Data

Clinical Data Strategy and Analytics

Artificial Intelligence in Clinical Research

CHIの第14回年次データストリームでは、臨床研究のデジタル技術の第一人者が集まり、E-clinical技術が臨床研究業界とヘルスケアITの展望をどのように変化させたかを検証しています。ヘルスケアデータのデジタル化、DDC(direct data capture)技術、臨床データのためのAI、臨床試験運営の最適化は、臨床データ管理と分析に影響を与える主な技術的進歩の一部です。このトラックでは、この分野の専門家が課題に取り組み、急速に変化する環境で成功するために必要な実用的なソリューションを明らかにします。2部構成となっており、個別のトピックと登壇者を設けています。第1部:臨床データ、戦略と分析(2月7日〜8日)、第2部:臨床研究における人工知能(2月8日〜9日)

2月6日(月)

SCOPE's 2nd Annual Masters of Clinical Research Golf Tournament* 8:00 am

Connect with your peers and colleagues at SCOPE's 2nd Annual Masters of Clinical Research Golf Tournament.
*Limited space available. Separate registration and fee required for Golf.

Conference Registration Open9:00 am

Open Workshop: Introducing ClinEco, the New B2B Clnical Trial Community and Marketplace1:00 pm

Sit down with a small cross-industry group for a 45-minute hands-on session to learn about, share feedback, and register for free for the new B2B clinical trial community and marketplace. ClinEco unites sponsors, CRO's, service providers, and sites to streamline partnering and vendor selection. We are currently onboarding leaders in clinical research to: Explore the Ecosystem. Engage Partners. Exchange Capabilities. Walk-ins welcome. Open to all SCOPE attendees.

User Group Meetings2:00 pm

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.

Part 1: Clinical Data Strategy and Analytics

ADDRESSING RACIAL INEQUITIES IN CLINICAL TRIALS & PARTICIPANT ENGAGEMENT AWARDS

5:00 pm

Organizer's Welcome Remarks and 2nd Annual Masters of Clinical Research Golf Tournament Awards

Micah Lieberman, Executive Director, Cambridge Healthtech Institute

5:05 pm Plenary Keynote Introduction

Tarra Shingler, Chief Commercial Officer, StudyKIK

5:10 pm INTERACTIVE PANEL:

Lighting a “Beacon of Hope” to Address Racial Inequity in Clinical Trials, Health, and Education

PANEL MODERATOR:

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

Launched in July 2021 as a $33.7M commitment from Novartis and the Novartis US Foundation, Beacon of Hope began as a 10-year collaboration to increase diversity among clinical trial participants and investigators; improve access to high-quality education and promising jobs; address inherent bias in the data standards, and find actionable solutions to environmental and climate issues that disproportionately affect health among communities of color. This session brings together leaders from collaborating partner companies Novartis, Sanofi, Merck, and one of the participating HBCUs to discuss how Beacon of Hope aims to improve the quality and inclusivity of clinical trials.

PANELISTS:

Adrelia Allen, PharmD, PMP, Director, Clinical Trial Patient Diversity, Merck

Rajbir Singh, MD, Executive Director of Precision Medicine and Health Equity Trials Design, Meharry Medical College

Priscilla Pemu, Doctorate, MBBS MS FACP, Associate Dean Clinical Research at Morehouse School of Medicine

Kimberly Fookes, Global Head, Diversity & Inclusion in Clinical Trials, Novartis

Celia J. Maxwell, MD, Associate Dean for Research, Howard University College of Medicine, Medicine & Health Affairs, Howard University Hospital

Jaydutt Vadgama, Prof & Exec VP Research & Health Affairs & Chief, Cancer Research & Training & Internal Medicine, Charles R Drew Univ of Medicine & Science

Naikia Byrd-Atkinson, Director, US Clinical Trials Diversity and Inclusion, Sanofi

SCOPE's 7th Annual Participant Engagement Awards Introduction5:40 pm

5:45 pm

SCOPE's 7th Annual Participant Engagement Awards

PANEL MODERATOR:

Kelly McKee, Vice President, Decentralized Clinical Trials (DCT), Medidata

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

Now in its 7th 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. PEA embodies the values and personal accomplishments of Jerry Matczak, who sadly passed away soon after receiving the inaugural 2017 award. We dedicate this award to Jerry in the hopes that it will serve as a reminder of his ideals and accomplishments. SCOPE’s 2023 Participant Engagement Award program is brought to you by Cambridge Healthtech Institute (CHI)’s SCOPE and is accepting submissions at: participant-engagement-award

PANELISTS:

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

Anne Marie Mercurio, Clinical Trial Volunteer and Patient Advocate

Marisa Rackley, Vice President, Clinical Site Start Up, Site Engagement, Trial Optimization, Takeda

Irena Webster, Vice President, Head of Development Operations, Forma Therapeutics

Kelly White, Senior Director, Head, Global Trial Optimization, Oncology, Merck & Co.

Kendal Whitlock, Head, Digital Optimization, RWE Clinical Trials, Walgreens Co.

SCOPE's Kick-Off Happy Hour6:30 pm

Close of Day7:45 pm

2月7日(火)

Registration Open7:00 am

Morning Brew & Pastries to Jumpstart Your Day (Sponsorship Opportunities Available) or Morning Coffee7:30 am

THE REALITY OF A TRIAL EXPERIENCE & NAVIGATING A GLOBAL CRISIS

8:30 am

Chairperson's Remarks

Marina Filshtinsky, Conference Producer, Cambridge Healthtech Institute

Micah Lieberman, Executive Director, Cambridge Healthtech Institute

8:35 am Chairperson'sPlenary Keynote Introduction

Jim Reilly, Vice President, Development Cloud Strategy, Veeva Systems

8:40 am

Would I Want My Mother to Be Part of a Clinical Trial?

Virginia Nido, Global Head, Product Development Industry Collaborations, Genentech, a member of the Roche Group

For many years, our industry has been talking about becoming more patient-centric and innovative in our approach to clinical trials and all the great things we are doing to make clinical trials more convenient for participants. But have we really changed the experience for patients or are we just continuing to admire the problem? Would you really want YOUR mother to be part of one of your clinical trials? We need to get real. It should not take a pandemic to make changes to our protocols and processes and ways of working. But we still have so far to go and together we must continue to drive an uncomfortable level of change.

9:05 am INTERACTIVE PANEL:

Navigating a Global Crisis: Pandemic, War, Hyperinflation, Supply Chain Disruptions…You Name It

PANEL MODERATOR:

Balazs Flink, Senior Director, Clinical Development Operations, Daiichi Sankyo, Inc.

Running a complex clinical trial involves a lot of moving pieces, forward planning, modeling, allocation of resources, and a neverending ability to adjust while maintaining the highest standards. It has never been easy, but many of us in the clinical research profession know how to do our part. The advent of DCTs, novel tech and data sources, and then the pandemic put us all to the test. However, we are now facing supply chain disruptions and other human/material resource challenges that make everything even more complicated. What is a clinical ops leader to do?

PANELISTS:

Gaurav Sawhney, Vice President, Head, Clinical Partner Management, Takeda Pharmaceuticals, Inc.

Bryan O'Neill, Global Head, Clinical Supply Operations, Daiichi Sankyo, Inc.

Deborah Profit, PhD, Vice President, Clinical Management & Applied Innovation, Otsuka America Pharmaceutical, Inc.

Ken Getz, Executive Director, Tufts Center for the Study of Drug Development

Help Us Set A World Record: Join Everyone For Group Photo At 9:25 Sharp In The Keynote to Make History!9:30 am

Grand Opening Coffee and Refreshment Break in the Exhibit Hall9:35 am

NEW TOOLS AND APPROACHES

10:35 am

Chairperson's Remarks

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

10:40 am

Methods for Automating Clinical Database Build - How to Leverage Metadata to Reduce Cycle Times

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

This session will showcase methods to minimize the cycle time for database build. The session will highlight a simple method to leverage standard metadata to iteratively prototype the clinical database while the protocol matures. We’ll explore emerging methods that build upon this concept to further reduce cycle times and increase quality.

11:10 am

Status Update of a next generation platform to optimize transformation and review of increasingly complex clinical trial data

Ward Lemaire, Head of Data Management, Integrated Data Analytics & Reporting, Janssen, J&J

Medical and Clinical data review is crucial to clinical development, assuring patient safety, determining drug efficacy, and assessing data quality. It involves a rigorous analysis of a wide variety of clinical data and as of today, this is largely executed using disjointed manual processes requiring integration of data from multiple sources before being able to extract actionable insights. Raw data, such as eDC, IVRS, Lab, etc., needs to be transformed into a standardized, user-friendly data model that can be visualized through different systems for review and discrepancy management by different functions. With the accelerated increase and complexity of clinical data sources we need to modernize and mature our digital environments to manage data flow and data review activities in a way that we can take full advantage of automation, get to near real-time access to data and provide the capability for integrated review processes and collaboration across the departments. Besides functional benefits, the platform will realize significant cost and time efficiencies and prepare for future capabilities driving risk based medical and clinical data review with Artificial Intelligence and Machine Learning capabilities.

11:40 am

Building Next-Generation Systems for Clinical Development

Narayanarao Pavuluri, Senior Director & Global Head, Clinical Database Services, Merck

The current generation of the software systems used in Clinical Research are siloed and moving the data from one system to another needs connectors and data movement. When the final submission is prepared, or any other major event such as Database lock for a study is performed, there is a lot of coordination and management to align all the functions. How can we build the next-generation of interconnected systems to alleviate these issues, and streamline processes to have a smooth flow of data with proper controls while providing enhanced functionality, user experience, and flexibility to individual functional areas

12:10 pm Artificial Intelligence Can Improve Patient Experience in Decentralized Clinical Trials

Lukasz Kidzinski, PhD, Director of Artificial Intelligence, Research & Development - Imaging, Clario

Kevin Thomas, PhD, Director of Artificial Intelligence, Research & Development, Clario

The clinical trial industry is undergoing a rapid transition toward decentralization, where some or all health assessments are performed remotely in participants’ homes instead of in medical centers. Adopting artificial intelligence in this setting can empower more patients to enroll in trials, successfully complete them without burden, and submit high-fidelity assessments of their health. In this talk we will discuss insights from our recent article in Nature Medicine on this topic.

Transition to Lunch12:40 pm

12:45 pm LUNCHEON PRESENTATION:Using AI to Drive Clinical Data Automation

Suman Kumar, Senior Manager, Life Sciences, Deloitte

Girish Rajeev, Global Head, Clinical Data Standards, Takeda Pharmaceuticals

The traditional flow of data across the clinical trial life cycle can become a complicated maze of manual effort, rework, and inefficiency-contributing to trial time and cost. Companies should harness AI to streamline the clinical trial data lifecycle, and open new opportunities. We’ll discuss: Challenges with traditional approaches to managing clinical study data and potential for AI to deliver faster, more efficient, and significantly less expensive clinical trials.

Coffee & Dessert Break in the Exhibit Hall (Sponsorship Opportunities Available)1:15 pm

ADVANCED ANALYTICS FOR CLINICAL OPERATIONS TRANSFORMATION

2:10 pm

Chairperson's Remarks 

Lily Xu, PhD, Senior Principal Data Scientist, Data Science, Vertex Pharmaceuticals, Inc.

2:20 pm

Accelerating Clinical Trial Enrollment via Med.ai - Site Intelligence Hub

Asha Mahesh, Director, Data & Analytics Engineering & Data Platforms, R&D Data Science, Janssen R&D

Site selection is one of the known bottlenecks for clinical trials. We created Site Intelligence Hub to overcome some of the challenges and to accelerate the process of study start-up.

