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Objective: To assess the potential actions of medical school deans, graduate medical education (GME) committee chairs, and hospital chief executive officers (CEOs) regarding future funding reductions for residency training. Specifically, institutions with emergency medicine (EM) residencies were surveyed to see whether EM training was disproportionally at risk for reductions., Methods: An anonymous 2-page survey was used. Ninety-eight EM residency programs were identified using the American Medical Association Graduate Medical Education Directory 1994-95. Seventy deans, 102 GME chairs, and 97 hospital CEOs were identified. The survey posed a hypothetical 25% forced reduction in residency positions and asked the decision makers for their responses. Options included: 1) proportional reductions of training positions from all residencies, 2) proportional reductions in either primary care or specialty residency positions, or 3) reduction or elimination of specific training programs. The survey asked for a first and second choice of residencies to be reduced or eliminated from an alphabetical list of 17. The survey elicited explanations for each program reduction., Results: 200 (74%) of 269 surveys were returned. Eighty-four responders selected specific residencies to be reduced or eliminated. EM was selected 8 times, making EM the seventh most vulnerable residency to be targeted for reductions. The decision makers who selected proportional reductions chose to reduce across all residencies 32 times, among only the specialty residencies 129 times, and among only the primary care residencies 3 times., Conclusions: In the setting of anticipated residency cuts, favored proportional reductions in specialty residencies would likely affect EM training. However, most GME decision makers with an existing EM residency program do not consider the EM residency a top choice to be reduced or eliminated.

Cell line characterization is an integral part of establishing quality control over the manufacturing process of a biological product. Characterizing the general and unique features of the continuous cell line and the absence or presence of contaminants establishes a fundamental knowledge about the raw material from which the biological product is being derived. Such information can be used for cell line selection, design of the purification scheme and extent of ensuing validation studies. Developing the selected cell line into a cell bank system allows for a constant source of starting material and decreases the likelihood of contamination. Characterization of the cell bank system may include a) identification of the cell line species of origin, b) identification of unique reference markers, and c) pre-testing for cross-contamination and adventitious agents. This paper introduces issues surrounding present and upcoming methods used for authenticity and characterization testing of cell banks.

The Center for Biologics Evaluation and Research, whose regulatory authority includes monoclonal antibodies, cytokines, vaccines, toxins and somatic cellular therapies, communicates to sponsors issues for consideration in the development of biological products through the publication of "Points to Consider" and "Guideline" documents. This paper summarizes the available "Points to Consider" and "Guideline" documents and outlines recommendations from these documents for characterizing the cells used to produce biological products.