Outsourcing in Clinical Trials UK and Ireland 2023

Welcome to Outsourcing in Clinical Trials UK and Ireland 2023

5 - 6

September

2023
  • Hilton Park Lane, London
  • Complimentary
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Featured Speakers

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James O’Shaughnessy​

Member of the House of Lords, former Health Minister, Senior Partner at Newmarket Strategy

James has operated at the highest levels of government, including as a Minister at the Department for Health & Social Care, as Director of the No.10 Policy Unit, and as an advisor to DHSC Ministers during the COVID-19 crisis. As Minister his responsibilities included implementing the Life Science Industrial Strategy, delivering a new pricing scheme with the pharmaceutical industry, chairing the National Genomics Board, and driving the digital transformation of the NHS. He was also responsible for preparing the health and social care sectors for Brexit and helping to design the post-Brexit regulatory regime.

In 2021 James became co-founder and Senior Partner of Newmarket Strategy, a consultancy dedicated to improving access to health innovation by providing strategic advice and technical support to the healthcare, life sciences and health tech sectors. At Newmarket, James provides senior counsel to multinationals, SMEs, investors, universities and charities across health and life sciences, with a particular focus on technology, digital and data. He is a Visiting Professor at the Institute of Global Health Innovation, where he chairs the Data, Health & Wealth programme, and is on the board at Health Data Research UK and the Albion Development VCT plc. In

January 2023 he was commissioned by the Government to carry out an independent review of commercial clinical trials in the UK. Outside of health, James chairs the Repairing our Social Fabric programme at the think tank Onward, is a Member of the House of Lords, and has a keen interest in education reform.

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Catherine Mela​

Executive Director, Head of Biosamples, AstraZeneca

As Head, Biosamples, Astra Zeneca Catherine has accountability for Clinical Biosampling within drug projects, Laboratory Alliance and technology, Biobanking and Human Biosample Governance across AstraZeneca. Biosamples group are >100 people based in UK, USA, SWE, POL, CAN and CN.

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Janet Messer​

Director of Approvals Service at Health Research Authority

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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Prof Sandip Mitra​

Deputy Director, NIHR Devices for Dignity MedTech Co-operative and Consultant Nephrologist & Professor of Renal Medicine, Manchester University NHS Foundation Trust

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.

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Nigel Hughes​

Scientific Director, Observational Health Data Analytics/Epidemiology, Johnson & Johnson

Nigel Hughes has a thirty-six year career spanning the NHS in the UK (16 years), NGOs and patient organisations (10 years) and within the pharmaceutical industry (18 years). He has worked clinically in HIV and viral hepatitis, liver disease, and in sales & marketing, medical affairs, market access and health economics, R&D, precision medicine, advanced diagnostics, health IT and Real World Data/Real World Medicine. His experience covers clinical, education, as an advisor, consulting, communications and lobbying over the years. He is currently the Project Lead for the IMI2 European Health Data & Evidence Network (EHDEN), and was Platform Co-Lead for the IMI1 European Medical Information Framework (EMIF), as well as consulting on numerous projects and programmes in the domain of RWD/RWE.

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Roman Fishchuk​

Head of Clinical Trials Department, Central City Clinical Hospital, Ukraine

CEO of a clinical trials unit that was founded from scratch in 2017 at a state hospital in Ivano-Frankivsk, Ukraine and now developed into an organization with 15-20 multi-specialty trials running simultaneously with a potential to grow. One of the founders and current Board member of the Ukrainian Association for Clinical Research. Adept ENT doctor and principal investigator in otolaryngology with ability to work in a multidisciplinary team, experience in delivering patient care in both public and private settings with the use of the latest industry equipment and technology, as well as establishing own private practice. Proactive and dedicated to seeking opportunities for cooperation with international specialists. Strong knowledge of Ukrainian medical policy landscape through working with the Ministry of Health of Ukraine on reforming healthcare services. Proven track record of planning and executing projects in medical sphere.

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    2023 Sponsors Include:

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    Company Information

    Medidata is leading the digital transformation of life science, with the world’s most used platform for clinical development, commercial, and real-world data. Rave RTSM is the only fully pre-validated randomization and trial supply management solution that can be configured in minutes and enables mid-study changes with minimal downtime and no change orders. RTSM is built on Rave EDC, so there is no double data entry and minimal reconciliation expediting study start-up and study-close out. Rave RTSM streamlines your operations and provides real-time visibility for your study teams. https://www.medidata.com/en/clinical-trial-products/clinical-data-management/rtsm/

    Company Website

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

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    Company Information

    Novotech is internationally recognized as the leading Asia Pacific centred Biotech Contract Research Organization (CRO) with global execution capabilities.

    Novotech is a clinical CRO with labs, phase I facilities, drug development consulting services and FDA regulatory expertise and has experience in over 5,000 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biotech clients conducting clinical trials in Asia Pacific, the US and Europe. Novotech has over 3000 staff globally and 34 office locations.”

    About Novotech- The Asia Pacific Centred Global Biotech CRO | Novotech CRO (novotech-cro.com)

    Company Website

    To learn more , please visit our website - https://novotech-cro.com/

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    Company Information

    Through innovative eClinical and Regulatory solutions and services, Calyx turns the uncertain into the reliable, helping bring new medical treatments to market reliably. With deep expertise in clinical development and more than 25 years supporting trial sponsors and clinical research organizations, Calyx harnesses its intelligence and experience to solve complex problems, deliver fast insights, and get new drugs to market every day.

