Dear Colleagues, This month marks my one-year anniversary as BIO's CEO. Like most of us in biotech, this post has been a labor of love. At no time in my 25-year career in this industry have I ever witnessed such awe-inspiring science. Today, we increasingly have the tools, talents, and technologies to address a range of challenges in human health, the environment, and food security – allowing us to alleviate an enormous amount of human suffering. These stunning advancements, though, are at a crossroads. Not only does the U.S. face intense global competition as the world's center of excellence in biotechnology innovation, but we also face a series of societal and political challenges that threaten key elements of our industry's foundation. In short, we are at an inflection point. We can either continue with a system that unnecessarily slows progress and distorts our choices, or reform it to better benefit patients and those in need.Eight years ago, President Trump highlighted the shortcomings of our drug approval system in his first address to a joint session of Congress. I recall it vividly, because I was there. As you may know, my daughter Megan has Pompe disease, a rare neuromuscular disorder. During his remarks, the President highlighted Megan’s condition and spoke directly to her in the audience. He added, “the slow and burdensome approval process at the Food and Drug Administration keeps too many advances, like the one that saved Megan’s life, from reaching those in need.” He was right then, just as he is right today. Yet the way that government reforms the FDA – as well as other regulatory bodies that oversee our industry – must strengthen these agencies, not weaken them. We have an opportunity now to accomplish just that, and we must seize it. "No organization is better positioned or more intensely focused on creating (and restoring) a strong and expedient innovation ecosystem than BIO." The Best Job You Could Ever HaveAs someone who…

Re: BIO Comments on Office of Management and Budget (OMB) Statistical Policy Directive No. 8 North American Industry Classification System (NAICS)-Request for Comments on Possible Revisions for 2027 (USBC–2024–0032)Dear Ms. Orvis,The Biotechnology Innovation Organization (BIO) welcomes this opportunity to respond to the request for public comment from the Office of Management and Budget (OMB), on behalf of the Economic Classification Policy Committee (ECPC), as a part of the review of the 2022 North American Industry Classification System (NAICS) for potential revisions to be made to the structure and content of the NAICS for 2027.