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03: Data-Tech in Clinical Trials [clear filter]
Monday, June 20
 

1:15pm CDT

#111: The Role of Sensors in Clinical Research: Integrating Sensor Generated Data into Data Platforms to Power Clinical Research and Patient Care
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-514-L04-P ; CME 1.00; RN 1.00

To advance the effective and efficient use of remote patient monitoring and digital endpoints in clinical trials at scale, this session will describe best practices for meeting stakeholder needs when integrating sensor data to cloud platforms.

Learning Objectives

Describe the role of data integration to successfully scale sensor technologies to power clinical trials; Define the needs of end users, from participants and investigators to biostatisticians and regulators, of sensor data generated during clinical trials; Apply a best practice framework to optimize sensor data integration into electronic data capture (EDC) systems and other cloud storage solutions.

Chair

Jennifer Goldsack, MA, MBA, MS

Speaker

Industry Update
Ariel Dowling, PhD

Industry Update
Shruti Iyer, MS

Industry Update
Gillian Livock, MBA

Results from a Survey of Biopharmaceuticals on Attitudes Towards the Use of Wearables and Sensors in Clinical Research
Alison Ritchie


Speakers
avatar for Ariel Dowling

Ariel Dowling

Director of Digital Strategy, Takeda Pharmaceuticals, United States
Ariel V. Dowling, PhD is a Director of Digital Strategy within the Data Sciences Institute at Takeda Pharmaceuticals. In this role, Ariel oversees the strategy, assessment, and deployment of digital devices in clinical trials across the organization. She was previously a Senior Clinical... Read More →
avatar for Jennifer Goldsack

Jennifer Goldsack

Chief Executive Officer, Digital Medicine Society (DiMe), United States
Jennifer Goldsack is the Chief Executive Officer of the Digital Medicine Society (DiMe). Founded in 2019, DiMe is the first professional organization for experts from all disciplines comprising the diverse field of digital medicine. Together, we drive scientific progress and broad... Read More →
avatar for Shruti Iyer

Shruti Iyer

Principal Innovation Architect, Clinical Innovation, Oracle Health Sciences, United States
Shruti Iyer is a Principal Innovation Architect supporting Clinical Innovation in the Health Sciences Global Business Unit at Oracle. Shruti has had over seven years of experience at Medtronic as a subject matter expert in end-to-end medical device product development focusing on... Read More →
avatar for Gillian Livock

Gillian Livock

SVP & GM, Connected Devices, Medable, United States
avatar for Alison Ritchie

Alison Ritchie

Sensor Solutions Director, Parexel, United Kingdom
Alison is the Global Head of Sensor solutions at Parexel. Alison has over 23 years’ experience within the clinical trial industry, 19 at Parexel. Alison plays a key role by selecting and implementing real world data and connected sensor device solutions for clinical trial use. Alison... Read More →

Monday June 20, 2022 1:15pm - 2:15pm CDT
Room 179 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  03: Data-Tech in Clinical Trials, Forum |   02: ClinTrials -ClinOps, Forum
 
Tuesday, June 21
 

9:00am CDT

#203: The Site Landscape: Data and Discussion of the State of the Clinical Research Site
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-541-L04-P ; CME 1.00; RN 1.00

Hear and learn from a panel of clinical research sites as they discuss data gathered from other sites all over the world. This data is critical to the continued success and sustainability of the clinical research sites and the panel will discuss what

Learning Objectives

Examine real-world data gathered from sites as it pertains to their operations; Discussdata points from a site prospective, guiding the industry on ways to deepen relationships; Explain how this data has changed and what its applications are to the industry.

Chair

Jimmy Bechtel, MBA

Speaker

Industry Update
David Vulcano, MBA, RAC

Industry Update
Brooke Hanscom

Industry Update
Shannon Zelenka


Speakers
avatar for Brooke Hanscom

Brooke Hanscom

Director, Clinical Site Operations, USA, Global Product Development, Pfizer Inc, United States
Brooke has worked in the pharmaceutical industry for 17 years focusing on clinical operations. With a range of experiences at big pharma, CRO and biotechs, Brooke works to bring the highlights of each type of industry to her current role of Director Clinical Site Operations at Pfizer... Read More →
avatar for David Vulcano

David Vulcano

Honorary President (SCRS); VP, Clinical Research Compliance and Integrity (HCA, HCA Healthcare | Society Clinical Research Sites, United States
David is a well-known leader in the clinical research industry through numerous associations, boards and initiatives. Among other things he is currently employed by HCA Healthcare, the largest private healthcare provider in the United States, as the Responsible Executive for Clinical... Read More →
avatar for Shannon Zelenka

