U.S. Senator Tommy Tuberville (R-AL) participated in a Senate Health, Education, Labor, and Pensions (HELP) Committee hearing focused on the future of biotechnology in the United States. The discussion included perspectives from Lowell Schiller, Nonresident Senior Scholar at the USC Schaeffer Institute; John Crowley, President and CEO of Biotechnology Innovation Organization; and Josh Makower, Yock Family Professor of Medicine and Bioengineering at Stanford University.
During the hearing, Tuberville asked Schiller about how the Food and Drug Administration’s (FDA) pre-check program could improve domestic pharmaceutical manufacturing. He referenced an executive order from President Trump aimed at supporting U.S. drug production by increasing communication during development stages and simplifying application requirements.
Schiller responded: “Thank you for the question, Coach. The program has a lot of potential. Some of the challenges around investment in domestic manufacturing goes to a degree of uncertainty about how FDA’s regulations will apply to those facilities. And so having earlier more frequent interactions with the agency through that process can help enormously. There’s other things that the Agency can be doing as well, things like updating manufacturing regulations to accommodate more advanced manufacturing techniques. The regulations were written for conventional older techniques, so updating them to take into account use of AI, use of continuous manufacturing would be incredibly helpful.”
Tuberville highlighted Alabama’s Hudson Alpha Institute for Biotechnology in Huntsville as a leading genomics research center with significant economic impact in the state—supporting 45 companies and creating 2,000 high-paying jobs while attracting over $300 million in research funding.
He asked Crowley what similar institutes are doing right and how such efforts could be encouraged nationwide.
Crowley said: “Senator, Coach, thank you for the question. You bring up a very important point and this is how medicines are made. If you look last year, nearly three quarters of all medicines approved by the FDA came [and] originated from startup biotech companies. Over time, well, more than half of all medicines come from these small businesses, these incubators of research. When we look at what it takes to make newer and better medicines, it’s an entire ecosystem. It’s what we call this virtuous circle of innovation grounded in our great academic universities or institutions like in Alabama, oftentimes funded and partnered with the important research that goes on at the National Institutes of Health. And that foundational research is what oftentimes spurs our startup companies. And so many times over and over again, it’s a great technology, a disease where there’s an unmet need. There are entrepreneurs, people giving angel money investments, startup capital. There are economic development funds in many of our states, such as in Alabama, to support these startup companies. And also too, having these clusters in so many—and really in each of your states—where innovators, entrepreneurs can come together, where there’s lab space provided, where they’re in proximity to academic research. Oftentimes, our startup companies—the founders—scientific founders—have joint appointments at local universities,state universities,and our startup companies.This is what’s so uniquely American.Biotechnology is only a 49-year-old industry.Our very first company Genentech was founded by a scientist at University California San Francisco,and venture capitalist as well.This happens every state.It happens Alabama.And as you go along that virtuous circle innovation,it takes community small companies,it takes contract research organizations contract manufacturers providers capital,often Wall Street ultimately driving private capital these incredibly risky,incredibly expensive,and incredibly important ventures.So again,I commend state Alabama what they’re doing promote research science development.This heart soul biotechnology,and it’s what we need strengthen continue.”
Tuberville then questioned Makower about maintaining America’s leadership role in biotechnology.
Makower answered: “Absolutely. Thank you for the question,S enator.Most importantly,we need remove unnecessary delays.Efficiency through process absolutely key as most innovations coming John Crowley mentioned small companies.Small companies rely venture capital very short timeline able achieve goals.So improving process shortening it allowing still rigorous but removing inefficiencies one primary ways we can do that.”
Senator Tuberville serves on several Senate committees including Armed Services,Agriculture,Veterans’ Affairs ,HELP ,and Aging.
