Statement by the Parker Institute for Cancer Immunotherapy on the 21st Century Cures Act

We are in the midst of a revolution in human biology, and with it, the transformation of medical treatments and disease prevention. Enactment of 21st Century Cures legislation arrives at a propitious moment in the advancement of scientific knowledge. The bill provides up to $4.8 billion in additional funding for the National Institutes of Health (NIH), for both research internally and at leading academic institutions. The support restores some of the funding losses – in purchasing power parity – that have occurred over the past 10 plus years. It provides nearly two billion dollars for new cancer research, funding for precision medicine, and the BRAIN project to study basic biology and tackle disorders like Alzheimer’s and Parkinson’s disease. Although the total NIH budget could exceed $32 billion annually, the funding pales when compared to other government investments, given the opportunity it has to change the length and quality of human lives.

In the past 20 years, we have sequenced the human genome, redefined drug development and created new tools from gene editing to tissue regeneration that enhance our understanding of human biology and deliver a healthier, disease-free existence. With this knowledge comes new approaches to precision medicine aimed at treating the right people, at the right time, with the right drug. The new law can also facilitate drug development, not just based on the new funding alone but also due to the new visionary paradigm of three government programs – the BRAIN Initiative, the Cancer Moonshot and Precision Medicine – built on increased data sharing and powerful partnerships between academia, philanthropy and the biotech and pharmaceutical industries.

Throughout my career, as an independent academic researcher, and now as president of the newly formed Parker Institute for Cancer Immunotherapy, I have seen the value of collaboration and sharing. The Parker Institute – founded and funded through a substantial commitment by Sean Parker – is a network of six major cancer institutions (UCSF, Stanford, UCLA, MD Anderson, Penn, and Memorial Sloan Kettering) whose aim is to accelerate cures for cancer. The investigators of the Parker Institute have been working together for more than a year on a new model of discovery and development in this arena.

The next step for the new Administration and for Congressional leadership is to effectively implement the law. We recommend several steps to achieve the most with the funding:

1) An implementation plan must be developed that breaks the mold of past NIH programming. Collaborative models, such as the Parker Institute, should be piloted within the NIH and beyond to accelerate discovery through collaboration. In keeping with the success of the Blue Ribbon Panel, created by Vice President Biden to advise the Cancer Moonshot Initiative, the NIH should convene leaders from both scientific and technical disciplines from all sectors rapidly deploy the new funding.

2) The NIH should follow the recommendations of Blue Ribbon Panel and similar efforts in the BRAIN and Precision Medicine Initiatives. The government can work across for-profit and non-profit entities to build bridges from research to drug development. Teamwork and translational studies do not have be dirty words in an organization that has pioneered and exploited single investigator-initiated research for decades. The two paths of discovery can co-exist.

3) The President should nominate and the Senate confirm highly qualified leaders for the NIH, the National Cancer Institute (a part of the NIH) and the Food and Drug Administration. The key issue for the new Administration is how the leaders of these large, competent and sometimes complex organizations can work simultaneously to meet the core missions of the institutions while implementing meaningful reforms to innovate and disrupt the business-as-usual approach to resource deployment.

4) Newly appointed leadership in DHHS should create an interagency/stakeholder allocation committee to bridge the various departments that support research among the various NIH institutes and beyond. We urge the federal government to take a broad, enterprise view to ensure that these funds are deployed smartly and where they can have the optimal impact for patients.

5) We must agree to a radical new approach to sharing data. Not only should there be more team scientific research, but those researchers should share their data and learnings more broadly with outside researchers and the patients involved in the clinical trials for new products. It is time to break down the silos and barriers to advancing knowledge for the best interests of patients who are waiting for new cures.

6)Implement the 21st Century Cure Act recommendations for the FDA to accelerate safe and effective therapies reaching patients including: access to new cancer medicines, both new and repurposed; a review pathway for biomarkers and other drug development tools to shorten development and reduce failure rate; research into treatments for rare pediatric diseases; new senior biomedical research service positions for product assessments.

In our view, advances depend on individual research efforts, with a sharing environment, and group efforts where researchers can achieve more than individual contributors acting alone. The government, philanthropic and commercial players cannot solve every key problem by acting alone. This is why we have formed dozens of commercial partnerships with technology firms, data firms and small and large life science companies.

President Obama, Vice President Biden and the remarkable bipartisan leadership in Congress have given us a gift that promises progress. Getting this law implemented with the same kind of energy and enthusiasm will require the same kind of focused effort. After a contentious election campaign and an era fraught with partisan disputes, we all can go into the new year with renewed hope that by working together we can accelerate the path to Cures for the 21st Century.

Sincerely,

Jeffrey Bluestone, Ph.D.
President and CEO
Parker Institute for Cancer Immunotherapy

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Contact Information:

Shirley Dang
Science Communications Manager
Parker Institute for Cancer Immunotherapy
sdang@parkerici.org
415-930-4385