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.

M. Khair ElZarrad, Ph.D., M.P.H., is the Director of the Office of Medical Policy (OMP) in FDA’s Center for Drug Evaluation and Research (CDER). He has served as the Deputy Director of OMP since 2017.

As Director of OMP, Dr. ElZarrad leads the development, coordination, and implementation of medical policy programs and strategic initiatives. He works collaboratively with other CDER program areas, FDA centers, and stakeholders on enhancing policies to improve drug development and regulatory review processes.

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.

Timil Patel is a oncologist and an acting clinical team leader in the Division of Oncology 2 at the U.S. Food and Drug Administration. In this role, he leads a team of oncologists and scientists who evaluate drug development programs for thoracic and head and neck cancers, from first-in-human trials to approval. His research focuses on modernizing cancer trials, particularly through decentralized and pragmatic approaches. Dr. Patel serves on the White House Cancer Moonshot's Data and Innovation Task Force and the FDA's Decentralized Trials Guidance Working Group. He completed hematology/oncology fellowship at Yale before joining the FDA.

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.

Eric S. Pittman is the Program Division Director for Bioresearch Monitoring West (BIMO-W) which is part of the Office of Regulatory Affairs’ (ORA) Office of Bioresearch Monitoring Operations (OBIMO) in the Food and Drug Administration (FDA). He is responsible for a group of professional investigators, supervisors, and support staff who work with each of FDAs product centers performing inspections of clinical and non-clinical trials, post-market adverse drug experiences, and risk evaluation and mitigation strategies. In addition to his division, Mr. Pittman is the U.S. Delegate to the Organisation for Economic Cooperation and Development (OECD) Working Party on Good Laboratory Practices.

Mr. Pittman previously led the Division of Human and Animal Food Domestic Operations in ORA Headquarters. Prior to that, he was a supervisory investigator in the Chicago District Office where he won the 2011 ORA Supervisory Investigator of the Year. He has also worked as a field investigator in the Chicago District and the Detroit District offices.

Mr. Pittman studied pharmacy and radiation physics in his undergraduate work at Purdue University. He also holds a Master of Business Administration from Youngstown State University.

Amy Davis is the Associate Vice President leading Lilly’s Clinical Trial Foundations team, which encompasses all of Lilly’s clinical development processes, systems, and community-based research strategy. She is a Pharmacy graduate of Purdue University and practiced Pharmacy prior to joining Lilly. During her over 25 years at Eli Lilly, Amy has held numerous leadership positions that span therapeutic areas supporting clinical and integrated drug development, medical affairs, strategy and operations, and project/portfolio management. In addition to her leadership roles Amy is noted as a Diversity and Inclusion champion. Amy also serves as Lilly’s representative and Executive Committee Representative to Springboard Enterprises.

Sharon Tamir, Leading the DHI team at MT-Pharma. Spearheading initiatives to integrate cutting-edge technologies into MT-Pharma’s clinical development. With a background in program leadership in a broad array of indications and a focus on CNS research, Sharon led the cross-functional product team in developing the strategy and driving the efficient execution of the approved strategy.
March 2019-2024, Sharon served as the Co-Chair and then the Chair of the program committee of ASENT- American Society for Experimental Neurotherapeutics. Currently, she is serving as a board member for ASENT.

Carolina is a graduated pharmacist with 19 years of extensive experience in the pharmaceutical industry, specializing in clinical research. Starting as a Site Monitor, she has progressively advanced to the role of Project Manager, a position held for over a decade. With a robust background in diverse therapeutic areas including oncology, hematology, infectious and inflammatory diseases, as well as rare and blood disorders, she brings a wealth of knowledge and expertise to the table.

A recognized leader in managing Decentralized Clinical Trials, Carolina has successfully navigated the complexities of modern clinical research, ensuring the highest standards of quality and efficiency. Carolina's dedication to advancing medical science and improving patient outcomes has been a driving force throughout her career.

Passionate about innovation and collaboration, she continues to inspire and lead teams towards groundbreaking achievements in the pharmaceutical field.

Shelly Barnes is the UCB Global Innovations Lead . She is accelerating innovative strategies and solutions driving the improvement of the patient experience within the conduct of their clinical trials. Ms Barnes is delivering solutions using novel technologies, transforming from traditional clinical trials to patient preferred clinical trials while maintaining quality, compliance and stakeholder commitments.  Ms Barnes actively represents UCB on several industry consortiums including DTRA, CTTI, TransCelerate and IMI.

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.

Shaalan Beg MD MBA FASCO is a medical oncologist and clinical investigator. He has been working at the intersection of health information technology and clinical research with the goal to make cancer clinical trials more accessible.

Expert in clinical research, pediatrics, pediatric critical care/cardiology and clinical pharmacology with over 10 years of experience. As a Distinguished Professor with Tenure at Duke University and a key member of the Duke Clinical Research Institute, Dr. Hornik specializes in clinical trials, drug development, and clinical pharmacology. His extensive background includes designing and executing clinical trials, including decentralized designs, real-world data analyses, and community-engaged research projects. He is associate director of iCubed, DCRI's Center for Clinical Research Innovation, and co-principal investigator for the new partnership between iCubed and the Biomedical Advanced Research and Development Authority (BARDA) Decentralized Clinical Operations for Healthcare and Research (D-COHRe) program to enhance decentralized clinical trial (DCT) capabilities to address public health emergencies (PHEs).

Justin Gundelach is a Program Manager with Mayo Clinic, currently leading the Operational Enablement team of their "Clinical Trials Beyond Walls" initiative. Justin holds a B.S. in Biology from the University of Minnesota Duluth, and an M.S. in Biochemistry from the Mayo Clinic Graduate School of Biomedical Sciences. During his 20+ years with Mayo Clinic, Justin has led a mix of both laboratory and human subjects research programs in the departments of Surgery, Pediatrics, and Cardiovascular Medicine, as well as facilitated consulting services to help Mayo Clinic's external and international partners grow their research infrastructure. Since 2022, Justin has led an internal consulting team specifically charged with facilitating the adoption of Decentralized Research Methods by study teams across all departments and campuses of the Mayo Clinic enterprise.

2004-2013: IROM Co., Ltd.
2013-2017: Kochi Medical School Hospital, Integrated Center for Advanced Medical Technologies
2018-present: Osaka University Hospital, Department of Future Medical Development, Academic Clinical Research Center

2001-2003 Intern at Kyushu University Hospital
2007-2008 Matsuyama Red Cross Hospital
2009-2012 Kyushu University Hospital (Dept. of Cardiology, Emergency and Critical Care Center)
2012-2013 Research fellow, Kyushu University Graduate School of Medicine
2013-2015 Reviewer of Medical Device, Pharmaceuticals and Medical Device Agency (PMDA)
2015- Center for Clinical and Translational Research, Kyushu University Hospital

Dr. Shinya Yamamoto is serial entrepreneur, social entrepreneur, business owner, investor, startup mentor, and social physicist. He has also been contributing to the biopharmaceutical industry for over 20 years. In addition to business, he has worked as a professor at several universities, engaged in academic and clinical research on technology & innovation management, science for policy, cognitive science, and digital health, creating startup ecosystems, and teaching activities such as MBA program. He has also served as a policy committee member and special researcher for various central government ministries and agencies. He is also the founder and representative of DICT - Design, Innovation, Co-Creation, Technology, a social experiment community for Web 3.0 as DAO (Decentralized Autonomous Organization).

His professional activities are as follows;
- Specially Appointed Professor, Social Entrepreneurship Promotion Lab, Smart-Aging Research Center, Tohoku University
- Guest Professor, Academic Clinical Research Center, Department of Future Medical Development, Osaka University Hospital
- Visiting Professor, Clinical Research, Innovation and Education Center, Tohoku University Hospital (CRIETO)
- Visiting Professor, Professional University of Information and Management for Innovation
- Part-Time Instructor, Global MBA Program, Hosei Business School of Innovation Management
- Expert Supporter, Organization for Advanced Healthcare Innovation
- Scientific Panel, The International Society for Professional Innovation Management

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.

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.

With over 20 years experience in managing clinical trials across Pharma, Biotech, and CRO companies, Andrew brings a wealth of expertise to the forefront of digitally enabled, high-quality clinical trials. A pioneer in the early adoption of decentralized trial methodologies, Andrew is deeply committed to reducing the burdens on both sites and patients, while accelerating the drug development process. His leadership continues to drive innovation in the evolving landscape of clinical research.

Biography coming soon

Dr. Richie is the National Executive Director of Research at Optum. She earned her Masters of Public Health from the University of North Florida and her Doctorate in Health Science from Nova Southeastern University. She started her research career at the Mayo Clinic in Florida where she served for nearly 20 years. She began as a Clinical Research Coordinator with a primary focus in Cerebrovascular Disease. Through a progression of leadership roles Dr. Richie served as the Research Operations Manager for all of research over a 5-year period including basic science, health services research and the clinical trial program. She joined Optum at the end of 2020 tasked with creating and expanding the research program. Overall her role in as National Executive Director at Optum is to build a cohesive network of community based sites through internal and external collaborative relationships.

Kiyoshi Aoyagi is a seasoned executive with over a decade of experience in clinical trial operations, patient recruitment, and business leadership. He began his career at Clinical Trial in 2007 as a Call Center Operator and quickly rose through the ranks to become Executive Director, overseeing multiple departments, including marketing, recruitment, and IT. In 2012, Kiyoshi transitioned to an executive-in-training role at CROee Inc. and later led CROee's expansion into the U.S. market.

In 2017, Kiyoshi founded Buzzreach, a patient recruitment company in Japan. As COO, his focus is on raising awareness about clinical trials and ensuring accurate information reaches potential patients, contributing to both the healthcare industry and society at large. His extensive leadership experience and strategic vision have been pivotal in driving growth and expanding Buzzreach's impact in the clinical trial sector.

Amanda Wagner Gee is an associate director at FasterCures, working on issues related to infrastructure and workforce to support clinical research closer to communities and co-leading the ENRICH-CT coalition. Her expertise is in areas related to clinical and preclinical research design and conduct. Prior to joining FasterCures, she worked at the National Academies on the Forum for Drug Discovery, Development, and Translation on projects related to the clinical trials enterprise, diversity and inclusion in clinical research, real-world data and real-world evidence, prevalent chronic diseases, reproducibility in biomedical research, and patient- and participant-engagement. She began her career as a research scientist working on drug discovery at the Harvard Stem Cell Institute and the National Center for Advancing Translational Sciences at the NIH. She received her master’s degree in cell biology from Duke University.

Bio Coming Soon