R&D Costs and Returns to New Drug Development: A Review of the Evidence

© 2012 by Oxford University Press. All rights reserved.This article reviews the extensive literature on R&D costs and returns. The first section focuses on R&D costs and the various factors that have affected the trends in real R&D costs over time. The second section considers economic studies on the distribution of returns in pharmaceuticals for different cohorts of new drug introductions. It also reviews the use of these studies to analyze the impact of policy actions on R&D costs and returns. The final section concludes and discusses open questions for further research.

Essays on the Economics of Higher Education

At least since the seminal works of Jacob Mincer, labor economists have sought to understand how students make higher education investment decisions. Mincer’s original work seeks to understand how students decide how much education to accrue; subsequent work by various authors seeks to understand how students choose where to attend college, what field to major in, and whether to drop out of college.

Broadly speaking, this rich sub-field of literature contributes to society in two ways: First, it provides a better understanding of important social behaviors. Second, it helps policymakers anticipate the responses of students when evaluating various policy reforms.

While research on the higher education investment decisions of students has had an enormous impact on our understanding of society and has shaped countless education policies, students are only one interested party in the higher education landscape. In the jargon of economists, students represent only the `demand side’ of higher education---customers who are choosing options from a set of available alternatives. Opposite students are instructors and administrators who represent the `supply side’ of higher education---those who decide which options are available to students.

For similar reasons, it is also important to understand how individuals on the supply side of education make decisions: First, this provides a deeper understanding of the behaviors of important social institutions. Second, it helps policymakers anticipate the responses of instructors and administrators when evaluating various reforms. However, while there is substantial literature understanding decisions made on the demand side of education, there is far less attention paid to decisions on the supply side of education.

This dissertation uses empirical evidence to better understand how instructors and administrators make decisions and the implications of these decisions for students.

In the first chapter, I use data from Duke University and a Bayesian model of correlated learning to measure the signal quality of grades across academic fields. The correlated feature of the model allows grades in one academic field to signal ability in all other fields allowing me to measure both ‘own category' signal quality and ‘spillover' signal quality. Estimates reveal a clear division between information rich Science, Engineering, and Economics grades and less informative Humanities and Social Science grades. In many specifications, information spillovers are so powerful that precise Science, Engineering, and Economics grades are more informative about Humanities and Social Science abilities than Humanities and Social Science grades. This suggests students who take engineering courses during their Freshman year make more informed specialization decisions later in college.

In the second chapter, I use data from the University of Central Arkansas to understand how universities decide which courses to offer and how much to spend on instructors for these courses. Course offerings and instructor characteristics directly affect the courses students choose and the value they receive from these choices. This chapter reveals the university preferences over these student outcomes which best explain observed course offerings and instructors. This allows me to assess whether university incentives are aligned with students, to determine what alternative university choices would be preferred by students, and to illustrate how a revenue neutral tax/subsidy policy can induce a university to make these student-best decisions.

In the third chapter, co-authored with Thomas Ahn, Peter Arcidiacono, and Amy Hopson, we use data from the University of Kentucky to understand how instructors choose grading policies. In this chapter, we estimate an equilibrium model in which instructors choose grading policies and students choose courses and study effort given grading policies. In this model, instructors set both a grading intercept and a return on ability and effort. This builds a rich link between the grading policy decisions of instructors and the course choices of students. We use estimates of this model to infer what preference parameters best explain why instructors chose estimated grading policies. To illustrate the importance of these supply side decisions, we show changing grading policies can substantially reduce the gender gap in STEM enrollment.

Essays in the Economics of Education

This dissertation is comprised of three essays in the economics of education. In the first essay, I examine how college students' major choice and major switching behavior responds to major-specific labor market shocks. The second essay explores the incidence and persistence of overeducation for workers in the United States. The final essay examines the role that students' cognitive and non-cognitive skills play in their transition from secondary to postsecondary education, and how the effect of these skills are moderated by race, gender, and socioeconomic status.

Economics of new oncology drug development.

PURPOSE: Review existing studies and provide new results on the development, regulatory, and market aspects of new oncology drug development. METHODS: We utilized data from the US Food and Drug Administration (FDA), company surveys, and publicly available commercial business intelligence databases on new oncology drugs approved in the United States and on investigational oncology drugs to estimate average development and regulatory approval times, clinical approval success rates, first-in-class status, and global market diffusion. RESULTS: We found that approved new oncology drugs to have a disproportionately high share of FDA priority review ratings, of orphan drug designations at approval, and of drugs that were granted inclusion in at least one of the FDA's expedited access programs. US regulatory approval times were shorter, on average, for oncology drugs (0.5 years), but US clinical development times were longer on average (1.5 years). Clinical approval success rates were similar for oncology and other drugs, but proportionately more of the oncology failures reached expensive late-stage clinical testing before being abandoned. In relation to other drugs, new oncology drug approvals were more often first-in-class and diffused more widely across important international markets. CONCLUSION: The market success of oncology drugs has induced a substantial amount of investment in oncology drug development in the last decade or so. However, given the great need for further progress, the extent to which efforts to develop new oncology drugs will grow depends on future public-sector investment in basic research, developments in translational medicine, and regulatory reforms that advance drug-development science.