2019 Agenda

  • 8:00 am

  • Registration and Morning Coffee/Tea

  • 8:30 am

  • Co-Chairs' Opening Remarks

    State of the Movement: What are the Sustaining Facets to Integrate Clinical Research as a Care Option (CRAACO) and Identify Treatment Gaps for Patients

    CRAACO co-chairs open the program addressing:  

    • Health systems and pharma share the common goal of serving patients and want a future of more care options.
    • Pharma wants to advance new therapies
    • Challenges include:
      • Access and healthcare disparity
      • Inequities in research  
      • Broader community engagement


    Jeff James

    CEO, Wilmington Health


    Sarah Larson

    Director of Global Clinical Operations, Biogen and Cancer Veteran

  • 8:45 am

  • Understanding the Goals of Care vs Research

    • Goals for care vs goals for research
    • Oversight and governance
    • Is there an ethical burden of breaking down the line between research and care?
    • What is the hesitation behind embracing the blurring of this boundary?
    • In areas like precision medicine, this is already blurring, how to manage?
    • Hurdles stopping large companies from thinking about this– Is it practical? Ethical?

    Moderated by:

    Jennifer Byrne
    Jennifer Byrne

    CEO and Founder, Javara

    Panelists:

    Gregory Burke
    Greg Burke, MD, MSc
    Chief Science Officer, Senior Associate Dean for Research, Wake Forest School of Medicine


    Amy Nordo

    Director eSource Implementation, Pfizer

  • 9:10 am

  • 🔑Keynote: Surgeon’s Perspective on Integrating Clinical Care and Clinical Research

    Dr Laura Esserman, the architect behind the I-SPY 2 TRIAL™ has achieved remarkable progress with this clinical trial in improving the outcomes of early stage, breast cancer for patients who are at high risk for early recurrence. I-SPY 2 is also impacting far beyond breast cancer by increasing efficiencies that promise to accelerate the development and delivery of more effective therapies for other cancer types and a range of other diseases. This would not be possible with out the integration of care and research. In this keynote session, hear this surgeon’s view on the future of integrating care and research.


    Laura Esserman, MD, MBA

    Director, UCSF Carol Franc Buck Breast Cancer Center; Alfred A. de Lorimier Endowed Chair in General Surgery; Professor of Surgery and Radiology, UCSF

  • 9:40 am

  • Grand Opening of the Exhibit & Networking Café

    • Meet the Exhibitors
    • Breakfast
    • Charge up at the CRAACO Charging Station
    • Tables for one-on-one meetings
  • 10:20 am

  • New Models of Clinical Research

    • Why CRAACO is beneficial in a broad way beyond individual academic centers
    • Where does CRAACO sit in the broader contextualized world?

    Moderated by:


    Craig Lipset, MBA

    Head of Clinical Innovation, Pfizer, Inc

    Panelists:


    Irfan Khan, MD

    CEO and FounderCircuit Clinical


    Joseph Kim, MBA

    Senior Advisor, Patient Experience and Design Innovation Design Hub Foundations, Eli Lilly & Company


    Kelly McKee

    Head, Patient Recruitment, Rare Diseases, Vertex Pharmaceuticals

  • 10:40 am

  • How Sanford Health Systems Integrated Clinical Care and Clinical Research - Going from 3% of Patients in Clinical Trials to 10% in 8 years: Case Study

    • Creating a system for all providers to work seamlessly
    • Educational programs and continual training across all areas of care and specialties for trial offerings
    • Identifying gaps in trial availability
    • Attracting providers who are interested in clinical research for their patients
    • NCORP site


    Lora Black

    Senior Director of Clinical Research, Sanford Health Systems

  • 11:10 am

  • Patient Impact with Advocacy and Data-driven Recruitment Support


    Katie Shaw

    Director, Global Patient & Site Solutions, Design & Delivery Innovation, IQVIA

  • 11:30 am

  • How to Invest in the Power of Patient Data through AI

    Medical data belongs to the people who generate it, so how can we harness the power of patient data as an asset of great value for the benefit of all stakeholders in clinical research? Doc.ai and their strategic partner discuss:

    • How do you use, leverage, and package data on a large scale to create predictive models?
    • New frameworks to catalyze new tools and models of data
    • Enabling patients to collect their real-world data
    • Creating a safe and secure feedback loop of shared data


    Shervin Kamkar

    VP, Business Development, doc.ai

  • 11:45 am

  • Pfizer’s Collaborative Approach with a Healthcare System to Integrate Clinical Research into Clinical Care


    Munther Baara

    Head, New Clinical Paradigm, Pfizer

  • 12:10 pm

  • How to Integrate Industry Sponsored Clinical Trials Into Your System to Give Patients the Best Options

    • How to build your programs
    • How to become and integrated care & research organization
    • How to integrate clinical research into your care system
    • Case study: University of Buffalo-Roswell Park and TrialScout’s strategic partnership


    Irfan Khan, MD

    CEO and Founder, Circuit Clinical


    Doug Plessinger

    Chief Clinical & Scientific Development Officer, Roswell Park/GBCT

  • 12:30 pm

  • Addressing Barriers Health Systems Face in Integrating Clinical Care and Clinical Research

    • Financial barriers – Speaking to administration’s bottom line
    • Historical barriers – Who are the key stakeholders that need to be converted into believers of the CRAACO movement?
    • Logistical issues – How can we make study startup a more streamlined process?
    • Culture change – Onboarding an outside group nested into an existing infrastructure
    • Does adding the offering of clinical trials disrupt the ability of the physicians in the clinics to have appropriate patient flow?
    • How do you offer patients the options of clinical research?
    • Insight from the front line of physicians seeing patients

    Moderated by:


    Lora Black

    Senior Director of Clinical Research, Sanford Health Systems

    Panelists:

    Gregory Burke
    Greg Burke, MD, MSc
    Chief Science Officer, Senior Associate Dean for Research, Wake Forest School of Medicine


    Adrian Hernandez, MD, MHS

    Vice Dean for Clinical Research, Duke University School of Medicine

  • 1:00 pm

  • Lunch & Networking

    • Meet the Exhibitors
    • Lunch
    • Charge up at the CRAACO Charging Station
    • Tables for one-on-one meetings
  • 2:00 pm

  • Weighing Your Options in Considering Clinical Research from a Patient Perspective

    • Strategies and ideas to reduce the burden to patients
    • Understanding of clinical care with their physician?
    • Communication, consent and data sharing

    Moderated by:


    Cindy Geoghegan

    Cancer Veteran, Patient Advocate

    Panelists:


    Allison Greiner

    Patient Advocate


    Sarah Larson

    Director of Global Clinical Operations, Biogen and Cancer Veteran


    Kelly Piacsek, PhD

    VP, Patient Centered Research, Aurora Research Institute

  • 2:30 pm

  • How Can Patient Advocacy Play a Role in Connecting Clinical Care and Clinical Research?

    • How can patient advocacy groups better educate their patients and caregivers on the advantages of participating in clinical research?
    • How can patient advocacy help demystify the clinical research process?
    • What is the patient advocacy perspective on integrating clinical care and clinical research?
    • How does patient advocacy work with health systems and pharma? What are the commonalities and obstacles to bridging this gap?

    Moderated by:


    Sarah Larson

    Director of Global Clinical Operations, Biogen and Cancer Veteran

    Panelists:

    Albert Rizzo-bw
    Albert A Rizzo, MD, FACP, FCCP

    Chief Medical Officer, American Lung Association


    Joy Rusthoven

    Executive Director, SURVIVEiT


    Lilly Stairs

    Patient Advocate, Head of Growth & Partnerships, Savvy Cooperative

  • 3:00 pm

  • Effectively Democratizing Access to Clinical Trials for All

    Making clinical research a care option is the ultimate opening of access to clinical trials.

    • Current state of affairs: Gross underrepresentation of minorities 5-6% are represented in trials, but it should be closer to 40%
    • What are the barriers to opening access?
    • How can we educate underserved communities about clinical research?
    • What are we doing to overcome this?
    • Does offering these care options enhance access in a broad sense?

    Moderated by:


    Jennifer Sheller, MPH

    Regional Head, North America, Merck

    Panelists:

    Jonathan Jackson
    Jonathan Jackson, PhD

    Director, CARE Research Center, Massachusetts General Hospital

    Cynthia Verst
    Cynthia Verst, PharmD

    President, Design and Delivery Innovation, IQVIA

  • 3:30 pm

  • Afternoon Networking Break

    • Meet the Exhibitors
    • Ice Cream
    • Charge up at the CRAACO Charging Station
    • Tables for one-on-one meetings
  • 4:00 pm

  • At the Starting Stages: Creating Infrastructure to Provide Outstanding Clinical Research

    • Having providers understand what’s in it for them
    • How do we keep a repository so we can all learn from the experiences we require?
    • How to create the infrastructure? Where to start?  
    • How do we understand how a physicians’ involvement in clinical care translates into revenue for the healthcare system?

    John Stewart
    John H Stewart, IV, MD, MBA, FACS

    Physician Executive for Oncology Services, University of Illinois Health

  • 4:25 pm

  • Using Research Networks to Support Clinical Research As a Care Option

    Members of the CTSA Consortium discuss the strategies that are being implemented broadly and in their individual institutions in order to provide clinical research opportunities to providers and communities, including:

    • Building Infrastructure through the Trial Innovation Network
    • PBRNs and CDRNs
    • Pragmatic Research: The Site Experience with the ADAPTABLE Trial

    Schuyler Jones
    Schuyler Jones, MD

    Associate Professor of Medicine, Duke University and Duke Clinical Research Institute


    Jamie Roberts, MPH, MA, CCRP
    Director, Clinical Research Networks, Duke Clinical Translational Science Institute (CTSI)


    Dixie D Thompson, BSN, RN

    Executive Director, CCTS Liaison Team, Utah Center for Clinical & Translational Science, Utah Trial Innovation Center

  • 4:50 pm

  • Leveraging EHR Data in Clinical Research

    • Regulatory changes and new standards to enable the use of EHR
    • How data passes from one environment to the other (EHR to EDC) 
    • Institutional hurdles to widespread adoption 
    • Brief Demo


    Hugh P Levaux, PhD

    CEO and Founder, Protocol First 

  • 5:00 pm

  • Building an Interoperable Data Network to make Patients the Brokers of Their Own Data

    Patients being able to control the use of their own data will become an important part of the definition of patient centricity, but it is going to take more than effective EMRs to make patients the true brokers of their own data. The Center for Medical Interoperability (CMI) is a neutral authority that is in the process of building critical national infrastructure that will streamline the sharing of digital healthcare data at all levels of care.

    • What future capabilities will healthcare demand from its supporting technology?
    • Why don’t we have ability to exchange/share/automate information among technologies (ex. EMRs, medical devices, software applications, databases, etc.)?
    • How have other industries achieved interoperability and data liquidity among technologies? Examples from finance, airlines, cable/ telecommunications industries
    • How does the absence of a standardized platform-based infrastructure impede innovation and contribute to the continual fragmentation of healthcare?
    • Is there a better way to design and structure our technical underpinnings so as to deliver benefits to all stakeholders? Is this scalable?
    • What does it mean to build the digital system around the person?

    Meredith Karney
    Meredith Karney

    VP, Health Economics and Value, Center for Medical Interoperability

  • 5:20 pm

  • Networking Reception

    Hosted by:

2019 Agenda

  • 8:15 am

  • Morning Coffee/Tea

  • 8:45 am

  • Co-Chairs Opening Remarks


    Jeff James

    CEO, Wilmington Health


    Sarah Larson

    Director of Global Clinical Operations, Biogen and Cancer Veteran

  • 9:00 am

  • Best Practices in Advancing Site Based Research


    Mark King

    VP, Research & Innovation, Novant Health

  • 9:10 am

  • Building an Infrastructure for the Integration of Care and Clinical Research with Consortia from Philadelphia, El Paso, and Chicago

    These consortia representing three geographic regions are taking steps to normalize clinical research within their respective health systems. They will discuss the aspirations, barriers, and processes of implementing these initiatives, including:

    • Interoperability of information systems
    • Availability for manpower
    • Practitioners having and making the time for research

    Moderator:


    Mark King
    VP, Research & Innovation, Novant Health

    Panelists:


    Joshua J Jacobs, MD

    Head of Research, Rush University Medical Center


    Emma Schwartz, MPH

    President, Medical Center of the Americas Foundation


    David Whellan, MD, MHS, FACC, FAHA, FHFSA

    Senior Associate Provost Clinical Research, COO, Thomas Jefferson University, PIER Consortium

  • 9:40 am

  • Networking Café, Morning Break

    • Meet the Exhibitors
    • Breakfast
    • Charge up at the CRAACO Charging Station
    • Tables for one-on-one meetings
  • 10:15 am

  • How to Offer More Options to Patients without the Administrative Burden- Making Clinical Research the Rule, Not the Exception

    • How are we ingraining this into the investigators and education of investigators?
    • Building awareness across the whole medical landscape – between patients, physicians and the community – to make processes go faster
    • Educating leaders and staff working to get therapies up and running
    • Can we get trials open and physicians engaged in a timely manner?

    Moderated by:


    Denise Snyder, RD, MS, LDN

    Associate Dean for Clinical Research, Duke University School of Medicine

    Panelists:


    Karin Gulbrandsen

    Senior Director, US Country Head, Global Clinical Operations, Janssen R&D


    Lani Hashimoto

    Clinical Program Benchmark Manager, Novartis


    Kelly Piacsek, PhD

    VP, Patient Centered Research, Aurora Research Institute


    Jennifer Sheller, MPH

    Regional Head, North America, Merck

  • 10:40 am

  • Challenges and Insights in Advancing CRAACO Concept in Health Systems

    A joint effort from the partnership between Center for Digital Health (CDH) at Yale, and the Network of Digital Evidence in Health (NODE.Health) focused on supporting and advancing Clinical Research as a Care Option (CRAACO). This session aims to discover barriers to clinical trials engagement and administration as well as what obstacles need to be removed for busy clinicians to facilitate patient participation in clinical research. 

    Results of this research intend to explore how digital health and EMR integration tools might eventually be transformed into a comprehensive collaboration platform to generate evidenced-based data in influencing decision making in CRAACO. Moreover, the survey report will provide insight into how to develop programs that support patient education, engagement and enrollment in clinical research. On a higher-level, this study hopes to continue to enhance relationships between sponsors and health systems to increase collaboration in clinical research.


    Greg Licholai, MD

    Faculty, Yale School of Management


    Yauheni Solad, MD, MHS

    Medical Director, Digital Health and Telemedicine, Yale New Haven Health

  • 11:00 am

  • Case Study: How Wilmington Health is Streamlining the Processes behind the Integration of Clinical Care and Research to Reduce the Burden to Patients and Investigators

    • Going from a fragmented patient journey to a streamlined one
    • How to take the patient experience to “just making it another visit type”
    • How to take study protocols and make them more native to EMR
    • General best practices for streamlining the process for patients and investigators
    • What it took to actively normalize the flows and processes of clinical research


    Jeff James

    CEO, Wilmington Health

  • 11:20 am

  • Virtual Trials: Reducing the Burden of Clinical Research to Create More Effective Care Options, but How?

    • How are virtual trials, telemedicine, and remote monitoring affecting the integration of clinical research into clinical care?
    • Where is the overlap within the community and what are the implications?
    • How to get started and what to expect and challenges?
    • Next steps
    • Thoughts on the future of virtual trials in healthcare?

    Moderated by:


    Craig Lipset, MBA

    Head of Clinical Innovation, Pfizer, Inc

    Panelists:


    Michelle Longmire, MD

    CEO and Co-founder, Medable


    Larsson Omberg

    VP, Systems Biology, Sage Bionetworks

  • 11:45 am

  • Company Spotlight: Complion

    The Power of eRegulatory to Transform Clinical Operations


    JT Tan
    Sponsor/CRO Innovation Lead, Complion

  • 11:55 am

  • Lunch & Networking

    • Meet the Exhibitors
    • Lunch
    • Charge up at the CRAACO Charging Station
    • Tables for one-on-one meetings
  • 1:00 pm

  • Changing the Way You Think About Clinical Research: Developing Competency Standards for PIs

    • How are these standards established?
    • What are we doing to propagate the use of them?
    • Helping career development and training
    • Pushing to get stakeholder buy-in for these competencies through the Workforce Innovation Steering Committee

    Moderated by:

    Jim Kremidas
    Jim Kremidas

    Executive Director, ACRP

    Panelists:


    Christina Brennan, MD, MBA

    VP, Clinical Research, Northwell Health

    John Stewart
    John H Stewart, IV, MD, MBA, FACS

    Physician Executive for Oncology Services, University of Illinois Health

  • 1:20 pm

  • Working through Payer Realities

    Payor representation will join Jeff to have a frank discussion on:

    • Understanding financial risk
    • Infrastructure needed
    • Value based systems and the effect on payment
    • Expanded access
    • Formularies and coverage

    Moderated by:


    Jeff James

    CEO, Wilmington Health

    Panelists:


    Van Crocker

    President, Healthagen a division of Aetna

    Neil Shah
    Neil Shah, PharmD
    Specialty Pharmacist, Blue Cross Blue Shield North Carolina
  • 1:45 pm

  • The Need for an Internal Advocate: How Can Clinical Research Professionals bring CRAACO into Clinical Operations?

    In this session, participants will receive an insider’s view of how being an advocate within pharma for patients and sites can benefit clinical trial awareness, participation, and experiences.


    Kelly McKee

    Head, Patient Recruitment, Rare Diseases, Vertex Pharmaceuticals

  • 2:00 pm

  • What can Pharma Do to Make it Easier for Health Systems to Collaborate for the Integration of Clinical Care and Clinical Research to Give Patients Best Options?

    • How does pharma work with a healthcare system so that they can get patients into treatment before the disease progresses and expand the program in an ethical, supportive, sustainable way?
    • If pharma and health systems cannot make this integration possible in a place where there is such a need for it, where will it happen?

    Moderated by:


    Ülo Palm, MD, PhD

    SVP, Global Drug Development Operations, Allergan

    Panelists:


    Bree Burks, RN, MSN, CCRP
    Senior Director, Vanderbilt Coordinating Center, Vanderbilt Institute for Clinical and Translational Research


    Sean Cunningham, MBA

    Director, Strategic Account Lead, Global Clinical Operations, Janssen Research & Development

  • 2:30 pm

  • Group Activity Call to Action: What are the Solutions to Ensuring CRAACO is Sustainable, Effective, and Achieving Intentional Goals

    Mary Hennings
    Mary Hennings

    former VP, Market Planning Innovation and Implementation, BCBS Massachusetts, Mary N. Hennings, Consulting LLC

    Joseph Ternullo
    Joseph Ternullo, JD, MPH

    Vice Chair, Immediate Past President, Society for Participatory Medicine

  • 3:15 pm

  • Conference Concludes