    Company Website

    To learn more , please visit our website - https://www.calyx.ai

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    Company Information

    At Merative, we’re building a more connected future in health. One where organizations can see the whole picture – and its pieces – at the highest levels of privacy and security.  We’ve been at the forefront of health innovation for nearly 50 years, pioneering the use of cloud, real-world data and industry-leading AI. Our name is new – but our trailblazing spirit isn’t. Our team spans the entire health industry and has decades of experience. We get the importance of knowing what it’s like to walk in your shoes – and having a partner who’s with you every step of the way.

    Company Website

    To learn more , please visit our website - merative.com

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    Company Website

    To learn more , please visit our website - www.tcr-solutions.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

    Emmes is a full service contract research organization collaborating with our clients to produce valued, trusted scientific research. We are known for our superior statistical leadership and data management expertise and proud to have supported  thousands of studies across a diverse range of diseases.  For more than 40 years, Emmes has been dedicated to research for a healthier world.

    Company Website

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

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    Company Information

    THREAD is a leading provider of a proprietary, decentralized research platform and suite of supporting services used by biopharma, CROs and life science organizations to remotely capture data from participants and sites during, in-between and in lieu of in-clinic visits. THREAD’s platform and supporting services are helping customers to shorten study launch timelines, reduce study budgets with Virtual Visits, and bring studies from the clinic to patients’ homes. THREAD provides key platform features such as eConsent, eCOA/ePRO, sensors, reminders, and telehealth Virtual Visits to support remote data capture, hybrid virtual studies, and fully decentralized studies in key therapeutic areas. In 2019, THREAD was acquired by strategic health care investors Water Street Healthcare Partners and JLL Partners.

    Company Website

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

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    Company Information

    Viedoc designs engaging software for the life science industry. By accelerating clinical trials on all levels, our solutions support major pharmaceutical, biotech, and medical device companies, as well as renowned research institutions worldwide. Headquartered in Uppsala, Sweden, Viedoc also has offi ces in America, France, Japan, Vietnam, and China. Since our inception in 2003, over 1 million patients in more than 75 countries have participated in studies powered by Viedoc. www.viedoc.com

    Company Website

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

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    Company Information

    YPrime’s cloud-based technology streamlines clinical trial data collection and management. Electronic clinical outcome assessments (eCOA) and interactive response technology (IRT) platforms introduce greater speed, precision and data quality to clinical trials. Our consulting services help clients simplify downstream processes, while moving faster and more efficiently to their next development milestone. 

    We innovate through pragmatic, forward-looking change that considers the needs of stakeholders in each clinical research role. We’re doing more than streamlining your processes. We’re streamlining your research, helping you get to your next milestone faster. 

    Company Website

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

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    Company Information

    eClinical Solutions is a leading global provider of cloud-based enterprise software and software-driven clinical data services. The elluminate® Clinical Data Cloud provides life sciences companies with greater control of their clinical trial data with one platform for all data sources, from aggregation through to standardization, visualization, and preparation for submission. elluminate software and data driven services have been used by more than 100 life sciences companies on over 500 clinical trials to reduce cycle time and improve data quality. For more information, visit www.eclinicalsol.com, or contact us at info@clinicalsol.com.

    Company Website

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

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    Company Information

    4MCS is an independent SMO (clinical research study site) with its Headquarters based in Greater Manchester. 4MCS has access to over 20,000 patients based on prescription data. Our strong links with General Practitioners, Pharmacists and Dentists in Greater Manchester allows us to identify and approach an additional 40,000 potential study participants in a shorter timeframe than under normal circumstances.

    Company Website

    To learn more , please visit our website - http://4mcs.co.uk/

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    Company Information

    ACM Global Laboratories is one of the largest global independent central labs in the industry. ACM is certified by the College of American Pathologists (CAP) and the Substance Abuse and Mental Health Services Administration (SAMHSA). The company delivers high-quality laboratory testing and diagnostic lab services in support of both clinical trials research, toxicology and individual patient care. ACM provides a powerful combination of operational excellence, scientific expertise and unsurpassed global service to customers in more than 65 countries. ACM performs more than 20 million laboratory tests each year—spanning all medical disciplines including pathology, microbiology, molecular diagnostics, toxicology and more.

    Company Website

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

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    Company Information

    The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally.

    Its innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture.

    The international company is a privately owned organisation which has grown organically over the past five decades now employing over 5,600 highly skilled personnel across 18 facilities including Europe, the US and Asia.

    The company has a global reputation for excellence built over 50 years of client service, delivering expertise right across the drug development lifecycle and offering a tailored solution to each of our clients.

    To keep up to date with latest news, follow Almac Group on Twitter and LinkedIn or visit almacgroup.com.

    Company Website

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

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    Company Information

    Altasciences is a forward-thinking, mid-size contract research organization offering pharmaceutical and biotechnology companies of all sizes a proven, flexible approach to preclinical and early phase clinical studies, from lead candidate selection to proof of concept. For over 25 years, Altasciences has been integrating into clients’ projects to help support educated, faster, and more complete early drug development decisions. Altasciences’ full-service solutions include preclinical safety testing, clinical pharmacology, bioanalysis, program management, medical writing, biostatistics, data management and more, all of which can be tailored to specific sponsor requirements. Altasciences… helping sponsors get better drugs to the people who need them, faster.

    Company Website

    To learn more , please visit our website - http://www.altasciences.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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    Company Website

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

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    Company Website

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

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    Company Information

    BTH Recruitment are a boutique headhunting firm specialising in the Pharmaceutical and Clinical industry. Our core business focuses on small-medium sized life sciences businesses, sourcing and securing the highest calibre individuals in the market (i.e. you!). We pride ourselves on the consultative approach we take, supporting you to find the best next step for your career. Our friendly and professional approach is complimented by our in-depth industry knowledge and experience.

    Company Website

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

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    Company Information

    Choice Health are a UK Imaging Diagnostics company specialising in Research and Clinical Trials. We connect medical imaging and consultants to Pharma, CRO and research clients globally. We work closely with the NHS, biotech vendors, and our network of 80+ highly specialised medical consultants to specifically focus on your clinical trials and medical research workload. Boost capacity, avoid delays, and ensure accuracy with our Imaging experts at Choice Health

    Company Website

    To learn more , please visit our website - www.choice.health

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      Why attend?

      We are delighted to welcome you to 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.

      It is becoming clear that the only options are to disrupt or be disrupted: and so, this event is focused on examining real world evidence into innovations and industry trends that you cannot afford to miss.

      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 investment opportunities within the clinical trial landscape.

      We look forward to you joining us!

      WHAT TO EXPECT FOR 2023?

      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

      2023 Agenda

      • 5 Sep 2023
      • 6 Sep 2023
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      Streams

      Stream one

      Clinical Operations and Outsourcing

      Stream two

      Clinical Technology and Innovation

      11 AM

      The real-world data/experience paradigm shift & new architectures

      • The emergence of federated data networks (FDNs) and trusted research environments (TREs) as a main architecture for evidence generation
      • The regulatory transition to FDNs in EU and UK - the role of EMA DARWIN EU(R) and MHRA strategy
      • Applications, e.g., pharmacovigilance and challenges e.g., governance

      Speakers

      11:30 AM

      Session Reserved for YPrime

      12 PM

      How precision medicine technologies can be used as complementary diagnostics to optimise clinical trial efficiency

      • Improving success rates of clinical trials for anti- inflammatory drugs using prognostic and predictive biomarkers for chronic inflammatory diseases (cIDs)
      • Overview current and next generationbiomarkers for Inflammatory Bowel Disease ( IBD)
      • GlyHealthtechnology– Glycomics as a Sweet Spot in Precision Medicine diagnostics
      • Addressing challenges in anti-Inflammatory drug development with GlyHealth biomarkers (stronger evidence, better selection and  higher approvalrates for drugs)
      • Optimising clinical trial efficiency with reliable, precision medicine biomarkers for Chronic Inflammatory Diseases (cIDs)

      Speakers

      12:30 PM

      Hybrid trials using DCT technology and processes; focus on patients and the sites

      • Highlighting the complexity that Hybrid/DCT brings whilst moving away from the common brick-and-mortar sites.
      • Discussing the rise in regulator concerns in areas such as investigator oversight, and participant’s safety when face to face contact is limited.
      • How we tend to focus too much on technology when it’s actually the processes for the patients and the sites that matter even more.
      • Major points to consider in designing hybrid/DCT trials; building blocks and practical examples to best prepare you to meet the needs of regulators whilst keeping the patient and sites front of mind.

      Speakers

      1 PM

      Lunch and networking

      2 PM

      INTERACTIVE SESSION: This workshop will explore different approaches and strategies for putting patients at the centre when collecting samples for decentralised and hybrid clinical trials

      • Primer on costs of centralised trials and how decentralisation helps to reduce costs and drive recruitment
      • Discuss benefits of decentralised clinical trials
      • Discuss challenges
      • What does the future look like?

      Speakers

      2:30 PM

      Running Up That Hill: Accelerate Cycle Times & Reach Patients Faster with elluminate

      This presentation will highlight how the elluminate Clinical Data Cloud and Biometrics Services can reshape your data architecture by automating data flows to keep up with the pace of data evolution and speed time to insights.

      Learn how elluminate and eClinical’s Biometrics Services deliver:

      • Operational insights across numerous data sources that provides definitive answers and analytics on enrollment, protocol compliance and safety
      • Improved study oversight with a holistic view of risk across all data sources
      • 50 out-of-the-box visualizations to support cross-study analysis for deeper insights with self-service access to clinical and operational analytics
      • Increased productivity across data management, medical monitoring, clinical operations, clinical programming and statistical analysis roles

       eClinical Solutions

       

      2:45 PM

      Featured toolkit coverage: Capturing a representative and equitable sample in health research

       

      • Research participants often do not represent the target population for treatment, limiting generalisability of research findings and perpetuating health inequalities
      • The Toolkit addresses this by providing guidance to inform representative and equitable inclusion in research
      • Use of the Toolkit may promote trust between communities and research institutions, increase participation in, and improve generalisability of health research

      Speakers

      3 PM

      PANEL DISCUSSION: Focusing on today’s Innovation & Technological Advancements

      • Are we making the most of Technology & Innovation in the UK Clinical Trial space?
      • How are these tools being utilised?
      • What’s next?
      • Considering the use of AI in healthcare & Clinical Trials

       

      Speakers

      3:30 PM

      Afternoon refreshments and networking

      8 AM

      Registration and refreshments

      8:50 AM

      Chairperson’s opening remarks

      Speakers

      9 AM

      PANEL DISCUSSION – Building back a thriving, competitive life science sector in the UK & Ireland

      The UK has fallen behind other countries in the number of studies initiated, with a drop of 44% in commercial clinical trials in the last five years taking us from 4th to 10th in the global standings. 

