Innovations and solutions for your trials and beyond.

Road to NEXT 2021


Welcome to Road to NEXT 2021!

A Medidata complimentary virtual event series, Road to NEXT 2021 is where Life Sciences professionals gather to discover and discuss the latest developments in digital transformation for clinical trials and drug development.

Designed to help us solve the impossible together, curated sessions from NEXT Global and new content are delivered over a few weeks across six-themed workstreams — Unified Platform, Trial Management, Virtualized Solutions, Data and Advanced Analytics, Medical Device, and Biovia Laboratory Informatics.

Register once, then build your own agenda across one or all workstreams.

We look forward to sharing with you what’s NEXT for you, your organization, and our industry.

Day-by-Day Event Agendas

Unified Medidata Platform

Create the scale and efficiency you need to run your trials quickly and successfully. Addressing the holistic clinical research process from start to finish, the Medidata Clinical Cloud helps life sciences organizations cut costs, mitigate risks, and deliver treatments and devices to market faster.

11:00 AM EDT

Creating a 360 View of the Patient with Data Unification

There has been a great deal of focus on how to make clinical trials more patient-centric, from trial virtualization, to patient education and engagement resources, to more patient friendly ePRO applications. What isn't discussed all that much is the data integration and advanced analytic capabilities on the back end that can enable clinical teams to support and monitor patients throughout their clinical trial journey. In this session, we will discuss and show how Medidata’s unified platform can empower clinical teams to put the patient at the center of the trial. We will show how data is collected directly from the patient through a wearable sensor or smartphone, and flows directly into Medidata’s unified platform. From there, we will discuss how that data is standardized, mapped, and analyzed to alert clinical team members of potential patient problems in near real time.

Gary Luck - Senior Director, Data Platform, Medidata

Marissa Ballesteros - Senior Director, Clinical Data Strategy, Medidata
11:30 AM EDT

Delivering a Superior Patient and Site Experience on a Unified Platform

Patient recruitment and retention in clinical research is challenging - especially in ultra-rare orphan diseases with a limited number of patients and several competing trials. Rezolute took a creative approach to this problem, working to be the sponsor of choice for sites treating patients with Congenital Hyperinsulinism (HI) - an ultra-rare pediatric genetic disorder. Key to this strategy was using Medidata’s unified platform - known as the Medidata Clinical Cloud - to create a seamless and easy experience for patients and sites from launch to completion. As part of this session, you will learn how Rezolute leveraged the Medidata Clinical Cloud to:

  • Create a best-in-class site and patient experience
  • Facilitate a quick and easy payment process
  • Provide a single system for data entry, supply management, and patient monitoring
  • Deploy an easy-to-use patient eDiary that collected meaningful real time data
  • Quickly incorporate and deploy protocol changes, based on regulatory feedback and patient reported outcomes
  • Gain efficiencies from implementing a single platform vs. managing multiple vendors
  • Secure full visibility and control over their clinical trial data to monitor access in real time
Erin O'Boyle - Head of Clinical Operations, Rezolute
12:00 PM EDT

Case Study: Operationalizing eCOA Platforms - Benefits and Lessons Learned

As clinical trials have increased in complexity, with ever greater amounts of data from disparate sources driving endpoints, the value of centralised management systems cannot be understated. This talk will explore the experience of Merck in moving to a platform-based eCOA system, fully integrated into the study EDC. The benefits and lessons learned will be discussed, as well as the future trends of trials in a world where data will become increasingly easy to capture.

Robert Schneck - Associate Director, Clinical Data Management, Merck

Paul O'Donohoe - Scientific Lead, eCOA and Mobile Health, Medidata
12:30 PM EDT

Clinical Trials in a Post Covid-19 World

Join a fireside chat with Katrina Rice, Chief Delivery Officer, Data Services at eClinical Solutions and Ted Kirby, Senior Director, Product Marketing at Medidata Solutions as they discuss the impact of COVID-19 on clinical trials and the industry's anticipated return to a 'new normal' post COVID-19 in the coming year.
As part of the session, Katrina and Ted will discuss:

  • Incorporation of more virtual solutions for patients, sites, and study teams
  • Advances in artificial intelligence and machine learning to help manage clinical data
  • How to handle increasingly complex clinical trial protocols
Katrina Rice - Chief Delivery Officer, Data Services, eClinical Solutions

Ted Kirby - Senior Director, Product Marketing, Medidata

Trial Management

Transform how your clinical trials are managed through an efficient, streamlined solution for operations. Learn how to leverage machine learning, and advanced analytics capabilities to reduce time-intensive manual review, streamline oversight, enhance collaboration, and accelerate study execution.

