I am a Director of Process & Digitalisation at Novo Nordisk, leading transformation initiatives across R&D with a focus on process intelligence, automation, and digital innovation. I work closely with business and IT stakeholders to improve performance, reduce cycle times, and build the foundation for scalable AI adoption. My focus is on turning data-driven insights into tangible impact and positioning R&D as a leader in digital excellence.

Dr. Jodie Allen leads Clinical Trial Diversity at AstraZeneca and is responsible for global strategy and capability building in clinical development and operations. A medical sociologist by training, Jodie has 15+ years experience working across academic public health, life science consulting, and in pharma (Commercial and R&D). The red thread in her work is delivering large scale organizational change to improve patient access, experience, and outcomes. Her background in human behaviour in clinical settings, experience in technology implementation, and impact measurement are currently being combined to ensure that clinical trial populations reflect disease state populations in AZ sponsored trials.

Moe Alsumidaie, currently the Chief Editor at The Clinical Trial Vanguard, is dedicated to providing the clinical research community with the latest and most detailed information on clinical trials. His extensive experience includes leading roles in enhancing clinical trial processes through innovative technology and strategic management. As the Head of Research at CliniBiz, he has significantly improved the efficiency and affordability of clinical trials using automation and AI, and at Annex Clinical, Moe spearheads the development of advanced data integration and visualization solutions. His career also includes impactful tenures at Applied Clinical Trials Magazine as an Editorial Advisory Board Member, as a guest lecturer at Rutgers University, and at leading organizations such as Stanford, Mt. Sinai, Abbott, Roche and Genentech, where he has been instrumental in optimizing clinical operations and implementing novel procedures in clinical trials quality control.

Dr. Nadir Ammour began his career as an oral surgeon in public healthcare moving into clinical development. He is working to bring eHealth/Digital innovation in clinical development to deliver new medicines to patients faster. He led several projects in that space such as the Verkko remote trial, Connected Hospitals Network (EHRs); wearables trials, and on-line patient recruitment. Nadir is a member of the Institute of Innovation Through Health Data, and various cross pharma leadership boards. He led an EIT Health consortium project, EHR2EDC aiming at connecting healthcare and research and involved in several European IHI/IMI Consortia. Dr. Ammour held various global positions previously at Wyeth, now at Sanofi. He is graduated in medical informatics, health economics and an MBA from Reims Management School, besides his Doctorate in Medical Dentistry

Mette Andersen is a General Manager at WCG, where she leads Data, Analytics, and Insights. With a Master of Business Administration (M.B.A.) from Harvard Business School, Mette Andersen brings a wealth of experience from previous roles at Merative and IBM. Her expertise spans Research, Social Entrepreneurship, Chemistry, Nanotechnology, Physics, and more. Mette Andersen's work at WCG focuses on optimizing clinical trial outcomes through data-driven insights and predictive modeling. She is also a core member of the Healthcare Practice, Digital Health Group, and Scientist Network at BCG.

With over 25 years in the pharmaceutical industry, Dr. Artem Andrianov is a leading expert in RBQM and clinical data quality. As the CEO of Cyntegrity, he specializes in data-driven risk management in clinical trials. His academic background includes a Ph.D. in Mathematical Modeling and an Executive MBA. Artem co-founded Cyntegrity in 2013, focusing on advancing RBQM. His specialized knowledge spans Spirometry, ECG, Oncology, ePROs, and clinical data management. Committed to making clinical trials safer and more reliable, Artem is a key figure in the evolution of RBQM.

A little over 10 years of experience, as a Pharmaceutical Physician, with proven record of leading clinical studies successfully as Principal Investigator in multiple therapy areas; I founded AMELI-BIOGROUP, a physician-led clinical research site(s) established with the core intention of delivering high-quality, ethically grounded, and patient-centered clinical trials. Trained in Emergency Medicine in London, UK, with a focus on Infectious Diseases, Tropical Medicine, and Aviation Medicine, I was deployed to West Africa during the Ebola crisis, where I served. In recognition of service, I was awarded the Queen Elizabeth II Ebola Medal for Service in West Africa. Encountering some unanswered inherited conditions in my career led me to form AMELI-BIOGROUP LTD.—to raise awareness and to advocate for patients—guided by clinicians who understand patient care firsthand and prioritize safety, scientific rigor, and meaningful participant engagement.

Daniel works with the UK clinical trial ecosystem to successfully execute Moderna’s clinical trial portfolio across Infectious Disease and Oncology in UK. Moderna has become one of the largest sponsors of UK Commercial Clinical Trials and continues to partner with the UK ecosystem to test and scale innovations to increase patient centricity of our trials and accelerate our development cycles. Daniel joined Moderna from the NHS, where he spent 9 years in strategy and transformational roles. Most recently, as Deputy Director of Life Sciences within NHS England, he ran a £125m fund to scale AI technologies in NHS. Daniel previously worked in the Private Healthcare Insurance industry, having started his career as a management consultant.

Justin Bandura is the Patient & Site Engagement Team Lead for Obesity, Liver Health and Cardiorenal at Boehringer Ingelheim. He has previously held roles in medical device, sales, project management, and legal affairs. His passion for global cross-Human Pharma collaboration and strategic partnerships has been instrumental in driving innovation in study start-up and conduct across Boehringer’s trial pipeline. Justin is deeply committed to engaging external stakeholders with clarity and purpose, ensuring trial sites feel heard and supported, and helping position Boehringer as a sponsor of choice in patient and site engagement.

Andrew Barron is AI &Innovation Lead, Clinical Operations at Syneos Health. With more than 25 years of global CRO experience across Syneos Health, ICON, and Quintiles (IQVIA), he has led large-scale clinical operations, study start-up, and organizational transformation initiatives. Today, he focuses on AI-enabled clinical development, strategic partnerships, automation, and technology-driven innovation, helping shape next-generation operating models designed to improve the speed, quality, and predictability of clinical trial delivery.

Andrea Bastek, Ph.D., is VP of Market Strategy at Florence Healthcare. Her team's mission is to identify the biggest challenges in clinical trial operations and harness technology to solve them. Prior to Florence, Andrea spent 15 years working in clinical trial operations in the cardiac medical device industry. She holds a Ph.D. in Bioengineering from Georgia Tech as well as a BS and MS in Biomedical Engineering from Tulane University.

Liz Beatty is Co-Founder and Chief Strategy Officer at Inato, where she oversees global growth and partnerships to advance the company's mission of bringing trials to all patients around the world. Prior to co-founding Inato, Liz spent 15 years at Bristol Myers Squibb, most recently as Head of Digital Clinical Trials. She began her career as a clinical research coordinator at the Yale Multiple Sclerosis Research Center.

Gleb Beliaev is a Director of Automations at Eli Lilly, where he leads process automation and digital transformation initiatives in Trial Capabilities organisation. With a career spanning 13 years in clinical trials, he brings a broad operational and strategic skill set to the intersection of technology and business efficiency. Outside the boardroom, Gleb is a passionate music enthusiast and dedicated vinyl collector, with a deep appreciation for the art of recorded sound.

Carrie Ben Said is a visionary leader in global clinical trial operations and currently serves as Clinical Trial Teams (CTT) Center of Excellence (CoE) Head at Novartis Pharma AG. She has driven the formation of the CTT CoE and orchestrated a global transformation of CTT ways of working across more than 300 teams, positively influencing over 5,000 associates. Under her leadership, the initiative strengthened team dynamics and fostered a culture of collaboration and continuous improvement. Carrie also established a cross-functional leadership network spanning 40+ functions and oversaw the launch of a coaching academy for CTTs that accelerated transformation by 30%. Her work exemplifies scalable innovation, strategic collaboration, and a deep commitment to excellence in drug development. Carrie brings a rich blend of clinical, academic, and operational expertise to global drug development. She has led cross-functional CTTs as a Study Leader, overseeing strategic planning and execution of Phase I–IV trials in NSCLC, pNET, NET, and MCL, while effectively managing multiple studies with precision and impact. Her foundation in patient care including four years in neonatal and pediatric intensive care with ECMO certification—and academic research as part of Mt. Sinai’s Cardiothoracic Surgical Trials Network uniquely informs her science-driven, patient-centric approach to clinical excellence. She holds a Master's degree in Public Administration (Global Health Policy & Management) from New York University and earned a Bachelor's of Science in Nursing from the University of Texas.

Physician (Dr. med.) with 20 years of experience in the pharmaceutical industry: Medical Affairs, Drug Development (Lead of international project teams), In-Licensing, (Pharmaco)Epidemiology, Controlling/Project Budgets/Analytics in Clinical Operations. After heading a Data & Analytics Team for Clinical Operations, Frank recently moved into a Subject Matter Expert (SME) role advising on performance metrics, dashboards and various other topics related to Digital Transformation.

Karina Bienfait, PhD, is the Executive Director and Head of Consent, Biospecimen & Imaging Management at Bristol Myers Squibb (BMS). In this role, Karina is responsible for end-to-end management of biological specimens, medical imaging and informed consent for all BMS-sponsored clinical trials. Since joining BMS, she has driven the implementation of a state-of-the-art specimen management system, developed policies and processes to ensure specimen and imaging oversight, and has strategically transformed end-to-end consent operations for specimens for both protocol-related and future-use testing. More recently, Karina has assumed responsibility for full informed consent management for all BMS-sponsored clinical trials as well as leadership of the R&D Data & Specimen Governance Council which oversees secondary use of clinical trial data and specimens. Prior to BMS, Karina was at Merck & Co. for 10 years, where she held positions of increasing responsibility within Clinical Pharmacogenomics and Clinical Specimen Management. Her last role was head of Global Genomic Policy, Process, and Compliance (GPPC), where was responsible for evaluating the impact of global genomic and biospecimen policies and laws/regulations on Merck’s research programs; developing Merck policies, processes, and consent related to genomics and biobanking; and ensuring the compliant use of biospecimens. In this role, Karina also implemented routine genotyping of patients participating in Merck’s clinical trials to identify genetic predictors of drug response. Karina is currently an Advisor to SCOPE for Biomarkers and Biospecimens and co-chair of the Industry Pharmacogenomics Working Group. She has also served as a member of the Genomics Roundtable of the National Academy of Sciences, Engineering, and Medicine. Karina completed an internship in Clinical Psychology at Nassau University Medical Center and a postdoctoral fellowship in Clinical Psychopharmacology in the Department of Psychiatry at Rutgers University – Robert Wood Johnson Medical School. She holds a PhD in Clinical Psychology from St. John's University and a B.A. in Psychology and French from New York University.

I am a Clinical Operations Lead at Novo Nordisk, with experience across the pharmaceutical and CRO industries, supporting clinical trial start-up and trial delivery. I bring both trial execution and trial oversight experience, with my current focus on the pre-planning and start-up phase—ensuring operational feasibility from a HQ, affiliate, site and participant perspective. I collaborate cross-functionally to translate operational needs into workable study plans, provide operational input to protocols and drive stakeholder alignment throughout the start-up process. I apply an end-to-end mindset to ensure that initiation activities set the foundation for high-quality, compliant trial execution.

With a background in Biology, Fred transitioned to the pharmaceutical industry 17 years ago. Over the past 12 years, he has specialized in Risk-Based Quality Management (RBQM) and Centralized Monitoring across a variety of roles. As RBQM Lead at CluePoints, Fred is responsible for driving the operationalization of RBQM for multiple clients.

Niklas BLOMBERG is the Executive Director of Innovative Health Initiative JU (IHI.europa.eu). Niklas joined IHI, the European public-private partnership for health research and innovation, in 2024. Prior to IHI, he spent 10 years as the founding Director of the European life science research data infrastructure ELIXIR (Cambridge, UK) and 14 years with AstraZeneca, leading teams across Sweden and the UK. Niklas is a Swedish national with undergraduate studies in biochemistry at the University of Gothenburg and a PhD in structural biology and bioinformatics from the European Molecular Biology Laboratory (EMBL) in Germany. In the IHI Public-Private partnership, Niklas enjoys the unique opportunity to bring together industry, academic, and civil society across the healthcare sector—from pharmaceuticals and biotechnology to medical technology and big data—and drive projects that address public health needs, improve patients' lives, and boost the competitiveness of Europe's health industries.

Łukasz received his PhD in biochemistry from Nencki Institute of Polish Academy of Sciences and after enjoying a career in academia he joined pharma industry in 2009. Initially, he was involved in preclinical development programs at Celon Pharma SA, where he led several drug discovery projects in psychiatric and metabolic diseases. Some of these projects are now continued in clinical development phase. Later on, Lukasz transitioned to clinical monitoring roles at Quintiles Inc. (now IQVIA) and then at Covance to eventually join Centralized Monitoring Team at AstraZeneca in 2016. Now Lukasz is leading the Centralized Monitoring group, which guides study teams through study de-risking exercise and identification of areas that are critical to study quality. In the study execution phase the team led by Lukasz performs continuous central monitoring of study data in search of risk signals at study, country, and site levels.

Elena Bolanos Cascales is the Head of Global Clinical Operations for Europe Mid East and Africa (EMEA) Region. She leads a team across 24 countries providing end to end site-facing operational capabilities with key goal of delivering the clinical development programs with high quality on time and on budget. From her early days in Spain, Elena is passionate about making an impact in patients’ life through the acceleration of clinical research to have longer and healthier lives. Over 32 years in several pharma a biotech industries, she developed a good understanding in clinical development processes across multiple geographies. Before becoming Head od EMEA GCO, Elena served as Head of EMEA Head of Growth Countries, where he provided strategic direction to increase clinical research in those countries, with focus in underserved populations. Prior to joining J&J, Elena worked in Lilly for 26 years, where she starter her career in Clinical Research, and in Amgen, where she led the Global Site management and Data Management Organizations, developing a deep understanding of different cultures and geographies. Elena has designed, led, and executed several transformational projects that have resulted into improved efficiency and substantial savings in clinical development, while creating very effective partnerships at European and global level to leverage expertise. She is also passionate about developing and leading teams through success. Elena has lived in Spain, United Kingdom and Switzerland, giving her a dep appreciation of different cultures a how diverse perspectives can enrich progress in Healthcare. Elena in Pharmacist, and earned an MBA from Instituto de Empresa (IE), Madrid. She lives in Basel, Switzerland.

Maria Lizza Bowen brings over 3 decades of pharmaceutical industry experience to her current role as Head of Protocol Excellence, Clinical Science at Daiichi Sankyo. She has developed deep expertise across the drug development spectrum, from preclinical laboratory studies through quality manufacturing and oncology clinical research. Throughout her career, Maria has led global Phase I through Phase III clinical trials and programs, contributing to successful NDA submissions and FDA approvals for targeted therapies. At Daiichi Sankyo, she drives strategic protocol innovation within Clinical Science, advancing protocol optimization and DocGenAI integration initiatives. Previously, she held senior positions at Bristol Myers Squibb, Novartis Pharmaceuticals, and Sanofi Pasteur, with particular expertise in oncology and hematology clinical research. Maria is also a published author of "Reflect: A Perspective on Understanding Your Reality and Becoming Unstuck" and continues to write on topics spanning pharmaceutical industry insights and professional development. Core Expertise: • Protocol Development and Innovation • Clinical Science Leadership • Oncology Clinical Research • Strategic Drug Development

Ashley Brenton, Ph.D., is the vice president of RWE at Syneos Health, where she leads RWD and RWE strategy and execution. Brenton has 25 years of experience in RWE and genomics, developing and executing innovative strategies for life sciences. She also has deep expertise in multimodal RWD, including claims, clinical, lab, genomic and multiomic data types. Prior to her career in industry, Brenton was a genomic engineer in academia. Brenton earned a doctorate in entomology with a designated emphasis in vector-borne diseases from UC Davis; she also holds a bachelor’s degree in public health studies from Johns Hopkins University.

Julia Brodsky is Vice President, Data Strategy & Products within R&D Data Science & Digital Health at Johnson & Johnson. She leads a team focused on establishing an AI-ready, innovation-driven data ecosystem that integrates, standardizes, and productizes high-value R&D data—enabling scientists to rapidly apply AI/ML and generative AI, while embedding rigorous data governance and stewardship to ensure integrity, quality, and compliance. With more than 20 years in pharmaceutical data science and analytics, Julia is recognized for building enterprise-wide data strategies and scalable data platforms in close partnership with technology teams to unlock the value of data assets. Prior to joining J&J in May 2025, she served as Vice President, Head of Strategic Data Products at Novartis US Oncology, where she built and led a shared services organization delivering data and visualization analytics across all US business units, supporting 1,000+ users. Earlier, Julia held senior roles at Symphony Health Solutions; Organon and Sanofi. She has also served on scientific advisory boards and industry councils. Julia holds a BA in Computer Science and both a PhD and MS in Statistics from New York University.

Nicholas Brooke is the founder of The Synergist. For more than a decade, he has been the driving force behind its mission to build the conditions for collective action, shaping pioneering initiatives in patient engagement, precision medicine, investor engagement, women’s health, clinical trial data network, and the Patient Engagement Professionals Society. He served as the founding Executive Director of Patient Focused Medicines Development (PFMD) from 2015 to 2025, establishing it as the global reference point for patient engagement. An economist by training, Nicholas brings together strategic insight, digital innovation, and coalition-building, making him a leading architect of multi-stakeholder collaboration in global health. Through The Synergist, he continues to guide a portfolio of high-impact programmes, ensuring they deliver systemic and sustainable change.

>22 years in clinical research at various quality assurance and clinical operations roles at CROs and pharma. Recently focusing on risk-based quality management at UCB (e.g., study complexity assessments, risk-proportionate approach to study monitoring models, and risk-focused oversight of service providers). Extensive experience in managing regulatory inspections at the clinical investigator sites and sponsor. UCB's representative in EFPIA working groups for ICH E6 R3 (2020-2025) and US-EU GCP Inspection Mutual Recognition Agreement (2019).

I am an English man living in Madrid for 7 years. Shortly after moving I was diagnosed with pancreatic cancer. I thought I would be dead in a few months as my father had been who died of PDAC 40 years ago. Fortunately I am still here, at least for the moment, having gone through chemo radio and whipple. Now I live a pretty normal life divividing my time between patient advocacy work, spiritual assistance to others, carpentry and motorcycle journeys. In April and May 2026 I spent 7 weeks on the bike alone from Madrid to eastern Turkey. My own little pilgrimage in a way to where Sufism was strong for centuries and where the origins of our civilizations began in eastern Turkey (and Syria)

Robert Buka is a Product Director for the Medidata AI Intelligent Trials portfolio. He leads the Study Feasibility product, which helps pharmaceutical sponsors and CROs use historical data and predictive algorithms to properly plan and execute their clinical trials to achieve study enrollment targets. Robert has 10 years of technology industry experience leading data science teams and delivering digital transformation projects. Robert studied Biology and Statistics at the University of Pennsylvania.

Dr. Qasim Bukhari is a AI scientist at Johnson & Johnson R&D DataScience, where he focuses on applying AI, generative AI, and machine learning to optimize clinical trials and improve operational efficiency. He develops software and predictive models that support smarter trial design, patient selection, endpoint prediction, recruitment and site optimization, and real-time decision support—bridging engineering solutions with clinical development needs. Previously affiliated with the McGovern Institute for Brain Research at MIT (working with John D. E. Gabrieli), Dr. Bukhari brings deep expertise in analyzing preclinical and clinical data to predict treatment and disease outcomes for personalized medicine. Trained with leaders such as Terry Sejnowski, Markus Rudin, and John Gabrieli, and recognized for his COVID data analytics featured in major media outlets like NY Times, Washington Post etc, he integrates sophisticated engineering tools and AI to accelerate translational research and operational excellence.

I am dedicated to harnessing data to tackle complex challenges in the pharmaceutical sector, particularly within clinical operations to streamline drug development and enhance patient access. 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.

Clare Campbell-Cooper joined Fortrea in February 2020 and serves as its Global Head of Digital Health and Innovation. Clare has over 25 years of industry experience and is a recognized leader within the field of digital health. Clare has a wealth of experience encompassing many disciplines within clinical research and has held management positions within Data Management, Clinical Monitoring, Phase I Operations, Strategy and Planning, Project Management and, most recently, Digital Health. Clare is an active member of several boards and associations and sees that working in a pre-competitive environment is critical to helping drive change within industry. Clare sits on the Kings College London Scientific Advisory Board, Centre for Pharmaceutical Medicine Research. In her role as Global Head of Digital Health and Innovation at Fortrea Clare is helping to change the face of how clinical research is developing. She specializes in strategy development for both internal and external partners. Clare's special interest lies in the relationship between the caregiver and physician team and how the use of digital technology can augment this.

Alessia Cantamessa is an RBQM specialist with deep expertise in protocol risk assessment, CtQ factor identification, and operational trial oversight. A pioneer in clinical AI integration, she focuses on bridging the gap between advanced technology and proactive risk management. Her work centers on leveraging AI-supported tools to standardize risk identification, ensuring study quality is robust, scalable, and audit-ready.

Dr. Guillermo Carbonell is a Senior User Experience Researcher at BI X, the digital innovation lab of Boehringer Ingelheim. With a background in cognitive psychology and human–computer interaction, he applies qualitative and quantitative research methodologies to guide product teams in creating digital solutions that serve users while delivering business value. Over the past year, Guillermo has worked closely with the Patient & Site Engagement team, co-creating with site coordinators to shape more usable trial technologies and processes. His work focuses on reducing technology burden, supporting sustainable site operations, and ultimately improving patient outcomes.

A global life sciences and healthcare executive leading change, transformation and innovation in patient engagement and clinical trials, through diverse and inclusive patient & HCP recruitment and collaboration, and leadership in equitable healthcare.

With over 14 years of experience in the Healthcare industry leading digital departments across Clinical Development & Operations. I am passionate about problem-solving, and I have a strong track record of delivering innovative and impactful solutions and organizational transformation leveraging Data and Human centric Design thinking. Recently as a Digital transformation leader, I have successfully led and executed multi-million-dollar project delivery and transformation globally across Commercial and Drug Development, by collaborating with various Business Unit heads and Senior Leaders. I have also been instrumental in redefining and conceptualizing Planning as a Product and drove concept designs for digital Products across Portfolio acceleration, Trial Design, Site Selection, Competitive intelligence, Patient centric solutions, Gen AI and LLM based use cases in Drug Development.

30-year industry experience across CROs & Pharma working in Clinical Operations, Business Development & Procurement. Following a Biology Degree, I started my career as CRA working for Icon before moving into Business Development at Covance and subsequently Kendle (now Syneos). I joined Bayer in 2003 heading up a European Clinical Outsourcing function. As the outsourcing function developed and ultimately moved into the Global Procurement function at Bayer I assumed greater responsibility. Responsibilities have included leading regional teams across Europe & Asia for Pharma Development sourcing activities and Global teams responsible for Pharma Development Category strategy. During this time I was also heavily involved in the management of key supplier partnerships. I moved back into Bayer R&D to take a role leading an agile team to identify and manage a portfolio of future solutions supporting new approaches to clinical trial Planning and conduct to deliver faster, better, cheaper trials. Subsequently moving to the Alliance & Partnership Management function in my current role as Strategic Alliances Lead, leading the Bayer's key strategic projects with external suppliers to enable the organizations ongoing transformation.

Narinder Chopra is Director, Patient, Site Engagement, and Feasibility at J&J Innovative Medicine, where he leads cross-therapeutic strategies that bring patient and site insights into clinical development, strengthen recruitment and retention, and build enduring site partnerships. With more than 30 years of global drug-development experience, Narinder has held senior leadership roles spanning clinical operations, country management, late-phase research, feasibility and patient-focused drug development. Before joining J&J, he spent more than 14 years at Biogen, where he established patient engagement and representative recruitment capabilities, led global and regional teams, and helped embed patient insights across development programs. He is passionate about translating the lived experiences of patients and sites into more inclusive, practical, and effective clinical trials.

Grzegorz (Greg) Cinciala is a Sr. Director, Clinical Quality Operations Lead in Oncology. His responsibilities include management of operational quality, supplier oversight, regulatory inspections and overall risk-based quality management (RBQM) strategy. Grzegorz has >15 years of Clinical Research experience, primarily in E2E Clinical Data Management Execution, building and leading high-performing teams across many Therapeutic Areas, leading cross-functional initiatives on data-driven optimization of clinical trials execution. Grzegorz holds a Master of Science degree in medical biotechnology from the University of Medical Sciences in Poznan, Poland.

Steve Clark was diagnosed with stage 4 colorectal cancer in 2013 and has since become an active patient advocate. He is a regular speaker for audiences of patients, healthcare professionals, researchers, and industry representatives as well as volunteering with several charities including being a Campaigns Ambassador for Cancer Research UK. Steve is a patient representative to several studies and study groups and has been co-author on several papers focussed on improving patient care. In 2017 he set up www.StriveForFive.org, a not-for-profit organization with the mission to give hope to fellow patients with stage 4 cancer and to advocate for improved care for those with advanced cancer. Steve was recently appointed as Visiting Lecturer on patient engagement at Kings College London in the Faculty of Pharmaceutical Medicine. He is a Patient Engagement Consultant for the pharmaceutical industry with Redwood Brand Curators and has worked in UK and global pharma for over 35 years in business management and global marketing. Steve is a former Chairman of the Pharmaceutical Marketing Society and was awarded Healthcare Communications Advocate by Communiqué.

Charles Craddock CBE, FRCP (UK), FRCPath, DPhil, FMedSci Professor Charles Craddock is Professor of Haemato-oncology at the University of Warwick and Academic Director of the Centre for Clinical Haematology at University Hospitals Birmingham. Professor Craddock is Chair of the UK Stem Cell Strategic Oversight Committee and was Medical Director of Anthony Nolan from 2010–2014. He is a past President of the British Society of Haematology. Professor Craddock pioneered the development of both the UK Haemato-oncology Trials Acceleration Programme and stem cell transplant trials network, IMPACT. In 2021 he founded Accelerating Clinical Trials Ltd, an innovative haemato-oncology trials delivery vehicle. He has published more than 275 papers in peer reviewed journals. Professor Craddock was awarded the CBE for services to medicine in the 2016 New Year’s Honours list and elected a Fellow of the Academy of Medical Sciences in 2020.

Strategic Visionary in Digital Transformation & Analytics Leadership with Proven Analytics Portfolio Management Expertise With a keen eye for Strategic Vision, I've been at the forefront of advancing analytical capabilities, particularly in site intelligence, operational metrics, and quality indicators. My prowess in Digital Transformation has been instrumental in the on-time delivery and precision of a diverse suite of predictive models, leveraging ML/AI and Generative AI technologies. My role extends beyond mere strategy. I've championed an analytical development portfolio including in-house data & analytics transaction platform serving >1400 users, generative AI, and advanced modeling for business intel, ensuring robust analytical methodologies are in place, which has been pivotal for leadership and governance decisions. My expertise in Business Analytics and Product Analytics has been the backbone of this success, coupled with a budget management responsibility of >$5M. Building and nurturing relationships is at the core of my approach. I've continuously influenced key organizational stakeholders, ensuring the seamless adaptation and implementation of analytics and intelligence strategies. My proficiency in Engagement Management and Data Governance has been crucial in maintaining positive vendor partnerships, emphasizing quality delivery and continuous improvement. As a people leader, I've instilled a performance-centric culture, emphasizing Business Planning and actionable metrics. My commitment to Data Strategies and analytical thinking has ensured project and portfolio deliveries are not just timely but also rooted in process improvement. I've coordinated work with an agile mindset, ensuring products are delivered with consistency and precision. My technical acumen extends to Natural Language Processing (NLP), Business Intelligence (BI), data visualization, and cloud platforms including AWS, positioning me at the intersection of strategy and technology.

Isabella is the Specialist Commercial Services Manager at the National Institute for Health and Care Research, who oversees the operational delivery of the Patient Engagement in Clinical Development (PECD) Service. With comprehensive experience in patient and public involvement, and stakeholder engagement, she really understands and values how better collaboration can help us all to raise the profile of the public voice in research.

Jörg Dobers is a medical writing strategist (senior director) with over 20 years of pharmaceutical industry experience. Based in Berlin, Germany, he works at Bayer AG, developing submission strategies and authoring regulatory documents for NDAs/BLAs/MAAs across multiple therapeutic areas, including cardiology, ophthalmology and radiology. He has led successful global drug approvals and serves as project lead for genAI-enabled document automation. Jörg holds a PhD in Molecular Biology and is an active EMWA and DIA member.

Ventsislav Dobrev is a seasoned healthcare and life sciences professional with over two decades of experience across pharma, medtech and healthtech. He has held leadership positions at large organizations including IQVIA, Novartis, Ypsomed and Roche. Currently, he leads a global function at Roche which is responsible to integrate digital biomarkers in clinical trials.

Keith Dorricott is an independent consultant and Director of DMPI Ltd since 2016. He developed his process thinking whilst at Kodak Ltd and is a Lean Sigma Master Black Belt. He has worked in two large CROs leading corporate process improvement for 10 years. He provides expert training and consulting services in metrics (KPIs, KRIs, QTLs), process improvement, and root cause analysis in clinical trials. He provides leadership to the Avoca Quality Consortium on metrics across the clinical trial spectrum including RBQM, QbD, and DCT. He is a member of the Scientific Advisory Board at the Centre for Pharmaceutical Medicine Research at King's College London. Keith's passion is improving the effectiveness and efficiency of processes by working with those on the ground who are running those processes.

