12th Annual Outsourcing in Clinical Trials UK & Ireland 2025

Welcome to 12th annual Outsourcing in Clinical Trials UK and Ireland 2025

10 - 11

June

2025
  • Hilton Park Lane, London, UK
  • Complimentary
  • Why attend?
  • Agenda
  • Advisory Board
  • Speakers
  • Plan Your Visit
  • Event Gallery
  • 2025 Sponsors
  • Media Centre
  • Why partner?
  • Resources
  • Contact Us
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Featured Speakers

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Prof. Lucy Chappell​

Chief Scientific Adviser, Department of Health and Social Care, Chief Executive Officer, National Institute of Health Research (NIHR)

Professor Lucy Chappell FMedSci is the Chief Scientific Adviser for the Department of Health and Social Care (DHSC), with overall responsibility for the department’s research and development, including the National Institute for Health and Care Research (NIHR), the government’s major funder of clinical, public health, social care and translational research.

Reporting to the Chief Medical Officer, the Chief Scientific Adviser provides science advice and analysis to ministers across the range of health topics and is involved in cross-government science policy.

Professor Chappell is Professor of Obstetrics at King’s College London, Honorary Consultant Obstetrician at Guy’s and St Thomas’ NHS Foundation Trust and an NIHR Senior Investigator. She will undertake the Chief Scientific Adviser role on secondment into government, while continuing some of her clinical and academic work.

DHSC Chief Scientific Adviser

Responsibilities include:

  • overall responsibility for the Department of Health and Social Care’s (DHSC) research policies and budget, including being head of the National Institute for Health and Care Research (NIHR)
  • supporting analysis and evidenced-based decision-making capacity in the department
  • working with Chief Scientific Advisers across government to maximise the impact of science to benefit the UK population
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Andrea Manfrin​

Deputy Director, Clinical Investigations and Trials, MHRA

Andrea is an academic, consultant, for-profit/non-profit organisations and entrepreneur with over 30 years of international experience in the healthcare sector, specifically focusing on pharmacy, the pharmaceutical industry, health services and pedagogic research. Andrea's goal is to provide better outcomes for everybody: patients, providers, and payers. He provides vision and strategic direction as a leader of small and large research teams from different cultural backgrounds. Andrea offers a unique combination of entrepreneurship and academic rigour, allowing him to succeed in various challenging projects.

Key accomplishments
• Co-led the conceptualisation of the Biomedical Evidence baSed Trans-disciplinary (BEST) health research institute, which focuses on people's health, linking basic and translational investigations from bench to bed to home.
• Led the creation of a multidisciplinary research method and statistical analysis unit (RMSAU), which supports the development of randomised controlled trials in Medicine, Dentistry, Pharmacy Practice, Health Services Research and Pedagogy.
• Co-founder of the Pedagogic Interest Group (PIG), which supports academics in research, widens participation and welcomes early career researchers who contribute to the next REF and students' experience.
• Created an innovative and bespoke pharmacist-led intervention using a patient-reported outcome measure (PROM) subject to an intellectual property right.
• Developed and led a national research project: a novel, cost-effective intervention in primary care that has changed policy and practice, allowing the government to allocate 36 million Euros to fund such services.
• Lead author of a scientific manuscript which is in the top 5% of all research outputs (n=26,673,263) ever tracked by Altmetric.
• Led an academic module, changing team culture and reducing student attrition by 93%.
• Managed a re-engineering process for improving efficiency and time management whilst optimising costs in a retail pharmacy business; the business achieved a return on investment of 52%.
• Created a pharmacy business from scratch and implemented sales and marketing strategies, achieving a return on investment of 900%.

Skills: statistical analysis and data mining, data presentation, health services research, clinical trials, business management, economics.

Research interests: health services research, clinical trials, outcomes research, effectiveness and cost-effectiveness of pharmacist-led interventions, pedagogic research, active learning, and data modelling.

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Alex Churchill​

Deputy Director, Clinical Trials Policy, Department of Health and Social Care

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Dr Janet Messer​

Director of Approvals, HRA

Experienced strategic leader with extensive experience of operations, business transformation and introducing digital systems. Systems-thinker with focus on delivering cross-sector improvement. Deep knowledge of health and care research regulation and governance.

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Dr Suki Balendra​

Director, Strategic Partnerships, Paddington Life Sciences and Director, North West London Clinical Trials Alliance

Suki Balendra a senior leader in the NHS with a 20-year background in facilitating, growing, and promoting health research in the U.K.  She has substantial, in-depth experience across sectors including industry, academia, NHS, and central government.

She is currently the Director of Strategic Partnerships for Imperial College Healthcare NHS Trust in Northwest London. She leads the strategic work with the Life sciences industry in the region with an emphasis on a new life sciences cluster in Paddington. Suki created and leads the North West London Clinical Trials Alliance. She started her career in the Biotechnology Industry at Abbott Diagnostics Ltd. Within a Good manufacturing practice (GMP) environment she worked on several operational projects to improve efficiency, cost, and reproducibility.

In 2018 she was seconded to the Office of Life Sciences within the Department of Business and Industrial Strategy. where she attracted and negotiated new business to increase the UK’s market share of health and care research activity. During the pandemic she provided operational leadership to the NHS covid vaccine research response in Northwest London.

Suki has PhD from the University of Warwick, and she is accredited to black belt in Lean Six Sigma. She is a passionate advocate for UK PLC as the number one destination to conduct clinical trials.

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Emily Pegg​

Associate Vice President, Medical, Northern European Hub, Eli Lilly

An experienced executive leader within the pharmaceutical industry with a clear focus on and passion for developing high performing cross-functional teams who work without barriers. Highly inclusive yet decisive, adaptable and with a track record of high quality delivery whilst motivating and inspiring the teams around me.

A GMC registered, NHS trained medical doctor with pharmaceutical industry experience across a broad range of therapeutic areas working with both pre-launch and in-market products in the UK and Europe. Known for being commercially astute and a strong cross-functional worker with 10 years of management experience up to a team size of 120 striving always to create a rewarding, high energy environment for my teams.

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Sarah Deeley​

Director, Country & Site Operations, Biogen

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Blanka Hezelova​

Associate Director, Precision Medicine Scientific Operations, Bioethics Coach, GSK

Blanka is an Associate Director within Precision Medicine Scientific Operations at GSK with over ten years of experience in research spanning from clinical site to sponsor roles, and expertise in biosample operations. She leads operational aspects of trials with a focus on innovation and excellence, successfully managing complex clinical studies while ensuring compliance and participant protection. Herf passion lies in ethical research and strategic improvements for operational efficiency.

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    2025 Sponsors Include:

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    Company Information

    Simply sourcing comparators – we offer a unique blend of small company flexibility and speed, backed with the large-scale buying power of the Orifarm Group, which is one of the largest pharmaceutical suppliers in Europe. With over €1.4B products sold in 2021 and more than 4,000 unique product lines sourced on a monthly basis, we have unparalleled access to “out of market” and manufacturer direct buying capability, both in the US and Europe.

    Company website: www.Orifarm-CTS.com

    Company Website

    To learn more, please visit our website - www.Orifarm-CTS.com

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    Company Information

    Imagine a paediatric-specific engagement platform, fully co-designed with children and child life specialists. The Little Journey app helps to reduce anxiety before, during and after paediatric clinical trial visits by educating and preparing children and families using engaging, age-tailored personalised multimedia that can be accessed anywhere at any time.

    Company Website

    To learn more, please visit our website - https://www.littlejourney.health/

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    Company Information

    Cytel Inc. www.cytel.com is a leading provider of clinical research services and trial design and analysis software primarily for the biopharmaceutical and medical device development markets.

    Cytel pioneered the statistical and computational science of adaptive clinical trials and has designed more validated adaptive trials than any other service provider.

    Company Website

    To learn more, please visit our website - http://www.cytel.com

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    Company Information

    Syneos Health (Nasdaq:SYNH*) is the only fully integrated biopharmaceutical solutions organization. Our company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to accelerate customer performance to address modern market realities. Created through the merger of two industry leading companies – INC Research and inVentiv Health – we bring together more than 21,000 clinical and commercial minds with the ability to support customers in more than 110 countries. Together, we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. To learn more about how we are shortening the distance from lab to lifeTM visit SyneosHealth.com. 

    Company Website

    To learn more, please visit our website - www.SyneosHealth.com

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    Company Information

    Medidata is powering smarter treatments and healthier people through digital solutions to support clinical trials. Celebrating 25 years of ground-breaking technological innovation across more than 35,000 trials and 10 million patients, Medidata offers industry-leading expertise, analytics-powered insights, and the largest patient-level historical clinical trial data set in the world. More than 1 million registered users across approximately 2,300 customers trust Medidata’s seamless, end-to-end platform to improve patient experiences, accelerate clinical breakthroughs, and bring therapies to market faster. A Dassault Systèmes brand (Euronext Paris: FR0014003TT8, DSY.PA), Medidata is headquartered in New York City and has been recognized as a Leader by Everest Group and IDC. Discover more at www.medidata.com and follow us @Medidata.

    Company Website

    To learn more, please visit our website - https://www.medidata.com

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    Company Information

    Founded in 2015 Teckro provides solutions to simplify and modernize clinical research for leading pharmaceutical and emerging biotech companies. To date, Teckro manages more than 100 clinical trials and is used by more than 11,800 active study sites around the world. Teckro employs more than 100 staff across its global headquarters in Limerick, Ireland, engineering excellence hub in Dublin, Ireland and its US-based office in Nashville, Tennessee. Visit www.teckro.com for more information.

     

    Company Website

    To learn more, please visit our website - http://www.teckro.com/

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    Company Information

    Medicover Integrated Clinical Services is a unique clinical research organization with 25 years of experience.

    We offer Patient Recruitment services through our own Clinical Research Network in Central and Eastern Europe with comprehensive Global Central Lab Services and access to over 8,000 tests from routine to advanced diagnostics including genetics, biomarkers, PK and PD, and PBMC isolation in more than 120 laboratories in Europe and India.

    Company Website

    To learn more, please visit our website - https://medicover-mics.com/

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    Company Information

    Optimapharm is a globally operating, leading, mid-sized, full-service CRO aiming to deliver new therapies to improve and save patients’ lives.
    With 26 strategically located offices, Optimapharm is giving unrivalled access to Patients and Investigators worldwide.
    Optimapharm conducts phase I – IV studies in all therapeutic areas. With very strong operational teams, Optimapharm has a reputation for excellence delivery in all projects, including rescue studies.

    Company Website

    To learn more, please visit our website - https://optimapharm.eu/

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    Company Information

    Greenphire is the industry leader of clinical payment technology, designed to improve the way research professionals work. We leverage our proprietary payments platform and workflow automation to help clients improve operational efficiency, reduce costs, mitigate regulatory risks, improve the patient and site experience and produce quantifiable results that improve clinical operations and strategic planning.

    Company Website

    To learn more, please visit our website - http://greenphire.com/

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    Company Information

    ESMS Global provides specialist support related to Clinical Trials and Medical Information. Our services include a Global Emergency Unblinding Service, Clinical Trials Direct to Patient Helpline, Serious Breach Reporting Service, and a Medical Information Helpline, all available 24/7, across the globe, in 45 languages.

    Company Website

    To learn more, please visit our website - www.esmsglobal.com

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    Company Information

    At Trilogy, medical writing is our passion. As specialists in clinical regulatory documentation, we provide a service that is more than just writing. We proactively plan, coordinate and write clinical documents to meet timelines, with a readability that reduces the time for review and approval.

    Company Website

    To learn more, please visit our website - https://www.trilogywriting.com/

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    Company Information

    TFS HealthScience is a global Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Bringing together nearly 700 professionals, we deliver tailored clinical research services in more than 40 countries. TFS supports customers with comprehensive solutions including full clinical development services, strategic and flexible resourcing. In partnership, we build solution-driven teams of experienced professionals working together for a healthier future. Our mission is to bring treatments to patients faster. For more information, please visit www.tfscro.com.

    Company Website

    To learn more, please visit our website - www.tfscro.com.

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    Company Information

    Medpace is a scientifically-driven, global, full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Medpace’s mission is to accelerate the global development of safe and effective medical therapeutics through its high-science and disciplined operating approach that leverages local regulatory and deep therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, Medpace employs approximately 6,000 people across 44 countries.

