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03: Data-Data Standards [clear filter]
Monday, June 24


#105: Addressing Heterogeneity of Real World Evidence in Drug Safety
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-522-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session addresses the concern of inconsistent real world evidence in drug safety by presenting 1) epidemiological approaches for assessing inconsistent findings in observational studies, 2) lessons learned from observational studies in a distributed research network and 3) challenges using methods that synthesize findings from observational studies.

Learning Objectives

Identify possible study factors contributing to heterogeneity of real world evidence using claims databases; Discuss lessons learned from observational studies in a distributed research network regarding heterogeneity of RWE; Describe methods for synthesizing findings from observational studies and their limitations.


Michael Blum, MD, MPH


Epidemiological Approaches for Assessing Inconsistent Findings in Observational Studies
Huei-Ting Tsai, PhD, MS

Minimizing Heterogeneity in Distributed Research Networks: Examples from the Canadian Network for Observational Drug Effect Studies
Adrian Levy, PhD, MSc

Challenges with Methods Used to Synthesize Findings from Observational Studies
Alicia Gilsenan

avatar for Michael Blum

Michael Blum

Deputy Director, Office of Pharmacovigilance and Epidemiology, CDER, FDA
Michael Blum, MD, MPH is currently Deputy Director, Office of Pharmacovigilance and Epidemiology in FDA CDER. He is a pediatric infectious diseases specialist. Dr. Blum worked as a medical reviewer in the CDER Division of Anti-Infective Drug Products, followed by over 20 years in... Read More →
avatar for Alicia Gilsenan

Alicia Gilsenan

Senior Director and Head, Epidemiology, RTI Health Solutions
Alicia Gilsenan, PhD, is Senior Director and Head, Epidemiology within RTI-HS and a licensed pharmacist. Dr. Gilsenan’s primary area of expertise is pharmacoepidemiology and therapeutic risk management and the structured benefit-risk assessment of medications. Since joining RTI... Read More →
avatar for Huei-Ting Tsai

Huei-Ting Tsai

Epidemiologist, Office of Surveillance and Epidemiology, CDER, FDA
Huei-Ting Tsai, Ph.D., is an Epidemiologist in the Office of Surveillance and Epidemiology in FDA CDER. Prior to joining FDA, she was an Assistant Professor at the Georgetown University Medical Center and served as the principle investigator of multiple grants to assess effectiveness... Read More →
avatar for Adrian Levy

Adrian Levy

Professor, Department of Community Health and Epidemiology, Dalhousie University
Adrian R. Levy PhD is Professor in the Department of Epidemiology and Community Health at Dalhousie University. He is author of over 150 peer reviewed publications (https://bit.ly/2CBWeI5) and is the co-editor of two volumes in the Springer Handbook of Health Services Research entitled... Read More →

Monday June 24, 2019 11:00am - 12:00pm
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA


#110: Automation with Intelligence: Transformation From Human Resource to Artificial Intelligence in Risk Management
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-524-L04-P; CME 1.00; IACET 1.00; RN 1.00

Learn 1) challenges in adapting AI in risk management; 2) approaches in proactively managing clinical operation risk and in streamlining the process for automation; 3) a automation model to transform resource based monitoring into risk based approach

Learning Objectives

Discuss challenges in adapting artificial intelligence in risk management; Discuss innovative approaches in leveraging real-time access to clinical data and analytics in proactively managing clinical operation risk and in streamlining the process for automation in risk assessment and mitigation; Discuss automation maturity model to transform resource based monitoring into risk based approach.


Hanming H Tu, MSc


Using Artificial Intelligence to Centralize, Standardize, and Ensure Data Integrity in Clinical Trial Monitoring
Michelle Marlborough

Artificial Intelligence in Risk Management
Susan Olson, PhD, MS

Utilizing AI to Transform Drug Safety Case Processing
Christina J Wocosky

avatar for Susan Olson

Susan Olson

Chief Operating Officer, edj
Susan is Chief Operating Officer at EdjAnalytics and manages operations and innovates advanced analytics solutions in life sciences. Edj is a Louisville, Kentucky company that offers advanced analytics for healthcare providers, pharmaceutical companies, government organizations, payers... Read More →
avatar for Hanming Tu

