2022 Archived Content

Clinical Data Strategy and Analytics

Data Strategies for a New Normal

February 8 - 9, 2022 ALL TIMES EST

E-clinical technologies have changed the landscape of the clinical research industry and healthcare IT in general. Digitalization of healthcare data, mobile data capture technologies, and cloud storage of data are a few of the main technological advances that influence clinical data management and analytics. These capabilities became critical during the past two years when many trials got interrupted because of COVID-19. Companies with strongest clinical data departments were able to rescue some of the ongoing operations and start new trials thank to the innovative data strategies in place. CHI’s 14th Annual Clinical Data Strategy and Analytics conference will be bringing together top clinical research informatics experts to discuss the challenges and find solutions necessary to navigate and thrive in the rapidly changing environment. Advisory Board: Sina Djali, Head of Clinical & Operations Analytics, Janssen R&D LLC Demetris Zambas, Vice President & Global Head, Data Monitoring & Management, Pfizer Inc.

Monday, February 7

8:00 am SCOPE’s Inaugural Masters of Clinical Research Golf Tournament

Connect with your peers and colleagues at SCOPE's Inaugural Masters of Clinical Research Golf Tournament. For more information on participating or how you can get involved as a sponsor, please visit the SCOPE Summit website for further details.

9:00 am Conference Registration Open (Gatlin Foyer)

2:00 pm User Group Meetings (ROOM LOCATIONS: St. John's 30 & 31 & St. John's 32)

Co-locate your User Group, a Workshop or even your company's Annual Meeting with SCOPE Summit. CHI will help market the event and manage logistical operations. We will co-market prospective attendees and extend your users a discount to attend the entire SCOPE conference. We are here to work with you. Use SCOPE as your gathering point! Learn more on the SCOPE Summit website.

5:00 pm KEYNOTE PRESENTATION:

Organizer's Welcome Remarks

Micah Lieberman, Executive Director, Cambridge Healthtech Institute (CHI)

5:05 pmChairperson’s Introduction: Proven Technology and Services to Support a Seamless Clinical Trial Journey for Participants

Tarra Shingler, MS, Senior Vice President, Global Business Solutions, StudyKIK

5:10 pm KEYNOTE PRESENTATION: Engaging and Understanding Patient Behavior to Improve Accessibility, Retention and Outcomes

Panel Moderator:

Dana Edwards, Chief Commercial Officer, Circuit Clinical

Patient-centric drug development that incorporates patient experience coupled with behavioral science and real-world evidence is evolving the way in which sponsors and regulators bring new medicines to the patients. This executive panel will discuss emerging trends along with case studies that demonstrate how understanding patient need, beliefs and their healthcare journeys influences participation in clinical trials and impacts outcomes.

Panelists:

Vicky DiBiaso, MPH, BScN, Global Head, Patient Informed Development & Health Value Translation, Sanofi

Brendan O'Neill, Senior Director Patient Recruitment Programs, Clinical Development & Operations & Global Product Development, Pfizer Inc.

Gretchen Goller, Senior Director & Head, Patient Recruitment Solutions & Clinical Development Operations, Seagen, Inc.

Thad Wolfram, President, Matrix Clinical Trials, Matrix Clinical Trials

5:45 pm KEYNOTE PRESENTATION:

SCOPE's 2022 Participant Engagement Awards Introduction

David Sall, President & CEO, Marketing, Patient Enrollment Advisors LLC

5:50 pm KEYNOTE PRESENTATION:

SCOPE's 6th Annual Participant Engagement Awards

Panel Moderator:

David Sall, President & CEO, Marketing, Patient Enrollment Advisors LLC

Now in its 6th year, the Participant Engagement Award (PEA) recognizes innovation and change in how the industry communicates with participants in the fields of recruitment and retention in clinical trials.

Participant Engagement Awards Judges:

Michelle Crouthamel, PhD, Head, Digital Sciences, AbbVie, Inc.

Kelly McKee, Vice President, Patient Recruitment and Registries, Medidata

Irfan Khan, CEO, Circuit Clinical

Gretchen Goller, Senior Director & Head, Patient Recruitment Solutions & Clinical Development Operations, Seagen, Inc.

Kimberly Richardson, Research Advocate, Founder, Black Cancer Collaborative

Alicia Staley, MBA, Trial Volunteer & Cancer Survivor; Vice President, Patient Engagement, Medidata

Participant Engagement Awards Contestants:

Angie Caprise, Senior Scientist, Global Trial Optimization, Merck & Co., Inc.

