Cambridge Healthtech Institute’s 9^th 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 9^th Annual “Protocol Development, Global Site Selection, Feasibility and Site Management” will cover the topics one should consider when planning and implementing a trial.

Final Agenda

Monday, February 18

9:00 am – 7:15 pm Registration Open (Plaza International Foyer)

2:00 – 5:00 pm User Group Meetings

Shared Investigator Platform User Forum

Trifecta Annual User Group Forum

5:00 – 6:15 pm Pre-Conference Plenary Keynote Panel & Participant Engagement Award (Regency PQ)

6:15 – 7:15 pm SCOPE’s Kick-off Networking Happy Hour Hosted by CHI (Sponsorship Opportunities Available) (Pool Decks)

7:15 pm Close of Day

Tuesday, February 19

7:15 am Registration Open and Morning Coffee (Regency OPQ Ballroom Foyer)

8:15 Opening Plenary Keynotes

9:35 Grand Opening Coffee Break in the Exhibit Hall (Plaza International Ballroom)

IMPROVING YOUR APPROACH TO STUDY PLANNING, PROTOCOL DEVELOPMENT, FEASIBILITY AND SITE SELECTION
Regency P

10:35 Chairperson’s Remarks

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

10:40 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

Historical site GCP quality performance data can be a useful decision point in combination with other site metrics for future site identification. A model incorporating a number of variables that reflect site performance, start up and site’s GCP status will be described along with real examples of its utility in site identification and performance predictions.

11:10 Feasibility for Early Stage Studies in Oncology

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

Early stage trials (First in Human, Basket Trials) present a unique design with adaptive planning. As such, feasibility in early stage trials requires a tailored and flexible approach in order to identify the optimal sites for study conduct. This presentation will share details and key learnings.

11:40 INTERACTIVE PANEL: Study Planning, Site Identification and Feasibility: Strategies for Success in Centralised and De-Centralised Organizations

Moderator: Elisa Cascade, President, Data Solutions, DrugDev

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

Sylvia Eberhardt, Business Lead, Shared Investigator Platform and Investigator Registry, Hoffmann-La Roche

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

This panel discussion will take a look at study planning, site identification and feasibility in 3 different companies, with a focus on strategies for success in companies that have largely centralised functions governing these processes vs. those that have a more de-centralised model with local responsibility for such tasks. In addition, the session will provide input on tactics (successful and unsuccessful) for driving standardization and evidence-driven activities. Topics to be discussed:

• Understand the different organizational structures that inform approaches to study planning, site identification and feasibility
• Identify challenges and opportunities that arise from both a centralized and a de-centralized approach
• Based on these insights, discuss best practices for strategies for study planning, site identification and feasibility based on organizational structure

  

12:10 pm Optimize Your Recruitment Efforts for Highly Competitive Patient Populations

Loni Branon, Senior Director, Sitetrove Citeline, Informa – Pharma Intelligence

Otis Johnson, PhD, Vice President, Feasibility and Informatics, ICON Clinical Research

Are you making the best site selection decisions as you design and plan your next clinical trial? Come join us to review patient-centric strategies that include creating new lines of communication with physicians and clinical investigators to increase study awareness and verification of access to the right patients. Creating these powerful connections enables increased patient and physician engagement, resulting in faster, more targeted patient identification and enrollment. Learn some newer approaches being used to analyze data to find the desired sites and patients.

12:40 Transition to Lunch

12:45 LUNCHEON PRESENTATION: Key Learnings from the PROTECT Registry

Dawie Wessels, MBA, MBChB, Chief Medical Officer, Synexus Clinical Research Limited

The PROTECT online clinical registry platform, run by the University of Exeter, follows a network of patients (baseline 17,000 expanding to 55,000 ) > 50 years old without dementia to determine genetic and environmental factors associated with cognitive decline and onset of Alzheimer’s Disease as well as the effect of various interventions in this population. We discuss the most recent findings to-date and the challenges of implementing and managing such a unique clinical trials asset.

1:25 SCOPE Turns 10! Champagne and Dessert in the Exhibit Hall (Plaza International Ballroom)

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

2:05 Chairperson’s Remarks

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

2:10 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

This presentation will report AstraZeneca’s recent transformation initiative focusing on patients, sites, and data-centric approaches to improve feasibility and site selection in late-stage studies. We will talk about the data sources involved, and other tools and strategies implemented for site selection and continuous predictive forecasting. We will share learnings from our experiences in terms of using historical and RWD data balanced with local insights to inform site selection decisions in a global organization.

2:40 Using RWE and Data Analytics for Enhanced Feasibility and Site Selection Strategies

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

As more varied data sources are becoming available across multiple industries, the potential to merge, overlay, and analyze data is proving to increase the ability to be predictive in achieving better operational and recruitment outcomes. Case studies utilizing RWE and varied data sources will be shared to highlight how insights were derived and applied to increase success and risk mitigation strategies.

3:10 INTERACTIVE PANEL: Quantifying Patient Burden to Improve Clinical Trial Planning and Execution

Moderator: Diane Carozza, Managing Senior Engagement Consultant, Medidata Solutions

Steve Schwager, Professor Emeritus, Cornell University

Ashley Williams, Associate Director, Global Clinical Operations, Biogen

T.J. Sharpe, Patient Advisor, Starfish Harbor, LLC

The burden of a trial and its procedures on a patient has the potential to substantially impact patient retention in a study. Sponsors have traditionally relied on subjective measures to understand this patient burden. New tools are available that provide an objective framework for quantifying and visualizing the burden on the patient from a procedure, a visit, and the overall protocol. Learn from our panel how clinical operations professionals are taking a data-driven approach to making patient-centric modifications to trial designs. Topics to be discussed:

• What is the value of incorporating patient burden into study design and strategies to improve patient retention?
• What are data-driven tools that can provide an objective framework for patient burden and its use by clinicians and patient experience teams to bolster patient retention?
• How can clinical operations and protocol designers make the important shift from subjective, often ad hoc assessment of patient burden to an objective, data-driven approach to improve patient-centricity in clinical trials?

  

3:40 Using Data Science and Technology to Design and Deliver Better Clinical Trials

Allen Kindman, MD, Vice President, Clinical Planning and Analytics, IQVIA

Access to data and innovative technology developments are enabling better protocol design and more efficient execution of clinical trials. In this presentation we will discuss how you can: - Assess and optimize your protocol using real-world data to avoid protocol amendments - Create precise and predictable study strategies - Provide seamless operational deployment, at scale, to deliver enrollment and high quality.

BREAKOUT DISCUSSION GROUPS
Regency R

4:10 Find Your Table and Meet Your Moderator

4:15 Interactive Breakout Discussion Groups

Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss key issues presented earlier in the day’s sessions. Delegates will join a table of interest and become an active part of the discussion. Bring your pharma, biotech, CRO, site, hospital or patient perspective to each of the discussions. 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.

5:00 Welcome Reception in the Exhibit Hall (Plaza International Ballroom)

6:30 Close of Day

Wednesday, February 20

7:15 am Registration Open (Plaza International Foyer)

Eric Delente, Head, Patient Consent, IQVIA Technologies

This session will explore how the recent introduction of informed consent form (ICF) authoring systems, including IQVIA ICF Author, have evolved the informed consent process by allowing sponsors and CROs to create, distribute, and track ICFs from a centralized portal, whether using paper forms or eConsent. It will also explore the features and benefits of these portals, showing why sponsors and CROs should consider adoption.

8:15 Session Break

CHOOSING DATA SOURCES, RESCUE SITES AND FOOLPROOF FEASIBILITY
Regency P

8:20 Chairperson’s Remarks

Lisa Jarosek, Senior Data Architect, CfDA (Center for Design and Analysis), Amgen

8:25 CO-PRESENTATION: Unknown Unknowns: Leveraging Technology to Identify Blind Spots in Country and Site Feasibility Data

Mary-Anne Tomas, Director, Site Intelligence & Selection, Study Optimization, Pfizer Inc.

Claire Sears, Director, Product Communications, Data Solutions, IQVIA Technologies

Lisa Jarosek, Senior Data Architect, CfDA (Center for Design and Analysis), Amgen

Increasingly sophisticated data sources are becoming more readily available to site and country selection teams for use in feasibility assessments. As teams look to add to their tool kits, there are necessary trade-offs that must be made due to limited resources – and some very expensive data options. Where do teams get the best return on their data investment? It’s valuable for these tradeoffs to be informed by an understanding of the feasibility data landscape and the value added by each category of data.

8:55 Landscape Analysis: Site Activation and Enrolment Patterns

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

The burden of adding rescue sites during a study to pharma companies is considerable in terms of time and cost, and yet understanding the landscape of rescue sites is limited. This session will present a framework for benchmarking use of rescue sites and associated findings from an analysis of shared CTMS from 13 different pharma companies. Specifically, we leveraged this data to investigate the distribution of sites activated and patients enrolled overall, and at the country and therapy level.

9:25 Foolproof Feasibility: Matching Standard of Care with Clinical Feedback and Site Intelligence

Matt Cooper, PhD, Director, Business Development & Marketing, Research Delivery, National Institute for Health Research (NIHR) Clinical Research Network Coordinating Centre

In the UK the National Institute for Health Research (NIHR) has developed a unique national strategy for delivering reliable feasibility reports using a three-pronged approach to be presented in detail. This foolproof approach to achieving accurate feasibility information is underpinning research delivery success in the UK and has contributed to record-breaking ‘time and target’ performance results (74%) for commercial contract research (74% figure is based on 466 commercial studies that closed in financial year 2017/18, 346 of which recruited 100% of their target within planned timescales).

9:55 Right-Sizing Technology in Early Clinical Development

Lorraine Rusch, PhD, President, High Point Clinical Trials Center

Clinical trials are driven by the industry’s need to innovate and provide decision making data rapidly. For compounds with measurable endpoints and wide toxicity windows adaptive Proof of Concept (POC) studies are the gold standard where safety and efficacy are evaluated in healthy volunteers and patients. This discussion addresses design and execution of POC studies incorporating technology to drive data collection in a way that safeguards efficacy evaluations from patient noncompliance due to technology burnout.

10:25 Coffee Break in the Exhibit Hall (Plaza International Ballroom)

IMPROVING SITE AND INVESTIGATOR SELECTION AND PERFORMANCE THROUGH COLLABORATIVE APPROACHES
Regency P

11:20 Chairperson’s Remarks

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

11:25 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

Current approaches to investigator qualification make it difficult for sponsors and CROs to identify study teams that are well-prepared for the quality conduct of clinical trials. This session will report recommendations from the Clinical Trials Transformation Initiative (CTTI) that are intended to disrupt current approaches to investigator qualification, resulting in 1) more streamlined and efficient learning, and 2) improved execution of study protocols. For example, reduced recruitment timelines, improved patient retention, and less time spent resolving discrepancies.

11:55 INTERACTIVE PANEL: The Missing Ingredient that Most Impacts Successful Site Performance

Moderator: Beth Harper, MBA, 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/President, Greater Gift, CEO, Javara

What matters most in clinical research is the people doing the work; however, staff qualifications are often not considered when it comes to site selection. There is a growing body of evidence to support the impact that more highly-qualified staff have on performance and the operational efficiencies that can be gained when these sites are used. Topics to be discussed:

• Current site selection processes and gaps in the data collected
• The value of site staff qualification analysis and standardization of competencies
• Industry issues associated with variance in site staffing training, development and assessment

12:25 pm Transition to Lunch

12:30 BRIDGING LUNCHEON PRESENTATION: Metrics, Standards & Technology: How to Harness Digital to Transform Protocol Creation

Bob Brindle, Venture Leader, Life Sciences, Cognizant

How much effort do you waste during clinical trial protocol creation? How do you know? How do you fix it? In this increasingly digital world, it’s frustrating to be constrained by traditional word processing tools, but making the shift to a digital process can be daunting. Join this session to discover the practical steps that will set you up to transform your process - and get a peek at what a digital protocol will enable.

1:10 Coffee and Dessert Break in the Exhibit Hall (Plaza International Ballroom)

2:10 Close of Conference