Hanming Tu

Vice President, IT, Frontage Laboratories, Inc.
* MS, MCRP * VP, Clinical IT & Database Administration (DBA) at Frontage * Manager, DBA in Accenture Life Science Cloud * Director, Clinical IT in Octagon Research * Over 20 years of pharmaceutical and clinical IT experience * Oracle Certified Professional (OCP) and DBA Master from... Read More →
avatar for Christina Wocosky

Christina Wocosky

Industry Principal, Innovation and Though Leadership, Accenture
Chris Wocosky is an Industry Principal in Accenture’s Life Sciences R&D practice, and is based in San Diego, CA. She served as the Product Manager for an AI Platform, PV First, for case intake and pre-case processing, and was instrumental in developing and bringing the platform... Read More →

Michelle Marlborough

Chief Product Officer, AiCure
As Chief Product Officer at AiCure, Michelle Marlborough is responsible for the product direction, definition and delivery of the company’s award-winning artificial intelligence platform. With over 23 years of experience in life sciences and software development, Michelle has been... Read More →

Monday June 24, 2019 11:00am - 12:00pm
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA


#118: Statistical Considerations for Trials Using Surrogate Endpoints for Accelerated Approval
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-19-531-L04-P; CME 1.00; IACET 1.00; RN 1.00

For slowly progressed diseases, it may take years, if not decades, to observe clinical outcomes, such as mortality. Owing to the regulatory agencies’ accelerated approval pathway, drug developers can now consider applying for a drug approval based on surrogate endpoints. In this session, many surrogate endpoints adopted in various diseases and statistical methods for determining the validity of the surrogacy will be discussed, including their implementation in real case examples.

Learning Objectives

Describe cases that utilize the accelerated approval and what good surrogate endpoints are for common and rare diseases; Identify how to apply appropriate statistical methods for assessing the association between surrogate endpoints and clinical outcomes.


Yeh-Fong Chen, PhD


FDA Update
Aloka Chakravarty, PhD

Statistical Assessment of Potential Surrogate Endpoints: Is the Bar too High?
Marc E. Buyse, DrSc

Using the Biomarker Endpoint for Accelerated Approval
Stephanie O. Omokaro, MD

avatar for Marc Buyse

Marc Buyse

Chief Scientific Officer, International Drug Development Institute (IDDI)
Marc Buyse holds master’s degrees from Brussels University (Belgium), the Cranfield School of Management (UK) and a doctorate degree from the Harvard School of Public Health (USA). He had worked for 12 years at the EORTC in Brussels and for 2 years at the Dana Farber Cancer Institute... Read More →
avatar for Aloka Chakravarty

Aloka Chakravarty

Deputy Director, Office of Biostatistics, Office of Translational Sciences, CDER, FDA
Dr. Chakravarty joined CDER in 1992. She is an internationally recognized thought leader in the area of safety evaluation, surrogate markers and biomarkers in drug development and has presented and published widely on it. Dr. Chakravarty received the FDA Award of Merit in 2008 and... Read More →
avatar for Yeh-Fong Chen

Yeh-Fong Chen

Mathematical Statistician (Team Lead), Office of Translational Sciences, CDER, FDA
Dr. Chen is the Team Leader of the Division of Biometrics IX within CDER of FDA, supervising reviewers for the Division of Non-Malignant Hematology Products. She joined FDA in 2000 after receiving her Ph.D. from the University of Iowa. She has had years' experience in reviewing drug... Read More →
avatar for Stephanie Omokaro

Stephanie Omokaro

Lead Medical Officer, Office of New Drugs, CDER, FDA
Dr. Omokaro is a Lead Medical Officer in the Division of Gastroenterology and Inborn Errors Products in the Center for Drug Evaluation and Research at FDA. She was educated in Biochemistry at Cornell University, and in medicine at Boston University. She completed a pediatric residency... Read More →

Monday June 24, 2019 11:00am - 12:00pm
Room 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA


#140: Use of Real World Data in Clinical Trials: Abstracting Endpoints from Encounters
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-540-L04-P; CME 1.00; IACET 1.00; RN 1.00

Standardizing real world data, consisting of EHR and claims encounters, into a clinical trial endpoint relies on a complex process of selecting the appropriate data-set and filtering, mapping and merging healthcare encounters from EHR to trial endpoints.This session will describe and appraise approaches and challenges in formulating the endpoints, in both prospective and retrospective research projects, with a focus on cardiovascular endpoints as well as demographic data.

