4th Annual

Integrating Clinical Care and Clinical Research.The Future of Healthcare Options.

Organized by the Conference Forum | Follow us on Twitter @ConferenceForum #CRAACOWWW.THECONFERENCEFORUM.ORG

Lead Sponsor Executive Sponsors

Hilton Raleigh North Hills, Raleigh, NC July 13-14, 2020

Clinical Research As A Care Option

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CLINICAL RESEARCH AS A CARE OPTION AGENDA

DAY ONE - MONDAY, JULY 13, 2020

8:30 am Co-Chair’s Welcome and Opening Remarks on Integrating Clinical Research and Clinical Care for the Benefit of Patients

8:45 am Keynote Presentation

9:15 am How Changing a Policy is Raising Awareness on Both the Clinical Research and Care Sides, Bolstering More Research Options for Patients • How Changing Duke’s Clinical Research Policy from No Cold-

Contact to Opt-Out is tackling one of the biggest challenges of CRAACO: lack of awareness between the Clinical Research area and the Clinical Care area

• The coming together of Duke’s Office of Clinical Research and the Duke University Health System to integrate Research and Care

• Integrating a culture of Care in Research and Research in Care

Denise Snyder, RD, MS, LDN Associate Dean for Clinical Research, Duke University School of Medicine

9:40 am Grand Opening of the Exhibits & Networking Café Graciously hosted by:• Breakfast • Meet the Exhibitors• Networking

10:20 am Industry Perspective: How BMS is Educating Diverse Patient Groups to Raise Awareness of Clinical Trials and More Options for Patients In this session, BMS shares the following:• Directing outreach to diverse groups of patients that better

match the epidemiology of diseases• Ensuring patients are armed with information about access to

clinical trials and certain diseases at a level that they want to hear it

• Educating patients and being culturally sensitive for patients in various socio-economic groups

Sharon HanlonHead of Clinical Trial Engagement & Contract Management, Bristol-Myers Squibb

10:45 am Patient Perspective: Creating Trustworthiness: Addressing Cultural Aspects and Changing Patient Perspectives on Research Rebekah Angove, PhD VP, Evaluation and Patient Experience, Patient Advocate Foundation

Colin GernerPresident and Co-Founder, StacheStrong

11:10 am Including Patients as Partners in Research and Identifying Areas for Improvement Adrian Hernandez, MD, MHS Vice Dean for Clinical Research, Duke University School of Medicine

Rosa Gonzalez-Guarda, PhD, MPH, CPH, RN, FAANAssociate Professor, Dorothy L. Powell Term Chair of Nursing, Duke University School of Nursing / Co-Director of Community Engaged Research Initiative (CeRi), Duke University Clinical & Translational Science Institute (CTSI)

11:40 am Operationalizing CRAACO within Clinical Trial Teams to Go From Strategy to Implementation? Kelly McKeeHead, Patient Recruitment, Rare Diseases, Vertex Pharmaceuticals

12:00 pm Best Practices for Pharma and CROs to Partner With IROs (Integrated Research Organizations) Moderated by:Jennifer ByrneCEO and Founder, Javara

Panelist:Keith Fernandez, MD Chief Clinical Officer, Privia Health

12:30 pm Wake Forest University on the Launch of their New Clinical Research Management Program to Help Unify Care and Research In this session, Wake Forest University provides an example in how they are making efforts to close the gap between care and research through their new Master’s program with a focus on the future of the clinical research landscape.Todd JohnsonVP, Wake Forest University withJennifer ByrneCEO and Founder, Javara

12:50 pm IQVIA Case Study

1:05 pm Lunch & Networking

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AGENDA CLINICAL RESEARCH AS A CARE OPTION

2:05 pm TRACK SESSION CHOICES

TRACK 1A

2:10 - 2:40 pm How Yale’s Patient-Centric Approach Grew Industry-Sponsored Research and Increased Participation from Underrepresented Communities Tesheia Johnson, MBA, MHSDeputy Director, Chief Operating Officer, Yale Center for Clinical Investigation

TRACK 1B

2:40 - 3:10 pmHow University of Kansas Medical Center Built Out Their Infrastructure and Workflow to Integrate Clinical Research and Clinical Care Katie Glavin, CCRP Clinical Research Coordinator, Department of Urology, University of Kansas Health Systems

TRACK 1C

3:10 - 3:40 pm Building a Robust Clinical Research Operation in an Outpatient, Ambulatory Setting: A Case Study In this session, Ms Herena will address how Briskin Center for Clinical Research — dedicated as a Comprehensive Cancer Center by the National Cancer Institute — has built up to be able to operationalize clinical trials in an outpatient, ambulatory setting. More specifically:• Processes and roles that help implement complex clinical trials • Creating tools that allow everyone to communicate in their

specific specialty• Assisting community practices in treating patients in clinical

trialsPamela Herena, MSN, RN, OCN Senior Director, Briskin Center for Clinical Research at City of Hope

TRACK 2A

2:10 - 2:40 pm How a Large Academic Medical Center is Connecting with Community and Smaller Hospital Care Centers to Provide Clinical Trials In this session, we discuss how Montefiore Medical Center is:• Raising clinical trial option awareness in the community

settings• Engaging patients• Building relationships with community hospitals to conduct

large scale studies• Working with medical device partnersGiora Weisz, MD Director of Interventional Cardiology, Montefiore Medical Center

TRACK 2B

2:40 - 3:10 pm How Holy Name Medical Center is Integrating Multiple Clinical Trials in a Community Hospital Care Setting In this session, Dr Barkama addresses how Holy Name Medical Center manages a faster startup process and high patient retention for a portfolio of more than 40 clinical trials. More specifically:• Utilizing a central research institute to support a wide range

of clinical trials• Engaging non-research physicians • Educating diverse groups of patients about researchRavit Barkama, MD, MPH Assistant VP, Clinical Development, Holy Name Medical Center

TRACK 2C

3:10 - 3:40 pm How Northwell is Increasing Patient Access to Clinical Research by Integrating Smaller Hospitals and Practices In this session, Dr Brennan will address how Northwell is expanding access and increasing flexibility to clinical research for patients by enabling patients to go to primary sites for initial enrollment and continue clinical trials at their preferred centers.Christina Brennan, MD, MBAVP, Clinical Research, Northwell Health

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CLINICAL RESEARCH AS A CARE OPTION AGENDA

3:40 pm Afternoon Networking Break

4:10 pm How Pfizer’s National and Global Collaborations are Making Clinical Research as a Care Option More Accessible • Lessons learned from Pfizer’s collaborations with academic,

community, and global health systems, as well as other companies

• Challenges Pfizer has faced in these global collaborations  • Update on Pfizer’s collaboration with Ochsner Health SystemAmy Nordo, MMCi, BSN, CPHQGlobal Product Development Strategic Partnerships, Pfizer

4:40 pm Progress on the First National Clinically Integrated Research NetworkJeff JamesCEO, Wilmington Health

5:00 pm Company Spotlights

5:30 pm Annual Networking Reception Graciously hosted by:

DAY TWO - TUESDAY, JULY 14, 2020

8:45 am Co-Chair’s Welcome and Recap

9:00 am Elligo Case Study

9:15 am UNC at Chapel Hill Update and Progress on Offering Clinical Research More Easily to Patients in Rural Settings and Helping PIs Start Up New Research How UNC established an Office of Research Support and Compliance focused on establishing research infrastructures and providing services and resources to support clinical research at each of the system’s hospitals.Laura VieraDirector, Clinical Research Operations, University of North Carolina at Chapel Hill

9:45 am How the Utah Center for Clinical & Translational Research is Partnering with Intermountain Healthcare, the Utah Department of Health and the VA Salt Lake City Health System to Achieve CRAACO Key discussion points include:• Expanding reach to 80% of Utah population• Integrating different EHRs and systems • Establishing a single IRB to support multi-center studies

Dixie Thompson, BSN, RNExecutive Director, CCTS Liaison Team, Utah Center for Clinical & Translational Science, Utah Trial Innovation Center

10:05 am Morning Break, Exhibits & Networking Café Opens • Breakfast • Meet the Exhibitors• Networking

10:45 am eSource for the Patient’s Sake eSource data (including EHRs, mobile devices and other forms of data that are collected and exchanged electronically) and the processes that are enabled through eSource data have wide-ranging potential benefits for patients.These include: • Opportunities to collect patient data through mobile devices

and sensors that facilitate patient participation in research (especially when ‘diary’ information is a part of the protocol);

• The use of real world data to augment clinical trial data for regulatory decision-making;

• Leveraging electronic health records for identifying patients eligible for clinical research;

• eSource documentation to streamline the research process from site to submission.

In this session, we discuss leveraging mobile devices, EHRs, eSource documentation and RWD to better manage patient data throughout the healthcare ecosystem.Moderated by:Rebecca Kush, PhDCSO, Elligo Health Research / President, Catalysis Research

Panelists:Sam Volchenboum, MD, PhD, MSDean of Masters Programs, Associate Chief Research Informatics Officer, Associate Director, Institute of Translational Medicine, UChicago Medicine

11:15 am Efforts and Progress to Reduce Burden to Patients with Flexible Clinical Trials Including the Use of RWE and Wearables Key discussion points:  • Update on efforts and progress• How is that data being pulled into research and healthcare? • What kind of clinical insights could this data have if it were

connected to a health system? • What is the role of wearable companies can have in

CRAACO?

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11:45 am Science37 Case Study with UCB

12:00 pm Inteliquet Case Study

12:15 pm Lunch & Networking

1:15 pm What Pharma Can Learn From Healthcare: What Challenges Already Have Solutions? In this session, the panelists discuss existing electronic infrastructures in healthcare that can be adapted and integrated into research and improve patient outcomes. More specifically:• Identifying solutions using existing electronic infrastructures

and regulations for patients to have access to research and providers to have access to patients 

• How to use this infrastructure to integrate research into the clinical workflow

• Aligning clinical research data collection with clinical care will improve both

Moderated by:Leslie Kelly HallFounder, Engaging Patient Strategy

1:45 pm Engaging Patients in Research Through Digital Innovation Moderated by:Jennifer Sheller, MPH Regional Head, North America, Merck

Megan McBride, MPHAssociate Director, Janssen Clinical Innovation, Janssen

2:15 pm Misaligned Incentives: Physician Perspectives on the Integration of CRAACO Moderated by:Craig Lipset, MBAFormer Head of Clinical Innovation, Pfizer

Panelist:Suzanne Steinbaum, DO, FACC, FAHA President, SRSHeart, Inc / Spokesperson, Go Red for Women, American Heart Association

2:45 pm Payor Panel

3:15 pm Group Activity Call to Action: Next Steps in Determining and Achieving CRAACO Goals

4:00 pm Conference Concludes

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