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OBJECTIVES/GOALS: To facilitate the development of innovative injection products by providing translational researchers with a regulatory and manufacturing road map for producing small batch sterile products for Phase 1 research use. To leverage recent AMC investments in facility improvements and pharmacy training in the areas of sterile product production, testing, and environmental controls, that can be used to support production of phase 1 clinical trial supplies METHODS/STUDY POPULATION: Searching and organizing relevant data and information from web portals and databases in the following: areas: FDA, EMA, USP regulations, regulatory science, pharmaceutical formulation and analytics, supply vendors, analytical testing laboratories, and product testing laboratories. Present the information using a user friendly format including flow charts and development timelines, taking the perspective of the translational investigator. RESULTS/ANTICIPATED RESULTS:
Choosing AMC resources vs outside consultants and vendors, leveraging local resources where possible
Qualifying and monitoring suppliers, testing laboratories, in-house departments, and Contract Drug Manufacturing Organizations (CDMO)
Bringing together the deliverables for the IND CMC section
Where and how to leverage available products and science to simplify safe and reliable production
DISCUSSION/SIGNIFICANCE OF IMPACT: Use and utility of injectable drug products, both small molecule and biologics, is growing rapidly, and is projected to continue to escalate well into the next decade. This is due not only to advances in medicine, but also to improvements in AMC-based sterile product production, and a better understanding of small batch manufacturing methods. All three trends align in academic medical centers (AMC) and can be utilized by translational researchers, if they can understand the potential and regulatory requirements.
Why has Australia not followed Canada, New Zealand and the United Kingdom in adopting a formal bill of rights at the national level? We argue that the Australian Constitution has made the difference. The Constitution has underpinned a comparatively strong parliamentary check on the executive, weakening the rationale for a bill of rights and impeding legislative initiatives towards this end; thwarted the drive for a constitutional bill of rights; and helped delegitimize statutory approaches to a bill of rights in general and the “dialogue model” in particular. The article ultimately questions the notion that a common approach to rights protection can apply across Westminster democracies.
National and international policies have encouraged the establishment of a representative network of marine protected areas (MPAs) in South Africa, with the aim of protecting marine biodiversity. The extent to which these marine and estuarine protected areas (EPAs) represent marine fish species and communities was assessed by comparing their species compositions with those of exploited areas, as sampled using four fishing techniques. Seven hundred fish species were sampled, representing one-third of South Africa's marine fishes. MPAs in coastal habitats scored c. 40% on the Bray-Curtis measure of similarity for species representativeness, but this score declined markedly for offshore ‘trawlable’ fishing grounds. The combined effects of sampling error, temporal variation and the effects of fishing on relative abundance suggest that 80% similarity would be the maximum achieveable. Forty-nine per cent of all fish species that were recorded were found in the 14 MPAs sampled. Redundancy in the MPA network was low, with fish species most commonly being represented in only one MPA or absent. There was greater redundancy in the 33 EPAs, with 40% of species being found in two or more EPAs, but many of these estuaries were adjacent to each other and embedded in large MPAs. Deep water fish communities (>80 m deep) and communities located on the west and south-east coasts of South Africa were most poorly represented by MPAs. Routine fishery surveys provide a robust and repeatable opportunity to assess species representativeness in MPAs, and the method used could form the basis of an operational definition of ‘representative’. In contrast to an assessment based on presence-absence data, this analysis of quantitative data presents a more pessimistic assessment of protection.
Objective: To study when and how an urgent public health message about a boil-water order reached an urban population after the Massachusetts water main break.
Methods: In-person surveys were conducted in waiting areas of clinics and emergency departments at a large urban safety net hospital within 1 week of the event.
Results: Of 533 respondents, 97% were aware of the order; 34% of those who lived in affected cities or towns were potentially exposed to contaminated water. Among those who were aware, 98% took action. Respondents first received the message through word of mouth (33%), television (25%), cellular telephone calls (20%), landline calls (10%), and other modes of communication (12%). In multivariate analyses, foreign-born respondents and those who lived outside the city of Boston had a higher risk of exposure to contaminated water. New modes (eg, cellular telephones) were used more commonly by females and younger individuals (ages 18 to 34). Individuals who did not speak English at home were more likely to receive the message through their personal networks.
Conclusions: Given the increasing prevalence of cellular telephone use, public officials should encourage residents to register landline and cellular telephone for emergency alerts and must develop creative ways to reach immigrants and non–English-speaking groups quickly via personal networks.
(Disaster Med Public Health Preparedness. 2011;5:235–241)