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Trk 07: Tech/Data/ Records/Subs [clear filter]
Monday, June 27
 

10:45am

#131: IDMP Update
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

CBER provided critical leadership and technical expertise to the development of IDMP standards and currently continues leading international efforts to delineate a common approach for their implementation and to consider their future application. This session will provide an update on this initiative.

Learning Objectives

Discuss the status of IDMP implementation.

Chair

Vada A. Perkins

Speaker

ISO IDMP: Benefits Beyond Compliance
Niels Gronning, MSc

Interoperability and Standardization Within the Life Sciences: Justification, Mechanisms, and Opportunities
Tom Macfarlane, RAC



Chair
VP

Vada Perkins

Senior Advisor for Regulatory Science, IDMP Topic Lead, CBER, FDA
Capt. Vada A. Perkins, MSc, BSN, RN, is the Deputy Associate Director for Review Management (acting) with the FDA's Center for Biologics Evaluation and Research, Office of the Director. He received his MSc. in Bioscience Regulatory Affairs from The Johns Hopkins University and his... Read More →

Speakers
avatar for Niels Gronning

Niels Gronning

Principal Consultant, NNIT A/S
With a professional and academic bacground within the pharmaceutical industry Niels Grønning possesses extensive knowledge within the area of IT & Life Sciences. His area of expertise is predominantly found within regulatory affairs, IT (strategy, architecture & compliance) and more... Read More →
avatar for Tom Macfarlane

Tom Macfarlane

Director, Life Sciences, Accenture Accelerated R&D Services
A Neuroscientist by training, Tom has worked in most therapeutic areas during time at Ipsen, Parexel and as a freelance consultant. Now at Accenture, he continues to represent clients to EMA and to facilitate drug development strategies; but also works with emergent technologies/concepts... Read More →


Monday June 27, 2016 10:45am - 12:00pm
204B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Tuesday, June 28
 

10:30am

#216: Implementing a Successful Metadata Repository: The Journey of a Thousand Milestones Begins with a Single Step
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

During this session, the value of metadata repositories will be discussed, and the audience will be provided with real-world practical experience regarding the traps to avoid, and the process to follow, to enable a successful metadata repository implementation.

Learning Objectives

Describe the complexities associated with defining metadata repository requirements; Discuss how to develop a methodology for implementing a successful metadata repository.

Chair

David Handelsman

Speaker

Semantic Metadata Repository at the Core of E2E eClinical Solutions
Isabelle M de Zegher

Implementing a Metadata Repository Based on Value and Not Technology
David Handelsman

Metadata Repositories: From the Outside In
Wayne R. Kubick, MBA



Chair
avatar for David Handelsman

David Handelsman

Senior Director, Industry Strategy, d-Wise
Dave Handelsman is a life sciences expert with 25 years of industry, software and management experience. As Senior Director of Strategy and Product Development at d-Wise, Dave is responsible for d-Wise’s growth and evolution, and for further establishing d-Wise as the go-to partner... Read More →

Speakers
avatar for Wayne Kubick

Wayne Kubick

Chief Technology Officer, HL7
Mr. Kubick is CTO for Health Level Seven International, intent on improving clinical research through technology and data standards. He was formerly CTO and a Board member for CDISC, and has 2+ decades in a variety of leadership roles in clinical R&D with BBN, Parexel International... Read More →
avatar for Isabelle de Zegher

Isabelle de Zegher

Vice President, PAREXEL Informatics
Isabelle de Zegher is Vice President, Integrated Solutions at PAREXEL Informatics where she is responsible for engineering strategy around Big Data, BI and Advanced Analytics. She has 25 years’ experience in Life Sciences, including extensive work on cross-industry forum on integration... Read More →


Tuesday June 28, 2016 10:30am - 11:45am
204C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm

#239: Cloud Compliance: Clinical Software Challenges and Vendor Auditor Views
Limited Capacity seats available

Component Type: Symposium
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

We will share practical experience and tips for addressing the compliance challenges for clinical solutions using cloud technology and auditing vendors of IaaS, PaaS, and SaaS services. Benefits, challenges, and possible remediation are discussed.

Learning Objectives

Identify infrastructure issues related to data integrity and system security for SaaS, IaaS, and PaaS services; Discuss audit compliance issues related to cloud based software solutions; Identify how to check for critical quality evidence based on 50+ audits of IT suppliers.

Chair

Teri Stokes, PhD, MS, MT

Speaker

Software as a Service (SaaS) and Cloud Provider Qualification: An Auditor's Perspective
Calvin H Kim, MS

Maintaining the Validation Status of Software as a Service (SaaS) in a Regulated Environment
Anu Virkar

Are You Cloud Compliant? Practical Considerations for Managing Clinical Data in the Cloud
Srinivas Karri, MSc



Chair
avatar for Teri Stokes

Teri Stokes

Director, Quality Assurance Compliance, Cytel Inc.
Dr. Stokes worked 11 years as a Medical Technologist in hospital, research, and central medical laboratories. Then 16 years at Digital Equipment Corporatin (DEC) first in the Large Computer Group, second in the Laboratory Data Products Group, and finally at DEC in Basel, Switzerland... Read More →

Speakers
avatar for Srinivas Karri

Srinivas Karri

Senior Director, Clinical Warehousing Cloud Strategy, Oracle Corporation
As an industry strategy lead for clinical data cloud based applications, I help identify, define and create new services to support management of clinical data using cloud based technologies and capabilities. I have over 20 years experience with developing, implementing, selling and... Read More →
avatar for Calvin Kim

Calvin Kim

Senior GxP IT Auditor, Bayer
Calvin is a seasoned IT auditor with over 20 years of experience in various sectors of GxP regulated industries. As a core member of a global QA organization responsible for quality oversight and regulatory compliance assessment of computerized systems (CS) and technologies used in... Read More →
avatar for Anu Virkar

Anu Virkar

Vice President, Quality and Compliance, eClinical, IBM Watson Health
Anu Virkar, MS, MA, PMP is the VP of Q&C. Anu has been in the SQA field for over 23 years, & has focused on clinical trial mgmt and Med device industry for over 15 yrs. She has extensive experience in software QA, SDLC, project mgmt as well as policy development, implementation. She... Read More →


Tuesday June 28, 2016 2:00pm - 3:15pm
201C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

4:00pm

#264: FDA Update on Data Standards
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-538-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will include information on required data standards in regulatory submission and FDA's efforts to develop, test, and support therapeutic area data standards. Discussion will include FDA's participation in and status of international data standards initiatives such as IDMP.

Learning Objectives

Discuss required data standards in NDAs, BLAs, INDs and ANDAs 2; Summarize FDA's efforts to develop, test and support therapeutic area data standards; Describe FDA's participation in and status of international data standards initiatives, such as IDMP.

Chair

Mary Ann Slack

Speaker

OCP Update
Eileen E. Navarro Almario

CDER Perspective
Colleen Ratliffe, MS, PMP

FDA Update
Stephen E. Wilson, DrPH



Chair
avatar for Mary Ann Slack

Mary Ann Slack

Director, Office of Strategic Programs, CDER, FDA
Ms. Slack has 30+ years extensive leadership and management experience in both the public and private sectors, developing informatics strategy and implementing business solutions. She currently serves as Director of FDA CDER Office of Strategic Programs, which plays a lead role in... Read More →

Speakers
avatar for Eileen Navarro Almario

Eileen Navarro Almario

Lead Medical Officer, OCS, OTS, CDER, FDA
Eileen Navarro is Associate Director for Clinical Affairs in the Office of Computational Science, OTS, CDER, where she leads a team of analysts in providing regulatory review and training support to medical officers, statisticians, and safety evaluators. She is a Fellow of the American... Read More →
avatar for Colleen Ratliffe

Colleen Ratliffe

Project Management Officer, Office of Strategic Programs, CDER, FDA
Colleen Ratliffe is a project management officer on the Data Standards team within the Office of Strategic Programs, CDER. The data standards team’s core functions include coordinating and leading projects that support and promote the development of data standards and policy and... Read More →
avatar for Stephen Wilson

Stephen Wilson

Director, Division of Biometrics III, Office of Biostatistics, OTS, CDER, FDA
Dr. Wilson has worked as a Statistical Reviewer and Supervisory Mathematical Statistician in FDA/CDER for 28 years and is currently the Director of the Division of Biometrics III and a Captain in the USPHS. He received his doctorate in Biostatistics from UNC/Chapel Hill in 1984.


Tuesday June 28, 2016 4:00pm - 5:15pm
204B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

4:00pm

#265: Enabling Innovative New Endpoint Measurement Using Mobile Technology
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-541-L04-P; CME 1.25; IACET 1.25; RN 1.25

Mobile phones and tablets are becoming ubiquitous and contain components and data some of which can be leveraged to make novel health measurements. This session explores three areas of innovation in the use of smartphones in clinical research.

Learning Objectives

Identify the potential of smartphones to act as a sophisticated measurement device for new and novel health outcomes measurement; Recognize smartphone sensors, components, and passive data in the measurement of health outcomes and the potential of Apple ResearchKit; Explore the potential of artificial intelligence approaches using smartphones including the potential of facial analysis in health screening and outcomes research.

Chair

Bill Byrom, PhD

Speaker

Leveraging Smartphone Sensors and Apple Research Kit to Measure Health Outcomes
Bill Byrom, PhD

Bringing Active Tests and Passive Monitoring for Parkinson’s Disease Into an Interventional Clinical Trial: Towards Measuring Health Outcomes Using Smartphones
Christian Gossens, PhD



Chair
avatar for Bill Byrom

Bill Byrom

Senior Director of Product Innovation, and Vice Director of ePRO Consortium, ICON, plc.
Bill serves as a Senior Director within Product Innovation at ICON, focusing on harnessing new technologies for clinical trials. He has worked in the Pharma industry for over 25 years and is the author of 60+ publications and an industry textbook on electronic Patient Reported Outcomes... Read More →

Speakers
avatar for Christian Gossens

Christian Gossens

Global Head, Early Development Workflows, F. Hoffmann-La Roche Ltd.
Christian is leading the Early Development Workflow team in Roche’s Research and Early Development Informatics (pREDi) organization. He is driving technology innovation into clinical trials - focusing currently on the adoption of mobile sensors for digital biomarker development... Read More →


Tuesday June 28, 2016 4:00pm - 5:15pm
203AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Wednesday, June 29
 

10:30am

#314: Transforming Clinical Protocols into a Digital Platform: Driving Quality and Efficiency End-to-End
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-16-539-L04-P; CME 1.00; IACET 1.00; RN 1.00

A panel of experts will discuss novel approaches to developing and implementing a machine-readable protocol. Representatives from the clinical development, data standards, and regulatory affairs disciplines will review the impact of traceability.

Learning Objectives

Discuss the evolution of a protocol from a document to a digital platform; Describe an end-to-end traceability model from protocol to analysis; Describe the approach to automate reuse of protocol level information.

Chair

Robert A. DiCicco, PharmD

Speaker

Panelist
Eileen E. Navarro Almario

Panelist
Rebecca D. Kush, PhD

Panelist
Christine Pierre, RN



Chair
avatar for Robert DiCicco

Robert DiCicco

Vice President, Clinical Innovation and Digital Platforms, GlaxoSmithKline
Rob DiCicco is the Vice President of Clinical Innovation and Digital Platforms at GSK. He is the Work Stream Leader for the Common Protocol Template Project sponsored by TransCelerate and one of the Team Leads on CTTI’s Mobile Clinical Trials Novel Endpoints Project. He has over... Read More →

Speakers
avatar for Eileen Navarro Almario

Eileen Navarro Almario

Lead Medical Officer, OCS, OTS, CDER, FDA
Eileen Navarro is Associate Director for Clinical Affairs in the Office of Computational Science, OTS, CDER, where she leads a team of analysts in providing regulatory review and training support to medical officers, statisticians, and safety evaluators. She is a Fellow of the American... Read More →
avatar for Rebecca Kush

Rebecca Kush

President and Chief Executive Officer, CDISC
Rebecca Daniels Kush, Ph.D. is a Founder and the President and CEO of the Clinical Data Interchange Standards Consortium (CDISC). Dr. Kush has worked for the NIH, academia, a global CRO and pharmaceutical companies in the U.S. and Japan. Dr. Kush earned a Ph.D. in Physiology and Pharmacology... Read More →
avatar for Christine Pierre

Christine Pierre

President, Society for Clinical Research Sites
Christine is the President of the Society for Clinical Research Sites, a global trade organization representing over 9,000 sites in 47 countries committed to providing sites a community and voice for site sustainability. Christine is an internationally recognized expert on the global... Read More →


Wednesday June 29, 2016 10:30am - 11:30am
203AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm

#340: eSource: Using Source Data Capture from Electronic Health Records to Improve Clinical Research
Limited Capacity seats available

Component Type: Session
Level: Basic
CE: CME 1.25; IACET 1.25; RN 1.25

eSource, in the sense of capturing source data for clinical trials directly from the EHR, holds great promise for improving speed, quality and efficiency in research. FDA, CDISC, and participating organizations will describe ongoing work.

Learning Objectives

Discuss an eSource implementation and its expected effect on data quality and efficiencies; Describe current work now underway in eSource with various organizations; Evaluate the readiness of your organization to implement eSource.

Chair

Michael A. Ibara, PharmD

Speaker

Academic Perspective
Amy Harris Nordo

Current FDA eSource Demonstration Projects and Overall Effort
Mitra Rocca, MSc

EHR Pilot Study: Lessons Learned Thus Far
Trisha D Simpson



Chair
avatar for Michael Ibara

Michael Ibara

Managing Partner, Fathom Digital Healthcare Consulting
20+ years’ experience in clinical R&D. Previously Head of Digital Healthcare for CDISC. Prior to that 15 yrs at Pfizer, leading implementations of global systems. Pioneered ASTER - the first time AEs were retrieved directly from an EHR and sent to FDA. Current work FDA project to... Read More →

Speakers
avatar for Amy Nordo

Amy Nordo

Product Manager, Maestro Care (Epic) for Research and eSource, Duke University
Amy Nordo RN/BSN, CPHQ, LNC, MMCi is a Product Manager for Duke University’s Office of Research Informatics. Amy draws upon her previous experience as critical care nurse, clinical research coordinator, healthcare quality professional and Epic credentialed trainer. In her current... Read More →
avatar for Mitra Rocca

Mitra Rocca

Associate Director, Medical Informatics, Office of Translational Science, CDER, FDA
Mitra Rocca joined FDA in 2009 as the Senior Medical Informatician responsible for developing the health information architecture of the Sentinel System. She leads the FDA CDER Health Information Technology board and serves as the medical informatics expert at CDER. Prior to joining... Read More →
avatar for Trisha Simpson

Trisha Simpson

Director, Global Biometry Standards, UCB Biosciences, Inc.
Trisha is currently the Director of Global Integrated Standards at UCB. She’s been in the pharma industry for over 20 years. Her work at UCB includes standards governance; overseeing a Metadata Repository (MDR) build; and initiating an Electronic Healthcare Record (EHR) data retrieval... Read More →


Wednesday June 29, 2016 2:00pm - 3:15pm
204C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA