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Cambridge Healthtech Institute’s 11th Annual

Enrollment Planning and Patient Recruitment:  

Strategic Enrollment Planning, Data-Driven Recruitment and Forecasting, and Central Campaign Management
February 13-14, 2018 | Hyatt Regency Orlando | Orlando, FL

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. CHI’s 11th 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.

Monday, February 12

9:00 am - 7:30 pm Registration Open

5:00 - 6:15 pm Pre-Conference Plenary Keynote Panel

6:308:30 pm SCOPE’s Kick-Off Networking Happy Hour on the Garden Terrace Hosted by CHI, DrugDev, Exostar, & Praxis

8:30 Close of Day

Tuesday, February 13

7:15 am Registration Open and Morning Coffee

8:20 Opening Plenary Keynotes

9:45 Grand Opening Coffee Break in the Exhibit Hall

INCORPORATING DATA AND PATIENT INSIGHTS INTO ENROLLMENT PLANNING AND TRIALS

10:45 Chairperson’s Remarks

Marisa Rackley, Director, Clinical Research Operations, Vertex Pharmaceuticals, Inc.

10:50 Leveraging Data and Analytics for Enrollment Planning and Trial Execution

Sue_GriffingSusan Griffing, Vice President, Global Head Country Clinical Operations, Roche

Clinical trials are still taking longer than planned and costing companies more than predicted. Of the challenges faced in trial execution, enrollment is still a major bottleneck for research. This presentation will talk to industry trends in this area and specifically how we are leveraging data to make decisions around operations.

11:15 Patient Voice Plans in R&D: Improving the Patient Experience and Clinical Trial Success

Katherine_CapperellaKatherine Capperella, Global Patient Engagement Leader, Janssen

Janssen has employed a focused approach to incorporating patient insights into clinical trial design. Working together, commercial and R&D colleagues gather patient feedback and modify clinical trials to improve the patient experience, leading to better recruitment and retention. This presentation will include case studies and an example of how patient engagement is being measured.

11:40 Bringing the Patient Voice and Community into the Drug Development Process

Francis_KalushFrancis Kalush, Ph.D., Health Programs Coordinator, Professional Affairs and Stakeholder Engagement (PASE), CDER, FDA

FDA’s Professional Affairs and Stakeholder Engagement at CDER has been working with all stakeholders: patients/patient advocates, health professionals and industry to bring the patient voice and perspective into the drug development and approval process. The goal would be to continue the support of novel therapies that directly address the need of patients living with diseases. Learn to effectively engage with FDA. Understand how to bring the voice of the patient into the drug approval process.

12:05 pm Learning from Other Industries

Ivor_ClarkeIvor Clarke, CEO, SubjectWell

This presentation focuses on the root causes of this industry’s challenges in patient outreach and engagement. Then we’ll take a look at how other industries have solved similar problems and what we can apply to patient recruitment.


12:30 Session Break

12:40 Luncheon Co-Presentation: Navigating Clinical Research from the Perspective of the Patient: A Journey in Humility

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


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

Our industry is dependent upon the good intentions of ordinary volunteers subjecting themselves to protocols that regularly include extraordinary procedures. Patients must understand their diagnosis, acquaint themselves to available trial/treatment options, comprehend the medical impact of their decisions, and choose a therapy – typically without a background in healthcare. This interactive session will walk the audience through the patient journey, focusing on treatment/trial selection from a newly-diagnosed patient with a potentially life-threatening disease perspective.

1:20 Coffee and Dessert Break in the Exhibit Hall

EXPANDING THE REACH OF TRIALS AND RECRUITMENT BEYOND TRADITIONAL METHODS: TELEMED, EMRs & RWD

2:00 Chairperson’s Remarks

Jill Johnston, President, Clinical Services Organization, WCG

2:05 Pharma Bands Together to Activate a New Audience: HealthCare Providers

Joe_KimJoe Kim, MBA, Senior Advisor, Clinical Innovation, Eli Lilly and Company

It’s no secret that attempts to inspire and enable health care providers to refer their patients into clinical trials have often failed. Reasons for this have been documented in peer reviewed literature and felt first hand by study teams in real world campaigns. Come learn about a key component of TransCelerate’s Clinical Research Awareness and Access workstream where they look to go beyond incentive models and skill building. Learn about a unique photojournalism campaign that seeks to activate the hearts of HCPs in a way that will make them believe in the benefit of research for patients, tomorrow and today.

2:30 Data-Driven Patient Recruitment with Real World Data at Roche pRED

Liping_JinLiping Jin, Data-Driven Recruitment Lead, Pharmaceutical Research & Early Development, Roche Innovation Center New York

With the increasing use of Real World Data (RWD) in the pharma industry, Data-Driven Recruitment (DDR) team at Roche Pharm Research & Early Development (pRED) would like to share our experience of integrating RWD (e.g. insurance claims, EMR) with trial metrics data to optimize study protocol design and target patient recruitment strategy. While the team has received positive feedback from our business partners (translational medicine, clinical program teams, and study leaders) we would like also to share the challenges to expanding the effort in broader US and international settings.

2:55 PANEL DISCUSSION: Innovation in Recruitment Is Not a 4-Letter Word

Kevin_HudziakKevin Hudziak, Innovation Lead, Clinical Innovation, Eli Lilly and Company


Mark_SpringerMark Springer, Project Lead, Clinical Innovation, Eli Lilly and Company


Taylor_WongTaylor Wong, LRL Procurement, Medical and Regulatory, Eli Lilly and Company


Rahlyn_GossenRahlyn Gossen, Founder & Principal, Rebar Interactive

Patient recruitment methods and execution have become stale. In the typical full-service model, a sponsor chooses one full-service supplier, who may not have expertise in all aspects of digital patient recruitment. To innovate in this space, Lilly Clinical Innovation sought to determine if creating a new patient recruitment sourcing solution would benefit the digital patient recruitment ecosystem. By analyzing each aspect of the ecosystem, we looked to identify the best in class vendors for each aspect of digital patient recruitment (e.g., creative, outreach, microsites, etc.) using Lilly TrialGuide as the centerpiece. This panel will examine the innovation and will represent the voices of Clinical Innovation, Research Procurement, and a supplier involved in the process. Our process for determining selected suppliers will be explored including defining the “Pitch Match” method for determining final suppliers. Communication, processes, challenges, best practices, and insights from all sides of the table will be explored and audience participation is encouraged.

3:20 Real World Data Meets Real World Evidence in Patient Recruitment and Engagement

Bonnie_BresciaBonnie Brescia, Founding Principal, BBK Worldwide

Today we have access to multiple health databases containing myriad data points that can be integrated, correlated and mined. The expectation is that these data will help researchers to better define target patient populations, improve protocol design, and enhance site selection. But will these efforts advance patient recruitment and retention? Using data from multiple global trials, we explore RWE pointing to the decisive role of support and engagement programs in recruiting and retaining study participants.

BREAKOUT DISCUSSION GROUPS

3:50 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.

5:00 Welcome Reception in the Exhibit Hall

6:30 Close of Day

Wednesday, February 14

7:15 am Registration Open

7:45 Breakfast Presentation: The Next Generation of Site Payments: Technology Do's and Don'ts

Stuart Thiede, President, Payments, DrugDev (An IQVIA Company)

Ineffective site payment processes can irreparably damage the site/sponsor relationship, resulting in the dreaded “one and done” mentality for many sites. However, leveraging a purpose-built technology solution can remove such concerns by ensuring reliable cycle times, efficient processing, real-time reporting, and transparency, all of which drive site satisfaction and simplify the lives of study teams. This session will highlight best practice technology and process models to ensure you achieve your site payment objectives.

8:15 Session Break

REACHING PATIENTS AND IMPROVING RECRUITMENT OPERATIONS USING EXISTING AND/OR INNOVATIVE TOOLS

8:25 Chairperson’s Remarks

Kevin Hudziak, Innovation Lead, Clinical Innovation, Eli Lilly & Company

8:30 Deploying Patient Recruitment Websites: Behind the Scenes in Big Pharma

Paul_WhiteheadPaul Whitehead, Ph.D., Head, Early Development Workflows, Roche

This talk will focus on the efforts that go into getting a patient recruitment website progressed from a study team request to production deployment. There are many factors to consider when deploying a new trial recruitment website in a global organization, these will be discussed, and strategies to reduce the effort will be presented.

8:55 Increasing Enrollment While Reducing Sites

Daniel Brunwasser, Associate Director, Marketing Operations, Consumer Marketing, Acurian

After decades of delayed trials, sponsors still face slow site setup and poor patient enrollment completing clinical studies on-time and on-budget. The traditional site-based model suggests that the more sites activated, the more patients and faster completion time happen. These delays prove that model lacks the productivity to move the chains, threatening time-to-file and time-to-market. Sponsors are now following a new model of enrollment and budget certainty built on reducing sites/countries for faster patient enrollment.

9:20 Lessons Learned from Rare Disease Trials: Community, Engagement, Recruitment and Retention

Marisa_RackleyMarisa Rackley, Director, Clinical Research Operations, Vertex Pharmaceuticals, Inc.

Although late-phase costs of conducting orphan drug development are smaller when compared to non-orphan drugs, rare disease clinical trials encounter many challenges in patient recruitment and retention. What lessons can experts in trial planning and operations learn, whether they are running rare or non-rare disease trials, and apply to improve engagement, recruitment and retention?

9:30 SCOPE’s 2018 Participant Engagement Award

Designed to inspire innovation and change in how the industry communicates with participants in the fields of recruitment and retention in clinical trials, this award embodies the values and personal accomplishments of Jerry Matczak, who sadly passed away soon after receiving the 2017 award. We dedicate this award to Jerry in the hopes that it will serve as a reminder of his ideals and accomplishments. Join us as Sites, CRO’s, e-Patient Advisors, Agencies, Start-Ups, and Sponsors present their elevator pitch on how they have raised the bar in engagement with potential study participants. This light hearted approach to a serious subject allows attendees a look into the latest innovations that put study participants first. Proud to announce 2018 Finalists:

Greenphire - Hope for Houston
Clara Health - Breakthrough Crew: Demystifying Clinical Trials Alongside Patient Advocates
GRYT Health Inc - Empowering patients t
o connect with peers and new treatment options
Brite Health - Improving patient experience, compliance, and retention using data-driven technology
mProve Health with Pfizer - Patient Engagement Hub


Learn More

Event Designers:

Kelly_McKeeKelly McKee, Advisor, Clinical Innovation, Eli Lilly and Company; Co-Creator of the SCOPE Participant Engagement Award


David_SallDavid Sall, President & CEO, Patient Enrollment Advisors; Co-Creator of the SCOPE Participant Engagement Award


Jeri_BurtchellJeri Burtchell, Director, Patient Initiatives, HealthiVibe, LLC


Shwen GweeShwen Gwee, Head of Digital Strategy, Global Clinical Operations Biogen


Angela_RadcliffeAngela Radcliffe, GM, Clinical Trial Solutions, PulsePoint


Micah_LiebermanMicah Lieberman, Executive Director, Conferences, Cambridge Healthtech Institute (CHI)


10:10 Coffee Break in the Exhibit Hall

INSIGHTS FROM SPONSORS: PATIENT OPINION LEADER (POL) ADVISORY PANEL & ONCOLOGY PATIENT RECRUITMENT

11:10 Chairperson’s Remarks

Rick Ward, Vice President, Commercial Operations, Trifecta

11:15 CO-PRESENTATION: Creating A Successful Patient Opinion Leader Steering Committee

Lynn_HaggerLynn Hagger, Ph.D., Patient Engagement Director, Respiratory, INA & CVMD, Global Medical Affairs, AstraZeneca


Abbe_SteelAbbe Steel, CEO, HealthiVibe, LLC

As pharma struggles to turn the concept of patient engagement into more than just a feel-good catchphrase, there is a growing trend to partner with patients in a more meaningful way to impact development throughout the drug life cycle. In response to this growing need, AstraZeneca developed a Patient Opinion Leader (POL) Advisory Panel – a collaborative group of patients and caregivers possessing not only the knowledge of living with their health condition, but also having expertise in a variety of subjects that intersect nicely with pharma to result in more valuable insights than the average patient could provide.

11:40 Oncology Patient Recruitment: Sponsor Insights

Archana_SahArchana Sah, Therapeutic Area Leader, Oncology, Genentech, Inc.

In today’s US landscape in oncology drug development, the competitive marketplace compels sponsors to be more predictive in their enrollment planning. About 80% of clinical trials do not recruit on time and about 30-40% of sites are low productive sites. This presentation will focus on recruitment planning in oncology studies with recommendations on tactics from landscaping through LPI for a more predictive recruitment planning.

12:05 pm Session Break 

IQVIA12:10 Bridging Luncheon Presentation: Taking Patient Recruitment into the Next Generation of Clinical Development

Kimberly Ray, Vice President, Site and Patient Networks, IQVIA

Using real-world insights to drive better Site identifications. Understanding Site and PI capabilities to drive ideal patients. The importance of communication and advocacy groups to drive engagement and retention.

12:50 Coffee and Dessert Break in the Exhibit Hall

1:30 Close of Conference

Melissa DolenGroup Discounts Are Available! Special rates are available for multiple attendees from the same organization. For more information on group discounts, contact Melissa Dolen at 781-972-5418 or mdolen@healthtech.com.


 

2018 SCOPE Conference at a Glance


 

For questions or suggestions about the meeting, contact:

MicahMicah Lieberman
Executive Director, Conferences
Cambridge Healthtech Institute (CHI)
T: (+1) 541.482.4709
E: mlieberman@healthtech.com

For partnering and sponsorship information, contact:

IlanaIlana Quigley
Senior Manager, Business Development
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5457
E: iquigley@healthtech.com

For media and association partnerships, contact:

RichRich Handy
Senior Director, Marketing
Cambridge Healthtech Institute (CHI)
T: (+1) 781.972.5456
E: rhandy@healthtech.com

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In Memory of Gerald “Jerry” Matczak
Matczak Jerry

Gerald “Jerry” Matczak, lead consultant in clinical innovation at Eli Lilly & Co., was a rare breed in the pharmaceutical world, someone who not only embraced social media, but also listened to activist patients. He has been a part of the SCOPE conference since its inception and won the Patient Engagement Award on Wednesday, the day before his passing. Matczak died suddenly on Feb. 2 at age 54. We will all miss him.

– Cambridge Healthtech Institute (CHI)