Speakers
DTRA 2025 Annual Meeting speakers included top executives, leading visionaries, clinical trial operations leaders, regulators, investors and more.
DTRA 2025 Hosts



Amir Kalali, MD
Co Founder, Co Chair, DTRA
Bio
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.
Craig Lipset
Co Founder, Co Chair, DTRA
Bio
Craig Lipset is the Co-Chair for the Decentralized Trials & Research Alliance (DTRA), the leading non-profit organization dedicated to the global adoption of decentralized research. Craig previously served as Head of Clinical Innovation at Pfizer, on the founding Operations Committee for TransCelerate Biopharma, and on the founding management teams for two successful startup ventures (Perceptive Informatics and Adnexus Therapeutics). In addition to DTRA, Craig serves on the Board of Directors for the Foundation for Sarcoidosis Research, on the Editorial Board for Therapeutic Innovation & Regulatory Science, and as an advisor for pharma, universities, investors and others seeking to identify and scale new solutions for medicine development. Craig is an Adjunct Assistant Professor in Health Informatics at Rutgers University, and an Adjunct Instructor at the University of Rochester Center for Health + Technology.
Jane Myles
Program Director, DTRA
Bio
Jane has focused on improving clinical trials and patient experience for more than 25 years. Her passion is driving innovation into the trial design and execution to get medicines to patients faster. Currently she is the Program Director at the Decentralized Trials & Research Alliance. She worked at Roche / Genentech for 17 years in many roles, including operational program manager for hematology ultimately working on driving patient facing technology into global trials. In prior lives she held various roles in DCT optimization at LabCorp, and ran global trials at Lilly and Sanofi. She’s a Canuck who loves San Francisco and the ocean.
DTRA 2025 Speakers
Junko Sato
Office Director, Office of International Cooperation (PMDA)
Bio

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Cynthia Grossman
Division Director for Patient-Centered Development at (CDRH), FDA
Bio
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.
Kevin Bugin, Ph.D
Head of Global Regulatory Policy and Intelligence, Amgen
Bio
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James Donohue
Senior Digital Health Lead, Genentech
Bio
Bio Coming Soon
Suna Avcil, MD
Associate Vice President and Head of Digital Medicines, Amgen
Bio
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
Senior Director-CTF Community Based Research, Lilly
Bio
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.
Jeremy Price
Senior Director Clinical Innovation & Strategic Solutions, Head of Decentralized Clinical Trials, Pfizer
Bio


Liz Quinlan
Director, Adaptive Clinical Trial Technology, CSL Behring
Bio
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
Senior Manager, Digital Medicine, Amgen
Bio
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.

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Lauren Tobe
Director Regulatory Policy & Strategy, Eli Lilly and Company
Bio
Katrin Ong
Senior Principal Capability Manager, Boeringer Ingelheim
Bio

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Shelly Barnes
Clinical Innovation, UCB
Bio
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 Kalamegaham
Head, US Regulatory Policy, Genentech
Bio
Bio coming soon


Jean Sposaro
Director, Industry Collaborations, Bristol Myers Squibb
Bio
Bio coming soon
Anthony Costello
CEO, Medidata
Bio

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Josh Schimmer
Managing Director and Senior Biotechnology Research Analyst, Cantor Fitzgerald
Bio
Dr. Molly Klote
President & CEO, Klote Medical Research Advisors, Previous OHRP & VA
Bio
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Rob Goodwin
Chief Operating Officer, Parexel
Bio
Rob has over 30 years of industry experience in clinical operations, safety and regulatory. Most recently, he was Senior Vice President of Clinical Development and Operations at Pfizer, where he was responsible for establishing, maintaining, and overseeing the global clinical development and operational capabilities required to develop Phase I through Phase IV study protocols and plans, execute clinical trials and deliver post marketing studies to support the introduction of new therapies for patients.
In 2021, Rob was recognized by PharmaVoice magazine as one of the top 100 most influential leaders in healthcare.
Rob earned a Master of Business Administration in Pharmaceutical and Chemical Studies from Fairleigh Dickinson University, a Master of Science in Research, Measurement and Evaluation from Southern Connecticut State University and a Bachelor of Science in Psychology from Eastern Connecticut State University.
Chris Regan
Managing Director, Pharma, MedTech & Health Solutions, Microsoft
Bio
Bio coming soon