2:45 pm Moving Clinical Research into the Digital Era with Autonomous Clinical Data

Julie Smiley, Senior Director Life Sciences Product Strategy, Oracle

With the exponential growth and complexity of clinical trial data sources, traditional study setup and conduct processes are becoming unsustainable.  Hear how Oracle has leveraged the TransCelerate DDF toolkit to automate study setup and data flow to help sponsors and CROs significantly streamline processes, while reducing costs and timelines.

3:15 pm

Hype vs Reality - How to Operationalize Data Science Approaches for Trial Operations

Taylor Uttley, Senior Director, Head of Strategy and Operations, Data Strategy & Solutions, Vertex Pharmaceuticals, Inc.

Lily Xu, PhD, Senior Principal Data Scientist, Data Science, Vertex Pharmaceuticals, Inc.

Using data Science to support trial operations has great potential to help accelerate and optimize clinical trials. We have experimented over the years with using public and private data sources to help study teams select sites and PIs, which is very important but sometimes challenging for rare disease clinical development. Along the way, we have realized that it is critical to work with the business to optimize the right questions for AI/ML applications to get the most value from large-scale RWD datasets. Lessons learned from the data science point of view will be shared.

3:45 pm Using In-Trial Analytics to Drive DCT Endpoint Quality

Alan Kott, Clinical Vice President, Practice Lead, Data Analytics, Signant Health

In this session we will present examples and use cases for applying advanced data analytics tools and principles to optimize endpoint quality in decentralized trials. 

DATA REQUIREMENTS FOR AI - POWERED SOLUTIONS

4:15 pmFind Your Table and Meet Your Moderator
4:20 pmInteractive Breakout Discussion Groups

Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the key issues presented earlier in the day’s sessions. Delegates will join a table of interest and become an active part of the discussion at hand. Bring your pharma, biotech, CRO, site, hospital or patient perspective to each of the discussions below. To get the most out of this interactive session and format please come prepared to share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing. Please visit the Interactive Breakout Discussion Groups Page for more information.

Welcome Reception in the Exhibit Hall5:00 pm

Close of Day6:30 pm

SCOPE out Pointe Orlando for an entertaining night out via our Courtesy Shuttle* (Sponsorship Opportunities Available)6:30 pm

*Courtesy shuttles will be available Tuesday and Wednesday 6:30-10:30pm (last pick up), bringing you to and from The Pointe Orlando.

The Pointe Orlando is an open air-entertainment destination, featuring local and brand names restaurants, bars, nightclubs, 20-screen movie theater, comedy club and family attractions.

Shuttles will run a continuous loop 6:30-10:30pm (last pick up) between Rosen Shingle Creek, Hilton Orlando, DoubleTree Orlando at SeaWorld, and Pointe Orlando. 
On-site look for our courtesy shuttle signage directing you to pick up locations within the hotels.

2月8日(水)

BREAKFAST PRESENTATIONS

8:00 amRegistration Open
8:30 am Breakfast Presentation Option #1Achieving the Impossible: Maximizing Patient Experience and Data Quality in a Complex Rare Disease Program

Caroline Jackson, Executive Vice President, Patient Services, mdgroup

Mobile health has a significant impact on patient retention and experience in clinical trials. However,it’s still under-utilized as there is a perception that more complex assessments and procedures cannot be conducted effectively in the home. This case study highlights how mdgroup worked with a client to implement complex sample collections in the homes of patients suffering from a rare disease, resulting in reduced travel burden and low dropout rates.

8:30 am Breakfast Presentation Option #2Strategies for Biopharma Companies to Boost Clinical Trial Enrollment

Dennis Akkaya, Chief Commercial Officer, myTomorrows

We would like to invite you to join us for an informative event about overcoming obstacles in recruiting patients for BioPharma clinical trials. During this event, we will delve into barriers such as lack of awareness and financial considerations that can impede clinical trial recruitment success. Additionally, impactful strategies to increase clinical trial participation and recruitment success will be shared.

