Agenda

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NEXT Global

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Keynote

Welcome to NEXT Global: Morning KeynotesOctober 5, 2021 | 9:00 AM ET

Arrow Next

Opening Remarks: Bernard Charlés, Vice Chairman and CEO Dassault Systèmes

Part 1: Dassault Systemés Life Sciences and Healthcare: Accelerating the Future

In the last few years, the life sciences industry has undergone unprecedented change in terms of how organizations develop and deliver new therapies. Coupled with the rapid advances in science and technology, today’s new classes of personalized therapies are requiring a much more integrated, collaborative approach focused on the patient. This shift will require technology partners that help drive this momentum forward in order to scale and accelerate innovation. Listen to Tarek Sharif, Life Sciences & Healthcare Chairman, Dassault Systèmes, and Glen de Vries, Life Sciences & Healthcare Vice Chairman, Dassault Systèmes, share their thoughts on the industry in a post-pandemic world and how Dassault Systemés Life Sciences is committed to helping fuel this innovation to deliver these therapies to patients faster than ever before.
Speakers: Tarek Sherif, Glen de Vries, Pascal Daloz, Paul McKenzie

Part 2: Ushering in the Next Decade of Technology Innovation in Life Sciences

Over the last 18 months, you – the Healthcare and Life Science community, have mobilized at unprecedented scale and agility to accelerate research, therapeutic development and clinical practice to blunt the COVID-19 pandemic. Thanks to your unrelenting efforts, we now have several highly efficacious and safe therapies accessible to billions of people across the globe. The Medidata platform was used extensively in these endeavors, supporting hundreds of research efforts and helping teams realize their scale and speed ambitions.

During the course of the conference, you will hear a lot more about how these innovators deployed the full range of Medidata’s capabilities available across Rave, Patient Cloud and Acorn AI in new and breakthrough ways.

You will also hear about Medidata’s next-generation platform, patient-centricity and AI capabilities that can help usher in the next decade of innovation in life sciences and the hundreds of COVID-19 studies Medidata has supported over the last 2 years. The importance of patient partnership and a mandate for innovation in technology to address the challenges facing today’s life sciences organizations have never been greater. You will hear about major product updates for Rave and Acorn AI from Rama Kondru and Sastry Chilukuri, Co-CEOs, Medidata and Anthony Costello, CEO, Patient Cloud, Dassault Systemés will cover patient-centric innovations. This presentation will include testimonials highlighting next-generation capabilities and how Medidata’s unified platform approach to technology and analytics helps to shape the next decade of innovation, accelerate the speed of clinical research, and ultimately deliver outcomes for patients. If you are attending NEXT, don’t miss this kick-off talk that sets the stage for the rest of the program.
Speakers: Sastry Chilukuri, Rama Kondru, Anthony Costello

Bernard Charles

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Tarek Sherif

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Glen de Vries

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Pascal Daloz

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Paul McKenzie

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Sastry Chilukri

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Rama Kondru, PHD

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Anthony Costello

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Breakout Session

Ask an Expert with Parexel: Custom Functions: Taming the Beast! October 5, 2021 | 10:10 AM ET

Arrow NextCustom functions are a very powerful tool for the RAVE EDC system-they can simplify data entry, move data, calculate formula functions, or they can be more complex. Parexel has an initiative that is building a library of custom functions that are commonly used, built into a framework with a governance process to ensure proper use and control, error handling, and logging. Join Ian Howson, Senior Manager, Clinical Database Programming, to learn how the framework aims to streamline the use of custom functions and avoid reinventing the wheel for every study.

Ian Howson

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Breakout Session

Breakthrough Innovations Supporting Clinical Trials During COVID-19October 5, 2021 | 10:30 AM ET

Arrow NextThe COVID-19 pandemic emphasized the pivotal role of technology in accelerating safe clinical trial execution. Medidata, along with the rest of the world, understood the unique need for speed and agility in conducting clinical trials during the pandemic. Recognizing that business as usual approaches were insufficient, Medidata partnered with clients to implement innovative processes for study planning, startup, oversight, and evidence generation. The results were transformative: vaccines and drugs reached the market in record time, and impact to in-flight trials was minimized. In this dynamic panel, hear from Medidata experts how COVID-19 catalyzed a transformation in the way data and technology are used to support and drive trials, and how these innovations are permanently changing the paradigm for clinical trial execution.

Heidi Ball

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amanda nite

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Olgica Klindworth

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Stephanie Chamberlain

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Breakout Session

Syneos Achieves Clinical Operations Excellence with CTMS and RBQM October 5, 2021 | 10:30 AM ET

Arrow Next Companies with robust processes for centralized monitoring, remote data collection and document review, as well as flexible on-site interactions, were successful in adjusting to complexities resulting from the COVID-19 pandemic. Now, more and more companies are reshaping their clinical operations by layering in risk-based quality management systems (RBQM) on top of traditional trial management solutions such as CTMS, to address the fundamental maturity of their processes.

In this presentation, Syneos will discuss:

  • Why they are moving to new ways of working with clinical operations solutions to help them achieve better business outcomes
  • How their teams can complete monitoring activities entirely remotely, all while ensuring proper oversight of trial delivery
  • The role of a transactional CTMS system to foster collaboration, drive real-time insights, document new kinds of oversight and reviews, and connect data sources for faster and better decision-making
  • What they see as the future of Clinical Operations and RBQM
Nicole Stansbury

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Martin Dowdall

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Breakout Session

Virtual Twins are the Catalyst to Achieve Sustainability October 5, 2021 | 10:30 AM ET

Arrow Next The growing global demand for therapies due to longer, more affluent living, presents many challenges to the Life Sciences industry. While the industry aims to improve the quality of our longer lives, there is a growing recognition that more must be done to improve its sustainability performance.

The virtual twin delivers the scientific capabilities for Life Sciences companies to operate more sustainably and create highly effective therapies to meet society’s growing demands enabling sustainable innovations in that can impact:

  • Society, which demands access to safe, effective, and affordable therapies
  • The environment, to reduce or eliminate GHG emissions and natural resource utilization
  • And businesses in realizing ethical and sustainable practices
Barbara Holtz

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Reza Sadeghi

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Steven Levine

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thomas muth

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Alicia Staley

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Breakout Session

Moderna: Solving the Impossible for COVID-19 with Medidata Technology October 5, 2021 | 10:30 AM ET

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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Lightning Talk

Lightning Talk: The Evolving Regulatory Landscape with Direct-to-Patient (DtP) October 5, 2021 | 11:00 AM ET & 2:00 PM ET

Arrow Next As the industry moves towards Decentralized Trials, regulators are assessing Direct-to-Patient (DtP) shipping and providing guidance. Staying current on regulations and understanding regional differences are critical to running a successful DtP trial.

Join our lightning Talk to understand changes in this area and how flexible technology solutions can help ensure you’re prepared for the next pivot.
Amanda Nite

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Lightning Talk

Lightning Talk: How CRO Accreditation Makes You More Competitive October 5, 2021 | 11:00 AM ET & 2:00 PM ET

Arrow Next We understand that as a CRO, you need to stay competitive, keep your employees updated on the latest technologies, and ensure that sponsors, sites and study teams are properly supported.

This lightning talk explains how the Medidata Professional Services team is dedicated to training your team on the latest Medidata solutions and releases so you can focus on supporting your clients effectively without delays or bottlenecks. Our accreditation program provides clients with the confidence that you fully understand Medidata solutions and the optimal ways to implement and configure our solutions to maximize their value and performance.
Tamsin Perrett

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Lightning Talk

Lightning Talk: Clearing Regulatory Hurdles Around eConsent October 5, 2021 | 11:00 AM ET & 2:00 PM ET

Arrow Next Hear from Medidata regulatory experts as they explain the perceived regulatory barriers to adoption of eConsent, and how we address these to help you eliminate regulatory concerns.
Valeria Orlova

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Breakout Session

Smarter, Safer Trials, From Anywhere: The Medidata Decentralized Clinical Trials (DCT) Program October 5, 2021 | 11:15 AM ET

Arrow Next Patient-centricity is one of the advantages of executing a decentralized clinical trial (DCT), by expanding access to larger pools of participants and by lowering the burden on patients in the trial to travel to investigative sites, increasing both enrollment and adherence.

The growth in decentralized trials has accelerated the use of direct data capture from patients. This poses a challenge to traditional modalities of data management and monitoring, which relied on edit checks, queries, on-site monitoring activities, and source data verification as the means to show control of quality and process.

With its comprehensive DCT Program, Medidata has become the first company in the world to unify direct patient data capture technology, direct-to-patient services, and study oversight and monitoring, on a single platform. The result is a solution for DCTs that considers the needs of patients, sites, and sponsors and creates a new model for consent, data acquisition, monitoring, investigational product supply and accountability, remote document review, video visits, wearable sensors, and data analytics.

Join this session, see first-hand how the Medidata DCT Program is revolutionizing the way decentralized trials are conducted.
Anthony Costello

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Lisa Moneymaker

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Breakout Session

The Transformation of Clinical Data Capture and Management October 5, 2021 | 11:15 AM ET

Arrow Next The clinical data capture landscape is changing rapidly with access to more capabilities for remote data capture either directly from patients or home nurses, whether in the form of patient diaries and questionnaires or from monitoring devices.

This shift has been accelerated by the ongoing COVID-19 pandemic and the resulting increase in decentralized clinical trials (DCTs).

These changes bring new or greater challenges for clinical data management teams. Data is:

  • Electronically sourced, rendering source data verification meaningless
  • Potentially high volume, high velocity, making traditional, manual 100% data point review impossible
  • Captured and stored in multiple different systems, creating more reconciliation work
And recent research has shown that data review and cleaning solutions such as edit checks and queries are inefficient, ineffective, and not scalable to meet the demand of ensuring high-quality data while not adding cost and time to the clinical trial.

Our expert panel will discuss:
  • The challenges that clinical data management teams are facing
  • How new and emerging technologies and processes can help
  • What new skill sets clinical data management teams should acquire to be more successful
Patrick Nadolny

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Tracy Mayer

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Wayne Walker

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Andy Gurd

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Breakout Session

Holistic Platform for Product Introduction October 5, 2021 | 11:15 AM ET

Arrow Next The creation of new therapies driving improved patient outcomes often results in contradictory requirements for designs, engineering and manufacturing, thus affecting the Life Sciences company’s ability to reduce risk in their clinical trials.