      • Exploring maintenance and growth of research delivery in NHS sites
      • Appreciating global life science industry timelines; highlighting regulatory approval, ethics reviews, and the time it takes to set-up at a site, and recruit the first participants
      • Unlocking costing for commercial contract research
      • Addressing clinical capacity within the NHS in order to increase revenue and increase trials based in the UK
      • Discussing MHRA Introductory measures to streamline the process of running trials making the UK a ‘more attractive’ place to conduct clinical trials

       

      Speakers

      9:30 AM

      Session Reserved for Novotech

      10 AM

      Busting RBQM Myths: Practical Tools for Proactive Data Quality Management in Clinical Trials

      It’s time to bust the myths of managing data quality in today’s complex clinical trials. The explosion of digital capabilities to collect and monitor data remotely is truly disrupting traditional paradigms and opening up opportunities to improve patient, sponsor, and site outcomes.

      However, as companies embrace digitalization, patient safety oversight and data reliability are the top concerns. Risk-based quality management (RBQM) strategies are increasingly used for decentralized trials to ensure data integrity and quality when various data types are collected and integrated from disparate sources. The industry still needs clarification about how best to implement these strategies in repeatable and scalable ways.

      Join us as we “bust” five myths about data quality oversight and provide practical guidance on establishing effective clinical operations strategies to support the complexity of today’s clinical trials.

      Speakers

      10:30 AM

      Morning refreshments and networking

      11 AM

      Diversity in Finding New Medicines

      • Discussing how diversity affects medical research
      • Focusing on the importance of diversity in health research
      • Why is diversity needed in clinical trials for the advancement of medicine?
      • Strategies for achieving IDEA (Inclusion, Diversity, Equity, and Access) in UK Clinical Trials
      • Recognising steps the FDA have taken to address unrepresented minority groups in US clinical trials – can/should the UK expect to follow suit?

      Speakers

      11:30 AM

      ‘Spare a thought for the hospitals’

      Speakers

      12 PM

      Operational Management and Clinicians: Leaders change culture-culture changes organisations

      In this session we will take the opportunity to reflect and learn from the lived experiences of our speaker, supported by tangible examples of culture transformation and organisational effectiveness. In exploring this, we will together consider the role of operational managers, and clinical leaders in influencing culture, leading by the shoulder of others and how through shared vision and values you can help improve the effectiveness of an organisation.

      Our aim is for you to learn, be curious and leave with energy and practical tips to help you lead well, approach change with confidence and recognise the value of collaborative leadership in challenging times.

      Speakers

      12:30 PM

      Implementation Science in biomedical research

      Speakers

      1 PM

      Lunch and networking

      2 PM

      Delivering trials through NHS Organisations

      As Research Lead for the NHS Trust Manchester Royal Infirmary at Manchester University Hospitals, one of the largest NHS hospital trusts in UK, Professor Sandip Mitra has been involved in delivering research trials for 15+ yrs working in partnership with industry and external stakeholders. He understands the growing need to interact with commercial organisations and research platforms and how to successfully engage with NHS systems and clinical teams to deliver research. 

      This session will cover the following: Navigating through NHS systems and pathways for efficient delivery of R&I trials

      Speakers

      2:30 PM

      Session Reserved for Calyx

      3 PM

      PANEL DISCUSSION: What are the different outsourcing relationships and how do you manage them?

      • What are the categories and the driving needs for 2023?
      • How has this changed over the years?
      • Key strategies that sponsor companies have – how has this changed?
      • Did the pandemic effect these strategies?

       

      Speakers

      3:30 PM

      Afternoon refreshments and networking

      4 PM

      Session Reserved for Event Sponsor

      4:30 PM

      Closing Keynote The Patients Perspective

      Helping patients on their clinical trial journey

      • Living with a rare disease
      • Patient expectations & considerations
      • Proven approaches to increase patient retention in clinical trials
      • Focusing on the future of patients in clinical trials

      Speakers

      5 PM

      Chairperson’s closing remarks followed by Drinks Reception

      Speakers

      END OF DAY 1 AND DRINKS RECEPTION 5 – 7PM  Exclusive drinks reception sponsored by TMS. Includes a selection of canapes, wine, beer, classic cocktails and live entertainment! An opportunity to meet experts and decision makers face to face, this is two hours of networking not to be missed!

      Streams

      Stream one

      Clinical Operations and Outsourcing

      Stream two

      Clinical Technology and Innovation

      11:30 AM

      Regulatory considerations for Remote Diagnostics in Decentralised clinical trials

      The session will discuss Regulatory Considerations to avoid pitfalls later down the line focussing on following key areas 

      • Regulatory Approval including application submission to regulatory bodies such as the MHRA
      • Informed Consent: to ensure participants understand the nature of the remote testing procedures and the risks and benefits involved
      • Data Security and Privacy: remote diagnostic testing involves the transmission of sensitive health information over digital platforms. Appropriate measures to protect the privacy and security of participant data will be discussed.
      •  Quality Assurance: to ensure that the data collected is accurate and reliable Remote diagnostic testing can offer several advantages in decentralized clinical trials, including increased convenience and reduced participant burden. However, it is essential to ensure that appropriate regulatory considerations are taken into account to ensure the safety and integrity of the study data.

      Speakers

      12 PM

      Session Reserved for EMIS

      12:30 PM

      Lunch and networking

      1:30 PM

      Data to Drive Sustainability

      Collecting and using data to make decisions that guide measurable and responsible clinical practices 

      • What is sustainability data collection?
      • Discussing how data is useful for sustainable development
      • Focusing on how to manage sustainability data

      Speakers

      2 PM

      Decentralised and people-centric trials

      how and why this approach could make it easier to run trials in the UK - including sharing details of the national survey the HRA recently conducted with the public to understand the views of patient and the public about participating in research

      • Understand what builds public trust in research
      • Explore actions you can take to make research more people-centred
      • Learn how you can implement people-centric and decentralised research in the UK

      Speakers

      8 AM

      Registration and refreshments

      8:50 AM

      Chairperson’s opening remarks

      Speakers

      9 AM

      OPENING KEYNOTE: CLINICAL TRIAL REVIEW

      The government Have appointed Lord James O’Shaughnessy to conduct an independent review into the UK commercial clinical trials landscape. This review will offer recommendations on how commercial clinical trials can help the life sciences sector unlock UK growth and investment opportunities. It will also advise on how to resolve key challenges in conducting commercial clinical trials in the UK.

