As we approach the 5^th anniversary of the April 1, 2005, CRADA mandate, we should all take a moment to reflect on the extraordinary progress made during the intervening years thanks to countless hours of effort by staff of the VA Technology Transfer Program (TTP) and the Office of General Counsel (OGC), including Regional Counsel (RC) attorneys. 

Of particular note:

·         At the present, there are over 600 active VA CRADAs with more than 220 different companies. 

·         Master CRADAs negotiated by TTP Technology Transfer Specialist Jeffrey Moore, PhD, and OGC Professional Staff Group (PSG) III continue to be the most expeditious path to an executed CRADA.  Over 50 CRADAs have been executed using the Novartis master alone.  VA expects to complete more masters during the coming weeks.

·         Jeff regularly reviews the CRADA Registry to identify companies that have executed 3 or more CRADAs and contacts them to assess interest in negotiating a master.  However, referrals from NPCs are welcome.  We understand that VA would like to have 10-15 new masters under negotiation during 2010.

In an ongoing effort to support TTP and OGC PSG III on CRADA-related matters, NAVREF representatives are in regular contact with these offices and we wish to share a few general points from the most recent conversation: 

·         Some NPCs will recall that designating CRADAs as “focus cases,” which are high priority cases for Regional Counsel attorneys, was explored during some of the Advanced CRADA Training sessions held in 2009, and in a letter NAVREF sent to PSG VI.   However, OGC PSG III will not designate CRADAs as “focus cases” because it is moving toward other metrics. 

·         Beta testing of the online CRADA Registry, which will replace the Excel spreadsheets currently being used, will involve five NPC volunteers and will begin as soon as VA IT resolves some firewall issues.  In the meantime, Jeff is working with IT personnel to work out systems for passwords and access.

·         With the assistance of PSG III, updated CRADA models will be forthcoming.  When finalized, these will reflect suggestions from collaborators and improvements in wording.  For the most part, the result is language that is more user-friendly and clearer to sponsors while still meeting VA requirements.  TTP will make an announcement when the CRADA models are updated. 

Updated models will be posted on the VA intranet as they become available.  To ensure that you are sending the latest version to a potential collaborator, always download models directly from the VA web site.  Go to:  http://vaww.research.va.gov/programs/tech_transfer/model_agreements/default.cfm (accessible on the VA intranet only)

In regard to CRADA reviews and processing:

·         It is the responsibility of NPCs to negotiate terms of CRADAs to the extent possible before involving RC attorneys or TTP.  It appears that some NPCs continue to send sponsor redlines to RC attorneys without first reviewing them and at least attempting to negotiate appropriate terms.  It is important that NPC personnel become familiar with CRADAs and their processes so they can take the lead and perform the first thorough review of the sponsor’s redlines.

CRADA annotations associated with model CRADAs provide a good sense of negotiating latitude on clauses.  For models, SOPs and annotations, see http://vaww.research.va.gov/programs/tech_transfer/model_agreements/default.cfm on the VA intranet.

Going forward, it is essential that every NPC have at least one staff member who is responsible for understanding CRADA requirements and negotiations with sponsors.  The CRADA 101 training conducted in December, and follow up CRADA 201 training planned for April, should be of help to those NPCs that to date have lacked such expertise. 

For those who missed the December training, or who would like to review some of the points made, a recording is available on the VA intranet at http://10.222.42.1/mediasite/Viewer/?peid=6b2cdbc965804632a99fb55dfaae3938.  The related PowerPoint slides are also available on the VA intranet at:

http://vaww.sharepoint.gc.va.gov/workgroups/sp/research/Training/Forms/AllItems.aspx?RootFolder=%2fworkgroups%2fsp%2fresearch%2fTraining%2fCRADA%20101%20%28Dec%202009%29&FolderCTID=&View=%7bBA6D926F%2d7985%2d4735%2d94F3%2dCF2242B37199%7d

If you have difficulty retrieving the slides, please contact Jeff (Jeffrey.Moore@va.gov) to request a copy of the PowerPoint slides.

·         Experienced personnel from eight NPCs have offered to assist other NPCs with CRADAs.  Any NPCs interested in receiving help should contact the NAVREF office, and we will do our best to match you up with someone offering the level of assistance you need.    

