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.

Cynthia (Cyndi) Grossman, PhD is Director of the Division of Patient-Centered Development at Center for Devices and Radiological Health at the US Food and Drug Administration. She is the former Head, Real-World Research Networks, Biogen Digital Health. Prior to Biogen, Dr. Grossman was Director, Science of Patient Input at Milken Institute’s FasterCures where she developed and led programs to advance patient-centered biomedical research and health care delivery. Cyndi is an experienced leader across industry, government, non-profit and academia, and is passionate about advancing better health outcomes for all through data and bringing the lived experience of patients into decision-making. She earned her doctoral degree in clinical psychology from the University of Vermont, trained at Brown University and has received multiple awards including Phi Beta Kappa and grants from NIH and PCORI.

Suna leads the Digital Medicine organization with an enhanced focus on digitally enabled decentralized clinical trials. She also drives the integration of decentralized elements and digital health technologies into planned clinical trials.​

Suna joined Amgen in 2018 and has held numerous leadership roles, including Country Medical Director for Amgen Turkey, Executive Medical Director for Canada, Scientific Communications Executive Director, Global Medical Platform Lead for Cardiology, and interim Therapeutic Area Head for Global Medical General Medicine. Most recently, Suna led the strategic planning and execution of digitally enabled trials as Executive Director, Digital Medicine.​

Prior to joining Amgen, Suna worked for Eli Lilly, where she held various positions in marketing, human resources, and medical management functions between 2002 and 2018. She held both affiliate and regional senior leadership roles with geographical responsibilities across Turkey, the Middle East, Africa, Asia, India, Russia, Israel, and Europe.​

Suna received her medical doctor degree from Hacettepe University in Turkey.

Brittany Niland is the Senior Director of Clinical Trial Foundations – Community-Based Research at Eli Lilly and Company, where she leads global strategy and implementation for community-based clinical research. With over 15 years of experience in oncology clinical development, she has a strong track record of driving innovation, advancing trial diversity, and delivering high-impact results across late-phase oncology programs. Her career began at Indiana University Simon Cancer Center, where she discovered her passion for clinical research. Since joining Lilly in 2016, she has held key roles in project and program management, clinical trial leadership, and diversity, equity, and inclusion strategy. Recognized for her cross-functional leadership and strategic vision, she has successfully managed global study teams, overseen trial operations across multiple CROs, and played a pivotal role in integrating acquired assets into Lilly’s portfolio. Brittany holds a Bachelor of Science in Medical Imaging Technology and an Associate of Science in Radiography from Indiana University. Outside of work, Brittany enjoys spending time with her 4-year-old daughter, running, and cheering on all the Indy sports teams.

Liz has been working within the pharmaceutical industry for close to 15 years and has spent about 10 of those years within the technical space of the industry. She started in clinical trial supply, spending time in Production, Logistics and Project Management. From there she transitioned to Project Management and Team Oversight for an eCOA solutions provider. This provided a good foundation for her move to CSL Behring, where over the last 6 years she has established a team, processes, and support for the use of adaptive clinical trial technologies within R&D. This team now supports oversight for use solutions like eCOA, eConsent, IRT, wearables, medical devices, etc. Liz loves learning how these solutions can be used to best benefit the sites and subjects who are so critical to the success of a trial.

Patrick Lee is a Senior Manager for the Digital Medicine team at Amgen, where he brings his DCT experience to build and scale Amgen's DCT capabilities. Prior to his current role, Patrick worked in various leadership positions within Amgen's Clinical Program Operations team, driving innovative protocol design for Inflammation and Oncology programs, designing a new data and insights-driven feasibility process, and helping to build a new patient recruitment and retention function - the Enrollment Lab.

Patrick's clinical research career began in 2017 as a Clinical Research Coordinator at Science 37, where he worked on the company's first fully DCT study with AOBiome. During his time at Science 37, Patrick helped to set up data management processes, served as a clinical SME to develop the company's NORA platform, and led several fully virtual and hybrid studies as a Clinical Project Manager. After his tenure at Science 37, Patrick joined the newly-formed Lightship in 2020 as the company's first Clinical Project Manager, overseeing the company's first DCT study with Verily and Pfizer and helping to build the Clinical Operations team.

