Speakers

Sharad Adekar, MD, PhD, CIP, is a Medical Chair Director at WCG. He is a physician scientist with clinical experience in family practice and pediatrics and research experience in immunology, oncology, cardiovascular diseases, infectious diseases, and neurology. Dr. Adekar has experience in human antibodies in terms of discovery, lead optimization, and preclinical development of monoclonal antibody therapeutics. At WCG, Dr. Adekar oversees IRB board meetings, ensures compliance with federal and state regulations, and provides scientific, ethical, and regulatory guidance to board members and clients. He offers in-depth knowledge in human subject research, scientific and regulatory research.

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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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Jamie Bendrick-Peart joined AstraZeneca as the Sr. Director Innovation & Strategic Projects in July 2024 with more than 25 years of industry experience. Her focus is on modernizing clinical trials to support sites and patients by simplifying and enhancing their trial experience. Jamie is trained as a pediatric pharmacologist and began her career as a bench scientist specializing in pharmacology and bioanalysis. Over the next 15 years she built a therapeutic drug monitoring core for both adult and pediatric transplant programs in an academic medical center, led a contract research lab as Chief Operations Officer, and acted as Vice President of Research and Development for an antibody company. Jamie then pivoted to clinical research, first at the site level, then through various roles in large pharma companies for more than 10 years. Her goal is always to find better, smarter ways to deliver clinical trial options for patients and is always open to ideas and suggestions!

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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 nclusive 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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Christina Brennan, MD, MBA has devoted her career to clinical research and currently serves as Northwell Health’s Senior Vice president of clinical research. Committed to the advancement of science and medicine, Dr. Brennan has more than 26 years of extensive clinical research experience. She received the Christine Pierre Clinical Trials Lifetime Achievement Award in 2023. She is a past chair for the board of trustees for the Association of Clinical Research Professionals and an ACRP fellow. She is on the executive and steering committee for the Clinical Trial Transformation Initiative (CCTI), with Duke University and the FDA. She also sits on the Leadership Council for the Society for Clinical Research Sites (SCRS). She is also an active member of the Women in Bio and the American College of Healthcare Executives. Dr. Brennan also has authored chapters in textbooks, coauthored many manuscripts and abstracts, and has presented at numerous scientific and research meetings. She is also adjunct faculty for the MPH program with Hofstra University. She was interviewed by Scott Pelley on 60 minutes television prime time for her work around COVID during the pandemic.

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Jen Brown is Director of Clinical Trials Research at Advocate Health, where she leads clinical trial operations and works to strengthen the infrastructure, processes, and partnerships that support research across the organization. With more than 25 years of experience in clinical research, Jen has led initiatives focused on improving clinical trial efficiency, activation, technology implementation, quality improvement, and research standardization. Jen is passionate about finding practical ways to make clinical research more efficient, reduce unnecessary barriers for research teams, and expand access to clinical trials for patients. She believes that meaningful change comes from bringing the right people together, challenging processes that no longer work, and using technology thoughtfully to make research easier to conduct and easier for patients to access. Jen is a Certified Clinical Research Professional (CCRP) and an active contributor to industry collaborations focused on advancing clinical research operations.

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Sara Brueck Nichols is a distinguished leader in health and technology with more than 20 years of management experience and more than 15 years in healthcare operations, technology, and data. As President of McCreadie Group Software, she is working to improve quality, efficiency, safety, and compliance within the pharmacy and clinical research spaces through advanced, automated software solutions. Most recently, she held key roles at UnitedHealth Group, where she led strategic initiatives focused on advancing technology, data management, improving operational efficiency and strategic initiatives to advance care and experience for 65M pharmacy benefit members. Sara is known for her expertise in strategic planning, financial management, and leading large scale change. She holds a Master of Healthcare Administration from the University of Utah and certifications in Lean Six Sigma and Data Science for Executives. She is a new, and passionate, member of the Family Advisory Council at Primary Children’s Hospital and an active member of the American College of Healthcare Executives. Sara lives in suburban Salt Lake City with her husband, 3 kids, and 2 dogs. She loves food, reading, running, and being in the mountains when there is not snow on the ground.

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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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Celia Carter is the Head of Product Management, Research Solutions at Verily, where she leads the development of AI-enabled products transforming how clinical trials are designed and executed. Her work focuses on protocol digitization and interoperable data to create a more connected, efficient clinical research ecosystem. Previously, Celia was VP of Product at Florence Healthcare, where she led a global product and design organization supporting clinical trial workflows across sites and sponsors. With 15+ years of experience across life sciences and technology, she has held leadership roles at Genentech/Roche and Signant Health, focused on advancing more modern, data-driven approaches to clinical research.

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Victor brings more than 30 years of expertise in clinical trials, spanning research, product development, study design, and operations within both industry and site organizations. He is highly skilled in all aspects of clinical trial development, designing studies that generate regulatory and commercial data. His robust background in electrophysiology, pulmonology, surgery, oncology, and orthodontics facilitates effective engagement with key opinion leaders. Victor has extensive experience negotiating with regulatory authorities across the US, EU, Canada, China, and Japan. His most recent experience has been in developing infrastructure, process and efficiencies to clinical trials operations for a large integrated hospital system. Because he has in-depth knowledge of both sponsor and site perspectives of clinical trial operations and management, he provides innovative solutions to optimizing trial start-up through execution.