    Company Website

    To learn more, please visit our website - http://www.medpace.com/

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    Company Information

    Almac Group is a global leader in providing a range of expert services and support across the drug development lifecycle.

    We are trusted experts in R&D, diagnostic services, API manufacture, formulation development, clinical trial supply services and technologies through to commercial-scale manufacture and distribution.

    We are recognised as an industry leader in client service, providing understanding, experience and knowledge to our clients as we work together to advance human health.

    Almac is trusted by the leading global biopharma companies to provide crucial services across their drug development projects. In the last 5 years alone, we have contributed to over 50% of all FDA approved New Molecular Entities (NMEs) and are currently supporting 30% of EU approved /pre-registered Gene therapy products.

    A privately owned organisation, Almac has grown organically over the past five decades, employing over 7,700 highly skilled employees across 18 facilities in Europe, North America, and Asia. Learn more about us at https://www.almacgroup.com/

    Company Website

    To learn more, please visit our website - https://www.almacgroup.com

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    Company Information

    At Viedoc, we design engaging software that modernizes clinical research so that necessary treatments can reach the people who need them faster. We believe in life and science, in people, and in our collective power to change the world and build a healthier future. That unmatched driving force is what pushes us to innovate, accelerate and improve every aspect of modern clinical studies.

    Company Website

    To learn more, please visit our website - www.viedoc.com

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    Company Information

    Suvoda is a global clinical trial technology company specializing in complex, life-sustaining studies in therapeutic areas like oncology, central nervous system (CNS), and rare disease. Founded in 2013 by experts in eClinical technologies, Suvoda empowers clinical trial professionals to manage the most urgent moments in the most urgent trials through advanced software solutions delivered on a single platform. Headquartered outside Philadelphia, Suvoda also maintains offices in Portland, OR, Barcelona, Spain, Bucharest and Iasi, Romania, and Tokyo, Japan. The company’s Net Promoter Score (NPS) consistently exceeds the technology industry average, contributing to the company being selected by trial sponsors and CROs to support more than 1,000 trials across 80 countries.

    Company Website

    To learn more, please visit our website - https://www.suvoda.com/

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    Company Information

    ClinChoice is a leading global full & functional service CRO, renowned for its exceptional product development and lifecycle management capabilities across the pharmaceutical, biotechnology, medical device, and consumer health sectors. With three decades of proven expertise and outstanding results, we excel in delivering top-tier services.

    Our deep regulatory expertise, clinical trial execution, and robust pharmacovigilance and biometrics capabilities position us as a trusted partner in global markets. ClinChoice proudly maintains a strong presence across the Americas, Europe, and Asia-Pacific, ensuring comprehensive support for our clients worldwide.

    https://clinchoice.com/

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    Company Information

    CMIC Group, founded as Japan’s first CRO over 30 years ago, is now the largest clinical CRO in Japan with a global presence. Our services span non-clinical studies, clinical trial management, GMP manufacturing, regulatory consulting, and sales/marketing solutions. We facilitate market entry in Japan, offer leading clinical trial expertise in APAC region, and bridge drug development between the US and Japan. With 7,000+ employees and 24 global sites, we’re your comprehensive partner in the pharmaceutical, biotech, and medical device sectors.

    Company Website

    To learn more, please visit our website - https://en.cmicgroup.com/

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    Company Information

    B. Braun specialises in manufacturing market leading infusion therapy products, many of which are supplied into clinical trials. With presence in over 64 countries around the world, we work closely with our partners to select solutions that fit with the individual clinical trial requirements.

    For more information, please visit:

    Company Website

    To learn more, please visit our website - bbraun.co.uk/en/products-and-therapies/bbraun-industrial-business.html

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      Why attend?

      We are delighted to welcome you to 12th annual Outsourcing in Clinical Trials UK and Ireland.

      This is a great opportunity to get together and network face to face, hear from our expert speaker line-up and discuss the latest innovations and regulatory updates in the industry.

      This exclusive event brings together attendees from established pharma, large and small, alongside biopharmaceutical companies and gives opportunity to dive into the operational challenges and innovations in clinical development found within the UK & Ireland region.

      This year will also focus on government initiatives for UK growth and opportunities within the clinical trial landscape.

      We look forward to you joining us!

       

      WHAT TO EXPECT FOR 2025?

      This exclusive event brings together attendees from established pharma, large and small, alongside with biopharmaceutical companies and gives opportunity to dive into the operational challenges and innovations in clinical development found within the UK & Ireland region.

      200+

      Attendees

      		50+

      Exhibitors

      		40+

      Speakers
      200+

      Attendees

      		50+

      Exhibitors
      40+

      Speakers

      Testimonials

      See What It's All About

      Agenda

      • 10 Jun 2025
      • 11 Jun 2025
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      Streams

      Stream one

      STREAM A: UK Clinical Trial Landscape Strategy

      Stream two

      STREAM B: Clinical Technology and Innovation

      Stream three

      STREAM C: Clinical Trials in Oncology

      10 AM

      PANEL DISCUSSION: Exploring the landscape for oncology clinical trials in the UK

      • New regulations and guidance around running oncology trials in the UK: what do you need to be aware of?
      • Running clinical trials in conjunction with the NHS: how to ensure your trial is a success
      • Developments in UK cancer research: what’s new in 2025?
      • Assessing the impact of political and economic changes on UK oncology trials
      • The role of the cancer drug fund in accelerating oncology clinical trials in the UK
      • New regulations and guidance around running oncology trials in the UK: what do you need to be aware of?
      • Running clinical trials in conjunction with the NHS: how to ensure your trial is a success
      • Developments in UK cancer research: what’s new in 2025?
      • Assessing the impact of political and economic changes on UK oncology trials
      • The role of the cancer drug fund in accelerating oncology clinical trials in the UK

      Speakers

      Richard Stephens
      Cancer Research Advocates Forum (CRAF-UK)
      Dr Davy Yeung
      COO, TCR Solutions
      Karolin Kroese
      Programme Lead, Experimental Cancer Medicine Centre Network
      Shasheen Payoe
      Clinical Account Manager, UK South and Ireland, Miltenyi Biotec
      Austin Smith
      Chief Medical Officer, Oxcia

      10:45 AM

      PATIENT STORY: Positive and negative experiences in a patient’s cancer journey: how should clinicians and patients work together?

      Speakers

      Maria Lawal
      Patient Advocate

      11:15 AM

      Morning refreshments and networking

      11:45 AM

      Running a successful trial for rare cancers: best practice for recruitment and engagement

      ·       Using the DETERMINE national platform precision medicine trial for rare cancer as a case study to share lessons learned and key factors to consider when  it comes to patients in a rare cancer trial

      ·       Collaborating with patient advocacy groups to facilitate recruitment, retention and patient engagement

      ·       Patient identification: how to find patients who are eligible to participate in your rare disease trial

      ·       Working with the Experimental Cancer Medicine Centres network of sites to recruit and refer patients nationally
      ·       Using the DETERMINE national platform precision medicine trial for rare cancer as a case study to share lessons learned and key factors to consider when  it comes to patients in a rare cancer trial

      ·       Collaborating with patient advocacy groups to facilitate recruitment, retention and patient engagement

      ·       Patient identification: how to find patients who are eligible to participate in your rare disease trial

      ·       Working with the Experimental Cancer Medicine Centres network of sites to recruit and refer patients nationally

      Speakers

      Stephen Nabarro
      Head of Clinical Operations and Data Management, Cancer Research UK

      12:15 PM

      Proof-of-concept: bold moves, big wins and lessons learned

      Fast, furious or never-ending: case studies on accelerating or unexpectedly inflating Phase IB/II timelines and budgets. A site team perspective

      Fast, furious or never-ending: case studies on accelerating or unexpectedly inflating Phase IB/II timelines and budgets. A site team perspective

      Speakers

      Dr. Claudia Hesselmann
      Founder & CEO, ARENSIA Exploratory Medicine

      12:45 PM

      CASE STUDY: Setting up a Phase 1 oncology trial in the UK

      ·       Running a study in conjunction with UK sites

      ·       The impact of regulatory changes on running oncology studies

      ·       Managing and negotiating costs to stay within budget

      ·       How to work effectively and efficiently with sites to set up your study
      ·       Running a study in conjunction with UK sites

      ·       The impact of regulatory changes on running oncology studies

      ·       Managing and negotiating costs to stay within budget

      ·       How to work effectively and efficiently with sites to set up your study

      Speakers

      Hilde van den Berg
      Clinical Operations Manager, Owkin

      1:15 PM

      Lunch and networking

      2:15 PM

      PANEL DISCUSSION: Patient centricity in oncology trials: where are the opportunities for the industry and patients?

      • Simple ways of improving patient experience in clinical trials including vocabulary and clear communication
      • Relieving burden on caregivers as well as patients: how can sponsors be more supportive of patients’ families and support network?
      • Working with patients from the beginning of your clinical trial design process
      • Assessing new innovation and technology which can increase support and relieve pressure on oncology patients
      • Where and how can trial sponsors step in to provide long term support for rare cancer patients?
      • Simple ways of improving patient experience in clinical trials including vocabulary and clear communication
      • Relieving burden on caregivers as well as patients: how can sponsors be more supportive of patients’ families and support network?
      • Working with patients from the beginning of your clinical trial design process
      • Assessing new innovation and technology which can increase support and relieve pressure on oncology patients
      • Where and how can trial sponsors step in to provide long term support for rare cancer patients?

      Speakers

      Diane Chisholm
      Head of Clinical Operations, Owkin
      Richard Stephens
      Cancer Research Advocates Forum (CRAF-UK)
      Lucy Clossick Thomson
      Director, Clinical Operations
      Karthik Maddi
      Associate Director, Pharmanovia
      Kathryn Gray
      Clinical Applications Specialist, Miltenyi Biotec

      3 PM

      Generative AI to improve patient recruitment and retention in oncology trials

      ·       Provide real-time feasibility insights for better site selection and study design

      ·       Instantly match eligible patients from unstructured EHR data in seconds

      ·       Surface future trial candidates based on clinical trajectory (e.g., second-line eligibility while still in first-line treatment)

      ·       Predict patient dropout risk and improve retention strategies
      ·       Provide real-time feasibility insights for better site selection and study design

      ·       Instantly match eligible patients from unstructured EHR data in seconds

      ·       Surface future trial candidates based on clinical trajectory (e.g., second-line eligibility while still in first-line treatment)

      ·       Predict patient dropout risk and improve retention strategies

      Speakers

      Suman Bhaskaran
      Chief Executive Officer and Co-Founder, Srotas Health
      Vikram Parimi
      Chief Technology Officer and Co-Founder, Srotas Health
      Matthew Konneh
      Chief Business Officer, Srotas Health

      3:30 PM

      Afternoon refreshments and networking

      4 PM

      Navigating complexities of managing radioligand therapy oncology trials

      • Site selection considerations specific to Radiopharmaceutical Therapy (RPT) clinical trials
      • A sponsor’s perspective of the technical knowledge and expertise required to deliver RPT studies
      • Country specific RPT clinical trial requirements and regulations
      • Challenges with just-in-time supply for RPT investigational products
      • Site selection considerations specific to Radiopharmaceutical Therapy (RPT) clinical trials
      • A sponsor’s perspective of the technical knowledge and expertise required to deliver RPT studies
      • Country specific RPT clinical trial requirements and regulations
      • Challenges with just-in-time supply for RPT investigational products

      Speakers

      Liz Emmerson
      Director Clinical Operations, Blue Earth Therapeutics

      4:30 PM

      Delivering research in NHS hospitals: the new NIHR Research Delivery Network (RDN)

      • The new NIHR RDN landscape
      • Delivering research in hospital settings
      • Research delivery in partnership
      • The new NIHR RDN landscape
      • Delivering research in hospital settings
      • Research delivery in partnership

      Speakers

      Prof Sandip Mitra
      NIHR National Lead for Research in NHS Hospital Setting, Deputy Director for NIHR Health Technology Centre for Long Term Conditions (D4D), National Institute for Health and Care Research (NIHR)

      5 PM

      Chairperson’s closing remarks

      Speakers

      Richard Stephens
      Cancer Research Advocates Forum (CRAF-UK)

      11:45 AM

      Managing Human specimens and data in the current changing geopolitical and regulatory landscape

      This session explores the evolving role of patient consent in clinical trials, focusing on how to maximize its value while ensuring ethical and regulatory compliance. As geopolitical and regulatory landscapes shift, the management of patient samples and data has become increasingly complex. Industry experts will discuss strategies for streamlining consent processes, enhancing transparency, and addressing the challenges of cross-border data and sample handling.

