Speakers 2026

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.

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.

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.

Bio

CAPT Dianne Paraoan, US Public Health Service, is the Director for the Office of Medical Policy (OMP) at FDA’s Center for Drug Evaluation and Research (CDER), where she provides Center oversight and leadership in the development of medical policy and procedures, and policy initiatives pertaining to drug development and clinical trial modernization, use of innovative technologies, patient labeling, and drug promotion and advertising. In OMP, CAPT Paraoan has advanced the use of emerging technologies in drug development and led efforts to promote the appropriate use of real-world evidence to inform regulatory decision-making. Over the past 20 years, in addition to her contributions to OMP, CAPT Paraoan has supported FDA/CDER’s mission in several roles in the Office of Executive Programs and Office of New Drugs. Prior to her career at the FDA, CAPT Paraoan served in the U.S. Army Nurse Corps. CAPT Paraoan holds a Master of Public Health and a Bachelor of Science in Nursing.

Bio

Steffen Thirstrup is a medical doctor and board-certified specialist in clinical pharmacology and therapeutics. He holds a PhD in pharmacology and has a long background in clinical internal medicine with special emphasis on adult respiratory medicine. Additionally, Dr. Thirstrup was appointed adjunct professor in pharmacotherapy at the Faculty of Health Sciences, University of Copenhagen, in 2012.

From 2004-09 Steffen Thirstrup worked at Danish Medicines Agency first as the Danish member of CHMP at the European Medicines Agency (EMA) for five years including 10 months as joint CHMP- and CAT-member, followed by a short period as head of Danish Institute for Rational Pharmacotherapy dealing with HTA and best practice guidelines for primary care. In 2011 Prof. Thirstrup rejoined the licensing division at the Danish Medicines Agency acting as Head of Division for Medicines Assessment and Clinical Trials. During this period Prof Thirstrup co-chaired the European Commission’s working group on market access for biosimilars medicinal products and acted as key scientific contact for the managing entity of the IMI beneficiaries for the PROTECT collaboration (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium).

In March 2013, Prof Thirstrup joined the pharmaceutical consultancy company NDA Group AB as a full-time medical advisor on NDA’s regulatory advisory board. In April 2014 Prof Thirstrup was appointed as director for the Regulatory Advisory Board at NDA Regulatory Services Ltd.

Since June 2022 Prof Thirstrup has been the Chief Medical Officer at the European Medicines Agency, Amsterdam, The Netherlands

Prof Thirstrup is author of more than 30 scientific papers, guidelines and text-book chapters as well as co-editor of 5th edition of Basal og Klinisk Farmakologi (Medical school pharmacology textbook in Danish).

Prof Thirstrup shares his life between Amsterdam and with his family in a small community (Værløse) just outside Copenhagen, Denmark

Bio

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

Ryan E. Ferguson, ScD, MPH, is a nationally recognized clinical trials leader who bridges rigorous research and everyday healthcare through pragmatic embedded trial methodologies. He serves as Acting Director of the VA Cooperative Studies Program (CSP) and Director of the VA CSP Coordinating Center in Boston, where he advances the design and delivery of large, multicenter studies in real-world healthcare settings. Since joining CSP in 2001, Dr. Ferguson has helped shape randomized trials that integrate research into routine care, align study procedures with clinical workflows, and generate timely, actionable evidence for patients, clinicians, and health-system leaders. As a Principal Investigator for the VA’s Point of Care Research Program, he leads innovation in pragmatic embedded clinical trials and translational science. His research also spans clinical trial methodology and the epidemiology of acute kidney injury and chronic kidney disease. Dr. Ferguson is a faculty member in the Department of General Internal Medicine at Boston University Chobanian & Avedisian School of Medicine.

Bio

Belén Fraile MD, MSc, MBA is Chief Data & AI Officer and Senior Vice President,Data Science for Johnson & Johnson. She leads the data science and AIorganization for R&D and is responsible for the end-to-end data, data science andAI strategy across the pipeline, from discovery through clinical development. Sheserves on the Innovative Medicine R&D Senior Leadership Team.She co-chairs the Innovative Medicine R&D technology governance council,which sets the group's data, AI and technology priorities, and oversees thecoordination of R&D and Johnson & Johnson Technology investment ininfrastructure, AI and reusable capabilities, including generative AI and agenticautomation. She co-chairs the Johnson & Johnson Enterprise AI Council andleads Disruptive Technology Risk Management for the enterprise.Belén is a physician and Fulbright Scholar with experience spanning pharma,medtech, and clinical care. She previously held leadership roles at Philips,Moderna, and Novartis, building data science and AI capabilities from the groundup. Earlier in her career, she led Population Health and Enterprise Analytics atDana-Farber Cancer Institute and practiced as an OB/GYN in Madrid, shapingher patient- and clinician-centered approach. She holds an MD from ComplutenseUniversity of Madrid, an MSc from the Harvard T.H. Chan School of Public Healthand an MBA from MIT, and is a guest lecturer at Harvard University.

Bio

Dr. Tala H. Fakhouri, PhD, MPH is currently the Chief AI & Regulatory Strategy Officer at Parexel.
Tala is the former Associate Director for Data Science & AI Policy at FDA/CDER, where she led policy tracks for AI and RWE including authoring FDA’s first AI and RWE guidance documents, co-chaired the CDER AI Council, and helped shape global regulatory frameworks for AI, digital health technologies and real-world evidence.
Prior to FDA, Tala held leadership roles at CDC including Chief Statistician for CDC’s flagship health study NHANES, and served on the Federal Committee for Statistical Methodology.

Bio

Jeremy Price is Head of Clinical Trial Capability Advancement at Pfizer, where he leads the Clinical Trial Concierge and a global team focused on identifying promising innovations and helping scale them to expand access to clinical trials and accelerate study execution. He previously founded and led Pfizer's Decentralized Clinical Trial Community of Practice and established Centers of Excellence for Business Adoption & Change Management and Project Management. Earlier in his Pfizer career, he led digital transformation initiatives across Global Product Development and R&D. Prior to Pfizer, Jeremy spent a decade in management consulting. Jeremy holds a BA from the University of Rochester, an MBA from UNC-Chapel Hill, and is a Fulbright Scholar.

Bio

With 15+ years of social content and digital media experience across the biopharma and lifestyle industries, Emily is currently the Director of Clinical Trials Advertising & Social Media at Pfizer.

Pairing creative production with media strategy, Emily leads brand content marketing campaigns that deliver measurable, data-driven business results.

Prior to this role, she held several roles at Pfizer and Scripps Networks Interactive (Food Network, HGTV, etc.), including leading Pfizer’s corporate channel digital video efforts.

Emily currently resides in Brooklyn, New York.

Bio

Patrick Lee, PhD is an Associate Director in Amgen's Digital Medicine team and is part of the efforts to build and scale Amgen's DCT capabilities, as well as supporting medical and product teams with strategic implementation of digital and decentralized modalities to facilitate faster evidence generation. He has spent the last 10 years in the decentralized clinical trials (DCT) space

he started at Science 37 as a coordinator on the company's first completed DCT study and eventually managed multiple DCT studies and served as a SME for the company's platform build. He later joined Lightship as the company's first project manager, helping to build the clinical operations team and delivering the company's first study. He is always looking to bring both his past experience in clinical operations, product development, and external relationships to enhance Amgen's digital and DCT capabilities.

Patrick also spent a decade behind the bench as a stem cell biologist, beginning his training in autologous cellular therapies at Stanford University's Institute of Stem Cell Biology and Regenerative Medicine. Patrick completed his Bachelor's degree in Neurobiology from the University of California, Berkeley and completed his Ph.D. with the Department of Molecular and Medical Pharmacology at the David Geffen School of Medicine at UCLA.

Bio

Katrin Ong graduated from the University of Würzburg and began her career as a Graduate Psychologist in a children’s foster home. After four years, she transitioned into clinical research, first as a project manager for a medical technology vendor, then joining Boehringer Ingelheim as Senior Project Lead in Digital Trials. In this role, she served as the global point of contact for trial teams across therapeutic areas, enabling successful implementation of eCOA and digital devices in clinical trials. This experience naturally led to her current position as Senior Principal Capability Manager in the Patient & Site Engagement Capabilities team, where she drives DCT enablement—covering strategy, technology, and services.

Bio

Derk Arts, MD, PhD, is a physician, researcher and the founder and CEO of Castor. He has worked on AI in medicine since 2012 and has been at the forefront of meaningful and safe AI adoption in clinical research. He sees AI's potential to take manual work out of research and widen access, and he is equally clear about the risks. His position is that AI belongs in clinical research only with validation, transparency and human oversight.

Bio

Anindita (Annie) Saha is Global Medical Device and Life Sciences Policy Director at Oracle. Annie focuses on global regulatory policy and intelligence for Oracle’s medical device, AI, and life sciences work. She was previously at the US Food and Drug Administration for over 20 years at the intersection of digital health, policy, and partnerships. Most recently, Annie was Director of the Digital Health Outreach Division at the Digital Health Center of Excellence (DHCoE) in the Center for Devices and Radiological Health where she supported promoting innovation of digital health technologies, including those enabled by artificial intelligence. She also served as the acting Associate Director for Data Science and Artificial Intelligence Policy at the FDA Center for Drug Evaluation and Research to support the use of AI across the drug development lifecycle. Additionally, Annie helped incubate and support advancing the science and adoption of patient input as evidence, including patient preference information (PPI), clinical outcome assessments (COAs). She has a Bachelor’s of Science in Bioengineering and a Minor in History from the University of Pittsburgh.

