Cambridge Healthtech Institute’s 10th Annual

Protocol Development, Global Site Selection, Feasibility and Site Management  

Improving Outcomes through Patient-Centric Trial Design, Modeling and Execution

February 19-20, 2020


Analytics-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 protocol development, trial planning, and execution. To overcome challenges in clinical trial design, planning, operations, and 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 10th Annual “Protocol Development, Global Site Selection, Feasibility and Site Management” will cover the topics one should consider when planning and implementing a data-driven and patient-centered trial.

Stay on and attend Part 2 (Thurs-Fri): Improving Study Start-Up, Site Activation and Trial Performance

Preliminary Agenda

ENGAGING WITH PATIENTS IN EARLY DESIGN AND EXECUTION OF TRIALS & DIGITAL PROTOCOL DEVELOPMENT

The Direct-To-Patient Approach for Trial Design and Planning: The Feasibility of Adopting a DTP Model

Antonieta Sosa, Director, Janssen Clinical Innovation

Engaging with Patients in Design and Execution of Trials: Ways to Make Clinical Trials More Patient-Centric

Lani Hashimoto, Clinical Program Benchmark Manager, Patient Engagement & Recruitment, Novartis

The Benefits of Cloud-Based, Digital Protocol Development

Kyle Holen, MD, Head, Development Design Center, Research and Development, AbbVie

BUILDING AND IMPLEMENTING A DATA-DRIVEN SITE SELECTION APPROACH USING ADVANCED ANALYTICS, DATA SCIENCE MODELING, AND CLINICAL INSIGHTS

CO-PRESENTATION: Designing a Feasibility Intelligence Platform to Merge Advanced Analytics, Data Science Modeling, and Clinical Insights

Michelle Everill, Senior Director, Head of Global Feasibility, Janssen
Miranu Sasu, PhD, Clinical Operations and Data Science, Janssen

CO-PRESENTATION: Challenges and Successes in Building and Implementing a Data-Driven Site Selection Approach

Sandra Smyth, Global Feasibility & Site Intelligence Director, AstraZeneca
Gabriela Feldberg, Practice Leader, Applied Analytics & Artificial Intelligence, AstraZeneca

Paradigm Shifters for Site Selection: Are We Looking at the Right Site Attributes to Build Predictive Algorithms and Analytics Platforms?

Oriol Serra, MBA, Head, Site Intelligence & Selection, Global Product Development, Pfizer

IMPROVING FEASIBILITY AND SITE SELECTION WITH AN EHR STRATEGY AND STRATEGIC PHARMA-SITE-CRO RELATIONSHIPS

CO-PRESENTATION: EHR Trial Strategy, Implementation and Case Studies

Jane Fang, MD, MS, Director, Leader of Digital Clinical Innovations, RWD/RWE for Clinical Trials, AstraZeneca

Marie Eckerd, Feasibility and Recruitment Partner, Director, AstraZeneca

Successful Strategic Partnerships Between CROs and Pharma: Methodology to Improve Data-driven Global Site Selection

Julia Andrews, Strategic Feasibility Manager, Program Delivery, UCB

PERFORMING STUDY FEASIBILITY AT THE SITE & NEW METHODS FOR PREDICTING SITE PERFORMANCE

CO-PRESENTATION CASE STUDY: Performing Study Feasibility at the Site -- The Right Study at the Right Time

Lisa Tindell, RN, Sr. Director, Clinical Research Operations, Minneapolis Heart Institute Foundation (MHIF)
Tamara O'Black, JD, Sr. Director, Compliance, Quality & Regulatory, Minneapolis Heart Institute Foundation (MHIF)

INTERACTIVE PANEL: New Methods for Predicting Site Performance: Looking Beyond the PI to Ensure Speed and Quality

Moderator: Jim Kremidas, Executive Director, ACRP
Jonathan Rowe, Executive Director, Head of Clinical Development Quality Performance and Risk Management, Pfizer
David Burrow, PharmD, JD, Director, Office of Scientific Investigations, Office of Compliance, CDER, FDA

PLENARY KEYNOTES

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

SCOPE’s 2020 Participant Engagement Award, in Memory of Jerry Matczak
Patient Perspectives as an Input to Feasibility and Clinical Trial Design
Digital Trends that Are Changing Clinical Research
Health Literacy Throughout Drug Development – Why It Matters to Pharma and to Patients
Implementing an Innovation Methodology to Accelerate Clinical Trial Innovation within Your Organization

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

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

 

Stay on and attend Part 2 (Thurs-Fri): Improving Study Start-Up, Site Activation and Trial Performance




For more details on the conference, please contact:
Micah Lieberman

Executive Director, Conferences

Cambridge Healthtech Institute (CHI)

Phone: (+1) 541. 482.4709
Email: mlieberman@healthtech.com

 

For partnering and sponsorship information, please contact:

Companies A-K

Ilana Quigley

Senior Manager, Business Development

Cambridge Healthtech Institute (CHI)

Phone: (+1) 781.972.5457

Email: iquigley@healthtech.com

 

Companies L-Z

Patty Rose
Senior Manager, Business Development

Cambridge Healthtech Institute (CHI)

Phone: (+1) 781.972.1349
Email: prose@healthtech.com