Join our experts to see how these requirements challenges can be overcome by using computer modelling and simulation within a systems engineering context. Complemented by methods to virtually plan and simulate manufacturing operations and processes to speed to new production introduction, Life Sciences companies can maximize resources and optimize production with resiliency. These technologies and methods, within a collaborative and traceable decision making platform, enables teams to identify the critical process parameters and quality attributes, as well as to validate the therapeutic system – from ideation through pre-clinical and into commercial manufacturing before being placed in the hands of patients and practitioners.
Guillaume Kerboul

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thomas muth

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Stuart Wright

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Barbara Holtz

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Bill Broderick

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Breakout Session

SCRS Presents: Challenges with Data Entry & Collection Across the Globe October 5, 2021 | 11:15 AM ET

Arrow Next An often overlooked but critical stakeholder in the collection and translation or entry of data is the clinical research site. Being the primary source for much of the data that is collected from patients and entered systems like EDC, their challenges and perspectives on this process are critical to the improvement of processes surrounding data collection and entry. Hear from a diverse patient perspective as we highlight the challenges surrounding data with sites from the US and EU.

During this panel discussion we will:

  • Explore the site prospective on the challenges they face as it pertains – to data entry and collection
  • Learn from a diverse perspective how this challenge is approached from different countries
  • Come away with key focus areas to tackle as you work to improve data quality and delivery
Jimmy Bechtel

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Vivienne van de Walle

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Jason Roth

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Taryn Collett

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Live Roundtable

Live Roundtable: Remote Monitoring Isn’t Going Anywhere, Is It? An Industry PerspectiveOctober 5, 2021 | 11:15 AM ET

Arrow Next One of the impactful outcomes of the COVID-19 pandemic was regulatory and industry acceptance of remote source document review and remote monitoring. Although the technology has been available for a number of years, regulatory headwinds made adoption more difficult. But in an effort to support clinical trial continuity during the pandemic, numerous regulatory agencies, including US FDA, permitted the the use of remote/virtual technology and processes. This was cause for relief but has also raised questions about how to best implement remote monitoring models to optimize clinical efficiency and quality.

Join the conversation to discuss:

  • Is Remote Monitoring here to stay? What will it look like post-pandemic?
  • What has fundamentally changed post-COVID-19 in how we think about adopting remote monitoring strategies?
  • What tools/solutions has your organization implemented to keep your trials running when you can’t get on-site, such as remote SDV/SDR?
  • What role does risk assessment play at your organization in helping determine remote monitoring strategies?
  • How has the adoption of remote monitoring strategies progressed with your investigator sites and your organization? And how much change management was required?
Brian Barnes

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Michelle Wetherby

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Breakout Session

AI Powered Enrollment Forecasting and Real Time Study Monitoring Against Industry October 5, 2021 | 11:15 AM ET

Arrow Next How well are you able to forecast enrollment and track external factors that can impact the performance of your ongoing study?

This session will provide insights from how life sciences organizations are benefiting from the industry’s largest operational trial dataset and advanced analytics to better plan their studies and be agile in responding to changes in the industry landscape.
Jef Benbanaste

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Keynote

Solving Medical Mysteries Through Crowdsourcing and Connectivity October 5, 2021 | 11:45 AM ET

Arrow Next Receiving a diagnosis can mean everything to a patient, as being able to put a name to a disease carries medical, financial, and social significance. We have an opportunity in our industry to reduce missed diagnoses and diagnostic error, which is the third leading cause of death behind heart disease and cancer. Innovative approaches, like crowdsourcing to identify uncommon diagnoses, are increasingly being used in public health and medicine to improve the understanding of diseases. Studies suggest that crowdsourcing can broaden public engagement in medical research and improve behavioral outcomes, though there is a need to better understand its effects on clinical outcomes and costs.

In this fireside chat, Medidata’s Janet Butler and Diagnosis Detective Dr. Lisa Sanders will discuss the power of connectivity and data sharing among the patient community to ultimately save more lives.
Janet Butler

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Lisa Sanders

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Wellness Session

Eye Yoga with Koya WebbOctober 5, 2021 | 12:15 PM ET

Arrow NextKoya leads us through her crowd favorite “eye yoga,” which will help us relax and reduce eye strain. Throughout the class, Koya will also guide participants through movements proven to reduce stress and tension from the body. This is the perfect option for those looking to engage a variety of participants in an unassuming way.

Koya Webb

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Wellness Session

Turning Dreams into Reality with Katie McKennaOctober 5, 2021 | 12:15 PM ET

Arrow NextHaving a dream is easy. Finding the courage, perseverance and sticktoitiveness to turn that dream into a reality is the real challenge. In this talk with Katie McKenna, Best Selling Author, Speaker, and Life Coach, she will share her story of surviving being run over by an 18 wheel truck, and how she took what felt like an impossible dream of rebuilding her life, and made it possible. You will leave this talk with insights, examples, and real life tools you can use to actualize your hopes and dreams and create the life you want to live!

Katie Mckenna

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Wellness Session

Essentialism: The Disciplined Pursuit of Less with NY Times Best Selling Author Greg McKeownOctober 5, 2021 | 12:15 PM ET

Arrow NextParticipants learn the value proposition for Essentialism and three practices for applying essentialism. Namely, explore what is essential, eliminate the nonessentials, and execute what matters most as effortlessly as possible.

Greg McKeown

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Keynote

Medicenna: Accelerating Insights and Breakthroughs in the World’s Most Challenging Diseases October 5, 2021 | 1:00 PM ET

Arrow Next In October 2020, the FDA granted Medicenna Therapeutics a precedent-setting agreement to design a phase 3 registrational trial using a hybrid external control arm in recurrent glioblastoma (rGBM), an aggressive form of brain cancer. Hear our esteemed panel discuss the challenges of studying and treating patients with life-threatening illness and the hope the Synthetic Control Arm® (SCA®) represents for accelerating trials to not only help current patients, but also how teams can reinvest the time and money saved from using an SCA to lead to an exponential growth in new therapies.
Bryant Fields

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Ruthana Davi

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Fahar Mewrchant

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Dr. John Sampson

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Breakout Session

DIY: Adjudication Made Simple October 5, 2021 | 1:30 PM ET

Arrow Next Transform your Endpoint Adjudication with Medidata Adjudicate. This product showcase will demonstrate Medidata’s innovative new cloud-based solution that supports investigator sites, CROs, data managers, the Clinical Event Committee (CEC) and sponsors who collect, manage, organize, adjudicate and submit clinical endpoint data.

Traditional manual, paper-based approaches to CEC management place significant time, cost, and resource burdens on organizations – and are prone to errors, bias and regulatory issues. Medidata Adjudicate helps remove these barriers and drives significant gains in efficiency, accuracy, data quality, and compliance. Its innovative design of easily configurable modules enables quick setup to manage all endpoint adjudication in clinical trials.

In this session, you will see Medidata Adjudicate in action with a brief solution overview and product demonstration.
Andrea Falkoff

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Cameron Kinnear

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Breakout Session

Oncology Clinical Trial Resilience During COVID-19 Pandemic 2020 October 5, 2021 | 1:30 PM ET

Arrow Next Beyond its morbidity and mortality from infection, the COVID-19 pandemic compromised population health through disruptions in global healthcare delivery including within clinical research and development. In the area of oncology clinical trials, the onset of COVID-19 was was followed by a >50% drop in trial patient enrollment and new trial launches by spring 2020.

In this session we will present results of analyses of the Medidata Enterprise Data to understand the longer term impact of the pandemic on clinical trial enrollment and trial availability in 2020.
Elizabeth Lamont

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Lisa Ensign

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Breakout Session

Prepare for What’s Next: The Future of Platform-Based Clinical Trials and DCTs October 5, 2021 | 1:30 PM ET

Arrow Next During the pandemic, life science organizations had to adapt quickly – and adopt new and novel technology – to remotely collect and monitor patient and trial data.

Much of this rapid shift was possible because of strong and flexible clinical development technology platforms, usually enabled by Decentralized Clinical Trials (DCTs)… but, how can life science organizations make sure they are prepared for what’s next?

Nitish Mittal, Vice President, Everest Group will join Joe Horine, Director, Analyst Relations, Medidata in a fireside chat to discuss Everest’s recently published Clinical Development Platform and Decentralized Clinical Trial PEAK Matrix Assessments.

Based on extensive research involving interviews with both providers and enablers of clinical development platforms and decentralized clinical trials, Nitish will share his insights on:

  • How life sciences firms are embracing a platform-first mindset to clinical trials
  • State of the market in DCTs and current adoption
  • How to ensure your clinical development platform is “future proof” State of the market in DCTs and current adoption
  • Best practices for deploying novel technology to decrease time and cost, while enhancing patient experience


Join this engaging discussion to learn how to prepare your technology infrastructure for the future of clinical trials.
Nitish Mittal

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Joe Horine

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Live Roundtable

Live Roundtable: Data, Privacy and AI – Oh My! How to Integrate your Systems for Success October 5, 2021 | 1:30 PM ET

Arrow Next Integrating systems and data is critical for a successful trial, especially with novel forms of data collection, the emergence of advanced analytics, and the resurgence of data privacy concerns. Getting it right from the start alleviates many challenges and pain points during the trial.

Join this session for a lively discussion about:

  • How the industry is tackling system integrations and the gains we are seeing
  • Leveraging machine learning algorithms and advanced analytics to benefit trial outcomes
  • How are we working through data privacy and blinding issues between systems?
  • What efficiencies/quality benefits have been gained through system integration?
  • Moving towards a unified platform
gary thompson

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Nicole Quinlan

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Breakout Session

Improving the Donor Experience Ultimately Helps Patients: The CSL Plasma Story October 5, 2021 | 1:30 PM ET

Arrow Next Blood plasma is the key component to many life-saving therapeutics for several chronic and acute life-threatening diseases, including many immunity disorders. Ensuring a healthy plasma supply relies on donor volunteers who may spend hours each month in plasma donation centers. Ensuring a positive donor experience relies on a complex network of donor, site, and manufacturing touchpoints in a heavily regulated environment.

