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Sunday, June 26
 

8:30am EDT

#24: Regulatory Considerations for Drug and Medical Device Development: Current Status and Trend of IND/NDA Practices in China
Limited Capacity seats available

Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-16-509-L04-P; CME 3.25; IACET 3.25; RN 3.25

An additional registration fee is required for all preconference tutorials Register today for this tutorial.

The Chinese regulatory landscape seems unique from and harmonious with global standards and practice. In 2015, Chinese good clinical practice (GCP) guidelines published by the China Food and Drug Administration (CFDA) have been amended significantly, of which some GCPs are overturning common ways that were implemented since 2003. The CFDA is enhancing inspective forces on the quality and integrity of clinical trial outcomes. GCP requirements on medical devices and diagnostics have also been strengthened by CFDA. The procedures of investigator new drug/new drug application (IND/NDA) review and approval have been greatly reformed. The quality of trial data is becoming more essential as evidence of supporting NDA approval. All of these updates are sure to impact the IND/NDA drug and medical devices/diagnostic strategies in China. This tutorial will provide insights into critical considerations impacting IND/NDA practices involving drugs and medical devices/diagnostics development in China and upcoming CFDA reformations of regulatory submission review and approval.

Who should attend?

This tutorial is designed for professionals in regulatory affairs, drug development, medical device/diagnostics, clinical trial management, monitoring, data management or clinical operations who have some basic knowledge of the Chinese regulatory environment and will benefit from learning updates of IND/NDA drug and medical device trials.

Learning Objectives

• Describe basic CFDA regulatory requirements for an IND/NDA process;
• Explain Chinese regulatory practice and trends for reviewing and approving submissions of drugs;
• Discuss the updated Chinese GCP guidelines for IND drug trials;
• Explain how to be compliant with Chinese GCP standards in the implementation of clinical trial;
• State how to complete the IND/NDA application process to the CFDA.


Speakers
EH

Earl Hulihan

Professor, SUTCM
Professor Hulihan is Principal with ew hulihan and associates, inc. For over 35+ years, Hulihan has been active in the DIA, in Medicine, as well as providing regulatory consulting, auditing, and training services to the global pharmaceutical community and regulatory authority personnel... Read More →
avatar for Daniel Liu

Daniel Liu

Chief Science Officer, Beijing Clinical Service Center
Daniel Liu, PhD, has served for more than two decades in global clinical research departments, in both management and operations, for such multinational drug companies as Novartis, Pfizer, Sanofi, Schering-Plough, Johnson & Johnson, and Medidata. Dr. Liu has served as Core Expert... Read More →


Sunday June 26, 2016 8:30am - 12:00pm EDT
104AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Preconference Tutorial, Tutorial |   Trk 08: Reg Affairs, Tutorial
 
Monday, June 27
 

8:30am EDT

#109: EHR in Clinical Research: Heralding a New Era
Limited Capacity seats available

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

This session will focus on the work completed by the CDISC EHR-to-CDASH (E2C) team mapping data from EHR into EDC as eSource. Ongoing studies will be profiled. Representatives from a sponsor, academia, and EDC vendor will present.

Learning Objectives

Identify the components of EHR systems; Discuss complexities associated with EHR to EDC data transfer; Describe data standards and proper mapping between systems; Describe regulatory implications; Discuss how this will be able to help clinical research sites.

