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03: Data-Data Standards [clear filter]
Sunday, June 23
 

9:00am

SC24: #24: Data Visualization in the Life Sciences
Component Type: Tutorial
CE: ACPE 3.25 Application UAN: 0286-0000-19-504-L04-P; CME 3.25; IACET 3.25; RN 3.25

Traditional approaches to medical product development rely on generating pages upon pages of analysis results to describe the safety and effectiveness of novel therapies. Study teams struggle to understand and communicate the story hidden within the data to their colleagues. First and foremost, with the high cost of conducting translational clinical research, it is common to collect as much data as possible on as many endpoints as possible. This phenomenon is further reinforced due to our limited understanding of biological mechanisms and pathways, including the potential genomic underpinnings of a disease or treatment response. For example, we may have a clear understanding for how a novel therapy induces an efficacious response, but there is typically limited knowledge into the downstream effects of the drug to other body systems. A second challenge to communication lies in the increased use of sensitivity analyses to assess the consistency and robustness of study results to varying assumptions. Given the volume of data to review and the variety of analyses to perform, it should come as no surprise that clear insight is often out of reach. In this environment, the traditional means of data summary – tables and listings – are ineffective for gaining insight; visualization is the key to effective communication for the modern clinical trialist. Ben Shneiderman stated that “the purpose of visualization is insight.” Therefore, the goal of this short course is to describe data visualization techniques to aid in the understanding and communication of results from applications in clinical trials and genomics research. Numerous practical illustrations and examples from the literature will be presented. To be accessible to a wide audience, this course will focus on principles and interpretation, and limit technical jargon. At least 2/3 of the course will focus on case studies specific to clinical trials, while the remainder will be spent on examples in genomics. An additional registration fee is required for all preconference short courses. Back to DIA 2019 Short Courses

Who should attend?

This short course is designed to be accessible to a wide audience, it will focus on principles, limit technical jargon, and interpret numerous examples of data visualization using data from the life sciences literature. The audience may include any individual interested in developing their skills for more efficient interpretation and communication of various aspects of study design and analysis.


Learning Objectives

At the conclusion of this course, participants should be able to:
  • Describe the transition from traditional methods of data analysis to visual approaches;
  • Interpret life science data using one or more data visualizations;
  • Assess the strengths and limitations of various graphical techniques;
  • Explain the “data story” of numerous clinical research examples using data visualization techniques.



Speakers
avatar for Kelci Miclaus

Kelci Miclaus

Sr Manager, Advanced Analytics R&D, SAS Institute Inc., JMP Division
Dr. Kelci Miclaus is Advanced Analytics Sr. Manager for the JMP Life Sciences division at SAS Institute where she manages the R&D team and develops statistical features for JMP Genomics and JMP Clinical software. She joined SAS in 2006 and holds a PhD in Statistics from North Carolina... Read More →
avatar for Richard C. Zink

Richard C. Zink

Senior Director, Data Management and Statistics, TARGET Pharmasolutions Inc
Richard C. Zink is Senior Director of Data Management and Statistics at TARGET PharmaSolutions. He is the 2019 Chair of the Biopharmaceutical Section of the American Statistical Association, host of the Biopharmaceutical Section Statistics Podcast, and Associate Editor for the DIA... Read More →


Sunday June 23, 2019 9:00am - 12:30pm
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Real World Evidence
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial
 
Monday, June 24
 

11:00am

#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.

Chair

Michael Blum, MD, MPH

Speaker

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



Speakers
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, Epidemiology, RTI Health Solutions
Alicia Gilsenan, PhD, is a Senior Director of 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 in 1997... 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

11:00am

#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.

Chair

Hanming H Tu, MSc

Speaker

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



Speakers
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 →
HT

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 18 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 →
MM

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

11:00am

#112: Collecting Better Patient Experience Data: Lessons Learned from Patient Organizations
Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-526-L04-P; CME 1.00; IACET 1.00; RN 1.00

We will present methods and success stories from three rare disease patient organizations that have collected meaningful patient experience data. Panelists will share their insights and challenges for data collection including surveys and patient registries.

