How can biotech and pharmaceutical companies work with the government in developing and supplying effective diagnostics, treatments and vaccines for COVID-19? What should these companies know?
Join Arnold & Porter on Thursday, March 26 from 12–2 pm Eastern Time for an introduction to contracting with the Biomedical Advanced Research and Development Authority (BARDA) and FDA emergency use authorizations. The session will be conducted in three blocks, so that participants may drop in and out for individual topics of interest. Sessions are as follows:
12:00–12:55 PM–Introduction to BARDA, Opportunities Available to Support COVID-19 Countermeasures, and Contracting with the Government
Kristine Blackwood, Legislative and Public Policy, will briefly describe BARDA, the current COVID-19 BAA and President Trump’s invocation of the Defense Production Act. Chuck Blanchard and Kristen Ittig, Government Contracts and National Security Practice, will discuss different contract structures available to BARDA, including FAR, OTA and CRADA contracts, and associated compliance obligations.
1:00–1:25 PM–Managing IP Associated with Government-Funded R&D
Kristen Riemenschneider and Mina Miljevic, Corporate Finance and Intellectual Property, will discuss intellectual property issues which arise when contracting with the US government for the research and development of new technology.
1:30–1:55 PM–Overview of FDA Regulatory Pathways and PREP Act Immunity for COVID-19 Countermeasures
Dan Kracov, Life Sciences and Healthcare Regulatory, will discuss the FDA “Emergency Use Authorization” process, the Public Readiness and Emergency Preparedness Act and related regulatory issues.