Chair

Trisha D Simpson

Speaker

EHR to EDC Data Transfer: Experiences and Lessons
Ian Sparks

The eSource Stakeholders Group and Next Steps
Michael A. Ibara, PharmD

EHR-EDC Integration Case Study: The Good, the Bad, and the Beautiful
Sue Dubman, MA



Chair
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 →

Speakers
avatar for Sue Dubman

Sue Dubman

Director, IT and Informatics Innovation, University of California San Francisco (UCSF)
20+ yrs. experience. Sr. Dir, IT Innovation, at UCSF. Part of a multi-disciplinary team to innovate changes in care & research. Previously Sue was Sr. Dir, Genzyme, strategy, standards and arch. Before that, served as Dir, NCI Informatics Initiatives & VP/CIO at 2 biopharmas. At NCI... Read More →
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 →
avatar for Ian Sparks

Ian Sparks

Senior Director, Research Science, Medidata Solutions Worldwide
Ian Sparks is a Senior Director in Medidata Labs, an innovation group focused on evaluating new technologies and data integrations. Ian's recent work has been in integrating wearable sensors and Electronic Health Records with EDC using CDISC and HL7 standards. Ian holds a bachelors... Read More →


Monday June 27, 2016 8:30am - 9:45am EDT
201C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 07: Tech-Data- Records-Subs, Session

10:45am EDT

#124: Risk-Based Monitoring in Clinical Trials
Limited Capacity seats available

Component Type: Symposium
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-518-L05-P; CME 1.25; IACET 1.25; RN 1.25

This symposium will examine the implementation of risk-based monitoring strategies in clinical trials and their impact on site performance, patient safety, data integrity, and study quality.

Learning Objectives

Discuss how risk-based monitoring (RBM) can help investigator sites improve overall site performance, with higher efficiency and improved patient safety; Describe best practices in site/CRO partnering to successfully drive efficiencies and improve oversight of patient safety and data quality; Identify the importance of planning the RBM strategy in order to make it actionable.

Chair

Ellen Kelso

Speaker

How to Successfully Plan and Implement a Risk-Based Monitoring Strategy
Francois Torche, MBA

Risk-Based Monitoring: What Does It Mean for Clinical Study Sites?
Jill Collins

The Impact of Risk-Based Monitoring on Site Performance: Reducing Risks While Improving Patient Safety and Study Quality
Robin Douglas, MA



Chair
avatar for Ellen Kelso

Ellen Kelso

Executive Director, Chesapeake IRB
Founder, managing member & CEO of Goodwyn IRB, Ellen Kelso is recognized for her experience & expertise in clin. trial mgt & reg. affairs. Has provided educ., consultation & services to the pharma industry supporting clinical research & regulatory strategies, submissions & compliance... Read More →

Speakers
avatar for Jill Collins

Jill Collins

Executive Director, Global Operations management, Innovation, INC Research
Jill Collins, Executive Director, Global Operations Management, Innovation at INC Research, with 20 years of experience in clinical operations, leads the development of transformative approaches to trials with a focus on data-driven process optimization, including INC’s RBM solution... Read More →
RD

Robin Douglas

Site Solutions Director, Site and Patient Networks, Quintiles
Robin Douglas has 22 years of clinical research experience, including 16 years as a site manager / administrator. Currently Robin serves as Site Solutions Director at Quintiles. Her core responsibility is to ensure an enhanced site experience when working with Quintiles which includes... Read More →
avatar for Francois Torche

Francois Torche

Chief Executive Officer, CluePoints
François holds a Master in Business Administration from the ICHEC School of Management, Brussels. Over the past 19 years in the pharmaceutical industry, he has held positions as statistical programmer, developer and IT project leader for companies such as GSK, UCB and IDDI. During... Read More →


Monday June 27, 2016 10:45am - 12:00pm EDT
113C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 01: Clinical Operations, Symposium
 
Tuesday, June 28
 

10:30am EDT

#217: Electronic Submissions Gateway: Next Generation
Limited Capacity seats available

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

Electronic Submissions Gateway (ESG) is an FDA solution for accepting electronic regulatory submissions. It has been in production since 2006. This session will provide an update and Q&A on its status and the technology and process enhancements.

Learning Objectives

Discuss the Electronic Submissions Gateway (ESG) process and solutions for submission of regulatory; Describe the technology and process enhancements planned for ESG._x000D_


Chair

Ron D. Fitzmartin, PhD, MBA

Speaker

FDA eCTD v4.0 Two-Way Communication
Mark A. Gray

Panelist
Virginia Hussong

Panelist
La Misha Fields



Chair
avatar for Ron Fitzmartin

Ron Fitzmartin

Senior Informatics Advisor, Office of the Director, CBER, FDA, United States
Ron Fitzmartin is Senior Informatics Advisor, 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 →

Speakers
avatar for La Misha Fields

La Misha Fields

IT Program Manager, Electronic Submissions Gateway, OIMT, OC, FDA
La Misha Fields is the Program Manager of the FDA’s Electronic Submissions Gateway (ESG) under the Office of Information Management and Technology located in Rockville, MD. She is an informatics and technology professional with over 6 years of FDA experience, including 5+ years... Read More →
avatar for Mark Gray

Mark Gray

Senior Project Manager, BSS, CBER, FDA
Mark has over 30 years experience in Information Management including; software developer/project manager in CBER; Director of Applications Development & Services in CDER; and PDUFA IT Program Director. Mark currently work’s for CBER’s Bioinformatics Support Staff. His responsibilities... Read More →
avatar for Virginia Hussong

Virginia Hussong

Director, Div. of Data Management Services & Solutions, OBI, OSP, CDER, FDA
Ginny Hussong has over 20 years of experience in the pharmaceutical industry, of which the past 10 have been in CDER. As Acting Director of the Division of Data Management Services and Solutions, she supports the receipt, processing and archive of electronic regulatory submissions... Read More →
avatar for Virginia Hussong

Virginia Hussong

Chief, Data Standards Program, CBER, FDA
Ginny Hussong is Chief of CBER’s Data Standards Program, and has been with FDA for 14 years. She was previously Director of Data Management Services and Solutions within CDER. As Chair of CBER’s Data Standards Committee, Ginny’s recent projects include creating a new joint data... Read More →


Tuesday June 28, 2016 10:30am - 11:45am EDT
201C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:30am EDT

#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 EDT
204C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 07: Tech/Data/ Records/Subs, Session

2:00pm EDT

#240: CFAST at Year Three: Innovative Approaches to Adding Breadth, Depth, and Value to Therapeutic Area Standards
Limited Capacity seats available

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

This CFAST session will focus on some of the innovative approaches being used to move towards E2E concept-based standards development and show the value these enhanced standards can bring for all stakeholders involved. Analysis elements (ADaM) and therapeutic area user guides (TAUGs) will also be discussed as well the therapeutic area (TA) Specification project which seeks to include TA metadata into the FDA standards catalogue.

Learning Objectives

Recognize the CFAST Initiative and the potential benefit of implementing these standards; Discuss some of the innovative approaches employed to move closer to E2E concept based data standards; Recall the FDA Therapeutic Area User Guide Specification project.

Chair

Rhonda Facile, MS

Speaker

CFAST Program Participation and the FDA Specification Project
Ron D. Fitzmartin, PhD, MBA

ADaM and Therapeutic Area User Guides: Current Thinking
Susan J. Kenny, PhD

Biomedical Concepts and End-to-End Metadata Development
Diane E. Wold, PhD



Chair
avatar for Rhonda Facile

Rhonda Facile

Vice President, Development Opportunities, CDISC
Rhonda Facile has over 25 years of clinical operations experience. She has worked in a global CRO, pharmaceutical and biotechnology companies both in the United States and abroad. She has experience in clinical trial monitoring, project management, regulatory affairs and standards... Read More →

Speakers
avatar for Ron Fitzmartin

Ron Fitzmartin

Senior Informatics Advisor, Office of the Director, CBER, FDA, United States
Ron Fitzmartin is Senior Informatics Advisor, 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 Susan Kenny

Susan Kenny

President, Maximum Likelihood, Inc.
Susan is a biostatistician with 20 years of experience in research for public health and for the pharmaceutical industry. She has been active in CDISC since 2000 and is a senior team member of ADaM. Her areas of interest included CDISC implmentation strategies and graphical methods... Read More →
avatar for Diane Wold

