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Meeting Program

9th Annual AACI Clinical Research Initiative Meeting
Loews Chicago O'Hare Hotel ~ Chicago, Illinois

Wednesday, July 12, 2017
7:00 am

Meeting Registration Begins - Artist Foyer

7:00 am

Exhibits Open - Artist Foyer

7:00 - 8:00 am

Breakfast - Avedon Ballroom C/D

General Session
8:00 am

Welcome - Cassatt Ballroom
Ms. Janie Hofacker
Association of American Cancer Institutes

Dr. Paul Martin
Fred Hutchinson Cancer Research Center

Dr. Roy Jensen
The University of Kansas Cancer Center

8:15 am

Supporting Patients Through Clinical Trials and Beyond - Cassatt Ballroom
With experience as both a cancer survivor and a cancer physician, Dr. Beck brings a unique perspective to her research and clinical leadership at Huntsman Cancer Institute. In her talk, Dr. Beck will address clinical research--especially encouraging clinical trial enrollment--and she will describe how her personal struggle with cancer has altered her views about supporting cancer patients throughout their disease trajectory. Dr. Beck's areas of research interest are end-of-life care, communication skills training, and female cancers.

Dr. Anna C. Beck
Huntsman Cancer Institute
University of Utah

9:15 am

Managing Trials at Affiliate Sites - Cassatt Ballroom
In this session, panelists will identify reasons for using affiliate sites, criteria for selecting sites, and the importance of building relationships and evaluating a site's readiness for trial participation. Panelists will also share ideas for establishing a budget to cover affiliate site costs for trial start-up, research staff, and non-reimbursable insurance charges. Session panelists will also discuss the challenges faced when the lead site has minimal authority over affiliate sites to ensure regulatory compliance or to address nonconforming sites that don't accrue subjects according to established metrics.

Moderator/Presenter: Dr. Carrie Lee
UNC Lineberger Comprehensive Cancer Center
University of North Carolina at Chapel Hill

Dr. Jennie Crews
Fred Hutchinson Cancer Research Center

Dr. Dennis Slamon
UCLA Jonsson Comprehensive Cancer Center

10:15 am

Break

10:30 am

Updated CCSG Guidelines - Cassatt Ballroom
This session provides an opportunity for an open dialogue about the NCI program award, "Cancer Center Support Grants (CCSGs) for NCI-designated Cancer Centers (P30)," including revisions to grant guidelines and instructions for renewing the P30 grant. Attendees will also hear about lessons learned and practical advice from two centers that have recently completed their CCSG competing renewal using the new grant criteria.

Moderator: Mr. Dave Gosky
UK Markey Cancer Center

Dr. Henry Ciolino
National Cancer Institute

Ms. Megan Kilbane
Case Comprehensive Cancer Center, Case Western Reserve University
Seidman Cancer Center at University Hospitals Cleveland Medical Center

Dr. Marcy List
The University of Chicago Medicine Comprehensive Cancer Center

Mr. David Loose
Coordinating Center for Clinical Trials
National Cancer Institute

12:00pm

Lunch - Avedon C/D

1:15 pm

2017 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: Dr. Paul Martin
Fred Hutchinson Cancer Research Center

Ensuring PEAK Training and Compliance in Cancer Clinical Trials
Dr. Richa Upadhyay
The Tisch Cancer Institute at the Mount Sinai Health System

Improving Reproducibility of Quantitative Imaging Endpoints
Dr. Daniel C. Sullivan
Duke Cancer Institute, Duke University Medical Center

Implementing a Research Nurse Model for the Clinical Trials Office
Ms. Helen Peck
Sylvester Comprehensive Cancer Center, University of Miami Health System

2:15 pm

Clinical Trials Coverage Analysis - 101 - Cassatt Ballroom
Completing clinical trials coverage analysis is the initial step in developing a clinical trial budget. In this session, panelists will discuss how to do a trial coverage analysis to create a trial budget for contract negotiations and a billing grid for assigning charges. Panelists will also explore ways to generate documentation to support medical necessity of care claims in the electronic medical record as well as billed charges and services requiring payer preauthorization. A representative from the National Cancer Institute (NCI) will discuss how they develop trial coverage analysis for National Clinical Trials Network (NCTN) phase II and phase III trials and NCI Community Oncology Research Program cancer control/prevention trials.  Panelists will also address regional differences in interpretations by the Centers for Medicare & Medicaid Services of national coverage determinations for clinical trials.

Moderator: Dr. Paul Martin
Fred Hutchinson Cancer Research Center

Ms. Andrea Denicoff
National Cancer Institute

Ms. Tesheia Johnson
Yale Cancer Center
Yale School of Medicine

Ms. Kelly Feehan
City of Hope Comprehensive Cancer Center

3:15 pm

Break

3:30 pm

Concurrent Breakout Sessions

A Deeper Dive Into Managing Community and Affiliate
Trials Sites
- Avedon A/B (Wednesday only)
Ms. Kim Keller
UNC Lineberger Comprehensive Cancer Center
University of North Carolina at Chapel Hill

Dr. Jennie Crews
Fred Hutchinson Cancer Research Center

Enhancing the Relationship between Medical Directors and CTO Administrative Directors - Avedon C
Ms. Jessica Moehle
Huntsman Cancer Institute
University of Utah

Dr. Theresa Werner
Huntsman Cancer Institute
University of Utah

Operationalizing Complex Clinical Trials Designs - Pollock
Ms. Rhoda Arzoomanian
Yale Cancer Center
Yale School of Medicine

Ms. Erin Williams
Simmons Comprehensive Cancer Center
UT Southwestern Medical Center

Research Center and Industry Staff Turnover and its Impact on Quality Data Capture -Warhol
Ms. Collette Houston
Memorial Sloan Kettering Cancer Center

Mr. Moshe Kelsen
Herbert Irving Comprehensive Cancer Center
Columbia University Medical Center

4:45 pm

General Sessions End

5:30 - 6:00 pm

Poster Session - Artist Foyer

6:00 - 7:00 pm

Welcome Reception - Artist Foyer

Thursday, July 13, 2017
7:00 am

Meeting Registration

7:00-8:00 am

Breakfast - Avedon C/D

7:00-7:45 am

Vendor Presentation: Going Paperless: Managing Regulatory & Clinical Trial Documents in Complion - Avedon B

7:00 am

Exhibits Open - Artist Foyer

General Session
8:00 am

Welcome - Cassatt Ballroom
Ms. Janie Hofacker
Association of American Cancer Institutes

8:15 am

So You Want to Run an Investigator Initiated Trial: Points to Consider - Cassatt Ballroom
This session will focus on developing investigator initiated trials (IIT) from concept to effective, well-designed trials which collect good data to match the study’s endpoints. 

Panelists will identify IIT challenges such as using multiple electronic data capture systems, bridging financial gaps when pilot or donor funding is limited, navigating complex industry and clinical research organizational structures, educating Principal Investigators and clinical teams about trials to ensure trial compliance (e.g., reporting trial results to ClinicalTrials.gov).

Moderator: Ms. Elizabeth Anderson
Stanford Cancer Institute

Ms. Kate Anderton
Hollings Cancer Center
Medical University of South Carolina

Mr. John Musser
Moffitt Cancer Center

Dr. Steve Williamson
The University of Kansas Cancer Center

9:15 am

Concurrent Breakout Sessions

The Burden of FDA Inspections - Avedon B (Thursday only)
Mr. Nicholas Farley
Dana-Farber Cancer Institute
Harvard Medical School

Ms. Therica Miller
Samuel Oschin Comprehensive Cancer Institute
Cedars-Sinai Medical Center

Enhancing the Relationship between Medical Directors and CTO Administrative Directors - Avedon C
Ms. Jessica Moehle
Huntsman Cancer Institute
University of Utah

Dr. Theresa Werner
Huntsman Cancer Institute
University of Utah

Operationalizing Complex Clinical Trials Designs - Pollock
Ms. Rhoda Arzoomanian
Yale Cancer Center
Yale School of Medicine

Ms. Erin Williams
Simmons Comprehensive Cancer Center
UT Southwestern Medical Center

Research Center and Industry Staff Turnover and its Impact on Quality Data Capture - Warhol
Ms. Collette Houston
Memorial Sloan Kettering Cancer Center

Ms. Moshe Kelsen
Herbert Irving Comprehensive Cancer Center
Columbia University Medical Center

10:30 am

Break

10:45 am

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 2016 CRI Annual Meeting. Each presentation will be 15 minutes. A Q & A session will follow.

Moderator: Mr. Nicholas Fisher
Siteman Cancer Center

Ms. Pamela Degendorfer
Princess Margaret Cancer Centre
University Health Network

Mr. Moshe Kelsen
Herbert Irving Comprehensive Cancer Center
Columbia University Medical Center

Ms. Krystal Merdinger
Fox Chase Cancer Center
Temple Health

11:45 am

Lunch - Avedon C/D

12:45 pm

Breakout Session Report Back - Cassatt Ballroom

1:30 pm

Evaluating and Streamlining Non-Value Added Activities in Your CTO - Cassatt Ballroom
Panelists will discuss challenges associated with conducting pharmaceutical industry-sponsored research where policies to address regulatory burdens create non-value added work for cancer center trial sites. Examples of non-value added activities include: use of sponsor portals; reviewing third party serious adverse event reports which don’t meet FDA guidance for reporting; and, managing multiple site and remote monitoring visits. Panelists will share advice on how to streamline clinical research operations to eliminate non-value added steps. 

Moderator: Ms. Tess Cummings
University of Maryland
Marlene and Stewart Greenebaum Comprehensive Cancer Center

Mr. Hobs Apell
The University of Kansas Cancer Center

Dr. Young Kwang Chae
The Robert H. Lurie Comprehensive Cancer Center
of Northwestern University

2:15 pm

Practices to Promote Sustainable Staffing and Retention Models - Cassatt Ballroom
Clinical trial leaders face continual staffing challenges. Panelists will share information--collected via surveys or pilot studies and workload metrics data—about the effectiveness of various staffing models (e.g., nurse vs non-nurse), and the challenges of retaining staff, promoting employee satisfaction, ensuring balanced workloads, and addressing industry and institutional competition for high performing staff.

Moderator/Presenter: Ms. Kristie Moffett
Moffitt Cancer Center

Ms. Pam Herena
City of Hope Comprehensive Cancer Center

Dr. Carrie Lee
UNC Lineberger Comprehensive Cancer Center
University of North Carolina at Chapel Hill

3:00 pm

Closing Remarks - Cassatt Ballroom
Ms. Janie Hofacker
Association of American Cancer Institutes

3:15 pm

Meeting Adjourn 

Program Subject to Change