Director, Head of COA and Patient Innovation, Regeneron, Rinol’s professional focus is centered around integrated innovation, design thinking, and clinical operation with 15+ years of experience in startup and pharma industry. Savvy, results-oriented leader with proven success in transforming and building eCOA organizations from the ground up. In his current role, he leads Clinical Outcome Assessment and Patient Innovation team within Regeneron pharmaceutical.

Bill Arneson is a seasoned professional with over two and a half decades of expertise in information technology and healthcare. Currently serving as the Director of Business Operational Transformation at Moffitt Cancer Center, he oversees teams of technical professionals, implements robotic process automation, artificial intelligence, optimizes systems and workflows, and collaborates closely with executives to foster innovation. With a robust background in healthcare revenue cycle, IT, and project management, Bill has a proven record of enhancing revenue cycle efficiency, achieving substantial cost savings, and deploying streamlined systems. He holds advanced degrees, professional certifications and excels in technical management and accelerated process improvements. Bill's commitment to delivering exceptional outcomes, complemented by his strong leadership abilities, positions him as a pivotal driver of organizational growth and operational excellence. Connect with him on social media, X.com @TheTechLeader and LinkedIn at Bill Arneson.

Brian Barnes is Director of Risk Management Strategy at BioNTech, with over 20 years of experience in clinical operations across sponsor, vendor, and technology environments. He specializes in developing risk-based monitoring strategies and implementing advanced analytics to optimize centralized monitoring and sponsor oversight. Brian leads initiatives that integrate AI-driven methodologies into clinical operations, enhancing operational decision-making and supporting scalable, efficient global development programs.

Sanjay is the Executive Director and Global Head of Clinical Technology Strategy & Operations at AbbVie where he leads an organization of technologists who enable AbbVie’s Clinical Trials' Data Collection, Aggregation, and Processing. Prior to AbbVie, Sanjay was the Global Head of Clinical Data Management at Allergan. Over more than 2 decades in the Clinical Operations—Clinical Data and Technologies domain, Sanjay has led global teams at Biogen, Novartis, Merck/MSD, and Schering-Plough. Sanjay is the past chair of the Society for Clinical Data Management (SCDM) board and has authored a number of clinical data-related publications.

Dan Boisvert is a senior biopharma leader with 20 years of experience advancing digital transformation and data innovation in clinical development. As Senior Director and Head of Data Stewardship at Biogen, he leads global efforts in data sharing, anonymization, standards, imaging, and advancing digital maturity. His work has cut clinical data access time by over 50%, earned an FDA/PhUSE Innovation Award for an AI-informed consent chatbot, and is delivering one of the industry’s first large-scale participant data return programs. Dan brings vision, pragmatism, and radical candor to optimizing clinical trials through data and AI.

Zoe Brusselle is an Agentic and Prescriptive Analytics Project Manager focused on transforming clinical operations through advanced analytics and AI-driven decision intelligence. Based in Boston, she leads initiatives that enable data-driven decisions and automated action workflows, helping clinical teams identify next-best actions and optimize execution. At Sanofi, she drives strategic AI programs that bring together data science, clinical experts, and business stakeholders to embed decision intelligence across clinical development. Her work improves trial efficiency, reduces operational risk, and supports physicians in delivering better care. With a degree in engineering plus a background in neuroscience and applied data science, she bridges complex scientific concepts and scalable operational solutions.

Dr. Kevin Bugin is the Head of Global Regulatory Policy and Intelligence at Amgen, Inc. Prior to his current role, Kevin was the Deputy Director of Operations in the Office of New Drugs (OND) in FDA’s Center for Drug Evaluation and Research (CDER). 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. Dr. Bugin is adjunct faculty at the George Washington University in the Clinical Leadership Program, focusing on areas of clinical research and medicines development. Dr. Bugin joined the FDA in 2008 in the Office of Business Process Support, then joined the Division of Gastroenterology and Inborn Errors Products within OND as a Regulatory Health Project Manager in 2010, and as the Chief of Project Management from 2015 to 2017. From 2017 until 2020, he served as the Director of Special Programs and the lead of CDER’s New Drugs Regulatory Program Modernization. Prior to joining the FDA, Dr. Bugin held roles in multiple areas and phases of drug development, including discovery (molecular biology) at the Virginia Bioinformatics Institute, translational research and technology transfer at the National Institute of Health’s Office of Technology Transfer, safety and pharmacovigilance with NIH’s National Cancer Institute’s Cancer Therapy Evaluation Program, and regulatory affairs and quality assurance at Amarex Clinical Research. Kevin received a BS in Biology and Chemistry from Virginia Tech in 2005, a MS in Biotechnology from American University in 2006, and a PhD in translational health science from George Washington University in 2020, with a focus on the Science of Team Science in drug development and regulatory science teams. He is certified in US regulatory affairs (RAC) and participates in numerous policy and regulatory science initiatives to foster drug development and promote innovation in clinical research.

I am dedicated to harnessing data to tackle complex challenges in the pharmaceutical sector, particularly within clinical operations to streamline drug development and enhance patient access. With a background in Data & Analytics Strategy, I specialize in solving problems and improving protocol design from an operational perspective. As an educator, I teach a modeling course at the university, mentoring aspiring data professionals. My focus is to leverage data-driven insights to optimize decision-making and contribute to more accessible treatments for patients.

Strategic, visionary leader with an established track record of building and leading multidisciplinary, global Informatics and IS/IT teams, driving change and simplification and delivering value through innovation. Over 20 years’ experience in the biotechnology and pharmaceutical industry working in both Discovery and Development leading projects, managing complex portfolios, driving change programs, identifying opportunities for strategic initiatives, and translating scientific and medical questions into innovative solutions. Areas of particular strength include: strategy development and implementation, translational medicine, biomedical and health informatics, evidence-based decision makings, data and decision science, and "Big Data" exploitation.

Maeva Cordoba, I'm a Digital Project Manager and Business Analyst Expert at Sanofi with a background of eight years as a Lead Global Study Manager in clinical development. Today, I focus on driving digital and AI-enabled transformation to help teams work more efficiently. I currently work on an AI-powered assistant designed to centralize study information, provide proactive alerts, and actionable insights to clinical teams. I believe AI can transform the way we manage clinical trials and support a new, smarter way of working across clinical operations.

Strategic Visionary in Digital Transformation & Analytics Leadership with Proven Analytics Portfolio Management Expertise With a keen eye for Strategic Vision, I've been at the forefront of advancing analytical capabilities, particularly in site intelligence, operational metrics, and quality indicators. My prowess in Digital Transformation has been instrumental in the on-time delivery and precision of a diverse suite of predictive models, leveraging ML/AI and Generative AI technologies. My role extends beyond mere strategy. I've championed an analytical development portfolio including in-house data & analytics transaction platform serving >1400 users, generative AI, and advanced modeling for business intel, ensuring robust analytical methodologies are in place, which has been pivotal for leadership and governance decisions. My expertise in Business Analytics and Product Analytics has been the backbone of this success, coupled with a budget management responsibility of >$5M. Building and nurturing relationships is at the core of my approach. I've continuously influenced key organizational stakeholders, ensuring the seamless adaptation and implementation of analytics and intelligence strategies. My proficiency in Engagement Management and Data Governance has been crucial in maintaining positive vendor partnerships, emphasizing quality delivery and continuous improvement. As a people leader, I've instilled a performance-centric culture, emphasizing Business Planning and actionable metrics. My commitment to Data Strategies and analytical thinking has ensured project and portfolio deliveries are not just timely but also rooted in process improvement. I've coordinated work with an agile mindset, ensuring products are delivered with consistency and precision. My technical acumen extends to Natural Language Processing (NLP), Business Intelligence (BI), data visualization, and cloud platforms including AWS, positioning me at the intersection of strategy and technology.

Vinod Das is a leading techno-functional expert with over 25+ years of experience in Pharmaceutical Research & Development IT. He is currently responsible for Artificial Intelligence enablement at Bayer Pharmaceuticals, he drives the integration of Generative AI and Language Models (LLMs) to accelerate drug discovery and clinical development. Vinod's strategic leadership in AI enablement has set new standards in pharma-tech innovation, earning him recognition as a key influencer in the industry. He actively collaborates with top academic institutions, and AI vendors to foster cutting-edge research and sustainable AI innovation. Vinod’s work bridges the gap between advanced technology and real-world applications, making him a thought leader in AI-driven healthcare outcomes.

Cris joined Sanofi Ventures in 2020 to lead investments in AI and Digital Health. He holds a 20-year track record of building startups, tech innovation platforms, and healthtech deal-making with some of the largest organizations in the world. Prior to Sanofi, Cris was a founding member of Johnson & Johnson Innovation and Global Head of Digital Innovation since 2013. He held chief digital and data responsibilities, driving digital health strategy and new venture partnerships throughout spanning the Pharmaceutical, Consumer and Medical Device businesses.? Previously, Cris led emerging technology programs within research informatics at Novartis for six years. With entrepreneurial DNA, Cris is notably known for his role in the innovation economy since co-founding Ultra Light Startups, one of the largest and oldest startup venture pitch accelerators in the U.S, catalyzing hundreds of companies in Boston, NYC, and Silicon Valley, leading to several acquisitions by major tech companies. Cris was named 40 Under 40 by the Boston Business Journal and a Top 40 Healthcare Transformer by MM&M Magazine.? Cris currently serves on the boards of Aetion, Carbon Health, Click Tx, Empatica, Medisafe, Nucleai, and Omada. Cris holds a M.Sc. in Computer Information Systems from Boston University and a B.S. in Business Administration from Suffolk University.?

