Cambridge Healthtech Institute’s 7th Annual

Protocol Development, Global Site Selection, Feasibility and Site Management:  

Improving Outcomes through Strategy, Relationships, Data and Execution
January 24-25, 2017 | Hyatt Regency Miami | Miami, FL


Data-driven global site selection, improved protocol design, 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, Sponsors and the Trial Volunteers. Cambridge Healthtech Institute’s 7th Annual “Protocol Development, Global Site Selection, Feasibility and Site Management” conference will cover the topics one should consider when planning and implementing a trial.

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

Preliminary Agenda

Monday, January 23

Recommended Pre-Conference Short Courses
2:00 pm - 6:00 pm
SC1: Social Media, Digital Marketing and Technology Growth Hacks to Enroll Patients Faster *
SC3: Clinical Trial Protocol Optimization *

*Separate registration required

Welcome and Networking Happy Hour on the Patio hosted by CHI, DrugDev and Praxis
6:30 pm - 8:30 pm

Tuesday, January 24 – Wednesday, January 25


OPENING PLENARY KEYNOTES
RE-THINKING THE DESIGN AND PLANNING OF OUR STUDIES


Two Keynote Sessions – Tuesday Morning and Wednesday Afternoon

  • Tuesday Morning: RE-THINKING THE DESIGN AND PLANNING OF OUR STUDIES
  • Wednesday Afternoon: MOVING TOWARD TRIALS OF THE FUTURE

Featuring:
Murray Abramson, M.D., Vice President, Global Clinical Operations, Biogen
Bardia Akbari, Pharm.D., Vice President, Product Global Development, Oncology, Genentech, Inc.
Robert DiCicco, Pharm.D., Vice President, Clinical Innovation and Digital Platforms, GlaxoSmithKline
Craig Lipset, MBA, Head of Clinical Innovation, R&D, Pfizer, Inc.
Paulo Moreira, Vice President, Global Clinical Operations - External Innovation, EMD Serono, Inc.
Christine Pierre, President, Society for Clinical Research Sites (SCRS)
John Reites, Head, Digital Health Acceleration, Quintiles
Jeremy Sohn, Vice President, Head of Digital Business Development & Licensing, Novartis
Katherine Vandebelt, Senior Director, Clinical Innovation, Eli Lilly and Company

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 AND PERFORMANCE: PROTOCOL DEVELOPMENT & EVIDENCE-BASED FEASIBILITY

Chairperson’s Remarks

Case Study: Redesigning the Protocol Process, Feasibility and Trial Design in Order to Avoid Downstream Problems
Silvana Giustino, Global Head, Clinical Development Expert Resources, pharma Research and Early Development (pRED), Roche

Data-Driven Feasibility Approach: Early Indication, Protocol and Site Feasibility
Silke Strommenger, Ph.D., Head Feasibility Planning and Analytics, Clinical Development Organization, Bayer

Case Study: Site-Level vs. Study-Level Trial Performance Metrics – Is There a Difference?
Christopher Conklin, Director, Feasibility Center of Excellence, Pfizer

Sponsored Presentation by PRA 

Luncheon Presentation (Sponsorship Opportunity Available)


RE-THINKING PROTOCOL DESIGN AND SITE SELECTION

Chairperson’s Remarks

End To End Data Flow: A Digital Protocol as the Platform for a Clinical Trial
Robert DiCicco, Pharm.D., Vice President, Clinical Innovation and Digital Platforms, GlaxoSmithKline

CO-PRESENTATION: Rethinking Site Selection from a Patient Lens
Abbe Steel, Founder & CEO, Executive, HealthiVibe, LLC
Speaker to be Announced, Janssen Research and Development

INTERACTIVE PANEL: Practical Protocol Design: The Value and Impact of Including the Site
Moderator: Michael Jay, Vice President, Society for Clinical Research Sites (SCRS)
Paulo Moreira, Vice President, Global Clinical Operations - External Innovation, EMD Serono, Inc.
Karin Gulbrandsen, Senior Director, U.S. Head, Global Clinical Operations, Janssen Research and Development (invited)
It’s no secret that protocols are rapidly becoming more complex, involving more practitioners and specialty procedures. This complexity extends to the inclusion/exclusion criteria, exacerbating difficulties with enrollment. Obtaining early input from investigators and site personnel can help, but only if they are included effectively and asked the right questions.

Sponsored Presentation by Bioclinica


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



DATA-DRIVEN GLOBAL SITE SELECTION & NAVIGATING THE GLOBAL INVESTIGATOR POOL

Breakfast Presentation Sponsored by DrugDev

Chairperson’s Remarks

Optimize Country Selection and Start Up Timeline Development
Kate Zarish, Director, Strategic Study Start Up, Development Operations, Clinical Field Operations, AbbVie

Case Study: Innovation in Data-Driven Site Selection: Benefits and Challenges
Shawn Tedman, Lead, Strategic Feasibility, Site & Patient Solutions, UCB BioSciences

The Global Investigator Pool: How Close Are We to Knowing the Full Picture?
Edward Mannello, Feasibility & Recruitment Director, Clinical Operations, AstraZeneca

Sponsored Presentation by citeline


BEST PRACTICES IN PATIENT-CENTRIC PROTOCOL DESIGN AND TRIAL FEASIBILITY

Chairperson’s Remarks

Best Practices in Protocol Design by Reducing Protocol Amendments
Stella Stergiopoulos, Senior Project Manager, Center for the Study of Drug Development, Tufts University

INTERACTIVE PANEL: Clinical Trial Feasibility Panel and Discussion
Moderator: Christopher Conklin, Director, Feasibility Center of Excellence, Pfizer
Marisa Rackley, Director, Clinical Research, Global Trial Optimization, Merck
Stella Stergiopoulos, Senior Project Manager, Center for the Study of Drug Development, Tufts University
Edward Mannello, Feasibility & Recruitment Director, Clinical Operations, AstraZeneca

Feasibility leaders from AstraZeneca, Merck, Tufts & Pfizer will discuss a variety of current topics in feasibility including: leveraging datasets to make evidenced-based recommendations, protocol optimization, predictive analytics & patient centricity in protocol feasibility. The panel members will speak about their respective companies’ approach to feasibility, how success is defined within their organizations and how they are overcoming current challenges they are facing. Questions from audience members will be strongly encouraged.

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

2017 SCOPE Conference at a Glance

SCOPE 2016 Wrap-Up

The 7th Annual SCOPE Summit, held February 23-25, 2016 in Miami, Florida, had record attendance with more than 1,150 industry leaders joining 3 days of in-depth discussions covering important issues in clinical trial planning and management. As SCOPE grew in attendance by 30% over last year, the 2016 program offered 12 distinct conference tracks, 2 symposia, 3 short courses, and 4 plenary keynote sessions, focused on 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, Outsourcing, Forecasting, Budgeting and Contracting, Quality (QbD) in Trial Conduct, Risk-Based Monitoring, Post-Marketing Studies, Observational Research, Statistics and Biomarker-Driven Trials.

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
Senior 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




Signature Sponsor

Bio Clinica Logo

Premier Sponsors

BBK  

ClinicalInk

Comprehend

OmniComm

PRA Health Sciences

QUINTILES

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> Media Partners

> 2016 Attendee List

> 2016 Attendee Profile