Speakers

Sandy Annis is the Executive Director of Clinical Operations at The University of Kansas Cancer Center, where she provides strategic oversight for clinical research operations across multiple disease programs, campuses, and community sites. With extensive experience in clinical trial management, workforce development, regulatory compliance, quality improvement, and research administration, she leads enterprise-wide initiatives focused on operational excellence, research growth, and patient access to innovative therapies. Sandy is recognized for her work in transforming clinical research operations through process improvement, workforce engagement, technology-enabled solutions, and cross-functional collaboration. Her recent efforts have focused on strengthening research infrastructure, expanding clinical trial capacity, leveraging AI and automation in research operations, and developing scalable models for investigator and coordinator support. She is passionate about advancing clinical research through innovation, leadership development, and operational strategies that improve both patient outcomes and organizational performance.

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Janice Ballard, BSN, is an experienced clinical research professional with more than 25 years of expertise in clinical trial operations, site management, and regulatory compliance within the pharmaceutical industry. She currently serves as the lead Clinical Research Manager on the Tempus project within Merck Research Laboratories' Global Clinical Trials Organization, where she provides project leadership for oncology clinical trials. Prior to this role, she spent many years as a Senior Clinical Research Associate, overseeing the conduct of research studies and supporting all phases of study execution, including startup, initiation, monitoring, and closeout activities. Janice holds a Bachelor of Science in Nursing from the University of Texas at Arlington and brings a unique combination of clinical knowledge and research expertise to drug development. Her background spans site-level coordination, monitoring, and clinical trial management.

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Tyler Beasley is Executive Director of Business Intelligence at Velocity Clinical Research. Throughout his career, he has worked at the intersection of business intelligence, commercial strategy, epidemiology, and clinical research, helping organizations leverage data to make more informed strategic and operational decisions. In addition to his industry role, Tyler has served as a professor of epidemiology for the past seven years. He is a speaker and thought leader on the application of business intelligence, analytics, and artificial intelligence to clinical research, with a particular interest in how data can strengthen collaboration between sponsors, CROs, and research sites.

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Rose Blackburne, MD, MBA is an experienced healthcare and global life science executive, she currently serves as Vice President, Head of Population Science Strategy & Women’s Health at Thermo Fisher Scientific. She is a leading voice in Women’s Health, and inclusive clinical research strategies, harnessing the power of AI, digital innovation, and data-driven insights to reimagine clinical trial design and improve patient outcomes. Through pioneering initiatives that expand inclusive representation, enhance patient access in clinical trials, and optimize care delivery, Dr. Blackburne is advancing a more equitable and effective healthcare ecosystem. She is a globally recognized leader in medical product development and has been instrumental in numerous approvals for pharmaceuticals, vaccines, medical devices and diagnostic tests. Dr. Blackburne has three decades of clinical leadership expertise in large health care systems and global clinical development in biotechnology and pharmaceutical sectors. She is board certified in obstetrics & gynecology and was a practicing physician and Principal Investigator for clinical trials prior to her career in the Contract Research Organization (CRO) industry. Dr. Blackburne has over 20 years of Clinical Research & Development experience and has held numerous Global leadership positions in across therapeutic areas in Ph I-IV programs. She has broad therapeutic expertise and has been instrumental in the approvals of several pharmaceuticals, vaccines, medical devices, and diagnostic tests. She leverages her medical, scientific and regulatory strategic insights to drive approvals for small, midsize and large biotechnology and pharmaceutical companies. Dr. Blackburne has been widely recognized for her medical and scientific expertise and contributions to advancing health equity, thought leadership, and organizational excellence: The 2025 United States Presidential Lifetime Achievement Award; NAACP W. Montague Cobb National Award for Excellence and Leadership in Health Equity; Thermo Fisher Scientific Lifetime Achievement Award; Top Blacks in Healthcare by BlackDoctors.org ; Biotech Leaders of Color (BLOC) Vanguard Award. Dr. Blackburne received her Doctor of Medici at the Morehouse School of Medicine, Atlanta, Georgia, and completed an Obstetrics and Gynecology residency at Columbia University/Harlem Hospital Center in New York, is board-certified by the American Board of Obstetrics and Gynecology. She holds a Master of Business Administration from the Darden Graduate School of Business at the University of Virginia, studied Health Policy and Health Care Delivery at Harvard University John F. Kennedy School of Government, and her B.A. at University of Virginia, in Charlottesville, Virginia. Dr. Blackburne resides in the metro Washington, DC area with her husband, Michael A. Covington.