      • The changing nature of patient consent
      • Geopolitical and regulatory impacts on data management
      • Innovative approaches to sample and data tracking
      • Future trends in patient consent and data usage
      This session explores the evolving role of patient consent in clinical trials, focusing on how to maximize its value while ensuring ethical and regulatory compliance. As geopolitical and regulatory landscapes shift, the management of patient samples and data has become increasingly complex. Industry experts will discuss strategies for streamlining consent processes, enhancing transparency, and addressing the challenges of cross-border data and sample handling.

      • The changing nature of patient consent
      • Geopolitical and regulatory impacts on data management
      • Innovative approaches to sample and data tracking
      • Future trends in patient consent and data usage

      Speakers

      Catherine Mela
      Head Precision Medicine Operations, GSK

      12:15 PM

      Unlocking the power of primary care for site optimisation

      Clinical trials are expensive, and choosing ineffective study sites can lead to wasted time and resources. Through collaboration with primary care, sponsors can benefit from targeted identification of the best locations for recruiting their desired patient population and reduce site burden through effective data sharing. Join us to discover how through collaboration with primary care, electronic health records can enhance recruitment from site selection through to screening.

      Clinical trials are expensive, and choosing ineffective study sites can lead to wasted time and resources. Through collaboration with primary care, sponsors can benefit from targeted identification of the best locations for recruiting their desired patient population and reduce site burden through effective data sharing. Join us to discover how through collaboration with primary care, electronic health records can enhance recruitment from site selection through to screening.

      Speakers

      Isabel Baker
      Market Solution Specialist, Optum

      12:45 PM

      An overview of high-fidelity synthetic data applications

      • Defining high-fidelity synthetic data
      • MHRA approach to synthetic data generation
      • Can synthetic data be used to validate ML algorithms?
      • Can synthetic data be used for sample boosting?
      • Can synthetic data address biases due to underrepresentation?
      • Can synthetic data be used to enhance clinical trials (CTs)?
      • Regulatory considerations
      • Defining high-fidelity synthetic data
      • MHRA approach to synthetic data generation
      • Can synthetic data be used to validate ML algorithms?
      • Can synthetic data be used for sample boosting?
      • Can synthetic data address biases due to underrepresentation?
      • Can synthetic data be used to enhance clinical trials (CTs)?
      • Regulatory considerations

      Speakers

      Puja Myles
      Director, Clinical Practice Research Datalink (CPRD), MHRA

      1:15 PM

      Lunch and networking

      2:15 PM

      PANEL DISCUSSION: Leveraging technology and innovation to support clinical trial execution

      • Adopting innovative technologies to improve clinical trial efficiency
      • Transforming clinical trials using AI driven data analysis
      • Identifying digital tools for patient engagement

       
      • Adopting innovative technologies to improve clinical trial efficiency
      • Transforming clinical trials using AI driven data analysis
      • Identifying digital tools for patient engagement

       

      Speakers

      Puja Runa Myles
      Director, Clinical Practice Research Datalink (CPRD), MHRA
      Lara Campana
      Senior Vice President, Research and Translational Science, Resolution Therapeutics
      Blanka Hezelova
      Associate Director, Precision Medicine Scientific Operations, Bioethics Coach, GSK
      Joseph Sutton
      PhD, Biosample Project Leader and Senior Scientist, Roche

      3 PM

      Has RBQM Reached Its Full Potential?

      Risk-Based Quality Management (RBQM) adoption is on the rise — but for many clinical teams, the expected gains in efficiency and cost reduction have yet to materialize.

      In this presentation, we’ll examine the disconnect between RBQM’s intended impact and its real-world results. We’ll explore common operational and strategic misalignments and share how TRI is helping clinical trial teams close this gap; transforming RBQM from a theoretical framework into a practical driver of performance and quality.

       
      Risk-Based Quality Management (RBQM) adoption is on the rise — but for many clinical teams, the expected gains in efficiency and cost reduction have yet to materialize.

      In this presentation, we’ll examine the disconnect between RBQM’s intended impact and its real-world results. We’ll explore common operational and strategic misalignments and share how TRI is helping clinical trial teams close this gap; transforming RBQM from a theoretical framework into a practical driver of performance and quality.

       

      Speakers

      Duncan Hall
      Chief Executive Officer, TRI

      3:30 PM

      Afternoon refreshments and networking

      4 PM

      SUSTAINABILITY SPOTLIGHT: Inspiring partnerships and action in sustainable healthcare

      Mitigating the environmental impact of clinical trials, in line with the broader imperative to address the interconnected climate and health crises.

      Mitigating the environmental impact of clinical trials, in line with the broader imperative to address the interconnected climate and health crises.

      Speakers

      Dr Fiona Adshead
      Chair, Sustainable Healthcare Coalition
      Pete Morley
      Clinical Sustainability Manager, Novo Nordisk
      Marie Lefebvre
      Local Innovation Lead, Sanofi

      4:30 PM

      FIRESIDE CHAT: Leveraging Process Improvements as Strategic Assets

      ·       Corporate Anthropology as the basis for process innovation and optimisation

      ·       Viewing Process Innovation as Strategic Assets

      ·       Communities of Practice as vehicles for process innovation and implementing optimal ways of working

      ·       Process Innovation within highly regulated SOP driven environments
      ·       Corporate Anthropology as the basis for process innovation and optimisation

      ·       Viewing Process Innovation as Strategic Assets

      ·       Communities of Practice as vehicles for process innovation and implementing optimal ways of working

      ·       Process Innovation within highly regulated SOP driven environments

      Speakers

      Dr Julie Munch Khan
      Chief Commercial Officer, Deallus
      Joseph Sutton
      PhD, Biosample Project Leader and Senior Scientist, Roche

      5 PM

      Chairperson’s closing remarks

      Speakers

      Dr Julie Munch Khan
      Chief Commercial Officer, Deallus

      8 AM

      Registration and refreshments

      8:45 AM

      Chairs opening remarks

      Speakers

      Asiyah Nawab, MSc
      Clinical Trial Analyst, GlobalData

      9 AM

      OPENING KEYNOTE: Clinical trials in the UK: a cross sector approach to making the UK a destination for clinical research

      • Government priorities: one year on
      • How organisations across the sector are working together to continually improve the system
      • What makes the UK a destination for clinical trials
      • Looking ahead
      • Government priorities: one year on
      • How organisations across the sector are working together to continually improve the system
      • What makes the UK a destination for clinical trials
      • Looking ahead

      Speakers

      Prof. Lucy Chappell
      Chief Scientific Adviser, Department of Health and Social Care, Chief Executive Officer, National Institute of Health Research (NIHR)

      9:30 AM

      AI-Powered Trials: Transforming Design and Execution

      Designing and running clinical trials is becoming more complex, with increasingly challenging conditions, evolving regulations, and growing demands for speed and cost efficiency. With rich patient and site-level data from over 35,000 historical and ongoing studies, Medidata’s AI-driven solutions transform study design and execution—enabling teams to make better, faster decisions and proactively mitigate risks across the study lifecycle.
      Designing and running clinical trials is becoming more complex, with increasingly challenging conditions, evolving regulations, and growing demands for speed and cost efficiency. With rich patient and site-level data from over 35,000 historical and ongoing studies, Medidata’s AI-driven solutions transform study design and execution—enabling teams to make better, faster decisions and proactively mitigate risks across the study lifecycle.

      Speakers

      Eleanor McLaurin
      Solution Specialist, Medidata

      10 AM

      KEYNOTE PANEL: Where is the clinical trial industry headed this year and beyond?

      • How do we ensure the UK is an attractive location for clinical research
      • Navigating new regulations around clinical trials smoothly and successfully
      • The impact of artificial intelligence: how far can we expect to move forward in the next 12 months?
      • Patient centricity in clinical trials: how can burden be reduced in order to make trials easier for patients to participate in?
      • Technological developments in 2025 and beyond: what changes can we expect to see in the next 3-5 years?

      • How do we ensure the UK is an attractive location for clinical research
      • Navigating new regulations around clinical trials smoothly and successfully
      • The impact of artificial intelligence: how far can we expect to move forward in the next 12 months?
      • Patient centricity in clinical trials: how can burden be reduced in order to make trials easier for patients to participate in?
      • Technological developments in 2025 and beyond: what changes can we expect to see in the next 3-5 years?

      Speakers

      Alex Churchill
      Deputy Director, Clinical Trials Policy, Department of Health and Social Care
      Esther Kitto
      Vice President, Clinical Operations, Resolution Therapeutics
      Sarah Deeley
      Director, Country & Site Operations, Biogen

      10:45 AM

      Troubleshooting Challenging Hospital Sites?

      • There are many obstacles to running a successful clinical trial – and hospital sites can be one.
      • Slow to set up, delays to patient recruitment, or poor data quality?
      • TCR-Solutions will share some experience and approaches to troubleshooting these challenges.
      • We cannot treat hospital sites like commercial vendors, and we must find a way to work with hospitals to ensure they deliver on time and target.
      • There are many obstacles to running a successful clinical trial – and hospital sites can be one.
      • Slow to set up, delays to patient recruitment, or poor data quality?
      • TCR-Solutions will share some experience and approaches to troubleshooting these challenges.
      • We cannot treat hospital sites like commercial vendors, and we must find a way to work with hospitals to ensure they deliver on time and target.

      Speakers

      Dr Davy Yeung
      COO, TCR Solutions

      11:15 AM

      Morning refreshments and networking

      11:45 AM

      MHRA: The new outlook of the Clinical Trials Unit

      • Activities
      • Innovations
      • International collaborations
      • Activities
      • Innovations
      • International collaborations

      Speakers

      Andrea Manfrin
      Deputy Director, Clinical Investigations and Trials, MHRA

      12:15 PM

      Navigating the Early Stage Landscape: Market Trends and Insights

      • Emerging trends in early stage Evaluating ex-US strategies
      • Observations from Novotech’s early-stage sponsors

       

       

      • Emerging trends in early stage Evaluating ex-US strategies
      • Observations from Novotech’s early-stage sponsors

       

       

      Speakers

      12:45 PM

      How can we all maximise the efficiency of study set-up?

      • Learn opportunities for navigating ethics and regulatory reviews quickly
      • Discover the ideal path through study set-up
      • Help NHS sites to follow national standards
      • Explore new UK clinical trials regulations
      • Learn opportunities for navigating ethics and regulatory reviews quickly
      • Discover the ideal path through study set-up
      • Help NHS sites to follow national standards
      • Explore new UK clinical trials regulations

      Speakers

      Dr Janet Messer
      Director of Approvals, HRA

      1:15 PM

      Lunch and networking

      2:15 PM

      PANEL DISCUSSION: Partnering for innovation: a new model to deliver commercial clinical trials at pace and scale

      • The Vaccine Innovation Pathway: delivering results and shaping the future
      • Real-world innovations in site-level delivery
      • Reimagining clinical research delivery: innovative models and collaborative approaches
      • Expanding primary care horizons: commercial trials in the community
      • Driving innovation from industry: lessons learned and future directions

      MODERATOR:

      Moderator to be confirmed

      • The Vaccine Innovation Pathway: delivering results and shaping the future
      • Real-world innovations in site-level delivery
      • Reimagining clinical research delivery: innovative models and collaborative approaches
      • Expanding primary care horizons: commercial trials in the community
      • Driving innovation from industry: lessons learned and future directions

      MODERATOR:

      Moderator to be confirmed

      Speakers

      Maria Koufali
      Head of UK Vaccine Innovation Pathway, National Institute for Health and Care Research (NIHR)
      Dr Paula Miller
      Acting Regional Director, Clinical Site Management & Monitoring EMEA, Moderna
      Prof Saul Faust
      OBE, Director, NIHR Southampton Clinical Research Facility, University of Southampton; Clinical Director, NIHR LCRN Wessex
      Dr Rebecca Clark
      Partner, Principal Investigator, Fylde Coast Clinical Research and Co-Clinical Lead, UK Vaccine Innovation Pathway

      3 PM

      Innovative approaches to driving clinical trial recruitment success

      This presentation highlights the value of a creative, multi-channel recruitment strategy that blends digital outreach, database activation, patient engagement tactics, and community partnerships. As the highest-recruiting site across all our trials, VCTC has successfully delivered participants for large-scale studies, complex rare disease trials, and challenging oncology rescue protocols, demonstrating the power of a flexible, patient-focused recruitment model.