9:00 amSession Break

AI FOR DATA SOLUTIONS

9:10 am Chairperson's Remarks

Jennifer Duff, MBA, General Manager, Clinical Development Solutions, Merative

9:15 am

Debunking the Myths with the Application of Advanced Analytics in Clinical Development

Nareen Katta, Head of Data Science & Analytics, AbbVie, Inc.

The data and analytics space continues to evolve rapidly, and leaders often get overwhelmed by the technical jargon like Big Data, Machine Learning, Artificial Intelligence, etc. This talk explores different case studies that highlight the successes and challenges of enabling advanced analytics in clinical development.

9:45 am Digitalized Clinical Development: The Future of Pharmaceutical Drug Development

Gregg Dearhammer, Senior Vice President, Data Sciences, Safety & Medical Services, IQVIA

Barrie Nelson, Founder & Executive Vice President, Clinical Innovation, Nurocor

Mike Sullivan, Executive Director, Global Clinical Development IT, Bristol Myers Squibb

Biopharma Companies are moving toward full automation and harmonization of business processes across the clinical development lifecycle, beginning with digitalized protocol through regulatory approval. This digital automation leads to efficiencies, which will significantly reduce the time and cost of drug development. Key industry organizations and thought leaders will share their experiences in realizing full digitalized clinical development. 

10:15 am A NEW Paradigm of Engineering-Forward Analytics Solutions Powering Digital Biomarkers

David Anderson, Ph.D., Principal Scientist, Clinical ink

Digital health technologies and biomarkers in clinical trials requires the highest standards of data collection, transmission, security, quality, and analysis. Scalable clinical analytics platforms built within core engineering frameworks are the only way to ensure the integrity, repeatability, and value of data standards and insights. The groundbreaking WATCH-PD study exemplifies how high-dimensional data sources - allowing more precise, objective, and higher frequency patient monitoring - enable digital biomarker development.

Coffee Break in the Exhibit Hall (Sponsorship Opportunities Available)10:45 am

AI FOR DATA SOLUTIONS (CONTINUED)

Sponsored Chairperson's Remarks (Opportunity Available)11:40 am

11:45 am

AI Usage in Clinical Data

Christopher P. Lamplugh, Associate Vice President & Head, Global Data Management & Standards, Merck & Co., Inc.

Rakesh Maniar, Head of eClinical Technologies, Global Data Management & Standards, Merck & Co.; Co-Lead, TransCelerate eSource Initiative; Immediate Past Co-Chair/Co-Founder, SCDM eSource Implementation Consortium

Exploration of AI training, accuracy and the precision of outputs in the validation of clinical data.

12:15 pm AI/ML Enabled by the End-to-End Digital Data Pipeline

Munther Baara, Vice President, Product Strategy and Innovation, EDETEK Inc.

Transition to Lunch12:45 pm

Part 2: Artificial Intelligence in Clinical Research

12:50 pm LUNCHEON PRESENTATION:Optimize Data Acquisition in a Data-Rich World

Walker Bradham, Product Leader, Clinical Development, Product Management, Merative

Amanda Cross, Vice President, Biometrics, Worldwide Clinical Trials

Jennifer Duff, General Manager, Clinical Development Solutions, Product Management, Merative

Whether you ride atop the wave of data in your next clinical trial, or swim hard against it depends on this: getting data management right - he first time. Learn about action-oriented tools that make it easier to collect, access and ensure data integrity and traceability for all the data you harness during decentralized trials. Employ quick configurations and built-in validation, then use that ocean of valuable data to deliver measurable results.

