A new collaboration launched last week by two Arizona-based philanthropic organizations aims to improve the way molecular diagnostics are developed and adopted by bringing together doctors, academics, industry players, and insurers.
With a $35 million gift from the Virginia G. Piper Charitable Trust and $10 million from the Flinn Foundation, the alliance, called the Partnership for Personalized Medicine, will create the Virginia G. Piper Center for Personalized Diagnostics. The founders envision the center to become the “hub for intellectual activities and collaborative endeavors related to personalized diagnostics and as a convening point for all stakeholders in this effort.”
The center, which will be led by 2001 Nobel laureate and Fred Hutchinson Cancer Center Director Lee Hartwell, will aim to “improve patient outcomes, reduce long-term healthcare costs, and avoid the costs associated with decreased productivity due to illness and disease,” a spokesperson for the collaboration told Pharmacogenomics Reporter this week.
Members of the center’s executive council, including Hartwell, Translational Genomics Research Institute President Jeff Trent, and George Poste, director of the Biodesign Institute at Arizona State University, have outlined a plan to develop the initiative.
The center will “employ a different scientific method to understand disease” and will “represent a radical new model in terms of its organizational structure,” the spokesperson for the partnership told Pharmacogenomics Reporter this week.
“It will use a systems approach and bring together stakeholders from across the healthcare chain and beyond, including discovery laboratories, insurance carriers, healthcare providers, healthcare economists and regulatory agencies,” the spokesperson said. “Together these stakeholders will design a better and more economical approach to healthcare.”
The molecular diagnostics will be developed by researchers at the Biodesign Institute, TGen, and the Fred Hutchinson Cancer Center. The center will also try to identify and validate protein biomarkers to better gauge disease risk; predict treatment response; and develop safer, more effective treatments, according to the alliance.
In order to develop these molecular diagnostics, the partnership will use several technology platforms for proteomics, bioinformatics, nanotechnology, and imaging research. The alliance has not yet determined specific disease areas that it will study. According to the spokesperson, the details of the project will be ironed out in the next year, and further details will be available in January.
According to the partnership, the development of molecular diagnostics today is hampered by the high cost of clinical trials and the difficulties of obtaining clinical samples. However, by bringing disparate stakeholders together, the partnership aims to promote a “new model” for developing molecular diagnostics.
“Over the past 18 months, the Piper Trust has sought a strategy that will advance the field of personalized medicine because we recognize that through genomics and proteomics breakthroughs, medicine can be tailored to the individual patient,” Judy Mohraz, president and CEO of the Virginia G. Piper Charitable Trust, told Pharmacogenomics Reporter this week.
“We can no longer afford the current one-size-fits-all medicine that has brought increasingly more expensive treatments,” Mohraz said. ”Personalized medicine will offer a whole new paradigm for the prevention, diagnosis, and treatment of disease.”
The Partnership for Personalized Medicine comes during a popular time for collaborations to advance genomic science. Recent collaborations in this area include pharma’s Serious Adverse Events Consortium; the C-Path Institute, the FDA and Ventana’s efforts to develop Rx/Dx submission guidelines; and a pilot project of doctors establish standardized genomic treatment guidelines (see related story, in this issue).
However, the leaders of the Partnership for Personalized Medicine hope the alliance will stand out from the others by building a new way to develop and deliver molecular diagnostics.
Under the aegis of the partnership, there will be various “demonstration projects” dedicated to developing a diagnostic for a specific condition. Each project will be paid for by an insurance company or other funders.
In this model, an insurer, which will include governments and private payors, would work with a team of clinicians to identify a disease or a therapeutic area in which a diagnostic could benefit both the insurers by lowering medical costs, and public health by improving patient outcomes.
Under the plan, an insurer would agree to reimburse a discovery lab for developing and implementing a diagnostic test. The discovery lab would then work with clinicians and biologists to define performance criteria for the test. From there, researchers would identify candidate protein biomarkers based on the different molecular profiles of diseased and normal tissue and perform assays on blood samples from patients and controls.
Ideally, a diagnostic test would emerge from this information. At this point, clinicians would administer the test and collect outcomes data. “Based on how effectively the test predicts actual outcomes and meets defined performance criteria, researchers would refine and improve the test,” the spokesperson said.
After several cycles of trials, refinement, and validation, when the test meets the appropriate performance criteria, the insurer would begin reimbursing the developers for the costs of the test, and it is expected that, depending on the outcomes data, the clinicians would alter the way they manage their patients.
“The PCPD will design these projects to generate compelling data and demonstrate the clear value proposition necessary to affect policy changes related to FDA approval and reimbursement for diagnostics by insurers.”
Having involved insurers from the outset of the demonstration project would increase the chances that these molecular diagnostics would be reimbursed, the partnership leaders are hoping. “Cost savings to the insurer would drive the financial model, and the willingness of the insurer to reimburse for the test would be tantamount to regulatory approval,” the spokesperson said.
The spokesperson for the partnership noted that countries with single-payor healthcare systems, like the UK, “will be eager to support demonstration projects that address diseases that are major causes of mortality in that nation.” Within the US, the partnership will target as underwriters or funders state and local governments, as well as large insurers and philanthropic organizations.
“The PCPD will design these projects to generate compelling data and demonstrate the clear value proposition necessary to affect policy changes related to FDA approval and reimbursement for diagnostics by insurers,” the spokesperson said. The projects will also garner intellectual property, which will help bring the partnership a return on investment and keep it a sustainable venture, the spokesperson added.
Ironing Out Details
According to the project’s leaders, within the next 12 months the PCPD will recruit personnel, purchase equipment, and secure real estate to house a base for the project. During this time, the PCPD will design these demonstration projects for various disease areas and secure partners.
The partnership is aiming to launch an average of one new demonstration project per year. The first demonstration project is slated to launch at the end of the 12-month period, and each project will take approximately three years to complete.
According to Flinn Foundation CEO John Murphy, 50 percent of the Flinn Fund for Arizona Proteomics Research will be dedicated to advance research collaborations in this field. Any funds left over will go toward creating a high-throughput proteomics production facility, he said.
According to a statement from the partnership, the proteomics production facility will focus on discovering new proteins for the development of diagnostic tests for early detection of cancer and more accurate disease management.