CRADA UPDATEJuly 27, 2006

Nancy Watterson-Diorio, CEO

Your nonprofit is at risk…

…as are all of the VA NPC’s

across the country.

WHY

1) There is little improvement in the NPC’s ability to execute and move ALL extramural research projects through the approval and execution process;

2) Sponsors are hesitant to work with VA because of the new CRADA regulations; and

3) Summer holiday schedules – typical slow down in business

WHAT REALLY IS AT RISK NATIONALLY

(cont.)• Loss of $200 M (Nat’l annual income;

unaudited figures) in extramural research grants AND $200 in M VERA dollars

• (TOTAL OF $400 M)

• Diminished ability to bring new technology and pharmaceutical interventions to our veterans

• Faculty leaving the VA to have access to institutions who support their academic research interests.

(cont.) WHAT REALLY IS AT RISK NATIONALLY

• Resignation of NPC staff with history and expertise in supporting VA research administration

• Reduction in research employees paid by NPC’s

• Buildings, facilities, additional financial support of programs, animal research facilities

BVARI BUDGET FIGURES – CLINICAL RESEARCH PROJECTS

BVARI INCOME

2004 (1ST 6 Months) $438,000

2005 (1st 6 Months) $1,455,000 ↑232%

2006 (1st 6 Months) $950,000 ↓35%

CRADA 2005 TIMELINE (cont.)

• April, 2005 - Jack Thompson, OGC sends CRADA notification to field attorneys

• April, 2005 - Jack Thompson compromises and NPC’s may continue to use CRA’s, but must assess for risk until such time as OGC creates a process for execution of CRADA’s

(cont.)

CRADA 2005 TIMELINE

• November, 2005 CRADA workshop

in Santa Monica:

o New model for clinical research agreements

(far from ready for release)

o Review of CTAA modification

o No deadline for implementation of CRADA until

further work is done to review CRADA and

amend CTAA’s

(cont.)

CRADA 2005 TIMELINE

• November, 2005 - formation of CRADA

Working Group

(Includes Technology Transfer Program (TTP), B. West, NPC Executive Directors, Paul Hutter and a Group IV attorney)

CRADA 2006 TIMELINE (cont.)

• March 15, 2006 – deadline for CRADA implementation (for those NPC’s with CTAA modifications)

• May 21, 2006 MAGI meeting – 1st public discussion with sponsors on the change to CRADA

• May 30, 2006 - Dr. Perlin signs “Letter to Sponsors” outlining the new model CT CRADA

(cont.)

CRADA 2006 TIMELINE

• June 1, 2006 - CTAA modification deadline o Purpose – VA to take the lead on IP

• July 14, 2006 - BVARI returns TTP survey

• July 21, 2006 - BVARI sends CT CRADA announcement to BVARI sponsor contacts

(cont.)

CRADA 2006 TIMELINE

• July, 2006 - BVARI takes a proactive approach to supporting and facilitating the new CT CRADA model.

• July, 2006 - BVARI receives information from Durham NPC stating that all CRADA’s, with the exception of phase III and phase IV clinical research projects, require TTP review. TTP is required to send each agreement to OGC for final comments.

PROBLEMS AS WE SEE IT (cont.)

• Only one TTP director, two tech transfer specialists, and one accountant are assigned and are responsible for:

- VA NPC oversight office – annual reports

- Material transfer agreements (inbound and outbound)

- Confidentiality agreements

- Phase I and II CRADA’s

- Investigator initiated CRADA’s

- Basic science CRADA’s

- Animal research CRADA’s

(cont.)

PROBLEMS AS WE SEE IT

• TTP is required to send all CRADA’s they review through OGC – slow process review.

• OGC’s opinions are not consistent and are not problem-solving in nature.

(cont.)

PROBLEMS AS WE SEE IT

• Communication is inconsistent between TTP, regional counsel, NPC’s, and sponsors.

• Sponsors are not given a consistent message about what the CRADA is and that many of the clauses are negotiable – no sense of urgency on the part of TTP/OGC in getting to an executed agreement.

QUICK FIXES (Cont.)

• Liaison between TTP and OGC needs replacement (Paul Hutter), or TTP and OGC responsibilities in regard to CRADA’s should be consolidated in one office committed to positive outcomes and a high level of responsiveness

• Increased staff capacity in TTP

• More authority given to regional counsel for review of CRADA’s

(cont.)

QUICK FIXES• Coordinated plan for NPC’s to market the

CRADA to sponsors

• Increased coordination by NPC’s to facilitate the master and single study CRADA’s

• Redesign CRADA registry (http://www1.va.gov/resdev/programs/tech_transfer/crada/master-crada-registry-list.xls) for clarity and marketing appeal to sponsors

(cont.) QUICK FIXES

• Update CRADA registry promptly

• Teleconference with Dr. Kuppersmith with Boston’s leadership

SUMMARY OF EXECUTED AND PENDING CRADA’s

• Only 2 CSP CRADA’s finalized; 1 CSP CRADA pending

• 0 Master CRADA’s finalized; 6 Pending

• 3 Single study CRADA’s finalized;

• 2 Model CRADAs for NPC use posted on TTP website: - CT CRADA- Basic Science

WHATS NEXT – BVARI PLAN (cont.)

• BVARI to stay in constant touch with TTP, Regional Counsel, NAVREF and VA NPC colleagues

• Press for commitment to improve Basic Science model and to finalize 6 master CRADA’s by September 15, 2006

• NWD to make follow-up calls to each of the sponsors who received our recent CRADA notification packet

(cont.)

WHATS NEXT – BVARI PLAN

• Develop a “basic science, animal model” CRADA template for 2 pending BVARI projects

• Continue to work on finalizing a CT CRADA with Millennium

• Await Amgen CT CRADA (Durham) for execution for BVARI faculty

BVARI BOARD ACKNOWLEDGEMENT,

COMMENTS, AND DISCUSSION