Coffee & Dessert Break in the Exhibit Hall with "Best of Show Award" Winner Announcement1:20 pm

NEXT-GENERATION DATA SOURCES & BUILDING A ROADMAP FOR AN R&D ORGANIZATION

2:20 pm Plenary Keynote Introduction

Ivor Clarke, CEO, SubjectWell

2:25 pm

Faster, Better, Cheaper: The Increasing Role and Opportunities for Real-World Evidence in Informing Regulatory Pathways

Christopher Boone, PhD, Global Head, Health Economics & Outcomes Research, AbbVie, Inc.

An open dialogue on the facilitators, barriers, and open opportunities to effectively utilize RWE for informing regulatory pathways from a biopharma company perspective. Additionally, we will highlight some of the novel use cases and key lessons learned by biopharma companies in utilizing RWE for discovery and development purposes.

2:35 pm

Advancing Evidence Generation of the Future

Amy Abernethy, MD, PhD, President, Clinical Studies Platforms at Verily; Former Principal Deputy Commissioner, FDA

Clinical research is undergoing a major shift, as we move towards continuous evidence generation to support accelerated drug development and approvals. In this talk, Dr. Abernethy will share her firsthand experience with the evolving use of real-world data and evidence at FDA during COVID. She'll speak to the need for quality longitudinal data sets, the role of technology, and how new approaches are transforming the clinical research field.

2:45 pm

Fireside Chat: Next-Generation Data Sources

Amy Abernethy, MD, PhD, President, Clinical Studies Platforms at Verily; Former Principal Deputy Commissioner, FDA

Christopher Boone, PhD, Global Head, Health Economics & Outcomes Research, AbbVie, Inc.

2:55 pm

Fireside Chat: Future-Ready Operations: Building a Multi-Year Roadmap

Lynne M. Cesario, Executive Director, Global Lead Risk Based Monitoring Program, Pfizer Global R&D Groton Labs

Jane Hiatt, Executive Director, Site Management and Monitoring, Early-Stage Development, Merck

Ward Lemaire, Head of Data Management, Integrated Data Analytics & Reporting, Janssen, J&J

With increases in complexity and new trial modalities, organizations need to constantly assess what the future needs. This chat will focus on the strategic choices and approaches to be considered, and how to plan out such a multi-year roadmap.

Booth Crawl & Refreshment Break in the Exhibit Hall (Sponsorship Opportunities Available). Last Chance for Viewing.3:25 pm

AI TO TRANSFORM CLINICAL DEVELOPMENT

4:25 pm Chairperson's Remarks

Josh O'Rourke, Chief Technology Officer, ObjectiveHealth

4:30 pm

AI for Clinical Operations Solutions

Prasanna Rao, Head, AI & Data Science, Data Monitoring and Management, Clinical Sciences and Operations, Global Product Development, Pfizer Inc.

This session will describe Pfizer's AI journey through the lens of clinical data, use cases, implementation, and key to success. Clinical Data Management for the Vaccine Study presented an opportunity for ML/NLP to assist in saving valuable time reconciling data. The foundation for a Smart Data Quality strategy was expanded to other TAs thanks to the solution's Pattern Recognition and Clinical Inference capabilities that will be explained in detail.

4:50 pm

Natural Language Generation in Clinical Research 

Brian Martin, Head of AI, R&D Information Research, Research Fellow, AbbVie, Inc.

Large language models are enabling a new realm of capability for Natural Language Transformation and Generation. The ability for computer systems to translate, transform, and even generate text will accelerate with a high value return many of our clinical processes.  We'll outline FOCAL - the Framework for Optimizing Clinical AI Language Workflows that we are building at AbbVie.

5:10 pm

Graph Machine Learning Meets Clinical Ops: The Lessons Learned and Best Practices from Building TrialGraph  

Shameer Khader, PhD, Senior Director AI & Machine Learning & Data Science, Digital Health & Bioinformatics, AstraZeneca Pharmaceuticals, Inc.