       

      VCTC, your Multi-therapeutic Clinical Research Centre
      This presentation highlights the value of a creative, multi-channel recruitment strategy that blends digital outreach, database activation, patient engagement tactics, and community partnerships. As the highest-recruiting site across all our trials, VCTC has successfully delivered participants for large-scale studies, complex rare disease trials, and challenging oncology rescue protocols, demonstrating the power of a flexible, patient-focused recruitment model.

       

      VCTC, your Multi-therapeutic Clinical Research Centre

      Speakers

      Dr. Victoria Aniyar López-Abadia
      MD Clinical Pharmacologist - Medical Director, VCTC

      3:30 PM

      Afternoon refreshments and networking

      4 PM

      SPONSOR AND SITE RELATIONSHIPS: Excellence in commercial research delivery: the London North West way

      • Overview of geographic, demographic and disease prevalence landscape in LNWH, which serves a largely under-served region of the UK
      • Building the research infrastructure
      • Impact case studies reflecting challenges and opportunities they present
      • Industry partner perspective
      • Overview of geographic, demographic and disease prevalence landscape in LNWH, which serves a largely under-served region of the UK
      • Building the research infrastructure
      • Impact case studies reflecting challenges and opportunities they present
      • Industry partner perspective

      Speakers

      Christiana Dinah
      Director, Research and Development, London North West Healthcare NHS Trust

      4:30 PM

      PANEL DISCUSSION: Unravelling the impact of ICH E6 Revision 3: implementing new standards in good clinical practice

      ICH E6 (R3) introduces significant updates to Good Clinical Practice guidelines, emphasizing risk-based quality management, patient centricity, and flexibility in trial design and execution. This panel discussion will address the impact of ICH E6 (R3) on clinical trials, comparing it to the previous ICH E6 (R2), discussing approaches to implementation, and considering varied interpretations among stakeholders.

      • Understand the key changes in ICH E6 (R3) and their implications for clinical trial conduct
      • Explore different approaches to implementing the new guidelines in diverse trial settings
      • Analyse the challenges, opportunities, and interpretations associated with ICH E6 (R3)
      • Highlight meaningful differences between ICH E6 (R2) and ICH E6 (R3) and their practical impacts

       

      ICH E6 (R3) introduces significant updates to Good Clinical Practice guidelines, emphasizing risk-based quality management, patient centricity, and flexibility in trial design and execution. This panel discussion will address the impact of ICH E6 (R3) on clinical trials, comparing it to the previous ICH E6 (R2), discussing approaches to implementation, and considering varied interpretations among stakeholders.

      • Understand the key changes in ICH E6 (R3) and their implications for clinical trial conduct
      • Explore different approaches to implementing the new guidelines in diverse trial settings
      • Analyse the challenges, opportunities, and interpretations associated with ICH E6 (R3)
      • Highlight meaningful differences between ICH E6 (R2) and ICH E6 (R3) and their practical impacts

       

      Speakers

      Kerri Fuller
      Director, Resp/Imm/ID PM Operations, GSK
      Piran Sucindran
      Head of Quality, Blue Earth Therapeutics
      Olajumoke Arogundade
      Senior Trial Delivery Manager, J&J
      Daizy Moumi
      Associate Director Clinical Operations, Complement Therapeutics

      5 PM

      Chairperson’s closing remarks

      Speakers

      Asiyah Nawab, MSc
      Clinical Trial Analyst, GlobalData

      NETWORKING DRINKS AND APPLE PRIZE DRAW

      Streams

      Stream one

      Clinical Operations and Outsourcing

      Stream two

      Clinical Technology and Innovation

      11:45 AM

      Using Primary Care Electronic Health Record Data to Access an Appropriate Targeted Subject Population, Matching Eligibility Criteria Effectively

      • An overview of the MHRA’s primary care research database, Clinical Practice Research Datalink
      • Using electronic healthcare research data (EHR) to find, recruit and follow-up patients for clinical trials
      • Considerations when using EHR data for finding and recruiting patients – advantages and limitations
      • Case studies on EHR enabled clinical trial patient recruitment and lessons learned
      • An overview of the MHRA’s primary care research database, Clinical Practice Research Datalink
      • Using electronic healthcare research data (EHR) to find, recruit and follow-up patients for clinical trials
      • Considerations when using EHR data for finding and recruiting patients – advantages and limitations
      • Case studies on EHR enabled clinical trial patient recruitment and lessons learned

      Speakers

      Brooke Jackson
      CPRD Real World Planning Team Lead at Medicines and Healthcare products Regulatory Agency

      12:15 PM

      Enhancing Clinical Trials: The Untapped Potential of Technology improving the Patient and Site Experience

      ·       The Missed Opportunity in Patient-Centric Design

      ·       Technology as an Enabler of Participation

      ·       Bridging Operational Gaps at Sites

      ·       The Case for a Strategic Tech Mindset in Trial Planning
      ·       The Missed Opportunity in Patient-Centric Design

      ·       Technology as an Enabler of Participation

      ·       Bridging Operational Gaps at Sites

      ·       The Case for a Strategic Tech Mindset in Trial Planning

      Speakers

      Steve Sanghera
      CEO, Inventus

      12:45 PM

      Lunch and networking

      2 PM

      Clinical trial investigations: looking at the trends and landscape for 2024 and what we can learn from them moving through 2025 and into 2026

      • Overview of global clinical trials for 2024
      • Assessing key sponsors, top interventions and looking at the trial landscape for 2024
      • Looking at key obstacles for terminated trials and evaluation of completed trials which have achieved endpoint status
      • Overview of global clinical trials for 2024
      • Assessing key sponsors, top interventions and looking at the trial landscape for 2024
      • Looking at key obstacles for terminated trials and evaluation of completed trials which have achieved endpoint status

      Speakers

      Priya Ravisekara
      Senior Pharma Analyst, GlobalData Plc

      2:30 PM

      Interactive Session: Maximizing Site Engagement: A Sponsor’s Perspective in the Evolving Clinical Trial Landscape

      ·       Understanding Site Needs: Aligning sponsor strategies with site capabilities and expectations

      ·       Building Trust and Transparency: Fostering long-term partnerships through clear communication and support

      ·       Technology & Tools: Leveraging digital platforms to enhance site-sponsor collaboration

      ·       Metrics That Matter: Defining and tracking meaningful engagement KPIs for sustained success
      ·       Understanding Site Needs: Aligning sponsor strategies with site capabilities and expectations

      ·       Building Trust and Transparency: Fostering long-term partnerships through clear communication and support

      ·       Technology & Tools: Leveraging digital platforms to enhance site-sponsor collaboration

      ·       Metrics That Matter: Defining and tracking meaningful engagement KPIs for sustained success

      Speakers

      8 AM

      Registration and refreshments

      8:50 AM

      Chairperson’s opening remarks

      9 AM

      KEYNOTE PRESENTATION: AI in clinical trials: assessing opportunities and challenges in developing an AI strategy

      ·       How AI and digitalisation can support streamlining of clinical operations and improve efficiency

      ·       Simple ways to implement tools such as GPT and GenAI in your trial

      ·       Where can AI be utilized to minimize workloads and increase overall output?

      ·       The regulatory landscape in the UK for the use of AI in clinical trials: what do you need to know?

      ·       Key limitations of GenAI and how these impact its potential uses for clinical trials in the UK
      ·       How AI and digitalisation can support streamlining of clinical operations and improve efficiency

      ·       Simple ways to implement tools such as GPT and GenAI in your trial

      ·       Where can AI be utilized to minimize workloads and increase overall output?

      ·       The regulatory landscape in the UK for the use of AI in clinical trials: what do you need to know?

      ·       Key limitations of GenAI and how these impact its potential uses for clinical trials in the UK

      Speakers

      Blanka Hezelova
      Associate Director, Precision Medicine Scientific Operations, Bioethics Coach, GSK

      9:30 AM

      Why are eCOA studies still so hard?

      Despite decades of experience implementing electronic clinical outcome assessments (eCOAs) in clinical trials, we continue to grapple with the same operational challenges during set-up and implementation. They’re solvable - yet they persist. Why?

       

      This presentation will discuss key barriers that continue to slow progress, including:

      •            Licensing and copyright holder review processes

      •            Perceived need for screenshots for IRB/EC submission

      •            Fragmented stakeholder collaboration and lack of true partnership

      •            Unbalanced expectations – electronic vs paper, BYOD vs provisioned

      •            Misconceptions around regulatory expectations

       

      By addressing these challenges head-on, and fostering genuine collaboration, we can solve them if we truly want to gain efficiencies and optimisations in clinical trial set-up.
      Despite decades of experience implementing electronic clinical outcome assessments (eCOAs) in clinical trials, we continue to grapple with the same operational challenges during set-up and implementation. They’re solvable - yet they persist. Why?

       

      This presentation will discuss key barriers that continue to slow progress, including:

      •            Licensing and copyright holder review processes

      •            Perceived need for screenshots for IRB/EC submission

      •            Fragmented stakeholder collaboration and lack of true partnership

      •            Unbalanced expectations – electronic vs paper, BYOD vs provisioned

      •            Misconceptions around regulatory expectations

       

      By addressing these challenges head-on, and fostering genuine collaboration, we can solve them if we truly want to gain efficiencies and optimisations in clinical trial set-up.

      Speakers

      Florence Mowlem
      Chief Scientific Officer, uMotif

      10 AM

      PANEL DISCUSSION: Current operational challenges in running commercial clinical trials in the UK/IE: the need for increasing our attractiveness globally

      ·       Ambition for the UK and the current status

      ·       Site set up: the need for research ready sites

      ·       Site recruitment: increasing our say do ratio
      ·       Ambition for the UK and the current status

      ·       Site set up: the need for research ready sites

      ·       Site recruitment: increasing our say do ratio

      Speakers

      Laura Clifton Hadley
      Head of Clinical Operations, Northern Europe, BMS
      Sarah Deeley
      Director, Country & Site Operations, Biogen
      Alex Churchill
      Deputy Director, Clinical Trials Policy, Department of Health and Social Care
      Esther Kitto
      Vice President, Clinical Operations, Resolution Therapeutics
      Rajinder Sidhu
      Associate Director, Research Governance and Operations, UCLH

      10:30 AM

      From setback to success: The art of clinical trial rescue

      In the complex world of clinical research, even meticulously planned trials can face unexpected hurdles that threaten to derail progress and encounter obstacles beyond the capabilities of a small-scale Clinical Research Organization (CRO). When studies falter, a well-executed rescue strategy with an experienced global CRO becomes crucial. Drawing from Parexel's extensive rescue-trial experience, this presentation unveils the blueprint for successful clinical trial transitions, focusing on four key phases:

       

      • Strategic Initiation & Planning - establishing a robust framework and standardized processes
      • Comprehensive Preparation & Due Diligence - ensuring stakeholder alignment on transition plans and timelines - Conducting thorough documentation review and gap analysis
      • Adaptive Execution & Transfer - How to operationalize a study transfer - Anticipating challenges and employing agile governance for real-time course corrections
      • Effective Closure & Delivery - defining clear transition thresholds and success metrics  - Ensuring continuity and maintaining data integrity throughout the process

       

      Suzanne McNally, Executive Director in Portfolio Management, Parexel

      In the complex world of clinical research, even meticulously planned trials can face unexpected hurdles that threaten to derail progress and encounter obstacles beyond the capabilities of a small-scale Clinical Research Organization (CRO). When studies falter, a well-executed rescue strategy with an experienced global CRO becomes crucial. Drawing from Parexel's extensive rescue-trial experience, this presentation unveils the blueprint for successful clinical trial transitions, focusing on four key phases:

       

      • Strategic Initiation & Planning - establishing a robust framework and standardized processes
      • Comprehensive Preparation & Due Diligence - ensuring stakeholder alignment on transition plans and timelines - Conducting thorough documentation review and gap analysis
      • Adaptive Execution & Transfer - How to operationalize a study transfer - Anticipating challenges and employing agile governance for real-time course corrections
      • Effective Closure & Delivery - defining clear transition thresholds and success metrics  - Ensuring continuity and maintaining data integrity throughout the process

       

      Suzanne McNally, Executive Director in Portfolio Management, Parexel

      Speakers

      Suzanne McNally
      Executive Director in Portfolio Management, Parexel

      11 AM

      Morning refreshments and networking

      11:45 AM

      Patient involvement and engagement, how well are you doing this?