      Speakers

      9:30 AM

      Accelerated performance of complex exploratory patient studies: practical insights from investigational site

      • Unique model of dedicated research clinics in Eastern Europe
      • Strategies for fast patient enrollment and retention
      • Operational tips for flawless study conduct
      • Takeaways after operating under unprecedented circumstances / case studies

      Speakers

      10 AM

      How NIHR infrastructure can enhance industry and commercial collaboration in clinical trials: the Greater Manchester Example

      • Outline of current NIHR Infrastructure
      • How NIHR infrastructure can support industry collaborations
      • Post Covid RESET and research recovery

      Speakers

      10:30 AM

      Rethinking Sponsor Oversight in a Digital First World

      The transition from a manual, paper-based approach to a digital first approach in clinical trials opens new opportunities for sponsors to achieve enhanced oversight on study progress, quality, and patient safety. This session will address how data insights generated from digital first clinical trials:

      • Increase speed and transparency
      • Redefine site engagement
      • Identify areas for corrective action sooner
      • Generate learning capital for other trials

      Speakers

      11 AM

      Morning refreshments and networking

      11:30 AM

      Protecting Our Planet: Minimising carbon impact in Human Biosample lifecycle in clinical trials

      • Focusing on the minimization of our carbon footprint of Human samples in clinical trials
      • Finding the balance between scientific impact & the cost to our planet
      • Small changes can have a large impact - cold chain

      Speakers

      12 PM

      Session Reserved for Merative

      12:30 PM

      Lunch and networking

      1:30 PM

      Fireside Chat – Reviewing shifts in the UK clinical trial space and thoughts on where we go from here

      This talk will include an overview on the huge decision for Cancer Research UK to consider taking their trials outside of the UK for the first time ever.

      Speakers

      2 PM

      Challenges of just in-time manufacturing and supply of investigational products (perspectives from experience with short-lived radiopharmaceuticals)

      • Overview of the supply chain: e.g., manufacture, release, importation
      • Specificities of local vs. centralised production, incl. redundancy/performance aspects and management of multiple CDMOs/vendors
      • IRT and IMP order/accountability
      • practical experience with US/Europe clinical trials
      • specific challenges with clinical trials in the UK (manufacture, Northern Ireland status, importation, release)

      Speakers

      2:30 PM

      KEYNOTE FROM THE MHRA: An overview of the MHRA’s consultation on new clinical trial legislation

      • An overview of proposals for the UK’s clinical trial legislation designed to make the UK the best place to research and develop safe and innovative medicines
      • Results from the MHRA’s consultation: feedback on proposals
      • What the new clinical trial legislation will mean for the future of clinical trials in the UK

      Tentative confirmation – MHRA Senior representative

      3:15 PM

      Afternoon refreshments, networking, and Apple Prize Draw

      3:45 PM

      PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

      During the roundtable discussion session, the conference hall will be divided into two ‘zones’. Delegates can choose which zone they would like to join. Each zone will be led by a table moderator and will focus on a different challenge within clinical operations in oncology trials. After 30 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.

      RT 1 Disaster Preparedness: How can the clinical trial industry prepare for the unexpected? Using the Ukrainian crisis as central to the conversation 

      Roman Fishchuk, Head of Clinical Trials Department, Central City Clinical Hospital, Ukraine

      RT 2 How do you successfully adopt and scale proven research & innovation across the health and care sector.

      Erica White, Director of Innovation, Royal Free London NHS Foundation Trust

      RT 3 Responsible AI in Healthcare & Clinical Trials – how industry and the NHS can work together

      Katie Tucker, Senior Innovation Consultant, Royal Free London NHS Foundation Trust

      RT 4 Strategies for achieving IDEA (Inclusion, Diversity, Equity, and Access) in UK Clinical Trials – where do we go from here? Recommendations on how to move forward. 

      Suki Balendra PhD, Director of Strategic Partnerships, Paddington Life Sciences. Life sciences Lead for the NIHR CRN North West London, Board Advisor

      RT 5 Paradigm shift: The power of partnership working

      Nicola Yallup, Head of Business Development and Marketing, NIHR Clinical Research Network

      RT 6 Making it easier to do clinical trials that everyone can trust: making research more transparent and increasing public involvement in a proportionate and agile way. Supporting best practice for all studies.

      Becky Purvis, Director of Policy and Partnership, Health Research Authority (HRA)

      Speakers

      4:45 PM

      Chairperson’s closing remarks

      Speakers

      END OF CONFERENCE

      2023 Speakers

      Select a speaker to learn more

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      James O’Shaughnessy
      Member of the House of Lords, former Health Minister, Senior Partner at Newmarket Strategy

      James has operated at the highest levels of government, including as a Minister at the Department for Health & Social Care, as Director of the No.10 Policy Unit, and as an advisor to DHSC Ministers during the COVID-19 crisis. As Minister his responsibilities included implementing the Life Science Industrial Strategy, delivering a new pricing scheme with the pharmaceutical industry, chairing the National Genomics Board, and driving the digital transformation of the NHS. He was also responsible for preparing the health and social care sectors for Brexit and helping to design the post-Brexit regulatory regime.

