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Post-Marketing Studies 

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Wednesday, February 6

11:30 am Conference Registration

12:05 pm Lunch on Your Own



OBSERVATIONAL STUDY DESIGN AND MANAGEMENT 

1:25 Chairperson’s Remarks

Carrie HurwitzCarrie Hurwitz, Director, Corporate Strategy & Business Development, McKesson Corporation - Biography 

1:30 Initiation of Non-Interventional Studies: Five Pearls of Wisdom for Strategy & Implementation

Aubrey Manack, Ph.D., Epidemiologist, Allergan - Biography 

This presentation outlines the approach taken to initiate and implement a non-interventional study. From the perspective of the study team lead, it will discuss the importance of obtaining cross-functional strategic buy-in, identifying accountability, engaging clinical operations and commercial teams. Given internal and external collaborations, the presentation will aim to address the usefulness of a well-developed communication plan and highlight the value of dedicated resources and oversight.

1:55 Data Collection and Management in an Observational Study

Fei XueFei Xue, M.D., Observational Research Director, Center for Observational Research (CfOR), Amgen, Inc. - Biography 

Observational studies based on existing databases are challenged by restricted data availability for the assessment of exposure, outcome and covariates. Supplemental data collection and data linkage methods can be leveraged to substantiate existing databases and statistical methods should be considered to optimize the analysis of available data. This presentation will provide an overview of considerations in the development of analytical plan using multiple existing databases for a long-term pharmacovigilance study.

Parexel NEW 2:20 Conducting Post-Approval Studies in a New Era: Innovation in Delivering Clinical Research Programs

Kate TrainorKate Trainor, Vice President, PACE, Global Head PM & Technology, PAREXEL - Biography 

Key industry dynamics, that increase emphasis on using outcomes and effectiveness data, along with pressures on the biopharmaceutical industry to contain costs, have forced companies to look at innovative and cost efficient tools and methodologies to conduct post marketing programs. This session will review recent innovations that aid in identification of large numbers of patients, effective site selection and processing, ensuring higher data quality, accelerate better decision-making and faster determination of evidence-based health outcomes.

OptumInsight 2:45 Pragmatic Clinical Trials -- A Randomized Trial with an Observational PersonalityDenise A. Hopkins, Pharm.D., Senior Director, Life Sciences, Late Phase Research, OptumBiography 
This brief presentation on pragmatic clinical trials (PCT) will highlight the role and the value of these interesting study designs that are technically randomized trials, but require management and analytic methods reserved for observational studies.  Differences between PCTs, explanatory randomized trials and observational designs will be reviewed, and the important key design and reporting elements of PCTs will be discussed. 

3:00 Refreshment Break in the Exhibit Hall

3:40 Best Practices in Managing Program Scope in Long Term, Observational Registry Programs

Catherine Koepper, Director, Global Registry Operations, Evidence Based Medicine, Genzyme, a Sanofi Company - Biography 

PRA 4:05 Managing Expectations: Top 8 Myths of Observational Research

Maria HarrisonMaria Harrison, Vice President, Late Phase Services, PRA - Biography 

4:30 Interactive Breakout Discussion Groups

Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the more poignant questions facing the industry. Delegates will join a table of interest and become an active part of the discussion at hand. It is an informal, yet informative, format that allows attendees to learn from each other and make some new contacts. To get the most out of this interactive format please come prepared to: share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing.

Topics include:

TABLE: Ontological Integration of Clinical Trial and Study DataModerator: Mike Cummens, M.D., CMO, Remedy Informatics• Deep data integration with an without semantic mapping and harmonization
• Reusing existing clinical trial data with and without an ontology
• Integrated research management of "alternative" data types (DICOM images, CT and MRI scans, echocardiogram and ECG tracings, EEG/PSG data, central laboratory data and other data not directly captured  in the CDMS or EDC)
TABLE: Outsourcing a Post-Marketing StudyModerator: Reinerio Deza, M.D., Head Global Pharmacovigilance, Cubist Pharmaceuticals, Inc.• Why Outsource, requirements, expectations
• Selection Process, Single vs Multiple providers
• Governance, Oversight, Escalation process 
TABLE: Registries and Their Utilization in Clinical ResearchModerator: Paula Hale, M.D. Senior Medical Director, Diabetes—Clinical Development and Research, Novo Nordisk, Inc.• Overcoming obstacles; meeting regulatory requirements
• Collaboration between industry sponsors, a new model?
• Creating a successful registry 
TABLE: Data Management in Observational StudiesModerator: Fei Xue, M.D., Observational Research Director, Center for Observational Research (CfOR), Amgen, Inc• What are factors to be considered when identifying appropriate database(s) for the purpose of a pharmacoepidemiology study?
• How to deal with specific limitations of existing claims or EMR databases in study design and analysis, e.g., misclassification and residual confounding?
• How to find resources for international databases?
 

5:30 Networking Reception in the Exhibit Hall

6:30 End of Day



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