Adam Dubayev works as a Senior Global Manager on scientific recruitment and retention initiatives. He is responsible for managing Steering Committees, Global Expert Panels, and National Study Coordinator Communities in clinical outcome trials. Adam joined Novo Nordisk in the beginning of 2023 and has been involved in landmark cardiovascular outcome trials, such as SELECT, SOUL and FLOW. Prior to joining Novo Nordisk, Adam worked in LEO Pharma, Denmark and Reckitt, United Kingdom, holding different positions across the organizations, including Quality Compliance, Global Medical Affairs and Global Clinical Operations. In addition, Adam worked as a Research Assistant at the Department of Clinical Biochemistry, Copenhagen Royal Hospital. Adam holds a master of science degree in Molecular Biomedicine from University of Copenhagen.

Marcus is a Senior Manager of Feasibility at Biogen with 10+ years’ experience shaping data-driven feasibility strategies that set studies up for operational success. He focuses on strengthening feasibility methods and decision-making so teams can align early on the right operational approach and deliver studies faster and smarter.

Kristina Duggleby is the first Operations Director for the NIHR Industry Hub. She leads the operational framework designed to deliver faster, more predictable, and globally competitive commercial clinical trials across the NIHR infrastructure. Kristina brings over 30 years of experience within the NHS and life sciences sector, including her role as Operational Lead for the UK Vaccine Innovation Pathway. Her work is focused on ensuring sponsors, CROs, and delivery organisations experience a single, coordinated, and accountable commercial trials pathway, spanning from pre-submission to the recruitment of the last patient.

Samantha Eells is an epidemiologist and strategic leader with over twenty years of experience spanning clinical research, technology product development, and biopharma innovation. At TriNetX, Sam applies a data-driven lens to solving some of the industry's most pressing clinical challenges. Sam’s career includes senior leadership roles at Science 37 and Lightship, where she built and guided solutioning teams to develop transformative offerings for sponsors, clinical sites, and study participants. Sam's foundation in rigorous scientific research was established over a decade at UCLA and the Lundquist Institute, where she led federally funded epidemiologic studies and industry-sponsored clinical trials.

Mireille Ermens is a senior leader in the field of clinical research and healthcare management with a rich background spanning over two decades. Armed with a degree of Socio Medical Science with distinction from the University Ghent, Belgium, Mireille brings a unique blend of expertise in biochemistry, mathematics, statistics, and preventive healthcare. A true polyglot, Mireille is fluent in Dutch, French, and English, with proficiency in German and Spanish, reflecting a deep commitment to effective communication across diverse cultural landscapes. With a leadership style centered around "Building Bridges with and for People," Mireille has led clinical development operations teams, navigating challenges in rare and chronic diseases, high-volume infectious diseases, and seasonal vaccine environments. Currently serving as the Senior Director of Global Feasibility and Start Up Support at CSL Limited, Mireille spearheads strategic assessments of clinical trial feasibility, facilitating optimal business decision-making through meticulous recruitment-time-cost analyses and evaluation of execution options. Prior to this role, Mireille served as the Head of Global Site Management and Monitoring Oversight at CSL Seqirus, while advocating for global process consistency with patient-oriented oversight agility. Mireille's extensive experience also includes senior positions at Eli Lilly and Hoffmann-La Roche. Mireille began her career as an ICU Coordinator in Intensive Care at the University Hospital, Ghent, monitoring and caring for patients post-cardiac surgery, demonstrating a commitment to hands-on patient care. With a career trajectory marked by innovation, strategic vision, and a relentless pursuit of excellence, Mireille is a dynamic speaker who brings a wealth of knowledge and expertise to any discussion on clinical research, healthcare management, and leadership in the pharmaceutical industry.

Jack Evans currently serves as Vice President, Head of Europe at Civia Health. Prior to joining Civia Health, Jack held senior leadership roles at EmVenio Research, Pratia, and PPD’s Accelerated Enrollment Solutions (AES), where he led global teams across Project Management, Commercial Strategy, and Site Operations. His work focused on expanding clinical research access through site networks and SMOs across EMEA, North and South America, and Latin America, supporting over 300 research sites across Phases I–IV and a broad range of therapeutic areas. Jack built operational infrastructure, cultivated client partnerships, and drove international portfolio delivery. His efforts have contributed to the growth and global reach of clinical research organizations. Jack holds a bachelor’s degree in Pharmaceutical Science from the University of Wolverhampton.

Mathias Fällström is a Director in the Process Excellence team within Clinical Operations at AbbVie, responsible for the oversight and improvement of processes for study start-up, site activation, and monitoring on a global scale. A registered nurse by background, Mathias has built a 20+ year career in clinical research — progressing from CRA and Study Coordinator to global leadership roles in operational strategy. The common thread in his work is translating complex clinical operations challenges into practical solutions that put sites and patients at the center. Mathias is a strong advocate for site- and patient-centric trial design, believing that sustainable performance is built on empowering sites and improving the patient experience — with technology and process innovation as the enablers. His current focus includes improving informed consent through shorter, more readable documents supported by AI, expanding and refining Vault Clinical to continuously improve the study start-up experience, and developing country intelligence tools that give study teams the insights they need to activate sites faster and enroll the right patients at the right time.

Caroline Feys is Senior Director, Innovative Health at J&J Innovative Medicine, where she leads efforts to accelerate the discovery, development, and deployment of innovative capabilities that transform clinical research. With more than 20 years of experience spanning R&D, Medical Affairs, Clinical Operations, and Innovation, she has built a strong track record of driving complex transformational programs that improve patient experience, enhance site engagement, and advance operational excellence across global clinical development.

Candice Fitzgerald is a pharmaceutical executive with 25+ years of experience in clinical operations and medical affairs across multi-national pharmaceutical companies (Roche, AstraZeneca, Alexion, Boehringer-Ingelheim, and Novo Nordisk). She has held various positions at Vice President level, setting strategic direction and vision, implementing and leading global organisational transformative change, cross-functional initiatives enhancing pipeline execution, evidence gap identification, and launch readiness. Other accomplishments include delivery of new target operating models (hybrid FSP / FSO), digital transformations, and customer engagement models that significantly enhanced productivity across the clinical development value chain. Her global leadership and executive oversight experience spans early to late stage development across 50 countries with diverse cultures and complexities. Originally from Australia, she has enjoyed an international career, moving to Germany with her family in 2021, and is currently located in Zurich, Switzerland. Candice holds a Master's Medical Science (Drug Development), University of NSW, Australia; a Bachelor of Applied Science (Health Information Management), University of Sydney, Australia; and a Harvard Certificate Executive Program for Senior Life Sciences.

Olivier Flexas is an experienced leader with 25 years of experience in the pharmaceutical industry. Currently serving as Digital Product Line Owner, Olivier has consistently emphasized digital innovation and user experience in all the projects he has led. Throughout his career, Olivier has worked in various business areas, ranging from research activities to commercial activities, including manufacturing activities. For the past 7 years, he has been dedicated to advancing clinical studies and promoting access to therapeutic solutions in development to the largest number of patients, while prioritizing diversity through solutions that accelerate recruitment or through Decentralized Clinical Trials (DCT), which use digital technologies to conduct clinical trials remotely. Additionally, Olivier recognizes artificial intelligence (AI) as a key driver of innovation, leveraging AI to enhance efficiency and outcomes in clinical research and patient care.

Mette Flindt Heisterberg, Competency Development Specialist, Novo Nordisk. Mette has a background in academic research and has a PhD degree from Basic and Clinical Research in Musculoskeletal Sciences, Faculty of Health and Science, University of Copenhagen. Since 2017 Mette has worked at Novo Nordisk within Clinical Operations as trial manager and within the latest years as Clinical Excellence Specialist overseeing improvement projects and ensuring alignment across our Clinical Operations organisation on processes and strategic.

Clinical operations leader with 25 years of experience across biopharmaceutical and CRO organizations, including more than 10 years in leadership roles spanning country, regional (Europe), and global clinical operations. Expertise in clinical site management, clinical development operations, and organizational transformation having helped to establish and scale a clinical trial risk management capability within Amgen Clinical Program Operations. Recently in 2025 served as the implementation lead at Amgen for Risk-Based Quality Management (RBQM), where she led the design and implementation of a modernized RBQM operating model, driving transformation of processes, roles, and technology.

Joanna brings over 20 years of managerial and technical experience in clinical research industry delivering business and data transformation solutions. She has extensive experience in clinical and non-interventional risk-based data and quality management, innovation, and change management methodologies driving operational efficiencies. Her technical experience, background in analytics and process improvement bring critical value to technology implementation ensuring trial execution for patient safety and reliable data to answer the trial scientific questions. With her expertise and enthusiasm, Joanna supports new ways of working with clinical data, knowing that the growing scale of accumulated data requires us to establish an entirely new relationship with it.

Amy is passionate about bringing together data and expertise to inform clinical trial strategy and design. Focusing on operational efficiency in trial planning, bringing the science alongside the perspectives of patients and trial sites. Amy is an established leader in data-led strategic feasibility, study start-up and patient engagement. She has led the creation and implementation of these capabilities in global pharmaceutical companies. Combined with a background in clinical trial and program management she also has extensive experience in complex global clinical trial delivery across a broad range of therapeutic areas and phases. She has been in the pharmaceutical industry for over 20 years and is currently the Head of Feasibility and Study Start-Up at Jazz Pharmaceuticals.

Agnieszka Gackowska is a graduate of the First Faculty of Medicine at the Medical University of Warsaw and has nearly 30 years of experience in the pharmaceutical industry and in clinical research. From 2023 to 2026, she was associated with Velocity, a global network of clinical research sites, where she served as Managing Director and Vice President of Clinical Operations, responsible for the company’s strategic development in Poland. From 2024, she also served as a board member of Velocity Skierniewice Sp. z o.o. and Velocity Nova Sp. z o.o. Previously, she spent 14 years working for CRO companies, holding global and regional management roles at IQVIA and Parexel, where she was responsible for, among other things, developing networks of research sites, collaborating with healthcare institutions, and managing the identification and selection of research sites as well as patient recruitment and engagement strategies. From 1997 to 2009, she was associated with GlaxoSmithKline and Novo Nordisk, holding various management positions in marketing and sales, with a particular focus on innovative therapies, educational programs, and collaboration with the medical community. Since March 2026, she has been co-founder and President of Medivera Sp. z o.o., which operates under the Integrated Research Organisation (IRO) model in collaboration with hospitals and other healthcare institutions. Medivera focuses on developing medical activities in the field of specialist care and on providing professional managerial and operational support for clinical trials conducted at healthcare institutions. The company supports the integration of clinical research into everyday clinical practice, the strengthening of capacity at public and private research sites, and the building of sustainable structures that enable research to be conducted in line with the highest standards of quality and ethics. Agnieszka Gackowska also has experience in the non-profit sector as Managing Director of the Foundation for Hemophilia in Poland. She is actively involved in advancing education in the fields of preventive medicine, modern therapies, and clinical research. She has co-developed programs and lectured in postgraduate studies on clinical research at the Medical University of Gdansk, the Medical University of Lublin, and the John Paul II Catholic University of Lublin. She collaborates with industry organizations, including SCRS, GCSA, IAOCR, and GCP.pl.

Originally graduated as a Pharmacist in Madrid, and later completed my academic education with an MBA and a Master's in Public Health from Liverpool University. Over 25 years of international experience within the pharmaceutical industry in Regulatory Affairs, Medical Affairs, Marketing, Scientific Communications, and Clinical Operations in global and local positions in areas from cardiovascular to oncological diseases. In the last 2 years, my main professional interest has shifted toward patient-centricity within clinical development, recently taking on new responsibilities as an R&D Patient Officer. The development and coordination of patient-centric activities within Clinical Development programs, support of global and local teams, identification of best practices, and development of KPIs are the main priorities of my new activity.

Eusebio García is a Senior AI Engineer and Data Scientist with over five years of experience applying artificial intelligence and advanced analytics in healthcare and life sciences. His work focuses on large language models (LLMs), natural language processing, Machine Learning and retrieval augmented generation to build secure, auditable decision support systems for regulatory, medical, and research workflows. At Bayer, he designs and deploys cloud native generative AI platforms that support evidence synthesis, feasibility assessment, and early stage study design by orchestrating multiple AI components across data aggregation, analysis, and scenario exploration. His work aims to reduce manual effort, accelerate insight generation, and enable more robust and timely R&D decision making.

Victor Gascon Moreno is a nonprofit communications and digital health professional with 15+ years of experience in marketing, fundraising, PR, and multimedia for global NGOs and social impact initiatives. Since 2014, he has specialized in e-health, awareness, and patient advocacy. He currently serves as COO of the Global Allergy & Airways Patient Platform (GAAPP), leading global initiatives focused on chronic allergic, respiratory, and immunological diseases.

Awara Gbéblewo is an Associate Director and Site Engagement Lead at CSL with over 15 years of experience in global clinical operations and strategic site partnerships. She has led complex clinical programs across Europe, North America and APAC working with lead organizations including Bristol Myers Squibb, Bayer and Boehringer Ingelheim. Her expertise spans site engagement strategy, clinical trial execution, operational excellence and cross functional leadership in global environments. She specializes in strengthening collaborations between sponsors, CROs and clinical sites to accelerate trial delivery while improving patient access and experience. Throughout her career, she has lead initiatives aimed at improving diversity and enhancing partnerships with healthcare institutions and local communities. Awara is passionate about shaping the future of clinical research through innovative engagement models and global collaboration.

Mr. Getz is an internationally recognized expert on R&D and clinical trial management practices and trends, the global investigative site landscape, site management and patient recruitment and retention practices, and the worldwide market for outsourcing clinical research functions. Mr. Getz’s research studies on protocol design complexity and clinical research efficiency and effectiveness, conducted over the past two decades, are considered by many in the research-based life sciences industry to be pioneering work. His 20+ years of original research benchmarking R&D management practices, global outsourcing and the investigative site landscape have contributed to industry-wide understanding of these critical markets and to improvements in management strategy and execution.

Dimitrios Giannikopoulos is an Expert Clinical Data Manager at Bayer AG, Wuppertal, with leadership experience across both the pharmaceutical industry and contract research organizations. He holds a Ph.D. in neuroscience, complemented by further training in clinical data management, data science, and statistics. His work focuses on advancing clinical data management through cross-functional, technology-enabled initiatives, including decentralized clinical trials and the evolution of CDM toward AI-enabled ways of working.

