1. The NAVREF Annual Conference sessions are still available for all registered attendees.  Please check out those sessions you missed the first time!  Additionally, the survey instruments are still open, please help us gather feedback:

 

1. Note that ORD has approved the Sterling IRB as the third commercial IRB that may be used by VA facilities participating in cooperative research activities.

1. New Requirements for Gifts-in-Kind.  Last week, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2020-07, Not-for-Profit Entities (Topic 958): Presentation and Disclosures by Not-for-Profit Entities for Contributed Financial Assets.  The new standard aims to increase transparency and improve disclosures related to in-kind gifts of nonfinancial assets.  The standard will require that in-kind gifts be presented separately in the revenue section on the Statement of Activities, and will require additional disclosures including:

•   Disaggregation by type of nonfinancial contribution received;

• A description of any donor restrictions on the use of the gift;
• Whether the gift was used or was monetized (converted to cash);
• If used, a description of the programs or other activities in which the gift was used; and
• A description of the method used to determine the fair value of the gift, including the principal or most advantageous market used to arrive at the fair value measure.

The ASU is effective for annual periods beginning after July 15, 2021. The standard is required to be applied on a retrospective basis and early adoption is permitted.

1. Legislative Update – Last Wednesday, the House unanimously passed S. 785, the Commander John Scott Hannon Veterans Mental Health Care Improvement Act, sending it to the President’s desk to be signed into law. The Senate-crafted bill addresses a wide range of mental health and suicide prevention measures, including opening the care aperture for more veterans.  It also include two provisions supported by NAVREF to solidify the ACT for Veterans initiative:

• Sec. 704 – to allow sponsored clinical research of VA to use accredited commercial IRBs
• Sec. 705 – to establish within the VA Office of Information and Technology an Office of Research Reviews to perform centralized security reviews and complete security processes for approved research sponsored outside the VA, with a focus on multi-site clinical trials.

 

Upcoming calendar events:                         

From Mr. Rick Starrs, NAVREF CEO:

It was great to see many of you virtually last week at the Annual Conference.  I hope everyone enjoyed a refreshing weekend.  We have 6 items of interest for you this week:

1. Thanks to all of you who attended the NAVREF Annual Conference last week—we had a total of 416 attendees, nearly doubling our previous record!  See attached press release.  The conference materials—recorded sessions and slides—will be available to all registrants for another 30 days, so don’t hesitate to check out the sessions you missed or download desired documents.  Please take the time to help us plan future events by completing our conference surveys:

 

1. The Office of Management and Budget recently issued its Final Guidance on amendments to its Uniform Guidance.  Courtesy of NAVREF Board Member Bob Forrester, attached is a summary of those changes (which will be effective November 12, 2020.  Thank you Bob!

1. See attached ORD COVID-19 Update from ORD.

1. We do not yet have a determination from OGC on the way ahead for using contracted personnel from staffing agencies.  You may continue to use staffing agencies such as Medix Staffing Solutions for hiring permanent NPC employees.

1. Legislative Update - Both the House and Senate are in session this week.  The passing of Supreme Court Justice Ruth Bader Ginsburg complicates an already full agenda including the need for a continuing resolution to avoid a government shutdown, the next COVID-19 relief package, and the possibility of a disaster relief package for communities across the country impacted by wildfires and hurricanes.  

 

1. Upcoming calendar events:                    

 

(Washington, D.C., September 16, 2020) - The National Association of Veterans’ Research and Education Foundations (NAVREF) held its sixth annual awards event on September 16th, honoring NAVREF members and staff nominated by their peers for demonstrating excellence in support of research and education for Veterans. The award ceremony was hosted by NAVREF CEO Rick Starrs in conjunction with NAVREF’s 28th Annual Conference.

The 2020 winners included Ms. Amy Kimball, MBA, of the Boston VA Research Institute (BVARI), who was awarded NAVREF’s prestigious Barbara West Award for Distinguished Service. Other awardees included Ms. Elaine Staats, MPH, Director of Sponsored Research at the Palo Alto Veterans Institute for Research (PAVIR) in Palo Alto, California, and Ms. Margaret Tiktin, DNP, CNP, MBA, Director, Clinical Research Center, at the VA Northeast Ohio Healthcare System in Cleveland.