Shannon Zelenka

Associate Director, Clinical Operations, PPD, Part of Thermo Fisher Scientific, United States
Shannon Zelenka has been at PPD, part of Thermo Fisher Scientific for 14 years. She is currently an Associate Director in the North America region for Clinical Operations within the CDSD organization. This includes leadership of 6 Clinical Managers and their teams. She began her career... Read More →

Tuesday June 21, 2022 9:00am - 10:00am CDT
Room 178 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  02: ClinTrials -ClinOps, Forum |   03: Data-Tech in Clinical Trials, Forum
  • Level Intermediate
  • Featured Topics RWD-RWE
  • Level Intermediate
  • Feature Topics RWD-RWE
  • Credit Type ACPE, CME, RN
  • Tags Forum

9:00am CDT

#205: Optimizing Evidence Supporting Fit-for-Purpose Digital Clinical Measures Across the Drug Development Life Cycle
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-543-L04-P ; CME 1.00; RN 1.00

Multi-stakeholder experts who participated in the Digital Medicine Society’s (DiMe) The Playbook will define and document evidentiary requirements for digital clinical measures used in a variety of different contexts of use in drug development.

Learning Objectives

Describe the evidentiary requirements for selecting, fit-for-purpose, meaningful digital clinical measures across the drug development lifecycle; Define the different levels of verification and validation needed to support the deployment of digital clinical measures across the drug development lifecycle, spanning pre-screening and exploratory through phase i, phase ii and phase iii to post-market.

Chair

Smit Patel, PharmD

Speaker

Panelist
Ariel Aguilo, MD

Panelist
Betsy Tschosik, PhD

Panelist
Elizabeth Nicki Bush, MHS

FDA Update
Michelle Campbell, PhD


Speakers
avatar for Ariel Aguilo

Ariel Aguilo

Executive Medical Director, Head Americas Oncology, Global Clinical Development, Labcorp Drug Development, Argentina
Ariel Aguiló, MD, is a board certified oncologist specialized in Gastrointestinal tumors. He is an Executive Medical Director and Head of the Americas Oncology Medical Team for Labcorp Drug Development. He provides subject matter expertise and support for the development and conduct... Read More →
avatar for Elizabeth (Nicki) Bush

Elizabeth (Nicki) Bush

Associate VP and Head, Patient-Focused Endpoints and Measurement, Eli Lilly and Company, United States
Elizabeth (Nicki) Bush is Associate Vice President and Head of Patient-Focused Endpoints and Measurement at Eli Lilly and Company, responsible for the design and implementation of patient-centered measurement strategies to support drug development efforts across Lilly’s portfolio... Read More →
avatar for Michelle Campbell

Michelle Campbell

Associate Director, Stakeholder Engagement and Clinical Outcomes, ON, OND, CDER, FDA, United States
Michelle Campbell is the Associate Director for Stakeholder Engagement and Clinical Outcomes in the Office of Neuroscience, Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). Dr. Campbell joined FDA in 2014 and was previously... Read More →
avatar for Smit Patel

Smit Patel

Program Director, Digital Medicine Society (DiMe), United States
Dr. Smit J. Patel, PharmD serves at the Digital Medicine Society (DiMe), a global non-profit organization dedicated to better health powered by digital medicine. His work focuses on applied approaches to the safe, effective, ethical, and equitable use of digital technologies to advance... Read More →
BT

Betsy Tschosik

Digital Innovation Chapter Head, Patient-Centered Outcomes Research, Genentech, a Member of the Roche Group, United States
Betsy Tschosik is Head of Digital Innovation in Patient-Centered Outcomes Research (PCOR) at Genentech, bringing expertise in patient-centricity and measurement science to the validation and use of digital measures in drug development. Prior to her current role in digital innovation... Read More →

Tuesday June 21, 2022 9:00am - 10:00am CDT
Room 180 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  03: Data-Tech in Clinical Trials, Forum |   02: ClinTrials -ClinOps, Forum
  • Level Intermediate
  • Featured Topics Digital
  • Level Intermediate
  • Feature Topics Digital
  • Credit Type ACPE, CME, RN
  • Tags Forum

2:00pm CDT

#249: Regulatory-Grade Real-World Evidence: Distilling to Practice
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-569-L04-P ; CME 1.00; RN 1.00

Real-world evidence (RWE) is increasingly used to complement randomized clinical trials (RCT), provide a better understanding of real-world effectiveness, and address information gaps. This session will explore various best practices, tools, and methods used.

Learning Objectives

Describe various levels of real-world evidence (RWE) validity and their relationship to current regulatory RWE guidance; Identify rigorous methodological approaches to maintain evidentiary standards and the impact of underlying data quality in RWE study results; Evaluate future study design using advanced RWE to support medical affairs, market access, and regulatory objectives.

Chair

Dan Riskin, MD, MBA

Speaker

Developing High-Validity Real-World Evidence to Meet Clinical, Regulatory, and Commercial Objectives
Dan Riskin, MD, MBA

FDA Update
John Concato, MD, MPH, MS

Practical Tools to Advance Fit-for-Purpose Use of Real-World Data in Regulatory Decision-Making
Cathy W Critchlow, PhD, MSc

Evaluating Machine Learning Derived Real-World Data to Support Regulatory Decision Making
Irene Nunes, PhD


Speakers
avatar for Dan Riskin

Dan Riskin

Founder and Chief Executive Officer, Verantos, United States
Dan Riskin is the founder and CEO of Verantos, the market leader in high-accuracy real-world evidence (RWE) generation. Recognized across the globe as an expert in healthcare AI, Dr. Riskin has developed products that influence the care of millions of patients annually. His advocacy... Read More →
avatar for Cathy Critchlow

Cathy Critchlow

Vice President, R&D Data Strategy, Amgen, United States
Dr. Critchlow leads R&D Data Strategy, focusing on synergizing cross-functional capabilities in multi-omics, clinical trial and real world data (RWD) to increase the probability of success in bringing innovative medicines to patients. She previously led Amgen’s Center for Observational... Read More →
avatar for John Concato

John Concato

Associate Director for Real-World Evidence Analytics, OMP, CDER, FDA, United States
Dr. John Concato is Associate Director for Real-World Evidence Analytics in the Office of Medical Policy, Center for Drug Evaluation and Research, FDA. As an internist and epidemiologist, his responsibilities related to real-world evidence (RWE) include developing internal Agency... Read More →
avatar for Irene Nunes

Irene Nunes

Vice President, Head of Regulatory Affairs, Flatiron Health, United States
Irene Nunes is VP, Head of Regulatory Affairs at Flatiron Health, leading strategy and policy professionals focused on advancing RWD/RWE for regulatory decision-making and market access globally by working with pharmaceutical companies, regulatory agencies, HTAs, policy organizations... Read More →
avatar for Dan Riskin

Dan Riskin

Founder and Chief Executive Officer, Verantos, United States
Dan Riskin is the founder and CEO of Verantos, the global leader in high-validity real-world evidence (RWE). Recognized across the globe as an expert in healthcare AI, Dr. Riskin has developed products that influence the care of millions of patients annually. His advocacy includes... Read More →

Tuesday June 21, 2022 2:00pm - 3:00pm CDT
Room 183 A McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  03: Data-Tech in Clinical Trials, Forum |   04: MedAffairs-SciComm, Forum |   09: Regulatory, Forum
  • Level Intermediate
  • Featured Topics RWD-RWE
  • Level Intermediate
  • Feature Topics RWD-RWE
  • Credit Type ACPE, CME, RN
  • Tags Forum
 
Wednesday, June 22
 

11:00am CDT

#321: FHIR in Clinical Research
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-611-L04-P ; CME 1.00; RN 1.00

This forum will assess where fast healthcare interoperability resources (FHIR) can play a role in clinical research. Experts will provide examples of success, share best practices and discuss a reference architecture for gathering data via FHIR.

Learning Objectives

Discuss examples of FHIR in clinical research; Describe best practices from industry experts.

Chair

Derk Arts, MD, PhD

Speaker

Panelist
Samuel W. Hume, MS

Panelist
Mike Ward

Panelist
Meredith Zozus, PhD


Speakers
avatar for Derk Arts

Derk Arts

Founder & CEO, Castor, Netherlands
Derk Arts MD, PhD has over fifteen years of experience in medicine, research and technology. He founded Castor to solve the biggest issues in clinical research: a lack of inclusivity, patient focus and impact of data. Castor enables sponsors worldwide to run patient-centric trials... Read More →
avatar for Samuel Hume

Samuel Hume

Vice President, Data Science, CDISC , United States
Sam Hume leads the CDISC Data Science team who develops tools and standards that support clinical and translational research. Sam directs delivery of the CDISC Library, co-leads the Data Exchange Standards team, and serves as a leader of CORE. Additionally, he oversees the CDISC Open-Source... Read More →
avatar for Mike Ward

Mike Ward

Associate Director, eSource Capabilities, Eli Lilly and Company, United States
MZ

Meredith Zozus

Professor; Division Chief and Director, Clinical Research Informatics, University of Texas Health Science Center, United States
Meredith is a Professor, Division Chief and Scientific Director of Clinical Research Informatics for the University of Texas Health Science Center at San Antonio. She is the lead PI of the ACE-RWD program.