Learning Objectives

Describe process to extract clinical trial endpoints from EHR and claims datasets; Identify how to apply a process to supplement objective EHR and claims dataset endpoints with correlated patient-reported outcomes.


Debra Fasteson Harris


Phenotypic Diagnosis of Rare or Difficult to Diagnose Diseases
Richard Gliklich, MD

PRO Perspective not Typically Available in EHR or Other Large Existing Real World Datasets
Amanda Harrington

avatar for Richard Gliklich

Richard Gliklich

Chief Executive Officer, OM1
Dr. Richard Gliklich is the CEO of OM1, Inc., an outcomes and technology company focused on real world evidence and measuring and predicting outcomes. Previously, he was founder and CEO of Outcome, which he led from inception through its acquisition by Quintiles. A graduate of Yale... Read More →
avatar for Debra Harris

Debra Harris

Associate Director (Operations), Pragmatic Health Systems Research (PHSR), Duke Clinical Research Institute
Debra Harris is the Associate Director of the Center for Pragmatic Health Systems Research at the Duke Clinical Research Institute where she focuses on the use of real-world data for clinical research. She is clinical trial-ist with more than 20 years of data management, cardiovascular... Read More →

Amanda Harrington

Lead Clinical Trial Coordinator, Duke Clinical Reserach Institute

Monday June 24, 2019 2:15pm - 3:15pm
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Beginner
  • Featured Topics What's Next
  • Featured Topics Real World Evidence,Innovative Trial Design,What's Next
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session


#169: How Statistics Can Help Improve Data Quality: ICH E6 R2
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-564-L04-P; CME 1.00; IACET 1.00; RN 1.00

ICH E6 (R2) guidance stresses the importance of centralized monitoring, especially by leveraging statistical analyses in order to assess data quality. This session will discuss how statistical methodology fits in the overall quality risk management strategy for the trial portfolio.

Learning Objectives

Discuss centralized statistical monitoring approaches and their impacts to data quality and integrity.


Cheng Su, PhD


Using Appropriate Count-Based Statistical Models for KPIs, Risk Metrics, QTLs, etc.
Michael Farnum, PhD, MS

ICH E6 R2: How Statistics Can Help Improve Data Quality
Stephen Young, MSc

Centralized Statistical Monitoring: A Large Pharma's Approach
Taras Carpiac, MBA

avatar for Taras Carpiac

Taras Carpiac

Director, Head of Innovation and Process Improvement, Amgen, Inc.

Michael Farnum

Senior Director, Covance
Michael Farnum is a Senior Director for Covance Informatics. In 5+ years working at Covance, he has helped to create the Xcellerate platform, consisting of data integration, analytics, and decision support tools that enable Risk-Based Monitoring, Medical Review, Statistical Review... Read More →

Cheng Su

Executive Director, Data Sciences and Analytics, Biomarin Pharmaceutical
Cheng got his Ph.D. in statistics from NCSU and has 22 years of experiences in both nonclinical and clinical areas. Cheng has a broad interpest in applying statistical thinking and analytics to support drug research and development. His specific areas of expertise include high throughput... Read More →
avatar for Stephen Young

Stephen Young

Chief Scientific Officer, CluePoints
As Chief Scientific Officer for CluePoints, Steve oversees the research and development of advanced methods for data analytics, data surveillance and risk management, along with providing guidance to customers in RBQM methodology and best practices. Steve worked for three bio-pharmaceutical... Read More →

Monday June 24, 2019 3:30pm - 4:30pm
Room 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
Tuesday, June 25


#233: Creating Clarity: Changes at CDISC to Make Standards Implementation Easier for all Stakeholders
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-593-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will discuss the recommendations of the Blue-Ribbon Commission, an overview of CDISC 2.0, the innovation initiative CDISC is currently undertaking to and what benefits these efforts will bring for all stakeholders.

