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NAVREF UPDATES – september 10, 2009

 

  1. 2009 Annual Conference
  2. Reminder: Send Letters to Your Senators
  3. 2008 IRS Form 990 -- Schedule J and R Guidance
  4. Raymond James New Sweep Account
  5. CRADA Update
1.  2009 Annual Conference.

 

Final Preparations are underway for NAVREF’s 2009 Annual Conference.  Speakers are fine-tuning their presentations in anticipation of a well-attended and lively conference.  Please watch for an email next week with a few final reminders.  Program Co-Chairs Eileen Lennon, PhD, and Bob Obana join me in looking forward to seeing many of you and your board members in Chicago.

 

2.  Reminder: Send Letters To Your Senators.

If you have not already done so, please send letters to your senators urging them to support prompt Senate action on S. 252 which includes a section that would update and clarify NPC authorities.  Our goal is to be able to share with the Senate leadership and the Committee on Veterans Affairs letters from every state where there is an NPC.  For details and a sample letter that should be sent by Monday, September 14, go to http://www.navref.org/newsletter/2009/update_09-08-2009_2.htm.  Many thanks to those of you who have already sent your letters and faxed or emailed copies to NAVREF.

3.  2008 IRS Form 990 – Schedule J and R Guidance.

 

The IRS is gradually rolling out clarifying guidance in regard to the new IRS Form 990 including IRS responses to frequently asked questions and reporting tips.  Guidance that may be of interest to NPCs includes:

 

Form 990 Part VI – Governance - http://www.irs.gov/charities/article/0,,id=211125,00.html

Form 990 Part VII and Schedule J regarding Reporting Executive Compensation - http://www.irs.gov/charities/article/0,,id=206636,00.html

Form 990 Schedule R regarding Related Organizations - http://www.irs.gov/charities/article/0,,id=211346,00.html

 

A number of NPC executive directors have inquired whether their NPC is “related” to VA under the new 990 instructions and therefore must report VA salary information for board members.  NAVREF has verified that a federal agency may be “related” to a nonprofit for purposes of the new 990, but whether a specific NPC is related to VA depends on each NPC’s board composition as well as other facts and circumstances. NAVREF encourages NPCs to discuss relatedness with their Form 990 preparers.

 

4.  4. Raymond James New Sweep Account.

 

In late September, the financial management firm Raymond James plans to launch the Raymond James Bank Deposit Program (RJBDP).  Like the Merrill Lynch Insured Savings Account (ISA), available cash will be deposited into interest-bearing accounts at one or more banks.  If the account holder’s cash balance exceeds the FDIC limit ($250,000 through the end of 2013), the excess cash will be deposited in the next bank(s) on the priority list.  This will provide FDIC coverage for up to $2.5 million per account holder.

 

Through careful review of RJ materials describing the RJBDP and discussion with RJ representatives, NAVREF has verified that the RJDBP meets the VA requirement that NPC funds must be held in instruments backed by the full faith and credit of the US government. With this new RJ program, NPCs that wish to use a brokerage firm to manage funds, including purchasing CDs and Treasuries, will have an alternative to Merrill Lynch.  Each NPC should evaluate for itself the brokerage services offered by RJ and its strength in the current economic environment.

 

Any NPCs interested in discussing an RJ account and services may contact W. Jay Sarmir, CFP.  Mr. Sarmir is already familiar with the investment constraints under which NPCs must operate.  Email: jay.sarmir@raymondjames.com; Phone: 866-325-0156 or 678-746-1503 (Atlanta, GA area)

 

5.  CRADA_Update.

 

Several NPCs recently pointed out that CRADA Registry data sent to TTP has not been uploaded to the TTP web site in a timely fashion.  NAVREF contacted TTP to discuss this and other issues related to CRADAs and was assured that the registry will be brought up to date shortly.  Please watch for an email from TTP notifying NPCs when this has been accomplished. 

 

TTP Deputy Director Jeff Moore, PhD, reports that the online CRADA registry should be ready in 4-6 weeks and at his request, NAVREF has provided him with the names of four NPC executive directors willing to help him with beta testing.  When operational, the online registry should be a useful resource for helping NPCs find other NPCs and VA sites participating in the same studies and should facilitate prompt execution of CRADAs.  The extent to which this tool will be useful remains highly dependent on NPCs entering their data at the time they initiate CRADA negotiations and then again after the CRADA has been signed.  Please take a few minutes to comply with these submission requirements in a timely manner.  

 

On related issues:

 

  • Jeff has agreed to consider a request to post online the letter signed by the Under Secretary for Health for each master template CRADA and to provide a pharmaceutical company contact for each.  This would give NPCs the information they need when a company representative is unaware of the master. 

  • The basic CRADA training manual promised by TTP remains under development.  Jeff anticipates completing this and scheduling a conference call sometime during the fall for any NPC personnel in need of basic CRADA training. 

  • New model VA confidential disclosure agreements (CDAs) remain under review by OGC. 

 

Jeff reported that the advanced CRADA training sessions hosted by five NPCs earlier this year have made a difference in the inquiries coming into TTP.  Although the volume of questions remains high, it appears that more CRADAs are now being handled in the field without TTP or OGC involvement.  Also, requests for TTP review of potentially significant changes to models are now better formatted and many are informal inquiries that can be handled quickly.  Jeff noted that TTP is aware of about 350 CRADAs being signed so far this year, more than twice the number signed during all of 2008.  

 

Jeff pointed out that VA now has 11 fully executed masters (see lists maintained at http://www.research.va.gov/programs/tech_transfer/crada/registry.cfm)

 

Amgen

Bristol-Myers Squibb

Genentech

GSK

Merck

Novartis

OncoGenex

Pfizer

Roche

Sanofi-Aventis

Sucampo

 

Also available for immediate use while they undergo final VA concurrence are masters with six other companies: 

 

Astellas

AstraZeneca

Avigen

Lilly & Lilly when Quintiles is the CRO

Regenesis Biomedical, Inc.

Takeda

 

Jeff is currently working on masters with:

 

Johnson & Johnson

Abbott

Boston Scientific

OSI

Boehringer-Ingelheim

Novo Nordisk

Fibrogen

Celgene

 

Jeff would like to have negotiations with more companies underway.  He encourages NPCs to suggest other companies that conduct - or would like to conduct - a significant number of studies with VA and may be interested in a master.  Please send an email to Jeffrey.Moore@va.gov with your suggestions and if possible, a company contact. 

 

Finally, Jeff will be speaking during the MAGI Clinical Research Conference – 2009 West being held in San Diego on October 4-6.   This will be another opportunity to educate pharmaceutical companies about VA CRADAs.

 

Questions or comments about this Update may be directed to::::
Email: navref@navref.org | Phone: 301-656-5005 | Fax: 301-656-5008
 

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last updated: 01/04/10

 

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