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Thomas “Tom” Closson, RPh, CIP, serves as Senior Vice President of Global Review Services at Advarra, where he has held a variety of IRB leadership roles for 16 years. In his current role, Tom provides strategic leadership for the review committees and operational teams across Advarra’s Institutional Review Board (IRB), Institutional Biosafety Committee (IBC), and Data Monitoring Committee (DMC) services. A registered pharmacist and Certified IRB Professional (CIP), Tom possesses more than four decades of experience spanning clinical pharmacy, healthcare operations, quality improvement, human subject protections, and research oversight. He earned his Bachelor of Science in Pharmacy with honors from Northeastern University.

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Carrie Croson is a Clinical Research Manager with more than 20 years of experience in human subjects research. She has expertise in regulatory compliance, study oversight, and research operations, supporting both industry-sponsored and investigator-initiated clinical research programs. Carrie currently oversees a team responsible for all aspects of regulatory management and monitoring across single-site and multi-site studies, ensuring regulatory compliance, operational excellence, and the successful execution of complex clinical research projects. Carrie was a driving force in the evaluation, selection, and implementation of Florence eBinders at Cincinnati Children's Hospital Medical Center (CCHMC) and within the NIH Rare Diseases Clinical Research Network (RDCRN) program. She served as the implementation lead for Florence eBinders and eConsent at CCHMC and led the adoption of Florence eBinders across the NIH RDCRN. In addition, she serves as the Florence system administrator for both organizations, providing strategic oversight and user support to maximize the platform's effectiveness. Carrie is committed to streamlining research processes, reducing administrative burden for study teams and investigators, and leveraging technology to enhance operational efficiency. She has a particular interest in implementing solutions that improve the research experience for participants while strengthening confidence, transparency, and engagement in clinical research activities.

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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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Jana Dock serves as the Director of Business Operations for Mercy Research, where she leads operational strategy and centralized business infrastructure supporting clinical research across Mercy Health, a multi-state community health system. A CPA with more than 20 years of healthcare leadership experience, she oversees clinical research reporting, metrics, billing compliance, technology platforms, and study start-up. Jana is particularly focused on using data and performance metrics to improve operational efficiency, support strategic decision-making, and help research programs scale effectively.

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Joelle Duker has over 13 years of progressive clinical research experience and has worked for academic medical centers, a global contract research organization, and several US and international medical device companies. She is currently the Director of Clinical Operations with VisCardia, Inc., a medical device company in the heart failure therapeutic area. Joelle has recently relocated to Boston, MA and is enjoying the "forever tourist" lifestyle, but remains a Maryland Terrapin through and through (Go TERPS!). Joelle proudly supports her husband, a member of the United States Navy, and her favorite (only!) niece in all of her endeavors. In her spare time, she enjoys traveling, being active (with kettlebells, her Peloton, Solidcore/PureBarre, and pickleball amongst other activities), and working at and visiting farmers markets.

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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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Founder and Principal Advisor at CRG Advisors, a boutique clinical research advisory firm specializing in Quality, Regulatory, and TMF (QRT) consulting services. We partner with Sponsors and CROs to strengthen inspection readiness, improve operational quality, and optimize Trial Master File health through practical, experienced support. Our services include: • Quality Assurance & Quality Systems • Inspection Readiness • Regulatory Support & Compliance • TMF Management & Remediation • SOP Development & Process Optimization • TMF Health Checks & Oversight • CAPA Management • Clinical Operations Support quality. regulatory. tmf. done right.

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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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Zoma Foster is the Head of Strategic Feasibility at UCB, a global biopharmaceutical company. In her role, she oversees various aspects of clinical trial planning and optimization to help ensure studies are positioned for success through a data-driven approach. She has 15 years of experience in clinical research, specializing in enrollment planning, protocol and trial feasibility assessment, and site identification and evaluation across multiple therapeutic areas. Zoma values connecting with research sites, learning from their experiences, and bringing their insights into clinical development, recognizing the essential role they play in the successful execution of clinical trials. Prior to joining UCB, she held roles at large CROs.

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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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Iburahim Haja, MBBS, MBA, CCRP, is a clinical research professional at the University of Chicago Medicine, specializing in complex bone marrow transplant and cellular therapy trials. His work focuses on clinical trial coordination, site readiness, workforce training and process improvement, with a particular interest in developing practical solutions that help research teams navigate increasingly complex trials. He developed a multidisciplinary readiness framework for clinical trial start-up that has been recognized and presented at national research conferences. With a background in medicine and healthcare management, Iburahim brings a unique clinical and operational perspective to improving how trials are designed and executed at the site level. At the heart of his work is a passion for accelerating clinical research and making research opportunities more accessible to every patient who could benefit.

