U.S. Sen. John Hickenlooper and Federal Drug Administration (FDA) Commissioner Robert Califf, MD, visited the University of Colorado Anschutz Medical Campus on June 23.
The senator and commissioner’s visit included a tour of the Gates Biomanufacturing Facility and a roundtable discussion with campus leaders and researchers. The discussion detailed continued research efforts underway at CU Anschutz in infectious disease, epidemiology, immunology and bioethics, to help inform Hickenlooper and Califf’s work in driving federal pandemic preparedness legislation and policy.
The tour, led by Matthew Seefeldt, PhD, executive director of the Gates Biomanufacturing Facility, gave Hickenlooper and Califf an overview of the history and growth of its operation to one of only a handful of locations nationally that manufactures both cell and protein biologic therapies.
(From left) FDA Commissioner Robert Califf, Sen. John Hickenlooper, Matthew Seefeldt inside the Gates Biomanufacturing Facility
Part of the tour also focused on the water-run fermenter inside the facility. The fermenter, along with other features of the Gates Biomanufacturing Facility, could allow CU Anschutz to leverage existing microbial-based recombinant protein production to rapidly produce proteins and vaccines for early-stage trials. This approach is important for nimble drug and vaccine development in response to another pandemic like COVID-19.
The roundtable discussion following the tour brought several campus researchers together to discuss wider insights into pandemic preparedness with Hickenlooper and Califf. Co-moderated by Thomas Flaig, MD, CU Anschutz vice chancellor for research, and Lori Sussel, PhD, associate vice chancellor for basic science research, the wide-ranging discussion centered on bridging the knowledge gap in what lawmakers might be missing from first-hand accounts in responding to COVID-19.
Califf, whose son graduated from the University of Colorado School of Medicine and practices in Colorado, led off the discussion, stating the tremendous response he saw from CU Anschutz in responding to COVID-19. He also noted the current challenges the FDA faces responding to future pandemics. Hickenlooper was interested in how the country can rebuild and restructure its public health system in the wake of the pandemic.
| Visit highlights continued partnership Hickenlooper’s visit to CU Anschutz in April 2022 took lessons learned from campus leaders during the COVID-19 pandemic back to Congress to help inform the Prepare for and Respond to Existing Viruses, Emerging New Threats (PREVENT) Pandemics Act – which was signed into law in December 2022 by President Biden. The legislation invested in new ideas around pandemic research, such as genomic sequencing. |
CU Anschutz researchers and faculty offered their expertise into several campus COVID-19 response areas and how federal policy could help bolster future federal pandemic response.
From data collection and public communication, to the importance of manufacturing cell and protein therapies quickly, campus representatives detailed a variety of process improvements that could be made in future pandemic responses.
Other areas discussed included the importance of having infrastructure in place to pivot research and clinical operations quickly to respond to a pandemic, as well as having flexibility in platform technologies. With respect to mRNA vaccines, the panel emphasized the importance of being able to scale rapidly and target specific proteins in viruses as they mutate. Discussion also touched on ongoing efforts around genomic monitoring from a public health perspective.
Hickenlooper, who is a member of the Senate Health, Education, Labor & Pensions Committee, is currently working on the reauthorization of the Pandemic and All Hazards Preparedness Act (PAHPA). That legislation addresses agencies, including preparedness programs at the FDA, Biomedical Advanced Research and Development Authority, the Administration for Strategic Preparedness and Response and other public health infrastructure programs.
Participants from CU Anschutz at the event included: