Road to NEXT 2021 - North America
Need Technical Assistance?
roadtonext21-na@getvfairs.io
Time: 11:00 a.m. to 5:00 p.m EST
Road to NEXT 2021
Innovations and solutions for your trials and beyond.
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
Powering Medical Device Clinical Development
Clinical Operations Excellence
Enabling Virtual & Decentralized Trials as the New Standard
Data & Advanced Analytics
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.
Add to Calendar04/13/2021 11:00 AM04/13/2021 11:30 AM America/New_York Empowering Clinical Teams to put Patients at the Center of Trials Empowering Clinical Teams to put Patients at the Center of Trials https://roadtonext21americas.medidata.com/ roadtonext21eme false MM/DD/YYYYAppleGoogle (online)Office 365 (online)OutlookOutlook.com (online)Yahoo (online)
Empowering Clinical Teams to put Patients at the Center of Trials
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
Gary Luck is a clinical development business and technology executive with 20 years of pharmaceutical industry and consulting experience. He has expertise in designing target architectures and technology roadmaps to deliver on strategic visions, advance business capabilities, and realize business benefits and value. He also has subject matter expertise in Clinical Data Integration and Transformation, Clinical Data Standards, Data Standards Governance, Electronic Data Capture, Clinical Data Management, Clinical Data Repositories, Statistical Analysis and Reporting, and Content Management.
Marissa Ballesteros - Senior Director, Clinical Data Strategy, Medidata
Marissa Ballesteros, RN, MPH, MBA, Senior Director, Clinical Data Strategy at Medidata, focuses her work on sensors and clinical data analytics & algorithm development. Marissa has a diverse background in clinical operations, business development, biosensor/platform and algorithm development. She has been responsible for the strategic direction and functional management of virtual/hybrid clinical trials. She has led the research in the clinical validation of biosensors in both hospital and ambulatory settings as Vice President, Clinical Programs & Research at BioIntelliSense. She has supported key strategic relationships including technology vendors, providers and payers. Marissa served as Director, Clinical Research and Strategic Initiatives at Qualcomm Life, leading validation studies of biosensors and supporting sales and M&A opportunities. Marissa has worked at Scripps Translational Science Institute, managing digital medicine studies and was the lead responsible for launching the mSToPS study in 2015, which was the largest virtual digital medicine study, screening for atrial fibrillation. She has a strong pharmaceutical industry background with over 17 years of Phase I-IV drug clinical trials experience at Hoffman La-Roche and Pfizer. She contributed to due diligences and managed key opinion leader strategic partnerships. Marissa has worked in pharmaceutical sales for Ortho-McNeil (Johnson & Johnson Company), and practiced in the cardiac telemetry unit, urgent care, and wellness care clinics, as a registered nurse. She received her Bachelor of Science in Nursing and Master of Public Health in Epidemiology from The Ohio State University and Master of Business Administration in Finance and Management from Fordham University.
Add to Calendar04/13/2021 11:30 AM04/13/2021 12:00 PM America/New_York Sponsor Case Study: Rezolute Creates a Seamless and Easy Experience for Patients and Sites Sponsor Case Study: Rezolute Creates a Seamless and Easy Experience for Patients and Sites https://roadtonext21americas.medidata.com/ roadtonext21eme false MM/DD/YYYYAppleGoogle (online)Office 365 (online)OutlookOutlook.com (online)Yahoo (online)AppleGoogle (online)Office 365 (online)OutlookOutlook.com (online)Yahoo (online)
Sponsor Case Study: Rezolute Creates a Seamless and Easy Experience for Patients and Sites
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
Erin O'Boyle joined Rezolute with nearly 20 years of operational and management experience across all phases of development covering several therapeutic areas, including oncology, anemia, idiopathic pulmonary fibrosis and rare disease indications. Prior to joining Rezolute, Erin worked at Fibrogen where she led all clinical outsourcing and governance activities from 2013 to 2018. Erin successfully contracted and managed all vendors for each clinical department which supported their various programs.
Add to Calendar04/13/2021 12:00 PM04/13/2021 12:30 PM America/New_York Sponsor Case Study: Merck Achieves Rapid Deployment with Platform Based eCOA Sponsor Case Study: Merck Achieves Rapid Deployment with Platform Based eCOA https://roadtonext21americas.medidata.com/ roadtonext21eme false MM/DD/YYYYAppleGoogle (online)Office 365 (online)OutlookOutlook.com (online)Yahoo (online)
Sponsor Case Study: Merck Achieves Rapid Deployment with Platform Based eCOA
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
Robert Schneck, Associate Director, Clinical Data Management, Merck
Robert Schneck has worked for over a decade in the eCOA space, first as a programmer and then as a project manager on the vendor side. He now works as one of the Program leads on the eCOA services team at Merck.
Paul O'Donohoe - Scientific Lead, eCOA and Mobile Health, Medidata
Paul O'Donohoe is Scientific Lead, eCOA and Mobile Health at Medidata Solutions, a clinical software platform provider. He is responsible for developing the company's scientific expertise for electronic clinical outcome assessments and mobile health, and is responsible for ensuring internal teams, partners and Sponsors are following industry, regulatory and scientific best practices when it comes to integrating technology into clinical trials. He is passionate about developing the field of eCOA and mobile health through research and active involvement in industry consortia, and is currently the Industry Vice-Director of the C-Path ePRO Consortium. Previously, Paul worked as a research psychologist at a child and adolescent mental health clinic based in Dublin, Ireland. He moved into the health consulting field with United BioSource Corporation where he worked across the health outcomes, health economics and health data capture groups. Prior to Medidata, Paul was Director of Health Outcomes at CRF Health, an eCOA provider, where he led their health outcomes team. He has a MSc in Cognitive and Clinical Neuroscience.
Add to Calendar04/13/2021 12:30 PM04/13/2021 01:00 PM America/New_York Fireside Chat with eClinical Solutions: How Clinical Trials Will Evolve in a Post-COVID-19 World Fireside Chat with eClinical Solutions: How Clinical Trials Will Evolve in a Post-COVID-19 World https://roadtonext21americas.medidata.com/ roadtonext21eme false MM/DD/YYYYAppleGoogle (online)Office 365 (online)OutlookOutlook.com (online)Yahoo (online)
Fireside Chat with eClinical Solutions: How Clinical Trials Will Evolve 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
Katrina Rice is an accomplished Chief Delivery Officer with an impressive career that spans over 20 years and includes advancement into increasingly demanding leadership roles. With a solid history of leading business transformations and managing global portfolios, she is as much at home scaling operations as she is in developing strategies that drive revenue growth. At eClinical Solutions, Katrina was recently promoted from Executive Vice President of Professional Services to Chief Delivery Officer. She has previously held various technical roles at Lockheed Martin Energy Group and Bayer.
Katrina holds a Bachelor of Science degree in Computer Science from Alabama Agricultural and Mechanical University and a Master of Science degree in Computer Science with Advanced Applications from the University of New Haven. In her free time, Katrina is an active participant in several organizations including the Healthcare Businesswomen's Association and Women of Color in Pharma. She is also a Member of Chief, a private network for women in senior leadership roles, a Board Member of the Central Connecticut Coast YMCA, and a Member of the Delta Sigma Theta Sorority Incorporated.
Ted Kirby - Senior Director, Product Marketing, Medidata
Ted Kirby is currently Senior Director, Product Marketing for the Medidata Rave Clinical Cloud and is based in New York City. Prior to Medidata, Ted served as Director of Account Management at Medable, where he oversaw commercial relationships with Medable's key Pharmaceutical and CRO accounts. His previous experience also includes stints at AiCure, a VC-backed startup using visual AI for medication adherence in clinical trials, Deloitte and IQVIA. Ted earned his undergraduate degree in business administration from the University of North Carolina at Chapel Hill and his MBA from Columbia Business School. In his free time, Ted enjoys Travel (on pause for now), boutique fitness classes (now virtual only), Bourbon (liqueur stores are still essential), terrible pop music, and classic cars.
Learn how to leverage machine learning and advanced analytics to reduce time-intensive manual review, streamline oversight, enhance collaboration, and accelerate study execution.
Add to Calendar04/20/2021 11:00 AM04/20/2021 11:30 AM America/New_York CRO Case Study: CTI Clinical Trial Services Adopts Remote Source Review Technology to Optimize their Monitoring Strategy CRO Case Study: CTI Clinical Trial Services Adopts Remote Source Review Technology to Optimize their Monitoring Strategy https://roadtonext21americas.medidata.com/ roadtonext21eme false MM/DD/YYYYAppleGoogle (online)Office 365 (online)OutlookOutlook.com (online)Yahoo (online)
CRO Case Study: CTI Clinical Trial Services Adopts Remote Source Review Technology to Optimize their Monitoring Strategy
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
Lisa Moneymaker - Vice President of Clinical Operations Technology, Medidata
Lisa is the Vice President of Clinical Operations Technology for Medidata Solutions. She has nearly 20 years of pharma, biotech, and medical device industry experience, delivering complex system solutions in support of excellence in clinical trial execution. Lisa has spent time both in consulting and in Information System leadership for Amgen, directing architecture and development of the Clinical Trial Management ecosystem. While at Amgen, Lisa was also allocated to leadership roles within TransCelerate Biopharma, driving industry innovation through delivery of the Shared Investigator Platform and the Investigator Registry.
Louis Minham - Senior Director, IT, CTI Clinical Trial and Consulting Services
Louis Minham , MBA, PMP is Senior Director, IT at CTI Clinical Trial and Consulting Services focusing on the global clinical systems required by a global, full-service CRO conducting trials in over 40 countries on 6 continents. Louis has been building/implementing systems in the Pharma/Biotech industry for over 25 years at many different levels. In those 25 years, Louis has been responsible for various types of systems, including EDC, CTMS, eTMF, ePRO, IWRS, Learning Management, eCTD, Safety, contract pricing, Salesforce, Document Management, etc. With the sudden impact of COVID-19 on the clinical trial industry, Louis has been challenged with rapidly implementing solutions to virtualize many aspects of clinical trials in order to keep up the pace of providing life saving solutions to doctors and patients around the globe in many rare disease areas."