      In 2021 James became co-founder and Senior Partner of Newmarket Strategy, a consultancy dedicated to improving access to health innovation by providing strategic advice and technical support to the healthcare, life sciences and health tech sectors. At Newmarket, James provides senior counsel to multinationals, SMEs, investors, universities and charities across health and life sciences, with a particular focus on technology, digital and data. He is a Visiting Professor at the Institute of Global Health Innovation, where he chairs the Data, Health & Wealth programme, and is on the board at Health Data Research UK and the Albion Development VCT plc. In

      January 2023 he was commissioned by the Government to carry out an independent review of commercial clinical trials in the UK. Outside of health, James chairs the Repairing our Social Fabric programme at the think tank Onward, is a Member of the House of Lords, and has a keen interest in education reform.

      Session Details:

      OPENING KEYNOTE: CLINICAL TRIAL REVIEW

      2023-09-06, 9:00 AM

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      Nigel Hughes
      Scientific Director, Observational Health Data Analytics/Epidemiology, Johnson & Johnson

      Nigel Hughes has a thirty-six year career spanning the NHS in the UK (16 years), NGOs and patient organisations (10 years) and within the pharmaceutical industry (18 years). He has worked clinically in HIV and viral hepatitis, liver disease, and in sales & marketing, medical affairs, market access and health economics, R&D, precision medicine, advanced diagnostics, health IT and Real World Data/Real World Medicine. His experience covers clinical, education, as an advisor, consulting, communications and lobbying over the years. He is currently the Project Lead for the IMI2 European Health Data & Evidence Network (EHDEN), and was Platform Co-Lead for the IMI1 European Medical Information Framework (EMIF), as well as consulting on numerous projects and programmes in the domain of RWD/RWE.

      Session Details:

      The real-world data/experience paradigm shift & new architectures

      2023-09-05, 11:00 AM

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      Janet Messer
      Director of Approvals Service at Health Research Authority

      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:

      PANEL DISCUSSION – Building back a thriving, competitive life science sector in the UK & Ireland

      2023-09-05, 9:00 AM

      Session Details:

      Decentralised and people-centric trials

      2023-09-06, 2:00 PM

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      Nigel Blackburn
      Director of Drug Development, Cancer Research UK

      Nigel is responsible for Cancer Research UK's early drug development activity, translating novel agent scientific programmes through to clinic. Currently, Nigel and his team at CR-UK Centre for Drug Development manage a diverse portfolio of ~16 novel agents at various stages of development from GMP production, regulatory preclinical studies, through to first-in-human, phase I and early phase II clinical trials. Nigel joined Cancer Research UK in May 2009, having previously worked in a variety of senior management roles in the pharma and biotech sectors

      Session Details:

      Fireside Chat – Reviewing shifts in the UK clinical trial space and thoughts on where we go from here

      2023-09-06, 1:30 PM

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      Ian Bruce
      Director, NIHR Manchester Biomedical Research Centre

      Session Details:

      PANEL DISCUSSION – Building back a thriving, competitive life science sector in the UK & Ireland

      2023-09-05, 9:00 AM

      Session Details:

      How NIHR infrastructure can enhance industry and commercial collaboration in clinical trials: the Greater Manchester Example

      2023-09-06, 10:00 AM

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      Emma Challans
      Chair & Founder of PRroud2bOps and Director of Organisational Development, Culture and Talent NHS Nottingham

      Experienced Board level Director and leader within the health and care sector. A values driven leader centred around people, continually striving for innovation and improvements that enhance patient, colleague and customer experience.

      My career demonstrates senior positions in the portfolios of organisational development, culture, operational management and delivery, consultancy and quality and improvement transformation roles.

      I have purposely gained experience both in the public and private sector, thus operating business and population based leadership and delivery. I am therefore experienced in both commercial and public facing businesses.

      Session Details:

      Chairperson’s opening remarks

      2023-09-05, 8:50 AM

      Session Details:

      Operational Management and Clinicians: Leaders change culture-culture changes organisations

      2023-09-05, 12:00 PM

      Session Details:

      PANEL DISCUSSION: What are the different outsourcing relationships and how do you manage them?

      2023-09-05, 3:00 PM

      Session Details:

      Chairperson’s closing remarks followed by Drinks Reception

      2023-09-05, 5:00 PM

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      Catherine Mela
      Executive Director, Head of Biosamples, AstraZeneca

      As Head, Biosamples, Astra Zeneca Catherine has accountability for Clinical Biosampling within drug projects, Laboratory Alliance and technology, Biobanking and Human Biosample Governance across AstraZeneca. Biosamples group are >100 people based in UK, USA, SWE, POL, CAN and CN.

      Session Details:

      Protecting Our Planet: Minimising carbon impact in Human Biosample lifecycle in clinical trials

      2023-09-06, 11:30 AM

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      Prof Sandip Mitra
      Deputy Director, NIHR Devices for Dignity MedTech Co-operative and Consultant Nephrologist & Professor of Renal Medicine, Manchester University NHS Foundation Trust

      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 trials through NHS Organisations

      2023-09-05, 2:00 PM

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      Sverre Bengtsson
      Co-Founder, Senior Vice President Strategic Relations, Viedoc

      Sverre Bengtsson started in the clinical trials industry over 30 years ago. He started as a statistician/statistical programmer, later into data management and since over 20 years into business development. He has been working in both CRO’s as well as in clinical trials technology companies, including the global first ePRO company. Sverre is very interested in making clinical trials efficient, in both study design but also in the processes and technologies used. Sverre co-founded Viedoc Technologies 19 years ago and is responsible for some of the major accounts but also the vision around the company. He’s on the board of both some industry organisations and in clinical technology companies.

