Cambridge Healthtech Institute’s 12th Annual

Enrollment Planning and Patient Recruitment

Strategic Enrollment Planning, Data-Driven Recruitment and Forecasting, and Central Campaign Management

February 19-20, 2019


Patient recruitment and up-front enrollment planning are critical to drug development programs. Patient recruitment if not adequately planned for can extend your development timeline by a number of years. Retention of patients throughout the life of a clinical trial is essential in order have complete data sets for your analysis and subsequent filings. In order to optimize both you have to have a plan and effectively leverage analytics and technology without losing site of the participant’s user experience. CHI’s 12th Annual “Enrollment Planning and Patient Recruitment” will cover the topics one should consider when drafting and strategically implementing a patient recruitment plan for a clinical development program.

Final Agenda

Stay on and attend Part 2 (Wed-Thurs): Patient Engagement, Enrollment and Retention through Communities and Technology

Monday, February 18

9:00 am 7:15 pm Registration Open (Convention Level)

2:005:00 pm User Group Meetings

Shared Investigator Platform User Forum

Trifecta Annual User Group Forum

5:006:15 pm Pre-Conference Plenary Keynote Panel & Participant Engagement Award (Regency PQ)

6:157:15 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 (Convention Level)

8:15 Opening Plenary Keynotes

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

Orlando N

10:35 Chairperson’s Remarks

Mark Summers, President, Patient Engagement, WCG

10:40 CO-PRESENTATION: The Changing Face of Digital Patient Recruitment: Better Data-Driven Decisions

McCormick_AmyAmy McCormick, Innovation Lead, Patient Experience and Design Innovation, Eli Lilly & Co.

Hudziak_KevinKevin Hudziak, Consultant, Innovation Lead, Patient Experience and Design Innovation, Eli Lilly & Co.

This talk will focus on new approaches to digital patient recruitment. It will focus on real-world examples using data-driven decisions to adapt recruitment and retention strategies. Examples on how to provide patients and caregivers with useful information to help guide them through their journey.

ICON-Corp 11:10 CO-PRESENTATION: Treating Patients Like Customers: Changing the Paradigm of Clinical Trial Recruitment

Goller_GretchenGretchen Goller, Global Head, Patient Recruitment and Retention, Clinical Research Services, ICON plc

McKee_KellyKelly McKee, Head, Patient Recruitment, Vertex

11:40 CO-PRESENTATION: Digitizing a Patient-Focused Clinical Trial Experience

Yates_StephenStephen Yates, Clinical Program Director, UCB

Erb_KelleyKelley Erb, Lead, TransCelerate’s Novel Digital Endpoints; Director, Digital Medicine, Pfizer

During this interactive session, leaders from TransCelerate Member Companies will candidly share their experiences collaborating to create solutions that will bring about innovative change, and address some of our industry’s greatest challenges. They will discuss two key initiatives that have the potential to transform clinical trials. The audience will learn how patient-facing digital technologies and thoughtful patient input and experience can be used to advance clinical research and create the patient experience of the future.

12:10 pm Virtual Interactions: Effective Patient Recruitment Strategies in the Digital Era

Kratz_MatthewMatthew Kratz, Senior Manager, Patient & Physician Services, UBC

This session will focus on employing the best global and US-centric practices around patient recruitment and harnessing digital tools to target potential patients. The session will address how using digital outreach has impacted rare disease trials and how important response mechanisms are to any recruitment effort.  Will also discuss regulatory and legal considerations when using digital tactics and the use of patient platforms to offer more to trial participants and improve retention and brand loyalty.

12:40 Transition to Lunch

12:45 LUNCHEON PRESENTATION: Bringing the Trial to the Patient: Virtual Trials and the Promise of Patient Engagement

Rose_Josh_RCT Josh Rose, Vice President, Global Head, Strategy, Research and Development Solutions, IQVIA

The shift to virtual trials is upon us. With it comes a myriad of benefits to both the patient and sponsor. This presentation will share how early adopter studies are delivering more rapid patient enrollment, higher retention, better data quality and overall faster cycle times.

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

Orlando N

2:05 Chairperson’s Remarks

Melanie Goodwin, Director, Patient Recruitment Programs, Clinical Development & Operations, Global Product Development, Pfizer

2:10 Lessons Learned from a Successful Phase 3 Program in Japan: Culture, Engagement, Recruitment and Retention

Dubourg_Julie Julie Dubourg, MD, Medical Director, Clinical Development, Poxel

This talk will focus on patient recruitment and retention in the settings of a first-in-class registration program in Japan. There are many factors to consider when planning a registration program in Japan from a European biotech company perspective and efficient strategies will be presented.

2:40 Can Historical Data and Analytics be Used for Recruitment Planning in Rare Diseases?

Dimitrova_Angela Angela Dimitrova, MD, Senior Director, Feasibility Group Lead Rare Diseases, Study Optimization, Pfizer

Rare disease studies are more difficult to enroll because of the much smaller patient pools. Planning enrollment durations for rare diseases is also more challenging and complicated due to rarity of data. In this presentation we will review the opportunities to use evidence-based and data-driven approaches to better plan enrollment in rare diseases.

3:10 The Digital Clinical Trial Recruitment Landscape: Insights and a Fireside Chat

Greene_JeffJeff Greene, Vice President, Digital Strategy & Insights, Decision Resources Group

Developed with Shwen Gwee, General Manager, Digital Accelerator, Global Drug Development, Novartis

More than ever, patients feel empowered to play an active role in their health decisions. That extends to their participation in clinical trials - and digital advances have made it a lot easier. Over 30% of U.S. patients have expressed interest in going online to find clinical trials. Among rare disease patients willing to participate in a clinical trial, nearly 60% have accessed prescription drug information from social media. But many pharma companies struggle to integrate digital solutions into their clinical trial recruitment strategies. Come join this interactive session where we’ll highlight DRG Digital’s latest study, The Digital Clinical Trial Recruitment Landscape. This session will also end with a brief fireside chat that discusses what clinical can learn from marketing to develop better digital strategies that enhance and accelerate trial recruitment.

BBK_Worldwide_tagline 3:40 Myth, Urban Legend and an Element of Truth: Dispelling Commonly Held Beliefs about Clinical Study Participation

Aaron Fleishman Aaron Fleishman, Director, Market Development, Business Development Innovation and Market Expansion, BBK Worldwide

Are site staff overburdened by multiple systems? Can an app really increase patient engagement? There’s no shortage of opinions of what makes patient recruitment and engagement for a clinical study effective. Leveraging data from BBK’s Study Voices survey of over 3,000 patients, site staff, and study personnel, this presentation will challenge common myths and legends and determine their veracity.

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.

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

6:30 Close of Day

Wednesday, February 20

7:15 am Registration Open (Convention Level)

IQVIA 7:45 BREAKFAST PRESENTATION: ICF Authoring - The Next Evolution of Informed Consent (Regency P)

Delente_EricEric 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

Orlando N

8:20 Chairperson’s Remarks

Neil Weisman, Executive Vice President, Continuum Clinical

8:25 Active Patient Identification: The Power of Patients and the Role of Grit in Pre-Determining Retention

Becker_Lynne Lynne Becker, Senior Data Analyst, Enterprise Intelligence & Data Solutions (EIDS) Program Management Office (PMO), Deputy Assistant Director Information Operations, Defense Health Agency (DHA)

Patient engagement implies a variety of methods that is differentiated amongst organizations and its application is becoming confused, perhaps diluting its intent. Patients are being bombarded with a plethora of technology, social media, wearables and now concierge services to become “engaged”; but engagement for a hospital administrator differs from a clinical trial sponsor, which differs from the clinician and even further differs from the actual patient. Our position is to pre-identify the grittiness of a clinical trial candidate before they are overwhelmed with these services. Then appropropriately apply your engagement resources in a more efficient manner to improve the clinical trial’s return on investment.

8:55 A New Ecosystem for Clinical Trials Recruitment: Go Where the Patients Are

Jadhav_Pravin Pravin Jadhav, PhD, Senior Director, Corporate Projects, R&D Innovation, Otsuka Pharmaceutical Development and Commercialization (OPDC)

Almost two-thirds of clinical sites do not meet patient recruitment targets. There have been a number of approaches explored to boost clinical trial recruitment with some mixed success. While there are tools with promising visuals by leveraging big data analytics, most tools do not provide any actionable insight for study teams to implement in areas “where the patients are.” An example of leveraging smart data analytics combining real world data, internal clinical operations data and publicly available resources will be discussed that supported development of a novel and actionable targeted recruitment approach.

9:25 CO-PRESENTATION: Creating a Connected Patient Engagement Platform through Innovative Digital Approaches

Brehm_Carolyn Carolyn Brehm, Associate Director, BMS Study Connect Business Lead, Bristol-Myers Squibb

Das_Mano Mano Das, IT Business Partner, Clinical Patient and Site Operations, Bristol-Myers Squibb

Through global expansion and innovative digital approaches, BMS has created an industry-leading patient engagement platform dedicated to increasing clinical trial awareness, participation and engagement. BMS Study Connect is a comprehensive clinical trial resource for patients and caregivers to learn about and find clinical trials, and connect with others. The platform delivers an experience that empowers patients, provides transparency, and supports patients and caregivers before, during and after a clinical trial.

9:55 Patient Engagement: Treating Patients Like Customers

Clarke_Ivor_RCT Ivor Clarke, CEO, SubjectWell

You’re a consumer. As such, what do you look for when choosing a product or service to meet your needs? Price? Quality? Convenience? Customer Service? All of the above? Patients are consumers too and they, just like you, are accustomed to being able to engage providers with ease. In this session, get insights into how other industries inform and engage consumers and explore how you can apply those same techniques to your next study.

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

11:20 Chairperson’s Remarks

Paul Ivsin, Managing Director, PEP Trials, The Patient Experience Project

11:25 Implementing Patient-Facing Technology in Clinical Trials: How to Overcome Industry’s Biggest Challenges to Benefit Patients, Sites and Sponsors

Kadhim_HassanHassan Kadhim, MBA, Director, Head of Clinical Trial Business Capabilities, Bristol-Myers Squibb Company

Patient-facing digital technologies (also called ‘Patient Technology’) have the potential to serve a variety of functions in clinical trials, such as capturing clinical endpoints, engaging patients, and facilitating remote study conduct. However, these technologies are not yet accepted as mainstream research tools, and the opportunities, challenges, and facilitators associated with their implementation in clinical trials have not been fully characterized. The audience will gain an understanding of factors associated with implementation and this session will also explore the assets developed by the TransCelerate Patient Technology Initiative freely available to clinical research professionals to address these opportunities.

11:45 How Roche is Planning to Use eConsent to Retain Patients for a Complex Oncology Trial

Danner_Olaf Olaf Danner, Global Studies Manager, Roche

This session will tell the story of a recent multi-cohort oncology study conducted by Roche. Specifically, it will identify how and why Roche developed targeted education and videos for each oncology cohort group, using eConsent, and how that improved engagement, enrollment, and retention. The talk will share: How eConsent was deployed to address each cohort group; the process for identifying, developing, and implementing each educational video; the benefits of Roche’s approach and why patients better understood the risks and needs of the trial.

12:05 CASE STUDY: Building a Patient-Centric Platform for Improved Recruitment and Retention

Goodwin_Melanie Melanie Goodwin, Director, Patient Recruitment Programs, Clinical Development & Operations, Global Product Development, Pfizer

Communications and trial support of patients before, during, and after trial participation is challenging, yet will positively support enrollment and retention efforts of our clinical trials. And while we have ways to solve each of these, how do we make the process simple for our study volunteers? By building a single platform solution that will allow each study volunteer to obtain information and support based on their individual needs.

12:25 pm Transition to Lunch

12:30 BRIDGING LUNCHEON PRESENTATION: Leveraging Analytics and the Patient Voice to Optimize Patient Recruitment & Retention Campaigns

Loll_Robert Robert Loll, Senior Vice President, Business Development & Strategic Planning, Praxis Communications, LLC

Andrea Berki-Nnuji, Director, Analytics, Praxis

As the world becomes more and more digital, it is important to tap into the endless amounts of data and conversations being shared on the Internet to glean patient insights and understanding. As we have lunch, we’ll explore case studies and discuss how our industry can utilize data and analytics to craft and optimize efficient and effective patient-centric enrollment campaigns.

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

2:10 Close of Conference

Stay on and attend Part 2 (Wed-Thurs): Patient Engagement, Enrollment and Retention through Communities and Technology