In November 2022, the Cellino leadership team was invited to participate in a White House Listening Session on “Harnessing Biotechnology and Biomanufacturing for Health Breakthroughs,” hosted by the Biden Administration’s Office of Science and Technology Policy. We were among a small group of industry and academic thought leaders asked to share our perspectives on specific medical breakthroughs that could be delivered through breakthroughs in biotechnology and biomanufacturing over the next 20 years.
At Cellino, our goal is to advance the autologous, or patient-derived, induced pluripotent stem cell (iPSC)-derived cell therapy industry through scalable biomanufacturing. Autologous iPSC-derived cell therapies have the potential to significantly improve quality of life for the millions of patients suffering from degenerative diseases. However, to ensure that these cell therapies are made accessible to the patients who need them in an equitable manner, biomanufacturing approaches must advance to scale manufacturing and decrease cost.
This is core to our vision at Cellino. We were ecstatic to hear alignment from fellow thought leaders at the White House Listening Session, and to see this message supported nearly verbatim in the Biden Administration’s “Bold Goals for U.S. Biotechnology and Biomanufacturing” in Goal 3.2:
“Enable Scale-Up: In 20 years, increase the manufacturing scale of cell-based therapies to expand access, decrease health inequities, and decrease the manufacturing cost of cell-based therapies 10-fold.
The Biden Administration’s ambitious goals for U.S. biotechnology and biomanufacturing represent a significant step forward in ensuring widespread availability of these groundbreaking treatments and underscores their dedication to reducing health inequities. The administration is backing up their goals with significant resources – in September 2022, the White House committed funding of over $2B to advance President Biden’s Executive Order to launch a National Biotechnology and Biomanufacturing Initiative.
ARPA-H, the Advanced Research Projects Agency for Health, was established in 2022 to advance high-impact biomedical research to drive moonshot health breakthroughs. ARPA-H currently has a budget of $2.5B and is actively focused on enabling “scalable solutions [for] manufacturing . . . that result in impactful, timely, and equitable solutions.”
At Cellino, we are convinced that the toughest technical problems require a multidisciplinary solution. We are entering a stage of scientific innovation where individual fields will become stalled if they are not actively collaborating across functional boundaries. Intracellular delivery is a key example of this – while the initial approaches to intracellular delivery were purely biological in nature (i.e., viruses), the introduction of chemical- (i.e., lipofection) and physical- (e.g., electroporation, optoporation, microfluidic squeezing, etc) delivery techniques addressed key problems with viral-based delivery and advanced the field significantly. Chemical and physical-based intracellular delivery tools are now commonly used in the development of many therapeutics.
Similarly, we are at a stage of healthcare and biomanufacturing where collaboration across academia, industry, and government will be necessary to advance important therapeutic modalities to the point that they are accessible to all patients who need them. Advancing a therapeutic modality to the point that it becomes standard of care requires more than just scientific innovation and clinical efficacy. It requires manufacturing approaches for scalable production, the infrastructure to enable widespread distribution, and the capital to support these efforts.
For these reasons, we at Cellino are incredibly excited and heartened to see the contents of the White House listening session represented so clearly in the Biden Administration’s “Bold Goals for U.S. Biotechnology and Biomanufacturing.” Increasing the scale and decreasing the cost of manufacturing cell-based therapies is a necessary step to ensure that this novel therapeutic modality is able to reach its full potential and impact patients in need, and collaboration across academia, industry, and government will be critical to achieving this important goal. We are grateful for the opportunity to influence policy towards a shared goal of ensuring affordable and accessible cell-based therapies for all patients in need.