In this session, learn why CSL Plasma chose 3DS solutions, including myMedidata and DELMIA, to create a unified solution for all plasma collection and manufacturing capabilities, and how this will impact donor and site experiences.

Anthony Costello

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Paul McKenzie

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Breakout Session

RTSM Efficiency Case Studies: Paving Your Way to Success October 5, 2021 | 1:30 PM ET

Arrow Next As part of the Medidata Clinical Cloud platform, Rave RTSM is designed to handle complex trials with possible mid-study changes. In addition, supply management regulations are more stringent than ever before and require robust functionality and extensive reporting. Syneos Health and Reata Pharmaceuticals have each taken the steps to become accredited as a Rave RTSM study builder and both will share how they have leveraged Rave RTSM to design and execute successful clinical trials. They will share some of the best practices their organizations have developed to implement trials faster, more efficiently and manage the rigors of supply management.

In this session you will learn:

  • The values that building RTSM on a platform provide
  • Strategies to manage complex trial designs
  • Recommendations for saving on study drug while minimizing site shipments
  • How vital, flexible and powerful reporting supports all study-related personnel
Marc Kaufman

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Voitek Gradziuk

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Joel Burnett

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Breakout Session

Where Do We Go From Here? Lessons Learned From The Pandemic October 5, 2021 | 2:15 PM ET

Arrow Next In March of 2020, the pandemic stopped clinical trial operations in their tracks. No patient visits, no on-site monitoring visits, no investigator meetings. The world shifted to a virtual model almost overnight.

As we return to a “new normal” in clinical research, what things should we keep doing virtually…and what things should we return to doing?

In this interactive panel session, hear industry leaders from clinical operations and data management discuss the impact of the COVID-19 pandemic on clinical trials, what changes they would like to see stay, what things they would like to see return, and why.

Topics of the discussion include:

  • Investigator meetings – to remote, or not to remote
  • Meeting patient needs inside and outside the clinic
  • Building a collaborative site relationship
  • Maintaining effective data and quality oversight
Linda Talley

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Caryn Barnett

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Sondra Smyrnios

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Breakout Session

Too Fast, Too Furious: How Can Data Managers Keep Up with the Shifting Landscape? October 5, 2021 | 2:15 PM ET

Arrow Next Remember hearing at past conferences that the future of Data Management is coming? Will the Data Management landscape change? Is there a shift in how the Data Manager will “clean” their data? Well, the future and changing landscape for the Data Manager is here. The COVID-19 pandemic has challenged the way clinical trials are executed. Traditional methods have been disrupted and our industry has to think creatively about data acquisition from a variety of sources. This has forced Data Management organizations to rethink what data cleaning means and enable new ways of implementing the best approach to collect, clean, and report on the data in their clinical trials.

In this session, you will learn about three approaches to data management and what actions each one can take right now to move towards the new normal. The areas of focus will be:

  • Use of Data Visualizations and Analytics
  • How to make the most of the tools you have now and how to update your processes to meet today’s needs
  • How to execute change, optimize and streamline your processes and use analytics for a true risk-based data management approach
Nicole Pollard

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Katrina Rice

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Breakout Session

Designing a Fit-for-Purpose Sensor Strategy October 5, 2021 | 2:15 PM ET

Arrow Next When designing trials with sensors, it is important to start with the data hypothesis and desirable endpoint(s). Once this critical step is completed, the dataset can be defined and the appropriate devices can be selected that best meet those requirements.

In order to best guide device selection, Medidata is sponsoring an internal study to gain first hand experience with several of the devices that have been integrated into Sensor Cloud. Each device will collect a range of measurements including actigraphy, sleep, respiration, cardiac output, blood pressure, pulse oximetry, temperature, and lung capacity.

This knowledge will be used to better guide customers in the selection of sensors for patient monitoring and help the Medidata team better support trials with sensors.

This study was carefully designed to meet several objectives, including:

  • Gain knowledge in device setup, provisioning, user experience, and data/metric types
  • Better understand Exercise Sensor Cloud/Digital Biomarker functionality by ingesting and processing real data from a variety of devices
  • Build a foundational dataset that will be used for algorithm development (i.e., 6MWT) and used to develop/test our common data model
  • The results and lessons learned

In this session, you will learn about the internal study design, get a preview into the data collected, and see the value of Sensor Cloud ingestion and analytics across a variety of devices.
Melissa Ceruolo

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Tom Doyle

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Breakout Session

Following The Journey of Demographic Data: Defining the Story Around Diversity in Clinical Trials October 5, 2021 | 2:15 PM ET

Arrow Next Improving diversity in clinical trials is a critical issue in our industry. However, to drive change, we need accurate measures of the current state and our progress. Join us as we discuss how data can be used to drive better diversity in clinical trials. We will dissect which metrics have been shaping the diversity story currently and which metrics could help deepen our level of understanding. Dig deep with our panelists as we explore how we can use diversity data to further tell a story of truth and trust as we strive for equity in clinical trials.
Fareed Melhem

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blair hirst

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Kim Riberio

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Gissoo Decotiis

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Breakout Session

Virtual Twins and the Future of Clinical Trials October 5, 2021 | 2:15 PM ET

Arrow Next Challenges to the safety and cost effectiveness of bringing new treatments to market are threatening the sustainability of progress in healthcare. We are at a crossroads. The era of consensus medicine has served us well, but must evolve to a more powerful medical paradigm that utilizes patient specificity as an asset. When faced with similar threats, other industries turned their focus to the development of virtual twins to deconstruct their most complex systems to reduce risk and systematically grow their understanding. Virtual twins, developed from real patient data are the focus of the Living Heart and Living Brain Projects.

Through partnership with Dassault Systèmes, the FDA has recently announced a pioneering project to transform the Living Heart into a virtual patient population to produce surrogate endpoints for a cardiovascular device in an in-silico clinical trial. These virtual patients can reduce cost and risk by serving as control arms or forming enrichment strategies, and eventually creating the scientific and evidentiary foundation for use of such tools in medical practice.
Steven Levine

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Live Roundtable

Live Roundtable: Improving the Rare Disease Patient Experience: Patient Voices October 5, 2021 | 2:15 PM ET

Arrow Next Improving the patient experience is critical in all clinical development, even more so for rare diseases where patients are scarce.

Join this discussion on how we as an industry can facilitate, engage and improve our approach to the rare disease patient experience.
Alicia Staley

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Pam Cusick

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Keynote

Moderna Part 1 Pioneering Next-Gen Medicine: How Moderna Delivered a Vaccine in Record Speed with a Strategic Partnership in Patient-Centered Technologies October 5, 2021 | 2:45 PM ET

Arrow Next Moderna has developed a new class of medicines at an unmatched speed the industry has never seen. Delivering more than 100 million doses in less than 12 months and forecasting to manufacture up to 1 billion doses in 2021 is a remarkable achievement that sets a new bar for the potential of future scientific innovation.

Join this exclusive discussion between two global industry experts, Marcello Damiani, Chief Digital & Operational Excellence Officer at Moderna, and Glen de Vries, Life Sciences & Healthcare Vice-Chair at Dassault Systèmes, as they explore the technology and innovation that powered the digitized delivery of a highly anticipated vaccine. Moderna and Medidata’s strategic partnership focused on bringing together a scientific mRNA platform with a clinical technology platform to address complex variables that needed to be harmonized in order to bring a COVID-19 vaccine to a global community.
Glen de Vries

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Marcello Damiani

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Keynote

Welcome Back to NEXT Global: Morning Keynotes October 6, 2021 | 9:00 AM ET

Arrow Next

Part 1: Patient Centered Technologies Move from Pilot to Prime Time

Join Anthony Costello, the newly appointed CEO of 3DS Patient Cloud, to see how patient partnerships combined with advanced technologies have the power to advance clinical trials like never before. Providing sponsors, sites, and patients with choice through decentralizing solutions is now mainstream, but not all technologies are created equal. With many point solutions currently on the market, there’s a gap in delivering superb patient and site engagement across an ever-growing ecosystem.

In this keynote, you will learn about the latest innovations within the Patient Cloud suite of products, all designed for patients by patients. This presentation will show you how to transform patient participation from a transactional experience to an expanded engagement pre, during, and post-trial, including how patients can enroll and participate from home using decentralizing technologies, and how patient data can be collected and ingested into a common model using Sensors without any additional burden to patients or sites, all on a single patient portal for life. If you’re looking to innovate and deliver patient-centric technologies to study design, you won’t want to miss this session!
Speakers: Anthony Costello

Part 2: Labcorp and Medidata’s Sensor Cloud: Creating a shared vision to transform clinical insights through digital health technology

In response to the changing dynamics of clinical trials, Labcorp and Medidata have extended their partnership focused on advancing the use of medical-grade sensors designed to accelerate biomarker discovery. Using Medidata’s Sensor Cloud to capture, ingest, normalize, and deliver sensor data for analysis, Labcorp and Medidata will work together to create new algorithms that will become digital biomarkers, and potentially, new digital endpoints. Join Medidata Patient Cloud CEO, Anthony Costello, and Jonathan Shough, CIO of Labcorp, as they discuss the shared vision for the next generation of clinical trials in the age of digital health technology.
Speakers: Anthony Costello, Bola Oyegunwa PhD

Part 3: Data Everywhere, Anywhere and at Anytime: The Changing Landscape of Clinical Data Management

We are entering the next phase of clinical research where the volume and types of data available give us unprecedented opportunities to understand a patient’s experience and disease. This transformation has been accelerated by the COVID-19 pandemic and our transition to remote/virtual/decentralized data capture and monitoring.

As the variety, volume, and velocity of data increase, we wrestle with new challenges in aggregating, contextualizing, cleaning, and reconciling that data to achieve a single, holistic view of the patient data from which we can drive actionable insights with intelligent analytics.

In this keynote, Medidata’s Wayne Walker and Lisa Moneymaker, and Matt Southwick from Amgen, will discuss the challenges that clinical data management and operations teams face, and offer their vision of how technologies and processes are transforming to accelerate operations, reimagine clinical trials, and rededicate data to develop new and novel therapies for patients.
Speakers: Lisa Moneymaker, Wayne Walker, Matt Southwick

Part 4: Analytics at the Crossroads: Integrating Data Science for Agile Therapeutic Development

Arrow NextIndustry innovators are seeking a competitive edge around the speed of clinical development. Novel data sources and the application of data science have become an increasingly important part of accelerating development, but questions still remain around how to integrate these insights into day-to-day development and operational activities. We find ourselves at a crossroads – in a world where data liquidity is growing, but ungoverned, how do you establish validity and directly link advanced analytics to measurable outcomes? Raj Malik, Chief Medical Officer, G1 Therapeutics, will join Medidata Acorn AI Leaders, Arnaub Chatterjee and Fareed Melhem as they share examples and applications of data and analytics to meaningfully move the needle in drug development and trial operations.
Speakers: Arnaub Chatterjee, Fareed Melhem, Rajesh Malik MD

Anthony Costello

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Bola Oyegunwa

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Lisa Moneymaker

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Wayne Walker

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Matt Southwick

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Arnaub Chatterjee

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Fareed Melhem

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Raj Malik

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Breakout Session

Ask an Expert with Premier Research: Data Quality Best Practices in the Era of Decentralized Clinical TrialsOctober 6, 2021 | 10:30 AM ET

Arrow NextStacy Weil, Senior Vice President, Clinical Informatics at Premier Research will be answering questions around quality in decentralized trails vs. traditional trial designs. Stacy will discuss the impact of emerging technologies on data quality and offer suggestions for maintaining data excellence.

Stacy Weil

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Wellness Session

Breathwork with Stuart SandemanOctober 6, 2021 | 10:30 AM ET

Arrow NextStuart Sandeman, founder of Breathpod and host of BBC Radio 1’s Decompression Session, has helped tens of thousands change their lives through the power of breathing. In this session, he will explain how you can use your breath to turn stress to calm, overwhelm to balance, and distraction to focus. Stuart has worked with award-winning artists, Olympic athletes, top business execs and global brands, so we are excited to have him as part of our Medidata NEXT Global event.

Stuart Sandeman

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Wellness Session

Effortless: Make it Easier to Do What Matters Most with NY Times Best Selling Author Greg McKeownOctober 6, 2021 | 10:30 AM ET

Arrow NextHave you been getting results in a way that has left you on the edge of exhaustion? In this session Greg McKeown, author of the New York Times bestseller, Effortless, will share five tools you can use right now to break through to the next level without burning out.

Greg McKeown

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Wellness Session

Anything is Possible with Paralympian, Blake LeeperOctober 6, 2021 | 10:30 AM ET

Arrow NextWe all face challenges and obstacles in pursuit of our personal and business dreams. For most of us, those are day to day frustrations to which we often attribute far more weight than we should. For others, like Blake Leeper, those obstacles include being born without legs. “Why me?!” – most people might lament if faced with such a daunting challenge, but not Blake. Instead, he chooses to take control of his own destiny every day by saying to himself, ‘Why not me? I’m strong enough for this! I’m smart enough for this! I can do this!’ And the boy who was not born to run has turned himself into one of the fastest men in the world. Indeed, Anything is Possible with Paralympian Blake Leeper.

Blake Leeper

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Keynote

From Solution to Success: Helping Patients Get Treatments, FasterOctober 6, 2021 | 11:00 AM ET

Arrow NextIn clinical trials, it’s no longer about a single technology product, working in isolation, on a discrete task.

It’s about a full suite of technologies – with strong services & support – to help you accomplish your biggest, and most challenging, clinical research objectives.

Come hear from Jackie Kent, EVP & Chief Customer Officer, and Joseph Schmidt, EVP, Professional Services, discuss how Medidata is offering a full suite of solutions to help customers solve their biggest research challenges.

As part of the session, Jackie and Joseph will discuss how Medidata:
Supports customers in their day-to-day work, with strong products and solutions
Works to deliver a superior customer and patient experience
Approaches clinical trial technology holistically – with services support in mind
Is setting-up for the future of clinical research
Jackie Kent

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Joseph Schmidt

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Mark Travers

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Breakout Session

Don’t Let Your Imaging Data Quality Get You Down! October 6, 2021 | 11:30 AM ET

Arrow Next Image assessments are often included as endpoints in clinical trials. The quality of the imaging data can have a direct impact on whether these endpoints can be evaluated. Uninterpretable data can lead to extended timelines for the trial, inaccurate endpoint assessments, potential regulatory concerns and increases the costs of the trial.

Advancements in AI and machine learning help track the quality of your images, assess issues before it goes to the radiologist and allow you to document and track trends in your quality steps – all of which help you reduce this bad data. It’s important to get it right from the start and the right technology solution, such as Rave Imaging, can help.

This session will showcase where the industry has been, how quality assessments have changed, and how technology helps.
Andrea Falkoff

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kevin volz

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Live Roundtable

Live Roundtable: Blurred Lines: The Intersection of Data Management and Clinical Operations October 6, 2021 | 11:30 AM ET

Arrow NextToday there are instances where more than 70% of clinical trial data points are not collected via eCRFs. Traditional data management and monitoring approaches using edit checks, listings compiled by programmers, queries, and 100% source data verification and review simply don’t work anymore.

Join this exciting roundtable to discuss:

  • What has fundamentally changed in how we now think about adopting RBQM tools in Clin Ops strategies?
  • What has fundamentally changed in how we now think about data cleaning?
  • What challenges in traditional data management are causing teams to look at incorporating risk-based approaches into their work to ensure data quality?
  • Where are the roles being blurred between the data manager, the central monitor and the CRA, and how can they work together effectively to ensure data quality and accuracy?
Lisa Moneymaker

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John Whitaker

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Breakout Session

Boston Scientific Leans Into Remote Monitoring October 6, 2021 | 11:30 AM ET

Arrow Next With the onset of the pandemic, Boston Scientific knew they needed to rapidly change course and turned to Medidata’s new Remote Source Review to help keep their trials running. Remote document review and verification were no longer a nice to have but a necessity. As an early adopter, Boston Scientific overcame many challenges in defining a new way of working and implementing a new technology – but it has paid off in the end. The value and efficiency remote monitoring brings to their trials means it is here to stay.

Join this session to learn more about the challenges Boston Scientific and Medidata overcame together to ensure a successful implementation, what they are doing to increase adoption within Boston Scientific and at investigational sites, and how they are bringing the future of remote monitoring forward.
Cindy Grabowski

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kevin walthers

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peter keller

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Breakout Session

Drug Repurposing with Advanced Analytics: COVID-19, Rare Disease, and Beyond October 6, 2021 | 11:30 AM ET

Arrow Next The conventional drug discovery process is estimated to cost nearly $1 billion over a minimum of 10 years (Wouters et al, 2020). The COVID-19 outbreak has highlighted the urgency to prioritize accelerated drug discovery through exploring existing approved drugs for its treatment. Given the lower developmental costs and shorter timelines, drug repurposing has continued to gain more recognition as an alternative approach to explore new discoveries and breathe new life into other disease areas as well, especially in rare diseases and within their respective patient profiles. In rare systemic inflammatory disorders, including Castleman disease, drug repurposing efforts have led to treatment breakthroughs. Conversely, though there have been dozens of drug repurposing efforts for ALS (amyotrophic lateral sclerosis) and other rare neurological disorders, there remains a need for more effective pre-clinical pipelines to identify promising approaches and improved data collection in real-world settings and clinical trials for repurposed therapeutics to be fully harnessed.

In this session with Medidata’s research partners, David Fajgenbaum (CDCN) and Project ALS leaders, we will discuss drug repurposing strategies and their challenges, along with leveraging real-world data and advanced analytics to build a comprehensive view of the patient story.
david fajgenbaum

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erin fleming

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Valerie Estess

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Sheila Diamond

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Breakout Session

Advancing New, Groundbreaking Therapies with Molecular Modeling/Simulation and Predictive Science October 6, 2021 | 11:30 AM ET

Arrow Next Dr. Francine Acher, research director CNRS at Université Paris Descartes and Dr. Anne Goupil-Lamy, principal field application scientist and fellow, BIOVIA Science Council, will moderate this stimulating session around recent scientific advancements in small molecule and biologics-based therapeutics made possible by 3D modeling/simulation and predictive science.

Question to be addressed are:

  • How are new techniques helping to advance the investigation of receptor activation mechanisms?
  • How can we rationally design biologics that selectively activate neuronal receptors to perform a variety of functions in the central and peripheral nervous systems?
Anna Goupil-lamy

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Francine Acher

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Breakout Session

Patient Insights – Lessons from the Frontline October 6, 2021 | 11:30 AM ET

Arrow Next The life science industry frequently uses patient centricity as a buzzword, but promoting the idea of patient centricity without action dilutes the term’s meaning and frustrates patients. By involving patients early on in trial design and solution development, you are truly putting the patient at the center of research. Medidata operates with a formal process called patient centricity by design (PCbD), part of our Patient Insights program.

Join this panel discussion to see how infusing the patient perspective into the software development life cycle improves the overall patient experience and discuss the importance of patient-centricity with Medidata’s VP of Patient Engagement, Alicia Staley, Medidata’s Senior Director of Product Management for RTSM and two patient advocates, Anne Marie Mercuiro and MarlaJan Wexler.

Alicia Staley

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Amanda Nite

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Marlajan Wexler

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anne marie mercurio

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Lightning Talk

Lightning Talk: Discover Medidata Knowledge Spaces and User Assistance: Your Key to Product KnowledgeOctober 6, 2021 | 12:00 PM ET & 2:30 PM ET

Arrow Next Whether you’re new to Medidata Knowledge Spaces or a seasoned “pro,” we have explanations, tips, and self-help galore on our Learn.mdsol.com site. Join our lightning talk to find out more about Knowledge Spaces and User Assistance that is available for you. Learn how you can access product documentation, FAQs, videos and more, to help you and your team get started and be successful. Hear what improvements are in the works to make your use of Medidata products even smoother.

Join our lightning talk to find out more about our Knowledge Space and how you can access product documentation, FAQs, videos and more – all focused on helping you and your team get started and be successful.
Nitza Hauser

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Lightning Talk

Lightning Talk: A Walk Through Diversity Reporting October 6, 2021 | 12:00 PM ET & 2:30 PM ET

Arrow Next Tracking diversity metrics and measuring diversity in clinical trials can vary across companies and studies. Take a walk with Blair Hirst through our Medidata Acorn AI diversity report.

blair hirst

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Lightning Talk

Lightning Talk: Navigating The Regulatory Landscape Around Wearables and SensorsOctober 6, 2021 | 12:00 PM ET & 2:30 PM ET

Arrow Next Hear from a Medidata regulatory expert as they explain the perceived regulatory barriers to adoption of sensors in clinical trials, and how Medidata addresses these to help you eliminate regulatory concerns.
lauren wheeler

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Breakout Session

Exploring the Chemical Space for Virtual Lead Optimization October 6, 2021 | 12:15 PM ET

Arrow Next We are at the dawn of a new era in drug discovery and precision medicine. With advances in AI and machine learning methods together with physics-based simulations at the scale and size required, we are able to more efficiently discover and design novel therapeutics. To find a desirable hit one must triage a complex 1027 chemical space. This daunting task requires automation and precision to advance a hit to a lead and optimize the design of the lead to meet the target product profile of the drug molecule.

In this session, we will explore topics including:

  • Need for an open discovery and development platform
  • Role of AI and generative design
  • Complex diseases
  • Precision Medicine
  • Experts in-the-loop
  • IP conflict challenges
Scott Bembenek

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Reza Sadeghi

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Breakout Session

Cambridge Rare Disease Network: Connecting the Rare Disease Patient Group with Industry to Accelerate Change October 6, 2021 | 12:15 PM ET

Arrow Next Fostering connection and communication between rare disease patients groups, advocates, experts, leaders and clinical developers will facilitate the pathway to the discovery of new treatments in rare disease. By sharing knowledge and experience, the journey towards better diagnosis, treatment and support for patients and their families is smoother and more certain. There are many untapped opportunities to find treatments for rare disease patients and for pharmaceutical companies who have a hard time finding patients for their trials.

Learn more about the Cambridge Rare Disease Network and their work with Medidata’s Social Innovation Lab to accelerate change by better connecting the rare disease patient groups with industry experts and leaders.
Corinne Daniel

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Jo Balfour

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Breakout Session

Expert Opinions: Best Practices for Considering the Use of a Synthetic Control Arm® Development October 6, 2021 | 12:15 PM ET

Arrow Next While randomized control trials (RCT) remain the gold standard for evaluating the safety and efficacy of a new treatment, they are not always feasible, and in some cases this may result in the use of a single-arm trial. However, in the absence of a traditional control group, these trials may not produce a satisfactory understanding of the data on their own to move a study forward. To bolster their findings, organizations may pursue the use of a Synthetic Control Arm® (SCA®) to provide scientifically-rigorous, supplementary data in order to guide internal decision making or bolster regulatory conversations.

This session will allow you to hear from industry leaders on their best practices for when they have sought to use external data and what they have learned including:

  • Situations when teams begin evaluating the use of external data.
  • Considerations for selecting a dataset or data vendor for your program
  • Navigating regulatory conversations in studies that used a SCA.
  • Internal applications of SCA findings — including pipeline development, medical engagement activities, and post-launch surveillance.
Ruthanna Davi

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Imi Faghmous

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Live Roundtable

Live Roundtable: Best Practices on Designing Decentralized Clinical Trials October 6, 2021 | 12:15 PM ET

Arrow Next You’ve decided to implement a decentralizing strategy in your next trial design, but where do you begin? And more importantly how do you bring it to scale? The number of Decentralized Clinical Trials (DCTs), also known as hybrid trials, virtual trials, remote trials, and direct-to-patient trials, was already growing prior to the pandemic. But COVID-19 forced many organizations to rapidly accelerate adoption of decentralizing technology, which showed great value to patients, sites and Sponsors.

Join this roundtable to discuss what qualifies as a decentralized trial, best practices around jumpstarting your path to decentralization, how to scale to fit the needs of your protocol, the role of technology in DCTs, and how virtualization benefits all clinical study stakeholders.
michael tucker

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oliver zitoun

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Breakout Session

5 Tips for a Quick Study Build October 6, 2021 | 12:15 PM ET

Arrow Next Clinical trial operators are being challenged to do more with less – less time, less resources, and less budget. As the pressure mounts to get studies up and running as quickly as possible, sponsors and CROs can use these five tips to get their studies built faster.
In this session, you will learn how to:

  • Identify key protocol, workflow and integration requirements early in the process
  • Get a workable study design deployed quickly into an interactive review state and user acceptance testing
  • Standardize study builds to save time in the long run
  • Leverage Medidata technology best practices

These tips will help you decrease build timelines and set you up for long-term success in your study.

Jeff Boehm

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Ian Howson

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Breakout Session

A Real World Example of an Adaptive, Phase III, Multi-Cohort Study Progression October 6, 2021 | 12:15 PM ET

Arrow Next The Medidata Professional Services team leveraged Rave RTSM cohort management to implement an extremely complex double-blinded gastro-intestinal (GI) trial including all possible cohorts based on future interim analyses. This adaptive trial required that the winning dose be blinded from the design from blinded users. With multiple and possibly unknown re-randomization events, the study was built to prevent the need for mid-study changes, delays to enrollment or possible change orders. The end result was a pre-validated, configurable design to efficiently handle the study conduct and was optimized using the Medidata Clinical Cloud platform. A trial of this complexity would have encountered a 4-6 month implementation duration and multiple costly mid-study changes. This RTSM implementation was completed in a much more abbreviated timeline and no mid-study changes/change orders are needed.
In this session, you will learn how to:

  • How to handle complex design considerations
  • How the study team was able to predefine all potential mid-study changes
  • How Medidata’s Professional Services team collaborated with its CRO partner
  • How the study documentation and study design impacted blinded and unblinded users
sheri Lillis

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cindy Lepore

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jess herrera

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Keynote

A Fireside Chat on Defying the Odds: Finding Your Way Back from a Life Interrupted October 6, 2021 | 12:45 PM ET

Arrow Next Suleika Jaouad was given a 35 percent chance of survival after being diagnosed with leukemia at the age of 22. We will hear from Suleika on how she used creative outlets to maximize her quality of life and wrote the Emmy award-winning New York Times column and video series “Life, Interrupted” from her hospital bed at Memorial Sloan Kettering Cancer Center. Once cured, she hit the road on a 15,000 mile trip around the United States, interviewing dozens of strangers about how they created their own roadmap. During this conversation with Alicia Staley, Medidata’s VP of Patient Engagement and fellow cancer survivor, Suleika will share her experiences, lessons learned, and how to navigate living “well” after years of dealing with severe disease. Be prepared to change the way you think about what it means to live your life to the fullest.
Alicia Staley

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Suleika Jaouad

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Wellness Session

Eye Yoga with Koya WebbOctober 6, 2021 | 1:00 PM ET

Arrow NextKoya leads us through her crowd favorite “eye yoga,” which will help us relax and reduce eye strain. Throughout the class, Koya will also guide participants through movements proven to reduce stress and tension from the body. This is the perfect option for those looking to engage a variety of participants in an unassuming way.

Koya Webb

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Wellness Session

Turning Dreams into Reality with Katie McKennaOctober 6, 2021 | 1:00 PM ET

Arrow NextHaving a dream is easy. Finding the courage, perseverance and sticktoitiveness to turn that dream into a reality is the real challenge. In this talk with Katie McKenna, Best Selling Author, Speaker, and Life Coach, she will share her story of surviving being run over by an 18 wheel truck, and how she took what felt like an impossible dream of rebuilding her life, and made it possible. You will leave this talk with insights, examples, and real life tools you can use to actualize your hopes and dreams and create the life you want to live!

Katie Mckenna

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Wellness Session

Essentialism: The Disciplined Pursuit of Less with NY Times Best Selling Author Greg McKeownOctober 6, 2021 | 1:00 PM ET

Arrow NextParticipants learn the value proposition for Essentialism and three practices for applying essentialism. Namely, explore what is essential, eliminate the nonessentials, and execute what matters most as effortlessly as possible.

Greg McKeown

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Keynote

A Virtual Book Club Discussion | Between Two Kingdoms: A Memoir of a Life Interrupted October 6, 2021 | 1:05 PM ET

Arrow Next Join Emmy-winning journalist, author, and cancer survivor, Suleika Jaouad, and Medidata’s SVP of Global Marketing, Wendy Lurrie, for an exclusive conversation and audience Q&A of the NEW YORK TIMES BESTSELLER, “Between Two Kingdoms: A Memoir of a Life Interrupted.” This is a story of survivorship and an inspiring exploration of what it means to reenter the world after being cured.

Please consider supporting your local independent bookstore and purchase the book with them. We are excited to announce that five attendees will receive a signed copy of the book following the discussion.

If you want to ask Suleika a question, learn more about her journey, or you simply are a fan – this is your chance to meet Suleika!
Suleika Jaouad

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Wendy Lurie

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Keynote

Walking the Talk: Patient and Community Engagement Initiatives that Guarantee Diversity in Clinical TrialsOctober 6, 2021 | 1:30 PM ET

Arrow Next Engaging a diverse array of communities across the entire lifecycle of clinical research is arguably unprecedented. Best-in-class sponsors involve a wider range of clinical sites and use innovative technology to enable decentralized clinical trials to reach more patients. But there is one more element that can guarantee diversity in clinical research. We must connect with underserved communities – local leaders, sites and individuals – in authentic, culturally sensitive ways. When we enhance this information exchange and seek feedback, we’re positioned to address the enrollment, drop-out and study satisfaction issues that negatively impact many trials today.

During this session, change agents from AbbVie, Memorial Sloan Kettering Cancer Center and Emerson Clinical Research Institute will share best practices on how to:

  • Transform trial design with resources and tools to mitigate mistrust and end exclusionary practices
  • Reduce patient burden and make it easier for individuals to participate and improve study satisfaction
  • Build sustainable relationships with trustworthy community partners before, during, and after the study
Bryant Fields

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Carol Brown, MD

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Fabian Sandoval

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Christopher Boone

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Breakout Session

AI to Action: Fully Digital Study Planning and Oversight October 6, 2021 | 2:00 PM ET

Arrow Next To date, AI and advanced analytics have lived alongside transactional systems. We believe that to unlock the next wave of value from analytics, they need to be embedded in users workflows, allowing a seamless transition from insight to action to resolution.

In this talk we will share how we can integrate Clinical Trial Management Solution with real time data and advanced analytics. We will cover how the integration works, a look into our forecasting dashboard, and how an integrated approach can drive proactive study planning, risk identification and mitigation, and dynamic reforecasting.
Lisa Moneymaker

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Fareed Melhem

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Breakout Session

The Site’s Perspective: End of Study Process with Technology October 6, 2021 | 2:00 PM ET

Arrow Next The End of Study Media process is usually very complex and time consuming for sponsors and sites. The current approach to the End of Study Media process can be more than a 15 step process. Medidata’s Site Cloud: End of Study has reduced that process to only 3 or 4 steps by eliminating the need to create and distribute physical media and by simplifying paper-based acknowledgment forms. It is all done seamlessly through a secure and trusted unified platform. This technology really takes the burden off the sites.

Join this session to get a product demonstration of the site user experience and see how the technology improves the site’s process and helps to eliminate manual efforts.
Timothy Galvin

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michelle mcbreen

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Breakout Session

Supporting Decentralized Clinical Trials with a Robust RTSM Solution October 6, 2021 | 2:00 PM ET

Arrow Next With the expansion of decentralized clinical trials, the need for Direct-to-Patient (DtP) shipment and facilitating patient dosing at home has become more prevalent. Medidata’s Rave RTSM DtP solution is robust and easy to implement with the flexibility to support direct-to-patient shipping across the entire study or at a site-by-site level. Sites also have the ability to define if study drug will be sourced at the site or shipped directly to the patient for each subject’s dosing visit.

Attend this session to hear a CRO partner, a sponsor, and Medidata discuss how to implement studies using some of Rave RTSM’s newest features and additional process change considerations.

What you will learn in this session:

  • How to improve patient engagement by utilizing DtP
  • How to use the variability of DtP configuration in RTSM
  • Addressing challenges with the implementation of a decentralized trial with DtP
  • Process change considerations when starting DtP
  • How to use re-randomization across cohorts
Stephanie Russell

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tiantian zhao

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Yan Moore

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Breakout Session

The Revolution is Here: Reinventing Clinical Trials with the Sensor Cloud Network October 6, 2021 | 2:00 PM ET

Arrow Next Developing a long-term strategy to support the use of wearable sensors and other digital health devices within clinical trials holds the potential to transform patient engagement while helping to drive more efficient, cost effective trials. At the heart of this effort lies the need to ingest, manage, and analyze massive and unprecedented amounts of data. This challenge motivated Medidata to create the industry’s first collaborative effort focused on developing a set of common standards with the goal of simplifying and expediting digital biomarker development.

Join a panel of cross-industry experts as we address key topics including:

  • Simplifying the integration model and deployment process for digital health technologies through new solutions spanning technologies, content, patient-centricity, guidance, and methodologies
  • Addressing challenges related to the standardization of sensor data and the development of digital biomarker discovery and new digital endpoints
  • Strategies for developing deeper insights and better means of measuring patient data throughout the clinical development process
Ben Schlatka

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Matt Biggs

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Jamie Adams

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Breakout Session

Advancing Cell & Gene Therapies with Robust, Innovative and Flexible Software Solutions October 6, 2021 | 2:00 PM ET

Arrow Next Cell and Gene Therapies (CGTs) address a variety of medical illnesses and conditions that presently have no other treatments (e.g. gene therapies and CAR-T cell approaches to fight many types of cancer). Most CGT challenges relate to scalability and manufacturability. The circular CGT supply chain, with its highly personalized and novel therapies, is complex and variable. It requires strict collaboration among R&D, CMOs/CDMOs and hospitals. Most importantly, CGT treatments are “Live Drugs” incorporating ex vivo, in culture and in vivo therapies.

This talk will cover the critical, end-to-end manufacturing analytics, laboratory informatics, and process performance reporting solutions required to drive innovation, reduce costs and accelerate Cell & Gene Therapies to patients.
Domenico Palumberi

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Brian Andrews

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Live Roundtable

Live Roundtable: Rethinking Minority Participation in Clinical Trials: More Than Mistrust October 6, 2021 | 2:00 PM ET

Arrow Next Bringing diversity to participation in clinical trials is top of mind, but how do we actually get there? And what are the reasons there hasn’t been success improving minority representation? It may not be what you think. Partnering with experts in this area is key to truly finding the answers to these important questions.

Join this roundtable session to discuss these challenges with two experts, Aisha Langford, PHD, MPH from NYU Langone Health and Sheila McGlown, a clinical trial patient and advocate. Aisha has authored several publications around social disadvantage indicators and enhancing shared decision making in clinical trials for minority populations. Sheila is a breast cancer survivor and advocates for the black breast cancer community.

Topics to be discussed will include:

  • Social disadvantage indicators
  • Racial & gender differences in clinical trial patient communication
  • Overcoming patient engagement barriers
  • Considerations for improving outreach to underrepresented populations
TJ sharpe

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aisha Langford

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sheila mcglown

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Breakout Session

TrialSpark: A Game-Changing Approach to a Clinical Trial Platform October 6, 2021 | 2:45 PM ET

Arrow Next The evolving landscape of clinical trials challenges clinical operations teams with increasing workloads yet fewer resources, and these have only been compounded in the wake of the pandemic. There is an acute need for organizations to modernize their business processes to drive more effective trial management. Additionally, as more remote and real-time data review practices are becoming common, the lines between traditional clinical monitoring, central monitoring, and data management are becoming blurred.

TrialSpark, a tech-driven drug development partner, recognized the need to transform their clinical operations in order to speed up their processes and remain agile to increasingly complex client demands.

Join this session to hear first-hand from TrialPpark:

  • Why they chose Rave CTMS + Rave eTMF on the Medidata Clinical Cloud to help them attain operational success and to deliver on their strategic goals, enabling them to increase their efficiency and effectiveness
  • The value of working with a trusted advisor for new technology adoption
  • What they see as the future of risk-based approaches to clinical operations and data management
Sean Lynch

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Breakout Session

A Journey into the Patient Experience with myMedidata October 6, 2021 | 2:45 PM ET

Arrow Next How do you make truly patient-centric clinical trials a reality? For Medidata, we have created myMedidata, a web-based patient portal, that enables virtual participation in clinical trials. Ranging in capabilities from pre-trial engagement with registries, to in-trial engagement with eConsent, eCOA, video visits and sensors, to post-trial engagement, every solution has been designed by patients for patients. Join Michael Tucker, Medidata’s Senior Product Solutions Specialist, as he provides an interactive tour of the patient journey through myMedidata capabilities.

Highlights include:

  • An end-to-end tour of myMedidata from a patient perspective
  • Using myMedidata Registries to simplify and broaden patient interaction pre- and post-trial
  • Key interoperability touchpoints for eConsent, eCOA, Sensor Cloud and myMedidata
Michael

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Live Roundtable

Live Roundtable: A Perfect Data Management Storm? Complex Trial Designs, Exploding Data Volumes, and Accelerated Timelines October 6, 2021 | 2:45 PM ET

Arrow Next The need to accelerate clinical development and deliver new, better therapies to patients faster and more cost-effectively, is driving innovation and complexity in trial designs. Adaptive (umbrella, basket, adaptive, platform, dose-ranging) studies, and programs that combine phases, are becoming more common in the development of treatments in oncology, rare disease, and other therapeutic areas.

What are the implications for clinical data management? In this dynamic, interactive roundtable, data management experts from Everest Clinical Research will lead and moderate the discussion posing questions such as:

  • What should the database design strategy for a combined phase trial look like?
  • How can we accelerate complex trials while maintaining regulatory compliance and data integrity?
  • What do we need to consider when designing data management processes and selecting/implementing technologies for complex studies?
nicola sinclair

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Aisling Wynne

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Keynote

Welcome to the Final Day of NEXT Global: Morning Keynotes October 7, 2021 | 9:00 AM ET

Arrow NextWelcome to the Final Day of NEXT Global: DCT Coffee and Tea with Anthony Costello, Patient Cloud, Dassault Systemes & Rosamund Round, Parexel

Anthony Costello

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Rosamund Round

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Keynote

Finally: From Years to Months! Medidata Drives Innovation in Clinical TrialsOctober 7, 2021 | 9:20 AM ET

Arrow NextThe global pandemic has accelerated innovation in clinical trial execution and has transformed the way data is captured and managed and the manner in which risk is minimized and quality is assured. In this Keynote presentation Tom Doyle, SVP Data Fabric R&D and Lisa Moneymaker, SVP, Clinical Operations Technology, will discuss the exciting evolution of Medidata’s solutions that are changing and enhancing our Partners’ and Sponsor’s experiences with clinical study design, conduct and oversight and our patients’ interactions with clinical trials. This lively discussion will focus on 3 key areas –

1) current Medidata R&D operations and customer success,

2) the future of Medidata products and solutions and

3) the evolution of rapid technology to support clinical trials.

Lisa Moneymaker

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Tom Doyle

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Keynote

Scott Gottlieb Returns to the Stage with Glen de Vries for a Candid Conversation on Impacts of the Changing Industry and Regulatory Landscape October 7, 2021 | 9:40 AM ET

Arrow Next Former Commissioner of the FDA Scott Gottlieb will join Medidata co-founder Glen de Vries to explore how changes in the healthcare industry and its regulation are creating a “Brave New World” for Clinical Development in a discussion that will touch on controversial topics and delve into some unexpected areas.
The FDA remains the gold standard regulatory body; Gottlieb’s knowledge and experience uniquely position him to reflect on how maintaining this position will require the FDA to have greater and earlier global collaboration in a more iterative process, especially in cases of public emergencies. Related questions in the discussion will cover:

How does the world now look at the FDA with respect to approvals?
What are the new parameters for evidence in the regulatory approval process?
Who is making the new therapeutic advances that the FDA needs to consider?
Why growing needs for data collaboration and sharing, and patient-centric approaches such as virtual trials and telemedicine impact the FDA involvement in the process as new trials continue to be on the rise.