11:00 AM EDT

Achieving Remote Monitoring Demands through Rapid Innovation

At Medidata, we believe that a holistic, risk-based, system-supported approach to trial design and execution is at the forefront of the way clinical trials will be conducted. To accomplish that mission we are excited to introduce new capabilities to support cross-functional risk management and an end-to-end remote motoring strategy with Medidata’s new Risk Management, Remote Source Review (RSR), and TSDV solutions. Hear first-hand from customers who are using this holistic approach to minimize risk and optimize their site monitoring.
During this interactive session, participants will learn about:

  • Medidata’s new Risk Management solution that supports cross-functional risk management activities
  • Using Risk Management to provide a framework to support an end to end remote monitoring strategy
  • Medidata’s new RSR solution that seamlessly, enables the collection, de-identification, management, and review of critical study documents
  • Combining Risk Management, TSDV, and RSR to focus efforts to allow you to identify and mitigate risks early resulting in more efficient onsite and remote monitoring activities
Louis Minham- Senior Director, IT, CTI Clinical Trial and Consulting Services

Lisa Moneymaker - Vice President of Clinical Operations Technology, Medidata
11:30 AM EDT

RBQM & Clinical Transformation: Supporting Trial Optimization During COVID-19 and Beyond

As the COVID-19 pandemic continues, optimized clinical trial operations has been a key differentiator for trial continuity. 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 to address the fundamental maturity of their processes. Learn how Medidata and partner Syneos Health are driving technology in the support of trial execution, enabling companies in what we believe is the unfolding of the future of clinical operations, allowing the realization of both optimized trial design, early risk and issue detection, and an improved relationship with the site, on a scale never before seen in clinical trials.

Nicole Stansbury - Vice President, Global Centralized Monitoring, Syneos Health
Lisa Moneymaker - Vice President of Clinical Operations Technology, Medidata
12:00 PM EDT

Detect the Unknown: From Lab Data to Sensor Data

Over a decade, there has been an 88% increase in the overall volume of patient data collected within clinical trials*. With this increase in data volume and types, comes the challenges of silos of data sources, manual data review processes, and non-integrated technology. All further emphasizing the risk of missing critical data errors, anomalies, and trends, and the need for automated data review and for better access to real-time data visibility across stakeholders.
During this interactive session, participants will learn more about:

  • Value of centralized and automated data quality review
  • Importance of enhanced centralized monitoring with data-driven site issue identification
  • Strategies to ingest massive data sets such as lab data and sensor data
  • Demonstrate how Medidata Detect uses advanced analytics to detect both known and unknown KRI, anomalies and trends across any data set
  • The automated flow of issue management information with a closed-loop process for issue identification and action

*Tufts Center for the Study of Drug Development (CSDD)

Lindsey Sarno - Senior Solution Consultant, Medidata

Jess Dolfi - Director, Product Management, Medidata

12:30 PM EDT

Accelerating Clinical Decision-Making with a Scalable, Data-Driven CTMS

The current landscape of clinical trials challenges clinical operations teams with increasing workloads but fewer resources. In this presentation, Catalyst Clinical Research discusses:

  • The challenges their team experienced with complex early phase oncology studies
  • Why they chose Rave CTMS + RaveTMF on the Medidata Rave Clinical Cloud to help them attain operational success and to deliver on their strategic goals, enabling them to increase their efficiency and effectiveness

Keya Watkins - Global Head, Clinical Development, Catalyst Clinical Research
Martin Dowdall - Vice President, Product Management (CTMS), Medidata

Virtual & Decentralized Trials

Virtualize elements of your trial including patient participation, monitoring activities, and direct to patient supply management. Learn about Medidata’s newest product offerings and how they benefit both the patient and your studies

11:00 AM EDT

Enabling Virtualizing Solutions Technologies Through a Single Destination Patient Portal

The Industry has begun to incorporate patient engagement point solutions into clinical studies, yet none have been widely adopted. Multiple point solutions can be used across each study - typically provided by varying vendors. By utilizing a unified platform approach, the need for integrating disparate solutions and reconciliation of data is reduced. The number of vendors required to provide virtualisation and/or patient engagement offerings is also minimized, streamlining the operations and reducing the costs of setting up and maintaining multiple systems. In this session, learn how multiple virtualizing technologies such as video visits, eCOA or eConsent can all be used through a single platform to enhance both the site and patient experience.

Anthony Costello - SVP, President, Patient Cloud, Medidata

11:30 AM EDT

Improving Access to Clinical Trials Through Patient Registries

Patient recruitment is often the rate limiting step in bringing new therapies to market. Creating an educated and empowered community of patients prepared to participate in clinical research will dramatically transform the way participants are recruited and engaged in clinical research. In this session, learn how patient registries improve patient access while optimizing experiences in clinical trials and hear first-hand from a patient advocate about their experience using registries.

Kelly McKee - Senior Director, Patient Registries and Recruitment, Medidata
12:00 PM EDT

COVID-19 and the Critical Need for Virtual Monitoring

Collecting and reviewing clinical trial data is complex and this has become even more so during the COVID-19 pandemic. Siloed data sources, manual processes, non-integrated technology, and 100% source data verification and review strategies have inhibited the collection and review of patient data, resulting in a reduced flow of critical clinical trial data, thus, risking overall trial success. During this session, we will explore how remote monitoring innovations are addressing the impact of COVID-19 and reducing clinical trial risk. Participants will learn about:

  • Minimizing data review challenges arising as shelter in place guidelines are relaxed with limited onsite capacity and increased demand for onsite monitoring visits
  • Critical virtual monitoring strategies including central statistical monitoring, central data monitoring, and remote source review
  • Leveraging next-generation analytical tools and algorithms to support virtual monitoring and maintain oversight
  • Where to begin to implement a holistic remote monitoring approach
Brian Barnes - Director, Product Management, Medidata

12:30 PM EDT

The Evolution of Trial Management and its Impact on Clinical Supplies

The state of clinical supplies is changing rapidly as we see trials moving towards virtualization. Providing clinical supplies directly to the patient’s home plays a huge role in virtualization but adds complexity to management of those supplies. We will explore the impact on logistics and strategies to manage the challenges that face sponsors, sites, depots, CROs and particularly patients on this webinar. Whether you are currently supporting virtualized trials or are exploring virtualization models, clinical supply managers and trial clinical study teams will learn how to adapt to this evolving paradigm shift.

Amanda Nite - Director, Product Management, Medidata
1:00 PM EDT

From Sensors to Insights: Transforming Clinical Research with Connected Device Data

While wearable sensors and other connected health devices have been in the market for a number of years, pharma 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 CRO's 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 virtual trials is only the beginning. The ability to distill 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.

Ben Schlatka - VP, Digital Biomarker Solutions, Medidata

Data & Advanced Analytics

Deliver actionable insights and accelerate clinical development by combining high-quality liquid data, technology, and expertise.

11:00 AM EDT

Optimize Clinical Operations End-to-End Through Real-Time Industry Data and AI

In this session, we will discuss how our data & analytics - built on the largest and most real-time cross-industry data - provides our customers with the agility and confidence in trial planning, site selection, and enrollment decisions; visibility into trial performance vs. the industry to avoid costly trial slow-downs; and an edge in new and competitive indications.
Specifically, we will dive into how we use data and analytics to:

  • Provide competitive landscape analytics to improve study planning
  • Identify and rank countries and sites to accelerate enrollment
  • Forecast enrollment to confidently plan your study and key milestones
  • Gain live study and industry insights to diagnose issues earlier and pivot
  • Re-forecast enrollment based on actual performance and changing industry conditions
  • Gain a cockpit view into your portfolio of trials for visibility into trials that require attention
Jef Benbanaste - Product Lead, Acorn AI Intelligent Trials, Medidata
11:30 AM EDT

