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YOUR GO-TO SOURCE FOR ANALYSIS OF ISSUES AFFECTING THE PHARMA & BIOTECH SECTORS
#JPMHC25
Several members of our firm’s life sciences team were on the ground at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco from January 13 to 16, 2025. It was an exciting and sunny four days, during which key players from across the life sciences industry gathered to engage in deal discussions and consider upcoming trends for the pharmaceutical, biotechnology, and healthcare industries. Although there was a notable increase in the level of security at the conference given recent events, the overall sentiment of the conference was one of optimism.
The US Food and Drug Administration (FDA) recently issued a notice of noncompliance to the FADOI Foundation, citing the organization’s failure to submit required clinical trial results to ClinicalTrials.gov. The notice reflects FDA’s increasing attention toward noncompliance with the agency’s requirements for submission of clinical trials information and may signal an increase in enforcement that we may see from FDA going forward.
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.
Biotech Week Boston
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.
Biotech Week Boston
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.
Biotech Week Boston
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.