Ms. Kimball was recognized for her outstanding service and dedication both to her nonprofit corporation (NPC) and to NAVREF. She has served as Chief Executive Officer at BVARI for the last three years. In that short time, she has revamped strategy, restructured staffing to align with BVARI’s business model, reduced the reliance on Intergovernmental Personnel Act appointments, and effectively leveraged national and local relationships to improve performance. She generously shares her knowledge and expertise with other NPC leaders in a compassionate, confident, and professional manner. She provided several best practice models and strategic approaches to problem solving that other NPCs have used to improve their systems. Ms. Kimball demonstrates the persistence, passion, and strategic understanding necessary to excel in this highly complex environment.

Ms. Staats took home the NAVREF Board of Directors Award for her comprehensive leadership and management of PAVIR's extensive sponsored research program. She has supervised the growth of PAVIR's research program to more than $30 million annually through effective collaboration with her local Chief of Staff and Research offices and with VA Central Office’s R&D Service, General  Counsel and CRADA offices; she is also PAVIR's principal liaison with Stanford University, responsible for compliance with the affiliation agreement. Ms. Staats manages these complex relationships in a steady, calm, engaging and resourceful manner and has deservedly earned the confidence and respect of her colleagues in each of these institutions and offices. She is widely regarded as an expert in her field and routinely advises other NPC and VA personnel on all things related to sponsored research.

Ms. Tiktin was awarded the Best Practice and Innovation Award for the tremendous value she added to NAVREF’s Clinical Trial Committee over the last year. She provided expert insight and understanding as the Committee developed guidelines for leading multi-site industry-sponsored studies. She helped identify those skills and attributes a site needs to successfully lead. Ms. Tiktin’s selfless contribution of time, effort, and expertise exemplified the spirit of collaboration between VA and NAVREF to advance the health of veterans.

We caught up with the National Association of Veterans’ Research and Education Foundations (NAVREF) to learn more about how the VA has been collaborating with the biotech industry and government agencies to accelerate COVID-19 research and improve veterans’ access to clinical trials.

VA Research has been working to improve collaboration with industry,particularly through the ACT for Veterans Initiative, which works to improve access to clinical trials among military veterans.

VA jumped in the COVID-19 fight, participating in a number of industry-sponsored studies for therapeutics including tocilizumab with Hoffman-La Roche and sarilumab with Regeneron, which are both used in arthritis care. 

In addition to participating in Operation Warp Speed and ACTIV, the VA also partnered with the Departments of Energy and Health & Human Services to coordinate and share health data, research, and expertise on COVID-19 therapeutics and vaccines. 

And VA’s Million Veteran Program (MVP) is collecting information about participants’ experiences, which could provide insight into the influence of race and ethnicity on disease susceptibility, severity, and outcomes since MVP’s population is around 20% African American and 7% Hispanic.

And it’s not just about COVID-19. VA is funding a phase 2 clinical trial exploring whether degarelix, a treatment used against prostate cancer, may improve clinical outcomes, as one example.

The bottom line? We need all kinds of collaboration to beat COVID-19. “Our industry is moving forward at an incredibly fast pace, and part of the reason is because of the unprecedented collaboration we’re seeing across the industry and with key government and nongovernmental partners,” as BIO’s Dr. Michelle McMurry-Heath recently said.

1. The 28^th NAVREF Annual Conference is open for registration at www.navref.org.  This year’s virtual event will run from 12-4pm ET on September 14-16^th with 5 plenary sessions, 12 breakout sessions, several “On Demand” sessions, and a variety of networking opportunities with colleagues and sponsors.  Register now for up to 3 individuals ($200) or up to 8 individuals ($400) from your site.  In addition to CEO/EDs and senior staff, NPCs should include ACOS-Rs and consider other research service staff as attendees within your group.  Please contact Hawk with any questions, htran@navref.org.   