Potential of Synthetic Controls In Clinical Research

Today’s clinical trials have become increasingly more complex, including difficulties in recruiting patients, ever rising costs and the heightened risk of failure. Sponsors are seeking ways to improve the probability of success while gaining efficiencies in the clinical development process. A synthetic control is the use of historical clinical trial data to replace or augment a control arm in a randomized clinical trial. It can make the trial more attractive to patients since prospective patients will have a higher chance of being assigned to the investigational therapy rather than to a possibly unacceptable standard of care. This novel approach can be used to enhance scientific decision making in clinical research. Armed with the insights gained from a Synthetic Control Arm, clinical development leaders are able to make better and more informed, evidence-based decisions around clinical trial design. This session will cover the following topics: Benefits of a Synthetic Control ArmⓇ for internal decision making Discussion of potential use cases for Synthetic Control ArmsⓇ Review key considerations and best practices when incorporating Synthetic Control Arms into your clinical trials

  • Benefits of a Synthetic Control ArmⓇ for internal decision-making
  • Discussion of potential use cases for Synthetic Control Arms®
  • Review key considerations and best practices when incorporating
  • Synthetic Control Arms into your clinical trials
Darshan Dalal - Global Clinical Program Leader, at Advanced Accelerator Applications, a Novartis Company
Arnaub Chatterjee - SVP, Acorn AI Product & Ecosystem, Medidata

12:00 PM EDT

Regulatory Success with External Control Groups — How to leverage Historical Clinical Data for better outcomes

As standards of care rapidly evolve and the availability of a new perceived superior therapy, adequately recruiting patients that meet the specific selection criteria and/ or retaining control arm patients can be challenging — making it difficult to address the research objective and often slowing or stopping product development. External control groups, built upon historical clinical trial data, can mitigate these challenges by augmenting or replacing a control arm in a randomized clinical trial. This novel approach has not only been successfully used to enhance scientific decision making in early phase clinical research, but is also starting to be used in regulatory settings for some indications. Attend this session to hear how real customers have leveraged historical clinical trial data to enhance clinical development decision making and aid regulatory conversations.

Ruthie Davi - Vice President, Data Science, Medidata

Bryant Fields - Senior Director, Integrated Evidence Commercial Lead, Medidata
12:30 PM EDT

Data Saves Lives

Access to health data has enormous potential to improve patient health and save lives. This potential faces many challenges and risks. From a global perspective, these include lack of patient awareness and understanding, complex legal requirements (such as the GDPR), divergent views on data ownership, and sovereign cloud and other localization initiatives or requirements. Join Andrew Kopelman (Chief Privacy Counsel, Medidata), Anne Bahr (R&D Privacy Officer, Sanofi) and Lee Parker (Director, Data Privacy EU+, Biogen) as we explore these issues, with a focus on global clinical trials.

Anne Bahr - R&D Privacy Officer, Sanofi

Lee Parker - Director, Data Privacy EU+, Biogen

Andrew Kopelman - Chief Privacy Counsel, Medidata

Medical Device

Optimize your approach to clinical trials with fit for purpose applications designed specifically for the Medical Device industry.

11:00 AM EDT

The Critical Need for Remote Monitoring for Medical Device Clinical Development

Remote site monitoring is no longer a “nice-to-have.” Continued success in clinical trial operations now requires a dedicated remote site access and monitoring strategy. Imagine reducing the need for on-site document review, while reviewing documents faster, mitigating risk AND reducing site burden. Join experts for a discussion on the challenges and benefits of implementing a remote monitoring strategy for medical device clinical development and how Medidata can help. In this session you will learn:

  • How to ensure overall patient safety and trial integrity with a move to remote monitoring
  • How to manage and review critical documents throughout the trial remotely
  • How to successfully implement a remote monitoring strategy
Andrew Hiar, MPH - Vice President, Clinical Affairs, Cepheid