Mitch Denker joined Janssen Oncology in September of 2020 and is the Head of Biomarker and Diagnostic Operations. Mitch has over a decade of experience in drug development and health technology. He has a passion for driving new product development to address unmet medical needs and increase the effectiveness of patient care through technology, data, and personalized healthcare strategies. Prior to joining Janssen, Mitch led data strategy and operations at PACT Pharma, where he was responsible for setting up clinical diagnostic and supply chain operations to enable the first in human treatment of personalized NeoTCR-based cell therapy. During his time at PACT, he developed a business plan and future state road map for IT, automation, and product development activities. Before PACT, Mitch led business development and alliance management at Syapse. He was responsible for pharma strategic partnerships, developing software products, and real-world data (RWD) analytic solutions to advance precision medicine. He spent over 9 years at Genentech, where he held various roles of increasing responsibility, including the Strategy and Operations Cancer Immunotherapy franchise lead. Mitch was the Biomarker Operations Lead for TECENTRIQ® (PD-L1) from the First-in-Human to market launch, ensuring implementation and execution of biomarker & companion diagnostic strategies in early and late phase clinical programs. Mitch worked on multiple oncology programs, including the ADCs pipeline, OX40, TIGIT, and the personalized cancer vaccine partnership with BioNTech.

Sina Djali has over 25 years of experience in drug and clinical development in various companies and academia. Currently he is the head of Integrated Clinical and Operations Analytics at Jansen Pharmaceuticals. In this role Sina is responsible for incorporating Risk Management principles through applied analytics in the day to day R&D clinical operations. This includes managing both data engineering and analytics/data science teams to provide sustainable solutions in support of R&D clinical operations. Prior to this role, Sina was the head of Risk Management – Central Monitoring at Janssen R&D. Previously he has been responsible for Clinical Process and System Department at Tibotec Pharmaceuticals, where he developed and implemented a data driven Quality Risk Management System. He has also held several positions in research, regulatory affairs and R&D Quality Assurance departments at Wyeth and Aventis Pharmaceuticals.

Dr. ElZarrad is the Deputy Director of the Office of Medical Policy (OMP) at FDA’s Center for Drug Evaluation and Research (CDER), where he leads the development, coordination, and implementation of medical policy programs and strategic initiatives. Dr. ElZarrad currently leads multiple projects focused on exploring the potential utility of real-world evidence, innovative clinical trial designs, and the integration of technological advances in pharmaceutical development. Dr. ElZarrad is the rapporteur for the International Council for Harmonisation’s ongoing work to revise the international Good Clinical Practice Guideline (ICH-E6(R2)). Prior to joining the FDA, he served as Acting Director of the Clinical and Healthcare Research Policy Division with the Office of Science Policy at the National Institutes of Health (NIH). At NIH he worked on policies related to human subject protections; the design, conduct, and oversight of clinical research; and enhancing quality assurance programs at pharmaceutical development and production facilities. He earned a doctoral degree in medical sciences with a focus on cancer metastases from the University of South Alabama, as well as a master’s degree in public health from the Johns Hopkins Bloomberg School of Public Health.

In her current role as Co-Founder and Senior Vice President of Strategy and Product Development at ClinEco, Inc., Marina Filshtinsky is leading platform development and working closely with an offshore team of engineers. She is also leading and coordinating the work with advisors and investors on go-to-market strategy, business model, and positioning the platform within the clinical trials industry. At her "day job" Marina is working as executive conference director for several CHI’s events including SCOPE and SCOPE Europe.

Chelsea Gallagher is the Senior Director of Drug Development Innovation and Digital Health Analytics. She is a thought leader in clinical design innovation and has spent the past few years building analytics solutions to optimize trial design for patients, investigators and sponsors, resulting in sustained tens of millions of dollars in cost avoidance per year . Her recent work has shifted focus to automation and optimized process, achieving timeline acceleration and reduced resource burden. With over ten years of experience in analytics across multiple functions, Chelsea has leveraged her expertise in design thinking, change management, and analytics techniques to solve challenging problems at BMS. She works with stakeholders to identify root cause pain points, recognize synergies across functions, and design solutions that meet future and current business needs

Mr. Getz is an internationally recognized expert on R&D and clinical trial management practices and trends, the global investigative site landscape, site management and patient recruitment and retention practices, and the worldwide market for outsourcing clinical research functions. Mr. Getz’s research studies on protocol design complexity and clinical research efficiency and effectiveness, conducted over the past two decades, are considered by many in the research-based life sciences industry to be pioneering work. His 20+ years of original research benchmarking R&D management practices, global outsourcing and the investigative site landscape have contributed to industry-wide understanding of these critical markets and to improvements in management strategy and execution.

Sharon Gour Arie is the VP of Value Creation at AION Labs, a venture studio backed by leading global pharmaceutical companies, where she helps build and invest in AI-driven startups transforming drug discovery and development. She supports portfolio companies from inception through growth, providing strategic guidance, industry access, and investor relationships. Prior to AION Labs, Sharon led global healthtech initiatives at Startup Nation Central, working with Fortune 500 companies, investors, and Israeli startups to drive international collaboration. She also played a key role in establishing Israel’s Pharma Innovation Community, strengthening the connection between Israeli innovators and global pharma. Earlier in her career, she worked in international business development at the Ministry of Health and served as a strategic analyst at Israel’s National Security Council. Sharon holds an MBA and a BA in Business and International Relations from The Hebrew University of Jerusalem, as well as an executive certificate in Strategic Innovation from Oxford’s Saïd Business School.