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Kevin Bugin is the Associate Vice President of Global Regulatory Policy and Intelligence at Amgen, Inc, where he leads a diverse team of professionals engaged in promoting innovative, efficient and effective approaches to developing and providing access to safe and effective new therapies to patients. Prior to his current role, Dr. Bugin was the Deputy Director of Operations in the Office of New Drugs (OND) in FDA’s Center for Drug Evaluation and Research (CDER). In addition, he led the establishment of the CDER Center for Clinical Trial Innovation (C3TI) which aimed to promote the implementation of innovative clinical trial approaches in drug development. From May 2020 through May 2021, Dr. Bugin served as the Chief of Staff for the Therapeutics Response Efforts as part of the US Government’s HHS and DOD operation formerly known as Operation Warp Speed. He is also an adjunct faculty at the George Washington University in the Clinical Leadership Program, focusing on areas of clinical research, regulatory affairs, and medicines development.

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Dr. Pamela Carrión, MD, MSc, is a medical oncologist based in Lima, Peru, with extensive experience in breast, genitourinary, and gastrointestinal cancers. She holds a Master’s degree in Oncology Research and has been certified by Harvard Medical School in Precision Oncology and Cancer Genomics. Additionally, she completed a postgraduate training program in Molecular Biology Applied to Oncology at the University of Liège, Belgium. With extensive experience in clinical oncology research, Dr. Carrión has served as both Principal Investigator and Sub-Investigator in numerous international clinical trials. She has participated in more than 50 global research protocols, leading patient recruitment, ensuring Good Clinical Practice (GCP) compliance, and overseeing clinical data management.

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As Director of Business Development at Mercy Research, Heidi Castle brings nearly 11 years of clinical research experience to her role leading industry-sponsored clinical trial budget negotiations, research billing compliance oversight, and study start-up optimization. A graduate of the University of Wisconsin–Madison, Heidi began her career as a research nurse, providing a unique perspective that bridges clinical care, research operations, financial strategy, and compliance. She is passionate about building strategic partnerships with sponsors, investigators, and operational stakeholders to streamline study activation and support organizational growth. Heidi lives in the Madison, Wisconsin area with her family and rescue pup, Nellie. Outside of work, she enjoys hot yoga, spending time at the lake, and enthusiastically (and sometimes a little too loudly) cheering on her son at basketball games.

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Annick de Bruin is the Chief Research and Insights Officer at the Center for Information and Study on Clinical Research Participation (CISCRP). She is responsible for the design, implementation, analysis and reporting of a variety of CISCRP research studies including the Perceptions & Insights studies and numerous Patient Advisory Boards. She has more than 25 years of experience conducting primary and secondary research studies in the healthcare, life sciences and consumer goods industries. She holds an MBA from the Graduate School of Management at Boston University and a Bachelor of Science degree from Bryant University.

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Joe Dustin is a clinical trials industry leader who has spent over 20 years driving digital transformation across clinical operations, the patient and site experience, and eClinical technology. At Sanofi, he leads a function within digital clinical development, reimagining how clinical data is acquired and integrated from the field by digitizing sites, cutting manual burden, and accelerating the path from data capture to decision. Prior to Sanofi, Joe held senior leadership roles spanning sales, product, strategy, and innovation at Biofourmis, Medable, Bristol Myers Squibb, and Medidata. He is also a board advisor to technology providers, and investors, helping them navigate market dynamics, sharpen product strategy, and prepare for AI-ready clinical operations. Joe holds a B.S. in Computer Information Systems and Political Science from Roger Williams University and resides in New Jersey. He’s an avid guitar player who dreams of one day traveling to space.

