Agenda

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NEXT EMEA Live Roundtables

The agenda overview is below. Please scroll down for more detailed information.

Wednesday, 13 October

9:30 – 10:00 AM BST

Trials Are No Longer One Size Fits All- The Value of Trial Dial

9:30 – 10:00 AM BST

Decentralise Clinical Trials to Unlock Value for Patients

9:30 – 10:00 AM BST

Finding the Light in a Dark Situation: Lessons from the COVID Crisis


10:00 – 10:30 AM BST

Leveraging a Unified Platform: How to Take Advantage of the Only Unified Platform Offering End-to-End Solutions

10:00 – 10:30 AM BST

The Digital Lab – Why and Why Now? (BIOVIA)

10:00 – 11:00 AM BST

CRO Breakout Session: The Patient-Centric Future of Clinical Trials

Thursday, 14 October

9:30 – 10:00 AM BST

Predictions from the Past and Clarity on the Present: How the industry is leveraging historical & ongoing studies to optimize the delivery of trials

9:30 – 10:00 AM BST

How to Make a Culture of Quality possible (BIOVIA)

9:30 – 10:00 AM BST

Modernisation of Clinical Trials (GCP)


10:00 – 10:30 AM BST

Cancer Research UK: Path to Rave EDC and Platform Capabilities (Simulive)

10:00 – 10:30 AM BST

Designing a Trial for Everyone:Moderna’s Real-time Approach to Achieving Diversity Representation and NEXT Closing Remarks (Simulive)

10:00 – 10:30 AM BST

Moderna:Solving the Impossible for COVID-19 with Medidata Technology

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NEXT EMEA Roundtables Details

Live Roundtable

Trials Are No Longer One Size Fits All – The Value of The Trial Dial. October 13, 2021 | 9:30 AM BST

Arrow Next The impact of the Covid-19 pandemic has obviously been multifaceted, but one obvious lesson has been the need for increased flexibility in many aspects of our lives. Clinical trials were already exploring “decentralisation” – shifting study tasks out of dedicated research sites into settings more convenient for the patient – long before lockdowns began. The quintessential decentralisation technology, electronic clinical outcome assessments (eCOA), has been allowing patients to complete study questionnaires from the comfort of their own home for decades. The pandemic, however, forced the industry to recognise the combined power of eCOA, eConsent, telemedicine, remote monitoring and other such technologies in enabling the continued running of clinical trials even when research sites were forced to close to patients. The future is flexible, and the ability to increase or decrease the amount of “decentralisation” in any particular trial based on the specific needs of that study will be key to minimising burden on patients and maximising the success of the trial.

Paul O'Donohoe

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Org

Live Roundtable

Decentralise Clinical Trials to Unlock Value for Patients (ACCENTURE)October 13, 2021 | 9:30 AM BST

Arrow Next Clinical trials are at the heart of the evolution of modern medicine, ensuring safety and efficacy while generating vast amounts of patient insights that is immensely resourceful for real-time and predictive analyses to better manage health outcomes. However, they come at a significant cost. ~85% of all clinical trials experience delays, with 94% being delayed by over a month. During the roundtable, we will discuss what decentralised clinical trials are, why we need them, and benefits to having them.

Prasun Basu

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Live Roundtable

Finding the Light in a Dark Situation: Lessons from the COVID Crisis October 13, 2021 | 9:30 AM BST

Arrow Next Despite the COVID-19 pandemic being a complete humanitarian crisis, there are positives that can and should be derived from a personal and industry perspective. The regulators offered pragmatic flexibilities and remote strategies in order to accelerate COVID research and to continue ongoing research. This interactive roundtable discussion looks at what non-traditional adaptations worked well and what could have been better in the case that we are fully prepared for the future. The roundtable session will explore and discuss some of the clinical experiences from the pandemic and the longer lasting impact of the regulatory flexibilities which in the longer term will accelerate clinical development… getting treatments to patients that need them faster.

Fiona Miani

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Live Roundtable

Leveraging a Unified Platform: How to Take Advantage of the Only Unified Platform Offering End-to-End Solutions October 13, 2021 | 10:00 AM BST

Arrow Next Leveraging a unified platform as part of your clinical trial technology approach has many benefits from large global pharmaceutical companies, to mid-size and emerging players.

Join this roundtable discussion on how you can best take advantage of the industry’s only unified platform offering end-to-end solutions for clinical research, regardless of your organization’s scale and reach

Learn the benefits of…
Eliminating data sharing and integrations between multiple vendors
Centralizing your clinical trial data – and workflows – in a single location
Choosing a platform with the flexibility to work with your existing technology infrastructure and systems
Creating a superior technology experience for patients and sites
Leveraging a unified platform to conduct decentralized clinical trials and deploy innovative advanced analytics capabilities

Ted Kirby

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Jonathan Palmer

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Anil Dhiri

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Live Roundtable

The Digital Lab – Why and Why Now? (BIOVIA) October 13, 2021 | 10:00 AM BST

Arrow Next For years, Life Sciences, organsations have looked to Digital Transformation to drive innovation, increase competitiveness and speed time to market. The recent pandemic seems to have accelerated this process. In this session, our experts will discuss how a digital lab can contribute to the overall business success, share examples of transformative deployments and reveal tangible outcomes our customers have reported. Join this round table of BIOVIA to learn more about the digital lab, discuss with experts relevant scenarios for your organizations and ask the lab-related questions you never dared to ask before.

Laurent Rebion

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She Yen Lok

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Live Roundtable

CRO Breakout Session: The Patient-Centric Future of Clinical Trials October 13, 2021 | 10:00 AM BST

Arrow Next Are your sponsors approaching you about Decentralized trials, do you know what areas within the clinical trial technology can enable a CROs to take a hybrid approach to clinical trial design or what the benefits are to the patients when considering DCT Trials?

Paul O'Donohoe

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Fiona Miani

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Faisal Shahzad

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alicia staley

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Live Roundtable

Predictions from the past and Clarity on the Present: How the industry is leveraging historical & ongoing studies to optimize the delivery of trials October 14, 2021 | 9:30 AM BST

Arrow Next The status quo of clinical development is that trials will take longer than forecast, and will often require some form of protocol and/or site alteration. As many as 80% of trials will not hit enrollment timeframes, and almost 60% of trials will undergo a significant protocol amendment. Despite well known challenges, many contemporaneous trials continue along the beaten path, with a reliance on anecdotal information and the same investigator networks multiple competing sponsors tap into. Scientific research is highly iterative and dynamic, however the practical operationalization of trials is decidedly less so.

In this talk we discuss how to tackle some of the most pressing challenges in optimising clinical trials: from how predictive analytics with operational data can provide greater certainty when designing, planning, and forecasting studies, to the applications of real-time insights in study rescue and proactive diagnosis of congestion and recruitment issues.

Ben McConnochie

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Rachel Horovitz

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Live Roundtable

How to Make a Culture of Quality Possible (BIOVIA) October 14, 2021 | 9:30 AM BST

Arrow Next Biopharma associations and regulatory authorities like the FDA or EMA endorse a “Culture of Quality” to reduce the Cost of Poor Quality and improve product quality. However, many companies are struggling to move to a true Culture of Quality. In this session, our experts will discuss the aspects and parameters that influence the establishment of a Culture of Quality and how an integrated Quality System can improve Quality across the organization. Join this round table of BIOVIA to discuss different approaches to a Culture of Quality, learn about capabilities that can support according initiatives and ask questions about how leverage technology to support a Culture of Quality.

Wesley Flake

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Chris Frost

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Live Roundtable

Modernization of Clinical Trials (GCP) October 14, 2021 | 9:30 AM BST

Arrow Next Within our highly regulated environment scientific and technological Innovations within clinical research only happen with regulatory approval and acceptance. Medidata with industry look to move the needle.
The International Conference on Harmonisation (ICH), Good Clinical Practice (GCP) working group has been progressing on renovating and modernizing the principles of clinical trials and GCP.
The new ICH GCP R3 revision is a very welcome update which addresses the application of GCP to a rapidly changing scientific and technological environment. It seeks to address the increasingly diverse trial types and the variety of different data sources to support regulatory decision making and acceleration of clinical research. In addition, the new US CUREs 2.0 addresses US law changes impacting clinical trials to facilitate greater patient centricity, greater diversity, uptake of technology to accelerate clinical research and pandemic preparedness initiatives.
This round table session discusses the impact of the evolving regulatory environment.

Fiona Miani

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Breakout Session

Cancer Research UK: Path to Rave EDC and Platform Capabilities October 14, 2021 | 10:00 AM BST

Arrow Next Upgrading from ‘Classic’ Rave to Rave EDC provides access to the power of the Medidata Clinical Cloud™ platform as well as an enhanced experience for EDC users. With Medidata’s latest EDC upgrade approach, iMedidata Study Groups are upgraded to Cloud Administration, old and new study data will be available on the platform, new studies will use Rave EDC, but existing studies can continue to use the ‘Classic’ Rave user interface to avoid the need for retraining and disrupting site and study team users.

In this session, you’ll hear from Medidata’s Platform Upgrade Operations team and Cancer Research UK on their reason for, preparation for, experience with, and outcomes from the new and improved upgrade process.

You will learn:

  • Cancer Research UK’s perspective on benefits of upgrading
  • Pros/cons of different ‘path to platform’ approaches for Cancer Research UK
  • How the upgrade process works
  • How to engage with Medidata to plan upgrades
Finlay Gailbraith

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Rachel Darby-Dowman

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Breakout Session

Moderna: Solving the Impossible for COVID-19 with Medidata Technology October 14, 2021 | 10:00 AM BST

Arrow Next The COVID-19 crisis emphasized the pivotal role of technology in accelerating safe clinical trial development. In fact, Medidata technology helped Moderna to bring a COVID-19 vaccine through the full clinical trial life cycle in under a year. For this effort, Moderna used a suite of Medidata technologies, including Rave EDC (electronic data capture); eCOA (electronic clinical outcomes assessment), and Detect (centralized statistical monitoring)—these tools allowed study teams to course-correct before trial quality and timing were affected by potential risks. Join this exclusive interview to learn how they delivered this phenomenal achievement…and how Medidata helped.

Laurie Callen

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Jackie Kent

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Jason Dacko

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Keynote

Designing a Trial for Everyone: Moderna’s Real-time Approach to Achieving Diversity Representation and NEXT Closing RemarksOctober 14, 2021 | 10:00 AM BST

Arrow NextModerna was leading the global race for vaccine development going into their phase III clinical study, and with the spotlight of the world waiting, they made the very important decision to slow down their study to ensure enrollment representation and extend trial access to more diverse communities. Discover how real-time data and visibility uncovered this imbalance in underrepresented populations and led to the evolution of an enrollment strategy to truly bring the trial to all patients.

Jackie Kent, EVP & Chief Customer Officer, hosts an engaging panel discussion with Moderna’s Melanie Ivarsson, SVP & Chief Development Officer, exploring the steps this clinical stage biotechnology company is taking to increase diversity and trust in today’s trials. Hear directly from a clinical trial participant, Keith Nix, as he shares his first-hand experience participating in the Moderna vaccine trial.
Jackie Keny

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Melanie Ivarsson

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Keith Nix

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Tarek Sherif

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Glen de Vries

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