Empower, Enable, Excite!
elluminate Engage
November 2 - 3, 2022
Empower, Enable, Excite!
elluminate Engage
November 2 - 3, 2022
November 2 - 3, 2022
Empower, Enable, Excite!
elluminate® Engage is a complimentary annual conference for eClinical clients and partners that brings together thought leaders, industry experts, and elluminate Clinical Data Cloud users to discuss topics on the cutting-edge of digital innovation. Join us in 2022 to exchange ideas, share best practices, and build on lessons learned to empower the elluminate community to create new and better experiences for interacting with clinical data. We encourage the attendance of team members across roles to maximize the value of different sessions.
Registration Now Open for elluminate Engage 2022
November 2 - 3, 2022
We look forward to connecting with you at Engage 2022! Register now to ensure you don’t miss out on important event communications.
Engage 2022 will be hosted live in-person at Convene in the Boston Financial District. Please note that it will not be streamed virtually.
*Registration for the elluminate Engage conference is limited to current clients of eClinical Solutions.
Plan Your Visit
Engage 2022 Venue
Convene
One Boston Place
201 Washington St, Boston, MA 02108
Hotel Accommodations
Kimpton Nine Zero *Book by Oct. 10 to receive Engage rate
90 Tremont St, Boston, MA 02108
Hyatt Centric Faneuil Hall *Room block full – you can still make a reservation at the standard nightly rate
54-68 Devonshire St, Boston, MA 02109
Speakers
Agenda
Day 1 - Wednesday, November 2, 2022
8:30-9:00 AM
Breakfast
9:00-9:10 AM
Welcome
Sheila Rocchio
Bob Arnesen
Sheila has more than 20 years of experience with 17 years in marketing, product management and strategy roles in life sciences technology companies. She spent 15 years at PHT Corporation (now ERT) in a variety of marketing and executive leadership roles helping to drive the company’s growth and the industry adoption of electronic clinical outcome assessments (eCOA). At eClinical Solutions, Sheila manages all aspects of marketing including branding, communications, lead generation, product marketing and product management. She enjoys finding creative ways to tell customer stories and building products and services that help clinicians, data scientists and technologists do the challenging and important work of bringing life-saving new therapies to market.
With over 20 years of experience in the medical and life science industries, Bob has built organizational strategies and processes for a myriad of organizations responsible for the collection of data including ePRO, Lab, IVR, and clinical data. As one of the founders of eClinical Solutions, he designs and implements strategies for the industry adoption of the technologies and services offered by the organization, as well as identifying and building strategic partner channels for business development. Bob’s unique interpersonal skills and drive in building positive company culture enables him to pursue his true passion, which is coaching, mentoring, and helping employees reach their personal and business objectives.
9:15-10:30 AM
Keynote: Digital Clinical 2025 - Blueprint for Success
Raj Indupuri
Nandish Poluru
Doug Barta
A technologist with over 23 years of industry experience, Raj Indupuri is responsible for establishing the eClinical Solutions vision and future-looking technology strategy. He is deeply passionate about fostering innovation to revolutionize the Life Sciences industry with ground-breaking technologies that will modernize clinical trials and bring treatments to patients faster. As an industry veteran who has been part of the evolution of Life Sciences and clinical data management for over two decades, Raj has an astute business vision to realize the digital future and enable progress and potential with data and analytics at the core of the company’s innovative products and solutions. Raj is responsible for the overall direction and management of the company and is a Mechanical Engineer with an MBA from Boston University who firmly believes data is the new fuel that will drive human progress.
Doug Barta currently serves as the Chief Information Officer of Cerevel Therapeutics, a leading neuroscience biopharmaceutical company based in Boston. Before Cerevel, Mr. Barta served as CIO of Parexel, where he oversaw technology globally for this $2+B CRO. Prior to Parexel, Mr. Barta was CIO of a Marsh & McLennan company, Guy Carpenter, a leading reinsurance brokerage and before that, he spent over seven years with Fidelity, where he completed his tenure as the COO of Fidelity Asset Management Technology. Mr. Barta is a Wharton MBA and a Cornell University Electrical Engineer.
10:30-11:00 AM
Break
11:00-12:15 PM
Panel: Building Better End-User Experiences
Mahesh Iyer
Marty Roche
Marcel Mackiewicz
Marty has over 20 years of experience in business development in the life sciences industry and has implemented a multitude of sales strategies and processes for global service organizations. His experience ranges from developing sales and marketing strategies for both clinical technologies as well as clinical services. His passion is combining the creative and consultative to give eClinical’s clients an experience that is memorable, positive, and unique. Marty joined eClinical Solutions in 2009 and is responsible for global business development and customer success.