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Edye T. Edens, JD, MA, CIP, CCRP is a life sciences attorney who has spent her career working at every level of the clinical research enterprise—as an IRB and HRPP professional, research compliance leader, clinical operations strategist, educator, business advisor, and legal counsel. As the founder of Edye Edens Life Sciences Law Group, she helps sponsors, CROs, academic medical centers, research sites, and emerging life sciences companies navigate the legal and regulatory realities of research with practical, operationally grounded advice. With more than 17 years of experience, Edye has guided organizations through FDA, OHRP, ORI, Good Clinical Practice (GCP), research misconduct, global ethics, and quality and compliance challenges. Her background includes leading research compliance programs at Indiana University, advising FDA-regulated clients as a senior attorney, supporting AI-driven regulatory innovation, and teaching the next generation of health law and compliance professionals as adjunct faculty. Known for combining legal rigor with empathy for those on the front lines of research, Edye is a nationally recognized speaker and trusted advisor who believes the best compliance solutions are both defensible and operationally achievable. She founded EEDEE Law to provide organizations with legal counsel from someone who truly understands how research gets done.

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Dr. Tala H. Fakhouri, PhD, MPH is currently the Chief AI & Regulatory Strategy Officer at Parexel. Tala is the former Associate Director for Data Science & AI Policy at FDA/CDER, where she led policy tracks for AI and RWE including authoring FDA’s first AI and RWE guidance documents, co-chaired the CDER AI Council, and helped shape global regulatory frameworks for AI, digital health technologies and real-world evidence. Prior to FDA, Tala held leadership roles at CDC including Chief Statistician for CDC’s flagship health study NHANES, and served on the Federal Committee for Statistical Methodology.

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Sharif Fakhr has more than 15 years of experience in finance, business development, strategy, and operations. He has led hospitals, academic medical centers, health systems, and biotech and pharmaceutical companies through transformation in finance, operations, research administration, business development, process improvement, and strategy. His expertise helps organizations manage financial and operational risks for stability and growth.

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Rosemarie Gagliardi is Senior Associate Dean for Collaborative Research & Partnerships and Assistant Professor of Population Health Sciences & Policy at the Icahn School of Medicine at Mount Sinai. A recognized leader in research administration and innovation, she provides strategic, operational, and financial leadership to support the growth and sustainability of clinical research programs while ensuring regulatory compliance and operational excellence across the Mount Sinai Health System. Professor Gagliardi also develops partnerships with industry, academic, and nonprofit organizations to expand research opportunities, advance translational medicine, and strengthen research infrastructure to accelerate scientific discovery. She co-chairs the Dean’s Translational Medicine Faculty Oversight Committee, which is charged with advancing this mission. A strong advocate for technology-enabled research transformation, Professor Gagliardi is at the forefront of applying artificial intelligence (AI) to improve clinical trial operations, collaboration, and efficiency. She received the 2026 MAGI Innovation Award for demonstrating how AI can automate research processes and identify compliance risk earlier in the clinical trial lifecycle, reducing administrative burden while improving trial quality, access, and speed. She serves on multiple steering committees and consortia focused on advancing innovation in clinical trial operations. An ACRP-certified Clinical Research Associate and alumna of public health education programs, Professor Gagliardi teaches Clinical Research Administration and Compliance at the CUNY School of Professional Studies, bringing decades of experience in clinical research leadership, administration, and innovation.

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Dakota Gallimore, is a Senior Regulatory Affairs Specialist at Cincinnati Children’s Hospital Medical Center and serves as a Florence System Administrator for both the institution and the NIH Rare Diseases Clinical Research Network Data Management and Coordinating Center (RDCRN DMCC). His work focuses on developing and supporting compliant electronic regulatory workflows, including eTMFs, eISFs, eConsent, eDOA, and eLogs, for FDA-regulated, investigator-initiated, and multisite research. He also leads Florence onboarding and training across hospital divisions and RDCRN consortia, with an emphasis on practical, inspection-ready processes that fit into study teams’ day-to-day work.

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I am Alfonso, CEO at Leon Research and member of the Managing board at AICROS, Full service CRO: (Clinical Research Organization). I have 16 years of experience in managerial and executive positions in different industries, during the last 10 years in clinical investigation. Having experienced working and studying in different areas, I have grown to become an open-minded person who thrives in diverse fields. I studied psychology and I joined the pharmaceutical industry in 2009 by being trained in clinical research. I am a very curious person eager to keep learning and apply all this knowledge to every project I am involved in clinical trials. My current role at Leon Research (full service CRO): In 2009 I became General Manager, and in 2016 I assume the role of CEO at Leon Research, a CRO for southern European Countries. My goal is to leverage the potential of Leon Research and its employees to make us grow. Our principles are: intelligence, creativity, flexibility and honesty. My current role at AICROS (alliance of CROs): Since 2013 I am part of the management board and in 2016, I became Marketing Director of AICROS. In all these years I have been involved in the design, management development and implementation of sales and marketing tools to build and nurture relationships with clients in order to create and grow our business opportunities in the pharmaceutical industry.

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Mitchell Hilbe has worked in clinical research since 2005 across CRO, sponsor, site, and education settings, with experience spanning clinical operations, late-phase research, expanded access programs, monitoring oversight, site relations, and workforce development. He is the founder of DiversiTrials, a CRO focused on practical trial execution, site partnership, and trust-centered operations, and serves as Chief Strategy Officer for Clinical Research Pro, where he supports training programs for current and emerging clinical research professionals. His work often focuses on the gap between documented compliance and real-world competence, including how teams make decisions under pressure, recognize quality risk, and communicate across sponsor, CRO, vendor, and site roles. Mitchell has presented nationally on topics including health literacy, risk-based thinking, cognitive bias, and clinical trial quality. He brings an operationally grounded perspective to training, emphasizing applied judgment, practical escalation, and workforce readiness beyond check-the-box documentation.

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Victoria Johnson, MBA, ACRP-CP, CPC is Director of Clinical Trials Administration at the Sutter Health Research Institute, where she leads enterprise clinical research strategy and operations across a large, integrated health system. She partners with executive leaders to transform how clinical research is governed, activated, and delivered at scale by aligning people, processes, technology, and policy. With more than 15 years of experience in academic medicine and integrated health systems, Victoria specializes in building high-performing research infrastructures that improve efficiency, strengthen compliance, and accelerate study activation. Her expertise spans clinical trial operations, research governance, regulatory strategy, CTMS and EHR integration, research finance, and organizational transformation. Victoria is a strategic leader behind Sutter Health's enterprise research modernization initiatives, including the Epic Research Module re-implementation and the development of standardized workflows that connect study startup, regulatory operations, budgeting, contracting, research billing, and trial execution into a unified operating model. Recognized for challenging conventional approaches to research administration, Victoria advocates for centralized governance, data-driven decision making, and technology-enabled innovation to reduce complexity and improve performance across research organizations. She is particularly passionate about leveraging artificial intelligence and digital transformation to reimagine the future of clinical research operations. As a speaker, Victoria shares practical strategies for helping health systems build research programs that are scalable, sustainable, and positioned for the future, enabling organizations to bring more clinical trials to patients while reducing administrative burden and operational fragmentation.

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Rachana Kanvinde, MS, CCRP, is a clinical research and healthcare operations leader with more than 20 years of experience advancing clinical trial strategy, operational excellence, and cross-sector collaboration across the clinical research ecosystem. Her experience spans gene therapy, rare disease, oncology, advanced therapeutics, site networks, and patient engagement, with a focus on designing scalable operating models that improve trial execution, expand patient access, and strengthen research quality. Throughout her career, Rachana has led operational strategy, research infrastructure development, site enablement, and cross-functional partnerships across academic medical centers, healthcare systems, site networks, sponsors, CROs, and patient advocacy organizations. She is recognized for aligning diverse stakeholders, translating strategy into execution, and developing practical approaches that strengthen site performance, improve enrollment, and advance patient-centered research. Rachana also serves as President of the ACRP Atlanta Area Chapter, is a published author, and is an invited speaker at national industry conferences. She is passionate about advancing innovative approaches that connect operations, technology, and community engagement to build a more efficient, collaborative, and patient-centered clinical research ecosystem.

