The goal of this special volume is to provide veterinary scientists with state-of-the art reviews in animal health and to inform human health scientists of the various challenges and collaborative opportunities associated with their animal health counterparts. The contributors are highly respected experts, providing invaluable insights into current issues and state-of-the-art advances within veterinary medicine.
Veterinary medicine; harmonization
The purpose of this study was to compare relative precision of two different abbreviated impactor measurement (AIM) systems and a traditional multi-stage cascade impactor (CI). The experimental design was chosen to provide separate estimates of variability for each impactor type. Full-resolution CIs are useful for characterizing the aerosol aerodynamic particle size distribution of orally inhaled products during development but are too cumbersome, time-consuming, and resource-intensive for other applications, such as routine quality control (QC). This article presents a proof-of-concept experiment, where two AIM systems configured to provide metrics pertinent to QC (QC-system) and human respiratory tract (HRT-system) were evaluated using a hydrofluoroalkane-albuterol pressurized metered dose inhaler. The Andersen eight-stage CI (ACI) served as the benchmark apparatus. The statistical design allowed estimation of precision with each CI configuration. Apart from one source of systematic error affecting extra-fine particle fraction from the HRT-system, no other bias was detected with either abbreviated system. The observed bias was shown to be caused by particle bounce following the displacement of surfactant by the shear force of the airflow diverging above the collection plate of the second impaction stage. A procedure was subsequently developed that eliminated this source of error, as described in the second article of this series (submitted to AAPS PharmSciTech). Measurements obtained with both abbreviated impactors were very similar in precision to the ACI for all measures of in vitro performance evaluated. Such abbreviated impactors can therefore be substituted for the ACI in certain situations, such as inhaler QC or add-on device testing.
AIM; APSD; impactor; inhaler; simplified
Persons with chronic spinal cord injury (SCI) have a high lifetime need for ongoing patient education to reduce the risk of serious and costly medical conditions. We have addressed this need through monthly in-person public education programs called SCI Forums. More recently, we began videotaping these programs for streaming on our website to reach a geographically diverse audience of patients, caregivers, and providers.
We compared information from the in-person forums to that of the same forums shown streaming on our website during a 1-year period.
Both the in-person and Internet versions of the forums received high overall ratings from individuals who completed evaluation forms. Eighty-eight percent of online evaluators and 96% of in-person evaluators reported that they gained new information from the forum; 52 and 64% said they changed their attitude, and 61 and 68% said they would probably change their behavior or take some kind of action based on information they learned. Ninety-one percent of online evaluators reported that video is better than text for presenting this kind of information.
Online video is an accessible, effective, and well-accepted way to present ongoing SCI education and can reach a wider geographical audience than in-person presentations.
Patient education; Spinal cord injuries; Media; Print; Digital; Video; Internet; Secondary complications; Prevention; Self-care; Quality of life
The immunogenicity profile of a biotherapeutic is determined by multiple product-, process- or manufacturing-, patient- and treatment-related factors and the bioanalytical methodology used to monitor for immunogenicity. This creates a complex situation that limits direct correlation of individual factors to observed immunogenicity rates. Therefore, mechanistic understanding of how these factors individually or in concert could influence the overall incidence and clinical risk of immunogenicity is crucial to provide the best benefit/risk profile for a given biotherapeutic in a given indication and to inform risk mitigation strategies. Advances in the field of immunogenicity have included development of best practices for monitoring anti-drug antibody development, categorization of risk factors contributing to immunogenicity, development of predictive tools, and development of effective strategies for risk management and mitigation. Thus, the opportunity to ask "where we are now and where we would like to go from here?" was the main driver for organizing an Open Forum on Improving Immunogenicity Risk Prediction and Management, conducted at the 2012 American Association of Pharmaceutical Scientists' (AAPS) National Biotechnology Conference in San Diego. The main objectives of the Forum include the following: to understand the nature of immunogenicity risk factors, to identify analytical tools used and animal models and management strategies needed to improve their predictive value, and finally to identify collaboration opportunities to improve the reliability of risk prediction, mitigation, and management. This meeting report provides the Forum participant's and author's perspectives on the barriers to advancing this field and recommendations for overcoming these barriers through collaborative efforts.
