Managing Late Stage Research and Observational Studies

Non-interventional studies are an integral part of clinical development programs and product development plans. Product safety profiles, comparative effectiveness data as well as health economic evidence obtained from non-interventional studies, are essential for multiple stakeholders. These stakeholders include but are not limited to the following: regulatory agencies, payers, health care management organizations, formulary inclusion decision makers, healthcare professionals, and patients. Cambridge Healthtech Institute’s Fifth Annual “Managing Late Stage Research and Observational Studies" conference is designed to facilitate knowledge exchange around all aspects of observational research from the designing and managing of post-approval studies, to applying the data obtained to pivotal business and medical decisions.

Stay on and attend Part 2: Leveraging Existing Data for Clinical and Observational Research
Keynotes | Monday Short Courses | Speaker Biographies

Monday, February 22

Recommended Pre-Conference Short Course
2:00 pm - 5:30 pm

SC3: Views and Conversations on Risk-Based Monitoring* - Detailed Agenda

*Separate registration required

Welcome and Networking Happy Hour on the Patio hosted by CHI, DrugDev and Praxis
7:00 pm - 9:00 pm

Tuesday, February 23 – Wednesday, February 24


Exploring the Need to Improve Clinical Trial Awareness  

Kelly McKee, Recruitment, Retention and Innovation Team Lead, Global Trial Optimization, Merck & Co., Inc.

ROI Expectations and Objectives for Optimized Patient Awareness and Engagement

Kenneth Getz, MBA, Director, Sponsored Research Programs, Tufts CSDD; Chairman, CISCRP

AN INTERACTIVE MULTI-STAKEHOLDER ADVISORY PANEL: Increasing Clinical Trial Awareness:  Who, What, Where, HOW?  


Kelly McKee, Associate Director, Global Trial Optimization, Clinical Development Execution Organization, Merck & Co., Inc.

Kenneth Getz, MBA, Director, Sponsored Research Programs, Tufts CSDD; Chairman, CISCRP


Joe Kim, Senior Advisor, Clinical Development Innovation, Eli Lilly and Company

Mark Sloan, M.D., Hematology & Medical Oncology, Boston Medical Center

Carley Medosch, MBA, Chronic Illness Advocate

Andrew Lee, M.D., Senior Vice President & Head, Global Clinical Operations, Merck & Co., Inc.

For more details on the Tuesday Opening Plenary Keynote and Wednesday Afternoon Plenary Keynote click here

Grand Opening Coffee Break in the Exhibit Hall                  


Building and Leveraging Data Resources and Capabilities: Patients, Partners and Platforms!

Cathy Critchlow, Executive Director, Amgen Center for Observational Research 

Changing Landscape of Pharmacovigilance Research

Sean Zhao, M.D., Head of US Patient Safety Surveillance at AstraZeneca 

Incorporating The Patient Perspective Into Pharmacovigilance
Emily Freeman, Ph.D. Director, Risk Management, Global Patient Safety, AstraZeneca

Leveraging the Patient Perspective to Uncover What Matters Most

Megan Leone-Perkins, Ph.D., Chief Scientist, Corporate, HealthiVibe, LLC

Impact of Post-Approval Evidence Generation on the Biopharmaceutical Industry

Christopher-Paul Milne, Ph.D., Director, Research, Tufts CSDD, Tufts University School of Medicine

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 to them 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.

View Detailed Interactive Breakout Discussion Groups

Welcome Reception in the Exhibit Hall


Similarities and Differences In Operationalizing Observational Studies Versus Clinical Trials

Alicia Gilsenan, Ph.D., Senior Director, Epidemiology, RTI Health Solutions

Non-Interventional Research Operational Management Considerations

Erica Elefant, Associate Director Clinical Scientist, Medical Affairs, Janssen Pharma  

PRA Health SciencesPhysician Participation in Real World Research – A Global Case Study

Kathleen Mandziuk, Senior Director, Scientific Affairs, PRA Health Sciences, Late Phase Services


Stay on and attend Part 2: Leveraging Existing Data for Clinical and Observational Research
Keynotes | Monday Short Courses | Speaker Biographies

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SCOPE 2015 Wrap-Up

Held February 24-26, 2015, in Orlando, Florida, the 6th Annual SCOPE Summit gathered more than 900 industry leaders, an attendance increase of 30% from 2014, for three stimulating days of in-depth discussions covering important issues in clinical trial planning and management. With 12 different conference tracks, a Clinical Informatics News Best Practices Awards and three plenary keynote sessions, SCOPE offered advances and innovative solutions in all aspects of clinical trial management and operations, including Data Integration, Feasibility, Site Selection and Management, Patient Engagement, Recruitment and Retention, Mobile Tech, Project Management, Forecasting, Quality (QbD) in Trial Conduct, Risk-Based Monitoring, Post-Marketing Studies, and Pharmacovigilance. The impressive executive audience at SCOPE came together for invaluable networking opportunities with more than 70% of the attendees titled as Executives from leading Pharma (24%), CRO (31%), and Biotech companies (20%). Industry leaders and key decision makers representing 13 different countries and more than 360 unique organizations shared case studies, collaborated on best practices and provided unique perspectives on poignant issues that the field currently faces.

For questions or suggestions about the meeting, please contact:

Marina Filshtinsky, M.D.
Senior Director, Conferences
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5496

For partnering and sponsorship information, please contact:

Ilana Quigley
Manager, Business Development
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5457

For media and association partnerships, please contact:

Rich Handy
Senior Director, Marketing
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5456

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Preliminary Agenda Available!

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