11th Annual Outsourcing in Clinical Trials UK and Ireland 2024

Welcome to 11th annual Outsourcing in Clinical Trials UK and Ireland 2024

11 - 12

June

2024
  • London, UK
  • Complimentary
  • Why attend?
  • 2023 Agenda
  • 2023 Speakers
  • Plan Your Visit
  • Event Gallery
  • Sponsors
  • Media Centre
  • Where to stay?
  • Contact Us
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Why attend?

WHAT TO EXPECT FOR 2024?

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

See What It's All About

2023 Agenda

  • 5 Sep 2023
  • 6 Sep 2023
Expand All

Streams

Stream one

Clinical Operations and Outsourcing

Stream two

Clinical Technology and Innovation

11 AM

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

11:30 AM

Quality eCOA: On Time and Within Budget. How Partnering with Specialists Achieves This for Any Sponsor Project

Clinical research is a team sport. The combined YPrime and Safira teams will outline how we partner to ensure delivery of a quality eCOA solution that is built for your specific protocol needs. Our combined specialized experience supports on-time and high-quality delivery, whilst reducing the burden on Sponsor teams

Speakers

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

 

Speakers

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

KEYNOTE Presentation – Future of UK Clinical Research: Achieving Our Vision

In this keynote presentation, Lucy Chappell, Chief Scientific Adviser to the Department of Health and Social Care and CEO of the National Institute of Health and Social Care Research, will discuss the achievements that have been accomplished to recover and improve the clinical trials ecosystem post-pandemic. The talk will be structured based on the five visions of The Future of UK Clinical Research Delivery’s implementation plan, which includes, streamlined, efficient and innovative research; clinical research embedded in the NHS; patient-centred research; research enabled by data and digital tools; a sustainable and supported research workforce.

Speakers

9:30 AM

Leveraging local relationships for best in-country solutions to accelerate global drug development

  • Partnering with a CRO to access European infrastructure, in depth local knowledge, site relationships and diverse patient populations
  • Strategies to fast-track clinical trial start-up and patient recruitment timelines
  • Are you ready for EU CTR? Challenges and lessons learned

Speakers

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 sponsored by Aixial

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 as they are essential in delivering your clinical trial

  • Do you spend enough time understanding all your clinical sites?
  • Are you managing them correctly?
  • How are you motivating them to deliver on your clinical study?

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

Implementation Science is a relatively new field of research to promote the systematic uptake of research findings and other evidence-based practices into routine practice. It aims to improve the quality and effectiveness of health services including the study of influences on healthcare professional and organisational behaviour.

The session will provide insight to Evidence as a foundation for Implementation Science by:

  • Outlining the different types of evidence
  • Discussing evidence translation strategies for dissemination and Implementation including stakeholder and types of dissemination and implementation strategies
  • Highlighting challenges in implementing evidence-based guidelines and policies into routine practice

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

The Landscape of Precision and Personalized Medicine (PM) Clinical Trials

This presentation will highlight:

 

  • The competitive landscape of PM indicating the top industry sponsors, CROS, non-industry sponsors, regions and countries leading the way
  • The research landscape of PM included the top therapy areas, indications, drugs in PM clinical trials
  • Use of virtual components in PM studies
  • Leading causes of trial termination/suspension/withdrawal (Low accrual, financial, business/strategic decision)

Speakers

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 2024?
  • 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

Charting a Course through Complexity: Leveraging Experience in Approaching Complex Clinical Trial Protocols

The landscape of clinical trials has undergone a remarkable transformation with the introduction of eClinical solutions, fundamentally reshaping day-to-day processes from traditional approaches. Automation and the integration of cutting-edge technologies are now the standard for clinical trial teams. However, amidst these advancements, the core requirements and understanding essential for running successful clinical trials remain steadfast. Experience emerges as the primary predictor of success – experience with protocol designs, study team and site expectations, and best standard practices.

Join Siobhan McKenna-Power, an industry veteran with 20 years of expertise in designing and delivering regulated systems, as she delves into the intricate distinctions involved in delivering these sophisticated solutions and why experience is critical. Discover how mastery of these crucial elements can be the key to achieving the successful implementation of technology solutions supporting modern clinical trials. Don't miss this opportunity to explore the perfect blend of cutting-edge technology and invaluable experience that can revolutionise the future of clinical trials.

Speakers

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 NETWORKING DRINKS RECEPTION SPONSORED BY TFS HealthScience

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

Commercial trials in the UK: How primary care can answer the call

Reflecting on the recent independent report from Lord O’Shaughnessy, this session will explore the potential of primary care to transform commercial clinical trials in the UK, including:

  • Harnessing the trusted networks established in primary care setting
  • Unlocking the potential of healthcare data for targeted trial recruitment at pace and scale
  • Thinking differently to drive diversity, representation and innovation in trial delivery

Speakers

12:30 PM

Lunch and networking

1:30 PM

Decentralised and people-centric trials

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

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

8 AM

Registration and refreshments

8:50 AM

Chairperson’s opening remarks

Speakers

9 AM

OPENING KEYNOTE: CLINICAL TRIAL REVIEW

In early 2023 Lord James O’Shaughnessy was commissioned by the Government to carry out an independent review of commercial clinical trials in the UK, which was published in May. The review offers recommendations on how commercial clinical trials can help the life sciences sector unlock UK growth and investment opportunities. It also advises 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

Think Ecosystem – how seamless technology integration is a win/win for everyone

Nothing in clinical research happens in a vacuum and the more healthcare and clinical trials collide, and research moves closer to the more natural point of care, the more it requires an ecosystem of technology solutions and capabilities to access the right insights at the right time. We believe that “thinking ecosystem” is critical to solving key industry challenges.

Join our session as we talk about the power of business partnerships and outsourcing to support data integration when it comes to successfully executing clinical research.

Speakers

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

Sponsor and NHS Site Collaboration to accelerate set-up timelines

Sponsors of trials of novel therapeutics rely on the world-leading multidisciplinary clinical and research expertise found within NHS Trusts to deliver their complex trials.  However, when faced with the current challenges of conducting commercial clinical trials within the NHS, it is tempting to more heavily weight timelines over expertise in site selection considerations. Another option is for Sponsors to choose to lean in and be part of the solution for UK clinical research. This talk will describe, from a Sponsor and NHS Trust perspective, how early Sponsor-initiated collaborative engagement on patient-pathway and protocol development can be undertaken in the shared aim of accelerating post-submission site feasibility and approval timelines, bringing these much-needed treatments to patients faster.

Speakers

2:30 PM

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

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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Lord 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.

James is 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. He is also a non-executive director at
HDR-UK and the Albion Development VCT plc. In early 2023 James was commissioned by the
Government to carry out an independent review of commercial clinical trials in the UK, which
was published in May.

 

Session Details:

OPENING KEYNOTE: CLINICAL TRIAL REVIEW

2023-09-06, 9:00 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

2023-09-06, 2:30 PM

Session Details:

Decentralised and people-centric trials

2023-09-06, 1:30 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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Abi Hunter
Senior Director Head of Clinical Sampling, AstraZeneca

As Head of Clinical Sampling at AstraZeneca, Abi is accountable for Clinical Sampling within all AZ sponsored drug projects, across all AZ therapy areas and all clinical phases from first time in human through to post marketing. Clinical Sampling are >50 people based in UK, USA, Sweden, Poland, Spain, Canada and China.

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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Professor Ian Bruce
Director, NIHR Manchester Biomedical Research Centre

Ian Bruce is Professor of Rheumatology and Vice Dean for Health and Care Partnerships, Faculty of Biology, Medicine and Health, the University of Manchester. He is Director of the National Institute of Health Research (NIHR) Manchester Biomedical Research Centre (BRC). ). Manchester BRC seeks to address the major causes of health inequity across our diverse urban, rural and coastal settings by providing infrastructure to support early translational research in Greater Manchester, Lancashire and South Cumbria with a focus on delivering ‘personalised health and care for all’. It is the largest BRC outside the Greater South-East.