Learning Objectives

Describe the importance of participating in registries and the methods by which data is collected; Identify strategies for overcoming the challenges of patient engagement to help provide pathways towards accelerating rare disease research.

Chair

Laura Trutoiu, PhD

Speaker

Panelist
Monica Weldon

Panelist
Pamela Mace, RN



Speakers
PM

Pamela Mace

Executive Director, Fibromuscular Dysplasia Society of America
At the age of 37, Pam Mace was diagnosed with a rare disease called Fibromuscular Dysplasia (FMD). She struggled with her health for the first few years after her diagnosis and realized that medical professionals had no real understanding of the disease. Pam became an advocate for... Read More →
LT

Laura Trutoiu

Director of Research, The Association For Creatine Deficiencies
Laura is a computer scientist and the Director of Research for the Association for Creatine Deficiencies. She holds a PhD in Robotics from Carnegie Mellon University and she has conducted research in several top industry labs including Disney Research, Industrial Light and Magic... Read More →
avatar for Monica Weldon

Monica Weldon

President/Chief Executive Officer, Bridge the Gap - SYNGAP Foundation
In November of 2012, Monica's twin son, Beckett, was the first to be diagnosed at Texas Children's Genetics Clinic with the gene mutation SYNGAP1 (6p21.3). When Beckett was 4 months old, she noticed he was not meeting the same milestones as his twin sister. Monica then began a journey... Read More →


Monday June 24, 2019 11:00am - 12:00pm
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

11:00am

#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.

Chair

Yeh-Fong Chen, PhD

Speaker

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



Speakers
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

Acting Director, Office of Biostatistics, Office of Translational Sciences, CDER, FDA
Dr. Chakravarty joined CDER in 1992. She served as an Adjunct Faculty in Depart. of Statistics, Foundation for Advanced Education in the Sciences, NIH. She is an internationally recognized thought leader in the area of safety evaluation, surrogate markers and biomarkers in drug development... Read More →
avatar for Yeh-Fong Chen

Yeh-Fong Chen

Mathematical Statistician, Office of Translational Sciences, CDER, FDA
Dr. Chen is the Acting Associate Director of the Division of Biometrics II within CDER of FDA, supervising reviewers for the Division of Metabolism and Endocrinology Products and Division of Anesthesia, Analgesia, and Addiction Products. She joined FDA in 2000 after receiving her... 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

12:30pm

Community Meet Up: Discussion on Data Quality, Real-Time Calculated Metrics, Compliance
Component Type: Forum
Level: Basic

For any conference attendees interested in the topic of data quality, real-time calculated metrics across systems and all while staying in line with the highest level of compliance. This discussion includes (but is not limited to): • Peer insights & challenges • Machine learning • Artificial intelligence • Disparate data • Workflow insights • Leveraging your current systems

Chair

Adam Federman


Speakers
AF

Adam Federman

Director, Business Development, Remarque Systems


Monday June 24, 2019 12:30pm - 1:30pm
Community Area Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:15pm

#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.

Chair

Debra Fasteson Harris

Speaker

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



Speakers
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 →
AH

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

2:15pm

#152: Making Data Meaningful: Using Data Visualization to Drive Efficiency in Safety Analysis
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-550-L04-P; CME 1.00; IACET 1.00; RN 1.00

Data visualization can transform and advance clinical trial safety analysis. Discover the latest data visualization use cases for safety and how dynamic data exploration yields meaningful data review, better patient outcomes and trial efficiency.

Learning Objectives

Discuss various data visualization examples that can be applied to the area of clinical trial safety analysis; Outline key benefits and efficiencies statisticians, medical monitors, and others in charge of safety can achieve through data visualizations that are being used in this area of clinical trials today.

