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Digital transformation in clinical trials isn’t a technology problem – it’s a change problem. Drawing on years of frontline experience adapting to industry disruption, this talk makes the case for embedding change management at the core of every transformation initiative. Jenn Embury shares proven approaches for engaging stakeholders early, mapping and challenging legacy processes, and avoiding the costly mistake of digitizing broken workflows. Through practical examples, the session demonstrates how disciplined assessments, clear program governance, and human‑centered change strategies turn digital ambition into sustained performance. This is a call to transform with people – not around them.
Key takeaways:
Why stakeholder engagement determines transformation success or failure
How to evaluate and redesign processes before digitizing
Practical techniques to bring clinical and regulatory teams along the journey
Jenn is a leader in Clinical Development and SaaS strategy with over 25 years of experience bringing a unique understanding of complex trial design including decentralized clinical trial (DCT) modalities from Sponsor, CRO, Site and SaaS operations and data model perspectives.
Jenn has championed large-scale change initiatives that successfully aligned operational goals with new technology. These initiatives modernized clinical development processes, increased cross-functional collaboration and enabled data-driven decision-making.
As the Clinical Customer Success at Veeva Systems, Jenn provided strategic advice and support to customers on product adoption, change management strategies, and validation best practices.
Jenn’s ability to translate operational and technical considerations into actionable strategies enables organizations to optimize trial execution and modernize their clinical development approaches.
Operations are now the primary rate-limiting factor in drug development. We’ve reached the practical limits of purely human-driven execution. Agentic teammates can help reduce this bottleneck by accelerating coordination, automating repetitive workflows, surfacing decisions earlier, and enabling scientific teams to operate with greater speed and precision.
Sid leads the Clinical Development and Data Science function at Recursion, overseeing Computational Biology, Decision Science, and Biometrics to drive the industrialization of clinical trials through AI-driven patient selection, protocol optimization, and full-scale trial execution. His team integrates multi-omics modeling, real-world data (RWD), and AI/ML applications to optimize clinical trial design, accelerate execution, and generate high-quality regulatory-grade evidence. This includes data-driven patient matching, site selection and engagement, as well as CMC and supply chain (CSC) planning and forecasting, ensuring trials are both efficient and scalable.
Dr. Pamela Tenaerts serves as Chief Medical Officer at Medable, where she leads the company’s medical strategy to advance responsible innovation in clinical trials. A physician and recognized leader in evidence-based research modernization, she drives efforts to integrate decentralized methodologies, AI, and digital endpoints into trustworthy and patient-centered study designs.
Before being named CMO, Dr. Tenaerts served as Medable’s Chief Scientific Officer and previously led the Clinical Trials Transformation Initiative—a public-private partnership co-founded by Duke University and the U.S. Food and Drug Administration—where she helped establish best practices for improving trial quality and efficiency.
She is an active voice in advancing patient engagement, Quality by Design approaches, and research ethics and regulatory collaboration, serving on the Drug Forum at the National Academies of Sciences, a founding member of the DiMe Society’s Council, and a board member of the MedStar Research Institute. Dr. Tenaerts earned her MD from the Catholic University of Leuven and her MBA from the University of South Florida.
Dan Schell is Chief Editor of Clinical Leader where he writes about topics related to clinical trial operations. Previously, he served as the Editorial Director of Life Science Leader magazine, another Life Science Connect community, for 14 years. In this role, he worked with the publication’s internal and external writers and editors on choosing the best topics for articles as well as refining all content to meet Life Science Leader’s high editorial standards. Prior to his work with Life Science Leader, he worked as an editor and copy editor for Life Science Connect. He joined the company in 2000 after 10 years of working for Encompass Health (previously Healthsouth) in marketing and business development and four years at an advertising agency.
Sam Warden is Vice-President and Global Head of GSK’s Clinical Programming and Business Excellence function with teams across Europe, US and Asia. She has led the group through a transformation to working in Open Source programming languages with an agile teams to delivery clinical study and project reporting at GSK for the past 4 years.
She is recognized as an influencer in the field of pharmaceutical data science and analytics. Her career spans 3 decades, bringing depth and perspective of not only how we manage, analyse and share data but why we do it. She is passionate about enabling the data to tell its story to support great decision making as well as innovative design to optimize resources and maximize results.
She has previously worked as a technology consultant to the industry, and held leadership positions at CROs, biotech and pharma companies in the UK and Switzerland.