Patrick earned his Bachelor's degree in Molecular and Cell Biology - Neurobiology from the University of California, Berkeley, and his Ph.D. in Molecular and Medical Pharmacology from the David Geffen School of Medicine at UCLA, where his research focused on autologous cellular replacement therapies using CRISPR-modified human induced pluripotent stem cells to treat rare diseases. He has had 10 years of basic science experience - starting off his career in 2009 in the Microbial Pathogenesis department at Genentech and beginning his stem cell training at Stanford University's Institute of Stem Cell Biology and Regenerative Medicine.

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.

Rasika Kalamegham, Ph.D, is Executive Director and Head of U.S. Regulatory Policy at Genentech, a member of the Roche Group. She joined Genentech in 2015 bringing considerable, scientific, regulatory and policy experience to her role. Rasika’s focus has been advancing regulatory frameworks to keep pace with emerging scientific knowledge. She has
recently focused on influencing FDA’s regulation of digital health – using AI/ML, digital,  decentralized clinical trials (DCTs) and other technology enabled approaches to improve drug development. She plays an active leadership role in many groups including BIO, where she chairs the AI workgroup;PhRMA;Real World Data Alliance, and chairs the Regulatory Forum at the Decentralized Trials and  Research Alliance.

A geneticist by training, she studied cell-fate specification during her post-doctoral work at the NIH. She then worked in increasingly senior positions at Friends of Cancer Research (FoCR), The
Pew Charitable Trusts and The American Association for Cancer Research (AACR) before joining Genentech.

Her work has led to important policy outcomes via passage of several laws including the Generating Antibiotics Incentives Now or GAIN Act (signed into law by President Barack Obama), Research to Accelerate Cures and Equity (RACE) for Children Act (signed into law by President Donald Trump), the Cancer Moonshot Initiative (spearheaded by President Joseph Biden) and others. Her work has also led to issuance of FDA guidances (Codevelopment of Two
or More New Investigational Drugs for Use in Combination, Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics etc.).

She is a sought-after expert speaker, widely published in peer-reviewed journals and author of several text book chapters.

Based in Washington, DC, she is always willing to chat about policy, dogs or baking.

Bio coming soon

With a career spanning over 37 years, Chris Regan has established himself as a key leader in strategy and innovation for Health and Life Sciences. As the Managing Director Pharma and MedTech in Microsoft’s Health and Life Sciences Industry Group. Chris's began his journey as a researcher, laying a foundation that seamlessly combined scientific rigor with innovative technical solutions.

Chris's deep-seated expertise stems from years of leadership roles where he has designed, innovated, and digitally enabled a myriad of industries ranging from Health and Life Sciences to Retail, Financial Services, and the Public Sector. His rich tapestry of experiences includes designing groundbreaking programs for diverse Healthcare and Life Science entities, reflecting a blend of scientific, technical, and industry-specific acumen. Over the past 22 years, Chris has been an integral part of the Microsoft family. For the last 14 of those years, he has been at the forefront of leading AI and Digital Strategy and Innovation teams, ushering in an era of Digital and AI revolution.

Recent Publications:
• Health Law: An Examination of Regulatory Frameworks Governing Protected Health Data in the EU and Germany and Their Influence on Health Outcomes (2024)
• Health Information Management Systems, Virtual Health in Patient Care and Clinical Research (Springer, 2022)
• Health Innovation Patterns and Practices (CRC, 2019)
• Digital Health Transformation Maturity Models (2019)
• Blockchain in Healthcare (2017 with update 2019)
• Pharma Factory of The Future (IFPAC, 2020)
• AIs Impact on Healthcare Delivery (2017)
• Digitizing Healthcare (2017)

Kristen Andrews, Head of Research Site Enablement at Labcorp, has over 25 years of experience in the clinical trials industry. Starting as a clinical research coordinator, her career has progressed through increasing levels of responsibility and leadership first at research sites and then in site relationship and decentralized clinical trial programs at CROs. She is a passionate advocate for patients, investigators and sites and is dedicated to advancing relationships between industry partners. Kristen holds a BA from Northwestern University and maintains CCRC certification through ACRP.

Becky Kottschade is an experienced clinical research administrator with more than 20 years of 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.