Zahiah (Zee Zee) Gueddar leverages over 17 years of diverse industry expertise encompassing delivery, finance, operational effectiveness, and the commercial sector. Zee Zee offers invaluable insight into the challenges encountered by sponsors, CRO’s, sites and patients. In her role leading IQVIA’s Financial Technology offerings, she serves as an innovative partner for clients seeking transformative outcomes and growth opportunities. Known as a strategic thinker and problem solver, Zee Zee is responsible for driving growth and differentiation, product go-to market and ensuring innovative and competitive offerings. Zee Zee is based in Southern California and is a graduate of San Diego State University.

Kristian Hammond is the Bill and Cathy Osborn Professor of Computer Science at Northwestern University and the co-founder of the Artificial Intelligence company Narrative Science (recently acquired by Salesforce). He has spent most of his career focused on the problem of making machines smarter. His research is aimed at bridging the human/machine communication gap between the data we gather and the information that is locked within it. Since the fall of 2016, he has been the faculty lead of Northwestern’s CS + X initiative, exploring how computational thinking can be used to transform fields such as the law, medicine, and education. He also directs Northwestern’s Master of Science in Artificial Intelligence (MSAI) as well as the Center for Advancing Safety of Machine Intelligence (CASMI). In January of 2023, he was named a Fellow of the Association for the Advancement of Artificial Intelligence (AAAI). He believes in humanizing computers with the aim of stopping the process of mechanizing people. Kris received his PhD from Yale.

Janie Hansen is a seasoned professional in Business Systems Transformation within Global Development Information Systems at Daiichi Sankyo, Inc. With over 20 years of experience as a business and integration architecture consultant in clinical systems, she has a proven track record of turning concepts into reality. Her expertise lies in delivering successful technology solutions and maximizing the value of technology investments in the pharmaceutical industry. Most recently, she has focused her efforts on leading transformative initiatives that leverage the potential of Generative AI.

As the former Senior Vice President and Head of Transformation at BMS, Staci was accountable to lead an integrated, enterprise focused transformation strategy and roadmap across Drug Development. This vision included a focus on adjacent partners functions to plan and deliver on our corporate pipeline and priority portfolio goals through optimization, acceleration and increased efficiency to drive delivery of our priority programs and long-term sustainability plans. Prviously, she served as Vice President, Innovative Health, Engagement, & Advocacy, at Johnson & Johnson, an appointed position, Staci was charged with creating an organizational pillar that delivers an integrated, differentiated and superior patient, site, health authority and industry leading experience for J&J’s clinical trials. With over 25 years in the biopharmaceutical sector, she is relentless in her pursuit to drive a transformational growth strategy that supports creating equal access to quality healthcare for all patients. A purpose driven leader, Staci is known for re-shaping global operations, creating an organization’s strategic vision and driving it into actionable goals, while building a more efficient and highly inclusive environment. She has an innate ability to create stability during times of uncertainty while managing conflicting priorities and multiple constituencies that lead to leadership accountability, controls and efficiencies that power enterprise value. With a proven track record in aligning cross functional leaders and capability, including quality, manufacturing, commercial, legal and regulatory, Staci successfully navigates operational complexity across often competing therapeutic areas including oncology, cardiovascular, neuroscience and immunology that leverage multiple platforms, modalities, and data science. Work experience transcends multiple industry verticals including the government, biotech, small to medium sized and big pharmaceutical companies. Active in several professional and community-based organizations, such as the National Coalition of 100 Black Women (NCBW100) and National Black MBA Association. Additionally, Staci is a founding member of Chief, the private network for executive women leaders and founded the Diversity Council at the Iona Preparatory School. She also an active member of Black Women on Boards.

A leader in the field of advanced analytics and data, Kyle helped create and now heads, AbbVie’s Development Design Center where he works with teams all over the world to ensure innovation, health technologies, and data tools are incorporated into AbbVie’s clinical trials. Whether it’s using real-world evidence and machine learning or incorporating wearables, sensors, and other devices into clinical trials, Kyle’s goal is to bring new and better treatments to more patients, faster. Before coming to AbbVie, Kyle was a physician who treated cancer patients and saw first-hand patients battle some of the most devastating diseases.

Youssef Idelcaid is Executive Director and Head of the AI Research Center at Gilead Sciences, where he leads efforts to advance artificial intelligence across global drug development functions. He contributes to Gilead’s Enterprise Data Science Council, supporting the development of AI policy, governance, and responsible adoption frameworks at scale. With nearly two decades of experience spanning biotechnology, fashion, and beauty tech at Genentech, Levi Strauss, and L’Oréal, Youssef is a trained engineer in the field of Computational and Applied Mathematics. Thought the year, Youssef's focus has been on translating cutting-edge AI research into scalable, real-world solutions that improve scientific and operational outcomes. A frequent speaker at biotech and AI conferences, he is also an active advocate for diversity in technology through the Women in Data Science community.

Focus on multimodal molecular and clinical data to inform clinical development and trial design with the emphasis on artificial intelligence and machine learning (AI/ML).

