Cambridge Healthtech Institute’s 4th Annual

Improving Site-Study Activation and Performance:  

Strategically Implementing a Process for Rapid Study Start-Up
January 25-26, 2017 | Hyatt Regency Miami | Miami, FL


Clinical trial site activation and efficient study start up are critical to drug development programs, in terms of time, cost and quality of data. In order to improve start-up times and outcomes, one needs an experienced clinical research investigator, motivated and capable team members, committed partners, and efficient communication by all. Everyone (Sponsor, CRO, Site) must communicate and execute effectively in order to accelerate clinical trial timelines and optimize study site activation. As an industry, we agree that we must improve the study feasibility process, better engage our patients, standardize metrics by which we measure success, better utilize data and analytics, and develop effective patient recruitment and retention programs. In addition, embracing cross-industry initiatives to standardize and improve processes in trial start up and management and moving beyond process improvement to enable digital innovation for clinical trials (remote trials, virtual trials, mobile health) are two key trends to consider when evaluating your own approaches in your studies. Cambridge Healthtech Institute’s 4th Annual “Improving Site-Study Activation and Performance” conference will cover these issues and topics one should consider when strategically implementing a process for rapid study start-up.

Preliminary Agenda

Arrive early and attend Part 1: Protocol Dev & Global Site Selection
Keynotes | Monday Short Courses | Speaker Biographies

Wednesday, January 25 - Thursday, January 26


Bridging Luncheon Presentation: Talk Title to be Announced

AFTERNOON PLENARY KEYNOTES
MOVING TOWARD TRIALS OF THE FUTURE

Plenary Keynote Chairperson’s Opening Remarks & Clinical Informatics News Best Practices Awards
Allison Proffitt, Editorial Director, Bio-IT World & Clinical Informatics News


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.


INTERNAL AND EXTERNAL COLLABORATIONS TO DRIVE SITE ACTIVATION AND PERFORMANCE

Chairperson’s Remarks
Joan Chambers, COO, CenterWatch

Rethinking Relationships in Biotech with CRO Partners, Sites and Patients to Improve Outcomes
Murray Abramson, M.D., Vice President, Global Clinical Operations, Biogen

Integrating and Leveraging Startup Documentation and Data to Speed Site Activation
Jason Methia, Vice President, Vault Study Startup, Veeva

Participating in Industry Collaborations: Translating the External Experience into Business Practice
Virginia Nido, Global Head, Industry Collaborations, Genentech, a member of the Roche Group

INTERACTIVE PANEL: Turbocharged Site Activation for Exceptional Performance
Moderator: Christine Pierre, President, Society for Clinical Research Sites (SCRS)
Craig Lipset, MBA, Head of Clinical Innovation, R&D, Pfizer, Inc.
Dex Bilkic, MBA, Leader, Business Support Group, Boehringer Ingelheim

Site activation can be the end of an exhausting process that started well before anyone met the site and goes through to contract and regulatory packet completion. Launching the site into active performance on the study requires a new input of fuel. We’ll discuss what really works when it comes to energizing sites.

STRATEGIES TO ENGAGE QUALITY INVESTIGATORS & REDUCE SITE ACTIVATION TIMELINES

Chairperson’s Remarks

Site-Sponsor Relationships and Key Drivers of Site Performance
Jim Kremidas, Executive Director, Association of Clinical Research Professionals (ACRP)

Models to Support Different Types of PIs and Understanding the Value of Each: ACRP Certified PIs & Research Naive PIs
David Vulcano, AVP & Responsible Executive for Clinical Research, Hospital Corporation of America (HCA)

Accelerating Clinical Trial Timelines by Optimizing Study Site Activation
Navreet Dhindsa, Director Clinical Operations, Clinical Operations, Merrimack Pharmaceuticals, Inc.

Sponsored Presentation by Go Balto

Sponsored Presentation by Frenova

VIRTUAL TRIALS & REMOTE TRIALS: WHAT IS THE FUTURE OF TRULY PATIENT-CENTRIC TRIALS AND HOW DO WE DO THIS NOW?
SPECIAL SHARED SESSION

Chairperson’s Remarks

Remote Trials: Moving beyond the Concept
Hassan Kadhim, Business Consultant, IT RDM, Boehringer Ingelheim

CO-PRESENTATION: Engaging with Sites and Patients to Enable Digital Innovation for Clinical Trials
Elizabeth Beatty, Head, Digital Clinical Trials, Bristol-Myers Squibb
Scott Rauscher, Associate Director, Global Procurement R&D, Bristol-Myers Squibb

INTERACTIVE PANEL: Digital Clinical Trial Lessons Learned: Panel Discussion from Pharma Innovators Who Have Run Virtual Trials
Moderator: Matt Hendricks, Partner, Pharmica Consulting
Hassan Kadhim, Business Consultant, IT RDM, Boehringer Ingelheim
Michelle Crouthamle, Project Manager, mHealth Technology, GlaxoSmithKline
Alex Simmonds, Associate Director, Health IT, Bristol-Myers Squibb
Jane Rhodes, Senior Director, New Initiatives, Innovation Hub, Biogen
Joel Dudley, Ph.D., Associate Professor, Genetics and Genomic Sciences, Icahn School of Medicine

In the past year, several large Pharma companies have begun experimenting with a new breed of reimagined clinical trials which leverage wearables and fewer clinical sites. Now the results from the first round of these experiments are in, and the pioneers who ran the studies are ready to share their findings. Join us as we discuss what aspects of these studies are ready for prime time, where there is still work to be done, and most importantly, how patients have reacted to this shift. The conversation will focus on platforms & technology from industry veterans, startups, and established newcomers such as Apple and their ResearchKit platform.

Arrive early and attend Part 1: Protocol Dev & Global Site Selection
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




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