Pharmaceutical companies can leverage systematic analyses of the data streams generated during clinical trials to improve future clinical trials. However, traditional analytical approaches cannot handle variables' sparsity or high-dimensional relationships. We have been developing TrialGraph - a technology solution to intelligently optimize tasks, including side effect prediction. During this session, I will share our lessons learned and best practice recommendation in building enterprise-scale analytic solutions to accelerate clinical development.

5:30 pm Connected Intelligence from Enrollment Planning to Trial Conduct

West Barnes, Senior Director, Product Analytics Center of Excellence, R&D Solutions, IQVIA

Wendy Morahan, Senior Director, Clinical Data Analytics, IQVIA Technologies

In this session you will learn how IQVIA is using real-world data and connected intelligence to build decision support technologies that can optimize clinical trial strategies based on sponsor constraints such as cost, risk, and time. West Barnes and Wendy Morahan will provide a closer look at how AI powered technologies can enable you to uncover deeper insights, make better decisions, and improve outcomes.

6:00 pm

What to build an AI model? Start with a data strategy first.

Victoria A. Gamerman, PhD, Global Head of Data Governance, Boehringer Ingelheim Pharmaceuticals, Inc.

Accelerating speed of delivering medicines to the people who need them starts with understanding the end to end data flow. This includes organizational models that have capabilities to describe data with its biases and leverage metadata to support the speed of finding necessary information contained in the data. The solution starts with a holistic Data Strategy that lives at the intersection of Clinical Strategy and Digital Strategy.

Close of Day6:30 pm

SCOPE out Pointe Orlando for an entertaining night out via our Courtesy Shuttle* (Sponsorship Opportunities Available)6:30 pm

*Courtesy shuttles will be available Tuesday and Wednesday 6:30-10:30pm (last pick up), bringing you to and from The Pointe Orlando.

The Pointe Orlando is an open air-entertainment destination, featuring local and brand names restaurants, bars, nightclubs, 20-screen movie theater, comedy club and family attractions.

Shuttles will run a continuous loop 6:30-10:30pm (last pick up) between Rosen Shingle Creek, Hilton Orlando, DoubleTree Orlando at SeaWorld, and Pointe Orlando. 
On-site look for our courtesy shuttle signage directing you to pick up locations within the hotels.

2月9日(木)

Registration Open7:15 am

BREAKFAST PRESENTATIONS

7:45 am Impacting Timelines vs Impacting Resources - It's Not Either / Or Anymore

Lisa Moneymaker, Chief Technology & Product Officer, Saama

Our industry is challenged to find the right resources to drive operational best practice. There is also an expectation to move at the “speed of Covid” for every trial. It feels like an either/or.

 

However, you can have both. You can accelerate timelines with fewer resources.

 

Join this exciting session to learn about:

  • The biggest time and resource drains on clinical trials

  • Applying AI/ML to improve efficiency

  • Challenging your own internal processes to get to market faster

Session Break8:15 am

CASE STUDIES AND ETHICAL USE DISCUSSION

8:25 am Chairperson's Remarks

Aditya Gadiko, Director, Product Management, Saama

8:30 am

AI-Enabled Endpoints and Decision-Making in Clinical Development

Gregory Goldmacher, MD, PhD, MBA, Head of Clinical Imaging, Merck & Co.

One of the most powerful applications of artificial intelligence is a form of pattern recognition that can operate at scale, using inputs that humans find difficult or impossible to evaluate. This allows measurement of safety and efficacy in clinical trials using fewer subjects, with greater confidence in the result than is possible with traditional methods. This, in turn, enables decision-making in early development that saves resources and reduces the risk of expensive late-stage failures. We will discuss the opportunities for sponsors to improve their trials using AI tools, with illustrative examples.

9:00 am Utilization of Artificial Intelligence and Lessons Learned from the Ph3 VISION Trial

Phillip Kuo, MD, PhD, Senior Medical Director, Scientific and Medical Services, Invicro

During this talk, we will discuss:
- Overview of the key obstacles and successes of the VISION trial
- Rationale underpinning the novel read criteria for the VISION trial
- Use of artificial intelligence in the quantification of PET imaging
- Combining quantification and personalized dosimetry to potentially improve outcomes.

