Please see below for an email from Amy Centanni, director of VA’s Technology Transfer Program (TTP), and make note of the three important documents attached to this email. These are the latest results of much hard work by the TTP, OGC and NAVREF members of the CRADA Work Group. These documents are applicable to the Phase I & II and Phase III & IV Clinical Trial CRADAs published previously and posted on the VA intranet at http://vaww.research.va.gov/programs/tech_transfer/model_agreements/default.cfm.

Although the document named “CRADA legal review process” is directed primarily to the field attorneys who review CRADAs, and the SOPs are directed toward NPC and facility Research Office personnel, all three documents are being disseminated broadly in the interests of coordinating smooth processing of CRADAs.

The CRADA Work Group continues to meet almost weekly in order to make progress on master CRADAs with major pharmaceutical companies as well as additional model CRADAs, including those appropriate for device studies, basic research, material transfers and PI-initiated clinical studies.

Please note that TTP has a new staff assistant, Ms. Noaline Stuart (Noahline.Stuart@va.gov). Emails regarding TTP administrative matters and notices regarding posting CRADAs to the CRADA Registry should be directed to Noaline.

From: Centanni, Amy [mailto:amy.centanni@va.gov]
Sent: Thursday, June 28, 2007 4:43 PM
To: VHA CO 12 ACOS; VHA CO 12 AO
Cc: Kupersmith, Joel; Francis, Joe
Subject: CRADA procedures

Dear all,

In furtherance of our transition from clinical trial agreements to CT CRADAs my office is providing additional documents that should assist you in negotiating and executing these agreements. The documents are as follows:

1. Standard Operating Procedures (SOPs) – this outlines the process for negotiating and executing CT CRADAs.
2. Legal Review Process – this outlines the legal process that will be followed by all regional counsel attorneys.
3. Annotations – this provides explanations and guidance on why certain provisions were changed, what is negotiable and what arguments you can use with the pharmaceutical companies during negotiations.

We continue to work on the remaining model agreements and hope to have those completed within the next three weeks. In addition we continue to work on master agreements. We are confident that we will have several signed agreements within the next several weeks. As soon as these additional documents are available my office will forward them to you for use in the field.

I thank you for your continued patience during this transition process.

Amy Centanni
Director, Technology Transfer (12TT)
Department of Veterans Affairs
810 Vermont Ave, NW
Washington, DC 20420
(202) 254-0199
(202) 254-0460 (fax)