I am a data scientist with 7 years of experience developing AI solutions across diverse domains. My work spans traditional machine learning and cutting-edge large language model applications, with a focus on extracting actionable insights from complex data. I specialize in translating technical AI capabilities into practical business outcomes. Currently, I'm exploring innovative LLM use cases in the pharmaceutical industry, where natural language processing can accelerate drug discovery, enhance clinical research, and improve patient outcomes.

Hassan Kadhim is the Global Head of Clinical Trial Business Capabilities, Clinical Innovation & Industry Collaborations at BMS. In his current role, Hassan's team owns the technology stack and capabilities within Global Development Operations, and drives change and innovation towards better outcomes for clinical trial stakeholders. Hassan is very passionate about transforming the clinical research arena in the pharma industry through the use of technologies and patient-centric clinical trials, and is a firm believer of the need for clinical innovation grounded in strong business practices for sustainability, change management and adherence to compliance and regulatory commitments. Hassan regularly appears and speaks at industry events around improving the clinical trial experience with digital tools, and wrote “The Remote Clinical Trials Model” whitepaper in 2016, to formalize a new patient-centric clinical trial research model leading to what we know today as Decentralized Clinical Trials. Beyond BMS, Hassan actively collaborates across industry collaborations such as Transcelerate and others to advance relevant and high-value industry challenges. He has a degree in bioinformatics and a graduate degree in pharmaceutical sciences, both from the University of Montreal in Canada.

Francis Kendall is an accomplished senior leader with extensive experience in the field of biometrics and drug development. With an MBA qualification and a people-focused leadership style, he has successfully led teams and implemented strategic change initiatives in multicultural environments. His notable roles include serving as the Head of Statistical Programming, Data and Data Sciences at Biogen, where he manages a that oversees key initiatives such as Data Stewardship, Data Science, and effective evidence delivery. Prior to that, he held positions at Astra Zeneca, Cytel, Roche, Pfizer, Novartis, Nycomed, Sandoz UK, and Hoechst UK, where he made significant contributions to statistical programming, data analysis, and strategic planning. Francis holds various qualifications, including being a Chartered Manager, Chartered Statistician, and member of professional organizations such as PHUSE and the Chartered Management Institute. He has also published articles in prestigious journals, demonstrating his expertise in artificial intelligence, machine learning, and clinical development.

Dr. Subha Madhavan is a dynamic and results-driven leader with a strong track record of excellence in organizations that operate in the nexus of science, technology and business. She is a world-class leader in AÍ/ML, Drug R&D, Precision Medicine, Digital Health, Data Science & Analytics, Bioinformatics, Product development, Clinical informatics and Health IT. She and her team were responsible for initiation, design and execution of several large national and international clinical research programs including Cancer Moonshot, TCGA, CPTAC and Human Cell Atlas. In her role as the Founding Director of the Innovation Center for Biomedical Informatics at Georgetown, she developed a workforce of over 25 employees, to include staff scientists, health IT, and operations personnel with full P&L responsibility for the business center and its R&D team. She has initiated and successfully directed several productive research and development programs at the Lombardi Comprehensive Cancer Center, MedStar hospital network, FDA, NCI and industry. She was co-leader of the FDA Center for Excellence in Regulatory Science at Georgetown and worked with the Oncology Center for Excellence, Vaccines and related biological products, and Office of the Chief Scientist. As an industry advisor, she advices biopharma, federal, academic clients develop organization-wide R&D, data science and digital health strategy.

Kwame Marfo joins Unlearn from Komodo Health, where he served as Senior Director of Product Strategy and Incubation. There, he led cross-functional teams to advance product development and drive market alignment across multiple healthcare segments, including clinical development and medical affairs. Prior to Komodo, Marfo spent more than a decade at Genentech in leadership roles across global clinical operations and manufacturing sciences and technology. As Director of Insights & Analytics for Genentech’s Global Clinical Operations, he co-founded a function that became central to trial strategy and execution, with a strong focus on improving trial representation, patient experience, and accelerating timelines. He holds a BS in Chemical Engineering from Stanford University and an MBA from the Haas School of Business at UC Berkeley.

Hrvoje Mohoric is an accomplished data and digital innovation leader with over 20 years of experience across the pharmaceutical and engineering industries. He currently serves as the Head of Clinical and Digital Innovation at Merck Healthcare KGaA, where he leads the development and implementation of clinical, data, and digital innovation strategies. His expertise in data governance and management has driven transformative initiatives at global companies like Novartis and Accenture. At Novartis, he was instrumental in establishing enterprise-wide data governance frameworks as well as data strategy and governance for clinical operations. As part of his fellowship at the World Economic Forum (WEF), he successfully managed the Global Supply Resilience Initiative in collaboration with UNICEF, fostering public-private data-sharing collaboration to improve supply chain visibility in West Africa and positively impact lives through the delivery of food and medicine.

Narayanarao (Rao) has been working in Pharmaceutical R&D and Consulting for the past 30+ years in the areas of Clinical Development, Statistical programming, and Submission preparation. Worked in and developed processes and software systems for all the functional areas. He has a passion for streamlining processes and systems to improve the quality of the work and outcomes, increase speed, and reduce cost at the same time.

