Determining Core Capabilities in Chemical and Biological Defense Science and Technology (2012) / Chapter Skim
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5 Management of Science and Technology at CBDP
5 Management of Science and Technology at CBDP
Pages 83-104
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From page 83... ...
In addition, since one of the objectives for this study is to provide input that will assist the DASD(CBD) in "identifying the current model for sustaining lab infrastructure within DoD and determining if this is the most effective method for maintaining DoD critical infrastructure," this chapter also presents observations regarding laboratory management within the CBDP.
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From page 84... ...
We suggest that the CBDP survey the facilities to identify where positive relationships exist, between Special Forces or the Services broadly, and seek to replicate such interactions. At the program management level, it may be difficult to encourage the strengthening of such relationships unless and until a capabilities-based approach is adopted as it may be challenging to see how providing R&D performers with greater operational context can be relevant to meeting specific requirements.
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From page 85... ...
One particularly stark example of the importance of an end-to-end project management authority, or at least consensus on the appropriate transition point, is in the development of medical countermeasures (see Box 5.1 highlighting some failures of medical products where poor transition between development stages was a contributing factor)
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From page 86... ...
In addition to challenges presented by the existing program management structure, the medical production process has not traditionally been a major focus of DoD, and as a result, the in-house expertise at the decisionmaking process is likely to be limited.
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From page 87... ...
Over the course of the committee's data-gathering, it was apparent that the current process for development of medical products has led to few, if any, new therapeutics. Discussions with CBDP staff indicated that the following factors are contributing to the low success rate: · Minimal communication between the JSTO-CBD and JPEO-CBD managers to facilitate product development; · An apparent expertise gap in the management offices, particu larly regarding identification and handling of critical transition points in product development; · Turnover in personnel at several levels without a committed leg acy of ongoing product development makes for multiple "starts and stops" during the process;
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From page 88... ...
The committee believes that a formal, preferably external, review of the process would be valuable before taking action to modify the current process . Establishing "Common Language" for Transition of Medical Countermeasures One possible model for managing medical product development transitions is demonstrated by the integrated portfolio for CBRN countermeasure development through BARDA.
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From page 89... ...
, as part of a broader strategy within the CBDP for FDA-regulated products to more efficiently use available advanced development funds, successful programs could be "parked" after construction of the IND or after Phase I trial completion. This could be especially useful when the program has multiple potential products in any given area of need.
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From page 90... ...
. 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 BOX 5.3 The Role of Medical Laboratories in Chemical and Biological Defense Research In the 1980s and 1990s, the funding at medical facilities for chemical and biologi cal research was provided by DTRA directly to the commanders for their allocation and distribution.
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From page 91... ...
This stewardship also extends to funding and directing the scientific work of the program. Successful Laboratory Management The CBDP relies upon a laboratory network and test ranges to provide RDT&E and produce products critical to the chemical and biological defense of the nation.
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From page 92... ...
There may be times when it is appropriate to undertake high-risk, high-payoff projects which may ultimately fail in addition to maintaining long-term focus on a specific area with low risk in order to provide fundamental understandings that support new developments. An effective program will create a balanced portfolio of these various research types.
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From page 93... ...
Internal, and especially external, standing technical review committees (supplemented by those with operational knowledge) are required to ensure that unsuccessful programs are terminated, to provide technical review for highrisk/high-payoff projects, and to encourage consideration of programs that may not have originated within the facility.
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From page 94... ...
In order to be effective, a balance should be found with significant amount of core funding "guaranteed" and the remainder pro vided through a competitive environment. Element 5: Effective Asset Management at the Laboratory Level Some local control of funding is considered by the committee to be an important component of successful laboratory management.
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From page 95... ...
can also help identify potentially underused facilities or resources that can be repurposed or exploited by others in need of additional capacity (note that this can also result in identification of opportunities of "Work for Others" funding)
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From page 96... ...
Also see Box 5.5. Clear Mission and Objectives The official CBDP mission is to "provide global chemical, biological, radiological, and nuclear defense capabilities in support of National Strategies." This is a broad statement and can be applied to a variety of activities.
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From page 97... ...
One area where this can be seen most clearly is development of licensed medical products. Coordination between multiple offices within DoD and with the FDA are required for successful transition of a prototypical medical product to clinical trials and ultimately to licensing.
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From page 98... ...
About the only certainty is that any multiyear plan involving CBD science challenges will require major revisions by the second or third year, if not sooner. The team and its leadership need to have the capability to react to major changes in plans and still achieve victory.
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From page 99... ...
Major DoD CB science challenges are inherently Big Science projects that need to be managed appropriately. The skill of effective team formation and mo tivation cannot be overestimated as necessary leadership criteria when it comes to managing Big Science challenges.
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From page 100... ...
With regards to laboratory-level funding, care should be taken to ensure that the recent construction of new buildings, some of which will place new demands on operations and maintenance budgets, does not cause the resources of laboratories and facilities to become overstretched. Effective Asset Management at the Laboratory Level Funding for CBD research at the laboratories is awarded through a competitive process directly to the principal investigators.
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From page 101... ...
Within DoD CBD laboratories, there was a noticeable lack of connectivity to research in other institutions and an independent review process, especially in the critical research phase. FINDINGS AND RECOMMENDATIONS This final chapter has brought forth a series of principle findings and recommendations that can assist the program in operating a successful laboratory environment.
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From page 102... ...
should evaluate alternative program management approaches, including incorporation of an endto-end project management authority, especially for the medical countermeasures program. Laboratory and Major Facility Management Finding 5.3: The principal RDT&E military organizations associated with the CBDP are benefiting from major facility investments that are planned to provide both capabilities and capacities to meet the anticipated needs of the program.
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From page 103... ...
Recommendation 5.2: The DASD(CBD) should formally review alternative laboratory management models, taking advantage of the numerous prior studies, reviews, and evaluations of laboratory and large facility management of S&T organizations.
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