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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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Leslie Ives is a patient recruitment and site engagement leader with more than 20 years of experience in the pharmaceutical and clinical trials industries, developing innovative patient and site engagement strategies for many of the world’s leading pharmaceutical and biotech companies. Working with key site stakeholders, disease-specific physician consultants, and patient partners, Leslie’s work focuses on making clinical trials efficient for sites and easier for patients to navigate. Leslie holds a bachelor’s degree in English and Biology and a master’s degree in Health Communications.

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Samantha Jackson manages clinical research technology across the OneOncology Research Network. She and her team lead the implementation and support of third-party research tools for participating sites and corporate teams, and design, develop, and deploy OneOncology's proprietary solutions — most notably its AI-powered central prescreening tool. She brings a decade of experience in data strategy, analytics, and healthcare technology.

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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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Jill Johnston brings 30+ years of clinical research experience to her dual role as Chief Innovation Officer and Head of Product Management at WCG. As Chief Innovation Officer, she drives innovation and integration across the enterprise, working with teams company-wide to identify, scale, and deliver new technologies, processes, and solutions for clients. As Head of Product Management, she leads product strategy across WCG's portfolio of clinical research solutions, shaping the direction of the products that sponsors and sites rely on every day. A seasoned executive in the pharma services sector, Jill previously served as President, Study Planning & Site Solutions at WCG, and as Vice President, Clinical Strategy at Veeva Systems. She spent much of her career at Covance (Fortrea) in a variety of executive leadership roles including Global Vice President of Business Transformation, and Head of Project Management where she led clinical study teams in all phases of trials across oncology, cardiovascular, metabolic, and neurology. Jill has been recognized throughout her career for her leadership, including Covance's Excellence in Process award and two Covance Chairman's Awards. She holds a Six Sigma Black Belt, Certified Project Management, and Certified Clinical Research Associate credentials, and was a founding member and Chapter President of the Association for Clinical Research Professionals (ACRP) in Philadelphia. Jill is passionate about accelerating clinical trials such that participants can access potentially life-saving treatments as quickly as possible, and she uniquely bridges clinical trial operations, client needs, and eClinical technology requirements. Outside of work, Jill enjoys traveling to visit her daughters and exploring new places around the globe. She is located in South Jersey, but often spends time in the Adirondacks with her husband and two Labrador Retrievers.

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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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Christy Karakos, CCRP, LPN, serves as Executive Director of Feasibility and Quality Control at Velocity Clinical Research, leading global teams focused on clinical trial feasibility, quality oversight, compliance, and operational excellence. With more than 22 years of healthcare experience and over 20 years in clinical research, she brings extensive expertise in clinical trial operations, quality systems, risk management, and strategic growth across Phase I-IV studies. Christy is passionate about advancing research quality, optimizing trial delivery, and fostering collaboration across sponsors, CROs, and research sites.

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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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Christine Lee, PharmD, PhD, is Founder and CEO of ACHIEVE Clinical Expertise, Inc., where she works with sponsors, research sites, and community clinicians to address one of the most persistent risks in clinical development: trials that struggle to reach the patients they were designed to serve. ACHIEVE builds clinician-centered infrastructure to strengthen study awareness, participant connection, site support, and trial execution, with a particular focus on identifying enrollment barriers early and creating practical pathways to keep studies moving. Dr. Lee previously served at the U.S. Food and Drug Administration, including as Acting Associate Commissioner for Minority Health and Health Equity and as a Deputy Office Director. Her experience spans regulatory science, clinical research operations, stakeholder engagement, and the development of scalable approaches to improve clinical trial participation and execution. She brings a cross-sector perspective on how sponsors, sites, and community clinicians can recognize operational risk earlier, strengthen site and participant support, and prevent enrollment and execution challenges from becoming study-level failures.

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Kacie Lopez Davies is a Research Manager at Fred Hutchinson Cancer Center with the eRegulatory Support operations team that oversees site administration for Florence eBinders and eConsent. Her team specializes in the implementation, training, oversight, and centralized support services for clinic teams and site administrators using Florence across the Cancer Consortium. She has a background as senior regulatory coordinator managing clinical research studies in oncology, neurology, rheumatology, and internal medicine.

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Heather Manley, MS, LPC, serves as Senior Site Director at Sequoia Clinical Research, where she oversees the organization’s flagship Lenexa campus and provides strategic and operational leadership across a diverse portfolio of Phase I–IV clinical trials. With more than 13 years of clinical research experience and over a decade in site leadership, Heather has built her career around the operational realities that drive trial performance. Her experience spans independent site, site-network, and multi-site environments and includes enrollment strategy, quality oversight, performance management, process improvement, team development, and the use of operational metrics to identify barriers and drive action. Heather has led research operations through periods of rapid growth, organizational change, and complex trial execution. Her experience working across site, sponsor, and CRO relationships has shaped a practical approach to recognizing emerging risk, understanding the operational issues behind performance metrics, and developing solutions that keep studies moving forward. Heather is passionate about translating frontline experience into practical, scalable solutions that help research teams recognize risk earlier, reduce operational complexity, strengthen site performance, and prevent manageable challenges from becoming threats to successful trial execution.

