AI (Re)Defining Pharmaceutical Exclusivities Academic Article

abstract

• This articles central thesis is twofold. First, the increased use of artificial intelligence (AI) technology, biomarkers, and new communications technologies have reduced both the time required (the time cost) and the associated monetary cost for conducting clinical trials, warranting a reduction in term of regulatory exclusivities, particularly for biologics. Second, the premise on which these exclusivities have been grated remain arguable and susceptible to misuse at a time when COVID-19 has exacerbated the need for policies that prioritize public health and access to health care. The article concludes that it is urgent to minimize the term of regulatory exclusivities.

authors

• Ragavan, Srividhya

published proceedings

• BIOTECHNOLOGY LAW REPORT

author list (cited authors)

• Kimball, J., & Ragavan, S.

citation count

• 0

complete list of authors

• Kimball, Jonathan||Ragavan, Srividhya

publication date

• January 2022

publisher

• Mary Ann Liebert  Publisher

published in

• Biotechnology Law Report  Journal

keywords

• Artificial Intelligence
• Biologics
• Data Exclusivity
• Fda
• Period Of Exclusivity
• Pharmaceuticals

Digital Object Identifier (DOI)

• 10.1089/blr.2021.29257.sr

URI

• https://scholarship.law.tamu.edu/facscholar/1532

start page

• 23

end page

• 29

volume

• 41

issue

• 1

URL

• http://dx.doi.org/10.1089/blr.2021.29257.sr