Touching on NEXT conference key topics including decentralized clinical trials and data-powered insights, Gottlieb and de Vries will offer their perspectives on:

What we need to do to meet the needs of patients and the future of drug development,
How industry response needs to move from being pandemic-based to season-based,
What needs to be done differently to form a more coordinated and integrated drug development and approval process — upstream and downstream from clinical trials — involving all collaborators including the FDA,
in rounding out what promises to be a highly engaging session for anyone involved in the present and future of Life Science and healthcare.
Glen de Vries

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Scott Gottlieb

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Wellness Session

Breathwork with Stuart SandemanOctober 7, 2021 | 10:00 AM ET

Arrow NextStuart Sandeman, founder of Breathpod and host of BBC Radio 1’s Decompression Session, has helped tens of thousands change their lives through the power of breathing. In this session, he will explain how you can use your breath to turn stress to calm, overwhelm to balance, and distraction to focus. Stuart has worked with award-winning artists, Olympic athletes, top business execs and global brands, so we are excited to have him as part of our Medidata NEXT Global event.

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Wellness Session

Effortless: Make it Easier to Do What Matters Most with NY Times Best Selling Author Greg McKeownOctober 7, 2021 | 10:00 AM ET

Arrow NextHave you been getting results in a way that has left you on the edge of exhaustion? In this session Greg McKeown, author of the New York Times bestseller, Effortless, will share five tools you can use right now to break through to the next level without burning out.

Greg McKeown

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Wellness Session

Anything is Possible with Paralympian, Blake LeeperOctober 7, 2021 | 10:00 AM ET

Arrow NextWe all face challenges and obstacles in pursuit of our personal and business dreams. For most of us, those are day to day frustrations to which we often attribute far more weight than we should. For others, like Blake Leeper, those obstacles include being born without legs. “Why me?!” – most people might lament if faced with such a daunting challenge, but not Blake. Instead, he chooses to take control of his own destiny every day by saying to himself, ‘Why not me? I’m strong enough for this! I’m smart enough for this! I can do this!’ And the boy who was not born to run has turned himself into one of the fastest men in the world. Indeed, Anything is Possible with Paralympian Blake Leeper.

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Breakout Session

Cancer Research UK: Path to Rave EDC and Platform Capabilities October 7, 2021 | 10:30 AM ET

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

Merck Takes a Patient-First Approach to eCOA with Medidata Professional Services October 7, 2021 | 10:30 AM ET

Arrow Next Since early 2019, Merck and Medidata have been relentlessly collaborating to create a patient – and site-first experience for eCOA execution – eliminating wasteful non-value add activities of the past and preparing authentic solutions in modality deployment, site/ patient readiness and usability.

Recently, due to the pandemic, we had to innovate faster to keep patients engaged by:

  • Preparing for successful Bring Your Own Device (BYOD)
  • Integrating the Clinical Event Record solution
  • Simplifying Merck’s approach to instrument design for vaccines.

The work we have done has transformed how clinical sites and patients participate in Merck trials – putting the control back in the hands of the end users and minimizing technology-related challenges, which have haunted the industry from a patient enrolment, safety and efficacy perspective over the past 20 years.
paul taylor

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Prasann Mehta

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Breakout Session

De-risking Trials for Serious Conditions with Synthetic Control Arm® (SCA®) October 7, 2021 10:30 AM ET

Arrow Next While all new drugs require substantial evidence to prove efficacy and safety, it’s an unfortunate reality that in some serious and rare conditions it can be very difficult to generate enough evidence from a fully randomized clinical trial alone. In large part, this is because the existing standard-of-care may be viewed as unappealing and the risk of being selected for a control group may dissuade patients from participating.

The use of external data, such as Synthetic Control Arm® (SCA®), can help overcome these obstacles and represent hope for breakthroughs in regulatory success by providing scientifically rigorous evidence and making it easier to recruit or retain by allowing for more patients to receive the experimental medication within the trial.

Join this session to hear from:

  • Dr. John Sampson, Professor of Surgery, Pathology, Immunology, Radiation Oncology at Duke University Medical Center on the unique challenge of treating patients diagnosed with life-threatening illness and the impact an SCA has on a patient’s decision to enroll in a trial.
  • Dr. Fahar Merchant, President and CEO at Medicenna Therapeutics, Inc on how external data increases the chances of trial success through faster enrollment timelines and lower costs.
  • Dr. Ruthie Davi, Vice President Data Science, Medidata Acorn AI (and former Deputy Director and Statistician at the FDA) on how an SCA can provide scientifically rigorous data and best practices for navigating regulatory conversations


The work we have done has transformed how clinical sites and patients participate in Merck trials – putting the control back in the hands of the end users and minimizing technology-related challenges, which have haunted the industry from a patient enrolment, safety and efficacy perspective over the past 20 years.
John Sampson

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Fahar Merchant

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Ruthanna Davi

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Live Roundtable

Live Roundtable: From Sensors to Insights: Transforming Clinical Research with Connected Device Data October 7, 2021 | 10:30 AM ET

Arrow Next While wearable sensors and other connected health devices have been in the market for a number of years, our industry has been slow to adopt new technologies driven mainly by concerns over patient data security and privacy. As these issues are addressed, many sponsors and CROs are now faced with developing a sensor strategy in support of more flexible, patient-centric trials. Identifying the right sensors in support of hybrid or decentralized trials is only the beginning. Distilling meaningful clinical insights from massive amounts of data requires a dynamic approach to data ingestion and analysis that will ultimately have the desired impact on the development of new digital endpoints.

Join Medidata’s Ben Schlatka, VP Digital Biomarker Solutions, and University of Arizona’s Dr. Marvin Slepian, as they discuss the state of digital health technologies and best practices for data ingestion and analysis in a rapidly expanding environment.
Ben Schlatka

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Marvin Slepian

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Lightning Talk

Lightning Talk: How the Customer Success Program Supports Customers During Clinical Trials October 7, 2021 | 11:00 AM ET & 12:30 PM ET

Arrow Next We understand that clinical trials are complex and can be impacted by higher study costs and delays if execution isn’t seamless. That’s why Medidata provides Customer Success for ongoing support to enable product adoption and maximize your long-term success. This lightning talk shares how our Customer Success team:

  • provides best practices and enablement of products to ensure the most efficient and effective use of your tools
  • provides comprehensive monitoring to proactively identify potential risks or delays to execution
  • collects and synthesizes process and product feedback to put a megaphone behind your voice.


We’re excited to be offering this service to better serve you, and are looking forward to introducing you to Medidata’s Customer Success team!
Jeff Ventimiglia

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Lightning Talk

Lightning Talk: Ensuring Medical Device Accountability with Changing Regulations October 7, 2021 | 11:00 AM ET & 12:30 PM ET

Arrow Next Globalization adds a new aspect to medical device trials with many sponsors/manufacturers conducting trials in multiple countries. Staying current on regulations and understanding regional differences are critical to running a successful medical device trial. Join our lightning talk to understand changes in this area and how flexible technology solutions can help ensure that device trials are executed compliantly and effectively.
meena Kaushik

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Lightning Talk

Lightning Talk: Automate Safety Data Transmission with Precision and Speed: What’s New in Rave Safety Gateway October 7, 2021 | 11:00 AM ET & 12:30 PM ET

Arrow Next Rave Safety Gateway helps Sponsors and CROs automate and accelerate the precise transmission of adverse events from Rave EDC to their safety system.

In this lightning talk, Medidata will give a brief overview of the recent updates to Safety Gateway that includes further enhancing its interoperability with safety systems. This helps sponsors report safety issues faster and reduces the burden of safety reporting on the clinical trial sites.
brian induni

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Breakout Session

Bringing It All Together: Unifying Data for Improved Study Conduct Decision-Making October 7, 2021 | 11:15 AM ET

Arrow Next Protocol requirements often involve multiple data points from different data sources to determine screening criteria and calculate endpoint measurements. Multiple methods of data collection from sources like EDC, RTSM, eCOA and Imaging increase data silos making it harder for site staff and study teams to access clean, reliable data reducing the ability to make effective decisions.

This session will use typical protocol requirements and illustrate the value of using a unified platform to collect and aggregate data to drive key study conduct decisions such as screening, open-label extensions, and cycle decisions.

During the session you will learn:

  • The challenges associated with protocol requirements that need data collected from multiple siloed sources
  • How unifying data accelerates and improves the quality of study conduct decision-making
  • Additional benefits of unifying data capture and management on a single platform
Christopher Burke

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Therese Dolan

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Breakout Session

Implementing Video Visits During Consent to Enhance Patient Engagement October 7, 2021 | 11:15 AM ET

Arrow Next From learning about a clinical trial to consenting and participating, many hours of education and care are spent between patients and their study teams. By replacing non-essential traditional site visits with virtual video visits, sites and patients receive valuable time back in their lives. Additionally, leveraging the option of impromptu video visits, a patient and study team can connect in near real-time when there is a need for an immediate visit. In this session, see how easily study staff can replace a scheduled site visit with a virtual one to engage a patient before consenting, during trial participation, and after the trial ends.
matt noble

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Dan Braga

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Breakout Session

Transforming The Patient Experience with myMedidata Registries and Circuit Clinical October 7, 2021 | 11:15 AM ET

Arrow Next The traditional model of recruiting and retaining patients study by study in a transactional nature isn’t working. Patients are more than the data they provide to a study and are looking to be engaged in novel and everlasting ways.

In this session, Kelly McKee, Medidata’s VP of Patient Registries and Recruitment, speaks with Irfan Khan, MD, CEO of Circuit Clinical about our new partnership and expanded patient-centered offerings pre-trial, in-trial, and post-trial. Kelly and Irfan will explore topics such as improving awareness, access, and diversity in clinical trials, reducing screen fail rates, measuring patient satisfaction, gathering insights, and providing additional opportunities for participation.
kelly mckee

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Irfan Khan

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Breakout Session

How to Navigate EU-US Data Flows for Global Clinical Trials October 7, 2021 | 11:15 AM ET

Arrow Next After nearly a decade in service, the EU Commission’s Standard Contractual Clauses for exporting personal data from Europe have been replaced. This replacement comes in the wake of the Schrems II decision by the Court of Justice of the European Union, which invalidated the Privacy Shield framework and placed increased importance on the new Clauses. Putting the new Standard Contractual Clauses in place, however, is not just a matter of having your lawyers sign some papers — The EU courts and regulators have both set requirements for personal data importers and exporters to understand and mitigate the risks associated with transferring data about Europeans around the world.

This session will demonstrate how to approach the required “transfer risk assessment” that accompanies the new Clauses, and gives practical insights for how to ensure a global clinical trial can include sites in Europe while staying in compliance with the GDPR.

anthony ford

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Elaine Morrissey

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Live Roundtable

Live Roundtable: Synthetic Control Arms® – Smarter, Faster, Cheaper Clinical Trials October 7, 2021 | 11:15 AM ET

Arrow Next With drawn-out timelines and billions in investments, traditional clinical trial methods are increasingly a barrier to cost-efficient and timely drug development. Synthetic data is addressing this head-on by harnessing historical clinical trial & real world data to create simulation scenarios and optimize protocol design. We will discuss what Accenture is seeing in the market and some of the unique challenges they are helping their clients with.
Joe Donahue

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sanjay Jaiswal

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Breakout Session

Ask an Expert with Accenture: Synthetic Control Arms – Ambition to ActionOctober 7, 2021 | 11:40 AM ET

Arrow NextSanjay Jaiswal, R&D Data Science & Cloud Driven Analytics, Accenture will spend time walking through what it takes to start planning for and building synthetic control arms and field the audience’s specific questions.

sanjay Jaiswal

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Breakout Session

Chimerix: Building, Populating, and SDV’ing a Rave EDC Study in 10 Weeks October 7, 2021 | 12:00 PM ET

Arrow Next Following Chimerix’s acquisition of Oncoceutics, they wanted to put an interesting compound on the path to an NDA (New Drug Application). This compound had been running as an Investigator-Initiated Trial (IIT) but was now being considered a Sponsor registrational study.

This decision was communicated to Chimerix at short notice, and they explored various options before deciding to reimplement and repopulate the database in Rave EDC, mirroring the structure and data from the site’s InForm database, so that it met the statistical programming requirements that were already in place.

Join this session to find out how Chimerix completed all of this in just 10 weeks to keep the compound on the path to regulatory submission.

In this case study session, Reyes and Agbessi will share:

  • The background and requirements for the new Rave EDC study build
  • Challenges they faced during the 4-week study build
  • How they entered and verified the source data in 6 weeks
  • The results and lessons learned
Reyes Osuna

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Agbessi Gblokpor

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Breakout Session

Data Saves Lives: The Promise of Clinical Trials Linked with Real World Data October 7, 2021 | 12:00 PM ET

Arrow Next As both the COVID pandemic and rapid advances in personalized medicine have demonstrated, there is a pressing need for a comprehensive, longitudinal view of the patients’ health journey. The linking of Clinical Trial (CT) and Real World Data (RWD) to create “Longitudinal patient Data (LPD)” is valuable to patients, investigators and sponsors – enabling a better understanding of longer term outcomes and efficacy while reducing patient and site burdens. Implementing data linkage in clinical trials requires a centralized, secure infrastructure, as well as buy-in from the most important stakeholders – patients. This session will explore the value proposition, patient perspective, and the legal and ethical consent basis for LPD.
Andrew Kopelman

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Akiko Shimamura

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Alicia Staley

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Breakout Session

Better Transparency for Collaborative Site Negotiations October 7, 2021 | 12:00 PM ET

Arrow Next The complexity of budgeting for the investigator grant and negotiating site budgets process is greatly underestimated. This critical part of the study start up process can be disconnected and disjointed when there is a lack of benchmarking data for budget creation. In this session, you will hear the site’s point of view of the budget planning and negotiation process. The panel will include an expert site representative with years of experience managing clinical trial budgets for sites, along with Medidata’s Grants Manager subject matter experts on all aspects of study budget planning and site budget negotiations.

Topics to be covered include:

  • Study budget planning using a centralized benchmark database
  • The budget negotiations experience at the site
  • Ways to make the process more collaborative
Shelley Douros

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brenda medina

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Dawn Pittinger

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Breakout Session

Reimagining the eCOA Study Experience for Patients, Sites, and Sponsors October 7, 2021 | 12:00 PM ET

Arrow Next Creating an intuitive and enjoyable experience for patients engaging with clinical research is essential for the success of any study. Sites and sponsors are also looking for scalable, centralized tools for collecting patient data. It is these motivations that inspired Medidata’s Patient Cloud team to create the next generation patient-facing experience with myMedidata eCOA. In this session, Medidata’s Paul O’Donohoe, Senior Director eCOA Product and Science, will provide a detailed overview of the new features and functionality within myMedidata eCOA that includes:

  • Delivering a better patient experience through an enhanced, proven questionnaire design
  • Creating faster, high quality study builds through Medidata Designer
  • Leveraging the power of Medidata’s industry leading global library to accelerate timelines
  • Enabling a flexible yet consistent patient experience across all Patient Cloud products
paul odonohoe

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Breakout Session

Defending the Realm: Conducting Trials in the Center of a Cyber War October 7, 2021 | 12:00 PM ET

Arrow Next 2020 saw the beginning of a once in a century global pandemic, heightened geopolitical tensions, and an exponential increase in cyber crime and attacks. These events tested the limits of our modern security infrastructure from small business, to large global corporations, and even our most trusted government entities.

In this session, we will review what happened last year from a cyber security perspective, how Medidata was able to deliver COVID-19 studies – safely and securely – in those trying times, and how we should adapt to the emerging threats this year and beyond.
Scott Sumner

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Breakout Session

LGBTQ+ Challenges in Clinical Trials and the Data Management Effects October 7, 2021 | 12:00 PM ET

Arrow Next As diversity in clinical trials is explored more and more, the LGBTQ+ patient community’s perspective is a necessary consideration for clinical trials and data collection. During this fireside chat, we will focus on:

  • LGBTQ+ Patient Provider Trust – what are the issues/gaps?
  • Challenges faced as a patient and advocate
  • Challenges that translate into data issues
  • Real life LGBTQ+ patient experience stories
Justus Harris

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Johnny Perez

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TJ sharpe

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Breakout Session

DCT Data Maps – Perspectives on Navigating the DCT Data Landscape with ACRO October 7, 2021 | 12:45 PM ET

Arrow Next The industry demand for decentralized clinical trials has left a gap for regulators, sponsors, and CROs in understanding how to get from traditional site based trials to fully decentralized clinical trials, and the world of hybridization in between. The Association of Clinical Research Organizations (ACRO) has taken a risk-based quality-by-design approach to developing a sustainable model for conducting decentralized clinical trials. The DCT Working Party, chaired by Medidata’s Fiona Maini and overseen by ACRO’s Karen Noonan, has worked collaboratively across all ACRO organizations to develop documentation which represents best practices across the industry. This session will cover an overview of the Working Party progress, a brief review of the materials available to sponsors, study teams, CROs and regulators, and provide keen insight from representatives of the Working Party on the collaborative effort and “What’s Next” for the DCT Working Party.

michael tucker

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fiona Maini

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ada wowk

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karen noonan

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Helen Howitt

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Breakout Session

Pfizer: Representativeness in Rare Disease Clinical Development October 7, 2021 | 12:45 PM ET

Arrow Next Though rare diseases are known to affect only a few people within one disease, collectively, 1 in 20 people will live with a rare disease at some point in their lives. Affecting 400+ million people worldwide, over 7,000 rare diseases have been identified in the U.S. alone. Only 500 therapies have been approved. In November 2020, the FDA recognized that designing clinical trials for rare diseases presents unique challenges above and beyond what we know in clinical development and that we must apply special efforts to enroll and retain participants to ensure that a diverse spectrum of the patient population is represented. In this session, Pfizer’s Katherine Beaverson and Medidata’s Sheila Diamond will:

  • Highlight awareness around increasing diversity and representativeness (i.e., patient input) in rare disease clinical trials
  • Distinguish between rare diseases to address challenges when examining diversity across patient sub-populations
  • Highlight challenges in clinical development and psychosocial components of the rare disease population
  • Discuss how we can apply lessons learned from the pandemic to rare disease drug development
  • Discuss access issues and highlight working with patient communities to drive disease awareness campaigns
Katherine Beaversoon

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Sheila Diamond

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Breakout Session

Hear From the FDA: Conducting Clinical Trials in the Pandemic October 7, 2021 | 12:45 PM ET

Arrow Next The US FDA and other regulatory authorities have offered pragmatic flexibilities in order to accelerate COVID-19 research and to keep other clinical trials moving during the pandemic.

In this session, an FDA expert will provide insights on the evolution of the FDA’s Guidance: “Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency.” We will also survey several adaptations discussed in the guidance with an eye towards the future.
John Concato

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Phil Coran

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Breakout Session

Praxis Precision Medicines and eClinical Solutions: Maximizing the Value of Rave EDC with a Portfolio Approach October 7, 2021 | 12:45 PM ET

Arrow Next Clinical research teams have seen an exponential increase in data types, volumes, and vendors as digital initiatives, external data sources, and decentralization expand throughout every trial. In fact, recent data from the Tufts Data Strategies & Transformation Study showed that database lock times have increased an average of five days in the last three years as a result of managing larger numbers of data sources.

To overcome these challenges and reduce database lock times, clinical teams are taking a portfolio approach to their studies, utilizing advanced technologies with Rave EDC for data access, transformation and analysis.

In this session, hear how Praxis Precision Medicines, a clinical-stage biopharmaceutical company, is using this collaborative portfolio approach with its CRO, eClinical Solutions, and Medidata. In this interactive panel, you will learn the:

  • Benefits of a portfolio approach to data management and the components involved
  • Ways to increase data access, standardization and control
  • Efficiencies gained from reuse of global libraries and standards – especially during start-up
  • Measurable results Praxis Precision Medicines and eClinical Solutions have seen with this approach

Join this session to help your organization grow and scale as you manage an increasingly complex clinical data environment.
Maria Mushaben

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Brian Sahl

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Michael Barrera

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Diane Lacroix

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Keynote

Designing a Trial for Everyone: Moderna’s Real-time Approach to Achieving Diversity Representation and NEXT Closing RemarksOctober 7, 2021 | 1:15 PM ET

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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