Sam holds an MBA, and a Bachelor of Science in Biology from the University of Manchester.
Manesh Patel is an influential business leader with 31 years of experience in the pharmaceutical industry. He has extensive expertise in capability building, operations management, programme and change management across diverse technology and operational settings. With a career spanning Tech, the Office of the CEO, R&D Strategy, and Clinical Operations, Manesh has played a pivotal role in setting up healthcare programs in Eastern and Southern Africa. Currently, he is a keen driver of capability development in Biostatistics.
Manesh holds an MSc in IT and a BSc (Hons) in Chemistry.
Chrissie is the Vice President and Head for Respiratory, Immunology and Inflammation Statistics at GSK. She leads a group of statisticians supporting the development of new and approved medicines in respiratory, immunology, hepatology, infectious diseases, neuroscience, renal, HIV, and global health. Chrissie also manages a group of statisticians based in India who support the R&D portfolio. Chrissie has worked in the Pharmaceutical Industry for 34 years and she has experience of developing and commercialising new medicines in a variety of disease areas across all phases of clinical development.
Chrissie is actively engaged in statistical societies, pharmaceutical trade associations and initiatives relating to the Pharmaceutical Industry. Chrissie leads the EFSPI Statistics Leaders Forum, and she is a member of the EFPIA Clinical Research Expert Group where she co-leads the Innovation in Clinical Trials team. Chrissie leads the EFPIA/EFSPI estimand implementation working group (ICH E9(R1)) and she represents GSK on the ABPI Clinical Research Project Team.
In 2019 Chrissie was given honorary membership for her outstanding service to PSI, and she was selected for the Women in Data “Twenty in Data and Technology” award which showcases phenomenal women who encompass every level of seniority and data discipline, and who continue to make role models visible within their industry professions.
Chrissie is a Chartered Statistician of the Royal Statistical Society (RSS). Chrissie has an MSc in Applied Statistics and a BSc (Hons) in Statistics with Management Science Techniques.
Sowmyanarayan Srinivasan (Sowmya) has over 25 years of leadership experience in Life Sciences R&D, seamlessly blending business acumen with technological expertise. Throughout his career, he has established and expanded R&D teams, playing multiple roles such as business and technology transformation, product management and industry platform development, all while driving thought leadership and innovation.
Currently, Sowmya serves as a Principal/Partner at ZS Associates, where he spearheads client initiatives to foster innovation and transformation within their R&D functions. As the co-lead of the Drug Development Practice, he convenes industry leaders in roundtables to tackle critical questions about emerging technologies and their practical applications to business challenges.
Sowmya’s diverse experience spans sponsors and consulting organizations, from startups to large enterprises, enabling him to offer balanced, impactful solutions tailored to specific challenges.
An active participant in industry forums such as SCDM, DIA, and PHUSE, Sowmya recently contributed his expertise as a panelist at the SCDM Leadership Forum’s annual conference in India in December 2024.
He is married with two daughters and passionately advocates for an inclusive society.
Sam Warden is Vice-President and Global Head of GSK’s Clinical Programming and Business Excellence function with teams across Europe, US and Asia. She has led the group through a transformation to working in Open Source programming languages with an agile teams to delivery clinical study and project reporting at GSK for the past 4 years.
She is recognized as an influencer in the field of pharmaceutical data science and analytics. Her career spans 3 decades, bringing depth and perspective of not only how we manage, analyse and share data but why we do it. She is passionate about enabling the data to tell its story to support great decision making as well as innovative design to optimize resources and maximize results.
She has previously worked as a technology consultant to the industry, and held leadership positions at CROs, biotech and pharma companies in the UK and Switzerland.
Sam holds an MBA, and a Bachelor of Science in Biology from the University of Manchester.
Manesh Patel is an influential business leader with 31 years of experience in the pharmaceutical industry. He has extensive expertise in capability building, operations management, programme and change management across diverse technology and operational settings. With a career spanning Tech, the Office of the CEO, R&D Strategy, and Clinical Operations, Manesh has played a pivotal role in setting up healthcare programs in Eastern and Southern Africa. Currently, he is a keen driver of capability development in Biostatistics.
Manesh holds an MSc in IT and a BSc (Hons) in Chemistry.
