Cambridge Healthtech Institute's 4th Annual

Patient Recruitment

Data-Driven, Patient-Centric Approaches to Patient Recruitment

May 13-14, 2019


Delays in patient recruitment can set back drug development by years and millions of dollars. Effective patient recruitment plans that leverage the latest analytics and technologies, as well as involve patient insight, are critical to successful clinical trials. CHI’s Patient Recruitment conference features best practices and case studies on successful patient engagement and recruitment using novel, patient-centric and data-driven approaches.

Final Agenda

Monday, May 13

7:25 am Conference Registration and Morning Coffee

Essex North

8:25 Chairperson’s Opening Remarks

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

8:30 Clinical Trial Enrollment Prediction: Data Models, Action, and Impact

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

Data analytics and enrollment modeling capabilities are being explored to establish more accurate clinical trial milestones. Without fail, each study is unique in execution and appears to slowly deviate from the plan. Instead of waiting to hit or miss these milestones, can we effectively predict our future performance and better understand which operational variables are contributing to the deviation from the plan much earlier? Join us for a discussion to address this question and review the operational actions that most significantly impact performance.

9:00 Reimagining Patient Recruitment

Jane Fang, MD, Head, Clinical Business Management & Analytics, MEDI Biologics Unit, AstraZeneca

The competition for right clinical trial participants is at an all-time high, especially true for precision medicine driven trials involving oncology and rare diseases. Trial recruitment has to go beyond traditional site centric approach that relies on obsolete site questionnaires. Patient-centric recruitment approach empowered by advanced data analytics of real world evidence data and trial intelligence information will provide deep insights of targeted patient population and treatment pathway for precision recruitment. The new way of patient recruitment leveraging Electronic Health Records (EHR) network platforms is also calling for new business capability in industry to bridge the worlds of healthcare providers and biopharma companies. The talk will share case studies and examples in exploring patient-centric recruitment driven by RWE and data analytics.

9:30 Leveraging Real World Data through Evidence Generation for Clinical Trial Optimization

Farhan (CJ) Hameed, MD, MS, Senior Director, Global Real World Evidence Center of Excellence, Patient & Health Impact, Pfizer Inc.

Changing external environment such as passage of the 21st Century Cures Act has become a key driver for the industry to build an innovative operative model for regulatory grade evidence generation. An integrated approach to bring Randomized Clinical Trial (RCT) and evidence generated through Real World Data (RWD) together can provide the opportunities from identifying the trial population, recruitment, effectiveness prediction, trial optimization and several other growing Real World Evidence (RWE) opportunities to improve the clinical trials execution and value generation across the organization.

10:00 Networking Coffee Break

St. George CD

10:30 Update of Data-Driven Recruitment with RWD and Advanced Analytics (e.g. Machine Learning) at Roche pRED

Liping Jin, Data-Driven Recruitment Lead, Pharmaceutical Research & Early Development, Roche

There has been an increase in use of Real World Data (RWD) and advanced analytics (e.g. machine learning) in the industry. On behalf of our Data-Driven Recruitment (DDR) team at Roche Pharm Research & Early Development (pRED), I would like to provide an update on our effort of integrating RWD with metrics data to optimize study protocol design and target patient recruitment strategy. The team has received positive feedback from our stakeholders and we have seen significant business impact. At the same time, I would also like to share the challenges of expanding the use of RWD in international settings and the potential of advanced analytics (e.g. machine learning) for the site prediction at our organization.

11:00 Optimizing Recruitment and Retention by Creating the Patient Experience of the Future

Anne Marie Inglis, PhD, Senior Director, Global In Country Clinical Operations, GSK

TransCelerate has been developing solutions to allow patients to easily find trials, understand studies and provide consent, participate in trial information exchange, utilize electronic medicine labels, provide feedback on their trial experiences, and ultimately own their digital medical records. Specifically, the session will explore the learnings, available tools, and industry impact that are being achieved by the following initiatives: Clinical Research Access & Information Exchange, Patient Technology, eConsent, eLabels, and eSource.

11:30 Sponsored Presentation (Opportunity Available)

12:00 pm Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

12:45 Session Break

St. George CD

1:25 Chairperson’s Opening Remarks

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

1:30 Physician Referral Programs: Case Studies of Innovative Pilots to Enhance Patient Recruitment

Charity Roddy, MBA, Senior Manager, Feasibility Enrollment Retention Optimization (FERO), Global Clinical Operations, Biogen

As recruitment for clinical trials becomes increasingly challenging, many sponsors and vendors are looking at innovative ways to support sites and help generate quality referrals for potential participation in studies. A large number of patients rely on their physician(s) to provide information on options for disease treatment, yet referrals to clinical trials from GPs and specialists continues to be lower than expected. This talk will explore why that may be while presenting three case studies of pilot programs aimed at addressing the unique challenges that may prevent physicians from referring patients to clinical trials.

2:00 Improving Patient Recruitment and Retention by Pushing Beyond Patient Centricity

Evan Ehrenberg, Co-Founder, CEO, Clara Health

2:30 Grand Opening Refreshment Break in the Exhibit Hall

3:15 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.

4:15 Welcome Reception in the Exhibit Hall

5:30 Close of Day

5:30 Dinner Short Course Registration

6:00-9:00 Recommended Dinner Short Course

SC1: Central Monitoring Deconstructed from Raw Data to Monitoring Actions: An In-Depth Walk Through

Tuesday, May 14

7:25 am Morning Coffee

Innovative Methods to Enhance RECRUITMENT AND RETENTION
St. George CD

7:55 Chairperson’s Opening Remarks

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

8:00 Keeping It Real

Linnea Olson, Lung Cancer Patient Advocate

8:30 Interactive Group Exercise: Solving Enrollment Issues

Essex Center

9:00 Interactive Group Discussion: The Intersection of Patient Recruitment and Study Sites

IQVIA 9:30 Leveraging Predictive Analytics to Enable Predictable Study Operations

Mark Springer, Associate Director, Consultative Services, IQVIA Technologies

Clinical supply budgets remain a big area of untapped potential efficiencies for both sponsors and CROs. While suppliers have focused on improving accuracy of their estimates, it’s usually in isolation and is often impacted by unexpected activities of upstream stakeholders. This session will share details of a collaborative approach that allows a clinical supply organization to leverage existing clinical technology for enrollment and timeline planning to inform their supply strategy.

10:00 Coffee Break in the Exhibit Hall

Essex North & Center

10:45 PLENARY KEYNOTE SESSION: Enabling Patient-Centric Clinical Trials

10:45 Chairperson Remarks: Patient-Centric Trials: How to Engage the Patients in a Clinical Study

Basker Gummadi, IT Strategy & Digital Transformation, Digital Innovation, Bayer U.S. LLC

Basker will share the results of the patients’ interaction and what is important to them and what keeps them engaged in a trial. He will also share his personal vision of how Digital technologies can help in this space.

10:55 KEYNOTE PRESENTATION: Patient-Centric Trials: Moving from What’s the Matter with Patients to What Matters to Patients

Lisa Shipley, Vice President, Global Digital Analytics, Merck

The overall percentage of potential patients that participate in clinical trial is very low. Engaging patients and removing barriers to patient participation in clinical trials is critically important to the development of new therapies to improve human health. Digital technologies are poised to improve patient participation and experience and shift from a site-centric to a patient-centric model. Pharmaceutical companies and CRO’s are exploring a number of different paradigms deploying technologies such as, telemedicine, wearables, and home-sampling.

11:15 KEYNOTE PANEL DISCUSSION: Going Virtual – Moving towards Patient-Centric, Site-Less Trials

Lisa Shipley, Vice President, Global Digital Analytics, Merck


Linnea Olson, Lung Cancer Patient Advocate


Laura Whitmore, Director, R&D Innovation, Corporate Projects, Otsuka


SHOGREN_MICHELLEMichelle Shogren, Head of Innovation in Portfolio and Operations, Pharma Development, Bayer


With the rise and integration of new technologies into clinical trials – mHealth, wearables, sensors, the internet of things – there is an unprecedented opportunity for revolutionizing how the industry performs clinical trials. New technology can help move clinical trials from sites directly into patient homes.

  • Virtual trials, decentralized trials, remote trials, site-less trials: What are we all talking about?
  • What are the latest successes and failures?
  • What are the barriers and challenges? How is the industry leveraging technology to make this a reality?
  • What are patients saying about their experience with virtual trials?
  • What does this mean for the future of clinical trials?

11:50 KEYNOTE PRESENTATION: Prescription of Digital Therapeutics: The Time has Arrived!

Atreja_AshishAshish Atreja, MD, MPH, FACP, Chief Technology Innovation and Engagement Officer, Medicine, Icahn School of Medicine at Mount Sinai


12:20 pm Networking Lunch & Dessert Break in the Exhibit Hall

1:20 Close of Conference. Stay on to Attend Patient Engagement & Retention.

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From the Producers of SCOPE