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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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My name is Ashley McCaffrey, and I am a regulatory specialist at Alcanza clinical research. I am on the central team which means I support all our sites. I have been in regulatory for over five years and have been a Florence user from day one. Our company was a beta testing company for Florence when they first started. They are changing the research game by making things easier for everyone involved. I am retired Air Force and married to my best friend who is also retired Air Force. We enjoy adventures and making memories together and spending time with our fur babies. I look forward to sharing tips and tricks to make everyone’s day easier!

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Kate McCaffrey, MBA is the Director of Regulatory Affairs & PRMS at Moffitt Cancer Center, where she leads institutional regulatory oversight, scientific review operations, and research governance activities supporting one of the nation's leading NCI Designated Comprehensive Cancer Centers. With more than 15 years of experience in healthcare and clinical research, including leadership roles at both Moffitt Cancer Center and Cleveland Clinic's Taussig Cancer Institute, she has built a reputation for advancing oncology research through operational excellence, strategic innovation, and high-performing teams. Throughout her career, Kate has led large multidisciplinary research organizations, overseen complex oncology trial portfolios, and implemented transformative initiatives that enhance trial activation, regulatory compliance, quality oversight, and financial sustainability. Her work has focused on leveraging technology, data analytics, and process improvement to accelerate research operations while reducing administrative burden and strengthening audit readiness. A frequent national presenter, Kate is recognized for her contributions to clinical research operations, workforce development, research quality programs, and scientific review modernization. She is passionate about developing future research leaders and advancing sustainable infrastructure that enables cancer centers to deliver innovative therapies to patients more efficiently and effectively.

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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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Allison Murphy is currently a Regulatory Specialist Senior at Moffitt Cancer Center in Tampa, FL. She has 14 years of clinical trial research experience, with the past 9 years spent in Regulatory Affairs. Allison currently oversees the regulatory submissions and manages the electronic investigator site files for over 100 clinical trials for the Immune Cellular Therapy program at Moffitt Cancer Center. In 2025, Allison lead the creation and implementation of a new Protocol Training Electronic Log process using the Florence e-binders electronic log capabilities. In 2026, she co-authored an abstract detailing the impacts of the new process on reducing the timeline, administrative burden and monitoring findings related to protocol training documentation for the American Association of Cancer Institutes (AACI) Clinical Research Innovation 2026 Annual Conference. Allison attended the conference to present the abstract during the poster session.

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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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Nia Nichols serves as Regulatory Manager for the Office of Clinical Research at Fox Chase Cancer Center, where she leads regulatory strategy and operations across Medical, Radiation, and Surgical Oncology. Her career has progressed from coordinating clinical trials at leading Philadelphia-area academic medical centers to managing regulatory operations for a complex oncology research portfolio at an NCI- designated cancer center. After earning her Bachelor of Science in Public Health from Temple University, Nia began building her clinical research career at Thomas Jefferson University, where she supported daily trial operations, participant recruitment and enrollment, specimen processing, data collection, and safety monitoring. She later joined Children’s Hospital of Philadelphia, leading regulatory submissions, informed consent activities, investigational product accountability, protocol and consent development, and monitoring readiness. Nia continued her work in pediatric clinical research at St. Christopher’s Hospital for Children, overseeing regulatory submissions, patient safety monitoring, study documentation, site visits, and protocol training. In 2022, she joined Fox Chase Cancer Center. As the Regulatory Manager, she manages and mentors Regulatory Coordinators, develops onboarding and competency programs, presents operational metrics to senior leadership, contributes to SOP development, and leads process- improvement initiatives, including implementation of the Florence e-Binder system to standardize documentation and strengthen audit readiness. Drawing on experience spanning clinical trial operations, regulatory compliance, patient safety, team development, and organizational change, Nia is committed to building efficient, collaborative research programs that support high-quality clinical trials and protect research participants. She is an ACRP Certified Professional and brings a practical, strategic approach to navigating the evolving clinical research environment.

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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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Erica Orcholski, MPA, CCRP, is the Regulatory Director in the Clinical Trials Office at the University of Minnesota's Masonic Cancer Center, where she has led regulatory affairs since 2015. She oversees regulatory compliance, investigator-initiated trial development, and staff development for the Cancer Center's clinical trials portfolio, partnering closely with the University's Human Research Protection Program on SOP development to keep research both compliant and workable. Her focus is building practical and reliable systems, from timely study startup procedures to investigator site file maintenance. She is committed to serving as a resource for the broader clinical trial regulatory community.

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Renata is the Senior Director of Clinical Research Informatics and Technology at Memorial Sloan Kettering Cancer Center (MSK), where she drives innovation in clinical trial technology and digital research infrastructure. With more than 16 years of experience in oncology research, she is recognized for advancing technology strategies that modernize trial operations, improve data quality, and reduce burden across the clinical research ecosystem, making trial conduct more efficient for investigators and participants. Her work focuses on the intersection of clinical operations, data, and emerging technology, including initiatives in EHR-to-EDC integration, AI-powered trial matching, and research systems modernization. Drawing on six years of prior experience in clinical research operations, Renata brings a practical, site-informed perspective to implementing scalable innovation in complex academic research environments.
Renata also co-leads the Clinical Research Innovation Consortium (CRIC), collaborating with peer institutions, sponsors, and technology partners to improving patient access to trials through digital innovation, and accelerating the adoption of technologies that create measurable operational impact across sites and sponsors.

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Stephany L. Park is the Clinical Research Regulatory Specialist at Northeast Georgia Medical Center, where she serves as her site's eSMF administrator and remote monitoring super user, overseeing Florence eBinders as the system of record for essential regulatory documentation across 35+ oncology studies. In this role, she manages document workflows, provider credentialing, and audit-readiness, ensuring every study stays compliant with ICH-GCP and federal regulations. She also coordinates site feasibility, IRB submissions, safety reporting, and study monitoring and closeout activities in partnership with the RealTime CTMS. Her deep, day-to-day fluency with Florence eBinders — from document architecture to inspection-readiness — gives her a global perspective on how eSMF technology shapes site-level research operations. Building on that foundation, Stephany is now leading efforts to expand standardized eSMF and remote-monitoring practices beyond oncology, helping scale consistent regulatory and document-management infrastructure across research programs institution-wide. Before moving into regulatory research, she spent 5+ years in quality control roles within FDA-regulated laboratories, an experience that shaped the compliance-driven rigor she brings to every study she supports today.

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Leslie Pimentel Byatt is Director of Clinical Trials Operations at the University of New Mexico Hospitals, where she oversees approximately 150 interventional clinical trials across two hospital campuses. With more than 30 years in clinical research — including international experience opening trial sites in Central America — she brings a practitioner's perspective to the intersection of operational excellence and emerging technology. A Fellow of the Association of Clinical Research Professionals and member of the ACRP Board of Trustees, Leslie is a recognized voice in clinical research workforce development and ethics. She has presented on applied AI ethics, leadership and project management at national conferences and webinars, and is actively developing AI governance frameworks for clinical trial site operations — with a focus on keeping human judgment central as automation reshapes the research enterprise. Leslie holds an MSML, MBA, and PMP certification, and will be completing a Doctor of Executive Leadership at the University of Lynchburg in December of 2026. She is the creator of the ALIGN leadership framework, designed to guide teams through complex, high-stakes change.

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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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Mark leads Investigator-Facing Systems at Eli Lilly, where he focuses on reducing friction between Lilly and clinical trial sites — and building the agentic AI strategies and data insight tools that will power the next generation of study team operations. He previously led Lilly's Clinical Trial Management Systems and Enterprise Automation teams, where he scaled enterprise platforms and introduced digital adoption and automation capabilities across clinical operations. His current work sits at the intersection of site connectivity, AI-enabled workflows, and the hard organizational questions that come before any agent can actually function.

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Clinical Research Professional with 20 years of experience that spans across all aspects of the industry including research site networks, contract research organizations and biotech. Dedicated to operational excellence while deploying and leading innovative projects to increase clinical trial enrollment, such as Just in Time (JIT), patient matching and decentralized clinical trials.

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Kaitlyn is a Project Manager on the Business Analytics team at a multi-site clinical research organization, where she leads and supports cross-functional initiatives focused on process improvement, operational efficiency, and technology implementation. She began her career in accounting and finance, spending more than three years supporting financial operations before transitioning into Compliance and Regulatory. Although she didn't come from a traditional regulatory background, her experience in finance and process improvement provided a unique perspective on building efficient, scalable workflows. Before leading her organization's enterprise eRegulatory implementation, Kaitlyn spent time working alongside the regulatory team to experience their day-to-day workflows firsthand and gain insight into the challenges they faced. She later led the implementation of the organization's Florence eRegulatory platform, overseeing system configuration, process design, document migration, and user adoption to modernize regulatory operations. Today, Kaitlyn continues to support strategic technology initiatives that strengthen collaboration and improve business processes across the organization. She is excited to share the workflows, lessons learned, and practical tips that have helped her organization get the most value from Florence.

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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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As a seasoned cross-functional leader and grey-space operator - at the intersection of Global Development and IT, Dilip Raghunathan brings deep expertise across the clinical data lifecycle, from standards and regulatory submissions to modern data platforms and AI. He focuses on enabling scalable transformation, modernizing Decision Platforms, advancing Digital Data Flow (DDF), and applying AI to improve trial execution, data quality, and decision-making in GxP-regulated environments.

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Meghana Rao is Senior Manager, Clinical Trial Lead at Olema Oncology, where she leads global Phase III breast cancer trial. Over more than a decade, she has worked across the full clinical research ecosystem: site, CRO, and sponsor, spanning pharmaceuticals and medical devices at organizations including Roche, IQVIA, Stryker, and Pliant Therapeutics. This 360-degree view gives her a practical perspective on how compliance, technology, and people come together to keep trials inspection-ready. Meghana serves on the Executive Board of ACRP's Northern California Chapter and is passionate about mentoring clinical research professionals and helping teams perform at their best.

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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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Amanda Rodriguez-Sullivan serves as the Head of Clinical Operations at Paradigm Health, where she leads the execution of pragmatic, prospective clinical studies by leveraging cutting-edge technology products and scalable service infrastructure to transform clinical trial delivery. Prior to her role at Paradigm, Amanda completed a four-year tenure at Flatiron Health, where she was instrumental in building the operational foundation for prospective clinical trial execution through centralized study operations and core technology solutions. Before Flatiron, she spent seven years as a Clinical Operations leader at the Prostate Cancer Clinical Trials Consortium (PCCTC), a specialized CRO where she led the early-phase trial portfolio. She began her career managing complex basket trials for solid tumor indications within immunotherapeutics at a top-tier academic medical center. Amanda holds a Bachelor of Science in Biology from Fordham University and completed a Master's program in Health Sciences from Drexel University College of Medicine

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Robert H. Romanchuk, BSHS, CIP, is Director of Regulatory Affairs and an IRB Chairperson at Univo IRB. Over more than 25 years in clinical research, Bob has worked on both sides of the IRB table—building and managing clinical research programs and spending more than a decade leading independent IRB review. His work focuses on the intersection of research ethics, regulation, and the practical realities of conducting clinical trials, with particular interests in informed consent, participant privacy, medical devices, and emerging technologies. A frequent national speaker and author, he is known for translating complex regulatory and ethical questions into practical issues for IRBs and research professionals.

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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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Zach Sawaged is the founder and CEO of Concordare Trials, a company based in New York and Pittsburgh that makes the clinical trial protocol machine-readable through its patent-pending Clinical Trial Protocol Model and uses it to generate study calendars, source documents, coverage analysis, budgets, and the configuration for the systems a study already runs on. The platform was built alongside research teams at Rutgers, NYU Langone, and UTMB, and is a finalist for the 2026 Fierce Pharma AI Innovation Awards. Before Concordare, Zach spent ten years on all three sides of clinical research: as a research coordinator at NYU Langone's cancer center, designing studies for sponsors such as Johnson & Johnson and Takeda at ZS Associates, and in business management at Veeva. He holds an M.S. in Biomedical Informatics from NYU.

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Katie Shaw is the Director of Central Research Services for the HCA Healthcare Research Institute based in Nashville, TN. She brings over of decade of clinical research experience to this role, where she oversees study activation, clinical trial budgeting, contracting, research education, regulatory affairs, CTMS systems and coverage analyses for HCA's network of over 50 sites. Katie is passionate about creating sustainable, efficient processes and intelligent software solutions that drive research forward and bring new therapies to patients. Katie holds an HCMBA from Belmont University and a BS in Strategic Communication from Texas Christian University.

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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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Ilan Slonim spent more than 15 years building software for regulated industries, most recently as a Principal Software Engineer at Zuora, after beginning his career as an officer in the technology track of Israel's Unit 8200. His habit of asking the right questions before building anything led him here.

He doesn't come from clinical research; his wife, a clinical operations director of nine years does. After years of dinner conversations about studies, particularly study startup, he started challenging the status quo: Why is the most important document in a trial still a static Word file? Why is progress tracked in manually updated spreadsheets? Why is the amendment process so manual and labor-intensive?

Those questions led him to found Trelice, the Atlanta-based platform for authoring clinical trial protocols as structured, machine-readable documents from the first draft, rather than digitizing them later. Designed around ICH M11 and CDISC USDM, Trelice carries changes through amendments and generates downstream documents—informed consent updates, visit instructions—directly from the protocol, so sponsors, CROs, and sites work from a single source of truth instead of PDFs and re-keyed worksheets.

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Jeff Smith is co-founder of the Innovation Network and the Whale Tank, platforms that help life science leaders discover and collaborate on emerging solutions. He co-founded Tryl, which won a SCOPE trophy and announced its acquisition during the SCOPE Summit. Like many in the field, Jeff’s path into clinical research began with a personal family tragedy. He now spends much of his time helping inspiring thinkers deliver the presentation of a lifetime. A magna cum laude graduate of Harvard Law School and a mostly recovered lawyer, he has published on health sciences in the Harvard Journal of Law & Public Policy and the Yale Journal of Health Policy, Law & Ethics. Last year, he and his team conducted over 50 cross-sector interviews focused on problems and possible solutions in clinical trial navigation. His best work was as a championship-winning middle school basketball coach.

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Since starting in research in 2016, I have valued the opportunity to continuously learn and grow each day. I find it deeply rewarding to contribute, even in a small way, to the development of new treatments that improve patients’ lives.

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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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Gokhul Srinivasan partners with the founders and technology leaders of healthcare and life sciences startups, from clinical research to genomics, turning agentic AI into trusted products and businesses that scale. As a Senior Partner Solutions Architect in the AWS Global Startup Program, he steers them through the three strategic decisions that determine growth: how to build solution on AWS that meets the governance bar of regulated industry, how to take it to market with AWS, and how to fund the path from pilot to production. At Research Revolution 2026, Gokhul joins Florence CTO Andres Garcia for “AI & MCP 101: A Primer on the New Age of Data Fluency with AI”. He is based in Raleigh, in the heart of North Carolina’s Research Triangle.

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Katie Moore is the Research Operations Manager at Northside Hospital in Atlanta, GA, and has worked in research for over 10 years. Her current role oversees the regulatory, systems, and projects teams supporting the oncology and cardiology clinical trials that take place across Northside's five-campus community healthcare system. The Northside Hospital Research Program launched the use of Florence eBinders in 2020, with eConsent following in 2024. Katie holds a BS in Biology with a certificate in Computational & Quantitative Biology from the Georgia Institute of Technology.

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Jess Thompson is the founder of Clinical Research Pro, with over 17 years of hands-on clinical research experience spanning clinical laboratories, research sites, CROs, and pharmaceutical companies. Driven by her passion for empowering clinical research professionals, Jess established Clinical Research Pro to advance education, professional development, and career growth across the industry. Under Jess’s leadership, Clinical Research Pro offers a supportive community that integrates professional development with wellness initiatives tailored to the unique challenges of clinical research. By emphasizing project management, risk management, change management, and leadership, alongside mental and physical well-being, Jess ensures that clinical research professionals are supported as whole individuals. Her deep industry knowledge, combined with a holistic approach to career and personal growth, allows Jess to deliver impactful training and resources that help clinical research professionals excel in both their work and their personal lives.

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Eric serves as the Clinical Research Solution Leader for Huron. He has a proven track record spanning 26 years, serving academic medical centers, community health systems, cancer centers and free-standing research institutes. During that time, Eric's has worked across the research spectrum, focusing on strategy, governance, operations, compliance, and technology assessment/implementation. Eric’s areas of professional interest include aligning clinical, education and research missions, addressing research health disparities, technology enablement and data maturity. He has led strategic research growth initiatives with top research universities, designed and implemented multiple research operating models and Clinical Trial Offices and deployed SaaS-based CRM technology solutions across universities, academic medical centers, community and children’s hospitals, cancer centers, and research institutes. With extensive experience providing leadership and oversight for 100's of engagements, he has served clients nationwide, driving innovation and operational excellence in research organizations.

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Rosanna Veggeberg serves as Director of the Investigator-Sponsored Research Unit (ISRU) at Fox Chase Cancer Center. Her career has taken her from neuroscience and brain imaging research to oncology clinical trials and, ultimately, leadership in investigator-sponsored clinical research. After earning her bachelor’s degree in Neuroscience from Brandeis University, Rosanna began her career conducting human pain research using brain imaging technologies. She later earned a master’s degree in Clinical Research from Boston University, where her thesis research examined the effects of repetitive concussions and subconcussive injuries on the brains of former NFL players as part of the research program portrayed in the film Concussion. After moving to Philadelphia, Rosanna joined Fox Chase Cancer Center as a Clinical Research Coordinator supporting interventional oncology and precision medicine trials across multiple disease areas. She later managed the Hematologic Malignancies and Bone Marrow Transplant/Cellular Therapy research team before taking on her current role leading the ISRU. Drawing on experience spanning scientific research, clinical trial operations, and research leadership, Rosanna is passionate about strengthening investigator-sponsored research through collaboration, operational efficiency,

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Jim Wagner is senior vice president of AI and Product Innovation – Site Enablement at WCG, where he leads the expansion of AI‑driven capabilities across study start-up and site enablement following WCG’s acquisition of The Contract Network. Previously, Jim was co‑founder and CEO of The Contract Network, an AI platform designed to accelerate clinical trial contracting and improve alignment between sponsors, sites, and CROs. Earlier in his career, he served as vice president of Agreement Cloud Strategy at DocuSign and as president of Seal Software. Jim is a Duke Law School graduate and a member of the Duke Law Tech Lab advisory board.

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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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Tiffany Whitlow is the Co-founder and Chief Development Officer of Acclinate, a digital health company dedicated to advancing health equity by ensuring communities of color are actively represented in clinical trials and genomic research. Under her leadership, Acclinate has secured over $13 million in funding, grown to a team of 40 across multiple locations, and partnered with global industry leaders. Tiffany spearheaded the creation of Acclinate's NOWINCLUDED, an award-winning community platform that empowers underrepresented groups to take control of their health journeys through trusted education and advocacy. With over a decade of expertise in business management, marketing, and community engagement, Tiffany’s visionary approach seamlessly bridges the gap between culture and technology. Her impactful work has garnered significant national recognition. In 2022 she was recognized as a Business in Alabama Women in Tech, 2024 and 2025, she was named to the prestigious Inc. Female Founders 250 list, and 2025 Birmingham Business Journal 40 Under 40. Beyond her work at Acclinate, Tiffany is deeply committed to her community, serving on the United Way of Madison County board. She is a dedicated advocate for diversity, leveraging her entrepreneurial spirit to drive systemic change and trailblaze pathways to healthcare equity.