Kassandra Remmel serves as the Clinical Research Manager of Oncology for the Sanford North Region and as the NCORP Administrator for Sanford Enterprise. Since joining NCORP leadership in 2023, she has played a key role in expanding access to clinical trials across rural communities, driven by her passion for ensuring equitable participation in cancer research. Kassandra also serves as Co-Chair of the Alliance Rural Health Subcommittee and as an Alliance Auditor, where she supports quality oversight and collaboration across member sites. She has been instrumental in advancing telemedicine-based oncology research and is currently working with Sanford’s Decentralized Clinical Trial Navigator to broaden trial accessibility for rural patients. Through her leadership, Kassandra continues to champion innovation, efficiency, and inclusivity in clinical research operations across the Sanford network.

Donna Hanson is a distinguished clinical research executive and thought leader with over two decades of global experience in strategic feasibility, trial optimization, and patient engagement. As Vice President of Strategy & Optimization at Advanced Clinical, Donna leads transformative initiatives that shape the future of clinical development, driving innovation, operational excellence, and inclusive trial design. Her expertise spans protocol simulation and optimization, country and site strategy, patient recruitment and retention, and diversity planning—ensuring trials are not only efficient but also equitable and patient-centered. She is a passionate advocate for mentorship and leadership development and moving the clinical research industry forward underpinned by ensuring sites, patients and caregivers are kept at the forefront of all.

Caroline Redeker is a clinical research innovator and leader with over 30 years of experience in creating new solutions and adding value to clinical development plans and programs. She spends much of her time creating value for customers, often building customized solutions in preferred provider or functional service provider models. She has been responsible for driving strategic corporate plans, including global expansion, creating new service offerings and building corporate efficiencies for Advanced Clinical. Prior to joining Advanced Clinical, Ms. Redeker worked within multiple contract research organizations, a site management organization and one of the first professional independent research sites. In the past two decades, she has led and grown multiple business development and marketing teams and managed key strategic client relationships. Caroline is a PharmaVoice 100 award recipient and HBA Luminary award recipient. She is passionate about developing meaningful and authentic relationships with all stakeholders in the clinical trial process and is 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.

Erica Coles Jacobsen is the Executive Director of Integrated Insights and Qualitative Innovation at Konovo (formerly InCrowd), where she leads strategic research initiatives that shape commercialization, market access, and product strategy for life sciences clients. With 20+ years of experience turning insights into growth across Pharma, FinTech, and private equity-backed ventures, Erica brings deep expertise in customer strategy, executive advisory, and high-performing team leadership. A Dartmouth College graduate with an MBA from the University of Virginia’s Darden School, she previously spent 17 years at C Space guiding customer-centric strategy for global brands. Outside of work, Erica serves as Chair of the Town of Newbury Finance Committee and enjoys life in coastal Massachusetts with her husband Todd, their two children, Cole and Annie, and their beloved doodles, Laney and Noodle.

With a background in information systems and clinical research experience spanning over 20 years, Rick has enjoy working to build and implement solutions for this exciting and challenging industry. He invented RealTime-CTMS to solve many of the daily challenges that face clinical research sites, and his team is working on many innovative software solutions that will continue to create efficiencies for sites and the entities that interface with them. 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.

With over 25 years in Clinical Research, Michelle Shogren has seen the clinical trial journey from every angle—patient, caregiver, site, CRO, and pharma. As CEO of Innovate In What You Do! LLC, she brings these perspectives together to help organizations design and deliver studies that truly work for their users.

Michelle specializes in bridging the gap from innovation to adoption through user-voice, strategy, human-centered design, and change management. As the industry embraces flexible, device-enabled, and community-based trials, her insights help sponsors, CROs, and sites adapt with purpose and impact.

Outside of her passion for adrenaline sports, Michelle is driven by one mission: transforming how we listen to and respond to the voices of patients, sites, and study teams.

Angela Radcliffe is a best-selling author, speaker, and advocate for teaching health, data and Al literacy. Drawing on 20+ years of experience centered around healthcare innovation, Angela combines deep Al healthcare expertise with authentic storytelling to engage diverse audiences and empower children and teens to succeed in a data-centric world. Driven by the preventable loss of her 21-year-old brother to an undiagnosed heart condition, Angela champions health literacy while navigating the complexities of raising three children across different technological generations, including a neurodivergent learner. This unique intersection of personal tragedy and parenting challenges and her journey from poverty to escaping domestic violence fuels her mission to advance health, data, and Al literacy for the next generation.