Wednesday June 22, 2022 11:00am - 12:00pm CDT
Room 180 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  03: Data-Tech in Clinical Trials, Forum |   02: ClinTrials -ClinOps, Forum

11:00am CDT

#320: De-Risking Decentralized: Understanding the Dimensions of Risk and Maximizing Data Quality in Decentralized Trials
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-610-L04-P ; CME 1.00; RN 1.00

How should your organization be monitoring risk in decentralized trials? This session will share insights of how to ensure effective oversight of dimensions of risk in decentralized trials and quality of participant self-generated data.

Learning Objectives

Discuss the evolving landscape of decentralized research; Appraise new sources of risk in decentralized trials and approaches to mitigate risks; Demonstrate how centralized monitoring technologies provide effective oversight of key risks and ensure quality for participant self-generated data; Propose opportunities to maximise patient engagement through analysis of participant usage metrics.

Chair

John James Hall, PhD

Speaker

Industry Update
Lynne Cesario

Industry Update
Patrick Nadolny, MS

Industry Update
Richard Young


Speakers
avatar for John Hall

John Hall

Senior Vice President, Europe and AsiaPac, CluePoints, Belgium
John is a senior life sciences executive with over 20 years of experience in the life sciences industry. He is currently SVP at CluePoints, a leader in the field of RBQM, where he leads commercial activities across Europe and Asia Pacific and CluePoints decentralised trial strategy... Read More →
MA

Mayank Anand

Vice President and Head, Global Data Strategy and Management, GlaxoSmithKline
PN

Patrick Nadolny

Global Head, Clinical Data Management, Sanofi, France
Global Head, Clinical Data Management, Sanofi Chair of the SCDM Innovation Committee SCDM Board Member Mr. Nadolny has almost 30 years of industry experience across pharmaceutical, device and biologics as well as technology solution development. Mr. Nadolny is a pragmatic leader focusing... Read More →
LC

Lynne Cesario

Senior Director, Global Risk Based Monitoring Lead, Pfizer Inc, United States
avatar for Richard Young

Richard Young

Vice President, Vault CDMS Strategy, Veeva Systems, United Kingdom
As a veteran of almost 25-years in life sciences, Richard has held multiple operational roles in Pharma and CRO organisations, such as GlaxoWellcome, Novo Nordisk, Chiltern and Parexel, before moving into eClinical Solutions, with Cmed and Medidata. Today, Richard brings Veeva customers... Read More →

Wednesday June 22, 2022 11:00am - 12:00pm CDT
Room 176 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  03: Data-Tech in Clinical Trials, Forum |   08: RD Quality-Compliance, Forum

1:45pm CDT

#342: Democratizing Data for Cancer Research and Real-World Evidence Generation
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-622-L04-P ; CME 1.00; RN 1.00

This forum will explore how collaboration and improved access to data across the cancer research and healthcare data ecosystem can lead to innovations in diagnosis and treatments. A panel of high-level experts from industry, academia and data-focused non-profits will provide their viewpoints on the data sharing landscape, progress to date, lessons learned, and ideas to ensure future sustainable success.

Learning Objectives

Describe the cancer research and healthcare data landscape; Discuss the importance of collaboration across key stakeholder groups; Explore innovative ideas for future success, especially around diagnosis and treatment.

Chair

Bron Kisler

Speaker

Panelist
Samuel Volchenboum, MD, PhD, MS

Panelist
William Louv, PhD

Panelist
Robert Stephen Miller, MD, FACP

Panelist
Karla Childers, MS


Speakers
avatar for Bron Kisler

Bron Kisler

Senior Advisor, Clinical Research Data Sharing Alliance, United States
Most recently, Bron has worked with the Founders and Board of Directors for the Clinical Research Data Sharing Alliance to launch this new non-profit alliance in 2021. He is globally recognized for his leadership in clinical research and international standards development with more... Read More →
WL

William Louv

Chief Executive Officer, Project Data Sphere, United States
Bill was named Chief Executive Officer of the CEO Roundtable on Cancer effective March 2022 after serving as Interim CEO since January 2022. He joined Project Data Sphere in April 2018, bringing with him broad leadership experience in statistics, epidemiology, and information technology... Read More →
avatar for Robert Miller

Robert Miller

CMO, ASCO
Robert S. Miller, MD, FACP, FASCO, FAMIA is a medical oncologist and informaticist who is Chief Medical Science Officer, CancerLinQ®, a health technology platform for oncology developed by the American Society of Clinical Oncology (ASCO) to improve quality of cancer care and advance... Read More →
SV

Samuel Volchenboum

Co-Founder, Chief Medical Officer, Litmus Health, United States
Dr. Volchenboum is an associate professor of pediatrics and the associate chief research informatics officer for the Division of Biological Sciences at the University of Chicago. He is the Dean of Masters Programs, and he designed and launched the UChicago Master’s in Biomedical... Read More →

Wednesday June 22, 2022 1:45pm - 2:45pm CDT
Room 176 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  02: ClinTrials -ClinOps, Forum |   03: Data-Tech in Clinical Trials, Forum

2:00pm CDT

#349: The Power and Uncertainty of Data: How it Can be Used to Drive Efficiency While Recognizing its Limitations
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-626-L04-P ; CME 1.00; PDU 1.00 PMI 2166J2Y14T; RN 1.00

The forum will discuss how the use of data and analytical tools has informed and streamlined pipeline/product strategy and internal resource allocation in various organizations. Presenters will share their experiences of how data and analytics enables them to make more informed decisions within their organizations.