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McKenzie Kays is a Senior Manager and IT Product Manager within Research & Development Business Insights & Technology at Bristol Myers Squibb, where she leads digital innovation focused on improving trial feasibility, as well as patient and site engagement across the clinical trial ecosystem. She is passionate about designing technology that reduces operational burden while keeping the needs of patients, caregivers, investigators, and study teams at the center of every decision. McKenzie has led the development of enterprise-scale solutions that streamline clinical trial collaboration, simplify investigator experiences, and leverage AI to improve the handling and routing of patient, caregiver, and site inquiries. Her work combines human-centered design, product strategy, and AI-enabled capabilities to create solutions that are both efficient and trustworthy. Throughout her career, she has partnered with cross-functional business, technology, and external stakeholder groups to translate real-world challenges into scalable digital solutions. With expertise in agile product management, innovation, and patient- and site-centric strategy, McKenzie brings a practical perspective on where AI can accelerate clinical operations—and where human judgment, empathy, governance, and oversight remain essential to ensuring quality outcomes and maintaining trust.

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Lauren Koehler has over a decade of experience in clinical research operations, workforce development, and regulatory compliance. As a Research Manager leading Emergency Medicine at Wake Forest University School of Medicine, she leads multidisciplinary research teams in fast-paced healthcare settings and has developed staffing models, training programs, and career pathways that strengthen compliance, improve retention, and support team wellbeing. Her work focuses on aligning operational excellence with people-centered leadership to help research teams achieve high-quality results while building sustainable, resilient research cultures.

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Andrea Kukla, MS, is a process optimization–focused leader in clinical research operations at Mayo Clinic. As a Program Manager in the Office of Clinical Trials, she leads an enterprise clinical trial operations team responsible for bringing new studies forward across the organization. Her work aligns strategy, operational excellence, and change management to strengthen research activation systems and processes. In prior roles, Andrea has led clinical trial operations, established new offices, advanced process improvement efforts, and enhanced service delivery through project and operations management expertise. Andrea’s work centers on leading complex transformational change, improving systems, increasing adoption, and accelerating study activation to elevate service delivery. Andrea holds an MS in Clinical Research Organization and Management from Drexel University.

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Kyle McAllister is the founder and CEO of Trially, a platform built to augment patient recruitment for clinical trials. With a background in EMR systems at Epic and Cerner and research at a large scale site network, Kyle brings a rare combination of healthcare infrastructure experience and firsthand knowledge of how AI actually performs - and fails -in real-world clinical settings.

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Cris McDavid is Executive Director of Global Clinical Data Operations, Risk-Based Quality Management (RBQM), and Integrated Data Delivery (IDD) at Parexel. With more than 20 years of experience in global clinical trial delivery, Cris has built a strong reputation for leading high-performing global teams, driving operational excellence, and fostering collaborative client partnerships. Cris is recognized for expertise in GCP, risk-based quality management, integrated data delivery, decentralized and adaptive monitoring strategies, centralized statistical monitoring, RBQM technologies, and end-to-end risk management. She has led the implementation of innovative processes and technologies that enhance trial quality, efficiency, and data-driven decision-making across complex clinical development programs. Currently, Cris leads Parexel’s RBQM and IDD operations, advancing strategies that integrate data, analytics, and operational oversight to improve trial execution and patient-focused outcomes.

