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Meeting Program

10th Annual AACI Clinical Research Initiative Meeting
Wednesday, July 11 Thursday, July 12
Loews Chicago O'Hare Hotel

Leveraging Change to Advance Cures for Cancer Patients

Wednesday, July 11, 2018
7:00 am

Meeting Registration Begins - Artist Foyer

7:00 am

Exhibits Open - Artist Foyer

7:00 am

Breakfast - Avedon Ballroom C/D

General Session
8:00 am

Welcome - Cassatt Ballroom
Janie Hofacker, RN, BSN, MS
Association of American Cancer Institutes

Carrie Lee, MD, MPH
UNC Lineberger Comprehensive Cancer Center
University of North Carolina at Chapel Hill

Stanton L. Gerson, MD
Case Comprehensive Cancer Center

8:15 am

Guiding Principles of Change - Cassatt Ballroom
By most accounts, the healthcare industry is facing a turbulent transformation, impacted not only by the policy changes directed at the industry but also the digital transformation that is affecting organizations across industries. The ability to successfully navigate constant change—and to help others do the same—is now a core competency for employees at all levels of organizations. What can managers do to help people weather the storm of constant change? In this address, Dr. Scott will share guiding principles of change, based on insights from research and cutting-edge practice in facilitating organizational change. Dr. Scott has more than 10 years of management and consulting experience in a variety of mid-sized, Fortune 500 companies, along with academic experience in program design and innovation. Dr. Scott has designed and taught courses on learning and performance improvement, leadership development and change management.

Kimberly S. Scott, PhD
Northwestern University

9:15 am

Clinical Research Initiative Strategic Plan Update - Cassatt Ballroom
As CRI approaches its 10th year, the time was right to reassess its goals to ensure that the initiative continues to meet the needs of the cancer centers and is contributing to the success of cancer center clinical research operations. To do this, AACI is developing a new five-year strategic plan for CRI.

Carrie Lee, MD, MPH
UNC Lineberger Comprehensive Cancer Center
University of North Carolina at Chapel Hill

9:30 am

Break

9:45 am

Linking Value for Patients, Health Systems and Academic Cancer Centers Across Network Practice Sites - Cassatt Ballroom
AACI President, Stanton L. Gerson, MD will present an overview of the AACI Network Care Initiative. The Network Care Initiative aims to build a roadmap for providing high quality cancer care to patients in the community setting. With acquisitions, mergers and affiliation agreements between academic cancer centers and network practice sites growing more common, the Network Care Initiative is identifying AACI cancer centers that have developed ways to provide value-added care beyond the main cancer center to patients in community settings. Dr. Gerson will share information from a comprehensive survey conducted by AACI exploring practices used to promote value-added care and clinical trials to patients.

Also in this session, panelists will discuss how they create and manage cancer clinical trials at network practice sites, select trials to open at network practice sites, support trial conduct, manage investigational drugs, discuss principal investigator oversight of trials, and address quality management to ensure trial compliance and data collection practices.

Moderator/presenter: Stanton L. Gerson, MD
Case Comprehensive Cancer Center

Robert Ferris, MD, PhD
UPMC Hillman Cancer Center

Patricia LoRusso, DO
Yale Cancer Center
Yale School of Medicine

Jane Welter, MBA
Mayo Clinic Cancer Center

10:45 am

Integrating Clinical Research into Clinical Care: Grasping the Low Hanging Fruit - Cassatt Ballroom
Cancer clinical trials are vital to providing cancer patients with promising treatments. Integrating clinical research with clinical care in today’s fast paced clinics is challenging for physicians, advance practice providers and the clinical care teams striving for efficiency in care delivery. Recognizing that every clinic is unique, this session will suggest best practices that can ease the burden of conducting cancer clinical research studies. Session panelists will discuss trial recruitment procedures, completing trial management tasks during patient visits, documenting trials care in the electronic medical record, and managing safety while providing timely appointments and patient care.

Moderator/presenter: Martha Mims, MD, PhD
Dan L Duncan Comprehensive Cancer Center
Baylor College of Medicine

David Marshall, MD
Hollings Cancer Center
Medical University of South Carolina

Mark Pegram, MD
Stanford Cancer Institute

11:45 am

Lunch- Avedon Ballroom C/D

12:45 pm

2018 CRI Abstract Presentations - Cassatt Ballroom
Abstracts received from AACI cancer center members focus on oncology research that illuminates clinical research challenges and solutions accelerating drug development for patients with cancer. The CRI Steering Committee will select three abstracts for presentation at this year's meeting. Each presentation will be 15 minutes and a Q & A session will follow.

Moderator: Carrie Lee, MD, MPH
UNC Lineberger Comprehensive Cancer Center
University of North Carolina at Chapel Hill

1:45 pm

Overcoming RECISTance to Providing Solid Tumor Evaluations for Cancer Clinical Trials - Cassatt Ballroom
In oncology clinical research, response evaluation criteria in solid tumors (RECIST) is the standard for providing objective, accurate and reproducible tumor evaluations to measure a patient's response to cancer treatment. Since RECIST criteria are not applied to tumor evaluations outside of a clinical trial, their use can be burdensome for investigators and radiologists. Panelists will describe how cancer centers implement various methods to obtain tumor evaluations for research trials (e.g., imaging software to evaluate radiology digital content, centralized radiology reviewers for providing research patient radiology assessments, integrating a dedicated radiologist into the cancer program). Costs and reimbursement structures and the pros and cons of each method will be discussed.

Moderator: Stefan Grant, MD, JD
Wake Forest Baptist Comprehensive Cancer Center

Gina Basinsky
Dana-Farber Cancer Institute
Harvard Medical School

Reginald Munden, MD, DMD, MBA
Wake Forest Baptist Comprehensive Cancer Center

Helen Peck, RN, MA, OCN, CCRP
Sylvester Comprehensive Cancer Center
University of Miami Health System

2:30 pm

Break

2:45 pm

"Note to Self": Ten Lessons for Writing and Running a Trial - Cassatt Ballroom
This session will examine lessons learned by an experienced investigator for developing and managing an investigator initiated trial (IIT) requiring Investigator New Drug Application (IND). Topics for discussion will include: writing a good protocol; preparing a trial budget; obtaining regulatory review approvals (e.g., feasibility, scientific and IRB approval); and finding enough time for competing clinical responsibilities and safety monitoring for enrolled patients. Also highlighted will be best practices for developing and maintaining an FDA required IND, the pros and cons of electronic FDA submissions, and the process for reporting safety data and FDA annual progress reports.

Moderator/presenter: Stephen Williamson, MD
The University of Kansas Cancer Center

Kaitlin Morrison, PhD
UNC Lineberger Comprehensive Cancer Center
University of North Carolina Chapel Hill

3:30 pm

Concurrent Breakout Sessions - Room Locations TBD

Lessons Learned from Working with NCI's NCTN Program
The NCI's National Clinical Trials Network (NCTN) includes five U.S. network groups and the Canadian Collaborating Clinical Trials Network. Membership in individual NCTN groups is based on criteria specific to each group, with AACI cancer centers able to participate as either a Lead Academic Participating Site or through the NCI Community Oncology Research Program. In this session, breakout leaders will facilitate discussion about lessons learned in working with NCI's NCTN.

Erin Williams, MBA
Simmons Comprehensive Cancer Center
UT Southwestern Medical Center

Jessica Moehle, CCRP
Huntsman Cancer Institute
University of Utah

Discussant: Andrea Denicoff, MS, RN
National Cancer Institute

Is Your Clinical Trials Office Prepared for a Disaster?
Breakout leaders will discuss how their cancer center was affected by recent disasters such as hurricanes Harvey, Irma, and Maria, and the measures that they implemented before, during, and after the disaster. This session will focus on encouraging participants to create disaster readiness plans to address issues which can halt cancer center clinical trials office operations.

Kristie Moffett, MHA
Moffitt Cancer Center

Tricia Bentz, MHA, CCRP
Hollings Cancer Center
Medical University of South Carolina

Listserv Topics
Breakout leaders will discuss highly trafficked discussions on the AACI CRI listserv. Final topics will be determined closer to the meeting based on what topics receive the most traffic in the months right before the meeting.

Ashley Baker Lee, CCRP
City of Hope Comprehensive Cancer Center

Better Monitoring and Provision of Inpatient Care for Investigational Therapies
Anticipating the financial and patient toxicities associated with care of the patient enrolled in a clinical research trial which cannot be performed safely in the outpatient treatment setting. This breakout session will discuss how cancer centers effectively staff and address financial costs, prepare for anticipated or unanticipated toxicities when administering novel investigational therapies requiring prolonged and direct observation or the patient or admission to special facilities which cannot be managed in an outpatient setting. Discuss points of this session will address: How to resource the trial?; Develop a trial budget to support unexpected financial costs; Work with inpatient leadership when unanticipated admission to specialized facilities is needed; Providing compliance for reporting acute unexpected toxicities; Communication with patients and families.

Tess Cummings, RN, MS, CCRP
University of Maryland
Marlene and Stewart Greenebaum Comprehensive Cancer Center

John Musser
Moffitt Cancer Center

4:45 pm

General Sessions End

5:00 pm

Vendor Presentation: Complion, Inc. - Room Location TBD

6:00 pm

Poster Session - Artist Foyer

6:30 - 7:30 pm

Welcome Reception - Sponsored by Forte - Artist Foyer

Thursday, July 12, 2018
7:00 am

Meeting Registration - Artist Foyer

7:00 am

Exhibits Open - Artist Foyer

7:00 am

Breakfast - Avedon C/D

General Session
8:00 am

Welcome - Cassatt Ballroom
Janie Hofacker, RN, BSN, MS
Association of American Cancer Institutes

Roy Jensen, MD
The University of Kansas Cancer Center

8:15 am

Modernizing Trial Eligibility Criteria and Closing the Gap on Missed Opportunities to Enrolling Patients to Cancer Trials - Cassatt Ballroom
Clinical trial eligibility criteria are to protect the safety of trial participants and define the trial population. However, excessive or overly restrictive eligibility criteria can slow trial accrual, jeopardize the generalizability of results, and limit understanding of the intervention’s benefit-risk profile. ASCO, Friends of Cancer Research, and the US Food and Drug Administration and the NCI have examined specific eligibility criteria, (e.g. brain metastases, minimum age, HIV infection, and organ dysfunction and prior and concurrent malignancies) and made recommendations for alternate criteria to extend trials to a broader population. In this session our panelists will discuss how recommendations based on review of clinical evidence, consideration of the patient population, and consultation with the research community were developed. The purpose of the session is to highlight these recommendations, discuss the impact on the NCI NCTN and other types of trials, how investigators can modify current and future trials to safely enroll patients who have been previously excluded from oncology clinical trials, and operationalize the effort at your cancer center.

Moderator: Roy Jensen, MD
The University of Kansas Cancer Center

Edward Kim, MD
Carolina Healthcare

Donald Harvey, PharmD, FCCP, BCOP
Winship Cancer Institute of Emory University

9:00 am

Concurrent Breakout Sessions - Room Locations TBD

Lessons Learned from Working with NCI's NCTN Program
The NCI's National Clinical Trials Network (NCTN) includes five U.S. network groups and the Canadian Collaborating Clinical Trials Network. Membership in individual NCTN groups is based on criteria specific to each group, with AACI cancer centers able to participate as either a Lead Academic Participating Site or through the NCI Community Oncology Research Program. In this session, breakout leaders will facilitate discussion about lessons learned in working with NCI's NCTN.

Erin Williams, MBA
Simmons Comprehensive Cancer Center
UT Southwestern Medical Center

Jessica Moehle, CCRP
Huntsman Cancer Institute
University of Utah

Discussant: Andrea Denicoff, MS, RN
National Cancer Institute

Is Your Clinical Trials Office Prepared for a Disaster?
Breakout leaders will discuss how their cancer center was affected by recent disasters such as hurricanes Harvey, Irma, and Maria, and the measures that they implemented before, during, and after the disaster. This session will focus on encouraging participants to create disaster readiness plans to address issues which can halt cancer center clinical trials office operations.

Kristie Moffett, MHA
Moffitt Cancer Center

Tricia Bentz, MHA, CCRP
Hollings Cancer Center
Medical University of South Carolina

Listserv Topics
Breakout leaders will discuss highly trafficked discussions on the AACI CRI listserv. Final topics will be determined closer to the meeting based on what topics receive the most traffic in the months right before the meeting.

Ashley Baker Lee, CCRP
City of Hope Comprehensive Cancer Center

Better Monitoring and Provision of Inpatient Care for Investigational Therapies
Anticipating the financial and patient toxicities associated with care of the patient enrolled in a clinical research trial which cannot be performed safely in the outpatient treatment setting. This breakout session will discuss how cancer centers effectively staff and address financial costs, prepare for anticipated or unanticipated toxicities when administering novel investigational therapies requiring prolonged and direct observation or the patient or admission to special facilities which cannot be managed in an outpatient setting. Discuss points of this session will address: How to resource the trial?; Develop a trial budget to support unexpected financial costs; Work with inpatient leadership when unanticipated admission to specialized facilities is needed; Providing compliance for reporting acute unexpected toxicities; Communication with patients and families.

Tess Cummings, RN, MS, CCRP
University of Maryland
Marlene and Stewart Greenebaum Comprehensive Cancer Center

John Musser
Moffitt Cancer Center

10:15 am

Break

10:30 am

Completing the NCI Cancer Center's Support Grant (CCSG):
New Expectations and Implementing the Changes
- Cassatt Ballroom
Session Highlights:
Meeting the expectations of shifting from performance metrics to science-based work and education and determining the impact on the cancer center's CCSG.
The role of disease-oriented teams and accountability for accrual demonstrating their impact within the CCSG.
Deciding whether we serve patients or science.
Balancing service to the patients with meeting research goals.
Managing the site visit and demonstrating cancer center efficiency.
What will define its capacity to represent the cancer center's analytical patient cases?

Moderator: Carrie Lee, MD, MPH
UNC Lineberger Comprehensive Cancer Center
University of North Carolina at Chapel Hill

Chad Ellis, PhD
UPMC Hillman Cancer Center

Krzysztof Ptak, PhD
National Cancer Institute

Megan Kilbane, MBA
Case Comprehensive Cancer Center

Gisele Sarosy, MD
National Cancer Institute

Walter Stadler, MD
The University of Chicago Medicine Comprehensive Cancer Center

12:30 pm

Lunch - Avedon C/D

1:30 pm

Trials and Tribulations - Cassatt Ballroom
In this session, presenters will report on the progress, or lack thereof, made in solving clinical trial operations problems that were presented in abstracts submitted for the 2017 CRI Annual Meeting. Each presentation will be 15 minutes. A Q & A session will follow.

Alex Zafirovski, MBA
The Robert H. Lurie Comprehensive Cancer Center of
Northwestern University

2:30 pm

Inclusion of Diverse Patient Populations in Clinical Trials - Cassatt Ballroom
NCI-designated cancer centers play a pivotal role in their communities and are expected to engage residents in research relevant to their catchment areas. Panelists for this session will discuss practices or partnerships with healthcare providers or organizations that support clinical trial participation for populations within their catchment area, particularly minority and underserved populations including, rural residents, the LGBTQ community, the elderly, persons of color and those of low socioeconomic status.

Moderator: Tess Cummings, RN, MS, CCRP
University of Maryland
Marlene and Stewart Greenebaum Comprehensive Cancer Center

Edith Mitchell, MD, FACP
Sidney Kimmel Cancer Center at Thomas Jefferson University

Mandi Pratt-Chapman, MA
GW Cancer Center

Tina Turner
Patient Advocate

3:30 pm

Closing Remarks - Cassatt Ballroom
Janie Hofacker, RN, BSN, MS
Association of American Cancer Institutes

3:45 pm

Meeting Adjourn 

Program Subject to Change