      • Discussing the collaboration that must exist between all parties (patients, coordinators, doctors) in order to have a successful trial
      • Importance of good communication to the patients and how this can streamline trial timelines
      • Exploring how patients could, and should, be influencing decisions and the R&D process before study start-up
      • Discussing the collaboration that must exist between all parties (patients, coordinators, doctors) in order to have a successful trial
      • Importance of good communication to the patients and how this can streamline trial timelines
      • Exploring how patients could, and should, be influencing decisions and the R&D process before study start-up

      Speakers

      Amelia Hursey
      Strategic Director, Parkinson Europe

      12:15 PM

      SMOs: The Hidden Engine of Japan’s Clinical Trials in Changing Times

      Japan’s clinical research landscape offers a unique model, characterized by well-established processes such as the Site Management Organization (SMO) system, which plays a critical role in site selection and accelerating patient recruitment. Over the past five years, Japan has made significant strides in streamlining its regulatory pathways, with median new drug approval timelines now approaching parity with those of the U.S. FDA.

      In this session, as Japan’s leading CRO and SMO, we will provide a quick overview of recent PMDA regulatory updates and deliver an in-depth view of how SMOs operate within Japan’s clinical trial ecosystem. Attendees will gain valuable insights into a proven model that enhances trial efficiency and support global development strategies.

      Japan’s clinical research landscape offers a unique model, characterized by well-established processes such as the Site Management Organization (SMO) system, which plays a critical role in site selection and accelerating patient recruitment. Over the past five years, Japan has made significant strides in streamlining its regulatory pathways, with median new drug approval timelines now approaching parity with those of the U.S. FDA.

      In this session, as Japan’s leading CRO and SMO, we will provide a quick overview of recent PMDA regulatory updates and deliver an in-depth view of how SMOs operate within Japan’s clinical trial ecosystem. Attendees will gain valuable insights into a proven model that enhances trial efficiency and support global development strategies.

      Speakers

      12:45 PM

      Lunch and networking

      2 PM

      Navigating the complexities of running clinical trials both home and away: strategies for success

      • Recruitment strategies: how Lilly selects countries for clinical trials
      • Criteria and processes used by Lilly to recruit and select countries
      • Key factors influencing country selection
      • Performance comparison: UK vs. Other Countries
      • Sharing experiences and lessons from conducting trials in the UK
      • Success stories and challenges faced
      • Recruitment strategies: how Lilly selects countries for clinical trials
      • Criteria and processes used by Lilly to recruit and select countries
      • Key factors influencing country selection
      • Performance comparison: UK vs. Other Countries
      • Sharing experiences and lessons from conducting trials in the UK
      • Success stories and challenges faced

      Speakers

      Emily Pegg
      Associate Vice President, Medical, Northern European Hub, Eli Lilly
      Victoria Bhui
      Associate Director, Investigator Engagement, Eli Lilly

      2:30 PM

      Advancing diversity in clinical research

      ·       Policy

      ·       Industry engagement

      ·       Community engagement

      ·       Media
      ·       Policy

      ·       Industry engagement

      ·       Community engagement

      ·       Media

      Speakers

      Dr Suki Balendra
      Director, Strategic Partnerships, Paddington Life Sciences and Director, North West London Clinical Trials Alliance

      3 PM

      Afternoon refreshments, networking, and Apple Prize Draw

      3:30 PM

      ROUNDTABLE SESSIONS

      During the roundtable discussion session, the conference hall will be divided into zones. Delegates can choose which zone they would like to join. Each zone will be led by a table lead/host and will focus on a different challenge within the industry. After 30 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.

      ROUNDTABLE 1:

      Enhancing Site Feasibility and Analytical Lab Testing: Strategies for Effective Communication and Sample Integrity

      Kerri Fuller, Director, Resp/Imm/ID PM Operations, GSK

       

      ROUNDTABLE 2: Innovative approaches to support sites facilitate study implementation including EHR data mining, eISF, and SSO login

      Marie Lefebvre, Local Innovation Lead, Sanofi

       

      ROUNDTABLE 3: The role of lived experience in clinical trials: meaningful patient engagement in clinical trials is vital to develop impactful and relevant outcomes

      Cameron Keighron, Project Coordinator, International Diabetes Federation of Europe and Trials@Home consortium member, Patient Advocate

       

      ROUNDTABLE 4:  MHRA draft guideline on the use of external control arms based on real-world data to support regulatory decisions

       

      Rebecca Ghosh, Real World Evidence Specialist, MHRA

       

      ROUNDTABLE 5: The EU CTR 536/2014, how is it going so far? Background, operational challenges, opportunities

       

      Riccardo Ferraiuolo, Sr Manager - Clinical Trials Transparency, Biogen

      During the roundtable discussion session, the conference hall will be divided into zones. Delegates can choose which zone they would like to join. Each zone will be led by a table lead/host and will focus on a different challenge within the industry. After 30 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.

      ROUNDTABLE 1:

      Enhancing Site Feasibility and Analytical Lab Testing: Strategies for Effective Communication and Sample Integrity

      Kerri Fuller, Director, Resp/Imm/ID PM Operations, GSK

       

      ROUNDTABLE 2: Innovative approaches to support sites facilitate study implementation including EHR data mining, eISF, and SSO login

      Marie Lefebvre, Local Innovation Lead, Sanofi

       

      ROUNDTABLE 3: The role of lived experience in clinical trials: meaningful patient engagement in clinical trials is vital to develop impactful and relevant outcomes

      Cameron Keighron, Project Coordinator, International Diabetes Federation of Europe and Trials@Home consortium member, Patient Advocate

       

      ROUNDTABLE 4:  MHRA draft guideline on the use of external control arms based on real-world data to support regulatory decisions

       

      Rebecca Ghosh, Real World Evidence Specialist, MHRA

       

      ROUNDTABLE 5: The EU CTR 536/2014, how is it going so far? Background, operational challenges, opportunities

       

      Riccardo Ferraiuolo, Sr Manager - Clinical Trials Transparency, Biogen

      Speakers

      Kerri Fuller
      Director, Resp/Imm/ID PM Operations, GSK
      Marie Lefebvre
      Local Innovation Lead, Sanofi
      Cameron Keighron
      Project Coordinator, International Diabetes Federation of Europe and Trials@Home consortium member, Patient Advocate
      Rebecca Ghosh
      Real World Evidence Specialist, MHRA

      4:30 PM

      Close of conference

      END OF CONFERENCE

      Speakers

      Select a speaker to learn more

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      Sarah Deeley
      Director, Country & Site Operations, Biogen

      Session Details:

      PANEL DISCUSSION: Current operational challenges in running commercial clinical trials in the UK/IE: the need for increasing our attractiveness globally

      2025-06-11, 10:00 AM

      Session Details:

      KEYNOTE PANEL: Where is the clinical trial industry headed this year and beyond?

      2025-06-10, 10:00 AM

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      Liz Emmerson
      Director Clinical Operations, Blue Earth Therapeutics

      Session Details:

      Navigating complexities of managing radioligand therapy oncology trials

      2025-06-10, 4:00 PM

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      Piran Sucindran
      Head of Quality, Blue Earth Therapeutics

      Piran Sucindran is Head of Quality at Blue Earth Therapeutics, a clinical stage radiopharmaceutical company focussed on targeted radiotherapeutics. Piran has previous experience of leading global quality and regulatory teams within an Imaging CRO, and prior to that worked as quality lead at a number of sites within the NHS. He is a member of the Research Quality Association (RQA) GCP Committee, Research Practitioners' Group, and lead on the 'Clinical Oversight of Computerised Systems' seminar."

      Session Details:

      PANEL DISCUSSION: Unravelling the impact of ICH E6 Revision 3: implementing new standards in good clinical practice

      2025-06-10, 4:30 PM

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      Laura Clifton Hadley
      Head of Clinical Operations, Northern Europe, BMS

      Laura Clifton-Hadley is Head of Clinical Operations, Northern Europe, based in the UK. She leads all clinical trial and late development activities across the Bristol Myers Squibb portfolio. Laura is an experienced leader, with experience in all phases of trials and therapeutic areas. Prior to BMS, she worked as the head of haematology and brain trials at University College London. She has more than 14 years of clinical operations experience, and more than 12 years of line management experience. She sits on various UK and IE industry bodies/government bodies to promote/facilitate commercial clinical research and to ensure that we are bringing the right studies to the UK and IE.
      Laura received her PhD in microbiology from the University of Reading. She also holds an honours degree in microbiology and virology from the University of Warwick.

      Session Details:

      PANEL DISCUSSION: Current operational challenges in running commercial clinical trials in the UK/IE: the need for increasing our attractiveness globally

      2025-06-11, 10:00 AM

      View In Agenda
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      Richard Stephens
      Cancer Research Advocates Forum (CRAF-UK)

      Richard Stephens has been a patient advocate for 25 years, surviving two cancers and a heart emergency, plus several co-morbidities and late effects. As a patient he has participated in four interventional studies and nine others. As an Advocate he has helped design over 30 more.

      Richard Chairs the UK Cancer Research Advocates Forum (formerly the NCRI Consumer Forum) and is the former Chair of BBMRI-ERIC’s Stakeholder Forum. He works with patient groups and advocates, academics and industry, and policy-makers, funders and regulators.  

      Richard helped found the AllTrials campaign and useMYdata movement, and he is the founding co-Editor-in-Chief of the Journal of Research Involvement and Engagement. His professional life has included careers in education, journalism and local government.

      Session Details:

      PANEL DISCUSSION: Patient centricity in oncology trials: where are the opportunities for the industry and patients?

      2025-06-10, 2:15 PM

      Session Details:

      Chairperson’s closing remarks

      2025-06-10, 5:00 PM

      Session Details:

      PANEL DISCUSSION: Exploring the landscape for oncology clinical trials in the UK

      2025-06-10, 10:00 AM

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      Stephen Nabarro
      Head of Clinical Operations and Data Management, Cancer Research UK

      Session Details:

      Running a successful trial for rare cancers: best practice for recruitment and engagement

      2025-06-10, 11:45 AM

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      Alex Churchill
      Deputy Director, Clinical Trials Policy, Department of Health and Social Care

      Session Details:

      PANEL DISCUSSION: Current operational challenges in running commercial clinical trials in the UK/IE: the need for increasing our attractiveness globally

      2025-06-11, 10:00 AM

      Session Details:

      KEYNOTE PANEL: Where is the clinical trial industry headed this year and beyond?

      2025-06-10, 10:00 AM

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      Karolin Kroese
      Programme Lead, Experimental Cancer Medicine Centre Network

      Session Details:

      PANEL DISCUSSION: Exploring the landscape for oncology clinical trials in the UK

      2025-06-10, 10:00 AM

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      Emily Pegg
      Associate Vice President, Medical, Northern European Hub, Eli Lilly

      An experienced executive leader within the pharmaceutical industry with a clear focus on and passion for developing high performing cross-functional teams who work without barriers. Highly inclusive yet decisive, adaptable and with a track record of high quality delivery whilst motivating and inspiring the teams around me.

      A GMC registered, NHS trained medical doctor with pharmaceutical industry experience across a broad range of therapeutic areas working with both pre-launch and in-market products in the UK and Europe. Known for being commercially astute and a strong cross-functional worker with 10 years of management experience up to a team size of 120 striving always to create a rewarding, high energy environment for my teams.

      Session Details:

      Navigating the complexities of running clinical trials both home and away: strategies for success

      2025-06-11, 2:00 PM

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      Victoria Bhui
      Associate Director, Investigator Engagement, Eli Lilly

      Victoria has worked at Eli Lilly and Company for 16 years across drug safety and clinical operations. In her current role, she leads a team of Clinical Research professionals who work to identify, evaluate, and set up investigator sites across the UK and Nordics. They are responsible for delivery of patients into trials, by forging close site relationships, across the full Lilly portfolio. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are advancing new discoveries to address some of the world's most significant health challenges.

      Session Details:

      Navigating the complexities of running clinical trials both home and away: strategies for success

      2025-06-11, 2:00 PM

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      Divya Manek
      Director, Clinical Operations, Eyebiotech
      Next speaker
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      Dr Rebecca Clark
      Partner, Principal Investigator, Fylde Coast Clinical Research and Co-Clinical Lead, UK Vaccine Innovation Pathway

      Dr Rebecca Clark is a Partner at Fylde Coast Clinical Research at Layton Medical Centre, a dedicated commercial trials centre in Blackpool. She is a highly experienced trialist with over 70 Phase II/III clinical trials conducted over the last 13 years, with multiple studies as Chief Investigator in the therapy areas of vaccines, obesity medicine, cardiovascular medicine, asthma and diabetes. She holds a number of senior leadership roles including co-clinical lead for the UK Vaccine Innovation Pathway, a UK clinical trials accelerator.

      Fylde Coast Clinical Research at Layton Medical Centre recruits amongst the highest number of commercial participants across the NHS in England and was in the top 1% of NHS recruiting sites when compared with all 637 sites across both primary and secondary care in 22/23. Study participant retention rates exceeded 99%. Her site regularly achieves UK FPV and she is renowned for accelerated set up and recruitment timelines, experience she is now bringing to her role in the UK VIP.

      Fylde Coast Clinical Research currently holds contracts with Eli Lilly, Moderna, Astra Zeneca, Roche, Amgen, Merck, Novo Nordisk and GSK, with whom they are members of the PEER preferred site network.

      Dr Clark continues to be recognised nationally for her excellence in clinical trial delivery, being a former recipient of the Gold Award for Clinical Site of the Year at the Pharmatimes International Clinical Researcher of the Year.

       

      Session Details:

      PANEL DISCUSSION: Partnering for innovation: a new model to deliver commercial clinical trials at pace and scale

      2025-06-10, 2:15 PM

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      Catherine Mela
      Head Precision Medicine Operations, GSK

      Catherine Mela is Executive Director, Head of Precision Medicine Operations, within GSK. In her role, Catherine is accountable for leading the Scientific Operations and Data Operations teams, driving the execution of precision medicine project strategies with efficiency and quality.

      Catherine has gained broad experience in laboratory and bio-sample operations, while leading sampling and laboratory operations teams in AstraZeneca and Roche.

      Prior to working in pharma, Catherine’s background was in Clinical research within the NHS.  She holds a PhD from Imperial College on ‘The impact of treatment strategies on immune responses in HIV-1 infection’.  Catherine is a fellow of the institute of leadership and is passionate about professional development, mentorship and creating a supportive environment for individuals within her teams.

      Session Details:

      Managing Human specimens and data in the current changing geopolitical and regulatory landscape

      2025-06-10, 11:45 AM

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      Esther Kitto
      Vice President, Clinical Operations, Resolution Therapeutics

      With over 40 years of experience in the clinical research industry, I’ve had the privilege of working in large pharma, biotech, and CRO environments. I began my career as a Clinical Research Associate and have since held a broad range of leadership, operational, and commercial roles, gaining extensive global experience in clinical development, business development, outsourcing, and contracting.

       My therapeutic expertise spans multiple areas including CNS, cardiovascular, ophthalmology and hepatology, with a strong focus over the past decade on the development of advanced therapy medicinal products (ATMPs), particularly cell and gene therapies.

       I am currently the Vice President of Clinical Operations at Resolution Therapeutics Limited, a pioneering UK-based biotechnology company developing regenerative macrophage cell therapies. I remain deeply passionate about clinical research, am a committed advocate of the UK biotech sector, and am firmly driven by the mission to help bring innovative medicines to patients worldwide.

       

      Session Details:

      PANEL DISCUSSION: Current operational challenges in running commercial clinical trials in the UK/IE: the need for increasing our attractiveness globally

      2025-06-11, 10:00 AM

      Session Details:

      KEYNOTE PANEL: Where is the clinical trial industry headed this year and beyond?

      2025-06-10, 10:00 AM

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      Dr Fiona Adshead
      Chair, Sustainable Healthcare Coalition

      Fiona chairs the Sustainable Healthcare Coalition that inspires partnerships and action on sustainable healthcare. She also works as an independent expert advisor and board member for national and global organisations on wellbeing and sustainability.

      She is a high-profile wellbeing and public health leader with a track record of reframing thinking and developing innovative strategy and programmes at the heart of business and government. Her previous roles include Deputy Chief Medical Officer and Director General in the UK Government, Director of Chronic Disease and Health Promotion at the World Health Organisation and Bupa’s Chief Wellbeing Officer.

      Fiona is a visiting Professor at UCL and is a Senior Associate at Cambridge Institute for Sustainability Leadership.  Fiona’s recent board roles include Fresenius ESG Advisory Board, My Green Lab, British Land’s Sustainability Advisory Panel, Marks and Spencer’s Sustainable Retail Advisory Board, and Business in the Community’s Wellbeing Leadership Team. Fiona is a member of the Health System Taskforce of the Sustainable Markets Initiative.

      Session Details:

      SUSTAINABILITY SPOTLIGHT: Inspiring partnerships and action in sustainable healthcare

      2025-06-10, 4:00 PM

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      Kerri Fuller
      Director, Resp/Imm/ID PM Operations, GSK

      Session Details:

      ROUNDTABLE SESSIONS

      2025-06-11, 3:30 PM

      Session Details:

      PANEL DISCUSSION: Unravelling the impact of ICH E6 Revision 3: implementing new standards in good clinical practice

      2025-06-10, 4:30 PM

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      Blanka Hezelova
      Associate Director, Precision Medicine Scientific Operations, Bioethics Coach, GSK

      Blanka is an Associate Director within Precision Medicine Scientific Operations at GSK with over ten years of experience in research spanning from clinical site to sponsor roles, and expertise in biosample operations. She leads operational aspects of trials with a focus on innovation and excellence, successfully managing complex clinical studies while ensuring compliance and participant protection. Herf passion lies in ethical research and strategic improvements for operational efficiency.

      Session Details:

      PANEL DISCUSSION: Leveraging technology and innovation to support clinical trial execution

      2025-06-10, 2:15 PM

      Session Details:

      KEYNOTE PRESENTATION: AI in clinical trials: assessing opportunities and challenges in developing an AI strategy

      2025-06-11, 9:00 AM

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      Dr Janet Messer
      Director of Approvals, HRA

      Experienced strategic leader with extensive experience of operations, business transformation and introducing digital systems. Systems-thinker with focus on delivering cross-sector improvement. Deep knowledge of health and care research regulation and governance.

      Session Details:

      How can we all maximise the efficiency of study set-up?

      2025-06-10, 12:45 PM

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      Dr Julie Munch Khan
      Chief Commercial Officer, Deallus

      Julie is the Chief Commercial Office at Deallus, a market leading strategy consultancy, which was acquired by Global Data  at the beginning of the year. Julie's career in life sciences spans 20 years with a focus on partnering with clients on strategy development on local, regional and global level . For more than decade Julie has led large global and regional competitive mindset training programmes for large pharma. Since 2017 Julie has regularly been engaged as an inspirational speaker on Competitive Mindset across brand, portfolio and corporate audiences. Her expertise includes clinical and commercial planning, brand & portfolio strategy  as well as advising organisation  on personalised healthcare approaches across various disease areas.  Julie holds a PhD in Neuroscience from Imperial College London sponsored by Pfizer.

      Session Details:

      FIRESIDE CHAT: Leveraging Process Improvements as Strategic Assets

      2025-06-10, 4:30 PM

      Session Details:

      Chairperson’s closing remarks

      2025-06-10, 5:00 PM

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      Christiana Dinah
      Director, Research and Development, London North West Healthcare NHS Trust

      • Fellow of the Royal College of Ophthalmologists
      • Medical Retina Sub-specialist in a busy, multi-cultural teaching hospital
      • Strong academic background in medical retina with expertise in commercial and non-commercial clinical trials
      • Teacher and trainer committed to clinical excellence

      Session Details:

      SPONSOR AND SITE RELATIONSHIPS: Excellence in commercial research delivery: the London North West way

      2025-06-10, 4:00 PM

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      Andrea Manfrin
      Deputy Director of Clinical Investigations
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      Shasheen Payoe PhD
      Clinical Account Manager, UK South and Ireland, Miltenyi Biotec
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      Dr. Claudia Hesselmann
      Founder & CEO, ARENSIA Exploratory Medicine

      Dr. Claudia Hesselmann, a chemist by training, with a PhD in molecular biology. Claudia has twenty years of expertise in the early phases of drug development. Her experience includes co-founding and holding management positions in various CROs. Her extensive background and social acumen, along with her first-hand knowledge of the industry, led Claudia to co-found ARENSIA Exploratory Medicine in Düsseldorf, Germany. Her primary aim is the contribution of innovative approaches to bring about substantial acceleration to the drug development process and enable more agile patient access to novel therapeutics.

       

      Session Details:

      Proof-of-concept: bold moves, big wins and lessons learned

      2025-06-10, 12:15 PM

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      Session Details:

      Interactive Session: Maximizing Site Engagement: A Sponsor’s Perspective in the Evolving Clinical Trial Landscape

      2025-06-11, 2:30 PM

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      Lucy Clossick Thomson
      Director, Clinical Operations

      Session Details:

      PANEL DISCUSSION: Patient centricity in oncology trials: where are the opportunities for the industry and patients?

      2025-06-10, 2:15 PM

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      Puja Myles
      Director, Clinical Practice Research Datalink (CPRD), MHRA

      Dr Puja Myles is Director of the Medicines and Healthcare products Regulatory Agency’s (MHRA) specialist real world data research service, the Clinical Practice Research Datalink (CPRD). She is a public health specialist and prior to joining CPRD, was a public health academic at the University of Nottingham, UK. She is a fellow of the Faculty of Public Health (UK), a senior fellow of the Higher Education Academy (UK) and has a doctorate in epidemiology. She has been the MHRA’s strategic lead on the development of synthetic data generation approaches and applications since 2017. In addition, she has led on Regulatory Science initiatives including AI explainability, handling concept drift, data quality standards for regulatory purposes, regulatory evidence derived from computer modelling and simulation approaches.

      Session Details:

      An overview of high-fidelity synthetic data applications

      2025-06-10, 12:45 PM

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      Duncan Hall
      Chief Executive Officer, TRI

      Session Details:

      Has RBQM Reached Its Full Potential?

      2025-06-10, 3:00 PM

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      Prof. Lucy Chappell
      Chief Scientific Adviser, Department of Health and Social Care, Chief Executive Officer, National Institute of Health Research (NIHR)

      Professor Lucy Chappell FMedSci is the Chief Scientific Adviser for the Department of Health and Social Care (DHSC), with overall responsibility for the department’s research and development, including the National Institute for Health and Care Research (NIHR), the government’s major funder of clinical, public health, social care and translational research.

      Reporting to the Chief Medical Officer, the Chief Scientific Adviser provides science advice and analysis to ministers across the range of health topics and is involved in cross-government science policy.

      Professor Chappell is Professor of Obstetrics at King’s College London, Honorary Consultant Obstetrician at Guy’s and St Thomas’ NHS Foundation Trust and an NIHR Senior Investigator. She will undertake the Chief Scientific Adviser role on secondment into government, while continuing some of her clinical and academic work.

      DHSC Chief Scientific Adviser

      Responsibilities include:

      • overall responsibility for the Department of Health and Social Care’s (DHSC) research policies and budget, including being head of the National Institute for Health and Care Research (NIHR)
      • supporting analysis and evidenced-based decision-making capacity in the department
      • working with Chief Scientific Advisers across government to maximise the impact of science to benefit the UK population

      Session Details:

      OPENING KEYNOTE: Clinical trials in the UK: a cross sector approach to making the UK a destination for clinical research

      2025-06-10, 9:00 AM

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      Prof Sandip Mitra
      NIHR National Lead for Research in NHS Hospital Setting, Deputy Director for NIHR Health Technology Centre for Long Term Conditions (D4D), National Institute for Health and Care Research (NIHR)

      Innovation-driven clinician and an enterpreneurial enthusiast based at the Manchester Academy of Health Sciences Centre, Manchester University Hospitals. Recognised as an influential health technology leader with major contributions to innovation in healthcare technology, dialysis and delivery systems.

      Passionate about transforming clinical services and patient pathways through enabling technology.

      In various leadership roles as Deputy Director of NIHR MedTech Cooperative Devices for Dignity, Vice Chair for EUDIAL, ERA-EDTA, Chair of the Haemodialysis Study group for UK Kidney Research Consortium. Driving safe and value based health care with national organisations as CQC Speciality Advisor, and as Clinical Reference Group Member for NHS England.

      Managing a diverse portofolio of translational clinical academic research with a global network of collaborators. A trainer, educator and mentor for health professionals at the University of Manchester. Several publications, patents, authored book chapters and media reports of the work in the field.

      Session Details:

      Delivering research in NHS hospitals: the new NIHR Research Delivery Network (RDN)

      2025-06-10, 4:30 PM

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      Maria Koufali
      Head of UK Vaccine Innovation Pathway, National Institute for Health and Care Research (NIHR)

      Maria Koufali, is an experienced senior leader in life sciences research and innovation, bringing over 20 years of cross-sector expertise in working with global pharmaceutical companies, digital health firms, diagnostics developers, and MedTech SMEs. She holds a PhD in Pharmacology and Neuroscience, an MBA (Distinction), and is the first NHS R&D Director nationally to be awarded the Nye Bevan Executive Health Leadership Award. Maria currently leads the UK Vaccine Innovation Pathway at NIHR/DHSC, a nationally mandated clinical trials accelerator. In this role, she has delivered over 20 high-priority commercial trials, expanded partnerships beyond Moderna and BioNTech to include smaller biotech firms and large pharma, and embedded site-readiness models and trial metrics to support faster delivery.

      Maria has built a wide network of trusted relationships across the life sciences sector and has consistently translated strategic ambition into operational delivery, regulatory compliance, and commercial value. Previously, as Managing Director of Research & Innovation at Nottingham University Hospitals NHS Trust, she designed and delivered the Trust’s entire NIHR infrastructure portfolio from the ground up, securing funding and oversight for a £70m suite including a BRC, CRF, BioResource, and the Medical Technologies Innovation Facility (MTIF)—a £23m translational platform that supports SMEs to take digital and MedTech innovations from prototype to trial. Under her leadership, the Trust’s commercial research income rose to over £13m per year. She has successfully navigated and aligned MHRA, HRA and ISO frameworks to support industry delivery at scale. Maria currently serves as Trustee and Chair of the Industry Advisory Board at the BBSRC-funded Quadram Institute, where she shapes translational and commercial strategy. She brings a proven ability to develop national infrastructure, deliver commercial growth, and work across government and industry to accelerate innovation that benefits patients and the UK economy.

      Session Details:

      PANEL DISCUSSION: Partnering for innovation: a new model to deliver commercial clinical trials at pace and scale

      2025-06-10, 2:15 PM

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      Pete Morley
      Clinical Sustainability Manager, Novo Nordisk

      Peter Morley is leading the global effort to assess and reduce the environmental impact of Novo Nordisk clinical trials globally. He represents Novo Nordisk on the Sustainable Markets Initiative Health Systems Task Force (Digital Healthcare in Clinical Research), collaborating with industry and academia to accelerate the decarbonisation of the clinical trials sector through shared frameworks and tools.

      With a background spanning more than 25 years in clinical operations, Peter combines his passion for sustainability with a sharp focus on innovation and digitalisation. This positions him at the forefront of setting the path for decarbonisation and driving the necessary changes to significantly lower the environmental impact of clinical trials.

      Session Details:

      SUSTAINABILITY SPOTLIGHT: Inspiring partnerships and action in sustainable healthcare

      2025-06-10, 4:00 PM

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      Diane Chisholm
      Head of Clinical Operations, Owkin

      Session Details:

      PANEL DISCUSSION: Patient centricity in oncology trials: where are the opportunities for the industry and patients?

      2025-06-10, 2:15 PM

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      Hilde van den Berg
      Clinical Operations Manager, Owkin

      Session Details:

      CASE STUDY: Setting up a Phase 1 oncology trial in the UK

      2025-06-10, 12:45 PM

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      Austin Smith
      Chief Medical Officer, Oxcia

      Session Details:

      PANEL DISCUSSION: Exploring the landscape for oncology clinical trials in the UK

      2025-06-10, 10:00 AM

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      Dr Suki Balendra
      Director, Strategic Partnerships, Paddington Life Sciences and Director, North West London Clinical Trials Alliance

      Suki Balendra a senior leader in the NHS with a 20-year background in facilitating, growing, and promoting health research in the U.K.  She has substantial, in-depth experience across sectors including industry, academia, NHS, and central government.

      She is currently the Director of Strategic Partnerships for Imperial College Healthcare NHS Trust in Northwest London. She leads the strategic work with the Life sciences industry in the region with an emphasis on a new life sciences cluster in Paddington. Suki created and leads the North West London Clinical Trials Alliance. She started her career in the Biotechnology Industry at Abbott Diagnostics Ltd. Within a Good manufacturing practice (GMP) environment she worked on several operational projects to improve efficiency, cost, and reproducibility.

      In 2018 she was seconded to the Office of Life Sciences within the Department of Business and Industrial Strategy. where she attracted and negotiated new business to increase the UK’s market share of health and care research activity. During the pandemic she provided operational leadership to the NHS covid vaccine research response in Northwest London.

      Suki has PhD from the University of Warwick, and she is accredited to black belt in Lean Six Sigma. She is a passionate advocate for UK PLC as the number one destination to conduct clinical trials.

      Session Details:

      Advancing diversity in clinical research

      2025-06-11, 2:30 PM

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      Amelia Hursey
      Strategic Director, Parkinson Europe

      Amelia joined the Parkinson’s Europe  team in Jan 2022 as Research Manager. Since then she has developed Parkinson’s Europe’s Research Strategy, embedding a Research Steering Group into the organisation and helping to increase the presence of Parkinson’s Europe in the clinical research world. She is also focused on bringing new initiatives to the table, such as the Parkinson’s Europe’s Engagement Network, which better connects the Parkinson’s

      community with research across Europe. Parkinson’s Europe is now a partner member of EUPATI and the Critical Path for Parkinson’s as part of this action.

      She has been working in the field of Neurodegenerative research since 2009 and is a Patient Organisations board member with EUPATI since Sept 2023.

      She previously worked for the UK NIHR’s DeNDRoN delivering clinical trials and then at Parkinson’s UK from July 2015 as Research Participation Lead.  She was responsible for initiatives to increase research participation for people affected by Parkinson’s, health care professionals and researchers, and created the innovative Parkinson’s UK Take Part Hub and co-produced the Staying Connected toolkit in collaboration with the HRA UK.

      Session Details:

      Patient involvement and engagement, how well are you doing this?

      2025-06-11, 11:45 AM

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      Maria Lawal
      Patient Advocate

      Session Details:

      PATIENT STORY: Positive and negative experiences in a patient’s cancer journey: how should clinicians and patients work together?

      2025-06-10, 10:45 AM

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      Karthik Maddi
      Associate Director, Pharmanovia

      Session Details:

      PANEL DISCUSSION: Patient centricity in oncology trials: where are the opportunities for the industry and patients?

      2025-06-10, 2:15 PM

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      Joseph Sutton
      PhD, Biosample Project Leader and Senior Scientist, Roche

      Joe Sutton is a Biosample Project Leader at Roche based in the UK. He leads the operational activities relating to clinical biosampling including centralised screening, safety and biomarker analysis. In this role, Joe influences PhI/II clinical trial design across oncology, neurology and rare disease indications and ensures biosampling plans and biomarker strategies bring optimal value, insights and patient centricity. Prior to working with Roche, Joe worked as a consultant at A4PBio and as a Senior Pharmacology Scientist at GW Pharmaceuticals. Before joining the pharmaceutical industry, Joe completed academic research focusing on therapeutic resistance mechanisms of prostate cancer at University of Cambridge (CRUK Institute) and for completion of his PhD from Edinburgh Napier University.

      Session Details:

      PANEL DISCUSSION: Leveraging technology and innovation to support clinical trial execution

      2025-06-10, 2:15 PM

      Session Details:

      FIRESIDE CHAT: Leveraging Process Improvements as Strategic Assets

      2025-06-10, 4:30 PM

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      Marie Lefebvre
      Local Innovation Lead, Sanofi

      Marie Lefebvre is a Local Innovation Lead at Sanofi, specializing in developing and implementing innovative strategies to optimize clinical trials. With a Master's degree in Physiology and Computer Sciences from Poitiers University, Marie brings extensive experience in digital project management and clinical operations to her role. At Sanofi, she leads the development and implementation of the UK Clinical Operation Innovation Road Map, focusing on gap analysis, change management, and the adoption of cutting-edge technologies. Beyond her professional achievements, Marie is passionate about sustainability, serving as a Climate Fresk facilitator and actively participating in various environmental initiatives within the industry.

      Session Details:

      ROUNDTABLE SESSIONS

      2025-06-11, 3:30 PM

      Session Details:

      SUSTAINABILITY SPOTLIGHT: Inspiring partnerships and action in sustainable healthcare

      2025-06-10, 4:00 PM

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      Rajinder Sidhu
      Associate Director, Research Governance and Operations, UCLH

      Rajinder Sidhu is the Associate Director for Research Governance and Operations for University College London Hospitals (UCLH) and University College London (UCL) Joint Research Office.  She leads on the necessary governance, policies, and operations for both the sponsorship of studies at UCL and UCLH (ranging from clinical trials and advanced therapies through to observational and data programmes) and the systems and infrastructures required to host research at UCLH (commercial and non-commercial). Rajinder has over 17 years’ experience in senior operational and governance roles at UCLH/UCL and has led large change programmes to streamline systems and embed leaner ways of working across the organisation.

       

      Prior to UCLH/UCL, Rajinder worked for Kings College London, Institute of Psychiatry as a researcher/coordinator for regional research studies into mental health services, and as a manager of international research centres. Rajinder also completed a PhD on consumerism within the NHS at Royal Holloway, University of London.

      Session Details:

      PANEL DISCUSSION: Current operational challenges in running commercial clinical trials in the UK/IE: the need for increasing our attractiveness globally

      2025-06-11, 10:00 AM

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      Fiona Maini BSc. MSc.
      Senior Director - Global Compliance and Strategy Medidata Solutions a Dassault Systèmes Company

      Fiona has worked within the Life Sciences and Healthcare domain for over 25 years working across GxP areas within the private and public sector environments.

      Fiona is currently a Senior Director at Medidata with a focus on quality management and general regulatory compliance and advocacy on topics within the good clinical practice domain.

      Over the past few years she has been chairing a number of trade association groups on topics such as new technologies in clinical trials, decentrialised clinical trials and a contributor to EU Artificial Intelligence initiatives.

      Prior to Medidata Fiona was a Director at Deloitte, where she led the Deloitte Global Centre for Regulatory Excellence for Life Sciences and provided governance of Deloitte services to the European Medicines Agency and their programmes.

      Fiona has a BSc in Chemistry and Management Science and an MSc in Chemistry

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      Dr Paula Miller
      Acting Regional Director, Clinical Site Management & Monitoring EMEA, Moderna

      With 20 years of global clinical research experience, Paula specialises in accelerating clinical trial delivery, optimising recruitment, and fostering strong site partnerships to ensure high-quality, efficient trial execution. Passionate about site engagement and strategic collaboration, she work closely with key stakeholders across the clinical trial ecosystem to drive performance, mitigate risks, and enhance trial delivery.

      Session Details:

      PANEL DISCUSSION: Partnering for innovation: a new model to deliver commercial clinical trials at pace and scale

      2025-06-10, 2:15 PM

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      Isabel Baker
      Market Solution Specialist, Optum

      Isabel is a Market Solutions Specialist at Optum UK, specialising in clinical trials and real-world evidence with a focus on EMIS Web primary care data and systems. She supports the UK’s only clinical trial recruitment solution fully embedded within the GP clinical system, enabling faster, more accurate patient recruitment while reducing the burden on sites.

      Session Details:

      Unlocking the power of primary care for site optimisation

      2025-06-10, 12:15 PM

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      Session Details:

      SMOs: The Hidden Engine of Japan’s Clinical Trials in Changing Times

      2025-06-11, 12:15 PM

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      Dr Davy Yeung
      COO, TCR Solutions

      Dr Davy Yeung’s career to date encompasses academia and the NHS. He has made valuable contributions to clinical research at the University of Cambridge, Imperial College, and other major academic institutions.

      Dr Yeung was also the Head of Research at various UK Hospital Trusts. During his time in the NHS, he gained considerable insight into the governance and delivery of clinical research in the UK. This unique perspective enables our sponsors to select, initiate and manage UK investigative sites for their clinical studies rapidly and effectively. Having collaborated with a wide range of influential leaders in the field of clinical research, Dr Yeung is himself highly respected and well known in the UK’s healthcare research and development sector.

      Session Details:

      PANEL DISCUSSION: Exploring the landscape for oncology clinical trials in the UK

      2025-06-10, 10:00 AM

      Session Details:

      Troubleshooting Challenging Hospital Sites?

      2025-06-10, 10:45 AM

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      Florence Mowlem
      Chief Scientific Officer, uMotif

      Flo is an expert eCOA scientist who has spent her career advising and guiding organizations on the electronic capture of clinical outcome assessments (COA) and the use of digital health technologies (DHTs) in clinical trials. She has a deep knowledge of clinical research, study design, and leveraging technology to support it, having worked at the intersection between science and technology to navigate for better solutions.

      Flo actively participates in industry consortia, regularly publishes, and presents at international conferences. She uses her passionate and progressive mindset for driving positive change in the industry, focusing on optimising clinical trial data capture to enhance the participant and site experience.

      At uMotif, she provides Scientific Leadership across the organization, ensuring that the scientific voice is embedded across all functional areas to inform rigorous scientific practices. She previously held positions at Signant Health, Medable, and ObvioHealth.

      Flo holds an MSc and PhD in Social, Genetic, and Developmental Psychiatry from Kings College London – which included the development of a new PRO.

      Session Details:

      Why are eCOA studies still so hard?

      2025-06-11, 9:30 AM

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      Dr Tariq Latif
      UK Clinical Trial Liaison, REGENERON

      Tariq is a Lead Clinic Trial Liaison at Regeneron responsible for expanding the clinical trial footprint in the region, providing key scientific insights and overseeing the successful delivery of oncology trials. With over 15 years of Oncology research experience, his leadership and strategic insight have fostered strong collaborations with the NHS, Private Hospitals, and research bodies such as the NIHR and Cancer Trials Office (Ireland).  These partnerships have driven impactful initiatives, with a view to significantly advancing oncology clinical research across UK and Ireland.

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      Rebecca Ghosh
      Real World Evidence Specialist, MHRA

      Dr Rebecca Ghosh is a Real-World Evidence Specialist in the Scientific, Data and Insight group at the MHRA where she is leading the MHRA the Real-World Evidence Scientific Dialogue Programme and Real-World Data Guidance series.  She has over 15 years experience working as an epidemiologist specialising in public health research using real-world data for a range of observational studies, spatial epidemiology and interventional research.  Rebecca holds an MSc in Public Health from the LSHTM and a PhD in epidemiology from Imperial college.

       

      Session Details:

      ROUNDTABLE SESSIONS

      2025-06-11, 3:30 PM

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      Steve Sanghera
      CEO, Inventus

      Steven Sanghera is the Chief Executive Officer (CEO) of Inventus Group Limited, a UK-based technology company specializing in providing fully provisioned mobile devices and digital solutions for the life sciences and clinical research sectors. He has been a pivotal figure in the company's development since its incorporation on May 6, 2020.

      Under Steve's leadership, Inventus Group has focused on delivering end-to-end device lifecycle management tailored for clinical trials. The company's services include provisioning customized mobile devices, implementing electronic Clinical Outcomes Assessment (eCOA) and electronic Patient-Reported Outcomes (ePRO) solutions, ensuring secure data collection compliant with EU GDPR and international standards, and promoting sustainable device recycling and redeployment strategies.

      Steve's strategic vision emphasizes innovation, compliance with international standards, and sustainable practices in device lifecycle management, positioning Inventus Group as a key player in the intersection of technology and clinical research.

      Under his guidance, Inventus Group has expanded its global footprint, establishing offices and logistics centers in the United Kingdom, Austria, the United States, Hong Kong, China and the Middle East. This international presence supports the company's mission to streamline clinical trials through technology-driven solutions.

      Session Details:

      Enhancing Clinical Trials: The Untapped Potential of Technology improving the Patient and Site Experience

      2025-06-11, 12:15 PM

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      Olajumoke Arogundade
      Senior Trial Delivery Manager, J&J

      A competently skilled, flexible, dependable, hard-working, conscientious and ambitious clinical research professional with a solid employment history (including 10 years clinical trial management experience).
      Hands-on responsibility for the leadership and conduct of clinical trials either through fully in-sourced, fully outsourced or hybrid operational model. Management and execution of Phase I-IV oncology and immuno-oncology clinical trials including the direction, planning, execution and interpretation of clinical trials under ICH/Good Clinical Practices.
      Experience within Biotechs, Pharma, CRO and University Investigator led research studies in Phase I - IV trials.
      Possess a thorough understanding of cross-functional clinical processes including data management, drug safety and regulatory affairs and have demonstrated the ability to lead a cross-functional team in a matrix environment.
      Assists in the development and implementation of strategy, policies and procedures. Manage aspects of external vendor contracts including CRO.

      Therapeutic areas worked in including Oncology, Infectious disease, Neurology, Vaccines, Cardiovascular, Diabetes and Dermatology.
      Proficiency in Microsoft Office programs, a number of clinical trial management, safety database and document repository systems with the ability to pick up new skills and learn quickly.
      Specialties: Clinical Trial Management, Data Management, study start up, ethics and regulatory submission, Trial Master File & Investigator site File maintenance.

      Session Details:

      PANEL DISCUSSION: Unravelling the impact of ICH E6 Revision 3: implementing new standards in good clinical practice

      2025-06-10, 4:30 PM

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      Daizy Moumi
      Associate Director Clinical Operations, Complement Therapeutics

      Session Details:

      PANEL DISCUSSION: Unravelling the impact of ICH E6 Revision 3: implementing new standards in good clinical practice

      2025-06-10, 4:30 PM

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      Suman Bhaskaran
      Chief Executive Officer and Co-Founder, Srotas Health

      Session Details:

      Generative AI to improve patient recruitment and retention in oncology trials

      2025-06-10, 3:00 PM

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      Vikram Parimi
      Chief Technology Officer and Co-Founder, Srotas Health

      Session Details:

      Generative AI to improve patient recruitment and retention in oncology trials

      2025-06-10, 3:00 PM

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      Matthew Konneh
      Chief Business Officer, Srotas Health

      Session Details:

      Generative AI to improve patient recruitment and retention in oncology trials

      2025-06-10, 3:00 PM

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      Asiyah Nawab, MSc
      Clinical Trial Analyst, GlobalData

      Asiyah Nawab, MSc, is an Analyst at GlobalData’s London office with the Immunology team. She is involved in the production of in-depth forecasting reports, opportunity assessments, and competitive landscape analysis reports for immunology-related areas. Additionally, Asiyah has extensive research experience in the field of Pharmaceutics, with her research in the encapsulation of drugs within microparticles using emulsion electrospraying, supplemented through in vitro bacterial studies. Asiyah holds a Master of Science in Pharmaceutics from University College London (UCL), and a Bachelor’s degree in Biochemistry from King’s College London.

      Session Details:

      Chairs opening remarks

      2025-06-10, 8:45 AM

      Session Details:

      Chairperson’s closing remarks

      2025-06-10, 5:00 PM

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      Dr. Victoria Aniyar López-Abadia
      MD Clinical Pharmacologist - Medical Director, VCTC

      Medical Doctor, Clinical Pharmacologist and Medical Director of VCTC, a patient centric clinical trial site located in the UK and Spain, dedicated to making clinical research accessible.

      Session Details:

      Innovative approaches to driving clinical trial recruitment success

      2025-06-10, 3:00 PM

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      Eleanor McLaurin
      Solution Specialist, Medidata

      Eleanor McLaurin, Solution Specialist for Medidata has spent over 20 years in the Life Sciences industry. Eleanor supports organisations to create efficiencies throughout the clinical development and regulatory lifecycle through adoption of transformational technologies and data driven clinical and regulatory development approaches. Eleanor has spent the last 6 years working with organisations to leverage practical applications of AI and to implement data strategies which enable reliable generation of evidence and insights for internal oversight as well as for regulatory inspections and submissions.

      Session Details:

      AI-Powered Trials: Transforming Design and Execution

      2025-06-10, 9:30 AM

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      Advisory Board

      Select a member to learn more

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      Bao Dinh
      Global Development Business Operation, Takeda

      With over 15 years of experience in Clinical Data Management, Bao leads business strategy and vendor operations for Takeda’s Clinical Data Management, Clinical Data Engineering, and Clinical Data Standards groups, driving organizational growth, managing global FSP partnerships, and enhancing cross-functional collaboration. As a member of the 2024–2025 OCT Advisory Board, Bao brings expertise in clinical outsourcing, strategic vendor partnerships, and RFP process optimization, providing a fresh vision for the organization.

      Beyond professional achievements, Bao is dedicated to fostering collaboration and investing in the local community. As a partner of The Town FC and a Silicon Valley angel investor, Bao champions ventures that advance sustainable growth, youth enrichment, and innovation in technology.’

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      Rosalie Filling
      Vice President, Senior Global Head R&D Operations, Endo Pharmaceuticals

      In her over 25 years of experience, Rosalie “Rosie” Filling has transformed R&D operations in every company she has worked for, developing clear-cut strategies to help advance clinical trials with high-quality operational execution and scientific excellence.

       

      Rosie is the Vice President, Senior Global Head R&D Operations Endo International plc. She is part of the global R&D leadership team and is charged with the coordination and implementation of clinical development strategies for the company’s research and development. She provides strategic direction and oversight of the R&D Operations team, which includes clinical operations, data management, biostatistics, medical writing, clinical supplies, trial master file/inspection readiness and business operations. This integrated team handles the execution of all aspects related to Endo’s clinical trials. Endo has active research and development programs in men’s health, orthopedics, and endocrinology. Beyond these therapeutic areas, the company also has focused development in the areas of sterile injectables and complex generic products.

       

      Rosie’s main focus at all times is on the end users—the patients. Bringing new and, at times, life-saving medications to patients drives Rosie’s sense of purpose.

       

      Rosie joined Endo from Lupin Pharmaceuticals in Blue Bell, PA where she was Senior Director, Head of Clinical Operations, and built the clinical operations organization to support the US and Global R&D Organization. Prior to Lupin, Rosie spent nearly five years at Teva in Frazer, PA where she was the US site head of Clinical Operations and was responsible for the successful delivery of Inhalation, Women’s Health, and Cardiovascular clinical trials. Earlier in her career, Rosie held various roles at Eisai, MGI Pharma and PPD.

       

      Rosie earned her B.S. in Biology with a minor in Chemistry from the University of Pittsburgh.

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      Kathleen Cohen
      Vice President, Clinical Development, Marinus Pharmaceuticals

      Kathleen Frenia Cohen is Vice President and Head of Clinical Development Operations at Marinus Pharmaceuticals.  Prior to joining Marinus, she spent 20+ years at PRA Health Sciences in a variety of project management and operational oversite roles. Kathleen graduated from the University of the Science in Philadelphia with a PharmD and completed a post-doctoral fellowship in Pharmacoeconomics and Outcomes Research from Rutgers College of Pharmacy. Kathleen resides in Media, PA.

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      THOMAS M TREMBLAY
      Vice President Of Clinical Development, Trefoil Therapeutics, Inc

      Thomas is a registered nurse with both clinical and over 30 years pharmaceutical development experience. His pharmaceutical development experience includes clinical operations, clinical science, clinical development, drug safety and quality. He is currently Vice President of Clinical Development at Trefoil Therapeutics and adjunct faculty at San Francisco State University.

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