Marcel has 20+ years of experience in clinical data sciences and is a global program data management leader. He has grown in his career with Merck KgaA based in Germany for the last 16 years, currently as the Director – Head of Late Stage Program Data Management. Prior to joining Merck KgaA, he held data management and health information management roles at Omega Mediation Clinical Research Services and the Institute for Medical Informatics.
12:20-1:05 PM
Consultant & System Integrator Perspectives: Best Practices and Lessons Learned from Data & Analytics Platform Strategies & Projects
Ian Shafer
Venu Mallarapu
Bob Arnesen
Karen Travers
Ian is a Partner in PwC’s Pharmaceutical Advisory Practice and has been working in the BioPharmaceutical industry focused on Clinical Development for the past eighteen years. Ian joined PwC in 2019 and is focusing on global clinical development business transformation enabled by digital technologies. Ian is a molecular biologist by education and received his undergraduate degree from the University of California, Santa Cruz in 1999. Ian’s project experience includes business strategy/roadmap development, operating model design, business case development, global digital business transformation, technology selection and implementation, business process design, change management, and SDLC management. Ian’s functional focus spanned program/protocol design, study start-up, clinical trial operations, data management, analysis and reporting, and submissions and has led 40+ major transformational programs during his career where 5+ were $100m capital investments.
Venu Mallarapu is a digital innovation leader with over two decades of experience in business and IT advisory, strategic consulting, relationship, and delivery management to global life sciences organizations. As eClinical Solutions’ Vice President of Global Strategy and Operations, Venu is responsible for strategic development to meet global demand for the company’s platform and service offerings. He brings his expertise in collaboration and building teams to drive adoption, market expansion and innovation of the elluminate® Clinical Data Cloud and eClinical Clinical Data Services, ensuring current and future clients recognize value as industry needs evolve. Venu is a subject matter expert in Clinical, Regulatory, Quality and Safety & Pharmacovigilance functions, and has delivered Strategy & Transformation Advisory Consulting to top global Pharma, Biotech, Vaccine, and Medical Devices clients. He has spoken at various Life Sciences and Tech industry events and is a recognized thought leader in R&D with published articles.
With over 20 years of experience in the medical and life science industries, Bob has built organizational strategies and processes for a myriad of organizations responsible for the collection of data including ePRO, Lab, IVR, and clinical data. As one of the founders of eClinical Solutions, he designs and implements strategies for the industry adoption of the technologies and services offered by the organization, as well as identifying and building strategic partner channels for business development. Bob’s unique interpersonal skills and drive in building positive company culture enables him to pursue his true passion, which is coaching, mentoring, and helping employees reach their personal and business objectives.
Karen Travers has more than 20 years of experience in a variety of technologies supporting life sciences, particularly clinical operations and regulatory affairs and most recently developing wearable medical devices utilizing complex machine learning and AIs.
Prior to joining Halloran, Karen worked at Quvium where she led the development of a wearable cough monitor. Before that, she worked in a variety of positions at Vertex Pharmaceuticals both in Clinical Development and Information Systems where she focused on implementing technology solutions to support various R&D efforts. She also spent time at Oracle Inc., and Parexel International.
1:05-2:00 PM
Lunch
2:00-3:00 PM
Breakout Groups
Role-based breakout sessions will highlight best practices and ways to maximize the benefits of elluminate.
elluminate for Data Management and Medical Review
Sy Truong
Diane Lacroix
Karen Skuba
Sy Truong started programming SAS in the late 80s and works as a data analyst and clinical systems architect in the biotech and Pharmaceutical industry for 30 years. In addition to developing to perform data analysis, he also implements clinical systems on different platforms integrating solutions with multiple operating systems and other applications. He has passions in writing and graphic designs. Sy has presented and taught courses at conferences including previous SAS Global Forum, CDISC, PharmSUG, WUSS and related conferences.
Diane Lacroix is a data management professional and leader with 19 plus years in the pharmaceutical/CRO industry. At eClinical Solutions, Diane is responsible for leading the data management function including building effective process and implementation strategies to ensure that clients receive maximum value and quality from the elluminate driven data services that Diane’s team delivers. Diane’s career in data management has included numerous leadership roles both at service providers and on the sponsor side. She has worked on all aspects of global trials from study startup through database closure and submission leading and managing successful teams and projects to ensure high quality and on-time delivery of clinical data assets. Diane has deep expertise in the oncology and rare disease therapeutic areas and in data management technologies including EDC systems and integration and analytics technology platform like elluminate.