Melissa Jane Bime, CoFounder & CEO, Infiuss Health

Melissa Gebhardt, Senior Director Business Development & CDx, Guardant Health

Fabio Gratton, Co Founder & CEO, CureClick LLC

Gwenn Oakes, Program Director, Global Trial Optimization, Merck

Adam Kleger, InVibe

Ian Greenfield, Tryl

Jeff Smith, Tryl

Panelists:

Michelle Crouthamel, PhD, Head, Digital Sciences, AbbVie, Inc.

Kelly McKee, Vice President, Patient Recruitment and Registries, Medidata

Irfan Khan, CEO, Circuit Clinical

Gretchen Goller, Senior Director & Head, Patient Recruitment Solutions & Clinical Development Operations, Seagen, Inc.

Kimberly Richardson, Research Advocate, Founder, Black Cancer Collaborative

Alicia Staley, MBA, Trial Volunteer & Cancer Survivor; Vice President, Patient Engagement, Medidata

Angie Caprise, Senior Scientist, Global Trial Optimization, Merck & Co., Inc.

Melissa Jane Bime, CoFounder & CEO, Infiuss Health

Melissa Gebhardt, Senior Director Business Development & CDx, Guardant Health

Fabio Gatton, Co-Founder & CEO, THREAD Research (formerly inVine Labs)

Adam Kleger, Head, Client Solutions, inVibe Labs

Gwenn Oakes, Director, Global Trial Optimization, Merck & Co., Inc.

Jeff Smith

Ian Greenfield, CEO, Tryl

6:35 pm SCOPE's Kick-Off Networking Happy Hour (Gatlin Terrace)

7:45 pm Close of Day

Tuesday, February 8

7:15 am Registration Open (Gatlin Foyer)

7:15 am Morning Coffee (Sponsorship Opportunity Available)

8:05 am KEYNOTE PRESENTATION:

Organizer's Welcome Remarks

Micah Lieberman, Executive Director, Cambridge Healthtech Institute (CHI)

8:10 amChairperson’s Introduction

Peyton Howell, Chief Commercial & Strategy Officer & President, Consulting, Parexel

8:15 am KEYNOTE PRESENTATION:

Fireside Chat: Fit-for-Future Data Operations in a Post-Pandemic World

Demetris Zambas, Vice President & Global Head, Data Monitoring & Management, Pfizer Inc.

Darren Weston, Senior Vice President, Integrated Data Analytics and Reporting (IDAR)and Janssen Clinical Innovation (JCI), Janssen Pharmaceuticals, Inc.

Cynthia Pan, RPh, Senior Director, Therapeutic Area Operations Leader, Global Clinical Operations, Regeneron

The COVID-19 pandemic continues to reshape our world and our approaches to clinical trials. During the last 20 months, the risk-benefit ratios of many innovative methodologies and technologies have inversed. Risk-averse organizations have grasped the realities that these new innovative methods are now the only means to efficiently execute clinical trials. This new reality and the ongoing need for real-time data collection and consumption require new creative and live data flows. An additional ramification of this evolution has been a significant improvement in the level of collaboration required and realized within our organizations and with our external partners and technology providers. Let us discuss how we can cement this “New Normal” to not only maintain the momentum but to ensure these valuable innovations are sustainable.

9:10 am KEYNOTE PRESENTATION:

Case Study: Moving Beyond the Promise of Connected Health, Learning from Implementation at Scale

Adama Ibrahim, Director, Digital Solutions, Technology, Platforms, Data & Digital Global Drug Development, Novartis Pharma AG

Justin Wright, MD, Vice President, Global Head Connected Health, Novartis

At Novartis Global Drug Development, we have a vision to accelerate digital products by developing one or more “connected health” solutions (connected device, wearable, software as medical devices) into our drug programs over the next 5 years. This showcase of the Connected Health group, formed to deliver the vision, will focus on presenting the real work that has been done as a collaboration to bring these digital health tools to clinicians, patients, and to pharma research that improve the overall health care experience and improve access to trials. How does an integrated patient experience deliver more value to patients, providers, and payers? How do you give patients their own digital data so they can be more engaged in their treatment plans? How can Connected Health improve clinical workflow, communication, data exchange, and clinical research? How do you do this at scale, beyond a pilot?

9:55 am Grand Opening Coffee Break in the Exhibit Hall (Gatlin Ballroom BCD)

10:55 am

Chairperson's Remarks

Aman Thukral, Director & Head, Clinical Systems & Digital Operations, AbbVie, Inc.

