Delivered just a few weeks after the CHIPS and Science Act, President Biden has issued a call-to-action for regulatory agencies and private biotechnology companies alike. In his recent Cancer Moonshot Speech, he has set the ambitious, yet attainable, goal of reducing US cancer deaths by at least 50% within the next 25 years.
The President’s speech outlined areas of focus for improvement in the biotechnology space, some of which are applicable to the cell and gene therapy industry.
These main areas of focus for our sector are:
- Making treatments more affordable and accessible.
- Making data more widely available; going hand in hand with the government’s effort to build up data reserves in this field to allow expedited innovation.
- Increasing US manufacturing capabilities for both materials to be used in biomanufacturing and the drug products themselves.
- Developing tools to ease the transition from research to manufacturing, allowing patients to have access to life-saving treatments earlier.
- Ensuring the uses of biotechnologies are ethical and racially just. These therapies need to be available for all, including underserved communities.
- Diversifying and training the incoming biotechnology workforce.
- Implementing biological risk management, including biosafety and biosecurity.
Many of these aims can be accomplished through automation of the manufacturing process and digitization of information capture during manufacturing. These changes reduce the cost of manufacturing cell and gene therapy products, mostly through time savings. They also facilitate an easier technology transfer of the manufacturing process, allowing efficient use of new or decentralized manufacturing facilities.
There were also regulatory changes enacted by President Biden’s associated Executive Order to promote progress in the biotechnology industry. Federal investment in research has increased, in addition to federally funded studies to increase US biomanufacturing capabilities, safety, and access to data. Better tools will also be created to assess the bioeconomy and promote international cooperation in biotechnology research and commercialization. In addition, regulatory agencies will be clarifying any areas of ambiguity in their guidance and will try to anticipate future industry needs. This will be done in hopes of accelerating the approval pathway for products.
President Biden’s powerful aim was announced exactly 60 years after President John F Kennedy delivered his Moonshot speech, expressing the need to send the US to the moon. Though both of these goals were ambitious, Cancer Moonshot is not as heavily funded and relies mostly on advancements and investments in the private sector. By making forward-looking changes to cell and gene therapy manufacturing now, we may be able to achieve major improvements in the near future. Just as Kennedy originally stated, we accept these challenges “not because they are easy, but because they are hard”.
Credit: Keara Traylor, Technical Operations Manager Ori Biotech