With over 25 years of leadership experience in the pharmaceutical industry, Bernhard has consistently advanced in roles with increasing responsibilities in project and people management. From managing smaller-scale projects to leading the global Xarelto initiative with over 500 team members, Bernhards career is marked by significant achievements in operational excellence and innovation. As Vice President of Clinical Operations, he led teams >1000 FTE in 40 countries, has transformed organizational structures, boosting productivity by > 25% through strategic resource allocation and flattening hierarchies. Currently, he is pioneering initiatives to empower decentralized decision-making and enhance customer engagement in Clinical Operations EMEA/LATAM, this strategy contributed propelling Bayer Clinical Operations from the global position 7 to 1 (Top Sponser) in the CenterWatch site relation survey.

Alejandro Gonzalez is a Senior Manager in Digital Innovation and Execution at Genmab with extensive experience in statistical programming, clinical trial data standards, exploratory analysis, and digital innovation. His work focuses on building controlled, reproducible AI-enabled workflows that augment clinical experts, reduce operational burden, and support scalable validation in regulated clinical environments. He is actively involved in advancing practical AI operating models that balance efficiency with transparency and human accountability.

Clinical Operations executive with 15+ years of leadership experience across both CROs and the pharmaceutical industry , leading feasibility, site selection, study start-up, site engagement, and clinical trial delivery across Europe. Led large-scale Clinical Operations and Study Start-Up organizations site-facing professionals, driving operational excellence from feasibility through site activation. Spearheaded site partnership models, contract negotiation strategies, recruitment readiness, and site-facing transformation initiatives to accelerate study timelines and enhance site experience. Currently serving as Senior Director, Global Clinical Operations Oncology Europe at Daiichi Sankyo, driving operational readiness, delivery excellence, and sustainable site partnerships across the region.

Zahiah (Zee Zee) Gueddar leverages over 17 years of diverse industry expertise encompassing delivery, finance, operational effectiveness, and the commercial sector. Zee Zee offers invaluable insight into the challenges encountered by sponsors, CRO’s, sites and patients. In her role leading IQVIA’s Financial Technology offerings, she serves as an innovative partner for clients seeking transformative outcomes and growth opportunities. Known as a strategic thinker and problem solver, Zee Zee is responsible for driving growth and differentiation, product go-to market and ensuring innovative and competitive offerings. Zee Zee is based in Southern California and is a graduate of San Diego State University.

Duncan has more than 25 years of experience in the life sciences industry. He founded TRI in 2012 to create innovative technology solutions for companies wanting to transform their trial management capabilities by implementing RBQM.

Terttu recently joined Syneos Health to lead the delivery of clinical projects from a sites and patients perspective. Her teams' activities range from feasibility, country/site selection to site management and monitoring. Driven by a passion to unlock the potential of participation to a clinical trial for all patients, she includes innovative ways of working wherever possible and impactful. Terttu graduated from Maastricht University in the Netherlands as a Medical Doctor and spent several years in surgery and Ob/Gyn clinics before joining the pharmaceutical clinical development ecosystem, in which she now has 20 yrs experience in Clinical development in different roles such as principal investigator in a clinical research centre, therapeutic director in a CRO, country and regional head for clinical study units in Sanofi, global head for Trial Operations (including data management) and head of the Clinical Innovation Office in Sanofi. Leveraging her experience as a PI, the well-being of patients and the support of investigators in trials has been a driving force in Terttu's work in the industry. With the development and implementation of innovations along the development journey she aims to make clinical trials ready for the future—a mission that has gained urgency as the global pandemic has propelled the health care industry into the 21st century in unprecedented ways.

Bert is an experienced Industry Executive and Innovation Leader. He has led several

transformational innovation projects in the healthcare domain; always with the goal to bring

efficiencies to clinical research and optimize the patient experience, making full use of the

potential technology holds.

Bert is an international industry expert in Clinical Research and Digital Health. He graduated

in Biomedicine with a PhD in Medicine from Utrecht University in the Netherlands. He held

senior management positions in Clinical Operations, Quality Assurance, and IT at several

large pharmaceutical companies. In the last 10 years he set his focus on patient-centricity and

digital medicine, designing ethical solutions based on robust science to optimize the patient

experience. He augmented this with digital health technologies, including developing

solutions for disease characterization and remote monitoring.

Bert is an entrepreneur, one of the co-founders of DEEP Measures Oy, a Helsinki, Finland-

based health-tech company that provides a collaborative ecosystem platform for developing,

validating, and deploying sensor-based digital health measures (digital biomarkers) in

pharmaceutical clinical trials. In 2024 he setup his own digital health consultancy company

with clients ranging from large-cap pharma to startups/scaleups and non-profit organizations.

He is a systems-thinker who realized digital health solutions can have significant

environmental impact with excessive volumes of e-waste. This led to the formation of an EU-

funded cross-industry consortium to drive circularity into clinical research and healthcare,

through the DiCE program.

bhartog@hdhc.nl

https://www.linkedin.com/in/berthartog/

Dr Daphne Hazell is a GP, clinical research leader, and CEO of the Primary Care Research Alliance (PCRA), a rapidly growing UK network enabling commercial clinical trials across primary care. With over 20 years’ experience in NHS general practice and clinical research, she brings a unique combination of frontline clinical insight and strategic leadership in trial delivery. She is also Founder and Medical Director of Clinical Research Solutions, a CRO supporting sponsors in MedTech and real-world evidence studies, and Founder of a small boutique research nursing delivering decentralised clinical trials in community settings. Dr Hazell has led the development of research infrastructure spanning millions of patients, mentoring practices to transition from research-naïve to commercially active sites. Her work focuses on improving feasibility, site selection, and delivery reliability in primary care.

Bachelor in Nursing, with 20+ years of experience in big Pharma, working with clinical trials in various roles and companies. Master student since 2023, Industrial drug development at the University of Copenhagen.

Nick brings over 30 years of experience in global clinical development, with a strong track record in driving operational excellence and transformation. Nick’s career includes leadership roles at major pharmaceutical companies such as Johnson & Johnson, GSK, Novartis, Altana Pharma, Chiron Biopharma, and Pfizer, as well as senior positions in the CRO sector. His expertise spans clinical operations, study and project management, data management, vendor oversight, and inspection readiness to MHRA, EMA, and FDA standards. Nick holds a BSc (Hons) in Pharmacology from the University of Edinburgh. He is passionate about advancing clinical development to improve patient outcomes and is active in supporting medical education and community initiatives in the UK. Outside of work, Nick enjoys spending time with his family, traveling, and staying active through sports such as squash. He’s also an avid follower of English rugby and cricket.

Tim Horlacher is an accomplished executive with extensive experience in research, development, and business strategy. Currently serving as VP, Head of Global Clinical Program Excellence, Clinical Development & Operations and formerly as Head of Research & Development, Strategy & Business Consulting at Bayer since January 2020, Tim also co-founded and leads SiBreaX. Previous roles include Senior Project Manager at Bayer and Project Leader at The Boston Consulting Group (BCG). Tim's academic background includes a Ph.D. in Biochemistry from ETH Zürich and a Diplom in Biochemistry from the University of Regensburg, complemented by a Fulbright Scholarship at Michigan State University. Tim's early career involved research assistant positions at the Max Planck Institute and ETH Zürich, as well as a business strategy consultant internship at Simon-Kucher & Partners and experience as a paramedic with the German Red Cross.

Sara Huehls, MS, MBA—Associate Director, AI & Automation Lead, CDD Hub | Eli Lilly and Company Sara Huehls leads AI and automation strategy for Eli Lilly's Clinical Development and Design Hub, where she drives cross-functional evaluation, deployment, and change management for AI solutions across the CDDA Tech Agenda portfolio. With a Master's in Data Science and an MBA, she brings an unusual combination of technical depth and organizational change expertise to a portfolio spanning TMF automation, investigator-facing tools, process automation, and AI capability building. A certified PROSCI practitioner and two-time Lilly Innovator Award recipient, Sara is known for translating AI strategy into durable adoption—moving teams from tool deployment to genuine capability change. She also co-developed a graduate data science course with Indiana University using de-identified clinical trial data.

Lars Hulstaert leads Data Science teams within Johnson & Johnson R&D focused on applying AI and advanced analytics to improve clinical trial planning and execution. His experience combines machine learning, software engineering, and pharmaceutical development across both commercial and R&D settings. Lars previously worked at Microsoft and holds an MPhil in Machine Learning from the University of Cambridge.

• Jeff Huntsman is the Chief Commercial Officer, responsible for commercial strategy and revenue. Mr. Huntsman joined EmVenio in 2024 with over 30 years of experience guiding global commercial teams in clinical development and regulatory spaces. Mr. Huntsman previously led a consulting firm and held Chief Commercial Officer roles at Citeline, ConnectiveRx, Parexel and LIQUENT, in addition to serving in executive leadership positions at several other organizations. Mr. Huntsman earned a BS in Marketing and Political Science from Ball State University in Muncie, Indiana.

With over 20 years of experience in clinical operations, clinical risk management, and central monitoring, Jesús Jadraque is an expert professional in executing and advancing risk-based approaches in clinical trials. His career spans a range of roles and leadership initiatives within clinical operations, evolving into a specialized focus on RBM and RBQM. Jesús actively contributed to the implementation of Quality by Design (QbD) and Risk-Based Monitoring (RBM) methodologies at Eli Lilly, and supported the transformation of Risk-Based Quality Management (RBQM) processes at Worldwide Clinical Trials. Currently serving as Associate Director – Central Monitoring Leader at Johnson & Johnson, he contributes to the delivery of the J&J R&D portfolio in Oncology through accountability for RBQM and Central Monitoring processes, while also driving process enhancements and supporting the ongoing evolution of the operating model. Jesús is driven by a strong commitment to continuous improvement and a passion for tackling complex challenges in an ever-evolving clinical research landscape.

Tom Johnson is a seasoned professional who has devoted the last decade to optimizing the clinical study process for life sciences companies, focusing on reducing technical burdens and enhancing efficiency in study start-up and application access management. Exostar's expansive community includes half of the world’s largest pharmaceutical companies, over 36,000 organizations, 122+ connected applications, and over 891,000+ individuals working in thousands of sponsors, CRO and site locations worldwide. With a Bachelor of Science in Industrial Engineering from The Georgia Institute of Technology, Tom brings a unique blend of academic expertise and practical experience to his role, driving impactful solutions within the life sciences industry.

Zhanna Jumadilova is a physician scientist and pharmaceutical executive with broad experience in Clinical Development, Medical Affairs, and General Management at major pharma and biotech companies. Currently, Zhanna leads Pfizer’s integration of pragmatic clinical trials into medical evidence strategies. Zhanna earned an MD with a fellowship in Clinical Immunology from Kazakh State Medical University and an MBA from the University of Pittsburgh. Zhanna has directed complex clinical programs, developed market access strategies, built new development organizations, and ensured regulatory compliance for both large and small companies. Widely published in medical literature, Zhanna is an active member of TransCelerate BioPharma and participates in other industry organizations and has collaborated with major regulatory bodies to advance innovation in clinical research.

Ibrahim is a senior leader in clinical data management and digital transformation at Novo Nordisk and has over 20 years of experience working with data and clinical studies. Ibrahim has also led multiple projects that evolve the way data management is conducted at Novo Nordisk and the broader industry. He is currently leading the DataNow Program to renew the digital infrastructure for clinical studies, with end users and patients as the focus.

Daniela is an experienced expert in clinical research, with over 30 years of professional experience in nursing, clinical trials, and study coordination. After completing her training and working as a registered nurse, she transitioned into clinical research in 2008. Since then, she has worked as a study coordinator and team leader in oncology and neurooncology, including positions at leading German university hospitals, a contract research organization (CRO), Freelance Study Coordinator and currently conducts clinical studies at a neurology practice in Munich. Since 2019, she has served as Chair of the German Association of Non-Physician Clinical Research Staff (BUVEBA e.V.). In this role, she is strongly committed to enhancing the visibility and professional recognition of study coordination, as well as advocating for the introduction of mandatory, standardized training in this field. Her particular focus is on bringing greater attention—within the scientific community, policymaking, and the public—to the central role of non-physician clinical research staff in the success of clinical trials. She especially emphasizes the importance of study coordinators in ensuring high-quality patient care, structured study management, and the maintenance of quality in trial conduct. She actively contributes to multiple initiatives focused on advancing Germany as a leading clinical trials location and increasing public awareness of the vital role of clinical research.

Ariel Katz is the CEO and Co-founder of H1, the leading healthcare platform that connects the world to the right doctors. Named to the Top 25 HealthTech Entrepreneurs of New York for 2025, Ariel leads H1 in delivering access to the largest network of doctors worldwide to accelerate drug development & commercialization, advance clinical research, and connect patients with the right care. Katz co-founded H1 in 2017 after previously launching ResearchConnection to help connect students with research opportunities, which grew to over 40 universities and was acquired by the Jefferson Accelerator Fund, Bill and Melinda Gates Foundation, and the Ewing Kauffman Foundation.

I have over 10 years of Regulatory Affairs experience working globally with expertise in early and late-stage drug development as well as life cycle management of drugs. My work spans the regulatory assessment of clinical endpoints, clinical outcome assessments, and data-driven analyses for regulatory acceptability across FDA, EMA and other global agencies. I contribute to labelling strategies that address transparency, clinical interpretability, and consistency between clinical trial outputs and label claims, working cross-functionally to ensure labels remain scientifically robust, regulatorily defensible, and suitable for prescriber and patient facing communication.

Camilla began her career at Novo Nordisk A/S in 2008, dedicating the first five years to the setup and specification of RTSM systems (randomization and dispensing) within the Clinical Supplies business area. In 2012, she transitioned to Data Management, initially serving as a Clinical Data Manager where she was responsible for setting up data collection systems. Later, she took on the role of Project Data Manager, focusing on the standardization and alignment of data management activities within projects. Since November 2022, Camilla has been Product Owner for in-house build metadata repository and study definition repository, OpenStudyBuilder, which is TransCelerate aligned Digital Data Flow initiative at Novo Nordisk, aimed at digitalizing the study specification process from protocol to submission.

