Pre-Conference Tutorials, Monday, March 8, 2010, 09:00

This is a preliminary programme. New speakers and sessions will be added. Visit www.diahome.org for the most recent additions to the programme.
The New NCI IT Architecture
Charles Mead, Senior Director, Healthcare and Life Sciences Strategy, Booz Allen
Hamilton, Chief Technology Officer, NCI, USA
Tuesday, March 09, 2010
09:00 Session 1102
PATIENT AND CLINICIAN REPORTED OUTCOMES USE IN GLOBAL MEDICAL
PRODUCT DEVELOPMENT: AN UPDATE ON INDUSTRY BEST PRACTICE AND
REGULATORY ISSUES
Session Chair:
John Weiler, President, Compleware Corporation, USA
Clinician rated or reported outcomes (ClinROs) have historically been the basis
for labelling claims, but both the European Medicines Agency and the FDA have
acknowledged the importance of patient reported outcomes (PROs) and,
increasing, new medical products are being approved based on PROs as well.
Regardless of the type of study endpoint used, outcomes need to be valid and
reliable and collected with integrity. It is critical that clinical trial sponsors
ensure the content validity of ClinROs and PROs. In addition, if the study
endpoint is collected electronically, steps must be taken to ensure measurement
equivalence. This session will detail the important content validity issues;
discuss study endpoint validation study designs and case studies; and share the
associated regulatory perspective. The audience will gain an understanding of
today’s regulatory considerations and industry best practice for PROs and
ClinROs.
Regulatory Perspectives when PROs and ClinROs are Deployed
Laurie Burke, Associate Director, Study Endpoints and Labeling Development,
Office of New Drugs, CDER, FDA, USA
Content Validity: Issues in the Development of Instruments
Jane Scott, Research Director, MAPI Values, UK
Leveraging Technology and Ensuring Measurement Equivalence for PROs and
ClinROs
Keith Wenzel, Senior Director, Product Management, Perceptive Informatics,
USA
11:00 Session 1103
EDC CASE STORIES
Session Chair:
Julianne Hull, Senior Director, Global Development Data Operations, Pfizer, UK
If 2007 has been the year when, for the first time in clinical trials history, the use
of eCRF has taken over the use of paper, there is still a lot of room for
improvement in the use of Electronic Data Capture and associated etools.
Development of new drugs implies more than ever before, the participation of
multiple countries and sites around the globe which raises new challenges. This
session will include case studies and various experiences presented from
pharma as well as the Contract Research Organisation (CRO) industry.
EDC - The Tool to Enable Speedy Decision Making
Mireille Zerola, Data Management Specialist III, Boehringer Ingelheim, Ltd., UK
Pros and Cons of Different EDC Tools in Different Scenarios with Focus on
Enabling Speedy Decisions
Thomas O’Leary, Vice President, Clinical Data Management, ICON plc, Ireland
Accelerate Decision Making Through Real Time Dictionary Coding
Douglas Burgener, Product Manager Data Management Solutions, Perceptive
Informatics, USA
Theme 11 - Theme 12
14:00 Session 1104
EMERGING TECHNOLOGIES FOR OPTIMISATION OF PATIENT TREATMENT
Session Chair:
Valdo Arnera, General Manager, Europe, PHT Corporation, Switzerland
If the use of "e" is increasing in the clinical trials arena, we can also start to see
the benefits of using technology in "standard" patient care, including but not
only in the EHR domain, allowing better follow-up and better treatments, as
well as often reducing the cost of therapies. This is the real future of eHealth
where telemedicine for example could translate into better and cheaper medical
care for every patient. This session will present some case studies in western
countries but also describe the efforts put in place to give access to EHR in
emerging nations.
An eHealth Project Providing Integrated Care and Risk Management for
Coronary Disease with Direct Patient Communication through an EDC system
Claus Lindenau, Head, Business Development, XClinical GmbH, Germany
How to Prevent COPD Exacerbation Using an eDiary
Gerard Criner, Pulmonologist, Professor, Temple University Medical School, USA
Joint Effort for Providing eHealth Technologies to Emerging Nations
Charles Jaffe, CEO, HL7, USA
16:00 Session 1105
IMPROVING DRUG SAFETY THROUGH THE USE OF NEW TECHNOLOGIES
Session Chair:
Sabine Brosch, Scientific Administrator, Pharmacovigilance and Risk
Management, European Medicines Agency, EU
Drug safety monitoring can be considerably improved through the use of new
technologies. This session provides insights into these new possibilities from
different point of views
Evaluating Drug Safety and Effectiveness through the Lens of eHealth Data
Wayne Kubick, Vice President, Phase Forward Lincoln Safety Group, USA
Integrated Web-Based Tools Supporting Regulatory Bodies: From clinical trial
national registries to the post- marketing safety surveillance tools
Marisa De Rosa, Head of Systems and Services for Health Department (SISS),
CINECA Inter-University Consortium, Italy
FDA View
Stephen Wilson, Director, Division of Biometrics III, CDER, FDA, USA
Wednesday, March 10, 2010
09:00 Session 1106
HEALTHCARE INTEROPERABILITY STANDARDS
Session Chair:
Wolfgang Summa, Executive Vice President, Business Development,
OmniComm Systems, Germany
With the involvement of Standards Development Organisations such as ISO,
CEN, HL7, CDISC and IHTSDO, the development of international standards for
the monitoring of drug safety has taken a new dimension. After a short
introduction on how these standards are currently being developed and how
they relate to each other, this session will provide an overview of the newly
developed standards, followed by a panel discussion with European Medicines
Agency and industry speakers.
What’s New about Standards? A General Overview
Pierre-Yves Lastic, Senior Director, Data Privacy & Healthcare Interoperability
Standards, sanofi-aventis, France
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