Learning Objectives

Discuss how various organizations leverage data sets and analytical tools for project management strategic planning purposes to optimize business operations/processes; Identify potential limitations and the future of data-driven decision making in pharma.

Chair

Ashwini Jagannath, MS

Speaker

Panelist
Jennifer Salvucci, MBA

Panelist
Hasini Jayatilaka, PhD

Panelist
Dhruv Kumar Vig, PhD


Speakers
AJ

Ashwini Jagannath

Associate Director, New Market Development Program Management, BeiGene, Inc., United States
Ashwini Jagannath is an Associate Director, New Market Development Program Management at BeiGene. She has over 10 years of life science experience, including 7 years of management consulting expertise covering the spectrum of strategic activities that bring an asset from development... Read More →
HJ

Hasini Jayatilaka

Senior Manager, Gilead Sciences, United States
Hasini Jayatilaka is currently a senior manager in the competitive intelligence group at Gilead Sciences where she leverages multiple data from multiple sources to support strategy and tactic development across multiple functions at the organization. Hasini was formerly a senior consultant... Read More →
avatar for Jennifer Salvucci

Jennifer Salvucci

Principal, Life Sciences, North Highland, United States
Jennifer Salvucci is Principal, Life Sciences for North Highland, the leading change and transformation consultancy, helping businesses transform with people at the heart of every decision. Jennifer has 20+ years’ experience in Life Sciences and healthcare developing and delivering... Read More →
avatar for Dhruv Vig

Dhruv Vig

Chief Executive Officer / Co-Founder, Langar Holdings, Inc., United States
Dr. Vig is the CEO of Langar Holdings (LH), a FinTech startup that combines private and public market data with industry expertise to create innovative products. Their first product is a pure-play HealthTech Index. Prior to co-founding LH, he led the development of Silicon Valley... Read More →

Wednesday June 22, 2022 2:00pm - 3:00pm CDT
Room 186 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  07: ProjectManagement-StrategicPlanning, Forum |   03: Data-Tech in Clinical Trials, Forum

4:15pm CDT

#368: Sneak Peak: First Share from Initiatives of a Global Collaboration to Address Barriers to Decentralized Trial Scale and Adoption
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-636-L04-P ; CME 1.00; RN 1.00

This forum will discuss how our alliance priorities are designed to improve the global adoption of decentralized research to improve study access and efficiency. The foundation for this mission is a common nomenclature & definitions for decentralized trials.

Learning Objectives

Describe the common nomenclature and definitions for decentralized research as defined through a global multistakeholder collaboration; Identify key performance indicators and benchmarks that highlight the productivity and impact of decentralized trials; Evaluate a Decentralized Research Readiness Framework considerate of change management best practices for sponsors, CROs, and sites.

Chair

Craig H Lipset, MPH

Speaker

Panelist
Jared Klingeisen

Panelist
Dawn Brockett, MPA

Panelist
Jane Myles, MS

Panelist
Alicia Staley, MBA, MS

Panelist
Amir Kalali, MD


Speakers
avatar for Dawn Brockett

Dawn Brockett

Head of Community and Partnerships, CNS Summitt, United States
Dawn Brockett is Head of Community and Partnerships for CNS Summit. She is a member of the leadership team of the Changing the Norm initiative of the Decentralized Trials & Research Alliance (DTRA). She is a patient advisor on an Anorexia Nervosa trial and adjunct faculty at Boise... Read More →
avatar for Amir Kalali

Amir Kalali

Co-Chair, Decentralized Trials and Research Alliance (DTRA), United States
Dr. Kalali is a physician scientist, recognized globally as a leading innovator at the intersection of life sciences and technology, and a convener of collaborative high impact forums. He is a board director of both private and publicly traded companies and advises companies in the... Read More →
avatar for Jared Klingeisen

Jared Klingeisen

Senior Vice President, Medable, United States
Jared serves as Senior Vice President at Medable. Since joining the company in 2018, Jared has successfully founded Medable’s delivery teams and built the operational model used to deliver more than 150+ trials hybrid and decentralized trials worldwide. He also led the formation... Read More →
avatar for Jane Myles

Jane Myles

Program Director, Decentralized Trials and Research Alliance (DTRA), United States
Jane has over 25 years of experience improving clinical trials and patient experiences. She has focused on driving innovation in trial design and execution to accelerate getting medicines to patients. Jane transitioned from molecule focus to portfolio focus about 14 years ago, first... Read More →
avatar for Alicia Staley

Alicia Staley

Vice President, Patient Engagement, Medidata, a Dassault Systèmes Company, United States
Alicia has over 20 years of experience in software design and information systems management. She has a Mechanical Engineering Degree from Syracuse University and from Boston University with a Masters of Information Systems and an MBA. At Medidata, Alicia works to infuse the patient... Read More →

Wednesday June 22, 2022 4:15pm - 5:15pm CDT
Room 183 A McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  02: ClinTrials -ClinOps, Forum |   03: Data-Tech in Clinical Trials, Forum

4:15pm CDT

#370: Where Are we Really on Data Interoperability?
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-638-L04-P ; CME 1.00; RN 1.00

With all the discussion of data interoperability, where are we really today? This session explores the current status of interoperability and data collaborations while giving insights into the challenges we currently face, and the value still left to be realized.

Learning Objectives

Review the current landscape of data interoperability, legislative changes, policy shifts, and partnerships; Assess the challenges still to overcome; Explore the value yet to be realized from improved interoperability.

Chair

Jessica Federer, MPH

Speaker

Panelist
Sadiqa Mahmood, DMD, MPharm

Panelist
Michelle Hoiseth

Panelist
Joy Bhosai, MD, MPH

Panelist
Anastasia Christianson, PhD


Speakers
AC

Anastasia Christianson

Vice President, Head of AI, ML, Analytics, and Data, Pfizer, United States
avatar for Jessica Federer

Jessica Federer

Partner, Boston Millennia Partners, United States
Jessica is a Partner at Boston Millennia Partners, investing in high-impact, tech-enabled companies transforming life science research and healthcare. Previously, Federer was the Chief Digital Officer at Bayer A.G., leading the global digital transformation across the pharmaceuticals... Read More →
avatar for Michelle Hoiseth

Michelle Hoiseth

Chief Data Officer, Parexel, United States
Michelle has been working in the drug and device development industry for 30 years. She has enjoyed a variety of positions that allowed her to create product development plans, run study operations, and support product commercialization objectives. Michelle presently serves Parexel... Read More →
avatar for Michelle Hoiseth

Michelle Hoiseth

Chief Data Officer, Parexel, United States
Michelle has been working in the drug and device development industry for 30 years. She has enjoyed a variety of positions that allowed her to create product development plans, run study operations, and support product commercialization objectives. Michelle presently serves Parexel... Read More →
SM

Sadiqa Mahmood

General Manager and Senior Vice President, Health Catalyst, United States
Sadiqa Mahmood is the SVP and GM of the Life Sciences business at Health Catalyst. Sadiqa’s work focuses on identifying and addressing areas of high unmet need for therapeutic development through application of real-world data. She is an advisor to several healthcare organizations... Read More →

Wednesday June 22, 2022 4:15pm - 5:15pm CDT
Room 185 AB McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  03: Data-Tech in Clinical Trials, Forum
 
Thursday, June 23
 

10:00am CDT

#405: How the Heck do I Get this Digital Endpoint to Work in my Clinical Trial? Nuts and Bolts for Trials Teams
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-648-L04-P ; CME 1.00; RN 1.00

This panel will discuss how the Playbook Clinical Trials Dossier has the action-oriented tools you need to help deploy a digital clinical measure in your clinical trial. Learn to use them to make better decisions faster.

Learning Objectives

Describe the optimal approach to selecting, developing, and deploying fit-for-purpose, meaningful digital clinical measures across clinical research; Determine right questions and when to ask while operationalizing digital clinical measures into a clinical trial; Apply the resources in The Playbook's Clinical Trials Dossier to navigate the multi-stakeholder process of planning for and running a clinical trial.

Chair

Jeanne Chung, MBA

Speaker

Digital Clinical Measures: Tools to Make Better Decisions Faster
Matt Biggs

Developing Novel Endpoints Using Voice Measurement
Jessica Robin, PhD

Current Challenges of Digital Clinical Measures in Drug Development
Jie Ren, PhD


Speakers
avatar for Matt Biggs

Matt Biggs

Vice President of Applied Science, ActiGraph, United States
At ActiGraph, I'm a member of our Scientific Department which specializes in digital health technologies. Over the past 10 years, I've had the opportunity to assist clinical trials, national cohort studies, and scientific research globally. With a focus on sensor selection, technology... Read More →
avatar for Jeanne Chung

