PERSUASIVE BUSINESS REPORT

Persuasive Business Report



Persuasive Business Report

Part I: Progress Report

A major impetus toward organizing the Global HIV-AIDS Enterprise was the need to accelerate the progress made in HIV-1 vaccine basic and translational research. Thus, the organizational strategy of CHAVI has been to simultaneously organize both the infrastructure and scientific program of CHAVI, and to establish an aggressive timeline for clinical trials and basic research to begin. (Gibb, 1979, 201-208) The CHAVI organizational meeting was held in Durham, NC, August 23-24, 2005 with 166 participants. These initial CHAVI Scientific plans were reviewed and revised, and plans were initiated to quickly organize CHAVI in the following areas. 1) Grants Management and Compliance; 2) Intellectual Property and Legal Issues; 3) Establishment of a CHAVI Clinical Trials Network for Blood/Tissue Sample Collection; 4) Establishment of Functional Leadership and Decision-making Capacity; 5) Establishment of Functional Discovery Teams; 6) Recruitment of a CHAVI Scientific Advisory Board and Organization of the First CHAVI Review. (Hall, 1983, 72-91)

For our post-grant award scientific strategic planning process, this fall, we have had four additional meetings:

Strategic Planning, Boston, Sept 30-Oct 2, 2006; Lab Data Analysis, Durham, Nov. 2,3, 2006; Mucosal Immunity Think Tank, Durham, Nov 9, 10, 2006; European Consortium for Host Genetics of Control of HIV Infection, December 16, 2006. In addition, the CHAVI Scientific Leadership Group will have one final planning meeting in Durham, February 13, 14, 2006. From all of these strategic planning efforts have come our expansion plans. (Kluckhohn, 1961, 55-61)



Grants Management and Compliance

At the CHAVI organizational meeting in August 2005, a grants management team of Duke, Oxford, UAB, Harvard and NIH grants managers met and established standard operating procedures for expediting subcontracting activities, as well as invoicing on grants compliance and accounting activities. In addition, to ensure appropriate and accountable CHAVI grants management, we have arranged a yearly CHAVI audit by the independent Duke Audit Office. (Schauber, 1999, 33-41) As of January 10, 2006, all domestic subcontracts have been written and approved by NIH, and funds for research on existing anti-HIV-1 infection patient samples released. Subcontracts for all but four international sites have been written and approved by the NIH, and funds have been released for site development.



Intellectual property and Legal Issues

We have hired the CHAVI Intellectual Property Manager and Legal Affairs Manager. They have written the CHAVI research agreement to include a global access plan for availability of CHAVI discoveries, and as well covering all aspects of CHAVI member interactions including confidentiality protection of intellectual property, compliance, liability, sharing of data, and sharing of reagents. For example, CHAVI participants have signed a master Material Transfer Agreement such that reagents and samples can be expeditiously shared among CHAVI members. (Schneider, 1996, 7-19)



Establishment of CHAVI Clinical Trial Sites for Recruitment of Acute HIV Infection and Exposed and Uninfected Samples

To meet the need for provision of clinical samples of blood, genital samples, breast milk, and other tissues for CHAVI research, we have established a network of collaborating clinical sites at Durban and Johannesburg, South Africa; ...