Karen is currently a Principal Implementation Consultant for eClinical Solution’s elluminate Clinical Data Cloud. She enjoys working with clients throughout the implementation process, and especially likes to get crazy with a pencil and paper to spec out custom reports for unique datatypes. She’s spent much of her working life in big pharma starting out in statistics, moving into the IRT world, and subsequently Data Management/Reporting and Analytics. She now enjoys working with the very dynamic and energetic team at eClinical Solutions, giving clients new pathways into their data.
elluminate for Programming and Biostatistics
elluminate for Clinical Operations
3:05-4:05 PM
DCT The Patient & Site Experience
Laurie Halloran
4:10-5:25 PM
elluminate Roadmap: What's Coming
Robert Musterer
Sam Anwar
Nathan Johnson
Sam has spent the past 20 years of his career leveraging cutting edge technologies to revolutionize clinical trials. In addition to software development, Sam has deep expertise in a diverse set of technologies including IT infrastructure, web technologies, information security, database design, business intelligence, big data platforms and analytics. As CTO at eClinical Solutions, he harnesses the power of software development, big data, AI and machine learning to help advance technology innovation in life sciences.
Nathan is an experienced SAS programmer with expertise in statistical analysis and reporting, standards development, and data management for clinical research. He is passionate about rethinking data mapping and transformations through increased standardization and automation. Nathan is interested in asking the right questions and finding innovative and creative solutions, making the complex simple, and helping every process become more efficient and more effective.
5:30-6:30 PM
Happy Hour
6:45-9:30 PM
10 Year Celebration Dinner
Day 2 - Thursday, November 3, 2022
8:30-9:00 AM
Breakfast
9:00-10:00 AM
Keynote: Your Peak Performance Mindset: Finding Flow and Thriving Under Pressure
Dr. Nate Zinsser
Dr. Nate Zinsser is an expert in the psychology of human performance who consults to individuals and organizations seeking a competitive edge. Dr. Zinsser has been at the forefront of applied sport psychology for over thirty years. He has published scholarly research in The Journal of Sport and Exercise Psychology, The Canadian Journal of Psychology and in five editions of the widely used textbook, Applied Sport Psychology: Personal Growth to Peak Performance. From 1992 to 2022, Dr. Zinsser directed a cutting-edge applied sport psychology program at the United States Military Academy’s Center for Enhanced Performance, personally conducting over seventeen thousand individual training sessions and seven hundred team training sessions for cadets seeking the mental edge for athletic, academic, and military performance. Dr. Zinsser’s latest book, The Confident Mind: A Battle-Tested Guide for Unshakable Performance, was released in January 2022. A PhD in sport psychology from the University of Virginia, Dr. Zinsser has taught at William Patterson College, East Stroudsburg University, and in the University of Virginia’s Continuing Education Division. His sport psychology training is complemented by his experience as a state wrestling champion, elite level mountaineer, and lifetime practitioner of Japanese karate and meditative disciplines. Dr. Zinsser lives in Fishkill, NY with his wife of 40 years.
10:05-11:05 AM
Better the Second Time Around: Lessons Learned Bringing in the elluminate Platform to Multiple Companies
Jaclyn Dye
Dawn Kaminski
Jaclyn Dye is a Data Management (DM) executive with 20 years of proven success in the Pharmaceutical industry. She specializes in building, leading and mentoring high performing Biometrics teams to deliver with quality and efficiency across global programs and therapeutic areas.
Dawn has over 20 years of experience in the pharmaceutical industry. She have worked within every level of clinical data management, from Data Coordinator to Senior Director where she participated in or had oversight for more than 250 clinical trials. During her time in the industry, she has provided consultation to organizations on clinical trial conduct, best practices in Data Management and data capture as well as developed standardized libraries and templates to support the adoption of CDISC standards. She is an active member of SCDM as a GCDMP SME, course designer and webinar presenter as well as Co-Chair of the annual conference (2018-2021) and serves on the SCDM Board of Trustees. Dawn is involved as a member of the CDISC-CDASH core team, Diabetes sub-team, CDASH CFAST Expanded Leadership Team and former Co-Chair of the CRF Library project. Dawn currently holds the position of Vice President, BD Operations, where she supports business development as a Clinical Subject Matter Expert for both software and data services as well as overseeing the Proposals and Solution Consulting departments.
11:05-11:35 AM
Break
11:35-12:35 PM
Product Breakout Groups
These sessions will be interactive and include Q&A and opportunities for attendees to share feedback with our product experts.
Risk-based Quality Management
Diane Lacroix
Jason Konn
Diane Lacroix is a data management professional and leader with 19 plus years in the pharmaceutical/CRO industry. At eClinical Solutions, Diane is responsible for leading the data management function including building effective process and implementation strategies to ensure that clients receive maximum value and quality from the elluminate driven data services that Diane’s team delivers. Diane’s career in data management has included numerous leadership roles both at service providers and on the sponsor side. She has worked on all aspects of global trials from study startup through database closure and submission leading and managing successful teams and projects to ensure high quality and on-time delivery of clinical data assets. Diane has deep expertise in the oncology and rare disease therapeutic areas and in data management technologies including EDC systems and integration and analytics technology platform like elluminate.
Within his current role as Product Manager at eClinical Solutions, Jason oversees key product development on the elluminate Clinical Cloud. He finds that it’s an exciting time to be helping pharma companies achieve their data strategies and feels fortunate to be working with an industry leading platform. Prior to his current role, Jason worked for several companies within the clinical trials space. His experience ranges from building an automated workforce, leading Agile development teams, establishing global laboratory processes, to driving company wide process improvement projects.
Statistical Computing Environment
Operational Insights
Haley Salinas
12:35-1:20 PM
Lunch
1:25-2:10 PM
Data Services Leading the Way - Our OWN Experiences with RBQM, AI & SCE
Katrina Rice
Grant Williamson
Demi Niforos
Diane Lacroix
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.
Grant Williamson has 15 years of experience in clinical programming and data management. As the Director of Data Acquisition at eClinical Solutions, he drives the combination of technology and clinical development expertise to guide life science companies through the optimal design, implementation, and use of all their data capture systems.
Demi Niforos is VP, Biostatistics and Statistical Programming for eClinical Solutions and has more than 20 years of drug development experience in both the CRO and Pharmaceutical/Biotech environments. Prior to joining eClinical Solutions she held leadership roles in biostatistics and data management across multiple companies including YM Biosciences, Viventia Biotech and AAIPharma. She has extensive expertise in the clinical development process from study planning to agency submission. Prior to joining eClinical Solutions, Demi led Biostatistics and Data Management for Arbutus BioPharma. Demi holds an M.S. in Applied Statistics from Worcester Polytechnic Institute and a B.S. in Mathematics and Science from Worcester State College.
Diane Lacroix is a data management professional and leader with 19 plus years in the pharmaceutical/CRO industry. At eClinical Solutions, Diane is responsible for leading the data management function including building effective process and implementation strategies to ensure that clients receive maximum value and quality from the elluminate driven data services that Diane’s team delivers. Diane’s career in data management has included numerous leadership roles both at service providers and on the sponsor side. She has worked on all aspects of global trials from study startup through database closure and submission leading and managing successful teams and projects to ensure high quality and on-time delivery of clinical data assets. Diane has deep expertise in the oncology and rare disease therapeutic areas and in data management technologies including EDC systems and integration and analytics technology platform like elluminate.
2:15-3:15 PM
Moving Beyond the Core Platform
David Weigand
David Weigand brings over 15 years of clinical research experience in various clinical programming, data management and project management roles across multiple therapeutic areas. In his role as Director of Clinical Data Reporting and Analytics at Bristol-Myers Squibb, David provides operational leadership of the clinical data reporting and analytics function enabling the presentation of clinical trial datasets, data reports, listings and visualizations to various stakeholder groups for data review, patient safety oversight, protocol deviation and data trend detection, internal decision making and statistical analysis. He holds a Bachelor of Science in Nursing from Penn State University.
3:15-3:30 PM
Day Two Highlights and Closing Thoughts
Sheila Rocchio
Sheila has more than 20 years of experience with 17 years in marketing, product management and strategy roles in life sciences technology companies. She spent 15 years at PHT Corporation (now ERT) in a variety of marketing and executive leadership roles helping to drive the company’s growth and the industry adoption of electronic clinical outcome assessments (eCOA). At eClinical Solutions, Sheila manages all aspects of marketing including branding, communications, lead generation, product marketing and product management. She enjoys finding creative ways to tell customer stories and building products and services that help clinicians, data scientists and technologists do the challenging and important work of bringing life-saving new therapies to market.
Key Themes
Sponsors
Breakfast/Lunch Sponsor
Breakfast/Lunch Sponsor
Reception Sponsor
Featured Speakers
Highlights from elluminate Engage 2021
During the elluminate Engage 2021 conference, we were lucky to hear from key experts working on the frontline of implementing digital transformation at their organization. The two-day learning and networking experience included sessions on the leading challenges associated with digital transformation and focused discussions on optimizing clinical data review and analysis using elluminate.
Engage Virtual 2021
Capitalizing on Digital Tailwinds to Accelerate Clinical Research – Evolution of Cloud Platforms for Data Review & Analytics
Panel: Decentralized Clinical Trial (DCT) Models, Technology & Strategy: What You Need to Know Now
The Innovation Imperative: The Need for Clinical Systems Interoperability & Benefits for Analytics
Panel: Leveraging the elluminate Platform to Solve Data Problems and Empower Clinical Teams in Emerging Biotechs
Access the elluminate Engage Archive On-Demand Sessions
Recorded Live: May 19, 2022 & Nov 3-4, 2021