Learning Objectives

Describe CDISC 2.0 and how this initiative and what benefits these efforts will bring for all CDISC stakeholders; Describe how beginning to end connected standards can streamline clinical data management make and data sharing easier.


Kit Howard, MS


CDISC 360 and CDISC Library: Continuing the Journey Toward Beginning-to-End Automation
Bess LeRoy, MPH

SEND: What's New Today and on the Horizon for CDISC's Standard for Nonclinical Research
Lou Ann Kramer

CDISC Primer: Making CDISC Easier: A Collaboration Between CDISC and PhUSE
Kit Howard, MS

avatar for Kit Howard

Kit Howard

Senior Director, Standards Development & Education, CDISC
Kit Howard has over 30 years’ experience in many areas of research and development, including developing data and process standards for exploratory through post-marketing human clinical research, pharmacogenomics and non-clinical research. She is CDISC's Senior Education Expert... Read More →

Lou Kramer

Senior Director, Standards Development, CDISC
Lou Ann Kramer is a Senior Director of Standards Development at CDISC. Prior to joining CDISC, she had over 30 years experience at a major pharmaceutical sponsor company where she held roles in IT, early phase Clinical and non-clinical regulatory. She managed non-clinical submissions... Read More →

Bess LeRoy

Head of Standards Development, CDISC
Bess LeRoy has over 15 years of experience working in public health research. She is currently the Head of Standards Development at CDISC. She has been a CDISC team member since 2011 and has been involved in the development of over 16 CDISC Therapeutic Area User Guides. Bess has a... Read More →

Tuesday June 25, 2019 10:30am - 11:30am
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA


#286: The Machines are Here! Learn About Real Uses of Machine Learning and Artificial Intelligence in Pharma
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-629-L04-P; CME 1.25; IACET 1.25; RN 1.25

Artificial Intelligence (AI) and Machine Learning ML) have become buzzwords in every industry. While most of AI's potential is yet to be reached, pharma is starting to see tangible benefits that can be applied across the industry. This session will discuss new technologies and methods leveraging AI and ML to transform aspects of MedDRA coding, WHO drug coding, and data quality.

Learning Objectives

Explain and contrast the definitions of Artificial Intelligence and Machine Learning; Describe how AI has impacted MedDRA coding; Discuss how to review ways in which AI has been implemented to improve the efficiency and accuracy of WHO drug coding and the challenges experienced along the way; Identify how pharmaceutical companies and CROs have leveraged machine learning technology to improve data quality and overall drug submission success.


Stacey Yount, MA


Introduction to Artificial Intelligence and Machine Learning: Application for MedDRA Coding
Cartic Ramakrishnan, PhD

How Can We Optimize the Use of Machine Learning for Increased Efficiency in Drug Coding?
Malin Jakobsson, MPharm, RPh

The Use of Machine Learning to Transform Clinical Trial Data Quality and Efficiency
Stacey Yount, MA

avatar for Malin Jakobsson

Malin Jakobsson

Product Strategy Manager, Uppsala Monitoring Centre
Malin is Product Strategy Manager for WHODrug at Uppsala Monitoring Centre (UMC). She is a pharmacist by training and she has been working with WHODrug in different roles for twelve years, from data validation to production and now she is involved in the strategic development of the... Read More →
avatar for Cartic Ramakrishnan

Cartic Ramakrishnan

Senior Technical Staff Member, Lead Cognitive Scientist, Life Sciences, IBM Watson Health
Cartic Ramakrishnan is a research scientist with a background in NLP and Machine Learning. He serves as lead scientist at IBM Watson health developing solutions to problems in the biomedical and healthcare domain. Cartic's recent work has focused on the development of NLP systems... Read More →
avatar for Stacey Yount

Stacey Yount

Vice President, Product, Medidata Solutions
As Vice President of Product at Medidata, Stacey Yount is the leader for the CTMS and Risk Based Monitoring platform. With 20 years of experience in clinical research, Stacey is an expert in data management, pharmaceutical efficiency, clinical development, CRO operations, and innovation... Read More →

Tuesday June 25, 2019 4:15pm - 5:30pm
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
Wednesday, June 26


#306: Methods for Integrating EHR Data into EDC and eSource Databases
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-19-647-L04-P; CME 1.25; IACET 1.25; RN 1.25

Panelists will share experience and methods that make the integration of EHR and clinical trial electronic data capture a reality that can be repeated – and without protocol-specific custom coding.

