As the world’s leading pharmaceutical, biotech companies, and scientists continue to research and develop a vaccine for COVID-19, what happens when that day finally arrives? The arrival of a vaccine will be a massive undertaking. FDA approval is just the first step in a process that could prove to be as novel as the coronavirus itself. Within the health care industry, its impact will not be limited to providers but will also affect traditional methods of distribution and supply chain practices. So when that day does come, are you, your health care provider/health system, and your company really prepared for it? Join Foley’s panel as they provide you with a quick overview of practical guidance on what to expect and prepare for in the coming weeks, or months, as we await approval and delivery of a viable vaccine.
While we invite you to attend the entire presentation, we understand how valuable your time is. For that reason, we have built in 5-minute breaks between each section where you may jump off, or jump on, to the sections that are of most importance to you. Don’t worry about disruptions as our webinar platform is designed so that you can see and hear us, but we cannot see or hear you.
11:00 – 11:25 a.m. ET: The FDA & the Vaccine – David Rosen, Partner and FDA Practice Group Leader and Co-Chair of the firm’s Life Science Industry Team will provide an overview on the requirements to obtain FDA Emergency Use Authorization, full approval of the vaccine, and what to expect from a safety perspective with an emphasis on the importance of post-market surveillance on the vaccine.
11:30 – 11:55 a.m. ET: Provider Vaccine Planning & Preparedness – Monica Chmielewski, Partner and Co-Chair of the firm’s Life Sciences Practice Group, and Vice-Chair of the firm’s Health Care Practice Group, will focus on provider considerations associated with receipt, distribution, and administration of the vaccine, including patient consent and liability, determining priority of access, employee training, and contracting considerations.
12:00 – 12:25 p.m. ET: Advance Planning: Supply Chain Considerations and Risk Mitigation for Continuity of Supply – Vanessa Miller, Partner and Co-Chair of the firm’s Supply Chain Industry Team, will focus on the need for advance planning & preparation with regards to Supply Chain Logistics, as well as addressing possible hurdles, cold chain logistics, and contractual risk allocations that may come into play.
12:30 – 12:55 p.m. ET: Distribution: Pricing & the “Middleman” – Michael Lockerby, Partner and Co-Chair of the firm’s Distribution & Franchise Practice Group, will address legal issues pertaining to how traditional distribution channels and pricing may differ upon release of the vaccine, at least at first.
1:00 – 1:30 p.m. ET: Full Panel Q&A – If you have a question that was not answered, this is the time to ask it! We highly encourage you to submit your questions ahead of time to Maggie Weschler, and indicate to which subject of our agenda that your question pertains.