March 31 OGC Decision Memo. VHA and OGC continue to implement the recommendations of the Review Team (see March 22 newsletter - http://www.navref.org/newsletter/2007/update_032207.htm) in regard to CRADAs and technology transfer in the VA. The latest development is a March 31, 2007, OGC decision memo from Deputy General Counsel Jack Thompson to Acting General Counsel Paul Hutter. The signed “agreed” document was sent to Regional Counsel attorneys last week, but is not available for general distribution.

The memo discusses “the latitude federal agencies have to negotiate interests in intellectual property that may result from research in collaboration with outside sponsors” as well as general principles and key elements of the CRADA statute. In signing the document, Mr. Hutter agrees to a number of OGC recommendations concerning interpretation of the CRADA statute. The conclusions reached will inform forthcoming VHA technology transfer policy that ultimately will guide CRADA intellectual property ownership and licensing terms.

Other CRADA Developments:

• The CRADA work group continues to meet weekly and has nearly completed a thorough revision of the model CT CRADA. It will be released for general use as soon as it undergoes final concurrence.

• Jim Klein, Counselor to the Regional Counsel, Region 12, who is based in their Lincoln, Nebraska office, has been detailed to TTP for four months to work on master CRADAs with major pharmaceutical companies.

• TTP has been granted authority to hire two additional staff members. These positions should be posted shortly and will be filled as soon as possible to help TTP handle the anticipated volume of CRADAs as the transition from clinical trial agreements moves forward.

NAVREF greatly appreciates the time and effort many people are devoting to advancing CRADAs for industry-sponsored studies. Updates will be provided as new developments occur.