As Prescribed

FDA’s Center for Biologics Evaluation and Research (CBER), the locus of regulating cell and gene therapies among other expanding areas of biotech, is poised for change on a number of important fronts—leadership, significant growth, and plans to address challenging scientific and regulatory issues. With a well-earned reputation of stability, and slow, plodding progress, moments with so many elements in flux at FDA don’t come around often, so it is worth keeping an eye on how these begin to unfold to have a sense of where CBER—central to many of the exciting developments in industry—is headed.

For our third and final Biotech Week Boston post, partner Stephen Altieri—one of the many within our 250-member-strong comprehensive cross-practice life sciences team with an advanced scientific degree—discusses efficient patent protection for emerging biotech companies with patent agent Emily Coury.

Fundraising is one of the key activities in the lifecycle of an emerging company: many CEOs of emerging companies have stated that they are always in financing mode. Given the high cost of bringing life science products to market, raising funds is especially challenging in the biotechnology sector.

Today marks the kickoff of the Biotech Week Boston event series, and for the rest of the week our As Prescribed blog will feature posts exclusively from our Boston life sciences lawyers. Local partners Michael Barron, Laurie Burlingame, and Stephen Altieri will be blogging from the capital of the commonwealth, where they are expressly positioned to advise biotech companies at all phases of their lifecycles, as well as the entities that invest in them.