Jeanne Chung

Program Lead, Digital Medicine Society (DiMe), United States
Jeanne is Program Lead at Digital Medicine Society (DiMe) bringing strategy, execution and innovation through her investment banking, management consulting, and entrepreneurship experience. She currently leads DATAcc - the digital health measurement collaborative community of 50 member... Read More →
avatar for Jie Ren

Jie Ren

Principal Scientist, Global Digital Analytics and Technologies, Merck & Co., Inc., United States
Jie champions digital endpoint development efforts and supports the implementation of digital health technologies in clinical development at Merck.
avatar for Jessica Robin

Jessica Robin

Director, Clinical Research, Winterlight Labs, Canada
At Winterlight Labs, I lead our clinical research program, which includes internal validation and development research, academic collaborations and clinical trials. In this role, I oversee study design, design analysis plans and help communicate the results of our studies relating... Read More →

Thursday June 23, 2022 10:00am - 11:00am CDT
Room 176 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  02: ClinTrials -ClinOps, Forum |   03: Data-Tech in Clinical Trials, Forum
  • Level Intermediate
  • Featured Topics Digital
  • Level Intermediate
  • Feature Topics Digital
  • Credit Type ACPE, CME, RN
  • Tags Forum
 
Monday, June 26
 

10:45am CDT

Inspired by Big-Tech and Humbled by Complexity of Clinical Research: Clinical Trial Digital Transformation
Component Type: Forum
Level: Intermediate

This session explores the challenges and lessons-learned from multi-year aspirational clinical trial digital transformation initiative.

Learning Objectives

Discuss considerations prior to embarking on a major digital transformation initiative in clinical development; Describe the significance of effective change management practices and the follow-through; Assess the pros and cons of the Agile development framework with complex initiatives.

Chair

Nareen Katta, MBA, MS

Speakers
avatar for Nareen Katta

Nareen Katta

Head of Data Science & Analytics, AbbVie, United States
Nareen Katta works as the Head of Data Science and Analytics at AbbVie. Nareen has over 20 years of experience in the pharmaceutical industry. In his current role, Nareen is responsible for building and executing the advanced analytics strategy, that covers both Scientific and Business... Read More →

Monday June 26, 2023 10:45am - 11:45am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  03: Data-Tech in Clinical Trials, Forum

1:30pm CDT

Building Trust: Data Privacy in Decentralized Clinical Trials
Component Type: Forum
Level: Intermediate

For the decentralized clinical trial modality to thrive, the data privacy concerns of multiple stakeholder groups must be addressed. This panel of industry luminaries will discuss how technology can continue to bring therapies to market faster while increasing diversity.

Learning Objectives

Identify data privacy concerns from multiple perspectives: patient/participant, sponsor, innovator, technology provider; Explore how to meet all stakeholders’ needs for the sake of diversity, equity and inclusion; Describe how to increase stakeholders’ trust so that the clinical trials community can utilize new technologies such as decentralized clinical trials to bring life changing therapies to market faster.

Chair

Jay Ferro

Speakers
avatar for Jay Ferro

Jay Ferro

EVP, Chief Information & Technology Officer, Clario, United States
Jay heads up Clario’s development, information technology and strategic sourcing initiatives. With over 25 years’ experience of working as a global technology leader, Jay has a wealth of knowledge which helps drive changes that are critical to managing data protection. An expert... Read More →

Monday June 26, 2023 1:30pm - 2:30pm CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  03: Data-Tech in Clinical Trials, Forum
 
Tuesday, June 27
 

10:30am CDT

The Future of Regulatory Submissions: Opportunities and Challenges
Component Type: Forum
Level: Intermediate

This forum will include a discussion on opportunities and challenges for future regulatory submissions and share knowledge and provide views to help overcome challenges in the areas of policy, technology, standards, data sovereignty and security, and records management. Panelists will include representatives from health authorities, industry, and non-profit organizations.

Learning Objectives

Describe the current regulatory submission mechanism; Explore opportunities for the future regulatory submission and data exchange, data sharing paradigm; Discuss challenges to implement changes from policy, technology, standard, data sovereignty and security, records management perspectives.

Speakers
avatar for Ethan Chen

Ethan Chen

Director, Division of Data Management Services and Solutions, OBI, OSP, CDER, FDA, United States
Ethan Chen provides overall leadership to CDER in streamlining electronic and traditional submissions and delivering solutions to enable rapid adoption of emerging electronic data standards. Since joining the FDA in 2012, Mr. Chen has led several critical initiatives as the CDER Informatics... Read More →

Tuesday June 27, 2023 10:30am - 11:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  03: Data-Tech in Clinical Trials, Forum
 
Wednesday, June 28
 

8:30am CDT

Real-World Data Quality: Components and Considerations of Data Sources Used for Regulatory Decision-Making
Component Type: Forum
Level: Intermediate

Through use cases, this forum will explore a tool to assess real-world data (RWD) quality that helps meet regulatory expectations and facilitate a discussion with Health Authorities regarding their expectations for the submission of patient-level data and for inspections.

