Using digital health to enable ethical health research in conflict and other humanitarian settings

Conducting research in a humanitarian setting requires quantifiable quality measures to ensure ethical study conduct. Digital health technologies are proven to improve research study quality and efficacy via automated data collection, improvement of data reliability, fidelity and resilience and by improved data provenance and traceability. Additionally, digital health methodologies can improve patient identity, patient privacy, study transparency, data sharing, competent informed consent, and the confidentiality and security of humanitarian operations. It can seem counterintuitive to press forward aggressively with digital technologies at a time of heightened population vulnerability and cyber security concerns, but new approaches are essential to meet the rapidly increasing demands of humanitarian research. In this paper we present the case for the digital modernization of humanitarian research in conflict and other humanitarian settings as a vehicle for improved research quality and ethics

Determination of the in vitro and in vivo oral drug delivery capabilities of complexation hydrogels

The promise of oral delivery formulations of therapeutic protein and peptides is one of high hopes but also of disappointment as, to date, parenteral administration remains the standard of care. A good example of this is in the case of human insulin delivery for diabetes where disease control, reduction of degenerative side effects and increased patient compliance could all be gained in the most rapidly growing disease in our country. Hydrogel carrier systems have shown promise as a potential solution for this unmet medical need. In particular a novel pH-sensitive poly[methacrylic acid-grafted-poly(ethylene glycol)] hydrogel system has shown promise by displaying enhanced insulin delivery in in situ animal models.In this work, a set of detailed in vitro and in vivo experiments were used to further qualify the insulin delivery capabilities of this novel system. The ability of the system to protect entrapped insulin in the upper gastrointestinal tract was confirmed via dissolution studies and the ability of the polymer system to enhance transport across the intetinal epithelium was confirmed using the Caco-2 in vitro model of intestinal transport. Lastly, the absolute oral bioavailability of insulin delivered via the hydrogel system was determined in rats and dogs. The application of pharmacokinetic models to the animal data shows the greatest gains on improving this delivery system can be made by optimizing the ability of the hydrogel to enhance protein transport across the gut wall.Ph.D., Biochemical Engineering -- Drexel University, 200

Effective knowledge management in translational medicine

<p>Abstract</p> <p>Background</p> <p>The growing consensus that most valuable data source for biomedical discoveries is derived from human samples is clearly reflected in the growing number of translational medicine and translational sciences departments across pharma as well as academic and government supported initiatives such as Clinical and Translational Science Awards (CTSA) in the US and the Seventh Framework Programme (FP7) of EU with emphasis on translating research for human health.</p> <p>Methods</p> <p>The pharmaceutical companies of Johnson and Johnson have established translational and biomarker departments and implemented an effective knowledge management framework including building a data warehouse and the associated data mining applications. The implemented resource is built from open source systems such as i2b2 and GenePattern.</p> <p>Results</p> <p>The system has been deployed across multiple therapeutic areas within the pharmaceutical companies of Johnson and Johnsons and being used actively to integrate and mine internal and public data to support drug discovery and development decisions such as indication selection and trial design in a translational medicine setting. Our results show that the established system allows scientist to quickly re-validate hypotheses or generate new ones with the use of an intuitive graphical interface.</p> <p>Conclusions</p> <p>The implemented resource can serve as the basis of precompetitive sharing and mining of studies involving samples from human subjects thus enhancing our understanding of human biology and pathophysiology and ultimately leading to more effective treatment of diseases which represent unmet medical needs.</p