Carolyn leads and shapes the AI Ethics, data governance and privacy practices for Johnson & Johnson Innovative Medicine R&D Data Science & Digital Health enabling efficient implementation of data science capabilities across R&D while protecting data privacy. She works closely with data science team(s), data transparency team, business owners, legal, compliance, privacy, and IT amongst others to design and implemented a Data Science Data Governance program and processes. She provides subject matter expertise for data diligence, partnerships and L&A. Additionally, Carolyn is leading the DSDH AI & Ethics Workstream. Carolyn has over 20 years of experience in the Pharmaceutical Industry. She has an established track record of leading security functions comprising of 3rd party risk management, cloud and SaaS offerings including compliance. This risk management supported the delivery of 15 billion dollars in revenue for a world leader in life sciences. Among her many achievements, she oversaw security and risk reviews for over 250 systems ensuring standards, policies and guidance were followed and maintained, oversaw innovative clinical digital trials working closely with legal, regulatory and business to ensure patient safety was first, and worked side by side with key global key stakeholders and leadership teams to evaluate pragmatic solutions for security and risk. She earned her Bachelor of Business Administration from Temple University and Master of Education degree from Arcadia University.

Gian Prakash is the Director of Data and Analytics supporting Global Therapeutics at AbbVie. With a wealth of experience in data and analytics coupled with a deep understanding of the pharmaceutical industry, Gian is instrumental in shaping the vision and strategy for data-driven initiatives within the organization. In his role, Gian leads efforts to integrate data, analytics and technology into AbbVie's global therapeutic endeavors, ensuring that data is leveraged effectively to enhance decision-making and drive successful business outcomes. Under Gian's leadership, the Data and Analytics team at AbbVie thrives on a culture of collaboration and innovation, continually seeking to enhance the impact of their work across the global therapeutic landscape. His dedication to excellence ensures that AbbVie remains at the forefront of leveraging data to deliver tangible benefits to patients and the healthcare community at large.

Angela Radcliffe is a clinical research expert and data ethics evangelist with over two decades of experience driving transformation and organizational agility at the intersection of health, tech, and data. Angela’s work has impacted >100 global clinical research efforts across almost every therapeutic area. As an author and speaker, Angela uses her personal journey to demonstrate how inclusive research can impact the root causes of our most challenging social issues such as homelessness, social justice, and climate change. She is committed to delivering on the promise of digital health and decentralized clinical trials in pursuit of health equity, giving data ownership back to humans to promote authentic patient engagement and trust, the promotion of health and data literacy for all, and normalizing clinical research as a care option.

Prasanna Rao is a distinguished AI practitioner and industry thought leader, currently serving as the Chief Products and Innovation Officer at Saama Technologies. With over 30 years of experience in information technology and analytics, including more than a decade in healthcare and life sciences, Prasanna brings a wealth of knowledge and expertise to his role. Previously, as Global Head of AI/ML, Clinical Data Sciences at Pfizer Research & Development, Prasanna worked closely with stakeholders, vendors, business SMEs, machine learning developers, and data scientists to foster innovation and advance the adoption of AI in clinical data sciences. His tenure at IBM Watson as a Watson Solution Architect was marked by significant achievements in implementing AI systems for a diverse range of clients. An accomplished speaker, Prasanna regularly presents at major industry conferences, including SCDM, DIA, SCOPE, DPharm, Tufts University CSDD, and Outsourcing Clinical Trials (OCT). He is also the holder of an IBM patent titled "Monitoring Clinical Research Performance," further cementing his status as a leading authority in leveraging technology for clinical development in the pharmaceutical industry. Prasanna continues to drive transformative advancements in AI and machine learning, delivering groundbreaking solutions to accelerate clinical research and development.

Dr. Bhargava Reddy has over 16 years of experience working in the pharmaceutical industry. He is currently Head of Advanced Insights at Janssen Pharmaceutical supporting clinical operations by providing data science solutions. Prior to this role, he was Associate Director of Advanced Analytics at UCB. In this role, he was responsible for the development and application of machine learning methodologies supporting clinical decision making within Immunology and. He was also leading the analytics work supporting Risk Based Monitoring. Prior to this role, he managed a statistical programming group and was also overseeing a large statistical programming group offshore. Dr. Reddy has published several methodology papers in peer reviewed academic journals in the areas of machine learning and deep learning. He is actively involved as an associate editor for the Frontiers in AI journal and also as a reviewer on several journals. He has a Ph.D. from Oklahoma State University and MS from Northwestern University.

