News
Examining the analytical curriculum Two workshops to study curriculum development in the analytical sciences are being funded by the National Science Foundation (NSF) and are being chaired by Theodore Kuwana, professor of chemistry at the University of Kansas. The first in the series was held last October, and the second is tentatively scheduled for March. According to NSF documents, the workshops are being financed by a grant of ~ $90,000, awarded through the Division of Undergraduate Education. Representatives from a broad range of academic institutions (including two-year, four-year, and graduate), government laboratories, and industry gathered at the first workshop to discuss what needs to be done to strengthen training and education in the analytical Theodore Kuwana sciences, Kuwana told Analytical Chemistry. He said that the first workshop made a good start of defining the issues. "I was simultaneously pleased and shocked that people [from such a broad range of institutions] were having the same thoughts [about curriculum reform]," says Pam Mabrouk of Northeastern University. Henry Blount, program director for the Analytical and Surface Chemistry program of the NSF Division of Chemistry, says, "This represents the bringing together of two very disparate camps. It's something like bringing the College of Arts and Sciences together with the College of Education in academia, which some folks don't think ever happens." Kuwana expects the final report from the fall 1996 and spring 1997 workshops to be available sometime in 1997. He hopes to hold a session at Pittcon 1998 so that the analytical community can discuss the final report generated as a result of the two workshops. Celia Henry
Specified, not well-characterized, biologics The well-characterized biologic is no more. At least the name is no more. Speaking at an October workshop at which the organizers and presenters persisted in calling 16 A
these biological pharmaceutical products "well-characterized", Bruce F. Madder of the law firm Fenwick and West told the audience that the U.S. Food and Drug Administration (FDA) is now using the term "specified biologies". Those attending the workshop were able to hear about FDA's policies only secondhand; Neil Goldman, associate director for research at the Center for Biologies Evaluation and Research (CBER), was originally slated to speak but was unable to attend. The specified biologies refer to predefined categories that include recombinant DNA-derived proteins, monoclonal antibodies, synthetic peptides with fewer than 40 amino acids, and synthetic plasmids and nucleic acids. Any product in these four categories will be assumed to be eligible for the reforms being implemented by FDA—elimination of lot release, elimination of the establishment license application, and greater flexibility for making changes to the production process (Anal. Chem. 1996, 68, 674A)— unless FDA presents compelling reasons for excluding a product. CBER will consider expanding the categories on a caseby-case basis. Mackler said that these policies are emanating from a "converted CBER", a "CBER that has seen the light". Lisa Raines, vice president for government relations at Genzyme Corp., said that the Biotechnology Industry Organization (BIO) has submitted a proposal to FDA to create an Accelerated Study and Approval Partnership (ASAP). The ASAP proposal merges several currently underused programs for accelerating the approval process for breakthrough therapies, which are defined as those products that represent a substantial gain in therapeutic value over existing products. It also consolidates the early clinical trials for drugs in the program and allows a streamlined "short form" application with loosened approval criteria. However, the "short form" approval would be followed by postapproval validation studies. Under BIO's proposal, FDA would retain the authority to withdraw marketing approval for ASAP products that did not prove adequately safe and efficacious in postmarketing studies. The ASAP proposal deals with clinical testing, and Raines doesn't think that the proposal will change the analytical testing procedures. The proposal has been presented to FDA as part of the industry's discussions about user fees, but Raines does not know when all differences between the industry and FDA will be resolved. Celia Henry
Analytical Chemistry News & Features, January 1, 1997
CO monitor recommendations The U.S. Consumer Product Safety Commission (CPSC) issued a report in October recommending 17 changes in the standards for home carbon monoxide detectors promulgated by Underwriters' Laboratories. The recommendations follow public hearings held in February during which participants complained about the tendency of the monitors to generate false alarms and asked for new alarm levels (Anal. Chem. 1996, 68, 237 A). Among the recommendations in the CPSC report are elimination of the "warning" signal on monitors that was triggered at a CO exposure level corresponding to an estimated 5% carboxyhemoglobin in the blood. On the other hand, the recommendations left alone the more life-threatening "alarm" signal that corresponds to 10% carboxyhemoglobin and added a new longterm exposure alarm level of 70 ppm CO for 240 min. In addition, CPSC proposed new definitions of "must not alarm" levels (50 ppm for 1 h, 30 ppm for 30 days). These changes, according to the CPSC report, will eliminate confusion about the differences between warning and alarm signals, reduce false alarms attributed to ambient air pollution, and improve public safety by adding a new threshold value that protects against harmful, continuous, low-level exposure. According to Elizabeth Leland of the CPSC, the report is now in the hands of Underwriters' Laboratory, which is beginning a technical review of the recommendations. Alan Newman
Analytical Chemists: The Next Generation Are you an analytical chemistry graduate student who's planning to attend Pittcon? If so, Analytical Chemistry would like to discuss your experiences as a graduate student over lunch. The information gathered from the group session will be used for a "Focus" article with a strict code of anonymity, so you don't need to worry about ramifications to yourself or to your advisor. For more information or if you are interested in participating, please contact Celia Henry by e-mail at
[email protected] or by telephone at 202-8724372.