Alexandra Berk
VP, RWE, Oracle Health and Life Sciences
Bio
With over 20 years of experience in clinical and observational research, Alexa started her career in academia (Memorial Sloan Kettering Cancer Center) and pharma (Novartis). Alexa blends subject matter expertise and business acumen, drawing from her career progression from designing and conducting research studies to leading scientific teams, to an executive owning life sciences services P&Ls at two Fortune 100 companies.
In addition to leadership roles at large companies, Alexa has experience in building digital health and data businesses from the ground up. She was an early employee at Ciitizen (now Citizen Health), leading Ciitizen's go to market as a RWE platform for life sciences and was instrumental in driving their transformation from a Series A start-up to a $550M acquisition by medical genomics company Invitae in 2021. After the acquisition, Alexa took on a broader role at Invitae as the Medical Director for Digital Health and Data.
Immediately prior to joining Oracle Life Sciences, Alexa led Life Sciences Solutions at CVS Health as Associate Vice President and General Manager, after initially joining CVS Health as Chief Scientific Officer for RWE in CVS Clinical Trial Services in 2022. Alexa was promoted after just one year at CVS into the role of GM to re-establish and build out CVS' Life Sciences Solutions following the closure of Clinical Trial Services. Alexa's leadership rebuilt CVS Life Sciences Solutions from a full shutdown to a thriving organization which met its revenue goals in its first year after relaunching.
Alexa is a globally respected thought leader and professional speaker, frequently presenting on topics around RWD/RWE, health AI, and innovative, patient-centric, and equitable design in clinical trials. She has co-authored numerous manuscripts and abstracts in the scientific literature, with a focus on oncology and rare diseases and best practices in research methods. She is a graduate of Barnard College and the New School for Social Research.
Jeff Huntsman
Chief Commercial Officer, EmVenio Research
Bio


Richie Pfeiffer
Senior Director, Patient First Digital Solutions, PPD, part of Thermo Fisher Scientific
Bio
Kristen Andrews
Head, Research Site Enablement
Bio
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.


Matt Veatch
President & COO, Navidence
Bio
Rebecca Kottschade
Director, Research Operations, Mayo Clinic
Bio
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.


Jennifer Miller
Profession & Co Director, Yale Program for Biomedical Ethics
Bio
Lora Black
Vice President - Clinical Research, Sanford Health
Bio

Justin Gundelach
Program Manager - Clinical Trials Beyond Walls, Mayo Clinic
Bio


Petros Okubagzi, MD
Vice President, Clinical and Translational Research, Medstar Health
Bio
Kassandra Remmel
Manager, Clinical Research, Sanford Health
Bio
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.


Manu Aggarwal
Partner, Industry Solutions, Everest Group
Bio
Ali Holland
Chief Customer Officer, Medable
Bio
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Don Harder
Head of Trial Solution Design, Care Access
Bio
Currently at Care Access, Don helps bridge the gap between client challenges and real-world solutions, ensuring that innovation doesn’t get lost in translation. He’s known for his ability to navigate complex ideas, find creative solutions to common problems, and—when the moment calls for it—crack a well-timed joke that diffuses even the most stressful situation.
Outside of work, Don can usually be found in the "mountains" of Indiana pedaling his mountain bike, or trying to keep up with his adult kids very involved lives.
Trupen Modi
Sr. Principle Director of Customer Transformation, Healthcare
Bio


Donna Hanson
Vice President, Strategy & Optimization
Bio
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
Chief Strategy Officer, Advanced Clinical
Bio
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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Erica Jacobsen
Senior Director, Qualitative Team Lead, Konovo
Bio
Bio coming soon
Alexa Richie, DHSc
National Executive Director, Research, Optum
Bio

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Rick Greenfield
Founder and CSO, Real-Time eClinical Solutions
Bio
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.
Michelle Shogren
CEO, Innovate In What You Do! LLC
Bio
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.

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Angela Radcliffe
Founder & CEO, How Mighty We Ventures
Bio
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.
Joe Dustin
Founder, Dauntless eClinical Strategies
Bio

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