Brian Barnes - Director, Product Management, Medidata
11:30 AM EDT

The Drive to Be Patient Centric with eConsent: A Medical Device Case Study

A global medical device manufacturer, Boston Scientific, dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world chose to implement eConsent. The company’s core philosophies about the criticality of patient-centricity in study design and conduct were closely aligned with Medidata’s own core tenets of driving patient-focused innovation through transformative technology. Key leadership at Boston Scientific stressed that their core focus for implementing eConsent on their studies was patient driven. If patients could be provided with a better understanding of the purpose, risks and benefits of the study and understand their rights and responsibilities from the very beginning, then the sponsor felt that they were supporting their ethical responsibility to the patient, resulting in better science in the end. Their secondary focus was to recognize operational efficiencies which would be derived in centralized monitoring, reconsenting, and enrollment reporting. This session will cover: How eConsent drives patient-centered outcomes and operational excellence. Key benefits of eConsent which have been identified through multiple sponsors and multiple studies. Real-world case study of implementation with Boston Scientific on medical device research studies.

Shari Swanson - Principal Business Analyst, Boston Scientific

Michael Tucker - Senior Product Solutions Specialist, Medidata
12:00 PM EDT

Introducing Medidata Adjudicate

Medidata Adjudicate is a full end to end Endpoint Adjudication management solution for sponsors and CROs. Endpoint adjudication is a critical function on clinical trials where safety or efficacy endpoint assessments are complex or multi-faceted. For these assessments, data is collected, collated and presented to an Adjudication Committee for standardized review and assessment.
Medidata Adjudicate is a streamlined, configurable, web based solution for all users including sites, sponsors, CROs and adjudication committee members. It allows for full end to end management and oversight of all adjudication activities and ensures the right data is being presented to the right user at the right time.
In this session we will cover:

  • What is Medidata Adjudicate
  • Use cases supported by Medidata Adjudicate for Med Device trials
  • The benefits of Medidata Adjudicate for sponsors, trial managers, trial coordinators and committee members
Andrea Falkoff - Director, Product Management, Rave Imaging, Medidata

12:30 PM EDT

Accelerating Clinical Decision Making with a Scalable, Data-Driven CTMS

The current landscape of clinical trials challenges clinical operations teams with increasing workloads but fewer resources. In this presentation, Catalyst Clinical Research discusses: The challenges their team experienced with complex early phase oncology studies Why they chose Rave CTMS + RaveTMF 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.

Keya Watkins - Global Head, Clinical Development, Catalyst Clinical Research
Martin Dowdall - VP, Product Management (CTMS), Medidata

Laboratory Informatics

Learn how labs are innovating by increasing productivity, reducing costs and accelerating product development. BIOVIA solutions support these capabilities end-to-end across research, development and QA for customers in life sciences.

11:00 AM EDT

Digitalizing Next-Generation Labs in the Cloud

Lab digitalization is advancing quicker than ever. The next-generation lab requires support for remote work, easier collaboration among scientists and standardized data and procedures to help ensure quality. See how to accelerate product design and development, while also saving time and costs with cloud-based solutions.

Stephen Hayward - Technical Product Marketing

Michael Millonig - Solution Consultant
11:30 AM EDT

Successes for Unified Lab

Learn about successful deployments of unifying lab informatics solutions—the results and the challenges resolved by transforming lab processes. Digitalizing lab processes and connecting analytical and process workflows end-to-end are essential capabilities for any drug discovery operation. In this presentation, we will discuss customer challenges and describe the journey that led to the development of BIOVIA’s new Unified Lab solution.

She Yen Lok - Senior Solution Consultant

Laurent Rebion - Global Solution Consulting Director
12:00 PM EDT

Next Steps for Your Lab

This session explains how you will be able to maximize productivity and innovation within your lab by deploying the soon-to-be-released, cloud-based electronic lab notebook, BIOVIA Scientific Notebook. Get an advance look at the features and workflows we are implementing in this next-generation ELN on the 3DEXPERIENCE platform.

Kirsten Gesenberg - Portfolio Director

Dennis Curran - Portfolio Director
12:30 PM EDT

Lab to Manufacturing

BIOVIA has optimized its life sciences lab informatics solutions to simplify the movement of lab processes, end-to-end, from the lab to manufacturing. Small and large biopharmas and biotechs are realizing the value of streamlining this tech transfer process, while also leveraging the capabilities of BIOVIA’s manufacturing analytics solution. See how both solutions can accelerate your products to market.

She Yen Lok - Senior Solution Consultant

Dennis Curran - Portfolio Director