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Michael is an attorney in the Life Sciences and Research practice group at H. Lee Moffitt Cancer Center and Research Institute, Inc. His practice areas and specialties include research and regulatory compliance, research ethics and misconduct, sponsored research agreements, clinical trial agreements, material transfer agreements, data sharing agreements, intellectual property, strategic partnership and collaboration agreements, sponsored research grants, conflicts of interest management. Prior to joining Moffitt, Michael provided counsel to academic and business leadership on a broad range of legal and compliance issues and oversaw sponsored research and contractual operations for several academic research institutions, including the Research Foundation for the State University of New York, Emory University, Georgetown University, Florida State University College of Medicine and Northern Arizona University. Michael earned his doctorate from the University of Pennsylvania, a Master of Laws (LL.M) degree from Texas A&M School of Law, a law degree from the University of the District of Columbia School of Law, a master’s degree from California State University, Fullerton, and a bachelor’s degree from Temple University. He also earned a graduate certificate in Risk Management and Compliance from Texas A&M University School of Law, and holds certifications in healthcare research compliance and corporate compliance and ethics.

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As CEO, Carlos Orantes provides leadership and strategic direction for the site network. With over 32 years of experience within the life sciences industry, his career has included executive leadership, operational management, LEAN Six Sigma process improvement, as well as systems and technology deployment. Most recently, Carlos served as Executive Director, Site Operations at Accelerated Enrollment Solutions, now Trial Med, a business of PPD later acquired by ThermoFisher Scientific. There, he led the site operations for the Americas site operations in support of the company’s vast global clinical trial network. Prior to joining PPD, Carlos served as Chief Executive Officer of Amplify Clinical and Accel Research Sites, where he developed the business strategy to effectively compete in Phase II-III clinical research involving multi-therapeutic trials and specialty vaccines. He also led activities related to both companies’ asset purchase by private equity. Earlier career positions included COO for Frontage Laboratories and close to 20 years of operational, quality assurance, process improvement, and laboratory management roles of increasing responsibility at organizations including Covance, later become part of LabCorp and now Fortrea. Carlos earned a Master of Business Administration degree from Old Dominion University, and a Bachelor of Science degree in Biology from George Washington University. He is a certified Lean Six Sigma Black Belt from Six Sigma Academy.

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Joslin Jose Plathottam, MBBS, MPH, is a Research Coordinator in the Department of Cardiology at the Icahn School of Medicine at Mount Sinai, New York. She earned her Bachelor of Medicine, Bachelor of Surgery (MBBS) degree in India and completed a Master of Public Health (MPH) in Epidemiology at The University of Texas Health Science Center at Houston. Since joining Mount Sinai in 2023, she has coordinated multiple cardiovascular clinical trials, with a focus on patient recruitment, retention, regulatory compliance, and clinical operations. As part of a multidisciplinary cardiology research team, Ms. Plathottam has supported the integration of artificial intelligence into clinical research workflows to enhance patient prescreening through electronic medical record queries. Her work includes evaluating AI-generated prescreening results against manual review to assess accuracy, identify discrepancies, and ensure appropriate participant selection. Her experience offers a practical perspective on the implementation of AI in clinical trial operations, emphasizing both its potential to improve efficiency and the continued importance of human oversight in research.

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Tara Rabe is Operations Administrator for Legal Contract Administration and the Office of Clinical Trials at Mayo Clinic, where she co-leads automation initiatives for the Research Shield. With more than 25 years of experience in research administration, contracting, and operational leadership, she has led large-scale process improvement efforts, implemented AI-powered technology, and championed the adoption of Robotic Process Automation to improve efficiency and reduce administrative burden. Tara focuses on aligning people, processes, and technology to accelerate study startup and advance clinical research operations.

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Jeff Repper is the Chief Operating Officer of Rovia Clinical Research, a Gauge Capital-backed clinical site network currently expanding across the United States. Jeff brings more than 20 years of operational leadership in clinical research to the role, having built de novo site networks from the ground up, created and deployed a global functional service provider for research sites, and led the operational infrastructure behind some of the industry's most ambitious site growth strategies. For Jeff, operational excellence and patient impact go hand in hand. Supported teams deliver better research, and better research gets breakthroughs to patients faster. A belief that closely aligns with Rovia's own people-first, results-driven values. It's also shaped his reputation as a recognized voice in the clinical research site community, where he speaks frequently on the operational and business challenges facing multisite organizations and is known for his collaborative, straight-talk approach to solving them.

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Eleana Rodriguez, Abgda, LLM | Director, Research Legal – Clinical Trial Agreements | University Health Network (UHN) | eleana.rodriguez@uhn.ca Eleana leads the Clinical Trial Agreements Office at UHN, ensuring that legal and regulatory frameworks are integrated into the decision-making practices of one of North America's largest research hospitals. She holds a Master of Laws with concentration in health law from the University of Toronto and a Doctor of Law from Universidad Central de Venezuela. Her firsthand experience implementing AI governance at a major academic research institution makes her an ideal voice on the institutional and cultural dimensions of adoption.

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Dr Louise Rossiter is the Research and Innovation Digital Transformation Lead at University Hospitals of Leicester NHS Trust in the United Kingdom, where she leads programmes focused on digital innovation, process redesign and the modernisation of research delivery within one of the world’s largest publicly funded healthcare systems. Alongside her work in healthcare, Louise is an internationally performed and published composer, holding a PhD in Music Composition. Her background across music, research and technology has shaped a distinctive systems-thinking approach to complex challenges, combining creativity, analysis and practical problem-solving. Her work spans digital transformation, business analysis and organisational change across multidisciplinary environments. She has developed champion networks to support sustainable change and worked closely with researchers, clinicians and technology partners to improve research processes, governance and user experience. Louise has a particular interest in the intersection of research operations, technology and artificial intelligence, and regularly collaborates with national and international partners to explore how innovation can improve research delivery and participant experience. Outside of work, she is an enthusiastic cyclist and charity fundraiser, bringing the same curiosity, resilience and determination to both professional and personal challenges.

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Michelle Rowe, RN serves as the Vice President of HCA Healthcare Research. In this role Rowe leads a diverse and large scale research portfolio including Graduate Medical Education Research that supports programming for more than 70 teaching hospitals, across 350 residency and fellowship programs with more than 5,500 residents and 5,000 faculty in addition to the HCA Healthcare Research Institute, the multispecialty clinical research arm of HCA Healthcare that is focused on advancing care for every individual through an affiliated network of expert physicians and site network that includes more than 50 sites across the country. In her role, she is responsible for the overall leadership, strategy, and direction of research operations within the HCA Healthcare network. Before joining HCA Healthcare in 2018, Rowe held several leadership positions, including assistant vice president of clinical operations at Sarah Cannon and regional oncology service line leader for Mercy Health. With over 20 years of experience in service line strategy, hospital operations, and program development, she is a seasoned nursing leader. Rowe is passionate about developing and mentoring future healthcare leaders and gives back to her community through serving on various non-profit boards.

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Dr. Shi is the Senior Manager of Global Clinical Compliance with nearly 15 years of experience in the medical device and pharmaceutical industries. She holds a Ph.D. in Chemistry and has built her career at the intersection of clinical research, quality systems, and regulatory compliance. Dr. Shi is also a certified quality auditor and certified quality engineer with extensive experience planning, hosting, and supporting regulatory and quality audits. Throughout her career, she has served as a primary compliance representative during inspections conducted by FDA, Notified Bodies, and other regulatory and certification organizations. She has led inspection readiness initiatives, coordinated cross-functional audit responses, managed audit documentation, and worked closely with clinical, quality, and regulatory teams to address findings and implement sustainable corrective actions. As a leader in sponsor-side electronic Trial Master File (eTMF) implementation, Dr. Shi has helped organizations establish standardized, inspection-ready eTMF processes while fostering collaboration between sponsor and vendor teams. Her practical experience gives her a unique perspective on building compliant, inspection-ready clinical systems while balancing operational efficiency.