Chrissie is the Vice President and Head for Respiratory, Immunology and Inflammation Statistics at GSK. She leads a group of statisticians supporting the development of new and approved medicines in respiratory, immunology, hepatology, infectious diseases, neuroscience, renal, HIV, and global health. Chrissie also manages a group of statisticians based in India who support the R&D portfolio. Chrissie has worked in the Pharmaceutical Industry for 34 years and she has experience of developing and commercialising new medicines in a variety of disease areas across all phases of clinical development.
Chrissie is actively engaged in statistical societies, pharmaceutical trade associations and initiatives relating to the Pharmaceutical Industry. Chrissie leads the EFSPI Statistics Leaders Forum, and she is a member of the EFPIA Clinical Research Expert Group where she co-leads the Innovation in Clinical Trials team. Chrissie leads the EFPIA/EFSPI estimand implementation working group (ICH E9(R1)) and she represents GSK on the ABPI Clinical Research Project Team.
In 2019 Chrissie was given honorary membership for her outstanding service to PSI, and she was selected for the Women in Data “Twenty in Data and Technology” award which showcases phenomenal women who encompass every level of seniority and data discipline, and who continue to make role models visible within their industry professions.
Chrissie is a Chartered Statistician of the Royal Statistical Society (RSS). Chrissie has an MSc in Applied Statistics and a BSc (Hons) in Statistics with Management Science Techniques.
Sowmyanarayan Srinivasan (Sowmya) has over 25 years of leadership experience in Life Sciences R&D, seamlessly blending business acumen with technological expertise. Throughout his career, he has established and expanded R&D teams, playing multiple roles such as business and technology transformation, product management and industry platform development, all while driving thought leadership and innovation.
Currently, Sowmya serves as a Principal/Partner at ZS Associates, where he spearheads client initiatives to foster innovation and transformation within their R&D functions. As the co-lead of the Drug Development Practice, he convenes industry leaders in roundtables to tackle critical questions about emerging technologies and their practical applications to business challenges.
Sowmya’s diverse experience spans sponsors and consulting organizations, from startups to large enterprises, enabling him to offer balanced, impactful solutions tailored to specific challenges.
An active participant in industry forums such as SCDM, DIA, and PHUSE, Sowmya recently contributed his expertise as a panelist at the SCDM Leadership Forum’s annual conference in India in December 2024.
He is married with two daughters and passionately advocates for an inclusive society.
There is an increasing willingness among the pharmaceutical industry to develop new treatments that better understand patient needs and satisfy their expectations. Social media has been identified as a promising data source for generating patient insights that can inform Patient-Focused Drug Development (PFDD). Although the technology is available (NLP, AI), multiple challenges remain. To contribute to reducing uncertainty and work towards establishing best practices for methodologically rigorous social media listening studies, the Pistoia Alliance will present the outcomes of its collaborative work with several pharmaceutical member companies.
While AI and automation successfully enhance isolated clinical data tasks, the true enterprise challenge is connecting these tools into unified workflows. Organizations are now shifting from task-specific productivity to enterprise-scale Clinical Data Intelligence (CDI). This CDI approach integrates study design, data collection, analytics, and metadata across the entire trial lifecycle. Key components include a unified Metadata Repository, semantic data traceability, and standardized asset reusability. Human-in-the-loop governance ensures critical decisions remain validated by expert oversight and enterprise compliance standards. Operationalizing this model requires connecting disparate data platforms and establishing rigorous, system-wide governance guardrails. Ultimately, this transformation accelerates clinical trials while ensuring data reliability and compliance across teams.
I am dedicated to harnessing data to tackle complex challenges in the pharmaceutical sector, particularly within clinical operations. With a background in Data & Analytics Strategy, I specialize in solving problems and improving protocol design from an operational perspective. As an educator, I teach a modeling course at the university, mentoring aspiring data professionals. My focus is to leverage data-driven insights to optimize decision-making and contribute to more accessible treatments for patients.
This presentation explores how digital health technologies have transitioned from hype to the “enlightenment” stage within the pharmaceutical industry. By identifying core organizational barriers, such as corporate investment, precedence for stakeholder buy-in, and development duration, it outlines the strategic shifts required to move from innovation projects to essential clinical utilities.
Illustrate how continuous digital measurement enables real-time, event‑driven data capture in clinical trials, shifting from episodic assessments to timely, actionable operational insight.
Demonstrate, through an example, how continuous digital measures improve trial monitoring, operational efficiency, and decision‑making during study execution.
Connect patient experience with operational impact, showing how continuous digital measurement supports more patient‑centric and effective next‑generation clinical trials.