ADA; anti-drug antibodies; immunogenicity; neutralizing antibodies; prediction; predictive sciences; risk assesment; risk management; risk mitigation
Leishmania (L.) amazonensis uses arginine to synthesize polyamines to support its growth and survival. Here we describe the presence of two gene copies, arranged in tandem, that code for the arginine transporter. Both copies show similar Open Reading Frames (ORFs), which are 93% similar to the L. (L.) donovani AAP3 gene, but their 5′ and 3′ UTR's have distinct regions. According to quantitative RT-PCR, the 5.1 AAP3 mRNA amount was increased more than 3 times that of the 4.7 AAP3 mRNA along the promastigote growth curve. Nutrient deprivation for 4 hours and then supplemented or not with arginine (400 µM) resulted in similar 4.7 AAP3 mRNA copy-numbers compared to the starved and control parasites. Conversely, the 5.1 AAP3 mRNA copy-numbers increased in the starved parasites but not in ones supplemented with arginine (p<0.05). These results correlate with increases in amino acid uptake. Both Meta1 and arginase mRNAs remained constant with or without supplementation. The same starvation experiment was performed using a L. (L.) amazonensis null knockout for arginase (arg-) and two other mutants containing the arginase ORF with (arg-/ARG) or without the glycosomal addressing signal (arg-/argΔSKL). The arg- and the arg-/argΔSKL mutants did not show the same behavior as the wild-type (WT) parasite or the arg-/ARG mutant. This can be an indicative that the internal pool of arginine is also important for controlling transporter expression and function. By inhibiting mRNA transcription or/and mRNA maturation, we showed that the 5.1 AAP3 mRNA did not decay after 180 min, but the 4.7 AAP3 mRNA presented a half-life decay of 32.6 +/− 5.0 min. In conclusion, parasites can regulate amino acid uptake by increasing the amount of transporter-coding mRNA, possibly by regulating the mRNA half-life in an environment where the amino acid is not present or is in low amounts.
Neuroscientists often need to access a wide range of data sets distributed over the Internet. These data sets, however, are typically neither integrated nor interoperable, resulting in a barrier to answering complex neuroscience research questions. Domain ontologies can enable the querying heterogeneous data sets, but they are not sufficient for neuroscience since the data of interest commonly span multiple research domains. To this end, e-Neuroscience seeks to provide an integrated platform for neuroscientists to discover new knowledge through seamless integration of the very diverse types of neuroscience data. Here we present a Semantic Web approach to building this e-Neuroscience framework by using the Resource Description Framework (RDF) and its vocabulary description language, RDF Schema (RDFS), as a standard data model to facilitate both representation and integration of the data.
We have constructed a pilot ontology for BrainPharm (a subset of SenseLab) using RDFS and then converted a subset of the BrainPharm data into RDF according to the ontological structure. We have also integrated the converted BrainPharm data with existing RDF hypothesis and publication data from a pilot version of SWAN (Semantic Web Applications in Neuromedicine). Our implementation uses the RDF Data Model in Oracle Database 10g release 2 for data integration, query, and inference, while our Web interface allows users to query the data and retrieve the results in a convenient fashion.
Accessing and integrating biomedical data which cuts across multiple disciplines will be increasingly indispensable and beneficial to neuroscience researchers. The Semantic Web approach we undertook has demonstrated a promising way to semantically integrate data sets created independently. It also shows how advanced queries and inferences can be performed over the integrated data, which are hard to achieve using traditional data integration approaches. Our pilot results suggest that our Semantic Web approach is suitable for realizing e-Neuroscience and generic enough to be applied in other biomedical fields.
Globalization of the pharmaceutical industry has led to a need to harmonize the regulatory requirements governing the marketing of medicinal products. To minimize the barriers impeding global drug product registration, the International Conference on the Harmonization of Technical Requirements of Pharmaceuticals for Human Use (ICH) was established in 1990. The ICH has developed a series of guidelines that reflect agreements reached by participating nations on aspects of the chemistry and clinical technical sections that will fulfill the regulatory requirements of these various jurisdications. Nevertheless, there continue to be points of divergent perspectives and barriers that can impede the use of foreign clinical data. Given the importance of these issues, the Regulatory Science (RS) section of the American Association of Pharmaceutical Scientists (AAPS), in conjunction with the Regulatory Affairs Professional Society (RAPS) and the Canadian Association of Professional Regulatory Affairs (CAPRA) cosponsored a public forum on this topic. This manuscript provides a summary of the speaker presentations and audience discussions regarding the design of clinical trials and the extrapolation of results from these trials to support international drug registration.
