Peptide Therapeutics and the Pharmaceutical Industry: Barriers Encountered Translating from the Laboratory to Patients

Peptides are receiving increasing interest as clinical therapeutics. These highly tunable molecules can be tailored to biocompatibility and biodegradability with simultaneously selective and potent therapeutic effects. Despite challenges regarding up-scaling and licensing of peptide products, their vast clinical potential is reflected in the 60 plus peptide-based therapeutics already on the market, and the further 500 derivatives currently in developmental stages. Peptides are proving effective for a multitude of disease states including: type 2 diabetes (controlled using the licensed glucagon-like peptide-1 receptor liraglutide); irritable bowel syndrome managed with linaclotide (currently at approval stages); acromegaly (treated with octapeptide somostatin analogues lanreotide and octreotide); selective or broad spectrum microbicidal agents such as the Gram-positive selective PTP-7 and antifungal heliomicin; anticancer agents including goserelin used as either adjuvant or for prostate and breast cancer,and the first marketed peptide derived vaccine against prostate cancer, sipuleucel-T. Research is also focusing on improving the biostability of peptides. This is achieved through a number of mechanisms ranging from replacement of naturally occurring L-amino acid enantiomers with D-amino acid forms, lipidation, peptidomimetics, N-methylation, cyclization and exploitation of carrier systems. The development of self-assembling peptides are paving the way for sustained release peptide formulations and already two such licensed examples exist, lanreotide and octreotide. The versatility and tunability of peptide-based products is resulting in increased translation of peptide therapies, however significant challenges remain with regard to their wider implementation. This review highlights some of the notable peptide therapeutics discovered to date and the difficulties encountered by the pharmaceutica lindustry in translating these molecules to the clinical setting for patient benefit, providing some possible solutions to the most challenging barriers. 

Permissibility of Non-Voluntary Collective Management of Copyright under EU Law – The Case of the French Law on Out-of-Commerce Books

The possibility of the EU member states to adapt copyright legislation to new circumstances and to address unforeseen issues is limited by the list of exceptions and restrictions of the InfoSoc Directive. In spite of this constraint, the EU copyright framework provides for a possibility of introduction of non-voluntary forms of collective rights management that can help to tackle some of the contemporary problems with remuneration and access. This article is an attempt to deepen the understanding of non-voluntary collective management and its possible use. First, it provides a detailed description of the French mechanism adopted for facilitating mass digitization and making out-of-commerce books available, which was implemented through a new form of collective management of copyright. Then, it examines the mechanism’s compatibility with the InfoSoc Directive through comparison with the extended collective licensing.

La loi applicable aux transferts de biens virtuels

Thèse réalisée en cotutelle avec l'université Paris1-Sorbonne

Older Adult Injury Risk Assessment in the Driving and Occupational Environments

Thesis (Ph.D.)--University of Washington, 2016-08

Standard Essential Patent in Telecommunication Standard: United States and China Comparison

Thesis (Ph.D.)--University of Washington, 2016-08

Discovery and efficient reuse of technology pictures using Wikimedia infrastructures. A proposal

Multimedia objects, especially images and figures, are essential for the visualization and interpretation of research findings. The distribution and reuse of these scientific objects is significantly improved under open access conditions, for instance in Wikipedia articles, in research literature, as well as in education and knowledge dissemination, where licensing of images often represents a serious barrier. Whereas scientific publications are retrievable through library portals or other online search services due to standardized indices there is no targeted retrieval and access to the accompanying images and figures yet. Consequently there is a great demand to develop standardized indexing methods for these multimedia open access objects in order to improve the accessibility to this material. With our proposal, we hope to serve a broad audience which looks up a scientific or technical term in a web search portal first. Until now, this audience has little chance to find an openly accessible and reusable image narrowly matching their search term on first try - frustratingly so, even if there is in fact such an image included in some open access article.

Licenciamento zero: da mudança legal à mudança organizacional

A Administração Pública Portuguesa tem sentido necessidade de se modernizar e, na procura desse objetivo, têm sido criados diversos programas de simplificação administrativa em Portugal. No âmbito de um desses programas – o Simplex, surgiu o programa Licenciamento Zero que visa reduzir os procedimentos necessários ao licenciamento de determinadas atividades económicas. O presente trabalho pretendeu demonstrar como se projetou legalmente a implementação do Licenciamento Zero e como se procedeu a implementação organizacional desta medida, procurando identificar as principais dificuldades da sua implementação. Pretendeu-se ainda conhecer os procedimentos de licenciamento antes do projeto Licenciamento Zero, e compará-los com a realidade posterior à sua implementação. Para isso, fez-se um foco na área da publicidade. Por fim, procurou-se compreender quais as vantagens desta desmaterialização, desburocratização e modernização administrativa para as empresas, bem como compreender quais as consequências positivas e negativas sentidas pelas entidades responsáveis pelo licenciamento, nomeadamente a Câmara Municipal de Vagos.

Transparency in European football : A study of financial disclosure transparency from a supporter perspective

Background and Problem: Despite the exploding increase in revenue by more than 500 percent (1996-2014) among European football clubs, the operating profit in the “big five” leagues are, paradoxically, inexistent or very low. Hence, there is a need for more transparent financial reporting in European football. To preserve the game’s well-being and establish a sustainable future, UEFA introduced Financial Fair Play (FFP) back in 2010 as a part of their club licensing requirements. The transparency that FFP is intended to improve is however only disclosed to UEFA and its member associations, which is only one of many stakeholders. In times of financial turmoil in European football clubs, where fair play and sustainability is frequently discussed since the implementation of FFP, one could ask; is it really fair play that not all European football clubs are obligated to be transparent towards all their stakeholders and supporters? Purpose: The purpose of this thesis is to, from a supporter perspective, look at how transparent European football clubs’ financial disclosure is. Methodology: The research has elements of both a deductive and an inductive approach and uses a disclosure checklist with a cross-sectional design, in order to measure disclosure transparency.  Empirical Results and Conclusion: Even though the empirical findings proved that financial reporting transparency are present within European football, the conclusion is that the financial reporting is generally not transparent within the industry.

Using Statistics to Set Priorities

In November 2015-March 2016, I assigned my Graduate Assistant, David Durden, a project to compile usage statistics and trends for digitized collections between 2013-2015 from UMD Digital Collections and our contributions to the Internet Archive between 2008-2015. The original intent of the project was to provide usage metrics to assist the Digitization Initiatives Committee in prioritizing projects or content areas. The project also uncovered trends that should impact how we think about making digital collections discoverable and accessible. For example, if 50-60% of traffic into UMD Digital Collections comes from outside the University or College Park, MD, how will this impact the potential usage of content when access is restricted to campus due to licensing, copyright, or ownership restrictions? With a growing population using mobile browsers, how will a flash-based viewer restrict users’ access to content? How might we develop content or its discoverability for a growing social media user base? In this talk, I will briefly discuss the usage trends for the represented collections, how we may use these in prioritizing future projects, and issues I will discuss with collection managers as we develop project plans and the Manager of Digital Programs and Initiatives as we develop the digital collections repository.

Análise do licenciamento ambiental como instrumento de política do meio ambiente no Rio Grande do Norte Período 1992-2003

This analysis on the ambient licensing is based on a research that identifies the fragilities and advances of the application of this instrument of politics of the environment in the ambient politics of the Rio Grande do Norte, in the period of 1992 the 2003. The isolated urban area of Búzios, situated in the City of Nísia Floresta/RN, situated in the eastern coast of the State, where concentrates the boarding of the ambient question as a matter in the Brazilian process of urbanization, over all the institutionalization and implementation of the ambient licensing. They are distinguished in the used methodology in consultation to the diverse involved social segments with the ambient subject in study, the example of the managers, technician and specialists, as well as the application of the legislation and norms techniques, the forms of appropriation of the common wealth and the procedures of ambient licensing of the competent agencies. The results of the research designate that the ambient licensing while instrument of the ambient politics is one of the alternatives more efficient as techniques in the process of sustainable development, since it is beyond the prerogatives to conciliate the activities and enterprises with the conservation of the environmental resources and natural benefits to the societies. In the RN one evidenced progress in the ambient legislation and the instructions techniques, and that the imperfections and limitations in the system of ambient licensing are not directly on to the instruments, but in the implementation of mechanisms of the ambient agencies. This because they do not make use of operational structure to apply in practical and established abilities, as an ambient management, institutional joint and deliberations of the State Counselor for Environment

Study into licences used by Open Access journals

The Knowledge Exchange Licensing Expert Group has commissioned a study which examined which licences or licence provisions are being used by open access and hybrid publishers when making their publications available in open access. The study intended to identify a ‘best practice’ licence model framework and to formulate recommendations with respect to an OA licence structure, taking into account the commercial and non-commercial needs of authors as well as the publishers. The study was undertaken by Maverick Outsource Services Ltd. This led to the following recommendations for an optimum licence in an open access journal: The author retains copyright; The author or rightholder grants to all users a free, irrevocable, worldwide, perpetual right of access to the work, and besides a licence to copy, use, distribute, transmit and display the work publicly and to make and distribute derivative works in any digital medium for any reasonable purpose, subject to proper attribution of authorship; A complete version of the work and all supplemental materials is deposited immediately upon initial publication in at least one online repository. This includes the permission as stated under 2, in a suitable standard electronic format; The copyright holder can retain the right to restrict commercial use if they wish; The copyright holder provides the publisher with permission to publish, subject to open accessibility of the work in online published form.

New developments in daily licencing practice workshop

New developments in higher education and research are having their repercussions in dailylicencing practice. Examples are; demands for perpetual access usage of licensed content incourse packs or virtual research environments text mining open access to publications. Atthe Knowledge Exchange workshop on LicencingPractice, twenty Experts discussed how these newdevelopments could be incorporated in licencing. The workshop consisted of four presentations oncurrent developments in licencing followed by threeparallel breakout sessions on the topics open access,new developments and data and text mining. This led toa lively exchange of ideas. Especially the aspect of dataand text mining provided valuable insights in how thiscould be incorporated in licencing. The Knowledge Exchange Licensing expert group willwork on how to implement the model provisions discussed. Input from the workshop was collected for a workshop with publishers to take place in March 2012 and will include these provisions in their licences. The various suggestions will be also shared with other international organisations working inthis field.