Dr. Abhishek (Abhi) Pratap is the Executive Director and Global Clinical Development Lead at
Boehringer Ingelheim, leading late-stage development and real-world evidence generation for
digital therapeutics in serious mental illnesses. He recently led a pivotal Phase III trial in
schizophrenia (NCT05838625), the first confirmatory study to demonstrate
improvement in negative symptoms. He has over 15 years of experience translating digital
health, real-world data, and neuroscience into patient-centered, regulatory-aligned evidence. His
work spans pivotal trials, value-based evidence strategies, and large-scale decentralized studies.
Dr. Rea Lehner is a strategic leader dedicated to transforming clinical trials and patient care through technology, data-driven solutions, and cross-functional collaboration. As Global Clinical Operations Excellence Leader at Roche, she drives the adoption of digital health and AI to accelerate the speed and efficiency of global clinical trial delivery. She previously spearheaded digital biomarker development and integration across Phase 1–4 trials at Roche and served as Associate Director Future Health Technologies at Singapore-ETH Centre. She holds a PhD in Health Sciences and Technology from Swiss Federal Institute of Technology and is a recipient of several research and leadership awards.
John combines 25 years experience in clinical data management, PCOR science and clinical trial operations with expertise leading the development of data pipelines, knowledge management products and new processes to advance the use of eCOA & digital measures in clinical trials.
John is an expert in the execution and scaling of patient and site facing clinical trial technologies who gained a BSc in Biology from the University of Bristol in the UK. Before joining DEEP John worked for Roche for 10 years where he led external industry collaborations and played a leadership role in the co-creation of a new operational framework and ecosystem of data and technology products to support the digital health technology lifecycle.
John now works for DEEP Measures as a Science Liaison where he partners closely with DEEP’s existing customers, helping them to maximize the value they can gain through using DEEP’s products and services. John has witnessed first hand the challenges key stakeholders face in discovering, developing, implementing and using new digital health technology tools and has a passion for enabling science through collaboration and co-creation of a more streamlined ecosystem.
Raja is focused on transforming life sciences with applied AI. As the VP for Machine Learning Raja is determined to change healthcare with the power of AI. He believes that imagination is the biggest barrier and motivates his team to create new narratives that fully leverage AI’s potential to reshape the industry from R&D through commercialization. Raja brings together a diverse set of technical and strategic capabilities, including machine learning, deep learning, generative AI, product development, life sciences expertise and business consulting skills. His team combines data science, domain expertise and consulting skills to create “superhero” change makers who drive impactful change by applying AI to life sciences and healthcare decisions. Raja is a trusted advisor to global life sciences companies, public sector clients, as well as international organizations.
https://www.linkedin.com/in/raja-shankar-4b80b41/
Clinical trials rarely fail because of bad science — they fail due to design decisions made upstream that don’t translate effectively into operational reality.
In this session, we explore the disconnect between protocol design and trial execution, and why traditional approaches struggle to ensure alignment across clinical, operational, and regulatory teams.
We will introduce what it truly means to be “AI-first” in clinical development — not as a toolset, but as a structural shift in how decisions are designed, validated, and governed.
Through real-world examples, we will show how a continuous intelligence layer can:
o Structure and retain the rationale behind design decisions
o Benchmark and strengthen protocols using external evidence
o Translate design into operational feasibility from the outset
The objective is simple: move from designing protocols that look right, to designing protocols that are proven to work — before the first patient is enrolled.
Marcus Lawrance is currently Head of the RWD Office in Medical Affairs at AstraZeneca, and is based in Barcelona, Spain.
Marcus has a masters in bioinformatics and has been working in the RWD space for the past 10 years across multiple roles both technical and strategic. He started in industry at GSK as a data scientist and then later at Roche, before going on to lead a team of data scientists there. His final role at Roche involved focused on improving data access and strategy for their digital health division. He joined AZ two years ago to lead oncology data strategy before taking on his current role.
Global biopharma executive with 20+ years of leadership experience transforming
clinical development through digital innovation, decentralized trial models, and
enterprise data strategies. Proven track record of building and scaling global
functions, delivering multi-million revenue growth ($5M → $23M), securing
enterprise investment, and leading cross-functional international teams.
Recognized industry thought leader in eCOA, hybrid and decentralized trials, and
connected data ecosystems. Experienced in influencing executive committees,
regulators, and external partners to accelerate development timelines, improve patient
access, and drive measurable business performance.
