Dr. Kalali is a physician-scientist, recognized globally as a leading innovator at the intersection of life sciences and technology, and a convener of collaborative high-impact forums. He is a board director of both private and publicly traded companies, and advises companies in the life sciences and technology sectors, universities, and investment groups. Dr. Kalali is the Co-Chair of the Decentralized Trials and Research Alliance (DTRA), Chairman and Chief Curator of the CNS Summit, a forum focused on the future of life sciences, and was the Founding Chairman, and sits on the Executive Committee of the International Society for CNS Drug Development (ISCDD), one of the first independent non-profits to bring together leaders in drug development to collaborate. He is a Professor of Psychiatry at the University of California San Diego, Editor of the journal Innovations in Clinical Neuroscience, and the Lead Editor of the book Essential CNS Drug Development., published by Cambridge University Press. He has authored over 250 peer-reviewed publications, and numerous book chapters. He has been involved in initiatives by the Institute of Medicine, as well as the NIH FAST and the NIH NCATS programs. Previously, for almost 20 years, he was the Global Head of the Neuroscience Center of Excellence at Quintiles, now known as IQVIA. In this role, he led the enterprise-wide strategy for neuroscience, encompassing drug development and health care services. He was responsible for numerous successful drug development programs that have led to dozens of approved new treatments for patients. Dr. Kalali regularly speaks at national and international scientific meetings on topics including leadership, drug development, clinical trials, innovation, technology, digital medicine, biohacking, and health.

Meghana Chalasani is the Associate Director for Clinical Trial Innovation in the Office of New Drugs (OND) in U.S. FDA’s Center for Drug Evaluation and Research (CDER). She is the program manager for the CDER Center for Clinical Trial Innovation and also co-leads the New Drugs Regulatory Program’s Advisory Committee workstream, a modernization effort to enhance CDER’s advisory committees. Previously, Meghana led OND's Advisory Committee Team and Science Strategies program, and worked closely on CDER’s Patient-Focused Drug Development program. Meghana holds a master’s in Health Policy and Management from Columbia University and a bachelor’s in Medicine, Health and Society from Vanderbilt University.

Anindita (Annie) Saha is an Assistant Director for the Digital Health Center of Excellence (DHCoE) at the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH). Ms. Saha is leading the development of partnerships, regulatory science, international collaborations, and operations for the DHCoE to empower digital health stakeholders in advancing healthcare and equity. She is working to advance the use of patient-generated health data, using digital health technologies (DHTs) in trials, and how to manage bias in DHTs and improve transparency. Additionally, Annie helped incubate and continues to support CDRH’s patient science and engagement efforts to advance the science and adoption of patient input as evidence, including patient preference information (PPI), clinical outcome assessments (COAs). Previously, Annie was the Director of Partnerships to Advance Innovation and Regulatory Science (PAIRS) where she oversaw a broad program portfolio, supporting a number of strategic partnership and regulatory science programs for CDRH. This included relationships with the Medical Device Innovation Consortium and other public-private partnerships, Network of Experts, Critical Path, and technology transfer. Ms. Saha began her FDA career as a researcher in the CDRH’s Office of Science and Engineering Laboratories in the Division of Imaging and Applied Mathematics in the area of imaging display technologies. Ms. Saha has a Bachelor of Science in Bioengineering and Minor in History from the University of Pittsburgh. She was a student researcher at the McGowan Institute for Regenerative Medicine working in tissue engineering and wound healing.

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As a Clinical Innovation and Digital Solutions Lead at UCB, Shelly leads initiatives that integrate novel digital solutions with forward-thinking study execution models. Her work focuses on reimagining how trials are designed and delivered, bridging operational excellence with innovation to drive measurable impact across patient engagement, data quality, and regulatory alignment. With a cross-functional lens, Shelly champions scalable solutions that not only modernize clinical research but also enable sustainable change across global development programs.

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Becky Kottschade is a clinical research administrator with more than 20 years experience in the field. Driven by her commitment to Mayo Clinic's primary value, the needs of the patient come first, Becky takes pride in leading the effort of defining best practice in how to successfully implement decentralized clinical trial capabilities from concept to large scale adoption. In her role as research administrator, she is focused on providing streamlined solutions and associated best practices for both people, process and technology improvements that allow researchers and study teams to provide the best care for patients on trial. In addition to her primary functions as an administrator, Becky has been recognized for her extraordinary commitment to relationship building, solutions-oriented excellence in customer service and leading teams through transformational changes at Mayo Clinic.

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Clinical Research Innovator, Leader and Mentor with over 30 years of experience in creating new solutions and adding value to clinical programs. Current member of Healthcare Businesswomen's Association (HBA), and Decentralized Trials Research Alliance (DTRA). Deputy Director of Midwest Mentoring Program for HBA and Co-Lead for Crowdsourcing Evidence and Roles & Responsibilities workstreams for DTRA. PharmaVoice 100 award recipient and HBA Luminary award recipient. Passionate about developing meaningful and authentic relationships with all stakeholders in the clinical trial process. Responsible for study optimization, including site and patient engagement strategies as well as global feasibility in order to deliver predictable timelines and deliverables. Driven to find new and better solutions that drive efficiencies and offer opportunities to improve the clinical research process.

Ms. Redeker is a graduate from Central Michigan University and holds a bachelor’s degree in business administration with a double major in finance and management.

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With a background in information systems and clinical research experience spanning over 18 years, I enjoy working to build and implement solutions for this exciting and challenging industry. I invented RealTime-CTMS to solve many of the daily challenges that face clinical research sites, and my team is working on many innovative software solutions that will continue to create efficiencies for sites and the entities that interface with them. Additionally, my team at ImageBloom is advancing patient recruitment with innovative methods that deliver superior results. There is an exciting future ahead for the clinical research industry as technology will soon accelerate the evolution of methods that streamline data processing and communication between sites, CROs, Sponsors, IRBs and other important vendors. Collaboration and standardization will be the keys to our mutual success in this endeavor.

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