·         The advanced CRADA training conducted around the country during the first half of 2009 appears to have helped NPC personnel and RC attorneys establish working relationships to facilitate completion of CRADAs. However, isolated problems still seem to be occurring.  To resolve problems:

o    For issues regarding TTP responsiveness, send an email to TTP Director Amy Centanni (Amy.Centanni@va.gov).

o    For issues with responsiveness at the Regional Counsel staff attorney level, communicate with the appropriate Regional Counsel or you may send an email to PSGIII Associate General Counsel Renée Szybala (Renee.Szybala@va.gov), to whom you should also send comments on the responsiveness of OGC PSG III attorneys.

General comments about problems are welcome, but details would allow more focused solutions so it is advisable to track your interactions with TTP and RC attorneys for each CRADA.  An Excel spreadsheet or other tracking device is fine.

·         The goal is field management of most CRADA reviews and approvals.  However, TTP is responsible for managing requests for CRADA reviews and questions when VA Central Office (CO) involvement is necessary.  Under the written SOPs, requests for CO review of a CRADA must be sent to Amy Centanni with a cc to Renée Szybala.  Amy will assign a TTP staff member and Renee will assign an OGC PSG III attorney to handle the case.

·         After an NPC’s attempts to negotiate and resolve issues in a redlined CRADA are complete, it is necessary to identify communications with RC attorneys and TTP as requests for formal – not cursory – review in order to start clocks ticking on SOP turnaround times.  Requests for “cursory” review will not punch the clock. 

If an NPC sends a CRADA to RC for review and the staff attorney has a question about a clause or redline for TTP or OGC PSG III, the time it takes for TTP or OGC PSG III to respond is not included in the turnaround time specified in the SOP.  When an NPC sends a review request to an RC attorney, it is incumbent on the NPC to follow up with the RC attorney as needed to obtain a timely response.  If an RC sends a question to TTP or OGC PSG III, the RC attorney should be following up with TTP or OGC PSG III as needed to obtain a timely response.

·         A new SOP on multi-site CRADAs was published in late 2009.  Multi-site CRADAs are appropriate when two or more VAMCs will participate in a study using the identical protocol.  This SOP requires NPCs always to inquire of sponsors whether:

1) The sponsor plans to enlist additional VA sites for the same study; and

2) The NPC is the first one associated with a VA site to be contacted. 

If the answer is “yes” to both 1) and 2), NPCs should send an email to TTP (Amy.Centanni@va.gov) and to OGC PSG III (Renee.Szybala@va.gov) asking for initiation of a multi-site CRADA. They will identify a lead NPC to negotiate the multi-site CRADA and an RC attorney to handle review and approval. 

If the answer is “yes” to 1) and “no” to 2), ask the sponsor what site and NPC has taken the lead on the multi-site CRADA and follow up with that NPC.  Also, check the CRADA registry (http://www.research.va.gov/programs/tech_transfer/crada/registry.cfm) where in process and previously approved multi-center CRADAs will be clearly identified. 

After a multi-site CRADA has been negotiated by the lead NPC, approved by the appointed RC and signed by the MCD, that CRADA must be implemented without change by any VAMC wishing to participate in that multi-site clinical trial. The result is that in effect, each multi-site study CRADA is a mini-master for that specific protocol.  NPCs will personalize the cover and signature pages, and may negotiate their own budget terms, but otherwise the body of the CRADA must remain unchanged.  This process is intended to facilitate multi-site studies and avoid duplication of effort.

The multi-site CRADA SOP can be found at:

Publicly accessible:  http://www.research.va.gov/programs/tech_transfer/policies/default.cfm

On the VA intranet: http://vaww.research.va.gov/programs/tech_transfer/model_agreements/default.cfm

As NPC staff gain more confidence and broader understanding of CRADAs and VA policies, we should continue to see an upward trend in both the number of CRADAs executed and the timeliness of completing the negotiations.  Where there are problems, we hope the above discussion and upcoming continuing training will be of help. 

As always, do not hesitate to contact the NAVREF office so we can incorporate your concerns – as well as your tips for successful outcomes - in our discussions with TTP and OGC PSG III.