      Session Details:

      Hybrid trials using DCT technology and processes; focus on patients and the sites

      2023-09-05, 12:30 PM

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      James Rudge
      Technical Director, Neoteryx

      Session Details:

      INTERACTIVE SESSION: This workshop will explore different approaches and strategies for putting patients at the centre when collecting samples for decentralised and hybrid clinical trials

      2023-09-05, 2:00 PM

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      Roman Fishchuk
      Head of Clinical Trials Department, Central City Clinical Hospital, Ukraine

      CEO of a clinical trials unit that was founded from scratch in 2017 at a state hospital in Ivano-Frankivsk, Ukraine and now developed into an organization with 15-20 multi-specialty trials running simultaneously with a potential to grow. One of the founders and current Board member of the Ukrainian Association for Clinical Research. Adept ENT doctor and principal investigator in otolaryngology with ability to work in a multidisciplinary team, experience in delivering patient care in both public and private settings with the use of the latest industry equipment and technology, as well as establishing own private practice. Proactive and dedicated to seeking opportunities for cooperation with international specialists. Strong knowledge of Ukrainian medical policy landscape through working with the Ministry of Health of Ukraine on reforming healthcare services. Proven track record of planning and executing projects in medical sphere.

      Session Details:

      PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

      2023-09-06, 3:45 PM

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      Martin Edobor
      Clinical Lead for Digital Transformation, NHS North East London

      Session Details:

      PANEL DISCUSSION: Focusing on today’s Innovation & Technological Advancements

      2023-09-05, 3:00 PM

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      Romain Bejot
      VP CMC & Supply, Blue Earth Diagnostics

      Session Details:

      Challenges of just in-time manufacturing and supply of investigational products (perspectives from experience with short-lived radiopharmaceuticals)

      2023-09-06, 2:00 PM

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      Nina Skorytchenko
      CEO, Avenna

      Nina is the co-founder and CEO of Avenna Ltd. Her mission is to make healthcare for chronic inflammatory disease (CIDs) more preventive and personalised. By developing more effective, affordable, and accessible precision medicine solutions we can enable early detection and treatment personalisation for variety of CIDs. Nina has background in finance, business, and healthcare and worked in large multinational companies including Nomura, Bloomberg and Schlumberger, as well as several entrepreneurship ventures.

      Nina’s main ability and expertise is to connect the worlds of scientific research and business. She uses this experience to translate the most promising, research-grade technologies into practical solutions for individuals, clinicians, and biopharma. Nina works in collaboration with leading scientists, clinicians, and patients to translate R&D stage technologies into practical clinical solutions. This includes design and execution of clinical studies and trials, development of bioinformatics infrastructure to facilitate the translation of precision health programs for chronic disease prevention into clinical practice.

      Session Details:

      How precision medicine technologies can be used as complementary diagnostics to optimise clinical trial efficiency

      2023-09-05, 12:00 PM

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      Surbhi Gupta
      Head of Regulatory Affairs, Thriva

      Experienced Medtech executive with track record of successfully leading multifunctional teams to develop prototype device towards clinic ready product.

      Specialised in identifying and progressing innovative healthcare assets towards commercialisation.

      Session Details:

      Regulatory considerations for Remote Diagnostics in Decentralised clinical trials

      2023-09-06, 11:30 AM

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      Suki Balendra
      PhD, Director of Strategic Partnerships, Paddington Life Sciences. Life sciences Lead for the NIHR CRN North West London, Board Advisor

      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:

      Diversity in Finding New Medicines

      2023-09-05, 11:00 AM

      Session Details:

      PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

      2023-09-06, 3:45 PM

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      Marisa Papaluca
      Expert medicines regulatory adviser. Former Senior Scientific Adviser, European Medicines Agency, and, Visiting Professor, Imperial College London

      Marisa Papaluca, MD , specialist in Internal Medicine

      Pharmaceuticals regulatory science expert with interest in evolving science and technologies applied to therapeutic innovation,  in particular for immunology driven, cardiometabolic and rare diseases. Currently Marisa holds the positions of Honorary Professor at Imperial College London, Faculty of Medicine and Emeritus Professor and lecturer at the University of Rome “Tor Vergata” on Pharmacogenomics. Former European Medicines Agency’s Senior Scientific Advisor,  Marisa’s work has been instrumental for many EMA operational and scientific activities (EU and international) on medical and therapeutic innovation (h-r-DNA pharmaceuticals, gene and cell therapy, nanotechnology, biosimilars, pharmacogenomics, personalised medicine, biomarkers, genome editing).

      Session Details:

      PANEL DISCUSSION: Focusing on today’s Innovation & Technological Advancements

      2023-09-05, 3:00 PM

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      Oliver Buckley-Mellor
      Research Policy Manager, The Association of the British Pharmaceutical Industry (ABPI)

      Experienced Policy Manager proficient in developing and delivering strategies to influence policy, building relationships between policymakers and innovators, and communicating policy positions to a range of audiences.

      Session Details:

      PANEL DISCUSSION – Building back a thriving, competitive life science sector in the UK & Ireland

      2023-09-05, 9:00 AM

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      Neelam Patel
      Former CEO, MedCity, NED, Health Research Authority

      Neelam has recently stepped down from being the CEO of MedCity, the life sciences cluster organisation for London, which plays a pivotal role in bridging industry, NHS and academia to boost innovation and economic growth. Neelam’s extensive experience spans the private, public and not-for-profit sectors. She has worked with the Association of British Pharmaceutical Industries, the European Innovative Medicines Initiative and collaborated with NHS England, NICE and Public Health England.

