In 1996, following an epidemic, Pfizer tested a new drug on 200 children in Muslim Nigeria. 11 children died while others were disabled. We study the effects of the disclosure, in 2000, of the deaths of Muslim children in the Pfizer trials on vaccine compliance among Muslim mothers. Muslim...

Based on our survey and discussions, we uncovered several thematic opportunities to improve interactions between the FDA and industry and to reduce clinical development times: 1) develop metrics and goals at the FDA for clinical development times in exchange for PDUFA like fees; 2) establish an...

Efforts to strengthen the global patent system for pharmaceuticals continue to be controversial, and what will likely be a similarly fraught international debate over price controls has begun. The outcome of international negotiations and the resulting policy decisions made by each country will...

This paper compares the clinical trial strategies and performance of large, established ("mature") biopharmaceutical firms to those of smaller ("early stage") firms that have not yet successfully developed a drug. We study a sample of 235 cancer drug candidates that entered clinical trials...

We derive the optimal funding mechanism to incentivize development and production of vaccines against diseases with epidemic potential. In the model, suppliers' costs are private information and investments are noncontractible, precluding cost-reimbursement contracts, requiring fixed-price...

This paper examines trends in the aggregate productivity of the pharmaceutical sector over the past three decades. We incorporate Ricardo's insight about demand-driven productivity in settings of variable scarce resources, and estimate the industry's responsiveness to changes in demand over this...

The use of "pay-for-delay" settlements in patent litigation - in which a branded manufacturer and generic entrant settle a Paragraph IV patent challenge and agree to forestall entry - has come under considerable scrutiny in recent years. Critics argue that these settlements are collusive and...

Even though management consultants increasingly recommend that in-house research be outsourced, little is known about the conditions favoring substitution or complementarity between internal R&D and external technology acquisition. In this paper, we attempt to provide a deeper understanding of...

Much has been written about the seemingly less formal, more agile biotechnology industry and its extensive interactions with academia and startups, as well as its distinct scientific, manufacturing and regulatory profile. Employing a data base encompassing all 96 biologics and 212 small...

We examine the relationship between patent protection for pharmaceuticals and investment in development of new drugs. Patent protection has increased around the world as a consequence of the TRIPS Agreement, which specifies minimum levels of intellectual property protection for members of the...