ADVI Instant: OSTP Releases Report on US Biotech and Biomanufacturing Goals
On March 24, 2023, in response to Executive Order 14081, the White House Office of Science and Technology Policy released a report outlining the administration’s goals for the U.S. bioeconomy. In the area of health, the White House hopes to “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.”
On September 12, 2022, the White House released Executive Order 14081, “Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy” which instructed The Secretary of HHS, The Secretary of Energy, The Secretary of Agriculture, The Secretary of Commerce, and the Director of the National Science Foundation to each submit a report, compiled by OSTP, outlining how each agency would accomplish the Biden Administration’s goal of advancing biotechnology and biomanufacturing. The director of OSTP, in coordination with the Director of OMB, APNSA, the APEP, the APDP, and the heads of the previously mentioned agencies would then develop a plan to implement the recommendations in the reports.
In the area of health care, The White House highlights future diagnostics and increased manufacturing of cell-based therapies.
HHS’s Goals for Harnessing Biotechnology and Biomanufacturing
- Accessible Health Monitoring
- Goal 1.1: In 5 years, leverage novel sensors to identify at least ten next-generation bio-indicators of health which can be monitored as part of healthy living and preventative medicine practice
- Goal 1.2: In 20 years, develop and distribute a simple-to-use “Health Kit”, or an affordable home testing kit, leveraging novel bio-indicators of health, which would meet the needs of diverse populations to decrease disparities in health outcomes by 50%
- Precision Multi-Omic Medicine
- Goal 2.1: In 5 years, collect multi-omic measures in large cohorts from diverse populations in large cohorts with participants from diverse populations and identify which measures are most relevant to the diagnosis and management of at least 50 diseases with high incidence and impact.
- Goal 2.2: In 20 years, develop molecular classifications for diagnosis, prevention, and treatment to address leading causes of disease-related mortality in the U.S. and make these actionable with development of the $1,000 multi-ome.
- Biomanufacturing of Cell-Based Therapies
- Goal 3.1: In 5 years, expand the technologies used to develop cell-based therapies to achieve at least 75% cell viability in patients
- Goal 3.2: 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.
- AI-Driven Bioproduction of Therapeutics
- Goal 4.1: In 5 years, leverage a national network of resource labs to address barriers in autonomous production and bioproduction of existing biotherapeutics, increasing manufacturing speed of ten commonly prescribed therapeutics by 10-fold.
- Goal 4.2: In 20 years, integrate artificial intelligence and machine learning (AI/ML) into the national network of resource labs to design novel biotherapeutics, increasing the speed of novel drug discovery and production by 10-fold.
- Advanced Techniques in Gene Editing
- Goal 5.1: In 5 years, further develop gene-editing systems for clinical use to enable, with little to no side effects, cures for ten diseases with known genetic causes.
- Goal 5.2: In 20 years, strengthen the biomanufacturing ecosystem to produce at least 5 million doses of therapeutic gene-editing systems annually
- OSTP believes the time to manufacture chimeric antigen receptor T-cell (CAR-T) therapy cell products must be shortened
- OSTP notes that the high cost of manufacturing CAR-T cell products stems from difficulty harvesting cells from each patient, supply chain logistics, and difficulty in identifying patients who may benefit from the treatment
- OSTP believes the following would accomplish the overall goals of increasing therapeutic efficacy and increasing manufacturing scale:
- Developing novel gene-editing techniques and genetic programming that can be leveraged to create next-generation cell therapies
- Pairing synthetic biology innovations with novel non-viral delivery vehicles
- Investigating shipping protocols and storage technologies to keep source and engineered cells at high viability without the use of toxic preservatives
- Developing robust clinical and genomic indicators to identify patients who may be a good candidate for cell-based therapies and computational models to identify and predict the therapeutic impact of important engineered qualities of the cell-based therapies
- Continuing to bring together clinicians, biologists, engineers, and synthetic biologists
- Harmonizing methods and standards across cell-based therapy manufacturing facilities by cell types, reducing cost and wait time
- Developing modular, platform-engineered cell-based technologies alongside patient-specific formulations
- Providing access to clinical-scale, cell-based manufacturing expertise as a national resource
- Testing and de-risking new biomanufacturing practices for next-generation biotechnology products in commercial-quality manufacturing facilities
- Partnering with clinicians and other hospital staff to create training materials to ensure equity of care across facilities and to consider equipment needs and assignment of clinical staff to patients receiving cell-based therapies
- Enhancing public engagement for the acceptance of cell-based therapies, leveraging experience with existing cell-based therapies such as CAR-T cells
ADVI will continue monitoring any developments and next steps. This is a delayed release. ADVI Instant content is distributed in real time for retainer clients. Get in touch to learn more about how we can support your commercialization, market access, and policy needs.