1. Reminder:  NAVREF annual membership renewal/enrollment ran from June 1-30.  Thank you to all of you who renewed for 2020-2021.  We are ahead of last year’s pace with only 10 NPCs remaining—to those of you who have not yet contacted us, please complete and return the 2020-2021 membership renewal packet with your most recent IRS form 990.  Due to the pandemic, NAVREF is offering flexible payment arrangements for anyone in need.

1. ORD COVID-19 Update – attached is the most current weekly update from ORD.  Most relevant for NPCs are pages 5-6 under “New Research Opportunities” related to Vaccine and therapeutic trials and the ACTIV site survey. 

1. Upcoming training sessions:               Thu, Jul 23, 1pm ET; Incorporating Grants and Grant Strategy into your Organization

1. PPP Forgiveness:  see attached message from Non Profit Quarterly offering a complimentary webinar for nonprofit financial leaders who have received a Paycheck Protection Program (PPP) loan and want to prepare effectively to seek loan forgiveness.  The webinar will be presented live on Thursday, July 23rd 2020 from 3:00 - 4:00PM ET and the recording will be made available 2-3 days after.

1. As NAVREF members, you each have full membership with the Society for Clinical Research Sites (SCRS).  Please see attached message highlighting how to take advantage of your valuable SCRS benefits.

1. Working Together in the Public Interest: Over 20 of the largest global pharmaceutical companies, joined by WHO and other multilateral organizations, have created a billion-dollar fund to support antibiotic R&D by smaller companies. The AMR Action Fund aims to reverse the dangerously fragile antibiotic pipeline. For background on AMR, go to www.amractionfund.com.

1. Check out the attached chart from the Adult Vaccine Access Coalition (AVAC) showing how the current vaccine development process is accelerating vaccine development to prevent COVID-19.

For many of us, the year 2020 began with the spirit of inspiration and new hope. Six months later, that spirit has been beaten, burned and placed in isolation. From disease to civil unrest, the past six months have been fraught with challenges unlike any seen in our lifetimes. These are, without a doubt, stressful times for all of us. However, these times are being met head-on with strong and passionate voices. In unison with our colleagues, national leaders, and many Americans, NAVREF supports these voices in saying enough is enough.

Although one more corporate statement might do little to change our country, our team believes saying nothing is a statement of compliance. Words matter. Words can ignite hate. And words can bring about change.

The NAVREF team undisputedly advocates for full equality. In our niche role supporting veterans’ health research, we focus on improving and saving lives through scientific discovery without discrimination. However, we must acknowledge that our industry is also imperfect. So, let us make our position very clear. We must usher-in equality and unity through systemic reform focused on equal justice for all and holding leaders accountable. This notion of justice and accountability is non-negotiable.

The NAVREF staff will play our part as we continue our mission to enhance veterans’ research.

To our members, the nation, and our human family, we wish you peace and positivity in these difficult times.

The Senate passed legislation on June 3rd to provide more flexibility for the Paycheck Protection Program (PPP), which provides help for small businesses amid the steep economic impact of the coronavirus.

"Today we're passing another piece of legislation that makes a few targeted changes to the program," Senate Majority Leader Mitch McConnell (R-Ky.) announced from the floor. "I'm proud the Senate is sending it on to the president's desk to become law."

The bill, which would extend the window for businesses to be able to spend loans granted under the program, passed the Senate by unanimous consent. The bill already passed the House last month, meaning it now goes to the President's desk where it is expected he will sign the bill into law.  

The new bill passed by Congress would extend the current language to allow businesses up to 24 weeks to spend PPP funds. It would also change a 75-25 divide included in the March bill — which required businesses to spend 75 percent of the loan on payroll and 25 percent on other fixed costs such as rent and utilities. The new language will change the ratio to a 60-40 split.