Chair

Demi Niforos, MS

Speaker

Summary of Safety Visualization Efforts
William Wang, PhD

Panelist
Nathan Bennett, PhD, MA



Speakers
DN

Demi Niforos

Vice President, Biostatistics and Statistical Programming, eClinical Solutions
Demi Niforos is VP, Biostatistics and Statistical Programming for eClinical Solutions and has more than 20 years of drug development experience in both the CRO and Pharmaceutical/Biotech environments. Prior to joining eClinical Solutions she held leadership roles in biostatistics... Read More →
avatar for William Wang

William Wang

Executive Director, Clinical Safety Statistics, BARDS, Merck Research Laboratories
Dr. William (Bill) Wang is an executive director, clinical safety statistics, Merck Research Laboratories. He has over 25 years of experience in the pharmaceutical industry, with ~18 years with Merck & Co Inc. He is co-chairing the ASA safety working group, and is a deputy topics-leader... Read More →


Monday June 24, 2019 2:15pm - 3:15pm
Room 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

3:30pm

#159: Understanding the Data Journey In Virtual Trials
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-556-L04-P; CME 1.00; IACET 1.00; RN 1.00

Virtual trials promise to improve clinical research. New methods of data collection and usage also bring new challenges. This forum will model the journey of data in a virtual trial, identify key challenges, and offer solutions for sponsors and CROs.

Learning Objectives

Recognize data collection and usage challenges at all stages of virtual trials; Design successful data practices in a virtual trial.

Chair

Jon Roth, MBA

Speaker

Panelist
Oladele Babalola

Panelist
Robert A. DiCicco, PharmD

FDA Update
Vaishali Popat, MD, MPH

FDA Update
Isaac R. Rodriguez-Chavez, MHS, PhD, MS



Speakers
OB

Oladele Babalola

Associate Director, Data Management, Apellis Pharmaceuticals
avatar for Robert DiCicco

Robert DiCicco

Deputy Chief Health Officer, IBM Watson Health
Rob DiCicco is a Deputy Chief Health Officer for IBM Watson Health where he focuses on Life Sciences. Rob joined IBM in 2018 after a long career in Pharmaceutical R&D spanning nearly 30 years. His area of expertise includes clinical pharmacology and experimental medicine, clinical... Read More →
avatar for Vaishali Popat

Vaishali Popat

Associate Director of Biomedical Informatics and Safety Analytics, OND, CDER, FDA
Dr. Vaishali Popat is an Associate Director for Biomedical Informatics in the Office of New Drugs, Immediate Office. Dr. Popat is the OND lead on biomedical informatics issues in areas such as staff training on the use of new review tools to make the evaluation of pre-marketing data... Read More →
avatar for Isaac Rodriguez-Chavez

Isaac Rodriguez-Chavez

Clinical Research Methodology, Reg Compliance and Policy Development, OMP, CDER, FDA
Dr. Isaac R. Rodriguez-Chavez serves as a FDA, CDER Officer for Clinical Research Methodology, Regulatory Compliance and Policy Development. He is a biomedical leader with expertise in Virology, Microbiology, Immunology, Vaccinology, and Oncology. Past positions in the last 20 years... Read More →
avatar for Jon Roth

Jon Roth

VP, Data Sciences and Biometrics, Biorasi
With over 25 years of clinical trial experience, including a decade as CEO/CTO of a clinical data driven CRO, and a penchant for innovative approaches to clinical study management featuring big data analysis and on-study analytics of live and historical clinical study data, Jon has... Read More →


Monday June 24, 2019 3:30pm - 4:30pm
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

3:30pm

#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.

Chair

Cheng Su, PhD

Speaker

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



Speakers
avatar for Taras Carpiac

Taras Carpiac

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

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 →
CS

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 Operations Officer, CluePoints
As CluePoints COO, Steve is primarily responsible for ensuring successful customer adoption of the CluePoints platform. Steve worked for three bio-pharma companies over a span of 15 years where he assumed leadership positions in data management and led the successful enterprise roll-out... 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
 

8:00am

#206: Single Source of Truth, Integrations, or IoT (Internet of Things): Exploring Ways to Improve Connectedness of Clinical Data
Component Type: Forum
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-574-L04-P; CME 1.25; IACET 1.25; RN 1.25

This panel discussion will explore ways to improve connectedness of clinical data in today's CDM world and talk about if Single Source of Truth, Integrations or IoT (Internet of Things) are the best ways to move forward.

Learning Objectives

Describe why, what, where, when and how of data integrations between clinical systems; Describe recent technologies in CDM world and how these technologies are increasing the need for efficient integrations; Identify current challenges in data integrations between clinical systems; Discuss ways to improve efficiency of integrations and use cases where technology has improved integration.

Chair

Joby John, DDS

Speaker

Panelist
Nick Neri, MS

Panelist
Kelly Ritch, MBA, MS

Panelist
Jennifer Price



Speakers
avatar for Joby John

Joby John

Senior Director, Technology Operations, Bioclinica
Dr Joby John is a versatile Clinical Research executive with over 16 years of experience in managing end to end clinical services like EDC, CDM, SDTM, SAS, IWRS, eTMF to name a few. She has worked with a wide array of global Pharma companies, CROs and FSPs in setting up and managing... Read More →
avatar for Nick Neri

Nick Neri

Director of Data Services & Integration, ERT
Mr. Neri has over 20 years of industry experience, and has established himself as a thought leader in the industry for applying next generation concepts and technologies to the clinical research space. He currently serves as Director, Data Integration and Services, CoE at ERT. Previously... 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 →
KR

Kelly Ritch

VP, Clinical Trial Solutions, ArcheMedX
Dynamic and innovative executive with 20 years experience creating, managing, and driving high-performance, outcomes, and long-term value. Strategic thinker with strong analytical skills as well as a proven ability to affect positive change and significantly improve business processes... Read More →


Tuesday June 25, 2019 8:00am - 9:15am
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10:30am

#229: An Industry Collaboration on Pharmacovigilance Analytics
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-592-L04-P; CME 1.00; IACET 1.00; RN 1.00

This session will discuss an initiative and how it is facilitating biopharmaceutical companies to enable earlier and systematic identification of potential safety issues to help minimize harm to patients, improve quality of analytic methods to improve product development, and deliver accelerated method development through collaboration and piloting. Join the Clinical Safety & Pharmacovigilance Community for a follow up Round Table discussion on Wednesday, June 26, 12:45-1:45PM in the DIA Community Zone 1, Sails Pavilion.

Learning Objectives

Discuss methods for collaborating and innovating in analytics to improve patient safety; Identify how to build awareness of opportunities for greater alignment across the industry in signal detection and management; Describe industry best practices of current and future signal detection and management.

Chair

Andres Gomez, PhD, MPH

Speaker

Panelist
John Van Stekelenborg, PhD, MBA, MSc

Panelist
Neal Grabowski, MS



Speakers
AG

Andres Gomez

Vice President, Head of Epidemiology, Safety Science, and Analytics, Bristol-Myers Squibb
Dr. Gomez joined at Bristol Myers Squibb Company as an Associate Director of Pharmacoepidemiology in the Global Pharmacovigilance and Epidemiology department in 2003. He currently heads the epidemiology, safety science and analytics groups which is accountable for the real world research... Read More →
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Neal Grabowski

Director, Global Patient Safety and Labeling, Amgen Inc.
Neal Grabowski joined Amgen in 2014 as the Signal Management Officer responsible for signal detection and management processes including the implementation of numerous systems, process oversight and continual improvement and vendor management. He is currently the Head of Safety Signal... Read More →
avatar for John Van Stekelenborg

John Van Stekelenborg

Director, Group Lead, Methods and Analysis, Johnson & Johnson
John van Stekelenborg is the Head of the Methods & Analysis group in the Global Medical Safety department of Janssen, the Pharmaceutical Companies of Johnson & Johnson. John has been with J&J since 2002 and assumed leadership of the M&A group in 2011 where he leads a group of data... Read More →


Tuesday June 25, 2019 10:30am - 11:30am
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10:30am

#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.

Chair

Kit Howard, MS

Speaker

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



Speakers
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 →
LK

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 →
BL

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

2:00pm

#274 EE: Pharma Powered by the Digital
Component Type: Workshop
Level: Basic

Pharma companies are experimenting with a range of digital health initiatives. This workshop will help the audience appreciate the complexity of implementing digital solutions through mock cases and interactive discussions about key challenges.

Learning Objectives

Identify opportunities and challenges associated with digital health technologies; Discuss approaches and strategies to more effectively engage in digital healthcare initiatives; Apply best practices to future digital health implementation.

Chair

Fabian D'Souza, MD, MBA


Speakers
avatar for Fabian D'Souza

Fabian D'Souza

Founder and President, Boston Strategic Partners, Inc.
Dr. D’Souza is the Founder and President of Boston Strategic Partners, Inc. a consultancy dedicated to serving pharma-biotech, devices/ diagnostics, and Health-IT through different practices: business and clinical strategy, HEOR, and medical communications. He has also led projects... Read More →


Tuesday June 25, 2019 2:00pm - 3:00pm
E and E Area Exh Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:00pm

#259: FDA Data Standards Update
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-611-L04-P; CME 1.25; IACET 1.25; RN 1.25

FDA CDER and CBER implemented a joint data standards strategy in 2018, with a supporting action plan that is a PDUFA VI commitment. This session will focus on accomplishments and challenges.

Learning Objectives

Explain current and emerging data standards at FDA; Describe the FDA's data standards process and collaborations with stakeholders.

Chair

Ron D. Fitzmartin, PhD, MBA

Speaker

CBER Study Data Standards Update
Wei (Lisa) Lin, MBA, PMP

CDER Update
Ethan Chen, MBA

CDER Update
Ta-Jen Chen, MS

CDER Update
Vaishali Popat, MD, MPH



Speakers
avatar for Ethan Chen

Ethan Chen

Director, Division of Data Management Services and Solutions, OBI, OSP, CDER, FDA
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 the several critical initiatives as the CDER... Read More →
TC

Ta-Jen Chen

Project Management Officer, OSP, CDER, FDA
TJ is a project management Officer at Office of Strategic Programs, CDER, FDA, where he is responsible for the development, testing, and implementation of electronic data standards for CDER regulatory review. As a FDA delegate to ICH E2B Expert Working Group and ISO TC 215 WG 6, he... Read More →
avatar for Ron Fitzmartin

Ron Fitzmartin

Sr. Informatics Advisor, FDA
Ron Fitzmartin is Senior Project Manager, Office of the Director, Center for Biologics Evaluation and Research, Food and Drug Administration. In this role Ron provides policy and strategy consultation and support on a wide range of topics focused on electronic regulatory submissions... Read More →
avatar for Wei (Lisa) Lin

Wei (Lisa) Lin

Study Data Standards Manager, Office of Director, CBER, FDA
Lisa Lin has worked as a Study Data Standards manager at FDA CBER for over a year. Currently she is responsible for all study data standards projects in CBER, including data validation, evaluation and testing of SEND standard for CBER, data analysis tool training and support. Before... Read More →
avatar for Vaishali Popat

Vaishali Popat

Associate Director of Biomedical Informatics and Safety Analytics, OND, CDER, FDA
Dr. Vaishali Popat is an Associate Director for Biomedical Informatics in the Office of New Drugs, Immediate Office. Dr. Popat is the OND lead on biomedical informatics issues in areas such as staff training on the use of new review tools to make the evaluation of pre-marketing data... Read More →


Tuesday June 25, 2019 2:00pm - 3:15pm
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:00pm

#261: Patient Experience Data: How Could this Data Enhance Decision-Making at Different Stages of Medical Product Development?
Component Type: Forum
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-613-L04-P; CME 1.25; IACET 1.25; RN 1.25

This forum will provide an opportunity for key stakeholders to discuss examples of various types of patient experience data, and how this data could potentially inform decision-making at different stages of medical product development.

Learning Objectives

Define patient experience data; Describe types of patient experience data that could inform medical product development; Discuss how patient experience data can inform decision making at different stages of medical product development.

Chair

Meghana Chalasani, MHA

Speaker

FDA Perspective
Michelle Campbell, PhD

Panelist
Elizabeth Hart, MD

Panelist
Isabelle Lousada, MA

Panelist
Kristina Bowyer, LPN



Speakers
avatar for Kristina Bowyer

Kristina Bowyer

Executive Director of Patient Advocacy, Ionis Pharmaceuticals
Kristina Bowyer is the Executive Director of Patient Advocacy & Engagement at Ionis Pharmaceuticals. Kristina has worked at Ionis for over 26 years and has spent the last seven years successfully building Ionis’ internal patient engagement program to ensure that the patient perspective... Read More →
MC

Michelle Campbell

Division of Neurology Products, Office of New Drugs, CDER, FDA
Michelle Campbell is the Sr. Clinical Analyst for Stakeholder Engagement and Clinical Outcomes for the Division of Neurology Products, Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). Previously, Dr. Campbell was a... Read More →
avatar for Meghana Chalasani

Meghana Chalasani

Senior Research Analyst, Office of the Center Director, CDER, FDA
Meghana Chalasani currently serves as a senior research analyst for the Patient-Focused Drug Development (PFDD) Program in FDA’s Center for Drug Evaluation and Research (CDER). She works closely on CDER’s various PFDD initiatives and provides strategic, regulatory, program, and... Read More →
avatar for Isabelle Lousada

Isabelle Lousada

Chief Executive Officer and President, Amyloidosis Research Consortium
As a former patient, Lousada has spent 20 years dedicated to patient advocacy, accelerating drug development, and promoting awareness of rare diseases. Lousada founded the Amyloidosis Research Consortium (ARC) in 2015 to address the critical needs in clinical trials and related research... Read More →
EH

Elizabeth Hart

Physician, Office of Tissues and Advanced Therapies, CBER, FDA


Tuesday June 25, 2019 2:00pm - 3:15pm
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

4:15pm

#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.

Chair

Stacey Yount, MA

Speaker

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



Speakers
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
 

8:00am

#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.

Chair

Gene Vinson

Speaker

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



Speakers
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

8:00am

#317: Designing Clinical Trials with the Right Endpoints: Applying ICH-E9(R1) - Getting the Questions Right (GTQR),Estimands and Handling Missing Data
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-657-L04-P; CME 1.25; IACET 1.25; RN 1.25

Industry and FDA experts will share how to operationalize ICH E9(R1) to design trials with clinically meaningful endpoints. Forum will include a summary from the DIA Stats Community GTQR Series, the Oncology Drug Development Working group on Estimands, and Tipping Point analysis to account for missing data.

Learning Objectives

Discuss key elements of ICH E9(R1) and GTQR; Define estimands and ongoing efforts for implementation; Identify how to apply estimands in oncology with time-to-event endpoint; Describe an overview and examples of applying tipping point analysis to explore the impact of missing data assumptions on study results, along with key considerations during the planning stage of these sensitivity analyses.

Chair

Munish Mehra

Speaker

Estimand Framework and its Impact on Oncology Drug Development: Findings From An Industry-Wide Working Group
Yi Liu, PhD

Assessment of Tipping Point Analysis for Handling Various Types of Missing Data
Martin Clancy, MSc

Estimands for Efficacy Analyses
Thomas J. Permutt, PhD



Speakers
MC

Martin Clancy

Senior Statistician, PHASTAR
I'm a Senior Statistician at PHASTAR, a specialist CRO offering statistical consultancy, clinical trial reporting and data management services by providing expert consultants and delivering in-house projects. Working in a Contract Research Organisation (CRO) for the past 4 years... Read More →
avatar for Yi Liu

Yi Liu

Director Biostatistics, Nektar Therapeutics
Yi Liu got her Ph.D. degree in Statistics from the department of Statistics at The Ohio State University. She is currently a director at Nektar Therapeutics responsible for clinical trials in collaborations with external partners and CMC and biomarker related statistical analyses... Read More →
avatar for Munish Mehra

Munish Mehra

Executive Director, Tigermed
Dr. Munish Mehra, is a drug development expert with Tigermed, providing services to Pharmaceutical and Biotechnology companies to design, analyze and report on Phase 2 and 3 studies. He has represented several sponsors at pre-IND, End of Phase 2 and pre-NDA meetings. He is a frequent... Read More →
avatar for Thomas Permutt

Thomas Permutt

Associate Director for Statistical Science and Policy, OB, OTS, CDER, FDA
Tom Permutt is Associate Director for Statistical Science and Policy, Office of Biostatistics, Center for Drug Evaluation and Research at FDA. Tom’s contributions to causal inference in clinical trials date from 1989 when he proposed an instrumental-variable estimator of the effect... Read More →


Wednesday June 26, 2019 8:00am - 9:15am
Room 11B 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 Forum

10:00am

#326 CH: 2020 and Beyond, Data Capture Across Systems, Functions, and Modalities
Component Type: Workshop
Level: Advanced

This workshop will lead an interactive discussion related to clinical trials of the future. How will pharmaceutical companies interact with sites and patients? How do we better connect trial conduct and outcomes to our data consumers?

Learning Objectives

Discuss organization strategy; Recognize data modalities and their impact on the clinical trial space; Describe clinical trials of the future with an emphasis on data and site management.

Chair

Muzafar Mirza

Speaker

Facilitator
John Manlay, MS



Speakers
MM

Muzafar Mirza

Director, Program Lead, Pfizer Inc
Muzafar (Muz) Mirza is currently a Program Lead for the Hematology Portfolio in the Oncology Therapeutic Area that is part of the Data Monitoring &Management (DMM) group at Pfizer. As well as managing aspects of the Oncology portfolio, Muz is working on addressing challenges related... Read More →
JM

John Manlay

Director Clinical Data Management, Pfizer Inc


Wednesday June 26, 2019 10:00am - 10:30am
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10:30am

#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.

Chair

Rakesh Maniar, MS

Speaker

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



Speakers
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. At Novartis, area of responsibilities includes technology optimization, enable adoption of new technologies & provide value added services for efficient clinical trial execution... 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 →
KB

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

10:30am

#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.

Chair

Jean M. Mulinde, MD

Speaker

FDA Perspective
Phillip D. Kronstein, MD

MHRA Perspective
Stephen Vinter



Speakers
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

Medical Officer, Senior Policy Advisor, 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

2:00pm

#360: Identification of Medicinal Products: FDA's Perspective and Approach
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-684-L04-P; CME 1.25; IACET 1.25; RN 1.25

This forum will discuss FDA's perspective on the five ISO standards for Identification of Medicinal Products and its approach to conformance, as well as its collaboration with industry and other regulatory agencies.

Learning Objectives

Identify the five ISO IDMP Standards; Describe FDA's approach to IDMP conformance; Explain the current scope of the FDA's IDMP approach.

Chair

Ron D. Fitzmartin, PhD, MBA

Speaker

FDA Update
Ta-Jen Chen, MS

Defining Substances for the IDMP Using the GSRS
Lawrence Nicholas Callahan, III, PhD



Speakers
TC

Ta-Jen Chen

Project Management Officer, OSP, CDER, FDA
TJ is a project management Officer at Office of Strategic Programs, CDER, FDA, where he is responsible for the development, testing, and implementation of electronic data standards for CDER regulatory review. As a FDA delegate to ICH E2B Expert Working Group and ISO TC 215 WG 6, he... Read More →
avatar for Ron Fitzmartin

Ron Fitzmartin

Sr. Informatics Advisor, FDA
Ron Fitzmartin is Senior Project Manager, Office of the Director, Center for Biologics Evaluation and Research, Food and Drug Administration. In this role Ron provides policy and strategy consultation and support on a wide range of topics focused on electronic regulatory submissions... Read More →
LC

Lawrence Callahan

Chemist, OCS, OCPP, Office of the Commissioner, FDA
Larry Callahan obtained his Ph.D. in Chemistry from the University of Chicago. He was previously employed at FDA, NIH and the United States Pharmacopiea (USP). He has been involved in Nucleic Acid, HIV, tuberculosis research and the development of analytical methods for biotechnology-derived... Read More →


Wednesday June 26, 2019 2:00pm - 3:15pm
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:00pm

#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.

Chair

Matthew Krumrai

Speaker

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



Speakers
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, 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 →
WX

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

4:15pm

#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.

Chair

Rebecca Lipsitz, PhD

Speaker

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



Speakers
avatar for Rebecca Lipsitz

Rebecca Lipsitz

Associate Director, Janssen
Rebecca Lipsitz is an Associate 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... 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 and Late Phase Research, Syneos Health
David Thompson, PhD is a health economist with 30+ 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

4:15pm

#394: Demystifying Basic Statistical Concepts for Anyone Involved with Clinical Trials
Component Type: Workshop
Level: Basic
CE: ACPE 1.25 Application UAN: 0286-0000-19-710-L04-P; CME 1.25; IACET 1.25; RN 1.25

Not a statistician? Then this workshop is for you!

Group activities and slide-based learning will be used to introduce commonly used statistical concepts using real clinical trial results from publicly posted FDA reviews.

Learning Objectives

Explain basic statistical concepts such as randomization, blinding, hypothesis testing, p-values, the challenges of false positives and adjusting for multiplicity, and approaches to handling missing data; Identify the appropriate statistical analysis for a given outcome; Discuss assumptions and limitations of analysis methods with a study team; Assess the clinical importance of statistical results.

Chair

Matt Baldwin, MS

Speaker

Facilitator
Stephen Corson, PhD

Facilitator
Munish Mehra



Speakers
avatar for Matt Baldwin

Matt Baldwin

Senior Biostatistician, Advance Research Associates, Inc (ARA)
Matt Baldwin is a Senior Biostatistician who works with Advance Research Associates to advance clinical solutions through analysis. Matt’s various positions have provided experience in randomization, generic and new drugs, statistical clinical development, DMC support, and analysis... Read More →
avatar for Stephen Corson

Stephen Corson

Senior Statistician, Phastar
I am a Senior Statistician working at Phastar, a specialist CRO offering statistical consultancy, clinical trial reporting and data management services to pharmaceutical and biotech companies. Prior to this I spent 3 years working as a Consultant Statistician in the Department of... Read More →
avatar for Munish Mehra

Munish Mehra

Executive Director, Tigermed
Dr. Munish Mehra, is a drug development expert with Tigermed, providing services to Pharmaceutical and Biotechnology companies to design, analyze and report on Phase 2 and 3 studies. He has represented several sponsors at pre-IND, End of Phase 2 and pre-NDA meetings. He is a frequent... Read More →


Wednesday June 26, 2019 4:15pm - 5:30pm
Room 11B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

4:15pm

#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.

Chair

Yuki Ando, PhD

Speaker

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



Speakers
YA

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 →
AT

Andrew Thomson

Statistician, Biostatistics and Methodology Support Office, European Medicines Agency (EMA)
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
 

9:00am

#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.

Chair

Tessa Brown, BSN, DrSc, MPH, RN

Speaker

FDA Study Data Standards Submission Update
Heather Crandall, MA

FDA Electronic Submissions Update
Jonathan Resnick, PMP



Speakers
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

9:00am

#409: Case Studies From FDA and MHRA: Good Clinical Practices
Component Type: Workshop
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-19-723-L04-P; CME 1.25; IACET 1.25; RN 1.25

If you were not able to join in person on day two of the FDA-MHRA Good Clinical Practice Workshop, Data Integrity in Global Clinical Trials – Are We There Yet? last October, and missed the case study sessions, you will have a second chance in this Workshop. Attendees will work with regulators on two of the previously presented case studies to investigate data integrity and discuss the impact of their findings on overall study reliability.

Learning Objectives

Evaluate how data management practices may impact data integrity and reliability; Discuss how data integrity is key to vendor selection; Describe and evaluate the impact of data blinding on data reliability; Evaluate how audit trails may be used to assess data integrity.

Chair

Gail Francis

Speaker

MHRA Perspective
Stephen Vinter

FDA Perspective
Jean M. Mulinde, MD



Speakers
avatar for Gail Francis

Gail Francis

Expert Inspector, GCP, Medicines and Healthcare products Regulatory Agency (MHRA)
Gail Francis joined the MHRA in November 2003 as a GCP Inspector. Prior to joining the MHRA, Gail spent approximately 10 years in the Pharmaceutical industry. Her first role in the Pharmaceutical Industry was in Pharmacovigilance, before moving into Clinical Research and has held... Read More →
avatar for Jean Mulinde

Jean Mulinde

Medical Officer, Senior Policy Advisor, 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 →


Thursday June 27, 2019 9:00am - 10:15am
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA