As was described in Chapter 1, the RDT&E elements within the CBDP draw upon and direct resources within a number of different laboratories and facilities. These include service laboratories, medical laboratories and facilities, and test and evaluation facilities. Each laboratory and facility has its own mission and management structure, and this has implications for the ability of the CBDP to successfully manage its projects and programs (see Box 5.3). This section presents a brief overview of the history of the management of laboratory research at medical and non-medical facilities, identifies elements of laboratory management the committee feels are critical for success, and presents possible alternative methods for
The Role of Medical Laboratories in Chemical
and Biological Defense Research
In the 1980s and 1990s, the funding at medical facilities for chemical and biological research was provided by DTRA directly to the commanders for their allocation and distribution. At that time, the laboratories performed basic science in support of understanding the medical response to exposure to chemical or biological agents. The research was not focused on the development of specific products, such as vaccines or countermeasures. Beginning in the early 1990s, DTRA began directing these R&D funds through MRMC (US Army Medical Research and Materiel Command), giving MRMC’s command structure both responsibility and authority for the science within their major laboratories. Under this new model, funding was allocated by program and, as a result, the laboratories became focused on the development of specific product targets, e.g., an anticonvulsant or a plague vaccine, though still on the basic science in support of that target. Advanced development leading to an FDA-licensed product was not within the laboratories’ purview.
When the JPO was formed, the role of the laboratories changed again. Now medical laboratories, specifically USAMRIID and USAMRICD, were asked to take candidate countermeasures beyond the basic science toward the development of a licensed product. This required the laboratories to produce pilot-scale lots of GMP (good manufacturing practices) candidate product and to conduct the GLP (good laboratory practices) pre-clinical studies in preparation for the initial submission to FDA for approval.
This continued until the formation of JSTO-CBD in 2003. Though the focus on specific product development continued after that point, investigators within the laboratories were asked to respond to specific requests for proposals in a competitive environment, rather than the laboratories pursuing a program (e.g., development of an anthrax vaccine) with guaranteed funding. With this change, the responsibility for performance remained with the laboratories and the authority to manage the programs resided at JSTO-CBD in Ft. Belvoir.