Dr. Jorge S. Reis-Filho leads Data Science and AI across AstraZeneca Oncology Research and Development, primarily focusing on the development and deployment of multimodal foundation models, advanced data science approaches, and agentic AI frameworks to drive innovation throughout AstraZeneca’s oncology pipeline and portfolio. Through the integration of rigorously validated AI-driven approaches across R&D, AstraZeneca aims to accelerate drug discovery and transform clinical development to advance its bold ambition in oncology: eliminating cancer as a cause of death. Dr. Reis-Filho earned a joint MD from the University of Porto, Portugal, and the Universidade Federal do Paraná, Brazil; completed histopathology training at the University of Porto; and obtained a PhD in breast cancer molecular pathology from the Institute of Cancer Research and the Royal Marsden Hospital in London, where he rose to Team Leader and subsequently Professor and Chair of Molecular Pathology. In 2012, he joined Memorial Sloan Kettering Cancer Center in New York, becoming Chief of Experimental Pathology and Director of the Experimental Pathology Fellowship Program in 2016. Author of more than 700 peer-reviewed papers, Dr. Reis-Filho has defined molecular taxonomies for rare tumours, created a predictive classification of breast cancer, elucidated the causes and consequences of intra-tumour genetic heterogeneity, and pioneered technologies ranging from single-cell DNA sequencing of archival tissue to FDA-cleared computational pathology diagnostics. His contributions to the field have been recognised by multiple awards, including the USCAP Ramzi Cotran Young Investigator Award (2010), the CRUK Future Leaders Prize (2010), the Goudie Medal and Lectureship (2023), the BCRF Larry Norton Award (2023), and the MSKCC William Gerald Award (2024). He is also the youngest individual ever elected Fellow of the Royal College of Pathologists by published works. Prior to joining AstraZeneca, Dr. Reis-Filho consulted for Goldman Sachs Merchant Banking and Bain Capital, in addition to serving on the boards of directors and scientific advisory boards for several biotechnology companies, guiding strategy across precision medicine and artificial intelligence.

Brandon leads the Integrative Clinical Data group in Digital R&D, a team of computational scientist, engineers, program managers and analysts focused on using ML/AI to integrate clinical and real-world data for several drug development applications, including drug repurposing, proxy endpoint identification, safety prediction, and simulation of novel mechanism of actions on a target cohort. Prior to joining Sanofi, Brandon worked as a Data Scientist building large language models at a healthcare company in Toronto. He was also a lead Data Scientist developing end-to-end software applications which derived cohort insights to inform combination drug treatments at a biotech company.

Dr. Pratik Shah directs a research program advancing the integration of artificial intelligence, deep learning, and machine learning into medical diagnostics and clinical development. A professor at the University of California, he holds faculty appointments in the departments of Pathology & Laboratory Medicine, Electrical Engineering & Computer Science, and Biomedical Engineering. Dr. Shah's research integrates AI, statistics, engineering, and biomedical science to advance the diagnosis and treatment of cancer, infectious diseases, and neurological disorders. His innovations include AI-powered computational staining for cancer diagnosis, non-invasive diagnostic medical devices, and deep reinforcement learning models for optimizing drug dosages—all aimed at reducing healthcare costs and improving patient outcomes. His work focuses on real-world biological and clinical insights and cost-effective solutions to enhance accessibility, precision, and efficiency in healthcare. Dr. Shah is an expert in the clinical translation of research findings, particularly in real-world deployment platforms designed to provide equitable and affordable healthcare. Research from his lab has been published in Cell Press, Nature Digital Medicine, and Journal of the American Medical Association. A strong advocate for the ethical and regulatory advancement of AI in medicine, Dr. Shah actively contributes to discussions shaping AI policies, ensuring that healthcare AI solutions are fair, transparent, and reliable. His work has influenced industry collaborations and frameworks designed to establish responsible AI practices in clinical settings. He serves as an expert reviewer for national grant panels on emerging technologies and as an advisor on responsible AI adoption and deployment. Previously, Dr. Shah was a Principal Investigator at the Massachusetts Institute of Technology (MIT), where he led a computational medicine research program at the MIT Media Lab. He also served as the principal investigator on a memorandum of understanding with the U.S. FDA to help establish AI and machine learning research ecosystems for clinical development. Dr. Shah holds a BS, MS, and PhD in biological and data sciences and completed fellowship training at Massachusetts General Hospital, the Broad Institute of MIT and Harvard, and Harvard Medical School.

Khushboo Sharma is the CEO of Accumulus Synergy, bringing nearly two decades of leadership in regulatory innovation and policy development. She joined Accumulus in 2022 as Chief Regulatory Innovation Officer, where she led strategic efforts to modernize regulatory frameworks and foster global collaboration. Prior to Accumulus, she held key roles at BIO, the trade association and spent 11 years at the FDA, including as Deputy Director of Operations in the Office of New Drugs in CDER. Her work has shaped major regulatory initiatives, including the New Drugs Modernization effort between FDA and industry. She holds a bachelor’s degree in biotechnology and an MBA in Biotechnology and Healthcare Industry Management from Penn State University.

Cheyenne is a computer scientist by training and a software engineer by practice, having worked for the past ten years developing solutions for internal company usage. Cheyenne has spent the last three years at Biogen, first designing and implementing flexible and robust systems for data ingestion and now leading technical infrastructure design and implementation for the Data Science and Applied Machine Learning team with a focus on maintainability and best practices.