clinical trials; regulatory requirements; international harmonization; foreign clinical data
The rapid growth and evolution of the pharmacy profession has created a wide array of opportunities for graduating pharmacists beyond traditional community pharmacy or hospital practice. Management and leadership positions in federal and state healthcare agencies, pharmaceutical companies, hospitals, retail pharmacies, academia and managed care organizations increasingly require the pharmaceutical knowledge obtained through a doctor of pharmacy (PharmD) degree combined with financial, organizational, and management skills. In these innovative positions, pharmacists are being called upon to assume responsibilities as executives and administrators in systems providing pharmacist care services to patients.
To endow students with knowledge and skills required to perform the duties required in these decision-making positions, the University of Kentucky College of Pharmacy has established 3 joint degree programs: the PharmD/Master of Business Administration (PharmD/MBA), PharmD/Master of Public Administration (PharmD/MPA), and PharmD/Master of Science in Economics (PharmD/MS). This paper describes these joint degree programs.
dual degree; joint degree; education; doctor of pharmacy degree; master of business administration; master of public administration
No study has evaluated the association between state endorsement of American Academy of Pediatrics (AAP) and American Public Health Association (APHA) national guidelines and unnecessary exclusion decisions. We sought to determine the rate of unnecessary exclusion decisions by child care directors in a state that endorses AAP/APHA guidelines and to identify factors that are associated with higher unnecessary exclusion decisions.
A telephone survey was administered to directors in metropolitan Milwaukee, Wisconsin. Directors were randomly sampled from a list of 971 registered centers. Director, center, and neighborhood characteristics were obtained. Directors reported whether immediate exclusion was indicated for 5 vignettes that featured children with mild illness that do not require exclusion by AAP/APHA guidelines. Weighted data were summarized by using descriptive statistics. Regression analysis was used to identify factors that were associated with directors’ exclusion decisions.
A total of 305 directors completed the survey. Overall, directors would unnecessarily exclude 57% of children. More than 62% had never heard of the AAP/APHA guidelines. Regression analysis showed fewer exclusions among more experienced compared with less experienced directors, among larger centers compared with smaller centers, and among centers that were located in areas with a higher percentage of female heads of household. Centers with ≤10% children on state-assisted tuition excluded more.
High rates of inappropriate exclusion persist despite state endorsement of AAP/APHA guidelines. Focused initial and ongoing training of directors regarding AAP/APHA guidelines may help to reduce high rates of unnecessary exclusions.
child care; exclusion; mild illness
In general, presence of the metabolic syndrome is associated with significant cardiovascular mortality and represents a growing public health concern in the United States. Patients with a schizophrenia have a three times greater risk of death compared to the general population, with cardiovascular disease being the most common cause of this mortality. Use of the atypical antipsychotics (AAPs) to treat schizophrenia contributes significantly to this cardiovascular disease risk. While currently several different clinical guidelines exist to monitor for the metabolic consequences of AAP use, implementation is lacking. Due to the under monitoring of side effects and the lack of alternative treatment choices in schizophrenia, research has focused on the identification of various biomarkers and pharmacogenomic targets to focus on those at greatest risk for metabolic syndrome, thus aiming to increase the efficacy and minimize the side effects of the AAPs. This has led to several different lines of research. This manuscript focuses on summarizing the differing metabolic syndrome criteria, monitoring guidelines for AAPs and the role of folic acid as it relates to metabolic syndrome within the schizophrenia population. It will concentrate not only on the pharmacogenomics of folic acid metabolism, but also its epigenetic interaction with the environment. From this work, genetic variation within both the methylenetetrahydrofolate reductase (MTHFR) and catechol-o-methyl transferase (COMT) genes has been associated with increased metabolic syndrome risk in schizophrenia patients treated with AAPs. Furthermore, the combination of folate pharmacogenetics and epigenetics has uncovered relationships between methylation, schizophrenia disease, treatment type and metabolic syndrome. Despite the several areas of biomarker research for schizophrenia related metabolic syndrome, translation to the clinical setting is still lacking and further studies are needed to bridge this gap. Future folate supplementation research may prove to be an easy and effective clinical tool for the prevention and/or treatment of metabolic syndrome associated with AAP treatment, but clearly more work needs to be done in this area.
Schizophrenia; Metabolic Syndrome; Folic Acid; Homocysteine; MTHFR; Epigenetics
The beneficial effects of adipose-derived stem cell conditioned medium (ADSC-CM) on skin regeneration have been reported. Although the mechanism of how ADSC-CM promotes skin regeneration is unclear, ADSC-CM contained various growth factors and it is an excellent raw material for skin treatment. ADSC-CM produced in a hypoxia condition of ADSC—in other words, Advanced Adipose-Derived Stem cell Protein Extract (AAPE)—has great merits for skin regeneration. In this study, human primary keratinocytes (HKs), which play fundamental roles in skin tissue, was used to examine how AAPE affects HK. HK proliferation was significantly higher in the experimental group (1.22 μg/mL) than in the control group. DNA gene chip demonstrated that AAPE in keratinocytes (p < 0.05) notably affected expression of 290 identified transcripts, which were associated with cell proliferation, cycle and migration. More keratinocyte wound healing and migration was shown in the experimental group (1.22 μg/mL). AAPE treatment significantly stimulated stress fiber formation, which was linked to the RhoA-ROCK pathway. We identified 48 protein spots in 2-D gel analysis and selected proteins were divided into 64% collagen components and 30% non-collagen components as shown by the MALDI-TOF analysis. Antibody array results contained growth factor/cytokine such as HGF, FGF-1, G-CSF, GM-CSF, IL-6, VEGF, and TGF-β3 differing from that shown by 2-D analysis. Conclusion: AAPE activates HK proliferation and migration. These results highlight the potential of the topical application of AAPE in the treatment of skin regeneration.
ADSC-CM; AAPE; stress fiber formation; RhoA-ROCK signaling; regeneration; proliferation; migration
To characterize the dissemination of study findings and assess project preceptor attitudes towards a required senior research project in a doctor of pharmacy (PharmD) curriculum.
A survey was conducted to determine preceptors' perceptions of the value of a required pharmacy student research project and dissemination of research results.
One hundred fifteen project preceptors (92.0%) responded. Most preceptors agreed that the projects provided a valuable learning experience to the students (87.5%) and were of value to them professionally (82.1%) and to their institution (78.2%). Study findings were disseminated primarily through institutional forums (47.3%). A smaller percentage of projects were disseminated externally through presentations at professional meetings (23.7%, poster presentations; 4.0%, platform presentations), and peer-reviewed publications (5.3%).
Despite a modest level of dissemination of project results through presentations at professional meetings and a low level of dissemination via published manuscripts, the majority of preceptors perceived a required student research project to be of value.
doctor of pharmacy degree; research; student research; curriculum requirements
To determine doctor of pharmacy (PharmD) students’ perceptions of a PharmD
and master of public health (MPH) dual degree program.
A seven-item survey instrument was developed and distributed to students at a
large metropolitan school of pharmacy during scheduled class time in April
Among the 611 students enrolled in the PharmD program, 447 (73%) responded.
Of those who responded, 72.3% were either “very likely” or “likely” to
consider enrolling in such a PharmD/MPH dual degree program, and 77.4%
believed that it would be attractive to future students. The most commonly
identified potential limitations to pursuing the dual degree were time
commitment (19.9%), increased workload and stress (11.2%), and tuition cost
(10.3%). The most notable advantages documented were increased job
opportunities for public health-related pharmacy positions (26.9%),
increased ability to serve patients and the community (13.4%), and increased
marketability for future jobs (8.7%).
PharmD student participants demonstrated overall positive attitudes and
interest towards a PharmD/MPH dual degree program.
Education, Pharmacy; Students, Pharmacy; Students, Public Health; Schools, Pharmacy; Program Development; Attitude; United States
Discussion of the influence of money on bioethics research seems particularly salient in the context of research on the ethical, legal and social implications (ELSI) of human genomics, as this research may be financially supported by the ELSI Research Program. Empirical evidence regarding the funding of ELSI research and where such research is disseminated, in relation to the specific topics of the research and methods used, can help to further discussions regarding the appropriate influence of specific institutions and institutional contexts on ELSI and other bioethics research agendas.
We reviewed 642 ELSI publications (appearing between 2003–2008) for reported sources of funding, forum for dissemination, empirical and non-empirical methods, and topic of investigation.
Most ELSI research is independent of direct grant-based funding sources; 66% reported no such sources of funding. The National Human Genome Research Institute (NHGRI) is the most dominant source of funding; 16% of publications acknowledged at least one source of NHGRI grant funding. Funding is acknowledged more frequently in empirical than non-empirical publications, and more frequently in publications in public health journals than in any other ELSI research dissemination forums. Dominant research topics vary by publication forum and by reported funding.
ELSI research is surprisingly independent of direct grant-based funding, yet correlations are apparent between this type of funding and publication placement, topics addressed, and methods used, implying a not insignificant influence on ELSI research agenda-setting. However, given the relatively low percentage of publications acknowledging external grant-based funding, as well as other significant correlations between publication placement and topics addressed, additional institutional contexts, perhaps related to professional advancement or valuation, may shape research agendas in ways that potentially exceed the direct influences of grant-based funding in this area. In some cases, grant-based funding may actually counter other potentially problematic institutional influences.
Genomics [Ethics]; National Human Genome Research Institute (U.S.); Ethics, Professional
Early detection and treatment of neonatal hyperbilirubinemia is important in the prevention of bilirubin-induced encephalopathy. In this study, we evaluated the New Jersey pediatricians' practices and beliefs regarding the management of neonatal hyperbilirubinemia and their compliance with the recommendations made by the American Academy of Pediatrics (AAP) in 1994.
A survey questionnaire was mailed to a random sample of 800 pediatricians selected from a list of 1623 New Jersey Fellows of the AAP initially in October 2003 and then in February 2004 for the non-respondents. In addition to the physicians' demographic characteristics, the questionnaire addressed various aspects of neonatal hyperbilirubinemia management including the diagnosis, treatment, and follow up as well as the pediatricians' beliefs regarding the significance of risk factors in the development of severe hyperbilirubinemia.
The adjusted response rate of 49.1% (n = 356) was calculated from the 725 eligible respondents. Overall, the practicing pediatricians reported high utilization (77.9%) of the cephalocaudal progression of jaundice and low utilization (16.1%) of transcutaneous bilirubinometry for the quantification of the severity of jaundice. Most of the respondents (87.4%) identified jaundice as an indicator for serum bilirubin (TSB) testing prior to the neonate's discharge from hospital, whereas post-discharge, only 57.7% felt that a TSB was indicated (P < 0.01). If the neonate's age was under 72 hours, less than one-third of the respondents reported initiation of phototherapy at TSB levels lower than the treatment parameters recommended by the AAP in 1994, whereas if the infant was more than 72 hours old, almost 60% were initiating phototherapy at TSB lower than the 1994 AAP guidelines. Most respondents did not regard neonatal jaundice noted after discharge and gestational ages 37–38 weeks as being significant in the development of severe hyperbilirubinemia. However, the majority did recognize the importance of jaundice presenting within the first 24 hours and Rh/ABO incompatibility.
The pediatricians' practices regarding the low utilization of laboratory diagnosis for the quantification of jaundice after discharge and underestimation of risk factors that contribute to the development of severe hyperbilirubinemia are associated with initiation of phototherapy at lower than AAP recommended treatment parameters and recognition of neonatal hyperbilirubinemia as an important public health concern.
Objective. To implement and assess the effectiveness of a capstone pharmacotherapy course designed to integrate in-class curriculum using patient cases and drug-information questions. The course was intended to improve third-year doctor of pharmacy (PharmD) students' clinical documentation skills in preparation for beginning advanced pharmacy practice experiences (APPEs).
Design. This 2-credit, semester-long course consisted of 6 patient cases and 12 drug-information questions posted electronically on an Internet-based medical chart, a public health presentation, a knowledge examination, and an objective standardized performance assessment. In class, students engaged in active-learning exercises and clinical problem-solving. Students worked outside of class in small groups to retrieve and discuss assigned articles and review medication information in preparation for in-class discussions.
Assessment. A rubric was used to assess the patient cases and questions that students completed and submitted individually. Data for 4 consecutive course offerings (n=622) were then analyzed. A significant improvement was found in the “misplaced” but not the “missing” documentation ratings for both assessment and plan notes in the final assessment compared with baseline. In course evaluations, the majority of students agreed that the course integrated material across the curriculum (97%) and improved their clinical writing skills (80.5%).
Conclusion. A capstone pharmacy course was successful in integrating and reviewing much of the material covered across the PharmD curriculum and in improving students’ clinical documentation skills.
clinical documentation; clinical thinking; case-based learning; pharmacotherapy
The traditional vertical system of sharing information from sources of scientific authority passed down to the public through local health authorities and clinicians risks being made obsolete by emerging technologies that facilitate rapid horizontal information sharing. The rise of Public Health 2.0 requires professional acknowledgment that a new and substantive forum of public discourse about public health exists on social media, such as forums, blogs, Facebook, and Twitter.
Some public health professionals have used social media in innovative ways: to surveil populations, gauge public opinion, disseminate health information, and promote mutually beneficial interactions between public health professionals and the lay public. Although innovation is on the rise, most in the public health establishment remain skeptical of this rapidly evolving landscape or are unclear about how it could be used. We sought to evaluate the extent to which public health professionals are engaged in these spaces.
We conducted a survey of professorial- and scientist-track faculty at the Johns Hopkins Bloomberg School of Public Health in Baltimore, Maryland, USA. We asked all available faculty via email to complete a 30-question survey about respondent characteristics, beliefs about social media, and usage of specific technologies, including blogs, Facebook, Twitter, and YouTube.
A total of 181 (19.8%) of 912 professor- and scientist-track faculty provided usable responses. The majority of respondents rarely used major social media platforms. Of these 181 respondents, 97 (53.6%) had used YouTube, 84 (46.4%) had used Facebook, 55 (30.4%) had read blogs, and 12 (6.6%) had used Twitter in the prior month. More recent degree completion was the best predictor of higher usage of social media. In all, 122 (67.4%) agreed that social media is important for disseminating information, whereas only 55 (30.4%) agreed that social media is useful for their research. In all, 43 (23.8%) said social media was helpful for professional career advancement, whereas 72 (39.8%) said it was not. Only 43 (23.8%) faculty said they would employ a full- or part-time social media consultant, and 30 (16.6%) currently employed one.
Despite near-universal appreciation of the potential for social media to serve as a component of public health strategy, a small minority are actually engaged in this space professionally, whereas most are either disinterested or actively opposed to professional engagement. Social media is seen by most as more useful for spreading information than obtaining it. As public discourse on a number of critical health topics continues to be influenced and sometimes shaped by discussions online from Twitter to Facebook, it would seem that greater discourse is needed about when and how public health professionals should engage in these media, and also how personal, institutional, and professional barriers to greater use of social media may be overcome.
Internet; social media; public health; blogging
The benefits of scientific medicine have eluded millions in developing countries and the genomics revolution threatens to increase health inequities between North and South. India, as a developing yet also industrialized country, is uniquely positioned to pioneer science policy innovations to narrow the genomics divide. Recognizing this, the Indian Council of Medical Research and the University of Toronto Joint Centre for Bioethics conducted a Genomics Policy Executive Course in January 2003 in Kerala, India. The course provided a forum for stakeholders to discuss the relevance of genomics for health in India. This article presents the course findings and recommendations formulated by the participants for genomics policy in India.
The course goals were to familiarize participants with the implications of genomics for health in India; analyze and debate policy and ethical issues; and develop a multi-sectoral opinion leaders' network to share perspectives. To achieve these goals, the course brought together representatives of academic research centres, biotechnology companies, regulatory bodies, media, voluntary, and legal organizations to engage in discussion. Topics included scientific advances in genomics, followed by innovations in business models, public sector perspectives, ethics, legal issues and national innovation systems.
Seven main recommendations emerged: increase funding for healthcare research with appropriate emphasis on genomics; leverage India's assets such as traditional knowledge and genomic diversity in consultation with knowledge-holders; prioritize strategic entry points for India; improve industry-academic interface with appropriate incentives to improve public health and the nation's wealth; develop independent, accountable, transparent regulatory systems to ensure that ethical, legal and social issues are addressed for a single entry, smart and effective system; engage the public and ensure broad-based input into policy setting; ensure equitable access of poor to genomics products and services; deliver knowledge, products and services for public health. A key outcome of the course was the internet-based opinion leaders' network – the Indian Genome Policy Forum – a multi-stakeholder forum to foster further discussion on policy.
We expect that the process that has led to this network will serve as a model to establish similar Science and Technology policy networks on regional levels and eventually on a global level.
The 2004 PT Section Education Committee took the first steps in addressing the charge: “How can the supply of highly qualified pharmaceutical scientist specialists in product development and related technologies that meet current and future needs be ensured?” This charge was borne out of earlier reports and current experience that suggest that: (1) graduate programs in colleges of pharmacy are increasingly failing to produce sufficient numbers of appropriately qualified specialists in product development and related pharmaceutical technologies and, (2) the pharmaceutical industry has been forced to recruit and train scientists from other disciplines. Surveys conducted by this committee of the membership (PT, PDD and BT sections) and a representative group of pharmaceutical executives validated this concern and provided insight into its nature and depth. For example, the executives reported that 50% or less of product development staff have undergraduate degrees in pharmacy and that 50% or less have advanced degrees in pharmaceutics/industrial pharmacy/pharmaceutical technology, yet entry-level PhDs in these specialties bring a better mix of skills to the product development table than their counterparts from other science disciplines, and that this advantage persist even after 4–6 years experience on the job. And the great difficulty in finding candidates with the, right mix of experience and education was also made clear by the surveys. Based in part on an analysis of these surveys, this committee developed an extensive list of issues to be addressed by future PT Education committees and AAPS. Among these were: (1) Should AAPS encourage and assist in the establishment of graduate programs in product development/technology and/or tracks in academic institutions whether or not they are colleges of pharmacy?, (2) Should AAPS develop standards for and qualify such educational programs and tracks? (3) How do we and what role should AAPS play in creating awareness in colleges and universities of our needs and the incentives to develop and maintain programs that meet these needs?, and (4) How can stable funding be provided for programs in product development and technology?
This paper maps key research questions for humanitarian health ethics: the ethical dimensions of healthcare provision and public health activities during international responses to situations of humanitarian crisis. Development of this research agenda was initiated at the Humanitarian Health Ethics Forum (HHE Forum) convened in Hamilton, Canada in November 2012. The HHE Forum identified priority avenues for advancing policy and practice for ethics in humanitarian health action. The main topic areas examined were: experiences and perceptions of humanitarian health ethics; training and professional development initiatives for humanitarian health ethics; ethics support for humanitarian health workers; impact of policies and project structures on humanitarian health ethics; and theoretical frameworks and ethics lenses. Key research questions for each topic area are presented, as well as proposed strategies for advancing this research agenda. Pursuing the research agenda will help strengthen the ethical foundations of humanitarian health action.
For quantitative bioanalytical method validation procedure and requirements, there was a relatively good agreement between chromatographic assays and ligand-binding assays. It was realized that the quantitative and qualitative aspects of bioanalytical method validation should be reviewed and applied appropriately.Some of the major concerns between the 2 methodologies related to the acceptable total error for precision and accuracy determination and acceptance criteria for an analytical run. The acceptable total error for precision and accuracy for both the methodologies is less than 30. The 4–6–15 rule for accepting an analytical run by a chromatographic method remained acceptable while a 4–6–20 rule was recommended for ligand-binding methodology.The 3rd AAPS/FDA Bioanalytical Workshop clarified the issues related to placement of QC samples, determination of matrix effect, stability considerations, use of internal standards, and system suitability tests.There was a major concern and issues raised with respect to stability and reproducibility of incurred samples. This should be addressed for all analytical methods employed. It was left to the investigators to use their scientific judgment to address the issue.In general, the 3rd AAPS/FDA Bioanalytical Workshop provided a forum to discuss and clarify regulatory concerns regarding bioanalytical method validation issues.
Adeno-associated virus type 2 (AAV2) capsid assembly requires the expression of a virally encoded assembly-activating protein (AAP). By providing AAP together with the capsid protein VP3, capsids are formed that are composed of VP3 only. Electron cryomicroscopy analysis of assembled VP3-only capsids revealed all characteristics of the wild-type AAV2 capsids. However, in contrast to capsids assembled from VP1, VP2, and VP3, the pores of VP3-only capsids were more restricted at the inside of the 5-fold symmetry axes, and globules could not be detected below the 2-fold symmetry axes. By comparing the capsid assembly of several AAV serotypes with AAP protein from AAV2 (AAP-2), we show that AAP-2 is able to efficiently stimulate capsid formation of VP3 derived from several serotypes, as demonstrated for AAV1, AAV2, AAV8, and AAV9. Capsid formation, by coexpressing AAV1-, AAV2-, or AAV5-VP3 with AAP-1, AAP-2, or AAP-5 revealed the ability of AAP-1 and AAP-2 to complement each other in AAV1 and AAV2 assembly, whereas for AAV5 assembly more specific conditions are required. Sequence alignment of predicted AAP proteins from the known AAV serotypes indicates a high degree of homology of all serotypes to AAP-2 with some divergence for AAP-4, AAP-5, AAP-11, and AAP-12. Immunolocalization of assembled capsids from different serotypes confirmed the preferred nucleolar localization of capsids, as observed for AAV2; however, AAV8 and AAV9 capsids could also be detected throughout the nucleus. Taken together, the data show that AAV capsid assembly of different AAV serotypes also requires the assistance of AAP proteins.
Objective. To assess the prevalence and characteristics of curriculum in dual doctor of pharmacy (PharmD)/master of public health (MPH) degree programs offered by US pharmacy programs.
Methods. An 18-item survey instrument was developed and distributed online to faculty members at US colleges and schools of pharmacy.
Results. Of the 110 colleges and schools that responded, 23 (21%) offered a PharmD/MPH degree. Common characteristics of these 23 programs included current PharmD program structure (3 + 1 year), early curricular recruitment, small enrollment, and interdisciplinary coursework occurring online and in the classroom. The impact of the dual degree on the curriculum and longevity of the dual-degree programs varied. About 55% of responding programs without a formal dual-degree program reported that additional public health training was available.
Conclusion. Twenty-one percent of colleges and schools of pharmacy offer a combined PharmD/MPH dual degree. Most programs required an additional 1 or 2 semesters to complete both degrees.
pharmacy education; public health; masters of public health; dual degree
These recommendations are the result of a national, multidisciplinary, year-long process to discuss whether and how to proceed with organ donation after cardiocirculatory death (DCD) in Canada. A national forum was held in February 2005 to discuss and develop recommendations on the principles, procedures and practice related to DCD, including ethical and legal considerations. At the forum's conclusion, a strong majority of participants supported proceeding with DCD programs in Canada. The forum also recognized the need to formulate and emphasize core values to guide the development of programs and protocols based on the medical, ethical and legal framework established at this meeting.
Although end-of-life care should routinely include the opportunity to donate organs and tissues, the duty of care toward dying patients and their families remains the dominant priority of health care teams. The complexity and profound implications of death are recognized and should be respected, along with differing personal, ethnocultural and religious perspectives on death and donation. Decisions around withdrawal of life-sustaining therapies, management of the dying process and the determination of death by cardiocirculatory criteria should be separate from and independent of donation and transplant processes.
The recommendations in this report are intended to guide individual programs, regional health authorities and jurisdictions in the development of DCD protocols. Programs will develop based on local leadership and advance planning that includes education and engagement of stakeholders, mechanisms to assure safety and quality and public information. We recommend that programs begin with controlled DCD within the intensive care unit where (after a consensual decision to withdraw life-sustaining therapy) death is anticipated, but has not yet occurred, and unhurried consent discussions can be held. Uncontrolled donation (where death has occurred after unanticipated cardiac arrest) should only be considered after a controlled DCD program is well established. Although we recommend that programs commence with kidney donation, regional transplant expertise may guide the inclusion of other organs. The impact of DCD, including pre-and post-mortem interventions, on donor family experiences, organ availability, graft function and recipient survival should be carefully documented and studied.
Protein-based pharmacophore models are enriched with the information of potential interactions between ligands and the protein target. We have shown in a previous study that protein-based pharmacophore models can be applied for ligand pose prediction and pose ranking. In this publication, we present a new pharmacophore-based docking program PharmDock that combines pose sampling and ranking based on optimized protein-based pharmacophore models with local optimization using an empirical scoring function.
Tests of PharmDock on ligand pose prediction, binding affinity estimation, compound ranking and virtual screening yielded comparable or better performance to existing and widely used docking programs. The docking program comes with an easy-to-use GUI within PyMOL. Two features have been incorporated in the program suite that allow for user-defined guidance of the docking process based on previous experimental data. Docking with those features demonstrated superior performance compared to unbiased docking.
A protein pharmacophore-based docking program, PharmDock, has been made available with a PyMOL plugin. PharmDock and the PyMOL plugin are freely available from http://people.pharmacy.purdue.edu/~mlill/software/pharmdock.
Protein pharmacophores; Docking; Scoring; Biased docking; Constraint docking; Confined docking; GUI; PyMOL