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Jeff Sorenson, Co-founder & CEO, Yunu Jeff Sorenson is the Co-founder and CEO of Yunu, where he leads the company’s vision to transform clinical trial imaging through connected, data-driven workflows. With over 30 years of experience in medical imaging, Jeff aims to apply his expertise to life sciences and focus on simplifying complex research processes. Jeff has been instrumental in developing solutions that bridge imaging, data, and collaboration across trial stakeholders.

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Jason Spivey is the Founder and Principal Consultant of Unifora, an independent consulting firm focused on helping teams across clinical research use technology more effectively throughout the study lifecycle. With nearly 20 years of experience across the life sciences landscape, including work with Bristol Myers Squibb, Signant Health, and THREAD Research, he brings a practical, field-tested perspective to the challenges sponsors, sites, and technology vendors face when selecting and deploying research tools. Jason’s background spans digital trial technology, IT and business system integration, solution design, cross-functional service delivery, QA, and UAT, vendor management, and change management. This experience gives him a uniquely balanced view of how clinical technology decisions are made, sold, implemented, supported, and experienced by the teams who rely on them. Through Unifora, Jason helps sponsors, sites, and technology vendors reduce complexity, align technology decisions to study needs, improve adoption success, and bridge gaps between technology providers and the research teams they support.

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Henry Wei, MD, is Executive Director, Development Innovation at Regeneron, aimed at accelerating clinical trials and drug development. Dr Wei previously worked at Google, the White House, Aetna, and McKinsey. Dr Wei has authored several patents on artificial intelligence, real-world evidence methods and drug safety. He earned his MD at Cornell, his graduate and undergraduate degrees at Harvard University, post-graduate training at NY Presbyterian Hospital and Memorial Sloan Kettering Cancer Center, and informatics training at Stanford and Harvard. Dr Wei is an adjunct Clinical Assistant Professor of Medicine at Weill-Cornell Medicine, and leads Regeneron’s JEDI program for medical students and other trainees.

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I am a Senior Certified Clinical Research Coordinator with over five years of experience managing clinical trials across multiple therapeutic areas at an independent research site. I hold a Bachelor of Science in Health Entrepreneurship and Innovation from Arizona State University, where I graduated summa cum laude. Throughout my career, I have been passionate about improving clinical research operations by leveraging technology to create more efficient, standardized, and compliant workflows. In my current role, I oversee complex study portfolios while leading initiatives focused on process improvement, electronic regulatory systems, workflow optimization, and the evaluation and implementation of emerging technologies. Having worked through the rapid evolution of eRegulatory, eSource, and AI-powered tools, I am particularly interested in how technology can reduce administrative burden, improve data quality, and allow research professionals to spend more time focused on participants. I enjoy sharing practical, real-world perspectives on what works, what doesn't, and how sites can thoughtfully adopt new technologies to strengthen clinical research operations.

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Leanne Woehlke is Executive Vice President at SOGLIA, a Patient Experience Organization (PXO) redefining how patients connect with clinical trials and life-changing treatments. With 25+ years in clinical research and coaching, she blends a deep understanding of the patient journey and regulatory landscape with innovative applications of AI and technology. Her human-centered approach removes barriers for patients through empathy and clarity while equipping sponsors and CROs with insights that accelerate progress. Leanne also hosts The Clinical Research Coach podcast, spotlighting patient perspectives, emerging trends, and practical strategies shaping the future of clinical research.

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Jeffrey Zimmerman serves as Executive Director of Innovation Technology for the PPD clinical research business of Thermo Fisher Scientific. With more than a decade at Thermo Fisher, he has held leadership roles across data science, application development, and innovation technology, focusing on AI-enabled and machine learning solutions that support clinical trial operations, decision-making, and user experiences. His broader experience includes leading data science and customer insights teams, applying big data analytics to evaluate the quality of patient care, and supporting academic research in multiple sclerosis through statistical programming. Jeffrey holds a Master of Science in Public Health from the University of Alabama at Birmingham. He is focused on applying analytics and emerging technologies to improve the efficiency, quality, and impact of clinical research.

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