11:00 am

Frictionless Data Flow

Xiaoying Wu, Vice President, Data Platforms & Privacy, Janssen Pharmaceuticals, Inc.

This presentation will address issues and solutions related to data flow and data management in novel trials including decentralized trials.

11:25 am

Data and Analytics Needed to Keep “Light Speed” Studies on Track from Planning through Submission

Ralph Russo, Senior Director & Global Head, Clinical Database Management, Pfizer Inc.

When asked to do what has never been done before in clinical research…how do you manage the complexity of delivering in just months, what would normally take years? Rising to that challenge requires not only organizational and personal commitment, but a means to plan and coordinate activities across diverse functions…from supplies to data management, to statistics and analysis, to submission and regulatory inspection. And everything in between. Keeping every aspect of a ‘light speed’ clinical trial/program requires data analytics and dashboards in real time across various data sources and types. This session will provide an overview of what helped Pfizer deliver the COVID-19 Vaccine data set for Emergency Use Authorization.

11:50 am

Direct Data Capture (DDC) for Clinical Development – an Abbvie Case Study

Aman Thukral, Director & Head, Clinical Systems & Digital Operations, AbbVie, Inc.

Anna Fuquay, eCOA and Digital Operations Associate II, AbbVie

Different Modalities of Direct Data Capture from EHR, EMR and Syndicated Data Sources Key Considerations and Lessons Learned from Abbvie's pilots

12:15 pm

Design StuDIO to Optimize Study Design and Delivery

Jade Dennis, Advisor, Design Hub, Eli Lilly and Company

Using data and analytics, study teams can optimize their protocol design with a direct impact on clinical development timelines, patient burden and study cost. An integrated set of advanced analytical tools and processes was developed that allows users to identify trends and make data informed decisions on study design leading to more feasible designs with reduced patient burden, cost and risk of protocol amendments.

12:30 pmWhat Should You Add to Your Current Data Strategies and Analytics Platforms for Disruptions Driven by COVID-19??

Greg Jones, eClinical Enterprise Strategy, Health Sciences, Oracle

The past 2 years have translated directly into “go faster” and embrace “virtual”. Your data strategies and analytics platforms can be foundational to the need to make this shift. This presentation will discuss critical elements to add to your data strategy and your analytics platform to facilitate your successful evolution to this new normal.

1:00 pm Transition to Lunch

1:05 pmLUNCHEON PRESENTATION: Faster, Smarter, Safer: Three Clinical Data Management Practices for the New Data Normal

Wayne Walker, SVP, Rave Platform Technology, Medidata, a Dassault Systèmes Company

Not all data is created equal. The variety of data sources and the volume and velocity of data, accelerated by the growth in decentralized trials bring new challenges for data management and monitoring teams. We’ll explore the changing data landscape and its challenges, and describe three pillars for modernizing clinical data management technology and processes to deliver higher quality data and critical insights, faster.

1:35 pm Coffee and Dessert Break in the Exhibit Hall (Gatlin Ballroom BCD)

2:30 pm Chairperson's Remarks

Chairperson to be Announced

2:35 pm

Building a Data Governance Structure Across R&D at Scale

Kiran Kodali, MBA, Global Data Strategy & Governance Lead, R&D, Sanofi

Karen Fanouillere, Head of Clinical Information Governance, Sanofi

We see the trend of a rapid growth at which data is being generated and consumed across organizations and industries. Most organizations have the ambition to manage ‘data as a strategic asset’ and maximize ‘the value from data.' To achieve this, organizations need to build a strong governance framework that would enable fast and seamless access to high quality data which will be used in generating insights that are critical for decision making across the value chain.

3:05 pmSimplifying AI adoption for clinical data analysis

Gary Shorter, Head, AI and Data Science, Artificial Intelligence, IQVIA Technologies

The shift from point solutions and manual tasks to a streamlined, connected, AI/ML driven data strategy can be a hard sell for risk averse stakeholders. But when life sciences companies take a well-defined crawl/walk/run/fly approach it can ease the transition and win over skeptics. Learn how taking a staged approach to automation can ease the transition and help move your data teams from data management to data science.

3:35 pm

Clinical Data for Translational Research – From Simple Questions to Complex Data Science Projects

Andrea De Souza, Senior Director, Research Data Sciences & Engineering, Eli Lilly & Company

Yue Wang Webster, PhD, Director, Information and Digital Solutions, Eli Lilly & Co.

Translational research is the process of turning observations in the laboratory, clinic, and community into interventions that improve the health of individuals. This is a bidirectional process. In the last two years, we have built a platform that enables scientists to gain biological insights from clinical observations by putting analysis-ready data in the hands of the scientists with speed and security.

4:05 pmHow to Measure Success in a Decentralized Trial

Jennifer Price, Executive Director, Data & Analytics, THREAD

It’s estimated that one quarter of all clinical studies have included a decentralize component or components. Our tools for measuring performance and success within these types of studies need to change to stay relevant to this new paradigm. There are currently no standards for metrics in decentralized trials. This presentation will provide thought leadership on a new analytics methodology to measure the compliance, timeliness and quality in a decentralized trials environment.

4:35 pm Find Your Table and Meet Your Moderators

4:40 pm Interactive Discussions

Interactive Discussions are informal, moderated discussions, allowing participants to exchange ideas and experiences and develop future collaborations around a focused topic. Each discussion will be led by a facilitator who keeps the discussion on track and the group engaged. For in-person events, the facilitator will lead from the front of the room while attendees remain seated to promote social distancing. For virtual attendees, the format will be in a Zoom room. To get the most out of this format, please come prepared to share examples from your work, be a part of a collective, problem-solving session, and participate in active idea sharing. Please visit the Interactive Discussion page on the conference website for a complete listing of topics and descriptions.

5:25 pm Welcome Reception in the Exhibit Hall (Gatlin Ballroom BCD)

6:40 pm Close of Day

Wednesday, February 9

7:15 am Registration Open (Gatlin Foyer)

BREAKFAST PRESENTATIONS

Come enjoy a breakfast with your peers while listening to your choice of two compelling industry presentations.

7:45 amPractical Approaches for Operationalizing DCTs Room Location: Gatlin A1

Kyle Hogan, President, Datacubed Health

Sponsors and CROs need more than change management to operationalize decentralized trials. In this session, Kyle Hogan will outline the approaches sponsors and CROs can take to build value in the decentralized trial participant journey, from pre-implementation to study launch and monitoring.

7:45 amOptimizing Clinical Trial Site Selection Utilizing Real-World Data  Room Location: Gatlin A2

Andrea Valencia Dremelj, Director BioPharma Business Operations, Biopharma, SOPHiA GENETICS

Delays in clinical trial patient enrollment are significant challenges for sponsors, especially for biomarker-targeted investigational therapies associated with rare genomic variants. Join us and discover the solutions offered by SOPHiA GENETICS, leveraging insights from multimodal datasets - including 770’000 genomic profiles - curated across 780+ healthcare institutions. We can better enable biomarker-driven clinical trials in oncology and inherited rare disorders to meet recruitment goals by identifying potential sites worldwide.

8:15 am Session Break

8:20 amChairperson's Remarks

Paul Bidez, Industry Vice President, Life Sciences, Manufacturing & Automotive, Industry Sales, Appian

8:25 am

Risk-Based Clinical Data Review: The Case for Expanding Risk-Based Approaches in Data Management

Catherine Celingant, Executive Director, Data Monitoring & Management & Lead, Oncology TA, Pfizer Inc.

Regulators have been encouraging trial sponsors to incorporate risk-based approaches into their clinical trial management practices for a few years now. Moreover, regulatory thinking seems to be evolving toward a pragmatic definition of data quality as “the absence of errors that matter”. This presentation will include current thinking and actual implementation of risk-based approaches to clinical data and metadata review.

8:55 am10X Efficiency in Clinical Data Quality Processes

Srinivasan Anandakumar, Vice President, Product Management, Saama Technologies

Current clinical data quality processes are manual, time-consuming, and prone to error. With a standards-based approach, accompanied by advanced systems that provide automation, analytics, and AI, sponsors can drive the efficiencies required to keep up with the explosive growth of data. In this session, you’ll learn best practices for cleaning, analyzing, and standardizing data from disparate sources so it’s ready for analysis and submission in record time.

9:25 am

Staying Ahead of the Curve: The Future Direction of Modernization of Statistical Analytics (MSA)

Lin Taft, Statistical Leader, Clinical Research, GSK

Following the successful launch of the Modernization of Statistical Analytics (MSA) Framework in 2021, and a conference and webinar tour across the industry, the TransCelerate Modernization of Statistical Analytics (MoA) team will provide an update on where they see the industry is, with respect to modernized analytical platforms, and what impact the MSA Framework has made.

9:55 amUsing Smart Standards-Driven Digital Protocols to Simplify the Design and Implementation of Clinical Trials

Eugene Schneider, M.D., EVP, Chief Clinical Development Officer, Clinical Development, Ionis Pharmaceuticals, Inc.

Scott Chetham, Ph.D., Co-Founder & CEO, Faro Health Inc.

In clinical trials, documents, data, and applications are separate with no single source of truth. Imagine a world where we can design/implement clinical trials in days. This vision is becoming reality with the use of smart templates to build trials and standards based ontologies linking downstream systems while using data to build real-time patient journeys and budget insights. Key learnings from co-developing and piloting a standards based platform will be shared.

10:25 am Coffee Break in the Exhibit Hall (Gatlin Ballroom BCD)

11:20 am

Chairperson's Remarks

Aman Thukral, Director & Head, Clinical Systems & Digital Operations, AbbVie, Inc.

11:25 am

Procedures Library Utilization: The Devil is in the Data Details

Mitzi Allred, PhD, Director, Clinical Operations & Head, Clinical Content Standards, Merck

Michael Morozewicz, Senior Manager, Biomedical Data Stewardship, Amgen

Development of standardized protocol structure has resulted in increased consistency across the industry, but continued standardization efforts are needed to further advance modernization of clinical research. By partnering with Standard Setting Organizations (SSOs) to develop common procedure descriptions that are accessible through user friendly technologies, numerous benefits could be realized. The project team examined several existing terminologies and data exchanges, summarized findings, and proposed a call to action for SSOs and collaborators to advance next steps.

11:55 am Transition to Lunch

12:00 pm Bridging Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

12:00 pmLUNCHEON PRESENTATION: What Is a Digitalized Clinical Trial and Why Should I Care About It?

Barrie Nelson, Vice President, Digital Clinical Innovations & Chief Standards Officer, Nurocor

Ralph Russo, Senior Director, Clinical Database Management and Standards, Pfizer

Steve Stowers, Director of R&D IT Business Partnering for Clinical Late Development Therapeutic Areas, R&D IT, Bristol Myers Squibb

In terms of industry adoption of digitalized processes, the Pharma industry is outpaced by every other industry sector apart from Oil & Gas. Digitalization opportunities exist for many aspects of clinical research. A digital backbone for clinical trials replaces analog documents, offers opportunity to reuse content across the lifecycle, allows more processes to run in parallel, connects systems and significantly shortens cycle times. Digitalization is the future for the Pharma industry.

1:30 pm Close of Part A Conference. Join Plenary Keynotes and stay on for Part B of SCOPE Summit!*

1:30 pm KEYNOTE PRESENTATION:

Welcome Remarks from CHI and the SCOPE Team

Micah Lieberman, Executive Director, Cambridge Healthtech Institute (CHI)

Thank you all for being here from the SCOPE team: Micah Lieberman, Dr. Marina Filshtinsky, Kaitlin Kelleher, Bridget Kotelly, Mary Ann Brown, Ilana Quigley, Patty Rose, Julie Kostas, and Tricia Michalovicz

1:35 pm KEYNOTE PRESENTATION:

Why Advancing Inclusive Research is a Moral, Scientific, and Business Imperative

Meghan McKenzie, Principal, Inclusion, Patient Insights and Health Equity, Chief Diversity Office, Genentech

Our industry is rightfully focused on the importance of diversity, equity, and inclusion in clinical trials. Many of us have been focused on this in our work and/or in our advocacy, both inside and outside of our organizations for some time. Why is inclusivity so important to PIs and patients? Why is it both a moral and a business imperative? Learn why representation in clinical research matters for your patients and how it shapes good science. The face of the world is changing and your success is tied to reaching ethnic minorities.

2:00 pm KEYNOTE PRESENTATION:

Implicit Bias Around Advocacy and Decision Making: Metrics of DE&I and Speaking the Language of Business and Leadership

Panel Moderator:

Kimberly Richardson, Research Advocate, Founder, Black Cancer Collaborative

What is the perspective of Black professionals and patient advocates as the medical and scientific industries grapple with effective ways to engage minority population? Where are their voices being heard and what can we learn from the cultural experiences they weave into their research methodologies and daily practices? Panelists will share their perspectives on how the Black voice should be included in advocacy and public and private aspects of clinical research.

Panelists:

Karriem Watson, PhD, Chief Engagement Officer, NIH

Monique Phillips, Global Diversity and Inclusion Lead, Bristol Myers Squibb Co.

Nikhil Wagle, MD, Assistant Professor, Harvard Medical School, Dana-Farber Cancer Institute

2:45 pm Booth Crawl & Refreshment Break in the Exhibit Hall (Gatlin Ballroom BCD)