Learning Objectives

Describe the difference between electronic medical record (EMR) systems and electronic health record systems (EHR); Define the key principles and methods for integrating medical record data with electronic data capture; Evaluate integration feasibility, scalability and costing for EHR and EDC/eSource data integrations.


Gene Vinson


Sponsor Perspectives on EHR to EDC Integration
Len Rosenberg

Technology Innovations for EHR Data Integrations
Hugh Levaux, PhD

Operational Lessons Learned for EHR to EDC Integrations
Gene Vinson

avatar for Hugh Levaux

Hugh Levaux

Founder & CEO, Protocol First
Dr. Hugh Levaux is Founder and CEO of Protocol First. The company offers innovative software solutions for clinical research such as Protocol First eProtocol, eSource and EDC integrated platform or Clinical Pipe -- industry’s first system-agnostic EHR-to-EDC connector application... Read More →
avatar for Len Rosenberg

Len Rosenberg

Head of Clinical Operations, Beat AML/Leukemia and Lymphoma Society
Dr. Rosenberg is a 30 plus year executive with proven experience in driving operational excellence at all levels within the pharmaceutical, biotechnology, eclinical and contract research organization sectors. With his diverse background which includes executive management, clinical... Read More →
avatar for Gene Vinson

Gene Vinson

Executive Director, Global Data Technologies, Biometrics, Syneos Health
Gene Vinson has over 15 years’ experience in a clinical research organization (CRO) and is currently the Senior Director of Global Data Technologies in Biometrics at Syneos Health. Gene has lead the implementation of multiple EDC Systems and is an expert in the implementation of... Read More →

Wednesday June 26, 2019 8:00am - 9:15am
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA


#332: eSource Adoption: Where We Are - Our Experiences from eSource Implementation
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-665-L04-P; CME 1.00; IACET 1.00; RN 1.00

The value of eSource is indisputable. TransCelerate member companies and other select organizations will share experiences of eSource implementation and discuss lesson learned to continue to progress towards the digitalization of clinical trials.

Learning Objectives

Discuss the application of eSource in clinical trials from an industry member consortium and others;Identify important lessons learned for future application and adoption of eSource within their organizations and continue to uncover unknowns in this emerging space related to technology and standards in need of further advancement.


Rakesh Maniar, MS


Digital Health Data Strategy Playbook : An Approach to the Implementation of Novel Digital Technologies in Clinical Trials
Louisa Xu

Combining Multiple Device Data to Understand Disease States
Nora Husani

Workflows for eSource
Ken Bengston

Direct Data Collection: Eliminating Paper Source in a Paperless Pediatric Trial - A Case Study
Jennifer Price

avatar for Rakesh Maniar

Rakesh Maniar

Global Head, Business Technology Services; Co-Lead, TransCelerate eSource Initia, Novartis Pharmaceuticals Corporation
Rakesh is a TransCelerate eSource Workstream Co-Lead and SCDM eSource Implementation Initiative Co-Chair/Co-founder. At Novartis, area of responsibilities includes technology optimization, enable adoption of new technologies & provide value added services for efficient clinical trial... Read More →
avatar for Jennifer Price

Jennifer Price

Senior Director, Clinical Data Management, Paidion Research
Jennifer has 25+ years of pharmaceutical industry experience with Biometrics, Data Management and related technologies. Jennifer currently is the head of Data Management for Paidion Research, a Pediatric CRO. In this role, Jennifer is responsible for the collection and management... Read More →

Ken Bengston

Director of eSource, Pfizer Inc
avatar for Nora Husani

Nora Husani

Senior IT Analyst, eSource, mHealth, Digital Biomarkers, Eli Lilly and Company
Nora Husani is a Senior IT Analyst at Eli Lilly and Company. She has a BS in Software Engineering from Miami University and has been working in the eSource, mHealth, and Digital Biomarkers space for 3 years.
avatar for Louisa Xu