Learning Objectives

Describe considerations in the publicly available real-world data (RWD) audit readiness considerations tool supporting audits of RWD used for regulatory decision-making; Discuss the regulatory expectations for the submission of patient-level data and for inspections using case studies to facilitate discussion.

Chair

Abi Seifert, MBA

Speakers
avatar for Abi Seifert

Abi Seifert

Global Head Country Development Quality, Novartis , United States
Abi has worked in the Pharma industry for over 25 years, serving in clinical development in both QA and operational roles. Her career started in clinical study monitoring and GCP auditing and evolved into roles that defined strategy around project management, process excellence and... Read More →

Wednesday June 28, 2023 8:30am - 9:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  03: Data-Tech in Clinical Trials, Forum

8:30am CDT

The Rapidly Changing Landscape of Data Collection and its Implications for Clinical Data Management
Component Type: Forum
Level: Intermediate

An expert panel will discuss how data acquisition in clinical trials is changing, what new opportunities and challenges arise for clinical data management teams, and how they need to respond to deliver high-quality analysis-ready data, faster.

Learning Objectives

Discuss how the evolution in data acquisition technologies and decentralized trials impacts data management teams; Describe how to apply new technologies to streamline clinical data review and cleaning; Create a roadmap for adopting the next generation of clinical data management skills, processes, and technologies.

Chair

Teresa Fishburne, MBA

Speakers
avatar for Teresa Fishburne

Teresa Fishburne

Vice President, Strategy and Transformation, Medidata, United States
Teresa leads Medidata’s Strategy & Transformation Team and is responsible for the delivery and execution of comprehensive and complex solutions for Pharmaceutical and Medical Device companies, globally. Teresa has over 20 years' experience in Clinical Operations including 10+ years... Read More →

Wednesday June 28, 2023 8:30am - 9:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  03: Data-Tech in Clinical Trials, Forum
 
Thursday, June 29
 

8:30am CDT

Effective Use of Intelligent Automation in Clinical and Regulatory
Component Type: Forum
Level: Intermediate

Panelists share how they use intelligent automation technologies across R&D to improve business performance (e.g., efficiency, speed to market and regulatory compliance), use cases they have implemented, and the value / benefits realized to date.

Learning Objectives

Identify how sponsor companies are reaping value from their intelligent automation (IA) initiatives across R&D; Differentiate between use cases that provide greater value from those that are not worth pursuing; Discuss approaches for planning and implementing IA technologies that consider people, process, and technology aspects, and avoiding or mitigating common risks or issues.

Chair

Cary Smithson, MBA

Speakers
avatar for Cary Smithson

Cary Smithson

Senior Director, Business Transformation & Systems Management, Cencora Pharmalex, United States
Cary Smithson is the Senior Director, Business Transformation and Systems Management at PharmaLex and has over 30 years of experience helping life science Regulatory, Clinical and Quality organizations drive increased productivity, streamline information management and enhance regulatory... Read More →

Thursday June 29, 2023 8:30am - 9:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  03: Data-Tech in Clinical Trials, Forum
 
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Exh Hall Community Area
Exhibit Hall
Exhibit Hall Booth #1719
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Level 3 F2 Entrance
Meeting Rm Lobby Level 1
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TBD
Virtual
  • 00: Plenary
  • 01 - Clinical Safety and Pharmacovigilance
  • 01: ClinSafety-PV
  • 02: ClinTrials -ClinOps
  • 03: Data-Tech in Clinical Trials
  • 04: MedAffairs-SciComm
  • 05: Patient Engagement
  • 06: PreClinical Dev-EarlyPhaseCR
  • 06 - Translational Sciences and Precision Medicine
  • 06: TranslationalScience-PrecisionMedicine
  • 07: ProjectManagement-StrategicPlanning
  • 08: RD Quality-Compliance
  • 09: Regulatory
  • 10: RegCMC-Product Quality
  • 11: Statistics
  • 12: Value-Access
  • 13: ProfDevelopment
  • 14: DIAmond
  • 15: Content Hubs
  • 16: Community Rounds
  • 17: Networking Opportunities
  • 18: Posters
  • 19: InnovationTheaters
  • 20: Short Courses
  • Level
  • Advanced
  • Basic
  • Intermediate
  • Featured Topics
  • AI and Machine Learning
  • COVID-19
  • Data Science
  • Decentralized Trials
  • Digital
  • Diversity Equity and Inclusion
  • Innovative Trial Design
  • Patient Perspective
  • Personalized Health Care
  • Regulator Perspective
  • Remote Work
  • RWD-RWE
  • Special Populations
  • Student Programming