Bio

Diego has 20 years of Clinical Research Experience. Passionate for the advancement of Clinical Research through scientific innovation and technology to improve patients' lives.
Detailed-oriented and data-driven clinical operations leader, with significant experience in the implementation and management of Decentralized and Hybrid Clinical Research solutions, with the use of technology.
Robust experience managing Investigator-Initiated/Sponsored Trials in Oncology.
Leading operational teams, strong cross-functional communication, and efficient vendor management to deliver quality projects and the right solutions to clients (Biotech, Pharma, Academia, Internal Stakeholders)
Continuously fostering a healthy work environment to create and grow collaborative and high-performing teams.

Bio

Samir Jain is the Head of EHR and Interoperability Solutions, responsible for building Medidata’s Healthcare Interoperability strategy and Site solutions. Samir has over 20 years of experience working with healthcare technologies and organizations. Samir started his career building EHRs, leading the interoperability and standards team at Allscripts. He later spent time building large scale Health Information Exchanges, as well as leading Clinical Platform and Product strategy at Teladoc and RubiconMD. Samir has also held a seat on Carequality’s Steering Committee, contributing to the mission of nationwide interoperability.

Bio

Robin Burges is Associate Director of Program Delivery at Advanced Clinical, where she provides operational leadership across complex clinical research programs and strategic initiatives focused on improving how clinical trials are planned and delivered. She brings a pragmatic, execution-focused perspective to program delivery, combining clinical operations experience with a strong focus on process improvement, technology adoption, and organizational change.

Robin is helping advance Advanced Clinical’s exploration of artificial intelligence through its 60-day AI sprint, with a focus on translating emerging capabilities into practical, scalable solutions for real-world clinical and business challenges.

Bio

Cheryle S. Evans is a senior-level executive with extensive, progressive experience including a track record of accomplishments in the healthcare/pharmaceutical research industry. With a robust background in operationalizing pharmaceutical clinical research, Cheryle has consistently demonstrated exceptional leadership and unwavering commitment to excellence. She was named President, Solutions in September 2025.

Bio

Don Harder, M.S. is a healthcare innovation leader with over 20 years of experience transforming how clinical research is designed and delivered. As Head of Trial Solutions Design at Care Access, he leads teams that create patient-centered clinical trial solutions aimed at expanding patient access and accelerating study delivery.

Previously, Don spent more than two decades at Eli Lilly & Company, where he started his career as a Biostatistician and then led enterprise initiatives in statistical computing, decentralized trials, patient experience, and other clinical innovations. His work has driven faster patient enrollment, improved trial efficiency, and delivered significant business impact—including initiatives with multi-million-dollar returns and reduced development timelines.

Don leverages his background in statistics and certifications in Lean Six Sigma to bring a unique blend of analytical rigor and creative problem-solving. He is known for translating complex challenges into practical, scalable solutions by combining strategy, design thinking, and agile execution. He has been recognized as a top innovator and is a named inventor on multiple U.S. patents in predictive clinical trial design.

Bio

Richie Pfeiffer is a clinical, business, and technology leader with 30 years of experience spanning healthcare, CRO and pharmaceutical services, and digital health. Based in Indianapolis, he has spent the past four years at Thermo Fisher Scientific as Senior Director of Patient First Digital Solutions, leading global strategies for decentralized clinical trials. Drawing on his background in healthcare, data, and technology, Richie develops patient-centered approaches designed to improve outcomes and operational efficiency. His areas of expertise include decentralized trials, wearables, AI and machine learning, enterprise imaging, large-scale data exchange, and real-world data. He is known for scaling innovative platforms and building strategic partnerships to advance practical, data-driven healthcare solutions.

Bio

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.

Bio

Ellie Gibbons is the Oncology Research Manager for the South Region at Sanford Health Clinical Research, bringing 20 years of experience in clinical research operations and leadership. At Sanford, she leads oncology research operations across multiple sites and contributes to enterprise initiatives focused on decentralized clinical trials, staff development, and expanding access to clinical research in rural communities. Ellie is also an adjunct faculty member at the University of South Dakota, where she supports clinical research education and workforce development. She is passionate about innovative research delivery models that reduce barriers to participation and bring clinical trials closer to patients.

Bio

Rachael Sawaya is a Director of Project Management at Emvenio Clinical Research with over seven years of experience in the decentralized clinical research field. Prior to Emvenio, she worked as a clinical research coordinator where she gained extensive knowledge of working at the site and has taken that experience to reduce the burden and better support sites to implement mobile visits. At Emvenio, Rachael oversees the execution of mobile visits across a wide variety of therapeutic areas and on a global scale. She supports clients throughout the implementation of mobile visits to maintain customer satisfaction and implement efficiencies across therapeutic areas and geographies. Rachael is passionate about implementing solutions for participants that increase participant engagement to ensure clinical trials can obtain critical long-term data, especially in rare disease and vulnerable patient populations.

Bio

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.

Bio

Dr. Dumais is a scientist with over 16 years of experience in behavioral and life science research. She has expertise in the implementation of electronic clinical outcome assessments (eCOA) and the development and validation of patient reported outcomes (PROs) to support labeling claims. She is currently Vice President of eCOA Science and Consulting at Clario, a global data and technology company that helps to minimize risk in clinical trials. She consults on best practices for questionnaire design and eCOA design/use to drive data integrity and patient engagement and develops custom site rater training and participant training for improving accuracy in COA reporting and improving inter-and intra-rater reliability.

Bio

Darshan Kulkarni, PharmD, MS, JD is a food and drug attorney, pharmacist, and educator with more than 20 years of experience advising life sciences companies on FDA regulatory, clinical research, and compliance matters. As Founding Attorney at the Kulkarni Law Firm, PC, he helps clinical trial sponsors, research organizations, and life sciences companies navigate complex regulatory challenges while supporting innovation and commercial success. His work spans decentralized clinical research, clinical trial agreements, risk-based quality management, artificial intelligence in clinical trials, data privacy, and emerging technologies, including tokenization. Darshan also teaches law and bioethics and regularly speaks on the intersection of science, technology, law, and healthcare. He brings a multidisciplinary perspective that combines scientific training, legal experience, and practical industry insight to help sponsors understand both the opportunities and regulatory considerations associated with evolving clinical research models.

Bio

Ryan is the Head of Life Sciences Solutions at Datavant. He has 15 years of experience at the intersection of life sciences, healthcare and technology, working in strategy and product leadership roles in support of clinical innovation and real-world evidence generation. Prior to Datavant, Ryan served as Senior Director of Clinical Trial and Real-World Data Products at Cerner (now Oracle Health). Ryan graduated with a BS in Biology from Butler University and an MBA in Strategy & Management from the University of Kansas.

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.

Speakers

DTRA 2026 Hosts

Amir Kalali, MD

Co Founder, Co Chair, DTRA

Bio

Craig Lipset

Co Founder, Co Chair, DTRA

Bio

Jane Myles

Program Director, DTRA

Bio

DTRA 2026 Speakers

Dianne Paraoan

Director, Office of Medical Policy, CDER, FDA

Bio

Steffen Thirstup

Chief Medical Officer, European Medicines Agency (EMA)

Bio

Meghana Chalasani

Associate Director for Clinical Trial Innovation, FDA

Bio

Rasika Kalamegham

Head, US Regulatory Policy, Genentech

Bio

Ryan Ferguson

Acting Director, VA Cooperative Studies Program, US Department of Veterans Affairs

Bio

Belén Fraile

Chief Data & Digital Officer in Life Sciences (R&D and Commercial), J&J

Bio

Tala Fakhouri

Chief AI & Regulatory Strategy Officer, Parexel

Bio

Jeremy Price

Head, Clinical Trial Capability Advancement, Pfizer

Bio

Emily Krassen

Director, Clinical Trial Advertising & Social Lead, Pfizer

Bio

Patrick Lee

Senior Manager, Digital Medicine, Amgen

Bio

Trevan Locke

Director, Global Regulatory Policy and Intelligence, Amgen

Bio

Katrin Ong

Digital Clinical Trial Innovation Manager, Boehringer Ingelheim

Bio

Derk Arts, MD, PhD

Founder & CEO, Castor

Bio

Anindita Saha

Global Medical Device & Life Sciences Policy Director, Oracle

Bio

Ali Holland

Chief Customer Officer, Medable

Bio

Diego Martinez

Associate Diretor, Decentralized Clinical Trial Solutions, Parexel

Bio

Jimmy Polewaczyk

Strategic Development Director, Medidata Link, Medidata

Bio

Robin Douglas

VP Research Site Engagement, Medidata

Bio

Samir Jain

Head of EHR and Interoperability Solutions, Medidata

Bio

Anders Lindquist

Senior Manager, Research Site Enablement, Labcorp

Bio

Robin Burges

Associate Director of Project Management, Advanced Clinical

Bio

Cheryle Evans

President, Solutions, Advanced Clinical

Bio

Don Harder

Head of Trial Solution Design, Care Access