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IPC Meeting in San Diego - Draft Minutes

6 Apr 2023 3:30 AM | Anonymous member (Administrator)

NAVREF Industry Partner Consortium Meeting

March 21, 2023 

San Diego, CA



               Kimberly Binaso (Genentech)

               Peggy Bradley (Biomedical Research Institute of Southern Arizona)

               Krissa Caroff (VA Partnered Research Program)

               Sean Cunningham (Janssen)

               Drew Darker (Janssen)

Theresa Devins (Cognition Therapeutics)

Allyson Gage (Cohen Veterans Bioscience)

               Kevin Havens (Exact Sciences)

               Calvert Lee (Palo Alto Veterans Institute for Research)

               Bill Leone (Avallano)

               Patricia Mader (Genentech)

               Waqar Malik (Wisconsin Corporation for Biomedical Research)

               Rebecca Rosales (Northern California Institute for Research and Education)

               Angie Smith (Northern Florida Foundation for Research and Education)

               Elaine Staats (Palo Alto Veterans Institute for Research)

               Hawk Tran (NAVREF)

               Katrina Washburn (South Florida Veterans Affairs Foundation for Research and Education)

               Phil Wellington (Seimans)

               Priscilla West (NAVREF)

               Rochelle Williams-Belizaire (Mirati)


Review of December 2022 IPC Minutes

For the next set of minutes, members would like to add a list of meeting attendees, as well as a list of ongoing items to bring forward to future meetings.  In addition, minutes will be circulated for review within a couple of weeks after each meeting.

VA Playbook


Dr. Washburn presented a detailed outline of the playbook, and the entire draft document was circulated in advance of the meeting for review.  There was a lengthy discussion about industry research that doesn’t go through VA NPC for contracting/funding administration, particularly with medical device research and/or unfunded research.  Ms. Caroff recognized the need for a separate VA research primer that would include such topics as:

  • ·        What qualifies as VA research
  • ·        Roles of VA programs and staff members in VA research
  • ·        Guidelines for unfunded research

It would be helpful to add more detail to the playbook regarding the following topics:

  • ·        The relationship between VA as the NPC.  NPCs can be misperceived as the gatekeepers to VA researchers, and we need to emphasize that NPCs exist to provide administrative resources and efficiencies, and support compliance with VA guidance regarding research contracting and regulatory compliance.
  • ·        The ability for a sponsor to pursue relationships with VA investigators at the same time they’re working with NPCs on contracting/budgeting issues.

NAVREF Member Directory 

Ms. West and Mr. Tran presented the 2023 NAVREF Member Directory for review and comment.  Individual member profiles include contact information, areas of research interest, number of unique patients, information about local research infrastructure, and investigators of note.  The following recommendations were made for future versions of the member directory:

  • ·        Break out cancer research interests into subgroups (i.e., lung, prostate, etc.)
  • ·        Merge NPC directory with broader VA medical center information
  • ·        Add contact information for contracting and budgeting
  • ·        In directory introductory information, add updated areas of national focus for VA research
  • ·        Identify sites that are participating in VA Lung Precision Oncology Program (LPOP)
  • ·        Add contact information for investigators of note
  • ·        Add demographic information for local patient population
  • ·        Add information about multisite NPCs
  • ·        Add VISN information
  • ·        Allow individual NPCs to update information in real time throughout the year
  • ·        Allow search functions so that it’s easier to identify sites with certain characteristics
  • ·        Link NPC profiles to NAVREF website map of member NPCs

VA Data Access

Ms. West presented an update on obtaining access to VA data to support clinical trials.  Upon review of the potential VA data sources mentioned at the December 2022 IPC meeting (National Center for Veterans Analysis and Statistics and the VA RAMP Open Data Portal), the data were found to be either inaccessible to outside organizations, or outdated and not in a useful format.

Since the last IPC meeting, there have been several conversations with VA leadership regarding the use of VA data to support clinical trials access for veterans.  While there is universal support for the idea, it would be precedent setting to allow the use of data by outside entities for this purpose.  Therefore, it’s unclear how to proceed in practice.  It would be possible to enter a CRADA agreement with VINCI, but they would charge NAVREF a high hourly rate ($250+/hour) for data analysis services.  The VA National  Artificial Intelligence Institute (NAII) has previously expressed interest in sharing resources with outside entities, so we will propose NAVREF funding of a 0.5 FTE data analyst position within NAII for two years.  This would give VA control over the types of data released to NAVREF and address VA concerns about data confidentiality.  The goal for this two-year trial period would be to test the utility of VA data for supporting clinical trials, and establish the effort required to provide different types of information.

Diversity and Equity in VA Clinical Trials

At the last IPC meeting there was enthusiastic support from Committee members to develop efforts in this area.  An IPC Diversity Equity and Inclusion (DEI) subcommittee was formed to start researching current efforts in this area, and determining how the IPC might best contribute.  DEI subcommittee members include:

               Sarah Abdella-El Kallassy (VA National Artificial Intelligence Institute)

Krissa Caroff (VA Partnered Research Program)

               Allyson Gage (Cohen Veterans Bioscience)

               Waqar Malik (Wisconsin Corporation for Biomedical Research)

               Priscilla West (NAVREF)

               Rochelle Williams-Belizaire (Mirati)

The DEI subcommittee will meet monthly and will present their findings and recommendations at the next IPC meeting.

Action Items for June 2023 Meeting

  • ·        Revise VA Playbook to incorporate feedback from today’s meeting.  Send final draft to VA Partnered Research Program for final review and comment.  Present final draft to IPC members at June meeting.
  • ·        Pursue NAVREF funding of 0.5 FTE data analyst for two years within VA, dedicated to the use of VA data to support clinical trials.
  • ·        Present findings of the IPC DEI subcommittee and recommend possible activities to support diversity and equity in VA clinical trials.
  • ·        Present mock-up of Industry Partner portal on NAVREF website for feedback
  • ·        Determine status of VA patient clinical study volunteer registry

Ongoing Items


  • ·        Work with Krissa Caroff on VA research primer
  • ·        Develop summary of potential methods of supporting decentralized clinical trials for VA consideration

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