12th GCC Closed Forum: critical reagents; oligonucleotides; CoA; method transfer; HRMS; flow cytometry; regulatory findings; stability and immunogenicity.

The 12th GCC Closed Forum was held in Philadelphia, PA, USA, on 9 April 2018. Representatives from international bioanalytical Contract Research Organizations were in attendance in order to discuss scientific and regulatory issues specific to bioanalysis. The issues discussed at the meeting included: critical reagents; oligonucleotides; certificates of analysis; method transfer; high resolution mass spectrometry; flow cytometry; recent regulatory findings and case studies involving stability and nonclinical immunogenicity. Conclusions and consensus from discussions of these topics are included in this article.

Small molecule specific run acceptance, specific assay operation, and chromatographic run quality assessment: recommendation for best practices and harmonization from the global bioanalysis consortium harmonization teams.

Consensus practices and regulatory guidance for liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS) assays of small molecules are more aligned globally than for any of the other bioanalytical techniques addressed by the Global Bioanalysis Consortium. The three Global Bioanalysis Consortium Harmonization Teams provide recommendations and best practices for areas not yet addressed fully by guidances and consensus for small molecule bioanalysis. Recommendations from all three teams are combined in this report for chromatographic run quality, validation, and sample analysis run acceptance.

Recommendations on biomarker bioanalytical method validation by GCC.

The 5th GCC in Barcelona (Spain) and 6th GCC in San Antonio (TX, USA) events provided a unique opportunity for CRO leaders to openly share opinions and perspectives, and to agree upon recommendations on biomarker bioanalytical method validation.

2012 white paper on recent issues in bioanalysis and alignment of multiple guidelines.

Over 400 professionals representing pharmaceutical companies, CROs, and multiple regulatory agencies participated in the 6th Workshop on Recent Issues in Bioanalysis (WRIB). Like the previous sessions, this event was in the format of a practical, focused, highly interactive and informative workshop aiming for high-quality, improved regulatory compliance and scientific excellence. Numerous 'hot' topics in bioanalysis of both small and large molecules were shared and discussed, leading to consensus and recommendations among panelists and attendees representing the bioanalytical community. The major outcome of this year's workshop was the noticeable alignment of multiple bioanalytical guidance/guidelines from different regulatory agencies. This represents a concrete step forward in the global harmonization of bioanalytical activities. The present 2012 White Paper acts as a practical and useful reference document that provides key information and solutions on several topics and issues in the constantly evolving world of bioanalysis.

Counting calories: resident perspectives on calorie labeling in New York City.

OBJECTIVE: The present study investigates consumer responses to New York City's 2008 calorie labeling regulation in 2 lower-income neighborhoods of New York City. METHODS: Focus groups were conducted, and 34 fast-food consumers participated. Group summaries and descriptive and analytic depictions of group responses and interactions were developed based on a thorough examination of the notes and tapes. RESULTS: Findings included that there is support for the regulation, as well as skepticism regarding the potency of calorie posting as a behavior change tool. In addition, there were strong beliefs about both parental responsibility for children's eating habits as well as the role of poverty, hunger, and lack of education in food selection. CONCLUSIONS AND IMPLICATIONS: Calorie labeling is one avenue for educating consumers about nutrition; however, given competing factors in food choice decisions as well as the realities of hunger and poverty, more proactive measures are needed.

Toward a smoke-free Harlem: engaging families, agencies, and community-based programs.

The aim of this collaborative public health study was to engage families, agencies, and programs in reducing secondhand smoke exposure in Central Harlem, New York City. Baseline interviews (n=657) and focus groups (n=4) were conducted with adult members of households with children who had asthma and asthma-like symptoms in the Harlem Children's Zone Asthma Initiative. The interviews concerned the prevalence and determinants of exposure of enrolled children to secondhand smoke. Key findings were that participants: (1) were generally aware of the hazards of secondhand smoke; (2) used strategies to reduce exposure to secondhand smoke in their homes; (3) believed that outdoor pollutants are sometimes just as bad for the health of their children as secondhand smoke; and (4) used smoking to provide stress relief and help diffuse otherwise volatile situations in their homes. The Harlem Smoke-Free Home Campaign was launched in October 2007 based in part on these findings.