Shafaat Ali Khan, MB, BS, Eli Lilly and Company Associate Director – Investigator Engagement Clinical Research Lead (CRL) Ali is a seasoned clinical research professional with a passion for revolutionizing the way clinical trials are conducted. As the leader of Lilly's Site and Investigator Engagement organization, Ali spearheads efforts to operationalize and execute highly decentralized clinical trials, driving efficiency and innovation in the field. With a strong focus on patient empowerment, Ali is on a mission to enhance patient education and improve access to novel investigational therapies and diagnostics. By leveraging advanced technologies and patient-centric approaches, Ali strives to break down barriers and ensure that more individuals can benefit from cutting-edge treatments. Recognizing the absolute need for achieving greater diversity in clinical trials, Ali is dedicated to promoting inclusivity and equity within the research landscape. By actively seeking to engage diverse patient populations, Ali aims to eliminate disparities in healthcare outcomes and contribute to more comprehensive and representative data. Ali's unwavering commitment to accelerating drug development is fueled by the desire to bring life-changing therapies to patients faster. He leads multidisciplinary teams at Lilly, to closely collaborate with sites and investigators to drive innovation across the drug development lifecycle. Combining his extensive expertise in clinical research with a genuine passion for improving patient outcomes, Ali is a catalyst for change in how clinical trials are conducted.

Garo Kiledjian is the Founder and CEO of SGMA, a 501(c)(3) nonprofit advancing Sexual and Gender Minority (SGM) inclusion in clinical research, life sciences and healthcare ecosystem. He also serves as COO for Trialogic, a site network for the largest global HIV healthcare provider. A personal loss to AIDS inspired Garo’s dedication to addressing healthcare disparities for marginalized communities. His diverse experience in administration, research, pharmacy, and finance strengthens his leadership. Garo served on the Executive GALA Committee for the National LGBTQ Task Force, a historic advocacy group focused on grassroots legislative and policy changes in DC. He holds a Bachelor’s from UCLA and studied Leadership and Global Strategy at Woodbury’s Graduate School of Business.

Dr. Naveen KK has worked in healthcare, CRO & ITES industries for 18+ years; he has experience working across pharmacovigilance, risk-based monitoring, cardiac safety services, and connected devices. Physician with MBA & Lean Six Sigma Black Belt Certification. He is currently working as Executive Director & Global Head, Central Monitoring, Medical Data Review, and Clinical Trial Safety in Labcorp.

Olgica Klindworth is Vice President for Data Quality and Risk Management at Medidata, where she focuses on developing Data Quality solutions, including creating AI-driven data surveillance approaches. Before joining Medidata, Olgica dedicated 17 years to PPD, with a decade spent in data management leadership roles. During her tenure, she built Data Management capabilities and supervised the execution of numerous clinical trials spanning various therapeutic areas. Olgica also played a pivotal role in developing Data Analytics and Centralized Monitoring processes and capabilities at PPD. Olgica holds a Bachelor of Science degree in Microbiology from the University of Texas at Austin and a Master of Science degree in Analytics from Texas A&M University.

Sven Knapinski has led CSL’s Site Engagement Team since 2024, driving initiatives to strengthen strategic partnerships with clinical research sites and institutions. He focuses on expanding and diversifying CSL’s global site network, centralizing organizational knowledge, and enabling more streamlined, effective engagement across Sponsors, CROs, and sites. With nearly 20 years of experience in Clinical Operations, primarily in Clinical Trial Management, Sven brings deep operational expertise and a strong focus on execution. He holds a PhD in Biology and began his career in a CRO, followed by experience in the medical device industry, before joining CSL (Vifor) over 12 years ago.

As Owner and Managing Director of LKL Consulting AS, I bring over 35 years of experience in the life science industry, including 25 years in leadership roles. My expertise spans clinical operations, medical affairs, and local/regional/global leadership. Through interim and consulting services I create value for organisations by combining strategic analysis with impactful execution, achieving strategic objectives and driving measurable business success. I have a strong track record of delivering complex strategic objectives, increasing performance, driving business transformation, leading high performing teams and building strategic partnerships. My leadership philosophy is strongly people focused, inspiring & empowering others through fostering a culture of trust, accountability and collaboration. What sets me apart is my unique combination of deep industry expertise, successful leadership in both country and international roles, and the energy I bring to every challenge. I’m passionate about driving innovation, delivering value, and making a difference for patients.

Maria Koutsopoulou is heading Global Development Operations (GDO) within the healthcare business of Merck KGaA, Darmstadt, Germany. In this role, Maria leads and manages all operations related to the conduct of Merck KGaA/EMD Serono clinical study portfolio – from Phase I to Phase IV studies, including investigator-sponsored studies (ISSs), in all therapeutic areas. Maria’s remit also includes bringing highly innovative, patient-centric operational designs and approaches to the development programs while overseeing operational and clinical data flow as well as utilizing technology and digital innovations to accelerate and simplify studies across the portfolio. Maria has more than 25 years of global clinical development experience in both the CRO and pharma industry, from early development to post-launch. She has a keen focus on accelerating drug development, elevating the R&D efficiency to the next level and she brings an entrepreneurial and innovative spirit to serve patients in need. In previous roles, she successfully led various clinical operations functions at the local, regional, and global levels.

Arun Krishnamurthy is a Product Director for Risk-Based Quality Management (RBQM) at Novo Nordisk, based in Denmark. With over 20 years of experience in clinical development and operations, Arun has led enterprise-level strategies spanning process optimization, technology enablement, and organizational change. Prior to joining Novo Nordisk in 2011, Arun was with Accenture, where he held leadership roles in Clinical Data Management, delivering large-scale, outsourced solutions for global pharmaceutical clients. At Novo Nordisk, he has held leadership positions across Data Management, Biostatistics, IT, and Clinical Operations, driving transformation and digitalization initiatives. Arun currently leads a cross-functional program to embed a coordinated, proportionate, Quality-by-Design-driven and data-centric approach to risk and quality management—strengthening decision-making, cross-functional collaboration, operational excellence, and patient safety.

Sofija Krivokapic is a Data Science Lead in the Clinical Quality team within R&D Biopharmaceuticals at AstraZeneca, based in Warsaw, Poland. She designs and deploys scalable AI and NLP solutions for the clinical domain, applying advanced models to detect patterns and surface emerging themes that enable a proactive approach to clinical quality. She develops and leads enterprise-grade Power BI initiatives, translating complex analyses into clear, actionable insights for stakeholders. Her work is backed by a master’s degree in Cognitive Science from the University of Warsaw, with a focus on computational approaches across psychology, data science, AI, and linguistics.

Dr. Tobias Kruse is the Chief Scientific Officer at Clariness.

He is the founder and former CEO of Trials24, a company supporting biotech and pharmaceutical companies, as well as CROs, in accelerating patient recruitment. Trials24 was acquired by SubjectWell in September 2024 prior to its merger with Clariness.

Before founding Trials24, Tobias co-founded ImevaX, a biotech company focused on vaccine development, where he developed the digital patient recruitment strategy. Tobias earned his PhD in Molecular Biotechnology from the Technical University of Munich. He holds numerous patents and has published papers in journals such as Nature and EMBO.

Christophe Lahorte, PhD, is Head of the Innovation Office and Head of the Scientific-Technical/Regulatory Advice & Knowledge Management Unit at the Belgian Federal Agency for Medicines and Health Products (FAMHP). A pharmacist by training, he began his career conducting research at the University of Ghent on the development of diagnostic and therapeutic radiopharmaceuticals. Since joining FAMHP in 2004, Dr. Lahorte has played a key role in the assessment of clinical trial applications, paediatric investigation plans, and scientific advice procedures. He previously served on the European Medicines Agency’s Paediatric Committee Formulation Working Group and has contributed to GMP inspections and regulatory evaluations at both national and European levels. As Head of the Innovation Office since 2017, he focuses on accelerating and facilitating the development of innovative medicines and healthcare products, working closely with academic researchers, start-ups, SMEs, and established companies. He represents FAMHP within the EU Innovation Offices Network (EU-IN) and participates in several European working groups focused on emerging technologies, borderline products, and regulatory innovation. Dr. Lahorte has extensive experience in scientific and regulatory advice, particularly in early-stage development, and has contributed to numerous national and European research and educational initiatives in collaboration with international organizations and institutions.

Sir Martin Landray is CEO of Protas (protas.co.uk), Professor of Medicine and Epidemiology at Oxford University, and a practising hospital physician. He has over 25 years’ experience of leading large, randomised trials with particular experience in cardiovascular and kidney disease. He is co-lead of the RECOVERY trial of treatments for COVID-19, which discovered 5 effective treatments and saving an estimated 1 million lives globally. His work focuses on the fusion of smart design and intelligent technology to drive gains in speed, quality, and efficiency. He has played leading roles in regulatory improvement initiatives working closely with regulators, government and health organisations (including FDA, EMA, MHRA, ICH, G7, WHO).

Jason has over 19 years of experience working in Pharma, 14 years of which have been with Janssen. For the last 5 years, he has been a member of Janssen Clinical Innovation where he applies his strong technical and collaboration skills and global project leadership in delivering transformational innovation projects that have the goal to shape the future of clinical trial operations at Janssen. Jason is the Focus Area Leader for Environmental Sustainability in Clinical Research and is leading the transformation of Janssen’s global clinical operations towards sustainability.

Disa has 20+ years of experience working in science and innovation, especially in the pharmaceutical industry. She is the Head of Data Products & Governance with the Data Science organization at Johnson & Johnson. Previously, she was at UCB as the Head of Innovation and held other leadership roles. She was awarded Top 100 Women in Technology, Financial Times' top 100 most influential BAME Leader, and featured on the cover of CIO Look celebrating Women in Tech. She co-authored a book titled 'Digital Health and Patient Data, Empowering Patients in the Healthcare Ecosystem'. Her passion is closing the gap for patients with unmet needs and exploring the right digital capabilities to accelerate the implementation of end-to-end patient solution.

Micah has 20 years of experience in the biopharma industry. He is an Executive Director at Cambridge Healthtech Institute (CHI) where he is a producer, content developer, and facilitator of the Summit for Clinical Ops Executives (SCOPE), the leading event in the US and Europe for biopharmaceutical industry executives focused on driving innovation in clinical trials and digital health. On a daily basis, he builds a broad community of clinical research stakeholders and industry thought leaders, performs market research, and ascertains ever-changing industry trends in clinical trial optimization, clinical innovation, patient recruitment, digital health, drug development, clinical trial technology, and population health. He is also the Co-founder and Vice President of Community and Business Development of ClinEco. ClinEco unites sponsors, CROs, service providers, and sites on the world's first B2B global clinical trial marketplace so each can expand clinical partnerships. SCOPE and ClinEco are owned by Cambridge Healthtech Institute (CHI). Please join our SCOPE and ClinEco communities! https://clineco.io/; www.SCOPEsummit.com; www.SCOPEsummiteurope.com

Erbin Lim is a visionary data leader with a relentless passion for leveraging Artificial Intelligence to create transformative business solutions. Armed with a PhD in Computer Science and a wealth of technical expertise across the entire software stack, Erbin is at the forefront of revolutionizing industries through AI-driven innovation. Throughout his career, Erbin has demonstrated an exceptional ability to harness the power of AI to solve complex business problems. He has a track record of translating business requirements into cutting-edge AI solutions, earning him recognition as a trusted advisor among business stakeholders. At Pfizer, Erbin's strategic implementation of data and AI solutions revolutionized clinical trial site selection processes. Through his thought leadership, he introduced advanced Data/AI/ML methods that significantly enhanced data accessibility and decision-making across various business units.

Twenty years of clinical research experience in both Pharma and CRO, focusing on global feasibility, site selection and study start-up for early and late phase clinical trials. With a keen eye towards optimizing clinical trial execution through informed data-driven decisions, Nadia looks to enhance site feasibility by leveraging real-world insights for optimal feasibility planning.

Rana Lonnen is a healthcare technology investor, entrepreneur, and molecular biologist. At Novartis, she leads strategic investments in technology companies, on a mission to transform the healthcare ecosystem and make positive impact on people’s lives. Previously, Rana was Head of Preclinical Development at a UK biotech, Auspherix; investment consultant to IP Group in London; Founder and CSO of a UK-based Biotech, Axendos therapeutics. Prior to this, she was a Wellcome Trust-backed principal investigator in drug discovery in the field of Infection, Immunity, and Inflammation, author and inventor on high impact peer-reviewed publications and patents; before this, Rana worked at Bristol-Myers Squibb, in sales and marketing. Rana holds a PhD in molecular biology and an MBA from Imperial College London. She personally cares about equitable healthcare, social justice, sustainability, and the future of antimicrobial resistance. In her downtime, Rana likes to make culinary experiments, be in nature, and read. Rana is a board observer at Aktana, Cota Healthcare, H1 Insights, Koneksa, Mekonos, NuvoAir, and Dopavision. She is based out of Basel, Switzerland.

Piotr Maslak is Senior Director and Head of Emerging Technologies at AstraZeneca. He leads global efforts to transform clinical trials with digital platforms and AI – accelerating development and making research more patient-centric. Piotr has a track record of scaling enterprise AI solutions and driving award-winning innovation. Recognized for driving digital transformation in pharmaceutical industry, he is passionate about challenging conventions and shaping the future of clinical research.

Dr. Tariro Makadzange is an infectious disease physician–scientist and the CEO of the Africa Clinical Research Network (ACRN), a pan-African platform advancing equitable participation in global clinical trials. Building on a career spanning academia, industry, and global health, she now leads ACRN’s mission to transform how clinical research is designed and delivered across Africa by strengthening site networks, embedding high-quality operational standards, and enabling locally led trial execution. Under her leadership, ACRN integrates digital infrastructure, data systems, and AI-enabled tools to improve trial efficiency, participant identification, and real-world evidence generation, while advancing policy and regulatory engagement to create a more enabling environment for research on the continent. She is also deeply committed to community engagement as a core pillar of clinical research, ensuring that trials are accessible, trusted, and responsive to local populations. Dr. Makadzange’s work focuses on shifting Africa from a marginal participant to a leading contributor in global clinical development.

Marcin Makowski is the Head of Centralized Monitoring and Data Analytics at GSK. Previously Marcin held similar positions at AstraZeneca and UCB. Last 10 years of Marcin’s career was revolving around establishing and improving Risk Based Monitoring models including centralized monitoring and quality tolerance limits. Marcin holds MD and PhD degrees from the Warsaw Medical University.

Javier Malpesa holds a degree in Chemical Sciences and a master’s degree in Analytical Chemistry from the University of Barcelona, as well as an MBA from IDEC at Pompeu Fabra University. He began his professional career in the pharmaceutical industry in 1997 at Biomedical Systems, and since 1999 he has been associated with the Novartis Group, where he started in the Clinical Operations department as a CRA. Since then, he has progressively taken on positions of increasing responsibility: in 2002 as Development Coordinator for the Cardiovascular, Metabolism and Respiratory areas; in 2008 as Respiratory Medical Advisor; and from 2009 to 2016 as Global Monitoring Operations Head for Spain and, ad interim in 2015, as MSL Head in Rare Diseases. Since 2023, he has held the position of Study Site Operations Country Head for Iberia, as well as the role of Global Drug Development Coordinator also for Spain.

