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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.
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.
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.
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.
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.
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!
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.
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
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.
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.
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.