Louisa Xu

Initiatives and Process Improvement Lead, Data Sciences and Statistics, AbbVie Inc.
Louisa is a Data Science Initiatives and Process Improvement Lead at AbbVie. She has been heavily involved with digital health initiatives and has a passion for innovation in life sciences and technology. Louisa has worked within several organizations at AbbVie including Clinical... Read More →

Wednesday June 26, 2019 10:30am - 11:30am
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA


#338: Expanding Use of Interactive Response Technologies in Clinical Trials: Maintaining Data Quality and Reliability
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-669-L04-P; CME 1.00; IACET 1.00; RN 1.00

Best practices for development and maintenance of IRT systems will be discussed. Examples of systems that were inadequately developed resulting in significant impacts on study conduct, data quality, and data reliability will be presented.

Learning Objectives

Describe the importance of ensuring that interactive response systems (IRT) used to conduct clinical trials are adequately validated and maintained; Discuss how errors resulting from IRT systems impact study conduct, data quality, and data reliability.


Jean M. Mulinde, MD


FDA Perspective
Phillip D. Kronstein, MD

MHRA Perspective
Stephen Vinter

avatar for Phillip Kronstein

Phillip Kronstein

Team Leader, Division of Clinical Compliance Evaluation, OSI, CDER, FDA
Phillip Kronstein, M.D. is a Team Leader for the Good Clinical Practice (GCP) Assessment Branch in the Division of Clinical Compliance Evaluation (DCCE)/Office of Scientific Investigations (OSI) at the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER... Read More →
avatar for Jean Mulinde

Jean Mulinde

Policy Advisor, Division of Clinical Compliance Evaluation, OSI, OC, CDER, FDA
Dr. Mulinde is currently the Senior Policy Advisor, Division of Clinical Compliance Evaluation in the Office of Scientific Investigations, CDER, FDA. Prior to joining the Office of Scientific Investigations, she was a Clinical Team Leader in the Division of Anti-Infective Products... Read More →
avatar for Stephen Vinter

Stephen Vinter

Operations Manager GLPMA and Laboratories Group, Medicines and Healthcare products Regulatory Agency (MHRA)
Stephen Vinter is Operations Manager for the GLPMA and Laboratories Group for the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Prior to joining the Agency in 2012, Stephen worked in Operations Management at a Contract Research Organisation. Stephen has also... Read More →

Wednesday June 26, 2019 10:30am - 11:30am
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA


#365: Leveraging Data Analytics to Drive Compliance and Quality in a Risk-Based Monitoring Environment
Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-689-L04-P; CME 1.25; IACET 1.25; RN 1.25

The abundance of data collected in clinical research offers an increasing opportunity for insights into risks, quality, and compliance.To realize the full value, the data must be harnessed in a manner that is useful and meaningful, which can be a challenge. The key lies in developing analytics and models that provide insights. Leveraging data is particularly valuable in an environment where Risk Based Monitoring (RBM) is now the norm and the models and dashboards derived from analytics can proactively indicate risks and issues. Interpretation can drive compliance and quality decision making and a focus on what matters most. Advanced analytics and machine learning can also be leveraged to detect irregularities that may indicate falsification and misconduct.

This session will explore the potential of data analytics and modeling as applied to risk-based monitoring activities as well as quality assurance oversight of risk-base monitoring.

Learning Objectives

Design an innovative and efficient sampling SDV method reflecting trends of data error occurrence; Assess how measured risk changes over time, comparing change in risk relative to operational attributes, and judging the effects of risk-based monitoringon risk mitigation; Define key changes to risk-based monitoring programs that may require changes to quality assurance oversight, including audit programs; Discuss how site audits may shift focus from on-site audit activities to remote.


