Trk 07: Tech-Data- Records-Subs [
clear filter]
8:30am EDT
#109: EHR in Clinical Research: Heralding a New Era
Chair
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...
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Speakers
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...
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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...
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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...
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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
- Credit Type CME, IACET, RN
- Audience Intermediate
- Featured Topics Electronic Health Records (EHR)
- Interest Area eClinical, Clinical Data Management, Regulatory Affairs, Information Technology
- format json
- Interest Area eClinical,Clinical Data Management,Regulatory Affairs,Information Technology
- Featured Topics Electronic Health Records (EHR)
- Credit Type CME, IACET, RN
- Tags Session
10:45am EDT
#130: Take Two Aspirin and Text Me in the Morning: Technology Suited for 20,000 Virtual Patients on the PCORI Aspirin Trial
Chair AC
Chief Executive Officer, Mytrus, Inc.
Anthony Costello: Co-Founder and CEO of Mytrus has co-founded many clinical & hi-tech start-up companies in N. CA. He was selected as PharmaVoice Top 100 Most Inspiring People in Clinical Research, served as Chairman of the Board for the Society for Clinical Data Management, on founding...
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Speakers AH
Co-Private Investigator, PCORnet Coordinating Center, Professor of Medicine, Duke Clinical Research Institute (DCRI)
Dr. Hernandez is a cardiologist with extensive experience in clinical research ranging from clinical trials to outcomes and health services research. He is the Faculty Associate Director of the Duke Clinical Research Institute and Director of the Health Services and Outcomes Research...
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Research Director, Research Action for Health Network (REACHnet), Louisiana Public Health Institute (LPHI)
As REACHnet's Research Director, Dr. Nauman works with a multi-institutional team to develop and optimize the informatics and technology infrastructures as well as stakeholder engagement to support efficient pragmatic clinical research. She leads the development of the network’s...
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Monday June 27, 2016 10:45am - 12:00pm EDT
201C
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
Trk 07: Tech-Data- Records-Subs,
Session
- Credit Type ACPE, CME, IACET, RN
- Audience Basic
- Featured Topics Clinical Trial Designs, Big Data, Electronic Health Records (EHR), Increasing Research and Development Innovation, Value-Based Evidence
- Interest Area eClinical, Clinical Research, Comparative Effectiveness
- format json
- Interest Area eClinical,Clinical Research,Comparative Effectiveness
- Featured Topics Clinical Trial Designs,Big Data,Electronic Health Records (EHR),Increasing Research and Development Innovation,Value-Based Evidence
- Credit Type ACPE, CME, IACET, RN
- Tags Session
10:45am EDT
#132: Electronic Implementation of New PRO Measures to Assess Treatment Benefit in Irritable Bowel Syndrome Trials: Lessons Learned
Chair
Executive Director, PRO Consortium, Critical Path Institute
Stephen Joel Coons is Executive Director of the Patient-Reported Outcome (PRO) Consortium at Critical Path Institute (C-Path). C-Path, an independent nonprofit organization, established the PRO Consortium in cooperation with the U.S. Food and Drug Administration and the pharmaceutical...
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Speakers
Senior Vice President, Strategic Development and Corporate Marketing, Bracket
Mr. Butler is the Senior Vice President of Strategic Development at Bracket. Bracket offers a unique suite of solutions, with a unique perspective on clinical research development. Mr. Butler is responsible for Strategic Development for Bracket’s service offerings in Randomization...
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Vice President, Product Strategy and Innovation, YPrime Inc
Cindy Howry is nationally recognized thought-leader in the area of eCOA which empowers the patient and engages them to maintain and improve their health, simultaneously enabling clinical teams to have real-time access to better quality clinical data. Ms. Howry has more than 30 years...
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Clinical Outcome Assessments (COA) Staff, OND, CDER, FDA
Sarrit Kovacs, PhD is a reviewer with the Clinical Outcome Assessments (COA) Staff in the Office of New Drugs (OND) in the Center for Drug Evaluation and Research (CDER) at FDA. Sarrit has nearly 20 years of social science research experience and is a consultant to CDER and other...
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President and Founder, Albemarle Scientific Consulting LLC
David is VP, Data Science and Head, Study Endpoints at Ironwood Pharmaceuticals located in Cambridge, Massachusetts. The Data Science group is responsible for development of analytical strategies bridging early phase research through development into the biopharmaceutical product...
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Monday June 27, 2016 10:45am - 12:00pm EDT
204C
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
Trk 07: Tech-Data- Records-Subs,
Forum
- Credit Type ACPE, CME, IACET, RN
- Audience Intermediate
- Featured Topics Disease Specific, Disruptive Technologies
- Interest Area eClinical, Study Endpoints
- format json
- Interest Area eClinical,Study Endpoints
- Featured Topics Disease Specific,Disruptive Technologies
- Credit Type ACPE, CME, IACET, RN
- Tags Forum
10:30am EDT
#217: Electronic Submissions Gateway: Next Generation
Chair
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...
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Speakers
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...
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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...
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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...
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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...
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Tuesday June 28, 2016 10:30am - 11:45am EDT
201C
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
2:00pm EDT
#240: CFAST at Year Three: Innovative Approaches to Adding Breadth, Depth, and Value to Therapeutic Area Standards
Chair
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...
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Speakers
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...
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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...
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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...
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Tuesday June 28, 2016 2:00pm - 3:15pm EDT
204B
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
4:00pm EDT
#263: Patient Centricity in Clinical Trials
Chair DB
Chief Technology Officer, eClinicalHealth Ltd
Doug Bain, Founder and Co-CEO & CTO of eClinicalHealth Ltd,, has been involved in the development, deployment and optimization of eClinical technologies since 1996. eClinicalHealth provides the high performance cloud driven clinical trial solutions - Clinpal - for end-to-end clinical...
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Speakers
Executive Consultant, Clinical Operations, Myokardia, Inc.
Bruno is a Clinical Operations Opinion Leader with over 24 years of experience in clinical trial management. His consulting practice has a focus on building capabilities in clinical trial execution. Bruno develops solution for his biotech clients around site selection, optimization...
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Director of Product Strategy - Digital Patient, ERT
Chris has a PhD in Behavioural Neuropharmacology and is an experienced product strategist with over 19 years’ experience in the delivery of innovative business and consumer solutions. Chris’ career started in the financial services and for the last 10 years, Chris has been translating...
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Tuesday June 28, 2016 4:00pm - 5:15pm EDT
201B
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
10:30am EDT
#313: The Future of Clinical Research Data: 2020 and Beyond
Chair
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...
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Speakers
Managing Director, Accenture
Dave Evans is a senior technology and clinical research executive with over 35 years of experience in the clinical research, regulatory and healthcare industries. He is recognized industry-wide as a leading technology visionary for developing and implementing complex process and...
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Director, Research Professor, Tufts Center For the Study of Drug Development
Kenneth A. Getz, MBA, is the Deputy Director and Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine, where he directs research programs on drug development management strategy and practice. He is also the Founding Chair of the Center...
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President and Chief Medical Officer, Semantica LLC
His expertise includes clinical data standards, regulated study data submissions, and regulatory submission and review policy. A former Associate Director for Informatics in OCS, he focused on developing, adopting, and implementing clinical data standards to support premarketing assessment...
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Wednesday June 29, 2016 10:30am - 11:45am EDT
204B
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
2:00pm EDT
#341: eTMF: Selection, Implementation, and What's Next?
Chair
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...
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Speakers MD
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...
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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
- Credit Type CME, IACET, RN
- Audience Intermediate
- Featured Topics Clinical Trial Transparency-Clinical Trial Disclos
- Interest Area Document & Records Management, Clinical Data Management, Regulatory Affairs, Clinical Research
- format json
- Interest Area Document & Records Management,Clinical Data Management,Regulatory Affairs,Clinical Research
- Featured Topics Clinical Trial Transparency/Clinical Trial Disclos
- Credit Type CME, IACET, RN
- Tags Session
2:00pm EDT
#342: Big Data in Health Care and Life Sciences
Chair
Lead Partner Life Sciences Strategy and Analytics, IBM Watson Health
John Piccone currently leads the Watson Health offerings for life sciences at IBM. In this role, he defines the analytics and cognitive solutions that Watson Health is offering to it’s pharmaceutical, biopharma, medical device and biotech clients. The current focus of his work is...
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Speakers AB
Genomics and Computational Biology Lead, Health and Life Sciences, Lockheed Martin Information Systems & Global Solutions
Amrita Basu is the Genomics and Computational Biology Lead at Lockheed Martin. Previously, she worked at the Broad Institute of Harvard and MIT on predictive modeling approaches for cancer drug discovery. Amrita holds a Bachelors degree in Electrical Engineering from Cornell University...
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Global Vice President, Life Sciences Product Strategy, Oracle Health Sciences, United States
As the global head of life sciences product strategy for Oracle, Jim collaborates closely with Oracle customers, regulatory agencies, analysts, and industry thought leaders to develop and help execute the overall business and product strategy for Oracle Health Sciences. He previously...
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Wednesday June 29, 2016 2:00pm - 3:15pm EDT
201C
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
4:00pm EDT
#362: Risk-Based Monitoring: Best Practices in Implementation for the Data Manager and Key Stakeholders
Chair
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...
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Speakers
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...
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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...
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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...
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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
- Credit Type ACPE, CME, IACET, RN
- Audience Intermediate
- Featured Topics Risk-Based Monitoring
- Interest Area Clinical Data Management, Regulatory Affairs, QA-QC, eClinical
- format json
- Interest Area Clinical Data Management,Regulatory Affairs,QA/QC,eClinical
- Featured Topics Risk-Based Monitoring
- Credit Type ACPE, CME, IACET, RN
- Tags Session
10:45am EDT
#407: Successful Application of Wearables and Remote Monitoring in Clinical Trials: Lessons Learned and Future Progress
Chair
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...
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Speakers
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...
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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...
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Thursday June 30, 2016 10:45am - 11:45am EDT
111AB
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
Trk 07: Tech-Data- Records-Subs,
Session
- Credit Type ACPE, CME, IACET, RN
- Audience Intermediate
- Featured Topics Clinical Trial Designs, Disruptive Technologies, Patient Engagement, Mobile-Wearable Technology
- Interest Area eClinical, Clinical Data Management, Public Policy - Health Care Compliance - Law, Regulatory Affairs, Clinical Research, Information Technology
- Tags Session
10:45am EDT
#408: Securing Internet-Driven Collaboration in Drug Development
Chair
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...
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Speakers
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...
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Thursday June 30, 2016 10:45am - 11:45am EDT
109AB
Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA