The biotech and life sciences industry has taken a financial hit in recent months, with tight budgets, high-profile setbacks and the unfortunate need to resort to layoffs. But, as we recently pointed out, the sector may be on the cusp of an innovation renaissance.
President Biden’s back-to-back announcements in September are a signal from the federal government of its belief that our industry has the profound potential to make a positive impact, and one worth supporting. These major announcements include a new national biotechnology and biomanufacturing initiative, and the renewal of President Barack Obama’s cancer moonshot program – which, in many respects, was a continuation of President Richard Nixon’s “war on cancer,” which began with the National Cancer Act of 1971.
Here is a quick snapshot of what you should know about these new initiatives:
Renewed Cancer Moonshot
- The primary goal of the initiative is to halve the U.S. cancer death rate over the next 25 years.
- The program will be taking an all-hands-on-deck approach, mixing the expertise and experiences of private companies, non-profit organizations, academia, healthcare providers, and patients. A White House-appointed Moonshot coordinator will organize this effort and report on activities with a “Cancer Cabinet,” composed of officials from various federal groups.
- There will be an increased focus on cancer screening and early detection. Through a combination of community health, cancer center networks and at-home screenings, the program will aim to make cancer screening routine and easily accessible. Moreover, significant efforts will be made to develop and deploy new testing technologies.
- On the therapeutic front, bringing forward targeted therapies will be a major goal of the program. Regulatory guidelines will also be streamlined to ensure therapies progress at a rapid pace.
National Biotechnology and Biomanufacturing Initiative
- This $2 billion initiative aims to expand the country’s biomanufacturing and biotechnology capabilities across multiple sectors – such as health, agriculture and energy – and help train the next generation of biotechnologists. The key areas for this initiative include mitigating the effects of climate change, increasing sustainability, and advancing new therapeutic technologies.
- Public-private partnerships will be expanded to help commercialize regenerative medicine, industrial biomanufacturing, and biopharmaceuticals. One specific focus of the initiative is gene therapy. The program aims to improve patient access to gene therapies, while the National Institutes of Health’s Accelerating Medicines Partnership® Bespoke Gene Therapy Consortium will support between four and six new clinical trials, each focused on a different rare disease.
- Regional biomanufacturing hubs will be established and grown over the next five years, while a first-of-its-kind facility that integrates engineering, automation, and biology – called BioFab Foundries – will be created specifically to allow groups to manufacture preclinical and early stage clinical products.
- Included in Biden’s executive order is the formation of the Data for the Bioeconomy Initiative which allows biotech companies, academia, etc., to have streamlined access to high-quality, wide-ranging biological data sets from federal information systems that can be used in research related to critical societal and global issues.
The original cancer moonshot spurred great progress within healthcare and the biotech industry. In the decades since, the cancer death rate has fallen 32 percent since its peak in 1991 – representing nearly 3.5 million avoided deaths. Throughout this decade, immunotherapies, such as CAR-Ts, rose in prominence, with yet many more new therapeutic modalities being discovered every year. As of this April, there are more than 2,700 cancer immunotherapies in development.
However, even after these incredible strides, there is much left to be done: Cancer, as a whole, is the second leading cause of death in the United States, and it’s quickly rising in people under 50 years of age. There are still many aggressive cancers that do not have any viable therapies beyond chemotherapy, such as glioblastoma, and those with a poor prognosis, such as mesothelioma with a five-year survival rate of just 10 percent.
However, with these new initiatives, research and development for cancer-fighting tools – and potentially therapeutics and interventions for other untouchable diseases – may be on the horizon. Some of the things that have been on our radar are:
- New cancer diagnostic and early detection technologies, which are either an improvement on the current DNA-based standards or completely new modes such as cfDNA or proteomics-based liquid biopsies
- Completely new ways to target and treat cancer, such as tunable immunotherapies, click chemistry-based strategies and mRNA therapies that combine multiple cancer-killing mechanisms of action and are hyper-personalized
- New rapid processes for biomanufacturing and efficient use and planning for the biotech and biopharma supply chain
- Innovations and solutions for trial recruitment, especially in decentralized or hybrid clinical trials. Though not as attention-grabbing as a new therapy, trial recruitment and thoughtful patient stratification are incredibly important and can doom a clinical trial if done poorly.
With enough time and financial support, we HDMZ-ers have long believed that the innovative minds in biotechnology and biopharma will eventually solve the enduring challenges associated with cancer and other diseases. Stay tuned, as we will be closely following these developments and providing our analysis on what positive changes come from them.