Innovation in the pharmaceutical industry: New estimates of R&D costs.

The research and development costs of 106 randomly selected new drugs were obtained from a survey of 10 pharmaceutical firms. These data were used to estimate the average pre-tax cost of new drug and biologics development. The costs of compounds abandoned during testing were linked to the costs of compounds that obtained marketing approval. The estimated average out-of-pocket cost per approved new compound is $1395 million (2013 dollars). Capitalizing out-of-pocket costs to the point of marketing approval at a real discount rate of 10.5% yields a total pre-approval cost estimate of $2558 million (2013 dollars). When compared to the results of the previous study in this series, total capitalized costs were shown to have increased at an annual rate of 8.5% above general price inflation. Adding an estimate of post-approval R&D costs increases the cost estimate to $2870 million (2013 dollars).

The Didache and Traditioned Innovation: Shaping Christian Community in the First Century and the Twenty-First Century

Church leaders, both lay and clergy, shape Christian community. Among their central tasks are: building communal identity, nurturing Christian practices, and developing faithful structures. When it comes to understanding the approach of the earliest Christian communities to these tasks, the Didache might well be the most important text most twenty-first century church leaders have never read. The Didache innovated on tradition, shaping the second generation of Christians to meet the crises and challenges of a changing world.

Most likely composed in the second half of the first century, the Didache served as a training manual for gentile converts to Christianity, preparing them for life in Christian community. This brief document, roughly one third the length of Mark’s gospel, developed within early Jewish-Christian communities. It soon found wide usage throughout the Mediterranean region, and its influence endured throughout the patristic and into the medieval period.

The Didache outlines emerging Christian practices that were rooted in both Jewish tradition and early Jesus material, yet were reaching forward in innovative ways. The Didache adopts historical teachings and practices and then adapts them for an evolving context. In this respect, the writers of the Didache, as well as the community shaped by its message, exemplify the pattern of thinking described by Greg Jones as “traditioned innovation.”

The Didache invites reflection on the shape and content of Christian community and Christian leadership in the twenty-first century. As churches and church leaders engage a rapidly changing world, the Didache is an unlikely and yet important conversation partner from two millennia ago. A quick read through its pages – a task accomplished in less than half an hour – brings the reader face to face with a brand of Christianity both very familiar and strikingly dissimilar to modern Christianity. Such dissonance challenges current assumptions about the church and creates a space in which to re-imagine our situation in light of this ancient Christian tradition. The Didache provides a window through which we might re-examine current conceptualizations of Christian life, liturgy, and leadership.

This thesis begins with an exploration of the form and function of the Didache and an examination of a number of important background issues for the informed study of the Didache. The central chapters of this thesis exegete and explore select passages in each of the three primary sections of the Didache – the Two Ways (Didache 1-6), the liturgical section (Didache 7-10), and the church order (Didache 11-15). In each instance, the composers of the Didache reach back into a cherished and life-giving aspect of the community’s heritage and shape it anew into a fresh and faithful approach to living the Christian life in a drastically different context.

The thesis concludes with three suggestions of how the Didache may provide a resource for the way the Church in the present thinks about training disciples, shaping community, and developing leadership structures. These conversation starters offer beginning points for a richer, fuller discussion of traditioned innovation in our current church context. The Didache provides a source of wisdom from our spiritual forebears that modern Christian leaders would do well not to ignore. With a look through the first century window of the Didache, twenty-first century Christians can discover fresh insights for shaping Christian community in the present.

Global Mental Health: Five Areas for Value-Driven Training Innovation.

OBJECTIVE: In the field of global mental health, there is a need for identifying core values and competencies to guide training programs in professional practice as well as in academia. This paper presents the results of interdisciplinary discussions fostered during an annual meeting of the Society for the Study of Psychiatry and Culture to develop recommendations for value-driven innovation in global mental health training. METHODS: Participants (n = 48), who registered for a dedicated workshop on global mental health training advertised in conference proceedings, included both established faculty and current students engaged in learning, practice, and research. They proffered recommendations in five areas of training curriculum: values, competencies, training experiences, resources, and evaluation. RESULTS: Priority values included humility, ethical awareness of power differentials, collaborative action, and "deep accountability" when working in low-resource settings in low- and middle-income countries and high-income countries. Competencies included flexibility and tolerating ambiguity when working across diverse settings, the ability to systematically evaluate personal biases, historical and linguistic proficiency, and evaluation skills across a range of stakeholders. Training experiences included didactics, language training, self-awareness, and supervision in immersive activities related to professional or academic work. Resources included connections with diverse faculty such as social scientists and mentors in addition to medical practitioners, institutional commitment through protected time and funding, and sustainable collaborations with partners in low resource settings. Finally, evaluation skills built upon community-based participatory methods, 360-degree feedback from partners in low-resource settings, and observed structured clinical evaluations (OSCEs) with people of different cultural backgrounds. CONCLUSIONS: Global mental health training, as envisioned in this workshop, exemplifies an ethos of working through power differentials across clinical, professional, and social contexts in order to form longstanding collaborations. If incorporated into the ACGME/ABPN Psychiatry Milestone Project, such recommendations will improve training gained through international experiences as well as the everyday training of mental health professionals, global health practitioners, and social scientists.