Add to Calendar04/20/2021 11:30 AM04/20/2021 12:00 PM America/New_York CRO Case Study: Syneos Health Achieving Early Risk and Issue Detection and Improved Site Relationships Through RBQM Adoption CRO Case Study: Syneos Health Achieving Early Risk and Issue Detection and Improved Site Relationships Through RBQM Adoption https://roadtonext21americas.medidata.com/ roadtonext21eme false MM/DD/YYYYAppleGoogle (online)Office 365 (online)OutlookOutlook.com (online)Yahoo (online)
CRO Case Study: Syneos Health Achieving Early Risk and Issue Detection and Improved Site Relationships Through RBQM Adoption
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
Stansbury joined Syneos Health in February 2019. She has 26 years of experience in the industry beginning as a study coordinator at a multi-therapeutic site followed by 21 years at a large, global CRO where she spent several years as a Clinical Research Associate (CRA) and Project Manager (PM) before moving into a leadership role where she led development of risk-based monitoring (RBM) strategy, process and tools. Stansbury has consulted with biotech companies on ICH E6 R2 compliance, conducted risk management training, performed detailed assessments of EDC, CTMS, RBM and eTMF technologies for a small CRO and completed a risk management and centralized monitoring process assessment for a large pharmaceutical company.
Stansbury's achievements and accomplishments include a yellow belt in Lean Six Sigma, completion of a Global Leadership program, recipient of the 2011 CEO Leadership Excellence Award, meeting with the FDA in 2014 to share RBM strategy ideas, participation on ACRO's RBM Forum, presentation at numerous industry conferences on RBM and publishing several articles on RBM and Change Management."
Add to Calendar04/20/2021 12:00 PM04/20/2021 12:30 PM America/New_York What Errors are Lurking in Your Data? Detect the Unknown from Lab Data to Sensor Data What Errors are Lurking in Your Data? Detect the Unknown from Lab Data to Sensor Data https://roadtonext21americas.medidata.com/ roadtonext21eme false MM/DD/YYYYAppleGoogle (online)Office 365 (online)OutlookOutlook.com (online)Yahoo (online)
What Errors are Lurking in Your Data? 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
Lindsey Samo - Senior Solution Consultant, Medidata
Jess Dolfi - Director, Product Management, Medidata
Add to Calendar04/20/2021 12:30 PM04/20/2021 01:00 PM America/New_York CRO Case Study: Catalyst Clinical Overcomes Operational Complexities with a Scalable, Data-Driven CTMS CRO Case Study: Catalyst Clinical Overcomes Operational Complexities with a Scalable, Data-Driven CTMS https://roadtonext21americas.medidata.com/ roadtonext21eme false MM/DD/YYYYAppleGoogle (online)Office 365 (online)OutlookOutlook.com (online)Yahoo (online)
CRO Case Study: Catalyst Clinical Overcomes Operational Complexities 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
Martin Dowdall - Vice President, Product Management (CTMS), Medidata
Martin Dowdall, is a Vice President of Product at Medidata, focusing on our Clinical Trial Management System (CTMS). Prior to joining Medidata, Martin spent 18 years at Eli Lilly and Company, in technical and business leadership roles and 4 years at Stericycle where he successfully led several successful business units. Martin has a reputation for utilizing technology to enable business transformation. Martin his B.Sc. in Information Systems from the University of Portsmouth, England. He currently lives in Larchmont, New York with his wife Sarah and his twin 5-year old boys Archer and Oliver.
Keya Watkins - Global Head, Clinical Development, Catalyst Clinical Research
Keya Watkins is the Global Head of Managed Services, Clinical & Biometrics Operations at Catalyst Clinical Research. In this capacity she is responsible for the quality and delivery of the clinical trial portfolio within the Catalyst CRO services business unit. Throughout her 22-year career in clinical research with both biopharma and clinical service providers, Keya has provided oversight of multidisciplinary teams in project management, clinical monitoring and site support services. She also served as an executive in both operational and commercial roles and has been involved in several complex, global trials in various therapeutic areas and phases with a concentration on hematology and oncology programs.
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.
Add to Calendar05/04/2021 11:00 AM05/04/2021 11:30 AM America/New_York Enabling Virtualization Technologies Through a Single Destination Patient Portal Enabling Virtualization Technologies Through a Single Destination Patient Portal https://roadtonext21americas.medidata.com/ roadtonext21eme false MM/DD/YYYYAppleGoogle (online)Office 365 (online)OutlookOutlook.com (online)Yahoo (online)
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.
Rosamund Round - Vice President, Patient Innovation Center and Decentralized Trials, Parexel
Kimberly Richardson - Patient Advocate
Kimberly Richardson is a seven year ovarian cancer survivor, stage 3A. She has been active since treatment in advocacy as an advocate leader of the Ovarian Cancer Research Alliance (OCRA). She speaks with legislators on the importance of funding for ovarian cancer research and is a member of the OCRA Health DIsparities Committee. Kimberly has developed SASEP, a collaborative program between researchers and patient advocates that creates educational content.
Anthony Costello - Senior Vice President, President, Patient Cloud, Medidata
Anthony Costello is Senior Vice President of Patient Cloud at Medidata. After beginning his clinical research career at Genentech 20 years ago, Anthony Costello has gone on to co-found several clinical trials technology start-up companies including Nextrials (acquired by PRA Health Sciences) and Mytrus (acquired by Medidata). Over his career, he has focused on disruptive and innovative technology that can simplify clinical trials for patients, sites and sponsors. He has been selected as one of the PharmaVoice Top 100 Most Inspiring People in Clinical Research, has served as Chairman of the Board for the Society for Clinical Data Management and is currently a member of the editorial advisory board for Applied Clinical Trials magazine. He is a frequent author and presenter on topics related to the efficient use of technology in clinical research.
Add to Calendar05/04/2021 11:30 AM05/04/2021 12:00 PM America/New_York Improving Access to Clinical Trials Through Patient Registries Improving Access to Clinical Trials Through Patient Registries https://roadtonext21americas.medidata.com/ roadtonext21eme false MM/DD/YYYYAppleGoogle (online)Office 365 (online)OutlookOutlook.com (online)Yahoo (online)
New Launch! Improve Access to Clinical Trials with myMedidata 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.
Rosamund Round is Vice President of Parexel's Patient Innovation Center. She is dedicated to improving clinical research access and experiences, which led her to create the decentralized clinical trials service. By partnering closely with patients she continues to drive Parexel's mission, to put patients at the heart of trials. Her role brings together experience in health psychology, innovation and patient engagement, and she has been delighted to help drive the industry's continuous improvement of patient centric practices.
Kelly McKee - Vice President, Patient Registries and Recruitment, Medidata
Kelly McKee recently joined Medidata as the Vice President of Patient Registries and Recruitment with 20 years of experience in clinical trial operations, patient recruitment and innovation. She is a proven clinical trial leader and trailblazer in operationalizing global patient-focused solutions across organisations including innovations in clinical trial awareness, access, and improvements in patient experiences. Kelly is passionate about celebrating the role that clinical trial participants bring in making new medicines and vaccines possible and was named one of PharmaVoice's 100 Most Inspiring Leaders in 2020, Centerwatch's Top 20 Innovators of 2018, and PharmaTimes' Clinical Researcher of the Year, Clinical Research Teams, in 2012.
Add to Calendar05/04/2021 12:00 PM05/04/2021 12:30 PM America/New_York How COVID-19 Sparked a Critical Need for Virtual Monitoring How COVID-19 Sparked a Critical Need for Virtual Monitoring https://roadtonext21americas.medidata.com/ roadtonext21eme false MM/DD/YYYYAppleGoogle (online)Office 365 (online)OutlookOutlook.com (online)Yahoo (online)
How COVID-19 Sparked a 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
Brian Barnes is a Director, Product Development – RBQM for Medidata Solutions. Brian has 15 years in the clinical development space and specifically supported RBQM for the past 9 years specializing in operational solutions for small to large pharma, biopharma, and biotech companies. Brian is a co-liaison within the Associate of Clinical Research Organizations (ACRO) RBQM Working Group and presented and published on the topic of RBQM within a number of industry meetings, conferences, and journals.
Add to Calendar05/04/2021 12:30 PM05/04/2021 01:00 PM America/New_York The Evolution of Trial Management and its Impact on Clinical SuppliesThe Decentralization of Trials and its Impact on Clinical Supply Chains The Evolution of Trial Management and its Impact on Clinical SuppliesThe Decentralization of Trials and its Impact on Clinical Supply Chains https://roadtonext21americas.medidata.com/ roadtonext21eme false MM/DD/YYYYAppleGoogle (online)Office 365 (online)OutlookOutlook.com (online)Yahoo (online)
The Decentralization of Trials and its Impact on Clinical Supply Chains
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
Amanda is currently Director, Product Management at Medidata, a Dassault Systemes Company and is responsible for developing and implementing the strategic direction for the Rave RTSM Product. She has been in the Life Science Industry for more than 20 years and has held multiple roles in the eClinical space as well as pharmaceutical development and manufacturing. Before joining Medidata two years ago, Amanda focused on patient centricity and reducing patient burden as the Sr. Director of Operations at Altavoz, an eCOA startup that was acquired by IQVIA. Prior to that, Amanda was Sr. Director, RTSM at Bioclinica and oversaw RTSM Operations. Amanda is also active in the Healthcare Businesswomen's Association and is the Monitoring and Evaluation Lead for Women in Healthcare Give Back.
Add to Calendar05/04/2021 01:00 PM05/04/2021 01:30 PM America/New_York New Launch! - From Sensors to Insights: Transforming Clinical Research with Connected Device Data New Launch! - From Sensors to Insights: Transforming Clinical Research with Connected Device Data https://roadtonext21americas.medidata.com/ roadtonext21eme false MM/DD/YYYYAppleGoogle (online)Office 365 (online)OutlookOutlook.com (online)Yahoo (online)
New Launch! - 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 - Vice President, Digital Biomarker Solutions, Medidata
Ben Schlatka joined Medidata in 2020 through Medidata's acquisition of MC10's Digital Biomarker Business. After beginning his career as a corporate "intraprenuer" at IBM, Ben grew a series of successful startups including including Volunteer Solutions.org (Sold to the United Way) and Nantero (Sold to Lockheed Martin). Most recently, Ben Schlatka was co-founder & CEO of MC10, a pioneer in sensors and new end point development in clinical research. Ben is passionate about using digital technologies to transform the lives of patients, in both clinical research and clinical practice. He holds an MBA from the Harvard Business School and frequently lectures on the formation of disruptive science based businesses.
Add to Calendar05/04/2021 01:30 PM05/04/2021 02:00 PM America/New_York New Launch! - From Sensors to Insights: Transforming Clinical Research with Connected Device Data New Launch! - From Sensors to Insights: Transforming Clinical Research with Connected Device Data https://roadtonext21americas.medidata.com/ roadtonext21eme false MM/DD/YYYYAppleGoogle (online)Office 365 (online)OutlookOutlook.com (online)Yahoo (online)AppleGoogle (online)Office 365 (online)OutlookOutlook.com (online)Yahoo (online)
CROs Only - Partnering with Medidata to go beyond transactional business and technology solutions
This session is targeted to smaller, boutique CRO partners, and is by invitation only.
With over 150+ partners, our Partner Program is designed to help you accelerate business outcomes, drive greater efficiency and productivity, amplify your brand's impact, and expand your reach. Whether you're an existing CRO partner or new to Medidata, join this moderated panel of CRO executives to learn more about the program to ensure you are leveraging all the resources at your disposal.
Sheila Antonio, Vice President, Data Management, Precision for Medicine
Sheila Antonio is Vice President of Data Management at Precision for Medicine. She is an executive level Clinical Data Management leader with extensive leadership and management experience in the CRO industry. Sheila has built self-sustaining global multi-site Clinical Data Management, Clinical Database Management and SAS/clinical programming functional areas in support of early phase, late phase, and nonclinical development and research (that include pharmaceutical, biotech and device trials).
Operationally, Sheila has greater than 25 years of experience in managing clinical trial data, SAS programming (SDTM), database design (CDASH/CDISC) and development, project management. She is a member of the Society of Clinical Data Management (SCDM). She serves as a key liaison with Sponsors, sites, vendors. Therapeutic area experience include (but are not limited to) oncology, various rare diseases, immunology, gastroenterology, cardiology, neurology, ophthalmology, and respiratory trials. Experienced in early phase FIH to Post Marketing trials and Registry studies. Sheila various data management data collection experiences, having worked with a multiple of clinical data management systems ( Electronic Data Capture (EDC)-based and paper-based trials).
Andrew MacGarvey - Managing Director, Phastar
Sheila Antonio - Vice President, Data Management, Precision for Medicine
Ivan Pessotto - Senior Director, Clinical Data Management, Everest Clinical Research
Jennifer Vergara - Director, Data Management, TD2
Katrina Weigold - Vice President, Global Partners, Medidata
CROs Only - Virtual Trials vs Trial Virtualization: The CRO Perspective
Changing the paradigm of study conduct to enable virtualisation of clinical trials, for both patients and sites, has become the industry's new focus. Multiple solutions exist to enable remote patient participation, however there has been a growing need for virtualising solutions to be incorporated in daily site operations, including monitoring and oversight.
Attend this session to learn how to boost trial participation, understand new virtualising technologies, how to address operational challenges, increase the value of CRAs, and more!
Anthony Costello is Senior Vice President, President of Patient Cloud at Medidata. After beginning his clinical research career at Genentech 20 years ago, Anthony Costello has gone on to co-found several clinical trials technology start-up companies including Nextrials (acquired by PRA Health Sciences) and Mytrus (acquired by Medidata). Over his career, he has focused on disruptive and innovative technology that can simplify clinical trials for patients, sites and sponsors. He has been selected as one of the PharmaVoice Top 100 Most Inspiring People in Clinical Research, has served as Chairman of the Board for the Society for Clinical Data Management and is currently a member of the editorial advisory board for Applied Clinical Trials magazine. He is a frequent author and presenter on topics related to the efficient use of technology in clinical research.
Lisa Moneymaker - Vice President, Product Management, Medidata
Deliver actionable insights and accelerate clinical development by combining high-quality liquid data, technology, and expertise.
11:00 AM EDT
Add to Calendar05/11/2021 11:00 AM05/11/2021 11:30 AM America/New_York Improve Decision Making and Accelerate Enrollment Through Data and Analytics Improve Decision Making and Accelerate Enrollment Through Data and Analytics https://roadtonext21americas.medidata.com/ roadtonext21eme false MM/DD/YYYYAppleGoogle (online)Office 365 (online)OutlookOutlook.com (online)Yahoo (online)
Improve Decision Making and Accelerate Enrollment Through Data and Analytics
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
Jef has led the launch and commercialization of multiple analytical SaaS offerings at Medidata and currently heads Intelligent Trials. Jef has over 15 years of experience improving business processes and decision-making through the use of technology and analytics. Prior to joining Medidata, Jef led projects at AIG which applied predictive modeling and machine learning techniques to improve risk segmentation and shape business unit strategies. He has a MBA from MIT and a BS from the University of Virginia.
John Van Hoy (PPD) - John Van Hoy, Executive Director, Data Science & Advanced Analytics, PPD
Add to Calendar05/11/2021 11:30 AM05/11/2021 12:00 PM America/New_York Potential of Synthetic Controls In Clinical Research Potential of Synthetic Controls In Clinical Research https://roadtonext21americas.medidata.com/ roadtonext21eme false MM/DD/YYYYAppleGoogle (online)Office 365 (online)OutlookOutlook.com (online)Yahoo (online)
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
Key considerations and best practices when incorporating Synthetic Control Arms into your clinical trials
Arnaub Chatterjee
Arnaub Chatterjee is Senior Vice President of Product and Ecosystem at Acorn AI, a Medidata Solutions company. Medidata is a global provider of cloud-based and analytic solutions in life sciences and in his role, he is driving efforts around the development, go-to-market, and delivery of capabilities that help life science clients accelerate their innovation. In addition to his role at Medidata, he also serves as Teaching Associate in the Department of Health Care Policy at Harvard Medical School and Lecturer in the Department of Policy Analysis and Management at Cornell University.
Darshan Dalal - Global Clinical Program Leader, at Advanced Accelerator Applications, a Novartis Company
Arnaub Chatterjee - Senior Vice President, Acorn AI Product & Ecosystem, Medidata
Darshan Dalal is a physician-epidemiologist with experience in both academia and pharma industry. He has been in the industry for over ten years in various roles, and currently leads early and late development for various compounds at Novartis Oncology. Having led several trial programs ranging from Phase-I to IV, as well as registries and RWE, he is interested in developing methods to enhance clinical research methodology and implement novel techniques to address clinical questions and advance the understanding on disease and its treatment. In his work at Johns Hopkins University Schools of Medicine and Public Health, Genentech, Novartis and Advanced Accelerator Applications (a Novartis Company), Darshan has worked extensively in disease areas including cardiomyopathies; atrial fibrillation; vitamin supplements; chronic kidney disease; breast, colorectal, lung and prostate cancer; malignant hematology; and genomics, proteomics and metabolomics. He has also served as a peer reviewer of many scientific journals.
Add to Calendar05/11/2021 12:00 PM05/11/2021 12:30 PM America/New_York Leveraging Historical Clinical Data for Better Outcomes Leveraging Historical Clinical Data for Better Outcomes https://roadtonext21americas.medidata.com/ roadtonext21eme false MM/DD/YYYYAppleGoogle (online)Office 365 (online)OutlookOutlook.com (online)Yahoo (online)
Leveraging 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
Ruthie Davi is a Statistician and Vice President, Data Science at Acorn AI by Medidata (a Dassault Systemes Company) and has a background in pharmaceutical clinical trials with more than 20 years working as a Statistical Reviewer, Team Leader, and Deputy Division Director in the Office of Biostatistics in CDER at FDA. At Acorn AI Ruthie is part of a team creating analytical tools to improve the efficiency and rigor of clinical trials, an example of which is the Synthetic Control work. Ruthie holds a Ph.D. in Biostatistics from George Washington University.
Jacob Aptekar - Senior Director, Trial Design Solutions Lead, Medidata
Jacob leads the Trial Design Solutions group within Acorn AI, focusing on novel data science applications for Medidata's clinical trial and real world data. Prior to joining Medidata he was an Associate at McKinsey & Company within their Digital McKinsey group. Prior to that, he founded and led Qurator, Inc, a start-up data science consultancy focused on RWE and renal disease. He holds an MD and PhD in Neuroscience from UCLA and a AB in Physics from Harvard.
Add to Calendar05/11/2021 12:30 PM05/11/2021 01:00 PM America/New_York Longitudinal Patient Data: Linking Clinical Trial & Real World Data to Create an End-to-End Patient Record Longitudinal Patient Data: Linking Clinical Trial & Real World Data to Create an End-to-End Patient Record https://roadtonext21americas.medidata.com/ roadtonext21eme false MM/DD/YYYYAppleGoogle (online)Office 365 (online)OutlookOutlook.com (online)Yahoo (online)
Longitudinal Patient Data: Linking Clinical Trial & Real World Data to Create an End-to-End Patient Record
Understand how to break down data silos across clinical trial and real world data to ensure greater understanding of drug efficacy and post-launch patient outcomes.
Employ proper patient consent, data linking, tokenization and patient identification technologies to fix the broken feedback loop and enable a wide variety of use cases, including patient safety monitoring, trial design and long-term therapeutic efficacy beyond the duration of clinical trials
Discover the rewards and risks associated with data linkage that facilitates merging information from clinical trial and real world data
Andrew Kopelman - Chief Privacy Counsel, Medidata
Andrew Kopelman is Medidata's Vice President, Assistant General Counsel & Chief Privacy Counsel, and is responsible for managing the company's domestic and international data privacy matters and intellectual property strategies. Prior to joining Medidata in 2012, Mr. Kopelman was an associate in the patent group at Jenner & Block, LLP, where he focused on patent litigation and client counseling involving pharmaceutical, computer and mechanical patents. Mr. Kopelman was previously an associate at Frommer, Lawrence & Haug LLP, where he focused on Hatch-Waxman pharmaceutical litigation. He is a registered patent attorney with the USPTO and is Certified Information Privacy Professional (CIPP/US).
achatterjee@mdsol.com
Lee Parker - Director, Data Privacy EU+, Biogen
Lee Parker is an English-qualified solicitor and privacy professional, focussed on the biotech and pharmaceutical industry. He is Director EU+ Privacy at Biogen, based in the canton of Zug in Switzerland. He is also Biogen's EU Data Protection Officer. He is a member of the EFPIA data protection working group and a member of the EMA's Technical Anonymisation Group, tasked with developing best practices in data anonymisation in the context of clinical data publication. Lee originally fell into data protection mainly by accident, when no one else wanted to do it, but feels it is the best professional "decision" he never made.
Optimize your approach to clinical trials with fit for purpose applications designed specifically for the Medical Device industry.
Add to Calendar04/15/2021 11:00 AM04/15/2021 11:30 AM America/New_York Sponsor Case Study: Cepheid's Journey to Mitigate Risk and Drive Patient Safety with Remote Monitoring Sponsor Case Study: Cepheid's Journey to Mitigate Risk and Drive Patient Safety with Remote Monitoring https://roadtonext21americas.medidata.com/ roadtonext21eme false MM/DD/YYYYAppleGoogle (online)Office 365 (online)OutlookOutlook.com (online)Yahoo (online)
Sponsor Case Study: Cepheid's Journey to Mitigate Risk and Drive Patient Safety with Remote Monitoring
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
Brian Barnes- Director, Product Management, Medidata
Andrew Hiar, MPH - Vice President, Clinical Affairs, Cepheid
Andrew Hiar, MPH, CCRA, Vice President of Clinical Affairs at Cepheid. I have worked in Clinical Affairs for nearly 18 years. I hold a BS Biology degree and a Master's in Public Health degree. I am also a certified clinical research associate (CCRA).
I started my professional career in the clinical lab as a Medical Technologist in the special chemistry and clinical toxicology department at Quest Diagnostics. After a few years at Quest Diagnostics, I decided the clinical lab was not in my long term plans. I applied for a Jr. CRA position at Vysis (later became part of Abbott Molecular) which became my first CRA position. My dad was a CRA and so I knew what a CRA was and what the job entailed. From there, I moved to Cepheid in 2007 for a Sr. CRA position. Over the last 13 years at Cepheid, I have held CRA and CRA manager positions as well as have led the Clinical Operations team which was responsible for all of the clinical trials at Cepheid. In January 2021, I was promoted to Vice President, Clinical Affairs at Cepheid which includes Clinical Operations, Clinical Research, Data Management and Biostatistics.
Add to Calendar04/15/2021 11:30 AM04/15/2021 12:00 PM America/New_York Sponsor Case Study: Boston Scientific Drives Patient-Centered Outcomes and Operational Excellence with eConsent Sponsor Case Study: Boston Scientific Drives Patient-Centered Outcomes and Operational Excellence with eConsent https://roadtonext21americas.medidata.com/ roadtonext21eme false MM/DD/YYYYAppleGoogle (online)Office 365 (online)OutlookOutlook.com (online)Yahoo (online)
Sponsor Case Study: Boston Scientific Drives Patient-Centered Outcomes and Operational Excellence with eConsent
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
Michael is a member of Medidata's Mobile Health team and is a subject matter expert in electronic informed consent and virtual trials. Over the last six years, Michael has worked collaboratively with sponsors, CROs, regulators, ethics committees and researchers around the world to pioneer the use of electronic informed consent and virtual trials. His 30-year career in medical research includes 8 years with the US government conducting and supporting surgical research and 22 years working in the commercial sector to provide technology solutions that improve and support preclinical and clinical research. Michael has been a participant in two clinical trials...but had to consent on paper because eConsent had not been invented yet! Michael is a decorated veteran of the United States Navy and resides in Austin, Texas where he is also an elected public official serving his local community.
Shari is a Principal Business Analyst in Rhythm Management's Clinical Project Management Organization at Boston Scientific. She has been working in the Medical Device Industry for 27 years and has over 20 years of clinical experience at both Boston Scientific and Medtronic, working in the Rhythm Management and Structural Heart divisions. She works collaboratively across divisions and has expertise in several areas of the clinical process, specifically Data Management, Central Monitoring and Technology Solutions. Shari also has experience managing projects and has a passion for innovation and has been the driving force in implementing eConsent.
Add to Calendar04/15/2021 12:00 PM04/15/2021 12:30 PM America/New_York New Launch! Medidata Adjudicate: Optimize your Endpoint Adjudication on a Single Platform New Launch! Medidata Adjudicate: Optimize your Endpoint Adjudication on a Single Platform https://roadtonext21americas.medidata.com/ roadtonext21eme false MM/DD/YYYYAppleGoogle (online)Office 365 (online)OutlookOutlook.com (online)Yahoo (online)
New Launch! Medidata Adjudicate: Optimize your Endpoint Adjudication on a Single Platform
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
Andrea Falkoff is Director of Product Management, responsible for the Medidata Adjudicate and Rave Imaging product roadmaps. Andrea also works directly with customers and internal stakeholders to ensure best practices are applied across imaging and endpoint adjudication trial builds.
Andrea joined Medidata from WorldCare Clinical, where she led the operations team, ensuring quality delivery of Imaging and Endpoint Adjudication trials for pharmaceutical, biotech and medical device companies. She has more than 14 years of experience working for various imaging/endpoint adjudication core labs and a proven track record for customer satisfaction and quality delivery.
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 and 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.
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.
Add to Calendar05/18/2021 11:00 AM05/18/2021 11:30 AM America/New_York "Getting to Market Faster and More Efficiently Sub Heading: Digitalizing Next-Generation Labs in the Cloud https://roadtonext21americas.medidata.com/ roadtonext21eme false MM/DD/YYYYAppleGoogle (online)Office 365 (online)OutlookOutlook.com (online)Yahoo (online)AppleGoogle (online)Office 365 (online)OutlookOutlook.com (online)Yahoo (online)
Getting to Market Faster and More Efficiently
Digitalizing Next-Generation Labs in the Cloud
Lab digitalisation is advancing quicker than ever. The next-generation lab requires support for remote work, easier collaboration among scientists and standardised 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, BIOVIA
Stephen Hayward - Technical Product Marketing
Steve Hayward is a PhD in Chemical Engineering, with a background in laboratory informatics, chemical modeling, and environmental analysis. Originally from Toronto, Canada, he currently leads product marketing efforts for informatics solutions at BIOVIA Dassault Systèmes in San Diego.
Michael Millonig - Solution Consultant, BIOVIA
Michael Millonig - Solution Consultant
Add to Calendar05/18/2021 11:30 AM05/18/2021 12:00 PM America/New_York BIOVIA's New Unified Lab Solution: The Results and the Challenges Resolved by Transforming Lab Processes BIOVIA's New Unified Lab Solution: The Results and the Challenges Resolved by Transforming Lab Processes https://roadtonext21americas.medidata.com/ roadtonext21eme false MM/DD/YYYYAppleGoogle (online)Office 365 (online)OutlookOutlook.com (online)Yahoo (online)AppleGoogle (online)Office 365 (online)OutlookOutlook.com (online)Yahoo (online)
BIOVIA's New Unified Lab Solution: The Results and the Challenges Resolved by Transforming Lab Processes
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, BIOVIA
She Yen Lok - Senior Solution Consultant
She Yen Lok is a senior solution consultant at BIOVIA Dassault Systèmes with over 20 years of experience in the Quality Control (QC) space. He worked with GSK in QC for over 14 years, first as an analyst and then implementing and supporting global LIMS in GSK's QC labs. He then joined VelQuest to help expand their Laboratory Execution solution into Europe. Following Accelrys' acquisition of VelQuest, he worked as a Pre-Sales Solution Consultant in their QC lab team. Today, he focuses on BIOVIA's laboratory informatics Solution in QC and Manufacturing.
Laurent Rebion - Global Solution Consulting Director, BIOVIA
Laurent Rebion - Global Solution Consulting Director
Laurent Rebion is global solution consulting director, life sciences, at BIOVIA Dassault Systèmes. With a background in computer science and biology, he has over 20 years of experience in working with the pharmaceutical and biotech industries from research to lab and manufacturing informatics.
Add to Calendar05/18/2021 12:00 PM05/18/2021 12:30 PM America/New_York "Next Steps for Your Lab Sub Heading: Maximize Productivity and Innovation within Your Lab M"Next Steps for Your Lab Sub Heading: Maximize Productivity and Innovation within Your Lab https://roadtonext21americas.medidata.com/ roadtonext21eme false MM/DD/YYYYAppleGoogle (online)Office 365 (online)OutlookOutlook.com (online)Yahoo (online)AppleGoogle (online)Office 365 (online)OutlookOutlook.com (online)Yahoo (online)
Next Steps for Your Lab
Maximize Productivity and Innovation within 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, BIOVIA
Kirsten Gesenberg - Portfolio Director
Kirsten Gesenberg is portfolio director for the BIOVIA Dassault Systèmes Electronic Notebook products. She began her career as a small molecule process chemist in the pharmaceutical industry. Since joining BIOVIA (then Symyx) 15 years ago, she has been involved in the successful implementation of BIOVIA Workbook across the Life Sciences industry. In 2021, Kirsten looks forward to moving the BIOVIA laboratory products onto the 3DEXPERIENCE platform.
Add to Calendar05/18/2021 12:30 PM05/18/2021 01:00 PM America/New_York Seamlessly Move from the Lab to Manufacturing with an Integrated Lab Informatics Solution Seamlessly Move from the Lab to Manufacturing with an Integrated Lab Informatics Solution https://roadtonext21americas.medidata.com/ roadtonext21eme false MM/DD/YYYYAppleGoogle (online)Office 365 (online)OutlookOutlook.com (online)Yahoo (online)AppleGoogle (online)Office 365 (online)OutlookOutlook.com (online)Yahoo (online)
Seamlessly Move from the Lab to Manufacturing with an Integrated Lab Informatics Solution
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.
Dennis Curran - Portfolio Director, BIOVIA
Welcome to the EY Better You Experience
Carolyn Slaski, Americas Vice Chair - Talent, welcomes you! Learn about what to expect from the Experience and why your visit is a great use of your valuable time.
Better You: The Experience and 2021 Annual Enrollment
Mike Spicci, Director of Benefits, highlights our Better You tools and resources that are designed to help you thrive - and how to best take advantage of them. He also introduces what's changing with your EY benefits for 2021 and reminders to help you prepare and make confident decisions during this year's Annual Enrollment.
What is Better You?
Watch an overview of Better You, our Better You website, and our Better You Buddy app to discover how you can benefit.
Add Settings
Do I need to register to attend?
Yes, you will need to register by providing your EY email address to enjoy all the features of the Better You Experience.
The live session times are not convenient for me. Can I still participate in the Experience?
Yes! The Better You Experience will remain open 24/7 for 30 days. Many sessions will be recorded for you to review during that time.
Where will the Better You Experience be held?
This is an online event only. You can participate anywhere you have internet access, using your desktop, mobile or tablet device.
Who will I be able to chat with?
You will be able to chat with representatives from many Better You resources during days of live events. If chat is not available, you will be able to connect by email.
Will my chats be private?
The chatrooms are visible to all visitors, so please do not share personal information. To chat 1:1 with a representative (if available), a special "Chat Now" feature is available on the page under "Booth Reps Online," or look for a direct invitation from a rep.
Will I be able to take away any information or brochures from the Experience?
Yes. You can collect documents during the Experience at the different booths you visit in the Exhibit Hall. They'll move into a swag bag, which you can then email to yourself.
Do I need a webcam to participate?
No, a webcam is not needed.
Do I need to download or install any software to attend the Experience?
No. You only need access to the internet.
What is the preferred browser?
Google Chrome, Edge, Safari, and Firefox.
Will I be identified on the site?
Entering your EY email address (or registering, if prompted) confirms you are eligible to enter the Experience. In doing so, you also acknowledge that it may be shared with EY and with benefits vendors if you choose to interact with them in their virtual booths and/or participate in live and on-demand presentations. EY protects your privacy and will not share or display other personal identifying information about you on the site or with our vendors.
Medidata Privacy Policy