Speakers

DTRA 2026 Annual Meeting speakers include top executives, leading visionaries, clinical trial operations leaders, regulators, investors and more.

DTRA 2026 Hosts

Amir Kalali
Craig Lipset
Jane Myles-1

Amir Kalali, MD

Co Founder, Co Chair, DTRA

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

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

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 2026 Speakers

Dianne Paraoan

Director, Office of Medical Policy, FDA

Bio coming soon

 
Dianne Paraoan
Steffen Thirstrup-1

Steffen Thirstup

Chief Medical Officer, European Medicines Agency (EMA)

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

Meghana Chalasani

Associate Director for Clinical Trial Innovation, FDA

Bio coming soon

Meghana Chalasani-1
Rasika Kalamegham-2

Rasika Kalamegham

Head, US Regulatory Policy, Genentech

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.

 

Sarah Leatherman

Deputy Center Director, Cooperative Studies Program Coordinating Center, US Department of Veteran Affairs (VA)

Bio coming soon

Sarah Leatherman
Belen Fraile

Belen Fraile

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

Bio coming soon
 

Tala Fakhouri

Chief AI & Regulatory Strategy Officer, Parexel

Bio coming soon
Tala Fakhouri
Jeremy Price-2

Jeremy Price

Head, Clinical Trial Capability Advancement, Pfizer

Bio coming soon

 

Patrick Lee

Senior Manager, Digital Medicine, Amgen

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.

Patrick Lee
Trevan Locke

Trevan Locke

Director, Global Regulatory Policy and Intelligence, Amgen

Bio coming soon

Katrin Ong

Digital Clinical Trial Innovation Manager, Boehringer Ingelheim

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.
 
Katrin Ong-1
Derk Arts-1

Derk Arts, MD, PhD

Founder & CEO, Castor

Bio coming soon
 

Anindita Saha

Global Medical Device & Life Sciences Policy Director, Oracle

Bio coming soon

Anindita Saha
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Ali Holland

Chief Customer Officer, Medable

25+ years in clinical drug development seeking innovative ways to remove bottlenecks and accelerate patient engaged choices for participation in clinical research. Excited now about the reality of AI powered transformation to deliver a new framework for global trial execution

Diego Martinez

Associate Diretor, Decentralized Clinical Trial Solutions, Parexel

Bio coming soon

 
Diego Martinez
Jimmy Polewaczyk

Jimmy Polewaczyk

Strategic Development Director, Medidata Link, Medidata

Bio coming soon

 

Samir Jain

VP of Product Management, Healthcare Data Interoperability and EHR Solutions, Medidata

Bio coming soon

Samir Jain
Anders Lindquist

Anders Lindquist

Senior Manager, Research Site Enablement, Labcorp

Bio coming soon

Robin Burges

Associate Director of Project Management, Advanced Clinical

Bio coming soon

Robin Burges
Cheryle Evans

Cheryle Evans

Presidnet, Solutions, Advanced Clinical

Bio coming soon

Don Harder

Head of Trial Solution Design, Care Access

Don Harder is a seasoned professional who manages to make complex challenges look easy—and occasionally even fun. With a career rooted in designing Clinical Research studies as a Biostatistician, Don has built a reputation for combining sharp strategy with an easygoing style that keeps teams engaged and projects moving forward.

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.
Don Harder
Richie Pfeiffer

Richie Pfeiffer

Senior Director, Patient First Digital Solutions, PPD, part of Thermo Fisher Scientific

Bachelor of Science in Nuclear Medicine
MS of Science in Health Informatics
Lead key areas in healthcare/hospital setting clinically and in technology and innovation, especially in the medical imaging, EHR, and digital health technologies.
Instrumental in brining to market Neuraceq, revolutionary radiotracer for the detection of beta amyloid plaque for Alzheimer's disease.
Lead product for the largest medical data exchange platform in the world.
Moved to the CRO/Pharmaceutical space to lead innovation and technology with focus in Decentralized Clinical Trials, Digital Health Technologies including wearables, sensors, and devices along with novel clinical solutions.
 

Rebecca Kottschade

Director, Research Operations, Mayo Clinic

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.

Becky Kottschade (2)
Eleanor Gibbons

Eleanor Gibbons

Clinical Research Manager, Sanford Health

Bio coming soon

Rachael Sawaya

Director, Project Management, Global Clinical Trials, EmVenio Research

Bio coming soon
Rachael Sawaya
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Rick Greenfield

Founder and CSO, Real-Time eClinical Solutions

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.

Kelly Dumais

Vice President, eCOA Clinical Science & Consulting, Clario, part of PPD

Bio coming soon

Kelly Dumais
Matt Veatch-1

Matt Veatch

President & COO, Navidence

Matt is the Chief Operating Officer of Navidence - working with clients in the healthcare Real World Data (RWD) ecosystem to support Real World Evidence and Clinical Trials, with major focus in "Computable Phenotypes" that allow researchers to characterize patient populations and cohorts of interest with great precision. Motivated by the needs of Life Science/Industry, government, academic and other stakeholders driven by a shared mission to create new treatment options for patients.

Matt's career builds upon 20+ years of Life Science R&D experience to shape new methods and paradigms and positively impact the entire clinical research industry.

David Menzies

Executive Director, Consulting and Technology Solutions, HealthVerity

Bio coming soon

 
David Menzies
Ryan Moog

Ryan Moog

Vice President, Head of Life Science Solutions, Datavant

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.

Darshan Kulkarni

Founding Attorney, The Kulkarni Law Firm

Bio coming soon

Darshan Kulkarni
Angela Radcliffe (1)

Angela Radcliffe

Founder & CEO, How Mighty We Ventures

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.