Viviane Manghi is the Senior Director, Strategy & Value Delivery as part of the Global Operations & Strategic Transformation team at Labcorp, with a background spanning clinical operations, central laboratory services and clinical consulting. She brings a cross-functional perspective to optimize trial delivery and focuses on shaping strategies that enhance site engagement, streamline workflows and enable more innovative trial delivery models. Passionate about innovation and collaboration, she helps bridge operational realities with long-term strategic goals in clinical development.

Yu Mao, MBA, PharmD, is Director at Janssen R&D (JRD) of Data Science and Digital Health as well as the DE&I Lead. In her current role, she leads the DE&I data science strategy across the JRD portfolio as well as advances a people first culture. Her focus is on developing novel data driven approaches to advance diversity in clinical trials end-to-end, with the goal to address health disparities and improve patient outcomes. She has been with Johnson & Johnson 5+ years, with strategic and operational experience in both the consumer and pharmaceutical sector. She is an ambassador for innovation and is a strong believer in data science and its ability to transform healthcare. Her foremost passion is for people and always strives to cultivate a strong, patient-focused culture.

Lydia Matombo is TA Director, Oncology, at AbbVie, where she provides Risk-Based Quality Management leadership supporting the oncology portfolio. She brings extensive experience spanning clinical data management, clinical operations, and enterprise RBQM, with expertise in Quality by Design, risk assessment, critical-to-quality factors, KRIs and QTLs, centralized monitoring, and risk-based study oversight. A Registered Nurse by training, Lydia brings a patient-centered perspective to clinical development. Her thought leadership focuses on translating risk and data signals into timely, proportionate decisions, building organizational capability, and making RBQM actionable across the clinical trial lifecycle.

Thera Max-Mos has a background in biotechnology, and entered the pharma industry shortly after completing her studies. She spent 16 years at Sanofi, primarily in clinical research. During her time at Sanofi, she was extensively involved in implementing new European legislation. This experience serves her well in her current position at CCMO, as head of the CCMO National Clinical Trial office since 2022. She is an active participant in the Regulatory Science Network Netherlands (RSNN), contributing to discussions on regulatory science, and strengthening the regulatory field.

Robert is a technology and innovation ecosystem gardener, dedicated to defining new methods for developing and deploying novel, value-adding solutions at scale for Novartis. His current mission is imagine, design and deploy an AI-powered decision-support backbone and rebuild our drug development processes around this technology core. Passionate about product-centric innovation and agile methodologies, Robert has led the development and scaling of several large-scale analytics and AI platforms across Novartis divisions and managed several technology platforms at scale. He explores data science approaches and partnerships to drive operational efficiency and empower associates with the data and insights they need for daily decision-making. Previously, Robert led strategy projects at BCG and has a background as a researcher in the medical imaging space and as a mechanical engineer specializing in joint biomechanics.

Emily McInturf, Director of Feasibility, has worked in the clinical research industry for the past 19 years. As a leader within PSI’s global feasibility team, Emily specializes in strategy development across multiple therapeutic areas – focusing on aligning a study’s design with top enrolling investigators in the right countries. Using PSI’s INTELIA platform, a machine-learning-powered system for data-driven feasibility and enrollment forecast, Emily models and compares hundreds of country and site combinations, their budgets and probability of success, ultimately recommending the most optimal enrollment scenario in line with each sponsor’s key objectives. As a director, Emily provides oversight for global feasibility and site identification activities for both pre- and post-award opportunities and projects.

Catherine is accountable for Clinical Biosampling Operations within GSK drug projects, Data Operations and Laboratory Alliance and Technology developments in Biosampling practice. Catherine is accountable for the Platform Sciences Graduate Program and for a team of Biosampling professionals in the UK, USA, Belgium, Poland, Canada and China. The Institute of Leadership and Management awarded Catherine a fellowship in recognition of her work on pharma leadership, in developing leadership training and inspiring junior leaders. With a background in academic science within university and hospital settings, Catherine retains an understanding of the needs of patients, clinicians, and the challenges of delivering quality clinical research, within a global healthcare setting.

Laura is a strategic leader in Global Development at Johnson & Johnson Innovative Medicine with extensive experience across clinical operations, feasibility and health data organisations. She currently serves as Global Feasibility Lead where she drives evidence-based country, site, and delivery strategies to optimise execution across complex global development programmes. Laura is recognised for her ability to translate scientific and operational insights into scalable, high-impact delivery strategies. She has led international teams, built cross-regional operational frameworks across Europe, and partnered with senior stakeholders to shape integrated approaches that enhance study performance and patient access. Holding a PhD in Biotechnology and Biochemistry, Laura is passionate about advancing high-quality, patient-centric clinical research through data-driven decision-making, innovation, and collaborative leadership.

Celia Miguel Blanco, PhD, is a Medical Writer at Bayer with a strong background in regulatory and clinical documentation. She authors study-level documents, including clinical study reports and protocols, ensuring high-quality, compliant, and strategically aligned content. She brings several years of industry experience in medical writing and has contributed extensively to clinical documentation. Celia is actively engaged in advancing the application of AI in medical writing, supporting the adoption of AI-enabled solutions and driving more efficient and scalable content development approaches.

I am a clinical research–focused Learning & Development specialist dedicated to elevating site training from a compliance exercise to a driver of real-world performance. Site training should do more than confirm completion—it should strengthen judgment, reinforce protocol ownership, and shape the behaviors that underpin high-quality trial execution.

Rosa Monesma is a Risk Advisor at Gilead with more than 20 years of experience in global pharmaceutical organisations. She brings deep expertise across clinical operations, data management, global quality, inspection management, and RBQM, enabling her to develop a comprehensive perspective on trial design, execution, and oversight. Rosa is actively engaged in internal capability building and process improvement initiatives, with a strong focus on inspection readiness. Her work focuses on embedding critical thinking and risk-based approaches across the clinical trial lifecycle and translating evolving regulatory expectations into practical, sustainable operational models grounded in quality by design principles.

Melissa Mooney has over 19 years of experience in the development of eCOA solutions for use in clinical trials. Melissa’s area of expertise is eCOA solution design where she has supported clients and eCOA vendors in developing robust and usable eCOA software solutions that meet eCOA protocol requirements. She also brings a plethora of experience in eCOA requirement gathering, leading eCOA User Acceptance testing, eCOA data management, and BD support.

I am Julia Movshovich, Associate Director of the Central Monitoring group within the Data Surveillance team and a Global TA Lead at Pfizer. With a keen eye for detail and a passion for ensuring quality and compliance, I oversee risk-based monitoring processes, ensuring quality and compliance. In my current role, I lead central monitoring activities for studies in Pfizer’s risk-based monitoring model across assigned Therapeutic Area. Collaborating with other Global TA Leads to implement global strategies, initiatives, processes, and standards to ensure consistent, efficient, and quality central monitoring processes to meet expected quality, timelines, and deliverables. Previously, I held various positions at CRO, where I was involved in central monitoring activities for RBM strategies, specification, development, validation, and delivery of standard data integration and reporting solutions. I also managed the delivery and ongoing maintenance of analytics solutions for RBM studies, including project management, requirements analysis and stakeholder liaison. I have 5 years of experience in the Risk Based Monitoring and 9 years in Clinical Trials. My educational background includes a BSc in Computer Science, a MA in European Studies, and a BA in Economics.

Timothy D. Mudric Jr., M.A., is Vice President of Clinical Development Strategic Enablement at Thermo Fisher Scientific, where he leads enterprise initiatives focused on AI-enabled innovation, operational transformation, and strategic enablement across global clinical development. With more than 20 years of experience in clinical research, he has held executive leadership roles spanning clinical operations, strategic feasibility, operational strategy, and strategic partnerships. His work has focused on advancing AI-powered solutions, modernizing feasibility and trial planning processes, and implementing enterprise capabilities that improve the efficiency and execution of global clinical trials. Tim has authored industry publications and presented at scientific conferences on strategic feasibility, clinical innovation, and the application of artificial intelligence to clinical development. He is passionate about helping the life sciences industry harness AI and digital innovation to make clinical trials faster, smarter, and more patient-centric.

Emilio Neto is a clinical research and drug development executive with more than 23 years of global experience leading clinical trial operations and country organizations. He brings deep expertise across Neuroscience and Rare Diseases, as well as Vaccines, Respiratory, Cardiovascular, and Oncology, with experience spanning the full clinical development lifecycle at the intersection of strategy, operations, and execution. Throughout his career, Emilio has led and integrated multiple functions across clinical development, including clinical monitoring, project and program management, therapeutic strategy, feasibility and site selection, patient recruitment and engagement, and regulatory operations. His experience includes navigating complex and evolving regulatory environments, enabling compliant, efficient, and scalable trial execution across diverse global markets. In his current role as Global Head of Country & Site Operations at Biogen, Emilio leads global site and country operations, with accountability for site engagement and clinical monitoring models, EU Clinical Trials Regulation, and patient-centric execution of clinical trials from Phase I through Phase IV. His work focuses on advancing operational excellence, strengthening regulatory readiness, and enabling scalable, high-quality global trial delivery. Emilio holds a PharmD from the University of São Paulo, an MBA from Fundação Getulio Vargas (FGV–EAESP), and a certification in International Business Management from the UCD Smurfit School of Business. He is currently pursuing a Doctor of Public Health (DrPH) at the UNC Gillings School of Global Public Health, where his research focuses on leadership, health systems, and improving representation of underrepresented populations in US clinical trials..

Christer Nilsson is a dynamic entrepreneur and the CEO of Replior, bringing over 30 years of leadership experience in IT, Finance, and Life Sciences.

Throughout his career, he has successfully launched and managed several businesses with a strong focus on innovation and customer satisfaction. At Replior, Mr. Nilsson is committed to a transparent and honest approach, ensuring that clients’ needs are at the heart of every decision.

He leads the integration of cutting-edge digital endpoints, sensor technology, and gamification strategies into clinical research solutions, aimed at reducing patient dropout and increasing compliance. Under his leadership, Replior is pioneering a more patient-centric and effective model for clinical trials.

Virginie Normand is Innovative Health Director, R&D at Johnson & Johnson Innovative Medicine. She has deep experience leading complex, high impact transformations, driving innovation to impact, and translating strategies into sustainable value—ultimately accelerating the delivery of medicines to patients.

Megan Olberding is Head of US Clinical Data Management at MSD, where she leads clinical data management strategy, operations, and talent development supporting the clinical development portfolio. With extensive experience in GCP-regulated environments, Megan has led initiatives spanning data quality, risk-based quality management, inspection readiness, and data governance. She is a strong advocate for the responsible adoption of AI and automation in clinical research, focusing on how emerging technologies can enhance efficiency, data integrity, and patient safety while maintaining compliance with GCP and global regulatory expectations.

Lord James O’Shaughnessy is Senior Partner for Global Policy at Newmarket Strategy, one of the UK’s leading independent health and life sciences consultancies, which he co-founded in 2021. James’s career has encompassed several senior policy positions in the UK Government, including the Prime Minister's Director of Policy and as a Minister at the Department of Health & Social Care with responsibility for innovation, research, and life sciences. He has been a member of the House of Lords since 2015. James is Chair of Cambridge University Health Partners, Visiting Professor at the Institute for Global Health Innovation at Imperial College, Trustee at Health Data Research UK, Non-Executive Director of Albion Enterprise VCT, and Patron of the Tessa Jowell Brain Cancer Mission. He carried out a landmark review of commercial clinical trials for the UK government in 2023.

Lorenzo is a strong clinical research professional with a PhD in Biology from Milan University and a Master of Business Administration from Warwick Business School. He has more than 15 years of experience in the Life Science Industry with roles in Clinical Ops, Business Development, Data and Clin Tech. Lorenzo strategically supports clinical tech solutions for Large Pharma companies and is actively involved in different clinical process and technology improvement and optimization workstreams (i.e. site payment, site interaction, start up, contract negotiation, budgeting, enrollment optimization). Lorenzo is Italian but moved to Basel, Switzerland, 4 years ago with the family.

Binita Patel works as the Diversity Strategy Lead for Bayer. Based in the UK, she has over 15 years of experience in Clinical Operations within the pharmaceutical industry and previously worked within the UK National Health Service in research and innovation, and in public health access. Binita has a passion for DEI; for the past two years, she has led Bayer UK’s local BRG chapter representing the LGBTQ+ community, believing that everyone has the right to bring their whole selves to work. Binita currently co-leads one of Transcelerate’s workstreams supporting the Diversity of Participants in Clinical Trials. In her spare time, Binita enjoys amateur nature photography.

Véronique has a background in statistics and programming. After a few years as statistician and programmer, Véronique entered Sanofi as Programming Group Head for Phase I studies, from 2003 to 2015, in Biostatistics & Programming Department (B&P) within CSO Platform (Clinical Sciences and Operations). Then she took a position as transverse coordinator for implementation of converged standards, processes, and tools in Biostatistics & Programming. In November 2018, Véronique was appointed as B&P Leader for Data Sharing and Transparency, as well as Privacy Champion.

Swapna is a clinical data management professional with a deep understanding of the regulatory requirements and industry standards that govern clinical data management. She is passionate about initiatives leading to improved trust & acceleration of clinical research and is driven by the ultimate purpose of transforming patients’ lives. As a dedicated proponent for patient centric innovation, she is currently championing Individual Participant Data Return. Over the past 12 years, she has held multiple roles within data management and worked on a wide range of clinical trials (Phase I to IV) with diversified parties such as CROs, pharma, and biotech.

Johann Proeve has over 45 years of experience as a biopharmaceutical industry expert, mainly in the former role of VP of Global Clinical Data Management at Bayer Healthcare. Awarded one of the 2018 MCC Champions by the Metrics Champion Consortium, and the ‘Best presentation on RBQM’ at the 2024 PHUSE Connect conference, Johann is widely regarded as the go-to source for Clinical Data Management and RBQM. In this regard, Johann has been invited to speak to clinical organizations worldwide, including regulatory bodies, sponsors, and CROs, at conferences like DIA, SCDM and SCOPE. Additionally, Johann has published numerous thought leadership articles for media, including ACT, Contemporary Clinical trials, and DIA Journal. Johann holds a Ph.D. in Zoology/Animal Biology, and he currently lectures at the University of Essen Duisburg (MSc in Pharmaceutical Medicine program).