9:25 am

How much uncertainty can AI eliminate in recruitment rate prediction?

Lucas Glass, Vice President, Analytics Center of Excellence, IQVIA

Estimating enrollment rates accurately is a critical function of portfolio and study planning but accurate estimations are notoriously difficult. Artificial intelligence can be used to generate recruitment rate predictions that mitigate risk and uncertainty. This presentation outlines methods, approaches, experimental results, and practical considerations for using machine learning to predict enrollment rates for clinical trials.

9:50 am

Leveraging AI and Machine Learning to Assemble Documents for Clinical Events Adjudication

Kris Ulstad, Staff Clinical Software Engineer, Clinical Data Operations, Abbott

Clinical Studies Adjudication (CSA) has been providing study teams and external committees with an easy way to set up, manage and submit clinical event assessments since 2011. We have made major enhancements to automate workflow and reduce event prep time. We have incorporated our Document Redaction Tool which uses Machine Learning to identify and redact PHI and other confidential information. With a new dashboard to help prioritize tasks, the CSA’s improved functionality will help users spend less time browsing screens and more time managing events so they can get adjudicated on time.

10:15 am PANEL DISCUSSION:

Ethical Use of AI: GMLP in Clinical Trials 

PANEL MODERATOR:

Prasanna Rao, Head, AI & Data Science, Data Monitoring and Management, Clinical Sciences and Operations, Global Product Development, Pfizer Inc.

This panel will address critical issues of AI applications in clinical development from the ethical use of AI point of view.

PANELISTS:

 Ethical Use of AI: GMLP in Clinical Trials

Brian Martin, Head of AI, R&D Information Research, Research Fellow, AbbVie, Inc.

Matthew Studney, Vice President, MRL IT, Merck & Co.

Lucas Glass, Vice President, Analytics Center of Excellence, IQVIA

Networking Coffee Break10:45 am

STRATEGY LEVEL DATA SOLUTIONS

11:05 am Chairperson's Remarks

Yan Liu, MD, MSc, PhD, Chief Medical Officer, Median Technologies

11:10 am

More Than Just Reports! - Transformative Journey to Bring Higher Impact

Seongjoon Koo, PhD, Head of Data and Analytics, Global Development Operations, Data & Analytics Global Dev Operations, Amgen Inc

I will introduce our journey to advanced analytics from traditional reporting. The motivation, challenges, initial successes, and lessons learned will be shared.

11:40 am From Concept to Breakthrough: The Case for AI in Data Management

Malaikannan Sankarasubbu, VP, AI Research, Saama

Clinical trials are digitizing rapidly and manual data management processes can’t scale to handle the volume of new data.

 

However, by applying artificial intelligence (AI) to key data management processes, sponsors and CROs can master these new challenges effectively - with existing resources.

 

Join this exciting session to learn how AI can be used to identify patterns and anomalies, recommend coding terms, surface critical actions, clean data automatically, and more.

12:10 pm

Merck's Strategic IT Approach to AI Use in Clinical Development

Matthew Studney, Vice President, MRL IT, Merck & Co.

This presentation will explain the strategic approach and various use cases for the application of AI throughout the Clinical Development environment at Merck.

Transition to Lunch12:40 pm

12:45 pm LUNCHEON PRESENTATION:Using Technology to Streamline Study Conduct in a Scalable, Efficient Manner

David Blackman, Executive Director Digital Trials Strategy, Oracle

Greg Jones, Life Sciences & Healthcare Chief Technology Officer, Oracle

Learn how a consistent foundation spanning governance to provenance of data, automated pipelines for consolidation and aggregation of data, and democratization to the generation of insights through the development of AI/ML models can help streamline your study and provide unprecedented insights into the clinical continuum.

Closing Remarks1:15 pm

Scope Summit 2023 Adjourns1:20 pm

* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。

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