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Dr. Kelly Willenberg has owned and led Kelly Willenberg & Associates for seventeen years. A registered nurse with more than 40 years of experience, she heads a nationally respected firm specializing in clinical research and healthcare compliance. She serves on the faculty of the HCCA Academies and sits on the Board of Directors for the Healthcare Compliance Association and the Society of Corporate Compliance and Ethics (HCCA/SCCE). In 2019, she was appointed by the Governor of South Carolina to the state’s Small Business Regulatory Review Committee. In 2026, she was appointed to the CDC's National Committee for Vital Health Statistics under Secretary R. Kennedy. Since 2017, Kelly has been an active advocate for handsfree legislation at both the state and national levels, a commitment shaped by the tragic loss of her husband in a hitandrun cycling accident. Her work reflects a deep belief in strengthening the healthcare community and expanding access across South Carolina. Hands-free legislation was passed in South Carolina in September of 2025, much of it due to Kelly's advocacy. In partnership with Prisma Health’s Upstate Foundation and Prisma Healthcare Midlands Foundation, she established the Dale A. Willenberg Congenital Heart Disease Endowment, which supports Camp Heart to Heart in the Upstate and the Norton Family Point of Care Ultrasound Program in the Midlands. Kelly is also an accomplished author, podcaster, and national speaker. She is a graduate of The Campaign School at Yale and Healing Politics, bringing a powerful blend of professional expertise, advocacy, and public leadership to every space she enters. She has aspirations of running for office.

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Donica Williams is a Clinical Trial Lead with more than 20 years of experience supporting pharmaceutical and medical device clinical research. Her career reflects a comprehensive understanding of the clinical research process, beginning with laboratory research as a Tissue Dissector and progressing through roles as a Clinical Research Assistant, Clinical Research Associate, Site Manager, and now Clinical Trial Lead. This diverse background has given her a unique perspective on the continuum of clinical research—from scientific discovery and product development to the successful execution of global clinical trials. In her current role as a Clinical Trial Lead, Donica provides strategic and operational oversight for a multicenter medical device study. She leads cross-functional teams and collaborates with executive leadership, investigators, contract research organizations (CROs), vendors, and research sites to ensure studies are executed efficiently, compliantly, and with the highest standards of quality. Her responsibilities include overseeing site activation, enrollment, and performance strategies; managing study timelines and operational milestones; identifying and mitigating study risks; supporting protocol implementation; ensuring regulatory compliance and adherence to Good Clinical Practice (GCP); maintaining study quality, data integrity, and patient safety; mentoring clinical research associates; supporting investigator and study team training; overseeing vendor relationships; and implementing operational strategies that enhance study execution and site performance. Throughout her career, Donica has supported pharmaceutical and medical device clinical trials across a broad range of therapeutic areas, including Oncology, Hematology, Rare Diseases, Cardiology, Central Nervous System (CNS), Gastroenterology, Gynecology, Ophthalmology, Vaccines, Endocrinology, Infectious Diseases, Dermatology, Pulmonology, Urology, and Medical Devices. Her extensive therapeutic experience has enabled her to successfully manage diverse clinical programs while adapting to the unique scientific, regulatory, and operational requirements of each specialty. Donica is recognized for her collaborative leadership style, operational expertise, and ability to build productive relationships across cross-functional teams. She is passionate about mentoring the next generation of clinical research professionals, sharing practical industry knowledge, and developing innovative solutions that strengthen site partnerships, improve study execution, and advance clinical research excellence. She earned her Bachelor of Science in Biology from Xavier University of Louisiana. In addition to her professional career, Donica serves in leadership with Top Ladies of Distinction, Inc., where she is committed to mentorship, community service, and leadership development.

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Sarah Wise is Senior Director of Research Operations at the Prostate Cancer Clinical Trials Consortium (PCCTC), where she oversees clinical operations, regulatory compliance, monitoring, and correlative sciences across a growing portfolio of multi-center oncology clinical trials. With more than 20 years of experience in clinical research management, including over 15 years focused specifically in oncology research, Sarah brings deep operational expertise to every stage of trial execution, from protocol development and site initiation through analysis and closeout. In her role at the PCCTC, Sarah leads the day-to-day infrastructure that connects coordinators, investigators, and sponsors across multiple sites, ensuring efficient and timely communication and workflow execution. She has extensive expertise in regulatory documentation, IRB requirements, Good Clinical Practice (GCP), and FDA compliance. Sarah also helps lead oversight of all SOPs and Quality Management initiatives across the organization. Prior to her role at the PCCTC, Sarah held roles responsible for oversight of clinical research contracts, budgets, and research billing at Memorial Sloan Kettering, oversight of the research team managing prostate cancer medical oncology studies at Memorial Sloan Kettering, and clinical research study management at Covance. Sarah holds a Master of Science in Clinical Research Organization and Management from Drexel University and a Bachelor of Science in Biology from Bucknell University. Sarah lives in the Philadelphia area with her family, though also enjoys traveling whenever possible.

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Andy is the Associate Director of Clinical Quality Assurance at Orca Bio. After graduating from the esteemed Colorado State University, Andy fell into a job as a research assistant. His punctuality and curiosity launched a 22 year career guiding Phase I–III drug, biologic, and medical device development programs and over a decade directing quality, auditing, and compliance functions across diverse organizations. Andy is animated by a commitment to education, collaboration, and innovation in clinical trials and directs modern QA practices to proactively ensure inspection readiness and operational effectiveness with cross-functional stakeholders. Andy has successfully hosted both PLA and BLA inspections and mostly enjoyed it.

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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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