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 Seventh Annual "Protocol Development, Global Site Selection, Feasibility and Site Management" conference will cover the topics one should consider when planning and implementing a trial.

Final Agenda

Monday, January 23

 1:00 pm Short Course Registration

Recommended Short Courses*

 2:006:00 pm SC3: Clinical Trial Protocol Optimization *

* Separate registration required

 2:00-6:45 pm Main Conference Registration


6:308:30 pm Welcome and Networking Happy Hour on the Patio hosted by:
  Cambridge Healthtech Institute       Drug Dev       INC Research       Praxis  

Tuesday, January 24

 7:15 am Registration and Morning Coffee

 8:20 Opening Plenary Keynotes

 9:45 Grand Opening Coffee Break in the Exhibit Hall


 10:45 Chairperson’s Remarks

April Lewis, Director, Clinical Trial Optimization Solutions, IMS Health

10:50 CoLAB: Redefining Collaborative Engagement with External Partners for Protocol Development

Megan_LakerMegan Laker, CoLAB Consultant, CDIO, Eli Lilly and Company

CoLAB is a capability at Lilly designed to bring together sites and patients to transform the clinical study experience. Prior to the final protocol, Lilly study teams, sites and patients work face-to-face to better understand operational issues within the protocol through a CoLAB Site and Patient Simulation. Site and Patient Simulations are a “dress rehearsal” for a clinical protocol. By engaging your customers upfront, you are paving a path to easier trial implementation.

11:15 Data-Driven Feasibility Approach: Early Indication, Protocol and Site Feasibility

Silke_StrommengerSilke Strommenger, Ph.D., Head Feasibility Planning and Analytics, Clinical Development Organisation, Bayer & Michael Fites, Senior Feasibility Strategist, Global Clinical Operations, Bayer

The data-driven feasibility approach will be managed using an evolving Feasibility Plan that begins during CDP development and will outline the specific steps required for the program and its studies. This plan defines the depth and breadth of feasibility along with planned timelines for feasibility. The aim is to plan early and allow the approach to be tailored to each program/study.

11:40 Case Study: Site-Level vs. Study-Level Trial Performance Metrics – Is There a Difference?

Christopher_ConklinChristopher Conklin, Director, Feasibility Center of Excellence, Pfizer

Leveraging data to support evidence-based enrollment planning, country selection, and site identification is a hot topic, and critical to the success of this approach is access to accurate metrics. This talk will present results of an analysis comparing actual site-level performance information (from CTMS data) vs. study-level data from public data sources, overall and for three selected therapeutic categories. The session will conclude with a discussion of the implications of these results on data sources used for evidenced based study planning and the potential need for participation in a cross-company collaboration for sharing of CTMS data.

  PRA Health Sciences 

 12:05 pm Protocol Development, Global Site Selection, Feasibility & Site Management

 Henning_MichaelMichael Henning, BSN, MBA, Vice President, Clinical Management, Americas, PRA Health Sciences

As an industry, we have hit a point of saturation with placing studies at the same sites and with the evolution of personalized medicine, putting more strain on site resources. During this discussion, innovative approaches will be shared on how to improve the start-up process and maximize site management to lessen the burden on sites while driving better performance and cycle times.

Synexus12:40 Luncheon Presentation: The Importance of Sites and Patient Insights to Compliment Data Driven Approaches

 Jane_RestorickJane Restorick, Chief, Business Operations, Synexus Clinical Research Ltd.

A site perspective on the feasibility process. This session will provide a site management perspective on utilizing investigator site expertise and real world experience and patient insights in study feasibility. We will share our clearly defined feasibility process and metrics from initial enquiry to full feasibility, illustrating resource requirements, and showcasing how including a site management organization earlier can reduce cycle times and accuracy of feasibility, study risks and mitigation.

 1:20 Coffee and Dessert in the Exhibit Hall


 2:00 Chairperson’s Remarks

Megan Laker, CoLAB Consultant, CDIO, Eli Lilly and Company

2:05 End to End Data Flow: A Digital Protocol as the Platform for a Clinical Trial

Robert_DiCiccoRobert DiCicco, Pharm.D., Vice President, Clinical Innovation and Digital Platforms, GlaxoSmithKline

The processes and systems downstream of protocol development are highly manual and inefficient often delaying study start up and study reporting by several months on each end. In 2016, the Common Protocol Template (CPT) project is attempting to digitalize key elements of the protocol in order to take advantage of ready now technology such as machine learning and artificial intelligence. The audience will learn an up-to-date status of industry adoption of the Template inclusive of how we are engaging the major stakeholders (regulators and investigator sites) to inform future direction.

2:30 Rethinking Site Selection from a Patient Lens

Abbe_SteelAbbe Steel, MSc, CEO, HealthiVibe, LLC

What we’ve learned from interviewing clinical trial participants and conducting patient satisfaction surveys is that nothing affects the patient’s overall study experience as much as site perception. Quality of communication, convenience, and the respect and encouragement of site staff are among the key themes we uncovered that have a direct impact on the patient’s study experience. And yet, typically the current site selection approach makes no use of patient feedback metrics, even though the potential benefits -- to patients and to study success -- are clear.

2:45 INTERACTIVE PANEL: Practical Protocol Design: The Value and Impact of Including the Site

Michael_JayMichael Jay, Vice President, Society for Clinical Research Sites (SCRS)

Tim_McGartyTim McGarty, MBA, Global Category Manager, Digital Development, eCOA, PR&R, Novartis

Robert_DiCiccoRobert DiCicco, Pharm.D., Vice President, Clinical Innovation and Digital Platforms, GlaxoSmithKline

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.

  • Understanding when and how to engage sites during your protocol development process
  • Engaging stakeholders beyond your internal ones (site leads, Site Advocacy Groups (SAGs), patients)
  • Learn how to improve your internal protocol design process and integrate the best of outside insights with your science and ops teams

Signal Path Horizontal3:20 Transformative Technologies in an Age of Increasing Trial Complexity

Bradford_HirschBradford Hirsch, M.D., Co-Founder & Board Member, SignalPath, LLC

Clinical research is becoming increasingly complex for numerous reasons - the adoption of novel trial designs, an increase in activities, and stringent eligibility criteria. As a site conducting research or an organization coordinating it, this complexity increases the potential for negative outcomes. In this session Dr. Hirsch will explore emerging technology-enabled solutions that have the potential to keep pace with rising trial complexity and expose new insights into site and study performance.

 3:45 End of Session, Beginning of Interactive Breakout Discussion Groups

 3:55 Find Your Table and Meet Your Moderator

 4:00 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. 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. Click here for details.

 5:00 Welcome Reception in the Exhibit Hall

 6:30 Close of Day

Wednesday, January 25

 7:15 am Registration

 7:30 Breakfast Presentation: eConsent: Put "Informed" Back in Informed Patient Consent

Eric_DelenteEric Delente, President, Patient Solutions, DrugDev; Co-founder of SecureConsent (Part of DrugDev)

Electronic informed consent makes the consenting process more efficient and effective for staff, sponsors, monitors, and most importantly patients by presenting the information in formats and language in which patients are comfortable. Join us for breakfast to learn the best practices, latest technological advances, and proven benefits of deploying an eConsent solution - including the impact it has on improving patient satisfaction and retention and help us put "informed" back in patient consent process.


 8:25 Chairperson’s Remarks

Sean Stanton, Senior Vice President, Global Operations, Research Network, Bioclinica

8:30 Optimize Country Selection and Start Up Timeline Development

Kate_ZarishKate Zarish, Director, Strategic Study Start Up, Development Operations, Clinical Field Operations, AbbVie

In this example, an electronic country intelligence tool is utilized to allow users to review country-specific information enabling data-driven decisions for global site selection. It provides quick and user friendly access to country-related study start up data. Expanding capabilities within the tool allows the clinical teams to capture additional country intelligence as the information is identified to best support country selection and study start up plan and time line development.

8:55 Innovation in Data-Driven Site Selection: Benefits and Challenges

Shawn_TedmanShawn Tedman, Lead, Strategic Feasibility, Site & Patient Solutions, UCB BioSciences

This case study describes some innovative techniques used by the Strategic Feasibility team at UCB. Central to our innovation is the incorporation of new commercial data sources and quantification of qualitative data to help inform the site selection process. True innovation isn’t always a smooth process. In addition to the team’s successes, this case study will discuss realistic challenges that have been encountered and limitations of our approach. The audience will gain an understanding of a mid-sized pharma company’s experience with innovation in the investigative site selection space.

9:20 The Global Investigator Pool: How Close Are We to Knowing the Full Picture?

Ed_MannelloEdward Mannello, Feasibility & Recruitment Director, Clinical Operations, AstraZeneca

The increased number of studies coupled with high investigator turnover and increasing protocol complexity all point to the need for a change in industry operating practices to help sustain our current investigator base. Investigator registries offer a solution that can benefit both investigators and industry. Attendees will learn about the status of these cross-industry collaborations and gain insight into the ROI for feasibility, site identification, and start-up. The learning objectives for this session are: Characterize the size and scope of the global investigator pool, describe the overlap of principal investigators across pharmaceutical companies, and understand the risk vs. benefit in investigator/metrics access from data sharing of information across companies.

Pharma Intelligence9:45 Co-Presentation: Choice, not Chance: How to Mitigate the Risk of Selecting a Non Enrolling Site for Your Clinical Trial

Loni_BranonLoni Branon, Director, Sitetrove/Chinatrove, Pharma Intelligence

Lut_De_BieLut De Bie, Study Placement Lead, Strategic Program Analytics, Global Clinical Development Operations, Janssen Pharmaceutica NV

This presentation will demonstrate the need for integrating multiple clinical trial data sources to better understand the competitive environment and identify potential challenges before initiating a study. Strategies to optimize site selection will be reviewed, including identification of top investigators globally with optimal experience to maximize the potential for enrollment success; and finally, the importance of monitoring the clinical trial landscape throughout the life of the study.

 10:10 Coffee Break in the Exhibit Hall


 11:10 Chairperson’s Remarks

Bonnie Brescia, Founding Principal, BBK Worldwide

11:15 Best Practices in Protocol Design by Reducing Protocol Amendments

Stella_StergiopoulosStella Stergiopoulos, Senior Project Manager, Center for the Study of Drug Development, Tufts University

Over the last five to ten years, drug development companies have introduced protocol governance committees to evaluate protocol design and feasibility. However, there is no current study looking to assess the effectiveness of these teams. Tufts CSDD conducted a study in collaboration with 15 large and midsized pharmaceutical and contract research organizations, examined 3,055 protocols across various phases and therapeutic areas to assess the number of protocol amendments. Best practices from companies with a small percentage of avoidable amendments will be discussed.

11:40 INTERACTIVE PANEL: Clinical Trial Feasibility, Evidenced-Based Recommendations, & Protocol Optimization

Christopher_ConklinChristopher Conklin, Director, Feasibility Center of Excellence, Pfizer

Marisa_RackleyMarisa Rackley, Director, Clinical Research, Global Trial Optimization, Merck

Stella_StergiopoulosStella Stergiopoulos, Senior Project Manager, Center for the Study of Drug Development, Tufts University

Ed_MannelloEdward Mannello, Feasibility & Recruitment Director, Clinical Operations, AstraZeneca

Feasibility leaders from Astra-Zeneca, Merck and 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.

QuintilesIMS vertical12:05 pm Bridging Luncheon Panel Presentation: The (Evolution) Revolution of Site Feasibility: The Current Model of Site Feasibility is Outdated, but Are We on the Brink of its New Evolution?

Alexandra_ChargeModerator: Alexandra Charge, Head, Consultative Services, Clinical Trial Optimization Solutions (CTOS), QuintilesIMS

Panelists: Mark Bagarazzi, CMO, Inovio Pharmaceuticals
Brendan O’Neill, Senior Director, Patient Recruitment Programs, Pfizer
Lucas Glass, Manager, Data Sciences, Analytics Centre of Excellence, QuintilesIMS

Innovation in technology and expansion of Real World Data (RWD) is substantially changing our industry, offering new approaches to the age-old operational processes in clinical development such as identification of sites and the act of surveying our investigators. With the expansion of RWD, the question now becomes could investigators’ input from the chore of site feasibility be minimized to such an extent that the only “feasibility” question remaining is whether they are interested in participating in a given study? This session aims to explore the current use of RWD in site selection and feasibility, and the future advancement in data availability and EMR technologies to further impact these processes.

 12:50 Coffee and Dessert in the Exhibit Hall

 1:30 Close of Conference

  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

 For partnering and sponsorship information, please contact:

Ilana Quigley
Senior Manager, Business Development
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5457

 For media and association partnerships, please contact:

Rich Handy
Senior Director, Marketing
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5456