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Full-Text Articles in Law
Paper Promises For Drug Innovation, Erika Lietzan
Paper Promises For Drug Innovation, Erika Lietzan
Faculty Publications
Innovation does not stop when a new medicine is launched. Development of new uses for already approved drugs, in particular, can make profound contributions to the public health. Whether a new use is suspected during the initial premarket trials, identified through focused research after approval, or discovered serendipitously by physicians treating patients, however, it requires extensive clinical testing before it can be approved by FDA. This testing takes time and money — three to five years on average, and as much as $300 million. This Article considers the incentives that federal law offers to companies to make this investment: patent …
Building A Culture Of Assessment In Law School, Larry Cunningham
Building A Culture Of Assessment In Law School, Larry Cunningham
Faculty Publications
A new era of legal education is upon us: Law schools are now required to assess learning outcomes across their degrees and programs, not just in individual courses. Programmatic assessment is new to legal education, but it has existed in higher education for decades. To be successful, assessment requires cooperation and buy-in from faculty. Yet establishing a culture of assessment in other disciplines has not been easy, and there is no reason to believe that it will be any different in legal education. A survey of provosts identified faculty buy-in as the single biggest challenge towards implementing assessment efforts. This …
A Solution In Search Of A Problem At The Biologics Frontier, Erika Lietzan
A Solution In Search Of A Problem At The Biologics Frontier, Erika Lietzan
Faculty Publications
This short paper comments on Professor Carrier's new article, Biologics: The New Antitrust Frontier. His article makes a profound initial contribution to a new area of scholarship, based on a large body of prior work considering antitrust issues relating to small molecule drugs. But Professor Carrier’s article, like my own forthcoming piece on innovation and competition in the biologics marketplace, is inherently speculative. We are making our best judgments about the nature of a still emerging marketplace and likely conduct in that marketplace, based on our understandings of a new regulatory framework that is itself still emerging, the broader legal …