Matthew Krumrai


Statistical Models of Risk Flux Reveal Dynamics of Risk-Based Monitoring Managed Clinical Trials
Kristin Stallcup, MS, PMP

Study on Designing a Method of Sampling SDV in a Clinical Trial Using Audit Trail Data
Yuhi Sakajiri

Subject Data Analysis and Potential Fraud and Misconduct Analysis for Data Quality in Clinical Trials
Wei Xue, DrPH

Maintaining Quality Assurance in a Risk-Based Monitoring Environment
Matthew Krumrai

avatar for Matthew Krumrai

Matthew Krumrai

Director, Clinical Quality Assurance, AbbVie
Matthew Krumrai is a Director of Clinical QA at AbbVie. Matt’s responsibilities include oversight of the clinical auditing program as well as process ownership of auditing within AbbVie R&D. Other responsibilities include inspection support as well as the QA therapeutic lead for... Read More →
avatar for Yuhi Sakajiri

Yuhi Sakajiri

Student, Waseda University
Yuhi Sakajiri (born in Chiba, Japan, in May. 1995) received B.Eng. degrees in Industrial and Management Systems Engineering from the Waseda University, Japan, in 2018. Since 2018, he engaged in quality management research at the university's M.Eng. course. His research interest is... Read More →
avatar for Kristin Stallcup

Kristin Stallcup

Senior Director, Xcellerate Customer Success, Covance
Kristin Stallcup brings 15 years of industry experience in various trial management capacities. Currently she serves as senior director responsible for implementation and adoption of the Xcellerate Informatics suite into business process. Previously she served in central monitoring... Read More →

Wei Xue

Centralized Monitoring Manager, IQVIA
Wei Xue is a Centralized Monitoring Manager in Data Trial Execution in IQVIA. Her expertise spans in statistical and machine learning analysis in risk-based monitoring, predictive analysis and potential fraud and misconduct analysis in clinical trials industry. Wei got her Doctor... Read More →

Wednesday June 26, 2019 2:00pm - 3:15pm
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA


#382: Real World Data Quality for Regulatory Decision-Making
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-701-L04-P; CME 1.25; IACET 1.25; RN 1.25

Demonstrating the quality of real world data (RWD) to support regulatory decision-making is a topic of great interest. This session will explore what is being done to demonstrate that RWD is of sufficient quality to support regulatory assertions.

Learning Objectives

Describe how sponsors and data companies can demonstrate data quality, how FDA defines data quality, and how FDA reviewers assess real world evidence data quality; Discuss challenges with demonstrating data quality and what can be done to make advances in this area.


Rebecca Lipsitz, PhD


Evaluating Real World Data and Evidence
David Martin, MD, MPH

Considerations for Selecting an Appropriate Real World Data Source
Brande Yaist, MHS

Aspects of Data Relevancy and Quality for Regulatory-Grade Real World Data
David Thompson, PhD

Real World Evidence Regulatory Grade Quality: Lessons from Recent Use Cases
Rebecca A Miksad, MD, MPH

avatar for Rebecca Lipsitz

Rebecca Lipsitz

Associate Director, Janssen
Rebecca Lipsitz is a Director in Janssen’s Global Regulatory Policy and Intelligence office. She advises and develops policy on a broad range of FDA-related regulatory issues. Her portfolio areas include Immunology, Infectious Disease, Vaccines, Precision Medicine, Combination Products... Read More →
avatar for David Martin

David Martin

Associate Director for Real World Evidence Analytics, OMP, CDER, FDA
David Martin is the Associate Director for Real World Evidence Analytics, Office of Medical Policy, FDA Center for Drug Evaluation and Research. He oversees demonstration projects intended to support the agency’s evaluation of real world evidence, reviews real world evidence submissions... Read More →
avatar for Rebecca Miksad

Rebecca Miksad

Senior Medical Director, Research Oncology, Flatiron Health
Rebecca Miksad is a health outcomes and clinical trial researcher who serves as senior medical director at Flatiron Health. In this role, Rebecca focuses on generating real-world evidence, establishing regulatory-grade quality and contributing to the development of clinically relevant... Read More →
avatar for David Thompson

David Thompson

Senior Vice President, Real World & Late Phase Research, Syneos Health
David Thompson, PhD is a health economist with 25+ years of experience in HEOR consulting and real-world research design. He currently holds the position of Senior Vice President for Real-World & Late Phase Research at Syneos Health, where he provides RWE design solutions to study... Read More →
avatar for Brande Yaist

Brande Yaist

Senior Director, Global Patient Outcomes & Real World Evidence, Eli Lilly and Company
Mrs. Yaist is the Senior Director of the Center of Expertise in Global Patient Outcomes and Real World Evidence at Eli Lilly and Company. She leads and develops the research talent and capabilities needed to provide scientific services/expertise and support across an array of core... Read More →

Wednesday June 26, 2019 4:15pm - 5:30pm
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA


#395: Utilization and Evaluation of Innovative Approaches for Efficient Drug Development
Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-716-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will discuss how to promote utilization of innovative methodologies such as M&S and Bayesian approach for efficient drug development. Regulators will present their recent activities for reviewing/qualifying innovative methodologies and share their experiences.

Learning Objectives

Identify how to recognize innovative methodologies recently applied for efficient new drug development and related activities in regulatory agencies aiming at accelerating drug development; Discuss how to consider the use of such methodologies in drug development through better communication between industry and regulatory agencies.


Yuki Ando, PhD


Utilization and Evaluation of Innovative Methodologies: PMDA Perspective
Yuki Ando, PhD

Extrapolation: Recent European Regulatory Considerations
Andrew Thomson, PhD, MA, MS

Model-Based Bayesian Methods in Pharmaceutical Clinical Trials
Neal Thomas, PhD


Yuki Ando

Senior Scientist for Biostatistics, Office of New Drug I, Pharmaceuticals and Medical Devices Agency (PMDA)
Dr. Yuki Ando is a Senior Scientist for Biostatistics of the Pharmaceuticals and Medical Devices Agency (PMDA), Japan. She received a master’s degree in Engineering from Tokyo Science University, and PhD in Health Science from Osaka University. Currently she is responsible for the... Read More →
avatar for Neal Thomas

Neal Thomas

Executive Director, Biostatistics, Pfizer Inc
Neal Thomas joined Pfizer in 2002, and has been a member of the Statistics Research and Innovation center since 2004 where he has worked on clinical and non-clinical applications in many therapeutic areas. He received a PhD in Statistics from the University of Chicago, and he was... Read More →

Andrew Thomson

Statistician, Biostatistics and Methodology Support Office, European Medicines Agency
Andrew Thomson is a statistician in the Office of Biostatistics & Methodology at the European Medicines Agency. He provides methodological advice and guidance across all stages of development, and across all therapeutic areas. He also is the lead of the Statistics subgroup of ICH... Read More →

Wednesday June 26, 2019 4:15pm - 5:30pm
Room 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Regulator Thinking
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session
Thursday, June 27


#406: Electronic Submissions Update
Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-719-L04-P; CME 1.25; IACET 1.25; RN 1.25

See the latest electronic submission metrics for regulatory submissions and conformance with study data standards. Learn about FDA's current challenges with building upon existing automation in submission processing and how you can help.

Learning Objectives

Discuss the status of electronic submissions and validation at the FDA; Identify key components of lifecycle management for electronic submissions; Apply proposed best practices for handling daily submissions and ensuring validation standards are followed.


Tessa Brown, BSN, DrSc, MPH, RN


FDA Study Data Standards Submission Update
Heather Crandall, MA

FDA Electronic Submissions Update
Jonathan Resnick, PMP

avatar for Tessa Brown

Tessa Brown

Deputy Director, Office of Business Informatics /OSP / CDER, FDA
CAPT Tessa Brown DHSc, MPH, BSN, RN began her career as a Commission Corp Officer of the U.S. Public Health Service (USPHS) in 2001. She has held positions in various organizations to include the Bureau of Prisons, Health Resources and Services Administration, and the Food and Drug... Read More →
avatar for Heather Crandall

Heather Crandall

Operations Research Analyst, OBI, OSP, CDER, FDA
Heather Crandall has been with the FDA for over 6 years, working in CDER’s Office of Business Informatics. She currently focuses on standards and processes around electronic submissions.
avatar for Jonathan Resnick

Jonathan Resnick

Project Management Officer, OBI, OSP, CDER, FDA
Jonathan Resnick is a member of CDER’s Electronic Submissions Team, with a focus on eCTD and has been with FDA for eight years. Prior to joining FDA, Jonathan spent 18 years working in IT project management supporting federal and private sector clients.

Thursday June 27, 2019 9:00am - 10:15am
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA