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Global Site Selection, Feasibility Assessment, Operations and Site Management


Data-driven global site selection, an optimized feasibility assessment process, and effective site management are critical to improving clinical trial timelines and outcomes. Too often companies fail to learn from past mistakes and take the same approach to protocol development, trial planning and program execution. In order to overcome challenges in clinical trial planning, operations and site management leaders should learn from the best practices of their peers, utilize data and technology to support decision making, and improve communication and relationships between Sites, CROs, and Sponsors. Cambridge Healthtech Institute’s Sixth Annual “Global Site Selection, Feasibility Assessment, Operations and Site Management” conference will cover the topics one should consider when planning and implementing a trial.

Stay on and attend Part 2: Site Activation
Keynotes | Monday Short Courses | Speaker Biographies

Monday, February 22

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

SC1: Implementing Social Media, Digital Marketing and Other New Strategies for Patient Recruitment*

*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


OPENING PLENARY KEYNOTES
PATIENT-SITE-SPONSOR-COMMUNITY VOICES: ENGAGING THE CUSTOMER, BUILDING TRUST AND FURTHERING RESEARCH

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?  


Co-Moderators:

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


Panelists:

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


IMPROVING TRIAL PLANNING: PRODUCT STRATEGY, A NEW RESEARCH ECOSYSTEM AND IMPROVED FEASIBILITY

Chairperson’s  Remarks

Jackie Kent, Sr. Director, Clinical Development Information & Optimization, Eli Lilly

Tying Product Strategy to Trials: Looking More Strategically at Why and How We Go to Certain Places for Trials

Mark Travers, Ph.D., MBA, Global Head, Monitoring Excellence & Interim Head of NA Region Global Clinical Trial Operations, Merck

CO-PRESENTATION: Designing a New Clinical Research Ecosystem around the Most Important Human – The Patient

Katherine Vandebelt, Senior Director, Clinical Innovation, Eli Lilly and Company

Jackie Kent, Senior Director, Clinical Development Information & Optimization Eli Lilly and Company

Operational and Strategic Approaches in Conducting Clinical Trial Feasibility

Susie Campos, Associate Director, Clinical Trial Intelligence, Global Clinical Trial Leadership, Novartis Pharmaceuticals 

 BBK Worldwide Are Your Investigators Championing Your Study within the Medical Community? A Strategic Look at Maximizing Referring Physician Contributions

Jaime Cohen, Strategic Consultation, BBK Worldwide

Luncheon Presentation

Speaker to be Determined, Quintiles


DATA-DRIVEN COUNTRY FEASIBILITY AND SITE PERFORMANCE PREDICTION

Chairperson’s Remarks

Susie Campos, Associate Director, Clinical Trial Intelligence, Global Clinical Trial Leadership, Novartis Pharmaceuticals

Country Feasibility: Data-Driven Methodologies

Michelle Everill-Flinders, Director, Feasibility Center of Excellence, Pfizer

IMS HealthCO-PRESENTATION: Predicting Success of an Unknown Site: The Science of Quantifying Performance Opportunity of New Sites

April Lewis, Head, Clinical Trial Optimization Solutions, IMS Health

Speaker to be Determined, Roche

INTERACTIVE PANEL: Generating Success of an Unknown Site: The Art of Supporting New Sites in Achievement of Performance Greatness

Richard Mayewski, Associate Director, Clinical Trial Intelligence, Novartis

April Lewis, Head, Clinical Trial Optimization Solutions, IMS Health

MDC Partners Advanced Feasibility Modelling

David Cocker, CSO, Business Development, ta-Scan, MDCPartners

Topic to be Announced

Frenova


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


THE ART AND SCIENCE OF SELECTING AND SUPPORTING SITES

BBKChairperson’s Remarks

Maria Cipicchio, Strategic Consultation, BBK Worldwide

Trial & Error vs. Evidence-Based Site Selection

Jorge Guerra, M.D., Executive Director, J.G. Guerra ClinOps Management; former SVP, Global Clinical Operations, Biogen

CASE STUDY: Selecting Sites for a Large US Abbott Nutrition Study Recruiting from Hospitals

Sonja Acosta, Project Lead / Sr. CRA, Scientific and Medical Affairs, Abbott Nutrition

Innovative Approaches to Decreasing Burdens Placed on Investigator Sites

Jennifer Burgess, Senior Director, Communications & Engagement, TransCelerate BioPharma, Inc

Topic to be Announced

Citeline


GENERATING TRIAL INTELLIGENCE TO ACCELERATE FEASIBILITY AND INCREASE TRIAL PARTICIPATION

Chairperson’s  Remarks

Speaker to be Determined

Maximizing Use of Claims/EHR Information during Clinical Development: Protocol through Patient Inclusion

Devin Trejo, MBA, Director, Oncology Feasibility Lead, Development Operations, Feasibility Center of Excellence, Pfizer

CO-PRESENTATION: Generate Trial Intelligence Insight through Internal and External Trial Information to Accelerate Trial Feasibility

Jill Loftiss, Senior Director, Oncology, Clinical Ops Head, AZ/MedImmune

Jane Fang, Ph.D., Director, R&D IS Lead, Clinical Business Management & Analytics, AZ/MedImmune

BRIDGING LUNCHEON PRESENTATION

 

Stay on and attend Part 2: Site Activation
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 Further Information

For questions or suggestions about the meeting, please contact:

Micah Lieberman
Executive Director, Conferences
Cambridge Healthtech Institute (CHI)
T: (+1) 541.482.4709
E: mlieberman@healthtech.com

For partnering and sponsorship information, please contact:

Ilana Quigley
Manager, Business Development
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5457
E: iquigley@healthtech.com

For media and association partnerships, please contact:

Rich Handy
Senior Director, Marketing
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5456
E: rhandy@healthtech.com

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