Cambridge Healthtech Institute’s 9th Annual

Protocol Development, Global Site Selection, Feasibility and Site Management

Improving Outcomes through Strategy, Relationships, Data and Execution

February 19-20, 2019


Data-driven global site selection, an optimized protocol development and 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 trial planning and 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 analytics to support decision making, and improve communication and relationships between Sites, CROs, and Sponsors. CHI’s 9th Annual “Protocol Development, Global Site Selection, Feasibility and Site Management” will cover the topics one should consider when planning and implementing a trial.

Stay on and attend Part 2 (Wed-Thurs): Improving Site-Study Activation and Performance

Monday, February 18

MONDAY USER GROUPS, KICK-OFF KEYNOTE, PARTICIPANT ENGAGEMENT AWARDS

User Group Meetings & Hosted Workshops (Opportunities Available): www.scopesummit.com/pre_conference_user_group_meetings

Plenary Keynotes: www.scopesummit.com/keynotes

Participant Engagement Award: www.scopesummit.com/participant-engagement-award

SCOPE’S Kick-Off Networking Happy Hour

Tuesday, February 19 - Wednesday, February 20 (Part 1 of SCOPE)

IMPROVING YOUR APPROACH TO STUDY PLANNING, PROTOCOL DEV, FEASIBILITY AND SITE SELECTION

CO-PRESENTATION: Evidence-Based Site Selection Profiles

Jonathan Rowe, PhD, Executive Director, Head of Clinical Development, Quality Performance and Risk Management, Pfizer

Oriol Serra Ortiz, MBA, Senior Director, Head Site Intelligence & Selection, Study Optimization, Clinical Development & Operations, Pfizer

Feasibility for Early Stage Studies in Oncology

Michael Fites, Senior Feasibility Strategist, Global Clinical Trial Services, Bayer

INTERACTIVE PANEL: Study Planning, Site Identification and Feasibility: Strategies for Success in Centralized and De-centralized Organizations

Moderator: Elisa Cascade, President, Data Solutions, DrugDev

Lorena Gomez, Director, Global Study Start Up & Essential Documents, Global Site Management Operations, Allergan

Tara Warren, Strategic Feasibility Manager, UCB Biosciences, Inc.

Laura Galuchie, Director, Global Clinical Trial Operations, Merck & Co., Inc. & TransCelerate Program Lead

USING MULTIPLE DATA SOURCES AND ANALYTICS TO IMPROVE FEASIBILITY AND QUANTIFY PATIENT BURDEN

CO-PRESENTATION: Applying a Data-Centric Approach to Feasibility and Site Selection

Sandra Smyth, Director, Central Feasibility and Recruitment Group, AstraZeneca

Michele Teufel, Patient Engagement Lead, Clinical Operations, AstraZeneca

Using Real World Evidence (RWE) and Data Analytics for Enhanced Feasibility and Site Selection Strategies

Michelle Everill, Senior Director, Head of Global Feasibility, Janssen

INTERACTIVE PANEL: Quantifying Patient Burden to Improve Clinical Trial Planning and Execution

Moderator: Speaker to be Announced

Christine Pierre, President, Society for Clinical Research Sites (SCRS)

Steve Schwager, PhD, Professor Emeritus, Cornell University

Diane Carozza, Managing Senior Engagement Consultant, Medidata Solutions

Additional Panelists to be Announced

PROTOCOL ADHERENCE, RESCUE SITES AND FOOLPROOF FEASIBILITY

Rescue Sites: An Analysis Framework and Associated Cross-Company Findings

Lorena Gomez, Director, Global Study Start Up & Essential Documents, Global Site Management Operations, Allergan

Foolproof Feasibility: Matching Standard of Care with Clinical Feedback and Site Intelligence

Divya Chadha Manek, PhD, Head, Business Development, National Institute for Health Research (NIHR) Clinical Research Network

IMPROVING SITE AND INVESTIGATOR SELECTION AND PERFORMANCE THROUGH COLLABORATIVE APPROACHES

Partnering with Qualified Investigators and Study Teams for Improved Site Performance, Efficiency, and Execution of Clinical Trials

Kathy Goldstein, PharmD, Senior Director, Head, Quality Management Lead, Regeneron Pharmaceuticals

INTERACTIVE PANEL: The Missing Ingredient That Most Impacts Successful Site Performance

Beth Harper, Workforce Innovation Officer, Association of Clinical Research Professionals (ACRP)

Jim Kremidas, Executive Director, Association of Clinical Research Professionals (ACRP)

Doug Schantz, Executive Director, Clinical Operations, AstraZeneca

Jennifer Byrne, Founder and President, Greater Gift, former CEO, PMG Site Network

 

BRIDGING LUNCHEON: Metrics, Standards & Technology: How to Harness Digital to Transform Protocol Creation

Bob Brindle, Venture Leader, Life Sciences, Cognizant


PLENARY KEYNOTES

Monday Evening, Tuesday Morning, Wednesday Afternoon Plenary Keynotes Featuring:

SCOPE’s 2019 Participant Engagement Award, in Memory of Jerry Matczak
Empowering Humans to Own Their Own Data
Digital Trends That Are Changing the Healthcare Experience
Why Do We Need Caregivers in Clinical Trials; Exploring Real-life Applications in Engagement and Retention
Welcome, Pharma, to AI. Here’s What You Have Been Missing.

For more details on the Plenary Keynotes: www.scopesummit.com/keynotes
For more details on the Participant Engagement Award: www.scopesummit.com/participant-engagement-award

INTERACTIVE BREAKOUT DISCUSSION GROUPS

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 key issues presented earlier in the day’s sessions. Delegates will join a table of interest and become an active part of the discussion at hand. Bring your pharma, biotech, CRO, site, hospital or patient perspective to each of the discussions below. To get the most out of this interactive session and 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: www.scopesummit.com/breakouts

Tuesday PM Welcome Reception in the Exhibit Hall

Stay on and attend Part 2 (Wed-Thurs): Improving Site-Study Activation and Performance


For more details on the conference, please contact:
Micah Lieberman
Executive Director, Conferences
Cambridge Healthtech Institute (CHI)
Phone: 541.482.4709
Email: mlieberman@healthtech.com

For partnering and sponsorship information, please contact:

Companies A-O

Ilana Quigley
Senior Manager, Business Development
Cambridge Healthtech Institute (CHI)
Phone: 781.972.5457
Email: iquigley@healthtech.com

Companies P-Z

Patty Rose
Senior Manager, Business Development
Cambridge Healthtech Institute (CHI)
Phone: (+1) 781.972.1349
Email: prose@healthtech.com

 


Signature Sponsor

IQVIA


Premier Sponsors

Appian

Bioclinica_new

ClinicalInk

Covance

DrugDev

ERT

PRA Health Sciences

Praxis

Syneos Health

UBC

Veeva