The Foundation for the National Institutes of Health (FNIH) takes on cancer through public-private research partnerships on prevention and early diagnosis.
Dr Stacey Adam is associate vice president for research partnerships at the Foundation for the National Institutes of Health. In her role, she leads the cancer research partnership programs. Adam is a molecular pharmacologist/cancer biologist skilled in molecular biology techniques, animal modeling, clinical genomics, systems biology, project and team management, and strategy consulting.
Labiotech asked Dr Adam about the organization’s role in the fight against cancer.
What does the FNIH do with respect to taking on cancer?
FNIH is committed to taking on cancer, and we lead multiple public-private partnerships that are focused on tackling the disease.
One of the Foundation for the National Institutes of Health’s (FNIH) major projects is The Partnership for Accelerating Cancer Therapies (PACT), a five-year, $220 million public-private research collaboration launched by the National Institutes of Health, the FNIH, and 12 leading pharmaceutical companies as part of then-Vice President Joe Biden’s Cancer Moonshot SM Research Initiatives. PACT is focused on efforts to identify, develop, and validate robust biomarkers to advance new therapies and treatments that harness the immune system to attack cancer. The partnership is also defining a set of standardized assays to be tested across a variety of studies, aiming to integrate immune and oncology biomarkers into clinical trials. This approach supports the harmonization of assays and allows for consistent generation of data to enable comparison of data across trials.
The FNIH Biomarkers Consortium cancer portfolio has numerous active projects advancing research on biomarkers for clinical use and regulatory qualification. The Consortium is working to identify novel biomarkers that will facilitate the development of less invasive methods for diagnosing and monitoring cancer, including imaging and liquid biopsy. New biomarkers have the potential to help the field better tailor immune-oncology (IO) treatments to specific patients, which will help stakeholders in pediatric oncology determine the molecular targets that should be highest priority for preclinical evaluation.
Our studies and partnerships are revolutionizing the way clinical cancer trials are conducted. The more projects the FNIH can facilitate, the more tools we will have to take on cancer.
Cancer is probably the most well-known disease globally, and yet tackling it seems to be a slow process. We saw huge advances due to COVID – how is the field of cancer progressing, and are there any major breakthroughs in sight?
The way the medical and scientific world tackled COVID-19 was unique in that it benefited from unified support and strong economic pressure. Unfortunately, as prominent as cancer is in the world, with more than 30% of the US population expected to receive a cancer diagnosis in their lifetime, it does not generate the acute economic impact that COVID-19 produced in the first years of the pandemic.
In addition, while the research and clinical communities did have to conduct studies to determine the disease pathobiology of SARS-CoV-2, as we are doing in cancer, the mechanisms of action for COVID-19 are more standard across patients than cancer when viewed in all its forms. Cancer, as a disease category, includes multiple diseases with numerous underlying causative mechanisms aggregated under a single name. These differences make it challenging to expect that cancer could be addressed with similar speed as the COVID-19 pandemic.
With that being said, I do believe that there are significant gains being made within oncology. The investments made over the last few decades, by the first Cancer Moonshot program in 2016 and now the second Cancer Moonshot program in 2021, allow for significant leaps forward. There are also major breakthroughs on the horizon, which help to further progress the battle against cancer. Simplified trials for agents have already been approved in one indication, such as the recently launched Pragmatica-Lung trial, overseen by SWOG Cancer Research Network and championed by the U.S. Food and Drug Administration (FDA) and the National Cancer Institute (NCI.) This is likely a direct result of the success of decentralized trials during the pandemic.
With many things, prevention is better than cure, are we doing enough to prevent cancer, and how do we do that?
The current research incentive structure is not set up to encourage cancer prevention research, even though prevention is far preferable to treatment of existing disease. Prevention studies often take years to conduct, some with decades of follow-up on the patients enrolled. Investigators also must enroll high numbers of patients to result in statistically significant findings that have the robustness to change clinical practice. Due to these factors, prevention studies can be quite lengthy and costly. Unfortunately, this delay in seeing return on such a substantial investment distinctly disincentivizes private sector entities from supporting prevention research. As a result, prevention trials are often sponsored by the government, public sector, or philanthropic organizations, which often have resource constraints.
To encourage additional partners to support prevention research, the field will need continue developing biomarker tools, such as liquid biopsy and other non-invasive methods, that can be deployed in standard of care clinical practice, and low-touch trials to allow more efficient data collection and patient follow-up to build the level of evidence necessary to validate surrogate endpoints for prevention trials. Another option for consideration to accelerate prevention research is to tap into real-world evidence to determine success of various prevention methods.
Early diagnosis is clearly helpful as the earlier cancer is detected, the better the chance of beating it. What are some of the most recent developments in diagnosis that give hope that some cancers can be treated earlier?
GRAIL Galleri, Cologuard, and other liquid biopsy and stool circulating tumor DNA screening assays can be used to detect different cancers, specifically finding a particular mutation or groups of mutations that are known for particular cancers or common across multiple cancer types. With the easy, routine clinic and at-home sample collection methods becoming more prevalent, it opens the possibility for other screening assays to be designed for early detection. This could lead to companies with current diagnostic and monitoring biomarker assays to join in prevention research, driving market competition, making cost less of an issue moving forward.
Key to early diagnosis is the creation of a method for standardization of data across liquid biopsy assays, so that the results can be compared across tests and clinical sites/trials. FNIH and other groups are engaged in developing these tools. In addition, ideally, there would be a consortium of group in the liquid biopsy field sharing methodology and data to create an end-to-end standardization through the entire process. The International Liquid Biopsy Standardization Alliance, a recognized FDA Collaborative Community, is one example of how this could be done.
Once we can standardize assay results, validation and qualification of particular biomarkers, regardless of the assay used, will be the natural next step toward prevention. Clinical validation of diagnostic and monitoring biomarkers that can be correlated with better patient outcomes allows them to be further refined for early detection of lower levels of cancer. Further qualification of these biomarkers, then allows them to be recognized as valid tests for regulatory and reimbursement organization support.
Recognition by these groups and deployment of valid biomarkers will ensure patients are able to receive medical care that prevents disease or catches it early enough for treatment to be more effective.
What are some of the research areas with the best hopes of making a difference, and are there any new tools to expedite some of these paths?
The use of artificial intelligence (AI) to mine data and determine better therapy combinations for each type of cancer can help treatments expand into larger groups of people. To use AI to its fullest extent as a research tool, we need to harness the power of data and create universally available databases. These databases could aggregate data in a federated model, allowing us to train AI in a comprehensive way.
This AI training on cancer data can also feed research on other diseases, helping with future drug development for multiple fields.
The other tool needed to make a difference in research is the deployment of decentralized trial models that allow treatments to reach more representative populations and underserved communities. By increasing trial diversity and creating a more representative research population, we can meet patients where they are, reaching more people and gathering more data that will help us make more universally relevant discoveries in an expedited fashion.
Partnering 2030: The Biotech Perspective 2023