Srivatsan has over thirty years of experience in growing businesses in the Digital, Data, AI, Analytics, IT, Product and Operations management areas across several industry verticals. Currently he is helping companies unlock exponential growth opportunities to scale their businesses by leveraging the power of AI. Previously as Chief Digital Officer for R&DS Technologies, IQVIA he was responsible for driving growth and leading product development and operations of R&DS Technologies. Prior to that, as Chief Growth Officer for EXL he oversaw the Sales & Marketing, Consulting and Strategy functions helping EXL become a Strategic digital transformation partner to its customers. Before that, as Venture partner, he grew Cognizant’s foray into Digital & Platforms. He identified, incubated and grew innovative digitally enabled ventures across the Healthcare & Life Sciences value chain. Early on, He was responsible for growing Cognizant’s Life Sciences business unit to be a Tier one provider. He has worked with the many of the top 50 global Life Sciences organizations providing them comprehensive end-to-end consulting, analytics, business process and IT solutions. He has provided strategic leadership in helping life sciences organizations leverage technology and the global delivery model to effectively transform their businesses. Srivatsan was recognized as the top 100 most inspiring people in the life sciences industry award by PharmaVOICE publication in 2010 and 2021. Srivatsan holds a bachelor's in electrical engineering from B.I.T.S. in India and a master's degree in electrical engineering & computer science from Northwestern University.

Aman Thukral is the Head of Clinical Systems & Digital Operations at AbbVie. He has over twelve years of experience in clinical development, technology planning & business-technology alignment. In his current role, he is responsible for eCOA operations, wearables and sensors, piloting new technology initiatives. Before this position, he had worked in Deloitte, Cognizant & GlaxoSmithKline at various levels.

Milijana Ugrenovic-Petrovic, MPM, LSSGB, is the Senior Director of Clinical Research Operations at Moffitt Cancer Center. She brings 21 years of experience in clinical research, including 4 years at UF Shands, where she focused on movement disorders clinical research before transitioning into oncology operations at Moffitt. Over her 17-year tenure at Moffitt, she progressed through roles as PRMS coordinator, screening coordinator, clinical trial coordinator, and operational manager before assuming her current leadership responsibilities. She provides strategic and operational oversight for a broad portfolio of therapeutic oncology trials, including bone marrow transplant and immune cell therapies, early-phase therapeutics, immunotherapy, thoracic, hematology, gastrointestinal, and sarcoma studies. She designed and implemented Portfolio360, a data-driven dashboard integrating real-time metrics on staff effort, revenue, expenses, and patient accrual to support transparent, data-informed decision making across the clinical research enterprise. She has presented at American Association of Cancer Institutes (AACI) conferences on workload acuity, screening coordination, inpatient trial optimization, and portfolio management. In collaboration with program chairs, faculty, clinical research medical directors, and CTO leadership, she has standardized processes aligned with GCP, FDA requirements, and institutional policy while maintaining patient-centered care. She mentors emerging leaders and fosters a culture of collaborative learning. At Moffitt, she serves on the Feasibility Committee, Cancer Committee, MPACT, and the Enterprise Data Governance Committee, partnering with Data Quality, Business Intelligence, and Data Engineering teams to strengthen governance, stewardship, and security practices. At the national level, she serves as a CancerX Judge, co-chairs the AACI Clinical Research Initiative (CRI) AI Taskforce, and is an active member of the AACI Clinical Research Innovation Consortium (CRIC). She also leads Moffitt’s Clinical Research Automation and Analytics Taskforce, advancing automation and data-integration strategies that elevate clinical research operations. She holds an MPM and Lean Six Sigma Green Belt and is a member of PMI, ACHE, and ASQ.

Eric Váquez Ferrer, PhD is a Global Study Manager with experience across biotech and pharma, leading end-to-end study execution and cross-functional delivery across clinical operations, data and regulatory teams. He focuses on applying AI-enabled tools to improve study planning, oversight, and operational decision-making, helping teams run smarter, more efficient clinical trials.

Henry Wei, MD, is the Head of Development Innovation at Regeneron, focused on accelerating clinical research. Previously, he worked at Google, the White House, Aetna, and McKinsey. He has authored patents on artificial intelligence, real-world data systems, and drug safety. He completed his M.D. and Internal Medicine residency at Cornell, additional informatics training at Stanford and Harvard, and oncology integrative medicine training at Memorial Sloan Kettering Cancer Center. He earned both his graduate & undergraduate degrees at Harvard University and published research on human neuroelectrophysiology and circadian biology. Dr. Wei is adjunct faculty at Weill-Cornell Medicine in Health Policy & Research.

Carrie Williams brings 20 years of experience in healthcare from several vantage points within the industry. Prior to joining McKesson Ventures in 2017, Williams served as vice president of strategy and business development for digital health provider Omada Health, having held roles within McKesson’s strategy and business development team previously, working to advance strategies aimed at innovation within hospital pharmacy and clinical trial patient recruitment. She began her career in drug development, where she managed oncology clinical trials in both large pharmaceutical and biotech settings. Williams holds an MBA from the Haas School of Business at the University of California at Berkeley and an undergraduate degree in biology from the University of Massachusetts Amherst.