Pedro Ramos is Co-founder and CEO of Promptly Health, a federated real-world evidence platform connecting +30 hospital and health system data across Europe and Brazil treating 70 million lives a year. He holds a PhD from Karolinska Institutet's Department of Learning, Informatics, Management and Ethics, and has previous healthcare management experience at Hospital Israelita Albert Einstein and Hospital das Clínicas in Brazil. He serves as scientific coordinator fo EU IHI projects building the regulatory and IP framework for secondary use of health data under the European Health Data Space. Pedro seats at the Advisory Board of the first European Health Data Space implementation pilot and the World Health Organization European Chapter for Digital Health .

Nersey Rastan is Chief Technology Officer at The Synergist, where he oversees the Synapse platforms, the Clinical Trial Distribution Network initiative, and co-leads the Digital Platform Work Package on the HI-READI programme, sitting on its Executive Committee. He is also a Steering Committee member of the HL7 Vulcan Accelerator programme, contributing to the digitisation of workflows across sponsors, investigators, patients and health authorities to accelerate real-world evidence generation.

Dr. Bhargava Reddy has over 21 years of experience working in the pharmaceutical industry. He is currently Head of Advanced Insights at Janssen Pharmaceutical supporting clinical operations by providing data science solutions. Prior to this role, he was Associate Director of Advanced Analytics at UCB. In this role, he was responsible for the development and application of machine learning methodologies supporting clinical decision making within Immunology and. He was also leading the analytics work supporting Risk Based Monitoring. Prior to this role, he managed a statistical programming group and was also overseeing a large statistical programming group offshore. Dr. Reddy has published several methodology papers in peer reviewed academic journals in the areas of machine learning and deep learning. He is actively involved as an associate editor for the Frontiers in AI journal and also as a reviewer on several journals. He has a Ph.D. from Oklahoma State University and MS from Northwestern University.

Carina Reinicke is a motivational leader with over 20 years of clinical development experience. She currently serves as global Chief of Staff and Head of Business Operations for Clinical Development Operations (CDO) at Boehringer Ingelheim, leading the delivery of shared business services and actionable insights to drive execution excellence and informed decision-making. Her background spans clinical data management from studies to submissions in oncology and respiratory, system lifecycle leadership, and global clinical operations. She has held leadership positions across Europe and Asia in Clinical Data Management, served as Global Head of Monitoring Management and Global Head of Capability Management. Carina brings strong business acumen and system lifecycle competencies, international leadership experience, and deep expertise in organizational development, including process and technology evolution. She is passionate about establishing empowered, high-performing teams and driving strategic transformation in clinical development execution.

Dr. Jean-Christophe Renondin is an accomplished and seasoned healthcare investor with over 20 years of relevant experience. Prior to joining Vesalius Biocapital IV, he was the Senior Healthcare Manager at the Oman Investment Authority (OIA), the Sovereign Fund of Oman, in charge of healthcare investments. Prior to this, he was Managing Director at Bryan Garnier & Co a pan-European investment bank in charge of the healthcare practice leading ECM and private placement transactions for European healthcare clients. He was also General Partner at CDC Innovation, investing in various European healthcare assets. From 1999 to 2005, he was Vice President at Sofinov, a subsidiary of the Caisse de Depot et Placement of Quebec (CDPQ), leading the healthcare investment fund, and Managing Director at MDS Capital, one of the leading healthcare investment firms in Canada. Jean-Christophe was also the General Manager of different international subsidiaries for Servier Laboratories, in Ireland and South Africa, and was at JP Morgan in the Healthcare Equity Research and Corporate Finance departments in New York. He earned his Medical’s Doctorate degree (MD) from Paris V Descartes University and his MBA from the Amos Tuck School of Business Administration.

Amy Ripston is the Founder & President of the Biospecimen Management Consortium (BMC), a non-profit organization dedicated to driving sample excellence in clinical research. Founded in June 2024, the BMC mission is to raise awareness of the importance and criticality of biospecimen management, develop industry standards and best practices, and advocate for change within the clinical trial ecosystem through standardization, policy, and thought leadership.

Sharon Rivera-Sanchez is a global health advocate, Triple-Negative Breast Cancer survivor, and the founder of Trials of Color, a nonprofit organization dedicated to bridging health equity gaps by increasing diversity in clinical trials. After participating in five clinical trials and losing her brother to colon cancer, she transformed her personal journey into a mission to redefine the future of clinical research through the lenses of equity and inclusion. An impactful speaker on the global stage, Sharon has presented at ASCO, AACR, DIA (Switzerland), and ESMO (Germany), bringing a vital patient perspective to international audiences. She is a trained Clinical Trial Ambassador through the University of Pennsylvania’s Abramson Cancer Center and recently contributed to FDA drug development sessions powered by GRASP Cancer, effectively bridging the gap between lived experience and medical innovation. Sharon currently serves on several prestigious advisory boards, including the National Cancer Institute and Massey Comprehensive Cancer Center. Through these roles and her leadership at Trials of Color, she continues to champion a future where medical research is accessible, inclusive, and driven by the communities it aims to serve. With 11 years of survivorship, Sharon combines professional strategy with a deep-rooted passion for community engagement. She Pioneered the “Bring a Friend to Clinical Trial” in 2024 where diverse patients have successfully joined different trials. Sharon is currently leading vital awareness campaigns for underserved populations across multiple states, focusing on reducing treatment barriers and improving public policy. Her unwavering dedication to advocacy is fueled by a commitment to driving systemic change and achieving true health equity in global healthcare.

Tracey Robertson is the Data & Analytics Lead within Clinical Development Operations, bringing deep cross-functional leadership experience spanning digital trials, data strategy, global systems implementation, and organizational transformation. Since joining Boehringer Ingelheim in 2004, she has held strategic roles across Patient & Site Engagement, Biostatistics & Data Science, IT for regulatory systems, and global process innovation, following an early consulting career serving major pharmaceutical clients. She holds a BSc (Hons) in Technology & Business Studies and an MBA in Information Management, complemented by PMP and CSM certifications.

Graham leads Langland’s Clinical Trial Experience team, bringing fifteen years of cross‑discipline expertise in advertising and trial engagement. He drives innovative strategies at study, programme and enterprise levels to tackle industry challenges and deliver impactful solutions. Known for rigour and meticulous execution, Graham has had a hand in multiple award‑winning campaigns. His core belief: the most effective work is forged through true client partnerships - where creativity, precision and accountability deliver meaningful, lasting outcomes.

Kayleigh Rogers is the the Head of Business Development and Alliances for Siteworks Clinical Research, a network of clinical research sites based in Germany. She has spent more than 10 years in business development and commercial roles in drug development and clinical trials and is a passionate advocate for continuous improvement in the clinical trials ecosystem.

Aurora M. Rojo Sanchís is a Hospital Pharmacy Specialist and PhD pharmacist currently leading the Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) Inspectorate at the Spanish Agency of Medicines and Medical Devices (AEMPS). In this role, she coordinates the Spanish GCP and GVP Inspectorate, conducts national and international regulatory inspections of clinical trials and pharmacovigilance systems, and is a member of the EMA's IWG GCP and IWG GVP working groups.

Matthieu Ruffin is a seasoned professional with 20 years of experience in clinical operations within large and mid-size pharmaceutical companies. He has strong leadership skills, having led global study leadership and development operations. Matthieu has successfully driven clinical operations strategies and delivered on business goals across key therapeutic areas and various types of clinical trials, from early- to late-phase trials. Currently, Matthieu serves as the Vice President, Head Study Leadership at Novartis, where he leads the global Study Leadership organization to ensure timely and quality execution and delivery of global clinical trials across all Novartis Development programs. He is accountable for the Novartis Clinical Trial Team model, related tools, and operational excellence. Matthieu ensures cross-functional excellence in clinical trial execution and leads the biospecimen scientist organization responsible for the operational execution of clinical biospecimen samples. Previously, Matthieu held the position of Global Head Development Operations, at Advanced Accelerator Applications (AAA), a Novartis company, where he led the Development Operations organization focusing on RadioLigand Therapy (RLT). He was accountable for delivering clinical trials from early to late phases in the AAA portfolio and drove timely and efficient trial execution in collaboration with global medical affairs, legal, research, and regulatory affairs functions. Matthieu holds a Postgraduate Degree in Combinatorial Chemistry and Drug Design, and a Master of Science Degree in Analytical and Organic Chemistry from the University of Orléans in France.

Experienced Clinical Research Specialist with an extensive background in the application of technological tools in clinical scenarios. High intensity worker with 9+ years’ experience in management of simultaneous projects including planning and design of the solution, on-time delivery reports and highly effective problem solving skills.

Nidhi Saxena is a healthcare leader with 20+ years of experience spanning market research, global operations, data & insights, and patient engagement across multiple Fortune 500 companies. She currently leads Global Patient Engagement Strategy at J&J R&D within Global Development, driving patient-centric innovation and large-scale solutions. Known as a collaborative, solution-driven leader, Nidhi focuses on transformation, patient and site centricity, innovation, and talent development to mobilize for impact.

Stephen's focus and attention remains on unifying the Drug Development process to create a more efficient and streamlined process. Thermo Fisher is the only company providing this significant value add to customers for a true end to end solution. The CDMO & CRO integration is a challenging one and Thermo Fisher is poised as the first and only company to have this offering to deliver ROI to Biotech & BioPharma. Stephen is also leading the Commercial efforts and engagements with VCs globally to bring valuable solutions to their investments with creative financial solutions and opportunity to accelerate the drug development process.

Medical Biology (1991) Four years in farma, twenty years in hospital cardiology research department and 10 years managing director of WCN Dutch cardiovascular research network.

Dr Claire Sears is Senior Director, Participant & Site Enablement at EMS Healthcare, a UK-based community site network. With over 20 years in pharmaceutical research, clinical technology, and academia, she is a leader in clinical trial technology and site engagement. Her extensive experience with THREAD, IQVIA, DrugDev and AstraZeneca, has covered roles in Strategy & Partnerships, Site Identification and Feasibility, and Medical Affairs. Claire believes in connecting people and ideas, fostering the adoption of digital technologies to support sites, CROs, and pharma sponsors.

Andrei Seryi is Director of Knowledge Management at PSI CRO, where he leads the strategy and implementation of enterprise knowledge, real-world data, and AI solutions supporting PSI CRO’s global operations. Andrei focuses on managing complexity at scale—connecting processes, digital platforms, and regulatory expectations into coherent, compliant ecosystems. His current work centers on the use of semantic technologies, graph‑based knowledge models, and AI‑assisted reasoning to enhance operational insight and outcomes for PSI CRO’s clients.

Shalome Sine is a Senior Manager and Quantitative Insights Specialist at the Center for Information and Study on Clinical Research Participation (CISCRP). Shalome believes that the patient's voice can be a powerful force toward building inclusive, efficient clinical trials. Through her work, she hopes to help clinical trial sponsors and teams bring actionable patient insights into practice to improve operational processes. Shalome manages both quantitative and qualitative patient voice projects, specializing in quantitative, survey-based insights from patients and the public. She holds a Master of Public Health from Tufts University and a Bachelor of Science from Penn State University.

I am a Biosample Project Leader at Roche with over five years of experience driving operational strategy within the organization. My career is built on a strong scientific foundation, having earned my PhD in Oncology, which naturally led me into the broader clinical research space. Before my current role at Roche, I spent several years navigating the complexities of central laboratories, followed by a valuable tenure in clinical operations. This diverse trajectory allows me to bridge the gap between critical scientific needs and practical clinical execution, ensuring the effective and seamless management of biosamples across the clinical trial lifecycle.

Malgorzata Skrzypczak is a Director, Data Surveillance at Pfizer, where she leads global approaches to risk-based quality management and centralized monitoring. She began her career in the clinical trial space over a decade ago, gaining hands-on experience across clinical data, analytics, and programming that continues to shape her leadership approach. In her current role, she defines scalable RBQM strategies and oversees the technical foundations that enable reliable oversight. Her work spans data integration, standardized processes, and the adoption of technology-enabled monitoring models across complex clinical programs. She brings a pragmatic, execution-focused perspective to advancing data-driven oversight in clinical development.

Zak Smith works on a variety of Tufts CSDD studies focusing on drug development performance, efficiency, economics, and innovation adoption. His research often focuses on protocol complexity, clinical trial participant and site burden, and diversity and representation in clinical trials. He also leads the analysis for the PACT consortium, which collects granular data on the use of DCT solutions and metrics of performance for the trials that deploy them. Many of these projects involve creating, compiling, and analyzing very large datasets. Zak completed his BS at Florida Southern College and received his MA from Brandeis University. He has worked as a research assistant at Harvard University and at the University of Massachusetts and began at Tufts CSDD as a research analyst.

Amandeep Sonik is an experienced leader with a strong focus on advancing Risk-Based Quality Management (RBQM) and building effective centralized monitoring capabilities. She has played a key role in developing and embedding RBQM approaches that enable proactive risk identification, data-driven oversight, and stronger quality management across clinical operations. Through her leadership, Amandeep brings together people, processes, and technology to establish scalable monitoring strategies and drive continuous improvement.

Stathis Stathelos is a Senior Director of Feasibility and Portfolio Delivery at AstraZeneca. With over 19 years of experience in the pharmaceutical industry, he specializes in clinical development and strategic operations. Stathis leads global execution strategies for Haematology and Oncology clinical trials, emphasizing data-driven feasibility and patient-centric solutions. Prior to AstraZeneca, he held pivotal roles at Regeneron and Amgen, optimizing clinical protocols and resource management. A Project Management Professional (PMP) and registered pharmacist, Stathis combines his profound understanding of therapeutic areas with a passion for innovation and strategic leadership in clinical development.

I, Jozien Sterck, am the Assoc Director of the Clinical Development Center Netherlands (CDC NL) at Novo Nordisk, where I lead the strategic and operational oversight of the clinical trial portfolio in the Netherlands, aligned with global R&D objectives. I hold a PhD from the Free University Amsterdam and have more than 30 years of experience in clinical research, including progressive leadership roles at Novo Nordisk since 1996. Throughout my career, I have been responsible for the oversight of clinical trials across multiple therapeutic areas, driving trial execution excellence, organisational development, and continuous improvement within clinical operations. I combine scientific depth with strong people leadership and a focus on compliant, high-quality clinical research delivery.

Adrienn Szabo (She/Her) is a clinical operations leader with over 15 years of experience driving global trial execution, patient centric innovation, and operational excellence. As Associate Director of Scientific Recruitment & Retention at Novo Nordisk, she leads high impact teams that shape recruitment, retention, and community building strategies for late phase clinical programs. Known for her visionary mindset, dynamic leadership style, and talent for uniting diverse trial stakeholders, Adrienn has built a career on elevating trial performance through structured insights, exceptional communication, and energizing team cultures.

Lawrence Tallon is the Chief Executive of the Medicines and Healthcare products Regulatory Agency (MHRA). He was previously Deputy Chief Executive at Guy’s and St Thomas’ NHS Foundation Trust, where he led the Trust’s approach to strategy, technology, innovation, and improvement. He has extensive experience across the healthcare sector in strategy and leadership roles, including within the Department of Health and Social Care alongside ministers and NHS leaders. Lawrence is committed to patient safety and healthcare innovation, as well as life sciences and risk-proportionate regulation.

Building on his academic and medical career, Mihail is evolving product strategy at TrialHub, a clinical trial planning and intelligence platform. His work centers on new ways of making trial planning more predictable — patient-first, and built on turning scattered data into connected insight. His current focus spans patient journey and care pathway intelligence, and how these can better support trial design and country strategy.

Sarah Thinnesen is a UK based Director of Site Enrolment and Engagement Leads at IQVIA, specializing in rare and complex diseases including pulmonary arterial hypertension and interstitial lung disease. She leads the strategic oversight and operational delivery of Site Enrolment and Engagement Leads, supporting study teams to optimize patient identification, screening, and recruitment, and ultimately improve study performance at site level. Her work focuses on bringing real-world field insights into study strategy, helping to bridge the gap between site potential and actual delivery. Sarah brings over 26 years of experience across clinical research, medical affairs, and frontline healthcare, including leadership roles in Biotech Corporations and more laterally IQVIA. She has extensive experience in KOL engagement, investigator-sponsored research, and study development, underpinned by her background as a cardiac intensive care nurse. Today, she will share practical perspectives on how integrated, field-based approaches—through Site Enrolment and Engagement Leads can help close the gap between site capability and real-world trial performance.

I am an AI Governance Specialist in R&D, working at the intersection of regulation, technology, and clinical development. My focus is on translating complex regulatory and ethical requirements into practical, scalable processes that enable the responsible use of AI in highly regulated environments. I support teams in operationalising AI governance by building clear frameworks, procedures, and documentation that ensure transparency, traceability, validation, and operational readiness. My work draws on global regulatory expectations and industry standards, helping to align innovation with compliance while maintaining focus on patient safety and data integrity. I take a pragmatic approach to governance—bridging strategy and execution—by making requirements actionable and fit for real-world use. This includes enabling consistent ways of working across projects and ensuring that governance becomes an integrated part of how AI solutions are designed, developed, and deployed. At this conference, I will share practical insights on how to make AI governance scalable, implementable, and supportive of innovation in complex, regulated settings.

Andy brings nearly two decades of clinical trials expertise, with the last ten years focused on innovations in patient engagement and support across service providers, CROs, and biopharma. With a foundation of media and journalism, his career has spanned the full clinical trials spectrum — from communication and patient engagement technology to travel and concierge services, mobile research nursing, and recruitment and retention. His well-rounded experience gives him the ability to see the patient experience from every angle. Andy has sat on both sides, in sponsor and provider roles alike. He joined Mural Health from a US biotech where he built and led patient services as a cross-programmatic function. Based in Cheshire, England, he serves as the primary point of contact for European customers.

Jane Twitchen graduated with a BSc in Medical Physics from the University of Exeter, UK, and commenced her career with Covance, supporting a number of trials investigating radioisotope image optimisation. Having developed a keen interest in processes and systems, she then joined SAS, where she worked in the Alliances team collaborating with partners such as PWC, McKinsey, and Accenture to define and implement solutions for pharmaceutical clients. During her tenure with SAS, Jane was also sponsored to complete her MBA. She proceeded to a number of software and service providers prior to joining Biogen in 2013, initially joining the Global Regulatory Affairs Quality and Operations team and moving to Global Clinical Operations in 2015. In her current role, Jane is Executive Director, Head of Biogen’s Clinical Trial Accelerator Unit and is responsible for delivery of Biogen’s goal to decrease its study start-up cycle times by more than 15%.

Prof Andrew Ustianowski is a consultant and clinical researcher in Infectious Diseases at the Regional Infectious Diseases Unit, Manchester, UK. He has been a PI/CI on over 120 studies and won national and regional awards for research delivery and recruitment. He is the Network Director of the NW Regional Research Delivery Network, National Institute for Health and Care Research, encompassing a population of 7 million, over 30 secondary care sites and several hundred wider care setting sites. He was the interim National Executive Director/CEO for the launch and establishment of the national Research Delivery Network, and was the designer and lead for the UK’s COVID Vaccine Research Programme and subsequently the UK’s Vaccine Innovation Pathway. He trained at Guy’s Hospital, London, within the North Thames Region in Infectious Diseases, Tropical Medicine and General Medicine, and undertook a PhD at University College London.

Stan van Belkum has 8 years experience within the National Institute for Public Health and the Environment (RIVM) initially as quality reviewer and later on as Deputy Head of the Medicines Evaluation Department. He is a Pharmacist by training. In 2001 he joins the Medicines Evaluation Board (MEB) holding different positions, from Programme manager to Head of Departments. During this period he has been member of several national and international working groups on electronic submissions, amongst which ICH M2. From 2013 to 2021 Stan van Belkum has been Deputy Director of the MEB responsible for the all primary business processes and operational management (350 FTE, budget 50M€). In 2021 he switched from the MEB to another competent authority in the Netherlands, the Central Committee for Research with Human Participation (CCMO) as Chief Executive. Main legal responsibility of the CCMO is protecting participants in medical-scientific research together with 12 other Medical Research and Ethical Committees (MREC) the Netherlands. Stan van Belkum is member of the Dutch Clinical Research Foundation (DCRF), the Heads of Medicines Agencies (HMA) and the Accelerating Clinical Trials in Europe (ACT-EU) Steering Group.

Viviënne van de Walle is a physician specialized in clinical research and certified in clinical pharmacology and pharmaceutical medicine. She is the founder of VivHo, a life science consultancy, and PT&R—Partner in Trials & Research, an independent research site in the Netherlands. She serves on the Global Exam Committee for the Certified PI Program (ACRP) and is actively involved in CISCRP, NVFG, ACRP, and SCRS. In recognition of her contributions, she received the Christine K. Pierre Site Impact Award (2022) and Healixia (2025). Vivienne has a strong focus on patient centricity, the use of eCOA and AI in research, and is widely known as the industry’s “unicorn”. With over 25 years of experience, she is a speaker, mentor, and bridge builder, passionate about sharing knowledge and sparking creative solutions: “I love it when you pick my brain.”

Zoltan is responsible for leading IQVIA’s efforts to drive the adoption of innovative patient recruitment and engagement methods in clinical trials. This includes working to infuse the patient voice into trial design and developing and scaling solutions to help bring novel treatments to patients including those traditionally underrepresented in clinical trials. Zoltan has more than 25 years of experience leading global and regional clinical trial operations, including patient recruitment, project and site management, vendor partner management, strategic partnerships and quality management.

Eric is Director of Strategic Projects—Alliance Management (Clinical Operations) at AstraZeneca, where he manages a multi-year program redesigning how Clinical Operations partners with CROs across both the Biopharma and Oncology portfolios. His central lesson from the trenches: changing your sourcing model doesn't just change who does the work—it pressure-tests every assumption in your operating model, from governance to technology to how your own teams are structured. Before AstraZeneca, Eric led growth strategy and advanced analytics at BD (Becton Dickinson) and delivered cross-industry transformation engagements at Deloitte. Based in Barcelona, he works across English, Spanish, and Catalan.

In his current role, Edward is leading Oncology Strategic Site Partnership within Global Site & Study Operations in R&D Pfizer. Driven by a deep passion for partnerships with sites and networks, Edward is committed to enhancing these key customizable strategic relationships across all Therapeutic Areas, cultivating the best partnership for the treatment of all patients globally. Edward started his career in the NHS in UK before transitioning to the pharmaceutical industry, in which he followed a dedicated carrier path from Clinical Research Associate to Senior Director, Regional Clinical Trial Management. Edward is committed to understanding site needs and fostering collaboration to maximize delivery/simplification of activities, driving impactful initiatives and relationships that elevate standards globally.

As the Vice President of Compliance & Security, Marc is leading the corporate security, quality and compliance initiatives at CRIO. Additionally, he’s serving as CRIO’s Data Protection Officer. Prior to CRIO, Marc was leading the Quality Assurance efforts at snapIoT. Before snapIoT, Marc was a key member of the Corporate Compliance and QA group at Clinical Ink from 2012-2021 and served as its Data Protection Officer from 2018 to 2021. He is a frequent contributor in the regulatory and compliance space and has participated as a speaker, panelist, and host at the following: SCDM EMEA Conference, SCDM India Annual Conference, SCDM Annual Conference, Society for Clinical Research Sites (SCRS) Global Site Solutions Summit, Association for Clinical Research Professionals (ACRP) Annual Conference, Society of Clinical Research Associates (SOCRA) Annual Conference, World Vaccine Congress.

Gernot Weber is a data and digital transformation leader with 10+ years of experience across J&J, Merck KGaA (Darmstadt), and Novartis, where he focused on unleashing the power of data and digital to innovate clinical trials. Gernot has led cross-functional teams and multi-product portfolios, developing enterprise data strategies, AI/ML products, and clinical platforms spanning semantic interoperability, protocol automation, and advanced analytics. A particle physicist by training with a PhD from research at CERN (Switzerland) and Fermilab (USA), and an Executive MBA, Gernot bridges science, technology, and business to solve complex problems in global R&D.

Brian Weiss is the Founder and CEO of Carebox, a clinical trial patient recruitment technology company that improves access to research-based treatment options and accelerates drug development. Through its condition-based matching platform, Carebox connects patients and physicians with relevant clinical trials, partnering with leading pharmaceutical companies, academic medical centers, and patient organizations to address the primary bottleneck in clinical research recruitment. Prior to founding Carebox in 2014, Brian led software product and development organizations at publicly traded CRM and healthcare technology companies. He holds a master’s degree in software engineering from Columbia University.

Linda White is an Associate Director of Risk-Based Quality Management at Jazz Pharmaceuticals, with over 15 years of experience in Clinical Operations. Current focus has been on training RBQM process and technology to all departments involved in clinical trials. As part of the leadership of a growing team, we aim to build a culture of Quality by Design and critical thinking into trial design and management.

Madeleine Whitehead has over 15 years of industry experience focusing on clinical process excellence, gained in both Sponsor and CRO settings. Madeleine is passionate about robust, user-centric processes which enable a compliant risk-based approach in the conduct of clinical studies. In her current role at Roche, Madeleine is dedicated to supporting Process Owners of global clinical development processes to created innovative, effective, and efficient mechanisms to operationalize clinical studies. Madeleine is a devotee of Good Clinical Practice who works to promote the understanding, appreciation, and application of GCP in clinical activities.

Bettina Wieneke is Head of Quality & Continuous Improvement (QCI) and a member of the GCTO Senior Leadership Team, where she leads global initiatives to advance clinical research quality, risk-based quality management, and continuous improvement across clinical trial operations. With over 30 years of experience in the pharmaceutical industry, Bettina brings deep expertise in clinical operations and quality management. She previously led Global Clinical Quality Management (GCQM), building a high-performing global team and establishing GCQM as a strategic partner to country operations. Bettina started her career as a Clinical Research Associate (CRA) and has held leadership roles across regional and global organizations. She holds a master’s degree in biology from the University of Konstanz and a business degree from the Chamber of Industry & Commerce. In addition, Bettina is a certified Six Sigma Black Belt and ACRP Certified Professional (ACRP-CP). She is based in Munich, Germany.

Dr. Aleksandra Wlasenko is a Study Director Community Lead at Novartis, where she bridges the gap between complex clinical execution and cutting-edge digital innovation. She leads functional activities within Study Leadership that provide operational support for clinical trial execution across all trials of the portfolio in the Novartis Development organization. With a Ph.D. in biomedicine, an M.Sc. in Biotechnology, and over a decade of experience leading global clinical trials, Aleksandra oversees the strategic execution of Phase 1 Radioligand Therapy (RLT) trials while simultaneously driving the large-scale integration of generative AI across the Study Leadership organization. As a champion for digital transformation, she established a global SME network to scale AI adoption among over 200 Study Leads, focusing on practical governance, human-in-the-loop decision-support tools, and the long-term professional growth of clinical teams. Her leadership is defined by a unique ability to translate emerging technologies into auditable, value-adding operational realities that enhance trial delivery and cross-functional excellence.

Marion Wolfs leads global Trial Risk & Integrity Management at Bristol Myers Squibb and has spent much of her career helping teams find risks before risks find them. Working across clinical development, enterprise risk management, analytics, and AI innovation, she is passionate about turning data into insight and insight into action. Marion has been a driving force behind analytical monitoring and risk intelligence approaches that help organizations move from hindsight to foresight, improving both decision quality and operational resilience. She believes that risk management should create confidence, not bureaucracy, and that AI's greatest value lies not in replacing expertise but in helping it accelerate.

Helen Kit-Yi Wong is the Risk-Based Quality Management (RBQM) Strategy & Implementation Lead at Merck Sharp & Dohme (MSD). She is based in Hong Kong. Helen has been in MSD for more than 25 years experiences and worked in various functions, including clinical research, regulatory affairs, operational excellence, clinical quality improvement and clinical quality management. She was the Senior Regional Director, Clinical Quality Management Asia-Pacific in 2016 – 2024. In November 2024, she moved to the current RBQM position. Helen graduated with First Class Honors and a Bachelor’s degree in pharmacy from the University of Sydney, Australia and a Master’s degree in Health Administration from the University of New South Wales, Australia. She is a certified Lean Six-Sigma Black Belt and has a Academy of Clinical Research Professionals (ACRP-CP®) certification.

Ms. Yanak is a Pharmaceutical & Central Lab executive known for successfully translating scientific strategy into clinical operations, via technology and innovation. She developed an Innovation Operating Model to pilot digital health and other ideas to transform drug development, and envisioned and led a multi-year strategic program to operationalize Precision Medicine at a Top 5 pharma, including transformation of the end-to-end specimen management policy, process, and technology infrastructure: standardizing protocols, digitizing informed consent, developing virtual specimen tracking, and using artificial intelligence to automate clinical study reports to expedite creation of big datasets for mining new biomarkers. Brenda has led transformative initiatives at several major companies, and acts as an Advisor to the Summit for Clinical Operations Executives (SCOPE).

Risk Based Quality Management (RBQM) and Global Clinical Operations leader with 16+ years of experience across AstraZeneca and Eli Lilly. Have expertise in clinical development, clinical data analytics and management, quality compliance and enterprise process transformation. Led multicultural teams of professionals supporting large-scale interventional clinical trial portfolios within Respiratory, Immunology, Cardiovascular, Renal Metabolism, and Virology. Strong track record in leading strategic R&D initiatives, inspection readiness, and executive stakeholder engagement.