Cambridge Healthtech Institute’s 6th Annual

Managing Late Stage Research and Observational Studies:

Strategies and Technologies to Enable Non-Interventional Studies
January 24-25, 2017 | Hyatt Regency Miami | Miami, FL


Non-interventional studies are an integral part of 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 regulatory agencies, payers, health care management organizations, formulary inclusion decision makers, healthcare professionals, and patients. Cambridge Healthtech Institute’s 6th 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 obtained data to pivotal business and medical decisions. Similarities and differences between clinical and observational studies will be addressed by the top industry experts.

Preliminary Agenda

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

Monday, January 23

Recommended Pre-Conference Short Course
2:00 pm - 6:00 pm
SC1: Social Media, Digital Marketing and Technology Growth Hacks to Enroll Patients Faster*
*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


OPERATIONAL CHALLENGES AND SOLUTIONS

Synergy between Observational and Clinical Studies
Cathy Critchlow, Ph.D., Executive Director, Amgen Center for Observational Research

Monitoring Post-Marketing Studies: Specific Features and Requirements
Rachel Edwards, Ph.D., Executive Director, Global Clinical Program Management, Amgen US

Breakfast Presentation Sponsored by DrugDev


RWD IN OBSERVATIONAL STUDIES

Building Differentiated Value Propositions in an Evolving Environment
Riad Dirani, Ph.D., Vice President, Global Health Economics and Outcomes Research (GHEOR), ‎Teva Pharmaceuticals

Opportunities and Challenges in the Use of RWE to Support Product Value Propositions
William Spalding, Ph.D., Director and Epidemiology Lead in Global Health Economics and Outcomes Research and Epidemiology, Shire

Patient Access and Outreach: The Role of Disease Foundations to Secure and Manage Real World Data
Ginger Spitzer, Executive Director, Foundation of Sarcoidosis Research


CONTINUITY OF PHARMACOVIGILANCE EFFORTS IN CLINICAL AND OBSERVATIONAL STUDIES

Strategic and Practical Considerations in Combining Clinical Trials and Observational Studies for Product Safety Profile Assessment
Sean Zhao, M.D., Head, US Patient Safety Surveillance, AstraZeneca

Leveraging Real-World Observational Data for Safety Contextualization throughout a Product’s Life Cycle: A Case Study
Jamie Geier, Ph.D., Epidemiology, Pfizer


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


Stay on and attend Part 2: Real World Data for Clinical and Observational Research
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:

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



2017 SCOPE Conference at a Glance

Scope Final Agenda 2016  

Signature Sponsor

Bio Clinica Logo

Premier Sponsors

BBK  

ClinicalInk

Comprehend

Drug Dev

inVentivHealth

OmniComm

Parexel NEW

PRA Health Sciences

QUINTILES

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> 2016 Attendee Profile