Selin has extensive experience spanning real-world data (RWD) and evidence generation, strategy, and partnerships. She has previously held roles across Medical Affairs, Data Science and Epidemiology in industry, including GSK and Roche, consulting, and academia. She represents AbbVie on working groups for the Council for International Organizations of Medical Sciences (CIOMs), the Innovative Health Initiative (HI) real-world evidence (RWE) and data strategic ideation group (SIG), and the European Federation of Pharmaceutical Industries and Associations (EFPIA) on RWD Quality. She holds a PhD in Molecular Epidemiology.
If you manage data, you know the drill; the systems, the numerous emails, the databases and of course, the data sheets…. so many data sheets! You sometimes wonder, is this really the only way to get work done? Through two vivid, real-world stories set in clinical data management, we explore what a day in the life looks like in 2026 and what that same day could look like in 2028 with agentic AI as a sparring partner. Same challenges. Handled very differently. The session unpacks what’s driving the shift across technology and the way the work gets done, then lays out the five shifts worth noting. This isn’t your typical dry, end-of-day session. Expect some theatrics, live audience participation throughout and an open panel at the close where the floor is yours. Come with questions. Leave with perspective. We’re eager to welcome you!
This session explores how advanced AI technologies — including large-scale simulation models and agentic automation — are reshaping clinical development. Attendees will learn how AI can optimize trial design, accelerate workflows and enable more robust, data-driven decision-making, ultimately improving trial outcomes and operational efficiency.
Raja is focused on transforming life sciences with applied AI. As the VP for Machine Learning Raja is determined to change healthcare with the power of AI. He believes that imagination is the biggest barrier and motivates his team to create new narratives that fully leverage AI’s potential to reshape the industry from R&D through commercialization. Raja brings together a diverse set of technical and strategic capabilities, including machine learning, deep learning, generative AI, product development, life sciences expertise and business consulting skills. His team combines data science, domain expertise and consulting skills to create “superhero” change makers who drive impactful change by applying AI to life sciences and healthcare decisions. Raja is a trusted advisor to global life sciences companies, public sector clients, as well as international organizations.
https://www.linkedin.com/in/raja-shankar-4b80b41/
Rebecca Jackson’s career spans 20 years in the life sciences clinical research industry, predominantly within pharmaceutical R&D with focus on innovative technologies and novel trial modalities. Rebecca has extensive experience gained from sponsor, vendor and CRO perspectives and is an industry recognized authority in clinical trial technology and operations including electronic health record use in clinical research, decentralization of clinical trials, digital health and digital biomarkers, drug delivery solutions and innovation technologies such as applied and generative AI. A Life Sciences graduate of the Open University holding an MSc in Clinical Trials from the University of Edinburgh, Rebecca is an active participant across several industry groups, research collaborations and international industry initiatives and an acknowledged industry expert.
During her ten-year tenure at J&J, Rebecca has successfully lead M&A technology migrations, developed core technology strategies, driven spearhead innovation projects and positioned J&J as the industry leader in EHR data acquisition. Working across multiple Therapeutic Areas, Rebecca’s digital transformation leadership spans medical affairs, early and late development, global clinical operations, supply chain and global public health.
Raja is focused on transforming life sciences with applied AI. As the VP for Machine Learning Raja is determined to change healthcare with the power of AI. He believes that imagination is the biggest barrier and motivates his team to create new narratives that fully leverage AI’s potential to reshape the industry from R&D through commercialization. Raja brings together a diverse set of technical and strategic capabilities, including machine learning, deep learning, generative AI, product development, life sciences expertise and business consulting skills. His team combines data science, domain expertise and consulting skills to create “superhero” change makers who drive impactful change by applying AI to life sciences and healthcare decisions. Raja is a trusted advisor to global life sciences companies, public sector clients, as well as international organizations.
https://www.linkedin.com/in/raja-shankar-4b80b41/
Gabriel is an infectious disease specialist and associate professor (MD, PhD) with a MSc in Engineering and expertise in AI, bioinformatics/omics and life science data applications. He is member of the EMA CHMP Methodology Working Party and the HMA/EMA Network Data Steering Group, and is currently building regulatory AI/data science capacity and competence at the Swedish Medical Products Agency, exploring use of real-world data and hoping for a better and data-driven world.
Professor Bola Grace has decades of leadership experience across multiple sectors, inducing pharma, biotech, and academia, providing strategic, commercial and technical direction to highly skilled cross-functional teams on complex programmes; and delivering numerous innovative award-winning products. She enjoys collaborative research and development, including the application of data science across therapeutic areas. She was worked extensively on digital measures, digital health technologies, and digital endpoints in clinical trials, with wide-ranging thought leadership pieces in the field. She was Senior Director Digital Biomarkers at GSK, and is currently Professor of Practice at University college London. She has a PhD from University College London and an Executive MBA from the University of Cambridge Judge Business School.
The promise of technology: Streamlining Data Flow
-The power of integrated CRO Services
-Full service CRO: tailored solution customized around Sponsor’s need
-Navigating complexity with Agility
-The innovative CRO:flexible, virtual, patient first
-Advancing health with Technology & AI
-The synergy: tech + CRO oversight = scalable success
Farrell Healion is Founder and Managing Director of OptiTrial, supporting sponsors and CROs in the strategy and implementation of patient-facing technologies, Digital Health Technologies, and DCTs. He focuses on translating digital ambition into practical, patient- and site-centric delivery that improves trial outcomes.
With over 14 years of experience across sponsor and supplier organisations, including leadership roles at AstraZeneca and Signant Health, Farrell has led digital transformation and global delivery across eCOA, eConsent, remote patient monitoring, digital endpoints, and next-generation trial solutions. He is a former Co-Chair of the C-Path PRO Consortium and a PharmaTimes DCT Clinical Researcher of the Year.
Clinical Research professional with over 15 years of experience in global clinical development, spanning Phase I–IV trials, NIS/PASS, and medical device studies. Certified Clinical Project Manager with extensive international monitoring experience (400+ visits) and strong expertise in global Regulatory Affairs (FDA & EMA). Recognized for leading cross-functional teams and mentoring clinical research professionals, he frequently contributes to international congresses as a speaker on clinical operations, regulatory strategy, and trial execution.
Professor Bola Grace has decades of leadership experience across multiple sectors, inducing pharma, biotech, and academia, providing strategic, commercial and technical direction to highly skilled cross-functional teams on complex programmes; and delivering numerous innovative award-winning products. She enjoys collaborative research and development, including the application of data science across therapeutic areas. She was worked extensively on digital measures, digital health technologies, and digital endpoints in clinical trials, with wide-ranging thought leadership pieces in the field. She was Senior Director Digital Biomarkers at GSK, and is currently Professor of Practice at University college London. She has a PhD from University College London and an Executive MBA from the University of Cambridge Judge Business School.
Noé Brasier, MD, is a board-certified internist (FMH, Swiss Medical Association) with a medical doctorate from the University of Basel (CH), where he investigated the clinical validity of a smartphone camera algorithm for detecting atrial fibrillation – the most common arrhythmia linked to stroke. Driven by curiosity and medical need, he later turned his research from physical wearables for vital sign monitoring toward translation of sweat analysis by wearable devices, working at the intersection of engineering and early clinical adoption.
After completing his clinical training, Dr. Brasier received the prestigious MedLab Fellowship at ETH Zurich (Zurich, CH) and an Early-Career Fellowship at Collegium Helveticum (Zurich, CH), where he laid the groundwork for translational concepts in sweat-based biomarker discovery, wearable sensing, and clinical implementation. He now serves as principal investigator of the AGE RESIST project, a joint Swiss-U.S. initiative supported by the Swiss National Science Foundation and the U.S. National Science Foundation investigating a novel age clock of resilience from sweat. This work is a collaborative effort between ETH Zurich, California Institute of Technology, Swiss Federal Laboratories of Materials Science and Technology (Empa), and Felix-Platter Hospital, a leading hospital for geriatric medicine in Switzerland.
At ETH Zurich’s Department of Health Sciences and Technology, Dr. Brasier lectures on translational medicine and created the new “Digital Biomarkers” course for medical students, introducing future doctors to digital health and wearable sensing. He also founded the Next-generation Digital Biomarkers Summit, now in its third edition in 2025, and set to become a Nature Conference in 2027, bringing global leaders together to advance clinical translation and implementation of digital biomarkers. Finally, Dr. Brasier is an expert monitor for the prestigious pathfinder challenge by the European Innovation Council.
Harriet leads the Digital Cancer Research team at the CRUK National Biomarker Centre, University of Manchester, where she is Co-PI on the UpSMART programme to digitise early phase cancer clinical trials. She is an expert on AI and digital health, having co-authored the NICE Evidence Standards Framework for digital health and care, and served as a committee member for the first British Standard on AI in health and care, BS30440. Her previous experience includes lab-based cancer research, research funding roles, and 7 years at NICE, where she was technical lead for NICE’s first digital health evaluation programme. Harriet is the community lead for CRUK’s DCSU Community of Special Interest for public involvement and diversity in data-driven cancer research. She has a PhD in molecular biology and an MSc in data science and artificial intelligence.
Dr Sumu Sethi is the Senior Director and Digital Health Strategy Lead for Respiratory, Immunology, and Inflammation at GSK, with a distinguished career in pharmaceutical innovation and patient-Centered care. She holds a Master’s in the Immunology of Infectious Diseases from the London School of Hygiene and Tropical Medicine and a PhD in Respiratory Medicine from the Royal Stoke University Hospital. After completing a postdoctoral fellowship, Sumu transitioned to the pharmaceutical industry, where she spent several years leading Phase I-IV clinical studies across various therapeutic areas within Clinical Operations. Driven by her passion for patient-centric innovation, Sumu has focused on advancing strategic innovation in clinical trials and clinical care, with a particular emphasis on digital biomarkers. She has also trained as a Design Thinking Coach, incorporating this approach into her programs to drive impactful solutions. In her current role, Sumu is at the forefront of shaping GSK’s Digital Health Strategy for respiratory, immunology and inflammation disease areas, leveraging cutting-edge digital sensors and integrating generative AI technologies to enhance clinical trial outcomes and revolutionize drug development.
Digital business units and Clinical Operations do not operate at the same speed and pretending otherwise is the source of most digital transformation disappointment in clinical research. Enterprise platforms are built for scale, governance, and longevity. Clinical Operations needs solutions that work this week, for this study, in response to this protocol amendment. This talk proposes a new organisational model: the embedded innovation incubator, a team that lives inside Clinical Operations but builds with Digital rigour. Drawing on a concrete AI-powered feasibility assessment tool as the proof of concept, this session challenges the audience to rethink not what technology they are building but where they are building it from.
Global biopharma executive with 20+ years of leadership experience transforming
clinical development through digital innovation, decentralized trial models, and
enterprise data strategies. Proven track record of building and scaling global
functions, delivering multi-million revenue growth ($5M → $23M), securing
enterprise investment, and leading cross-functional international teams.
Recognized industry thought leader in eCOA, hybrid and decentralized trials, and
connected data ecosystems. Experienced in influencing executive committees,
regulators, and external partners to accelerate development timelines, improve patient
access, and drive measurable business performance.
Nelly Marmy Conus has over 30 years of experience in clinical research, spanning academic, industry, and hospital settings. Beginning as a postdoctoral fellow in cancer research, she transitioned from basic and animal studies to leading clinical trial development and management.
Throughout her career, Nelly has held senior R&D leadership roles in multinational consumer healthcare companies and has been a driving force in the digital transformation of clinical trials. Over the past seven years, she has focused on advancing Decentralized Clinical Trials (DCTs), serving as Head of Business Development and Operations at a virtual clinical research startup, Patient-Centric Digital Solutions Lead at Novartis, and Digital Clinical Solutions Lead at Syneos Health.
She currently leads the Medical Research Department in Cardiology at Insel University Hospital in Bern, overseeing a team of 25 clinical research professionals and more than 70 active studies. Her passion lies in improving the experience of patients, investigators, and research partners through innovation and the digitization of clinical research.
Nelly holds a PhD in Biochemistry from the University of Fribourg (Switzerland), a Diploma in Clinical Trial Management from the University of Canberra, and an MBA from the University of Rochester/Bern.
Jonathan Crowther has spent the better part of a decade at the forefront of data-driven clinical operations building predictive analytics platforms at Pfizer that served over 1,400 users, and now leading Merck Healthcare’s Operational Design Center, where his team is redefining how global trials are planned, from early feasibility through to execution. His career sits at a rare intersection: deep scientific training, including a PhD in Biomedical Sciences from KU Leuven, combined with operational experience across some of the industry’s most complex trial portfolios. Jonathan’s conviction is simple but pointed: the clinical operations industry has over-indexed on platform procurement and under-invested in the connective tissue that makes platforms actually work.