The FY20 Defense Appropriations Act provides funding to the Department of Defense Lupus Research Program (LRP) to support the full spectrum of research projects or ideas that specifically focus on scientific and clinical lupus issues, which, if successfully addressed, have the potential to make a major impact in lupus research.  As directed by the Office of the Assistant Secretary of Defense for Health Affairs, the Defense Health Agency J9, Research and Development Directorate manages the Defense Health Program (DHP) Research, Development, Test, and Evaluation (RDT&E) appropriation.  The managing agent for the anticipated Program Announcements/Funding Opportunities is the Congressionally Directed Medical Research Programs (CDMRP) at the U.S. Army Medical Research and Development Command (USAMRDC).

 

The FY20 LRP Program Announcements and General Application Instructions for the following award mechanisms are posted on the Grants.gov website.

 

Applications submitted to the FY20 LRP Idea Award and/or Impact Award must address one or more of the following Focus Areas:

 

• ·         Understanding how lupus disease heterogeneity impacts risk of disease, disease presentation, clinical course, and outcomes; using a diverse range of research disciplines including, but not limited to, biopsychosocial studies, personalized medicine, variation in treatment studies, personalized medicine, variation in treatment studies, health economics, socioeconomic studies, environmental studies, and epidemiological studies
• ·         Understanding lupus disease heterogeneity including, but not limited to, strategies and technologies to subtype patients and understanding lupus disease mechanisms
• ·         Improving quality of life for individuals living with lupus including, but not limited to, access to healthcare resources, outcome research, symptom control, comparative effectiveness research, and issues and challenges that when addressed make day-to-day living with lupus easier and life more fulfilling
• ·         Understanding how the underlying genetic components and gene-environment interactions of lupus relate to clinical disease characteristics using functional genomic studies
• ·         Determining the pathobiology of lupus disease in target human tissues including, but not limited to, imagining studies, genomics of lupus in particular tissues, and metabolomics

Applications submitted to the FY20 LRP Transformative Vision Award must address the following Focus Area:

 

• ·         Improving quality of life for individuals living with lupus including, but not limited to, access to healthcare resources, outcome research, symptom control, comparative effectiveness research, and issues and challenges that when addressed make day-to-day living with lupus easier and life more fulfilling

https://cdmrp.army.mil/funding/lrp

 

Idea Award – Letter of Intent Due August 25, 2020

All investigators at or above the level of postdoctoral fellow (or equivalent)

·         Supports highly innovative, untested, potentially groundbreaking ideas in lupus research.

·         Emphasis is on innovation

·         Must address one of the Fiscal Year 2020 (FY20) LRP Focus Areas

·         Clinical trials are not allowed

·         Preliminary data are not required

·       The maximum allowable funding for the entire period of performance is  in total costs

·       The maximum period of performance is 2 years

 

Impact Award – Letter of Intent is Due August 25, 2020

Investigators at or above the level of Assistant Professor (or equivalent)

·         Supports innovative, high-risk/high-reward research

·         Emphasis is on impact

·         Must address one of the FY20 LRP Focus Areas

·         Clinical trials are not allowed

·         Preliminary data are encouraged but not required

·         The maximum allowable funding for the entire period of performance is $750,000 in total costs.

·         The maximum period of performance is 4 years

 

Transformative Vision Award – Letter of Intent due August 25, 2020

Independent Investigators at or above the level of Assistant Professor (or equivalent)

·         Supports high-risk, high-reward studies that have the potential to make a significant near-term impact on the quality of life of lupus patients

·         Emphasis is on near-term impact to quality of life

·         Must address the FY20 LRP TVA Focus Areas

·         Clinical trials are allowed

·         Animal studies are not allowed

·         Preliminary data are required

·       The maximum allowable funding for the entire period of performance is $2,500,000 in total costs

·       The maximum period of performance is 4 years

 

A pre-application is required and must be submitted through the electronic Biomedical Research Application Portal (eBRAP) at https://eBRAP.org prior to the pre-application deadline.  All applications must conform to the final Program Announcements and General Application Instructions available for electronic downloading from the Grants.gov website.  The application package containing the required forms for each award mechanism will also be found on Grants.gov.  A listing of all CDMRP and other USAMRDC extramural funding opportunities can be obtained on the Grants.gov website by performing a basic search using CFDA Number 12.420. 

