Foley & Lardner LLP recently issued the following announcement.
With both a short-term focus on immediate issues relating to the current COVID-19 pandemic as well as a long-term eye toward potential future pandemic situations, experienced partners from across Foley’s Life Sciences Industry Team will address:
Emergency Use Authorization and other expedited FDA and state approval pathways
Reimbursement strategies and navigating local restrictions on setting up specimen collection sites for CLIA-certified labs
Government contracting, stockpiling, and other supply chain considerations
Associated patent strategies and existing procedures for fast-tracking examination and issuance, plus additional considerations for entering into R&D and other strategic partnerships
The rapid spread of the novel coronavirus (COVID-19) has created unprecedented urgency to develop and rapidly launch RNA and serological diagnostic assays along with new antiviral therapeutics and vaccines to combat the virus. To meet the emergency, FDA has issued a series of extraordinary orders making it possible to immediately launch certain types of assays using an abbreviated registration system and also allowing states to issue approvals. Companies are racing to meet the challenge and transform their manufacturing to satisfy critical new needs for a range of products that will support the diagnostic and therapeutic pipeline, though questions abound on how exactly to accomplish this.
In an emergency public health situation such as we find ourselves in now, for example, how does a company get its diagnostic, vaccine, therapeutic, or other related medical care product developed, approved, and launched into the marketplace quickly? Moreover, what mechanisms exist to obtain funding from the new government appropriations for tackling the virus and to contract or partner with the government? Additionally, which aspects of these new technological developments can be protected with intellectual property to secure the investments being made?
Please join Foley on Thursday, March 26, for a webinar exploring the critical business and legal considerations behind such issues. There is no fee to participate in this program, but advance registration is required.
When: March 26, 2020
Original source can be found here.