Diane Wold

Director, Concept Modeling, CDISC
Diane Wold received her PhD in Statistics from UNC-Chapel Hill. She joined Burroughs Wellcome in 1984 as a project statistician held a variety of positions, leading to her current role in Data Standards at GSK. Since 2002, she has been active in CDISC, and currently provides consultation... Read More →


Tuesday June 28, 2016 2:00pm - 3:15pm EDT
204B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

4:00pm EDT

#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, United States
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 EDT
204B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 07: Tech/Data/ Records/Subs, Session

4:00pm EDT

#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 EDT
203AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 07: Tech/Data/ Records/Subs, Session
 
Wednesday, June 29
 

10:30am EDT

#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 EDT
203AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 07: Tech/Data/ Records/Subs, Forum

10:30am EDT

#319: Unlocking the Mysteries of Knowledge Management and Potential Applications for Clinical Development
Limited Capacity seats available

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

Knowledge is a valuable asset that organizations acquire through experience and possess within their employees. Implementing a structured approach to managing knowledge can effectively help achieve desired business outcomes of quality improvements and employee engagement. This session will provide an overview of key principles of knowledge management (KM), discuss elements of a KM framework that can support application within clinical development, and offer ideas on how KM practices can be applied to specific business processes.

Learning Objectives

Recognize key principles of knowledge management and suggested approaches to implementation strategy; Identify a knowledge management framework that can be tailored and applied within a clinical development organization; Discuss how knowledge management may be applied to a specific business process or functions.

Chair

Kathy Salzano

Speaker

Overview of TransCelerate Conceptual Knowledge Management Framework
Christa A. Maurer

Unlocking the Mystery of Knowledge Management: Applying Concepts to a Trial Master File
David William Fryrear, MSc

Application of Knowledge Management in Regulatory Intelligence
Carolyn Louise Hynes, PhD



Chair
avatar for Kathy Salzano

Kathy Salzano

Director, Quality and Continuous Improvement, Merck & Co., Inc.
Kathy Salzano is a Director of the Quality and Continuous Improvement organization at Merck & Co., Inc. Kathy has over 25 years of experience at Merck in various leadership roles supporting the execution and oversight of GCP quality and compliance programs within Clinical Development... Read More →

Speakers
avatar for David Fryrear

David Fryrear

Senior Director, R&D Quality Assurance, AbbVie, Inc.
David Fryrear is a Senior Director in R&D Quality Assurance at AbbVie.  In this role, he is the global head of clinical and pharmacovigilance quality assurance and has responsibility for R&D documentation standards and Quality Knowledge Management.  Prior to joining AbbVie in January... Read More →
avatar for Carolyn Hynes

Carolyn Hynes

Senior Director, Global Regulatory Intelligence, GlaxoSmithKline
Carolyn Hynes is a Senior Director in the Global Regulatory Affairs Department at GlaxoSmithKline and is based in the UK. She leads the Global Regulatory Intelligence team. Prior to joining GSK in 2011, she spent 10 years working at Janssen Research & Development where she was a Director... Read More →
avatar for Christa Maurer

Christa Maurer

Sr. Compliance Specialist, Bristol-Myers Squibb Company
For the past 5 years, Christa has managed a team of Quality Managers responsible for operational risk management and inspection readiness in Asia and the Americas. She previously worked abroad in China and India in her quality role. Her prior experience includes Outsourcing & Contract... Read More →


Wednesday June 29, 2016 10:30am - 11:45am EDT
204A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm EDT

#341: eTMF: Selection, Implementation, and What's Next?
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

This session will walk through the steps from vendor selection to global implementation of an eTMF software and associated services - both as a general approach and a case study for a top ten pharmaceutical company. It will elaborate on the various workstreams established to ensure success.

Learning Objectives

Describe the hurdles to successful global implementation of an eTMF; Discuss the importance of a robust TMF structure; Recognize that an eTMF is not about the software, its about the processes and workflows.

Chair

Karen Jane Roy, MPharm

Speaker

eTMF: Challenges and Possible Solutions
Laxman Kumar Jakkala, SR, PhD

Global Implementation of a Full Service Provision eTMF Software and Services: A Case Study
Martina M Duevel, DrSc



Chair
avatar for Karen Roy

Karen Roy

Chief Strategy Officer, Phlexglobal, United Kingdom
Karen Roy has been responsible for the development of the TMF business at Phlexglobal since 2007, with a focus on creating solutions for our Clients’ TMF challenges. She started in Business Development, moving to Client Solutions, and now her focus is on strategy. In her role as... Read More →

Speakers
MD

Martina Duevel

Senior GCPM ONC, eTMF Process Owner Representative, Bayer Pharma AG
Dr. Martina Duevel eTMF Process Owner Representative, Bayer In the pharmaceutical industry for 16 years with roles in QA and Clinical Project Management. Project Lead for eTMF implementation and maturation, and Process Owner Representative for internal oversight and vendor govern... Read More →
LJ

Laxman Jakkala

Director, Global Quality Assurance, MakroCare


Wednesday June 29, 2016 2:00pm - 3:00pm EDT
204B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 07: Tech-Data- Records-Subs, Session

2:00pm EDT

#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 EDT
204C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 07: Tech/Data/ Records/Subs, Session

4:00pm EDT

#362: Risk-Based Monitoring: Best Practices in Implementation for the Data Manager and Key Stakeholders
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-534-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will explore how companies are implementing successful risk-based monitoring (RBM), with particular emphasis on the realignment of processes and roles, and applying central monitoring and data quality oversight to support the RBM strategy.

Learning Objectives

Define key challenges in risk-based monitoring (RBM) implementation; Identify how processes and roles need to change in the organization to support the RBM; Discuss real-time analytics as a key enabler to achieve adaptive, centralized monitoring; Demonstrate how results from analytics can be turned into actionable items to mitigate risks.

Chair

Teresa Ancukiewicz, MA

Speaker

Lessons Learned in Implementing Risk-Based Monitoring and eSource: The Data Manager’s Expanded Role
Vadim Tantsyura

Risk-Based Monitoring Best Practices for the Data Manager: Lessons Learned from Sponsors and Sites
Amita Malik, MS

Using Powerful and Pragmatic Central Statistical Analytics to Drive Quality into Clinical Trials
Erik Doffagne, MSc



Chair
avatar for Teresa Ancukiewicz

Teresa Ancukiewicz

Senior Manager, Clinical Data Management, Boston Scientific Corporation
Senior Manager in Clinical Operations at Boston Scientific, CCDM. Responsible for providing leadership on outsourcing initiatives and Risk Based Monitoring. Over 20 years of experience in data management, process development and improvement, and vendor management. Active in the DIA... Read More →

Speakers
avatar for Erik Doffagne

Erik Doffagne

Product Manager, CluePoints
Erik holds a bachelor degree in Computer Science and a master degree in Biostatistics. He has more than 10 years of experience in the life science industry. Erik has spent the last 5 years at developing methodology and technology for central statistical monitoring. Erik has co-authored... Read More →
avatar for Amita Malik

Amita Malik

Senior Manager, Product Management, Oracle Health Sciences
Senior Manager in Oracle Health Sciences Product Management organization, responsible for providing product leadership on current market leading Clinical Data Acquisition and Management products. Prior to Oracle, worked at Phase Forward and led delivery of large scale technology adoption... Read More →
avatar for Vadim Tantsyura

Vadim Tantsyura

Director, Data Management, Target Health Inc.
Dr. Tansyura has 15+ years of pharmaceutical experience, including a Head of DM role at Regeneron, Infinity and Cincinnati Children's Hospital. Dr. Tantsyura is a co-founder and member of the Advisory Board for OpenCDISC (2008-2010) and SCDM board member (2014-2016). Dr. Tantsyura... Read More →