 

For email notification when Program Announcements are released, subscribe to program-specific news and updates under “Email Subscriptions” on the eBRAP homepage at https://eBRAP.org.  For more information about the LRP or other CDMRP-administered programs, please visit the CDMRP website (https://cdmrp.army.mil).

 

Point of Contact:

CDMRP Help Desk
301-682-5507
help@eBrap.org

The FY20 Defense Appropriations Act provides funding to the Department of Defense Duchenne Muscular Dystrophy Research Program (DMDRP) to support research addressing discovery and development of therapeutics, devices, and other interventions.  As directed by the Office of the Assistant Secretary of Defense for Health Affairs, the Defense Health Agency J9, Research and Development Directorate manages the Defense Health Program (DHP) Research, Development, Test, and Evaluation (RDT&E) appropriation.  The managing agent for the anticipated Program Announcements/Funding Opportunities is the Congressionally Directed Medical Research Programs (CDMRP) at the U.S. Army Medical Research and Development Command (USAMRDC).

 

The FY20 DMDRP Program Announcements and General Application Instructions for the following award mechanisms are posted on the Grants.gov website.    

https://cdmrp.army.mil/funding/dmdrp

 

Idea Development Award – Pre-application due August 12, 2020

Independent investigators at all academic levels (or equivalent).

·       Supports the development of innovative, high-impact ideas that advance the understanding of Duchenne muscular dystrophy (DMD) and ultimately lead to improved outcomes.

·       Must address opportunities and challenges in the development of safe and effective macromolecular and cellular therapies that address primary pathology of DMD.  Eligible therapeutic strategies include: gene therapy, genome editing, oligonucleotide therapies, exon skipping, protein therapeutics, and cell therapies. Therapies that will be efficacious across the life-span, particularly in adolescents and adults are encouraged.

·       Preliminary data are required.

·       Clinical trials are not allowed.

·       Maximum funding of $350,000 for direct costs (plus indirect costs).

·       Maximum period of performance is 2 years

 

Translational Research Partnership Award – Pre-application due August 12, 2020

Investigators at or above the level of Assistant Professor (or equivalent)

·       Supports the development of translational research collaborations between two independent investigators to address a critical problem or question in DMD and to accelerate the movement of promising ideas into clinical application.

·       Partnerships where one partner in the collaboration is a research scientist and the other is a clinician are strongly encouraged.

·       Must address one of the FY20 Translational Research Partnership Award Focus Areas

·       Preliminary data are required.

·       Clinical trials are allowed.

·       Maximum combined funding of $1,200,000 for direct costs (plus indirect costs)

·       Maximum period of performance is 3 years

 

A pre-application is required and must be submitted through the electronic Biomedical Research Application Portal (eBRAP) at https://eBRAP.org prior to the pre-application deadline.  All applications must conform to the final Program Announcements and General Application Instructions available for electronic downloading from the Grants.gov website.  The application package containing the required forms for each award mechanism will also be found on Grants.gov.  A listing of all CDMRP and other USAMRDC extramural funding opportunities can be obtained on the Grants.gov website by performing a basic search using CFDA Number 12.420. 

 

For email notification when Program Announcements are released, subscribe to program-specific news and updates under “Email Subscriptions” on the eBRAP homepage at https://eBRAP.org.  For more information about the DMDRP or other CDMRP-administered programs, please visit the CDMRP website (https://cdmrp.army.mil).

 

Point of Contact:

CDMRP Help Desk
301-682-5507
help@eBrap.org

The Friends of VA Medical Care and Health Research asked Congress on May 21st to support an additional $50 million towards Veterans Affairs COVID-19 research. As many know, the VA Office of Research and Development has been working tirelessly to quickly setup trials and studies aimed at finding solutions to fight COVID-19. This shift of effort has also required as shift of resources which is where FOVA has come in to play. Read more about this effort here in their letter to Congress.