      Neelam regularly supports companies with R&D, advising on the UK regulatory and access landscape, and is actively working to shape delivery of appropriate real estate infrastructure for life sciences companies. Other roles include seats on the advisory board of the Innovation Centre in Digital Molecular Technologies at the University of Cambridge, and she is a Non-executive director on the board of the Health Research Authority.

      Session Details:

      Diversity in Finding New Medicines

      2023-09-05, 11:00 AM

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      Erica White
      Director of Innovation, Royal Free London NHS Foundation Trust

      I am an innovative senior change management professional with significant experience of end-to-end delivery on large complex projects and transformation programmes. I spent the first 20 years of my career in Banking, starting out in my home country of New Zealand before moving to Ireland and then onto the UK. Working in the same industry across multiple countries and cultures has given me a strong appreciation for the different life experiences and perspectives that individuals contribute.

      Session Details:

      PANEL DISCUSSION: Focusing on today’s Innovation & Technological Advancements

      2023-09-05, 3:00 PM

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      Greig Duncan
      Solution Sales Specialist - Clinical Operations, Medidata

      Greig is a subject matter expert at Medidata, focusing on Clinical Trial Innovation solutions, with over 10 years working with world-leading cloud-based software solution providers, helping to streamline the clinical operations processes - enabling organisations to get better oversight of their trials and make them faster, safer, and smarter. Greig works collaboratively with global sponsors, CROs, sites and researchers to advance the use of decentralization technologies for hybrid and virtual clinical trials.

      Session Details:

      Busting RBQM Myths: Practical Tools for Proactive Data Quality Management in Clinical Trials

      2023-09-05, 10:00 AM

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      Brian MacNamara
      Senior Product Manager, Teckro

      Brian MacNamara is a Senior Product Manager at Teckro, with over 15 years experience in start-ups and SMEs bringing digital solutions to customers in the healthcare & communications industries. Teckro's mission is to modernize and simplify clinical trials, and are currently working with most of the top pharma companies to fast track the shift to digital first clinical trials.

      Session Details:

      Rethinking Sponsor Oversight in a Digital First World

      2023-09-06, 10:30 AM

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      Krzysztof Potempa
      Founder And Chief Executive Officer, Braincures

      Neuroscientist and social entrepreneur with nearly 20 years of experience in turning data into knowledge that can change lives in academic, industry and startup settings. After nearly losing a family member to depression, he decided to set up BRAINCURES to passionately enable better treatments and prevention of brain diseases that affect at least 1 in 10 people worldwide. The BRAINCURES Discovery Engine (BDE) Platform algorithms can deliver at least 6 fold higher drug discovery success rates and shorten the 12 year development life cycle by at least 4 years without deep learning steps associated with trendy artificial intelligence (AI) techniques. The biology powered technology has been recognized by invitations to speak worldwide and the Beanstalks 2017 Best Mental Health Startup Award. www.braincures.com

      Session Details:

      PANEL DISCUSSION: Focusing on today’s Innovation & Technological Advancements

      2023-09-05, 3:00 PM

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      Bob Stevens
      Patient Advocate, Group CEO, MPS Society & Rare Disease Research Partners Vice Chair, LSD Collaborative Co-Chair, International MPS Network

      Having spent over 20 years in the Construction and Plant Hire Industry many of which were spent at Director level I decided to move into the Charity sector. I wanted to make a difference and use my business skills to help organisations become sustainable within the third sector.

      This decision was based upon my own personal experiences of having two lovely young boys with a rare genetic disorder called MPS type 2 (Hunters).

      After spending sometime back on the front line with Surrey County Council learning about the difficulties facing those with disabilities I decided to move back into senior management and I became the Managing Director for a Charity based in Woking called LinkAble. In 2017 I was recruited to the MPS Society/MPS Commercial to begin the process of taking up the reigns as CEO . In December 2017 I became Group CEO.

      Session Details:

      Closing Keynote The Patients Perspective

      2023-09-05, 4:30 PM

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      Antoine Vigneau
      Senior Director, Biosamples Head of Alliances and Technology, AstraZeneca

      I am an experienced leader and people manager with experience in Alliance management, clinical operation, sample management, scientific and laboratory management. I have a track record of delivering studies, projects, process improvements, innovative solutions and cohesive, high performing teams.

      I thrive on interacting and collaborating with clients and/or stakeholders and being able to use my creative mindset to understand and exceed their expectations.

      Finally, I love a challenge, something to get my teeth into, and a chance to learn and develop.

      Specialties: Alliance management, People management, coaching, resource management, stakeholder management, Project management, client communication, GLP, GCP, immunology, sample management, system development, process improvement/optimization

      Session Details:

      Data to Drive Sustainability

      2023-09-06, 1:30 PM

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      Becky Purvis
      Director of Policy and Partnership, Health Research Authority (HRA)

      Session Details:

      PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

      2023-09-06, 3:45 PM

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      Nicola Yallup
      Head of Business Development and Marketing, NIHR Clinical Research Network

      Session Details:

      PANEL DISCUSSION: What are the different outsourcing relationships and how do you manage them?

      2023-09-05, 3:00 PM

      Session Details:

      PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

      2023-09-06, 3:45 PM

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      Katie Tucker
      Senior Innovation Consultant, Royal Free London NHS Foundation Trust

      Session Details:

      PROBLEM-SOLVING ROUNDTABLE DISCUSSIONS

      2023-09-06, 3:45 PM

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