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Government, researchers, industry have ‘huge opportunities for alignment’ to advance cancer care
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Initiatives led by government agencies and collaboration between private and academic research are the keys to further advance cancer research, according to a panel of experts who presented at the Medical Innovation Summit held this week at Cleveland Clinic.
Further, greater government investment and implementation of policies are needed to propel progress forward.
“Collaborative efforts across and between private sector enterprises, research institutions and our government agencies are essential if we are to discover, introduce, bring to scale and commercialize solutions,” panel moderator Reed Tuckson, MD, managing director of Tuckson Health Connections said during the discussion.
Genomic research
As part of its strategy, the U.S. government has worked closely with NIH, Veterans Affairs and the FDA to implement a clear strategy for the use of precision medicine.
“About 5 to 6 years ago, ... it became clear that there were implementation opportunities, and [NIH] embraced that and began to build a portfolio of genomic medicine implementation research that we have continued to grow,” Eric Green MD, PhD, director of the National Human Genome Research Institute at NIH, said during the panel discussion.
Despite early criticism, NIH has worked extensively in collaboration with research institutions and the private sector to build a portfolio for the use of precision medicine.
“It is very important for us to be able to slowly, but surely, build that complete portfolio all the way through to implementation,” Green said. “Beyond implementation, we also ... fund research, and we think about the societal implications of this even beyond clinical implementation. We think about the ethical, social and legal issues associated with genomic advances. All of which is a responsibility as a funding agency.”
‘Knock down’ barriers
Although pharmaceutical companies, research institutes and government agencies have made advances in cancer research, barriers still exist.
Brian Bolwell, MD, chair of the Taussig Cancer Institute at Cleveland Clinic, noted the biggest barriers include:
- that fewer than 5% of patients are enrolled in clinical trials;
- a lack of standardization of genomic testing in basket trials;
- strict patient eligibility; and
- the length of time it requires to initiate a clinical trial.
“These are very real problems that those of us in day-to-day clinical research face,” he added.
However, Bolwell feels the biggest barrier occurs between research institutions and pharmaceutical companies.
“One of the biggest challenges we have is our relationship with pharma, with relation to how to monitor disease in clinical trial research,” he said during the panel discussion. “The amount of minutia that we are required to actually document and report is euphemistically excessive.”
Despite these barriers, genome sequencing data are projected to include 60 million human genome sequences by 2025. Eighty percent of these data will be derived from routine health care, compared with only 20% currently, according to Green.
“The richness of that available data for the studies we will be doing is very different. So, that brings up a whole other set of challenges of how to harvest that data,” he said.
Most patients agree to share their medical and genomic data and, as a result, a plan to enable simpler access should be implemented, Green said.
“We should start thinking about a future — not that far off — where data won’t be research data,” he added. “It will actually be clinical data available for research. We need to knock down some of the barriers associated with accessing that data. That is where the real opportunity is going to come in.”
FDA focus
Following the initiation of the cancer moonshot initiative, the FDA has worked to implement strategies regarding former Vice President Joe Biden’s “Urgency of Now” campaign.
As a result, the agency has made conscious efforts to translate data from ongoing research into actionable and informative decision-making in a modern and efficient manner, according to Anna Abram, deputy commissioner of the FDA.
“There should always be urgency and prioritization of this work because it is so important to caring for patients and making sure we are always being focused in delivering high-quality care,” she said during the panel discussion. “We are at such an exciting point in medicine right now, where our knowledge of disease has never been greater and, at the same time, in terms of the advancements of technology and data.”
In conjunction with their efforts, the FDA initiated the Oncology Center for Excellence — designed to enhance the work of cancer research — on behalf of patients with cancer.
“This is an important development that is very much in parallel with the concerted effort to have a patient-focused paradigm and to integrate patient perspectives into the development of products and into patient-reported outcomes,” Abram said. “It is continually coming back to how we better serve patients and fulfill our mission to protect and promote public health.”
To make precision medicine available to patients while maintaining safety, the agency has worked to gather patient perspectives regarding risk-benefit calculations, as well as patient thresholds during treatment.
“Instead of speed, I say [it is more about] efficiency and really making sure the development and review processes are as efficient as possible,” Abram said. “That puts an emphasis on [the FDA] being clear and predictable about what we are expecting as part of those development programs and working with sponsors early on, so they have clear guidance and expectations about what we need to see to determine [whether] a therapy has reached that threshold of safety and efficacy.”
Veteran s Affairs partnerships
In conjunction with these efforts, Veterans Affairs has additional data — from its Million Veteran Program and corporate data warehouse — that it has offered to enhance research in precision medicine.
“For Veterans Affairs, federal and nonfederal researchers, and academic and private partners, we are looking to open up these data resources to researchers in a safe and secure way that is comfortable [for] our patients and those involved. We absolutely want to be able to open this unique asset to others,” Jennifer Lee, MD, deputy under secretary for health for policy & services at Veterans Affairs, said during the panel discussion.
Lee acknowledged the importance of partnerships to improve care and advance research.
Veterans Affairs partnered with the Prostate Cancer Foundation under an initiative from the cancer moonshot initiative, for which the organization committed approximately $50 million over the next 5 years to advance prostate cancer research and open access to clinical trials for veterans.
Veterans Affairs also partnered with NCI to address its own clinical trial barriers regarding clinical trial infrastructure and timing.
Moving forward
Regardless of current barriers, governmental agencies, research institutions and pharmaceutical companies have aligned to further efforts in the fight against cancer.
“We have huge opportunities for alignment, whether that comes from our professional societies or from cancer centers doing more to educate people within our immediate geographic area,” Bolwell said. “The field is changing so quickly that sometimes it is hard to know what to do with the information that a physician receives.”
Moving forward, Bolwell stressed the importance of genomic tumor boards.
“When a tumor is sequenced and you get a result, what does that result mean?” Bolwell said. “Is it actionable? What are the appropriate priorities within the different possibilities of how to react to that gene? Having genomic tumor boards that are accessible to clinicians throughout the country, is a major opportunity [in which we can see success] in the near future.”
Following two FDA approvals of CAR T-cell therapies for patients with leukemia, Abram applauded this pivotal reflection point for the industry.
“This cuts to the heart of precision medicine,” Abram said. “In our minds, when we think about precision medicine and patient-focused care, we have the ability to take a patient’s own cells, modify them and put them back in patients to go and attack cancer, [which] is just a tremendously exciting milestone that we have now come to and are looking to accelerate.”
Moving forward, the FDA would like to continue to communicate its expectations to streamline the regulatory process.
“It gets back to us being predictable and clear so that those who are involved in developing and researching these potential promising, safe and effective therapies have as much predictability to what will be expected of them as they seek to bring them forward on behalf of patients,” Abram said. – by Kristie L. Kahl