 2020-2022 and 12 team members enrolled in 2023 cohorts. Ms Sozio is a 2023 HBA Luminary and holds a Biology degree from the University of Pittsburgh as well as a Masters Degree in Anthropology.

Ms Sozio is passionate about building cohesive and collaborative teams that are empowered to deliver project work for customers ultimately accelerating the ability to bring medicines to patients.

Summer Starling, DrPH, MPH, manages the development and implementation of CTTI projects. Along with her colleagues, she is accelerating progress towards the Transforming Trials 2030 Vision.

Dr Starling has more than 15 years’ experience in public health. She joins CTTI from within the Duke University School of Medicine, where she led mixed methods research studies with clinical investigators at Duke to understand and improve patient experiences in clinical research. Earlier in her career, she was a senior scientist and a Ford Foundation Doctoral Fellow with the Public Health Institute in Oakland, CA, conducting research on adolescent health and decision-making. She has also worked as a consultant for Johnson & Johnson and other healthcare companies, where she led client-centered research programs and organizational change campaigns. 

Dr Starling received a Doctor of Public Health (DrPH) from the University of California, Berkeley, and a Masters in Public Health (MPH) in sociomedical sciences from Columbia University.

Alan Switzer joined Fortrea in 2013 and holds the role of Director, IT Client Delivery.  In this capacity Mr Switzer leads the modernization of clinical trial systems through the delivery of the Fortrea Xcellerate Risk Based Quality Management suite of products that leverages statistical analytics to improve access to clinical data and enable faster and more accurate decision making throughout the trial. Prior to Fortrea he was the Global Director of Data Centers and Applications for ICON Clinical Research where he led the delivery of a virtual server architecture to increase reliability and scalability of the IT infrastructure. In his early career, he spent several years with Unisys as a Solutions Architect where he served clients in the Pharmaceutical, Energy and Telecommunications industries to define and implement IT strategies with a focus on process and controls. Mr Switzer earned his undergraduate degree in Electrical Engineering from Boston University, and his MBA from The Wharton School.

Anthony K. Taylor, DHSc, MSPharm, is an experienced leader, executive, former clinical research scientist and U.S. Army medic with comprehensive industry knowledge and a proven record for delivering results within large, mid-size, and small pharmaceutical organizations. Dr Taylor is Project Management Professional (PMP®) Certified and has a solid background in leading global clinical programs and teams. He has been in the pharma industry for almost 20 years and has held positions of increasing responsibility. When he is not leading large cross-functional initiatives, Dr Taylor enjoys spending time with his family and playing tennis in the U.S. Tennis Association (USTA). He is recently married, has two children, and lives in the Chicago-area with his family.

Jaydev Thakkar, Chief Operating Officer of Biofourmis currently leads global operations across various business functions, including Customer Success, Sales and Marketing Operations, Clinical Research Operations and Supply Chain. Mr Thakkar has over 25 years of experience in leadership roles at organizations that include fortune 100 companies and rapidly growing start-ups. Prior to Biofourmis, Mr Thakkar was instrumental in founding a Digital Health and Innovation group at world’s leading biotech, Amgen, where he served for 14 years. During this time, Mr Thakkar led its “beyond the therapy” digital innovation strategy to maximize product value and clinical outcomes across the patient journey—from clinical development through product launch and post-marketing. At Amgen, Mr Thakkar also led information technology operations for the company’s large portfolio of global clinical trials—including some of the largest ever in the industry, with more than 27,000 participants across 50 countries and more than 1,000 sites. Before Amgen, Mr Thakkar was a telecommunications, technology and finance consultant who co-founded a technology startup and also managed his family’s manufacturing business in India.

Bernadette Tosti is the Chief Product Officer at ProofPilot. Ms Tosti was previously Vice President, Patient Experience at Science 37 where she led all patient access and engagement activities including feasibility, provider network, and patient outreach. Prior to her role at Science 37, Ms Tosti was the Executive Director of Clinical Trials at Quest Diagnostics, where she built patient and provider outreach and data and technology solutions to support the life sciences industry. Earlier in her career, Ms Tosti held a variety of clinical development technology, patient engagement and sales positions with increasing responsibility at IQVIA, inVentiv, and Veritas Medicine. She holds a bachelor’s degree in English from Boston College.

Mark Travers joined Merck in March 2015 as Executive Director, Head of Monitoring Excellence with a remit of building the ME Group, improving all aspects of site monitoring within Merck, re- valorizing the CRA position and making Merck partner of choice with our Investigator sites and suppliers. Dr Travers implemented Risk Based Monitoring and SMART. In May 2015, he became interim Head for the NA Region with overall responsibility for delivering MRLs clinical trials in both Canada and the US. In June 2017, Dr Travers was promoted to the position of VP, Head of GCTO Regions. In this position, he is responsible for over 3,200 colleagues in 4 regions and 48 countries managing and monitoring all of MRL s clinical studies.

Micky Tripathi is the National Coordinator for Health Information Technology at the U.S. Department of Health and Human Services, where he leads the formulation of the federal health IT strategy and coordinates federal health IT policies, standards, programs, and investments. Dr Tripathi has over 20 years of experience across the health IT landscape. He most recently served as Chief Alliance Officer for Arcadia, a healthcare data and software company focused on population health management and value-based care, the project manager of the Argonaut Project, an industry collaboration to accelerate the adoption of FHIR, and a board member of HL7, the Sequoia Project, the CommonWell Health Alliance, and the CARIN Alliance.

Dr Tripathi served as the President and Chief Executive Officer of the Massachusetts eHealth Collaborative (MAeHC), a non-profit health IT advisory and clinical data analytics company. He was also the founding President and CEO of the Indiana Health Information Exchange, a statewide HIE partnered with the Regenstrief Institute, an Executive Advisor to investment firm LRVHealth, and a Fellow at the Berkman-Klein Center for Internet and Society at Harvard University.

Dr Tripati holds a PhD in political science from the Massachusetts Institute of Technology, a Masters of Public Policy from Harvard University, and an AB in political science from Vassar College. Prior to receiving his PhD, he was a Presidential Management Fellow and a senior operations research analyst in the Office of the Secretary of Defense in Washington, DC, for which he received the Secretary of Defense Meritorious Civilian Service Medal.