Professor Bruce qualified in medicine from Queen’s University Belfast in 1988 and gained his MRCP in 1991. He trained in medicine and rheumatology in Northern Ireland and completed his MD thesis on the pathogenesis of systemic vasculitis in 1995. He was the Geoff Carr Lupus Fellow at the University of Toronto with Murray Urowitz and Dafna Gladman (1996-98) before moving to Manchester in 1998.

He is former Chair of the Systemic Lupus International Collaborating Clinics (SLICC) group and a member of the British Isles Lupus Assessment Group (BILAG). He leads the BILAG Biologics Register for SLE and is Chief Investigator on the SLICC/LFA/ACR Damage Index Renewal Project. He is Chair of the Astra Zeneca Anifrolumab in SLE Global Steering Group.

Professor Bruce’s research is focused on the association between inflammatory rheumatic diseases and premature atherosclerosis/coronary heart disease as well as personalised medicine in SLE.

Session Details:

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

2023-09-06, 2:30 PM

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-Rasool
Chair & Founder of Proud2bOps 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:

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

Dr Martin Edobor is an NHS GP and Clinical Lead for Digital transformation at North East London ICB. He is the former clinical director for North Newham Primary Care Network and former Chair of the Fabian Society

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:

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

2023-09-05, 3:00 PM

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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Dr 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, MD, Internal medicine, is currently Honorary Professor at Imperial College London, Lecturer in pharmacogenomics at the University of Tor Vergata Rome, and member of the Editorial Board of Precision NanoMedicine Journal.

Former European Medicines Agency Senior Scientific Advisor, Marisa is expert in pharmaceuticals regulatory science with established professional track record in strategies for advanced and innovative health products pipelines. Liaison with regulators, sponsors, clinicians, patients and public health professionals, constitutes important elements of Marisa’s professional asset.

Session Details:

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

2023-09-05, 3:00 PM

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

Oliver Buckley-Mellor is a Research Policy Manager at the Association of the British Pharmaceutical Industry. He has spent most of his career working on the policy environment for clinical research, having previously served as a Policy Advisor at Cancer Research UK. Oliver has an MA in Public Administration and Public Policy and a BA in History.

Session Details:

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

2023-09-06, 2:30 PM

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Neelam Patel
Non-exec director Health Research Authority, former CEO MedCity, Advisor

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.

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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

Session Details:

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

2023-09-05, 3:00 PM

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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 two sons diagnosed with a rare disease (MPSII) changes your perspective and priorities in life. Having spent over 20 years in construction, many of which were at Board level, Bob decided to pursue a career in the Charity sector. At first becoming a Trustee, then progressed to Managing Director and Group CEO of various patient organisations, supporting those living with rare diseases and complex needs. Bob wanted to bring together his family experiences of a "Rare life lived" and commercial attributes in order to improve the lives of those most marginalised in society whilst, at the same time, helping to create a more sustainable financial future for patient organisations both in the UK and globally. As well as being Group CEO of the MPS Society/Rare Disease Research Partners he is proud to serve as Vice Chair of the LSD Collaborative, Board Member of the worldwide International MPS Network, Acting Chair of the New Born Screening Collaborative and work as a patient representative for MPS in various global charitable access programs that provide a possible lifeline to treatments in selected areas of the world. These are not job roles, but a way of life!

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

2023-09-05, 11:00 AM

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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

Nicola Yallup is National Head of Business Development and Marketing (BD&M) at the NIHR
Clinical Research Network (CRN). She leads the national and international promotion of the
CRN, wider NIHR and UK ecosystem as a prime place for undertaking clinical research. Nicola
is passionate about partnership and growth, working with commercial and non-commercial
organisations and across the UK's research infrastructure to attract research that enables
access to innovative treatments for patients.

Nicola has held a number of cross-NIHR roles including programme leadership for the NIHR
Digital Strategy and delivery of COVID-19 Vaccines Research. Prior to this she led change
delivery within both private and public sector organisations, notably NHS Digital, Ford Motor
Company and Citibank.

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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Dr Alison McMorn
PH.D – VP, CLINICAL DEVELOPMENT, AMO PHARMA LTD

Dr. McMorn is an experienced clinical development researcher with over 25 years of industry experience and has a strong focus in CNS and paediatric drug development. She has worked for both Pharmaceutical Companies and Contract Research Organisations including holding positions at SAR Monitoring Services Ltd, Mundipharma International Ltd and Shire Development Inc. Starting her career at SAR as a Clinical Research Associate (CRA) she subsequently moved to Mundipharma where she was responsible for initiating the first paediatric clinical research program for the company. At Shire Dr. McMorn led, planned and managed global paediatric and adult clinical development programs for a wide variety of indications including psychiatry, pain, gastrointestinal and hepatology across all phases of development (Phase 0 to Phase 4). In addition she was responsible for harmonizing Clinical Trial Administrator (CTA) working practices across all regions for the company. In 2015 Dr. McMorn joined AMO Pharma Ltd, a virtual pharmaceutical company focused predominantly on paediatric neurodevelopmental rare diseases, as VP of Clinical Development. She holds an undergraduate degree in Pharmacology and a PhD in Psychology from the University of Leeds, UK.

Session Details:

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

2023-09-06, 2:30 PM

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Jennifer Duff
General Manager, Zelta Clinical Trials Solutions (Merative)

Jennifer Duff has over 25 years of experience in the Life Sciences industry with specialization in enabling and scaling industry-leading services and technology solutions for biopharma clients.  She has collaborated with teams across the Life Sciences industry, from large to mid-sized companies, as well as many of the major technology providers over her career.

Jennifer has an MBA in Biotechnology and Healthcare Management.  Her focus is on challenging industry norms and seeking powerful, novel solutions that drive business growth and deliver improved outcomes for Life Sciences clients and the patients they serve.

Session Details:

Think Ecosystem – how seamless technology integration is a win/win for everyone

2023-09-06, 12:00 PM

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Professor Lucy Chappell
Chief Scientific Adviser, Department of Health and Social Care

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:

KEYNOTE Presentation – Future of UK Clinical Research: Achieving Our Vision

2023-09-05, 9:00 AM

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Achilleas Zaras
Senior Manager, Solution Consulting, eClinical Solutions

Achilleas has 12+ years of experience in software industry involving software demonstrations, managing a team of 15+ developers, hands-on coding in Microsoft .Net platform and Business Intelligence Suites like QlikSense. He has enjoyed a progressive career in diverse roles including responsibilities of a Sales Engineer, Team Manager, Software Engineer and Business Intelligence Analyst in various industries like Banking, Retail and now the Pharmaceutical industry with eClinical Solutions.

Session Details:

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

2023-09-05, 2:30 PM

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Angela Ibald
Managing Director, Emmes Biopharma

Angela has been working for the biopharmaceutical Industry for the past 19 years in various roles including clinical development , post marketing research , business operations and real world evidence . She held senior position in Real World Evidence generation at  both Sanofi and Bayer and has recently joined EMMEs as head of Real World Evidence. Prior to embarking on a career in the pharmaceutical Industry Angela worked as an Epidemiologist at the LMU Institut of Epidemiology in Munich. Angela holds a Doctorate degree in Environmental Epidemiology as well as a Masters Degrees in Public Health , Nutrition and Business Administration.

Session Details:

Implementation Science in biomedical research

2023-09-05, 12:30 PM

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Davy Yeung
Managing Director, Tailored Clinical Research Solutions

Session Details:

Spare a thought for the hospitals as they are essential in delivering your clinical trial

2023-09-05, 11:30 AM

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Rachel Haines
Director of Clinical Operations, Rinri Therapeutics

Rachel is the Director of Clinical Operations at Rinri Therapeutics, a biotech realising the potential of cell therapies to treat hearing loss. A hearing scientist by training, Rachel has worked in translational research and clinical trials within both public and private sector since 2007. She has extensive experience leading teams in the delivery of multi-centre, multi-national , drug, interventional and surgical trials.

Session Details:

Sponsor and NHS Site Collaboration to accelerate set-up timelines

2023-09-06, 2:00 PM

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Shaun Cochrane
Deputy Director R&D, Guy's and St Thomas' NHS Foundation Trust

Shaun is a highly experienced and skilled, MSP qualified healthcare executive and academic scientist with over 15 years of corporate, non-profit business and academic experience. From roles, as Assistant Professor through to Chief Executive Office, I have a multi-disciplinary skill set, knowledge and the experience to make highly valuable contributions to healthcare organisations. Successes include the effective increase in market share and new-market entry of pharmaceutical products, the development of a new biologicals manufacturing plant, marketing and awareness campaigns for heart disease and the inspiration and empowerment of medical science students.

Session Details:

Sponsor and NHS Site Collaboration to accelerate set-up timelines

2023-09-06, 2:00 PM

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Dr. Claudia Hesselmann
Founder and CEO, Arensia

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:

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

2023-09-06, 9:30 AM

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Willie Muehlhausen
Co-Founder, Safira Clinical Research Limited

Willie is a successful clinical trial technology optimist who co-leads the SAFIRA team to improve patient experience one system at a time. He is an award-winning thought leader, recognised by PharmaVoice100, CenterWatch Top 20 Innovator awards, and the eCOA consortium Vice Chair appointment (2011-2013). Willie co-authored the industry-leading ePRO implementation handbook to support a mindful adoption of ePRO in clinical research. Current research activities include the application of AI to eCOA deployment and translations.  His work has recently been referenced in FDA Guidelines and ISPOR reports and is instrumental in paving the way for wide adoption and regulatory acceptance of the “bring your own device” modality for eCOA.

Session Details:

Quality eCOA: On Time and Within Budget. How Partnering with Specialists Achieves This for Any Sponsor Project

2023-09-05, 11:30 AM

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Callum Leavers
Associate Portfolio Director, YPrime

Callum Leavers is an Associate Portfolio Director at YPrime based in the UK with over 15 years of clinical research experience. In this leadership role, he is responsible for implementing operational excellence within portfolio management and ensuring quality and consistency across the project management teams. Callum is an eCOA subject matter expert. He has held varying operational roles in global organizations providing technology solutions to sponsors, CROs, sites, and patients.

Session Details:

Quality eCOA: On Time and Within Budget. How Partnering with Specialists Achieves This for Any Sponsor Project

2023-09-05, 11:30 AM

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Siobhan McKenna-Power
Client Services Lead, 4G Clinical

Siobhan McKenna-Power has over 20 years of experience designing and delivering regulated systems, with over 8 years designing and delivering RTSM systems for clinical trials.   She first developed an interest in clinical trials when her father took part in multiple Phase III drug and device trials due to his progressive Chronic Obstructive Pulmonary Disease and was eager to contribute in her own way when the opportunity presented herself.

Siobhan is a strong believer in first time quality and works with our sponsors to understand complex protocols.  Siobhan has a keen understanding of what the needs of the end user are and works to ensure that even the most complex trials are easy for Investigators to work with, and that patient safety is the foremost priority of any RTSM system.

Siobhan is a graduate of Maynooth University (formerly National University of Ireland, Maynooth) with a BSc in Computer Science and Software Engineering. She is currently working on a Level 7 Diploma in Risk Management.

Session Details:

Charting a Course through Complexity: Leveraging Experience in Approaching Complex Clinical Trial Protocols

2023-09-05, 4:00 PM

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David Chia
Senior Business Development Manager, Novotech

Results-driven senior business development bringing over 18 years of comprehensive achievements in strategic clinical development and operational analysis for biotechnology, pharma and life sciences companies. Recognized for the ability to influence business inflection drivers, develop efficient data strategies and align synergies across multiple stakeholders, which result in increased productivity and value creation.

Expertise in creating and maintaining successful strategic alliance partnerships between service providers and biopharma sponsors. Highly experienced in all aspects of clinical development both on the business and operation.

Session Details:

Leveraging local relationships for best in-country solutions to accelerate global drug development

2023-09-05, 9:30 AM

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Diana Filipescu
Business Development Manager, EastHORN (A Novotech Company)

Diana Filipescu is from Bucharest, România. Diana has a regulatory background, with 11 years of experience in clinical trials. She worked in Regulatory for almost 8 years and then transitioned from Regulatory Line Manager to Business Development Manager. She has earned two BSc., one in Management and the other one in Law. In addition, she also has a MSc. in Health Management. She is very passionate about finding new ways to improve the healthcare industry by ensuring compliance with all applicable laws and regulations. Her goal is to make sure that all medical products are safe for consumers.

Session Details:

Leveraging local relationships for best in-country solutions to accelerate global drug development

2023-09-05, 9:30 AM

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Dr. Ian Wood
Clinical Director, EMIS

Session Details:

Commercial trials in the UK: How primary care can answer the call

2023-09-06, 12:00 PM

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Dr. Brendan Buckley
Chief Medical Officer, Teckro

Dr. Brendan Buckley is a medical graduate of University College Cork (UCC) and a doctoral graduate in Biochemistry of Oxford University. He brings more than 40 years of experience in academic clinical practice as a physician in endocrinology, diabetes and clinical pharmacology.

 

Brendan is also a non-executive director of a number of biopharma development and services companies. He chairs the board of the leading Irish research charity, Fighting Blindness, and is a member of the board of Breakthrough Cancer Research. He was a member of the Board of Directors of the Irish Medicines Board (now the Health Products Regulatory Authority), chairing its statutory Advisory Committee for Human Medicines. In the past, he was also a member of the European Medicines Agency Committee for Orphan Medicinal Products (COMP) and of the European Medicines Agency (EMA) Scientific Advisory Committee on diabetes and metabolism.

 

Brendan is an Honorary Clinical Professor at UCC and an Adjunct Professor at University College Dublin in the respective medical faculties. He was Director of the European Collaborative Centre for Clinical Trials in Rare Diseases at UCC. With more than 150 scientific papers published in his career, Brendan also authored the opinion-leading book Re-Engineering Clinical Trials. He has directed a number of very large outcomes trials in metabolic/cardiovascular disease and chairs the independent data and safety monitoring boards for a number of large clinical development programs.

Session Details:

Rethinking Sponsor Oversight in a Digital First World

2023-09-06, 10:30 AM

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Harald Wagner
Director Clinical Operations, AMS Advanced Medical Services

Harald Wagner, has 30 years of experience in drug manufacturing, research & development in various sponsor- and CRO functions with his background in pharmaceutical technology. During the recent decades his focus has been on Clinical Operations of large scale and long-term Clinical Studies, as well as pioneer projects establishing new processes and clinical systems early, such as EDC, Risk-based Monitoring, eTMF, CTMS, wearables, ePROs or Decentralized Clinical Trials, leading the Clinical Operations department of the European CRO AMS Advanced Medical Services

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Jan Nielsen
Community Manager Life Sciences, BSI Life Sciences
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Sonnika Lamont
GlobalData Analyst – Trials Intelligence, GlobalData

Session Details:

The Landscape of Precision and Personalized Medicine (PM) Clinical Trials

2023-09-05, 2:30 PM

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Ameeta Retzer
Equity, Diversity and Inclusion Lead, National Institute of Health and Care Research Applied Research Collaboration West Midlands

Ameeta is a Research fellow at the University of Birmingham based at the Centre for Patient Reported Outcomes Research and the National Institute for Health and Care Research Applied Research Collaboration West Midlands (NIHR ARC WM) Public Health theme, ARC WM EDI lead, EDI Representative for the Public Health Research for Health Consortium of the NIHR School for Public Health Research, the University of Birmingham Institute for Applied Health Research (IAHR) EDI lead, and leads the IAHR EDI in Research working group.

Session Details:

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

2023-09-05, 2:45 PM

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