Wednesday June 29, 2016 4:00pm - 5:15pm EDT
204C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 07: Tech-Data- Records-Subs, Session
 
Thursday, June 30
 

10:45am EDT

#407: Successful Application of Wearables and Remote Monitoring in Clinical Trials: Lessons Learned and Future Progress
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-16-537-L04-P; CME 1.00; IACET 1.00; RN 1.00

The usage of wearables can be a challenge in the regulated and traditionally risk adverse pharmaceutical industry. This session reviews a case study of utilizing wearables from planning, to IRB, to final report in a large pharma clinical sub-study.

Learning Objectives

Describe the importance of reviewing standard processes when inserting wearables into a clinical trial; Discuss the support structure necessary for combining traditional clinical research with emerging technologies; Demonstrate an understanding of the change management necessary to run a successful wearables trial.

Chair

John H. Bunch

Speaker

Internet of Medical Things (IoMT) and Clinical Development: Challenges and Opportunities
Yury Rozenman

How to Get From Unknown Unknowns to Known Unknowns
Tilo Hache, MBA



Chair
avatar for John Bunch

John Bunch

Senior Innovation Project Manager, PPD
John Bunch is a PMP, Six Sigma, and Proci certified project manager now focused on pharmaceutical and CRO innovation projects intended to positively impact patient trial experience, improve data frequency and reliability, and bend the cost time curve for drug development. Mr. Bunch... Read More →

Speakers
avatar for Tilo Hache

Tilo Hache

Work Stream Leader Mobile Patient Data, Novartis Pharma AG
Tilo's career career started in Roche, developing and implementing large corporate IT platforms for more than 50'000 employees. Since 2003, he had positions with increasing responsibility in Novartis IT and Sourcing, for example to operate the global Personal Computer environment... Read More →
avatar for Yury Rozenman

Yury Rozenman

Director, Business Development, Qualcomm Life
Yury Rozenman leads Qualcomm Life pharmaceutical business development organization. Yury has considerable experience of working in and consulting to the pharmaceutical industry, strategic studies, new product and business development and manufacturing across the healthcare and life... Read More →


Thursday June 30, 2016 10:45am - 11:45am EDT
111AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:45am EDT

#408: Securing Internet-Driven Collaboration in Drug Development
Limited Capacity seats available

Component Type: Session
Level: Basic
CE: CME 1.00; IACET 1.00; RN 1.00

This session covers the current role of global SAFE-BioPharma standard for identity and access management trust and EngageZone, Merck's initiative enhancing collaboration between it and hundreds of partner organizations. _x000D_


Learning Objectives

Evaluate risk associated with Internet-based collaboration; Discuss approaches to develop secure, trust-based information sharing; Define critical terminology such as multi-factor authentication, federation, and identity and access management.

Chair

Mollie Shields-Uehling

Speaker

Industry Perspective
Andrew Porter



Chair
avatar for Mollie Shields-Uehling

Mollie Shields-Uehling

President and Chief Executive Officer, Safe-BioPharma Association
The SAFE-BioPharma standard assures the identity trust inherent in implementation of the TransCelerate Shared Investigator Portal, in Merck’s EngageZone portal, and in other industry collaboration portals. Digital signature applications certified compliant with the SAFE-BioPharma... Read More →

Speakers
avatar for Andrew Porter

Andrew Porter

Director of Enterprise Architecture, IT Planning & Innovation, Applied Tech, Merck & Co., Inc.
His expertise includes creating the architectures for Identity and Access Management (IAM) and Enterprise Knowledge Management (EKM) solutions that support Merck's External Partner Program (EPP) and clinical trials initiatives. Mr. Porter has also provided architectural alignment... Read More →


Thursday June 30, 2016 10:45am - 11:45am EDT
109AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA