Challenges and Opportunities in Personalized Medicine

BIOtech Now
Jeremy Isenberg

Last week the sixth annual Patient and Health Advocacy Summit brought hundreds of patient advocates, industry experts and policymakers together to engage on important issues facing the patient community today. This year’s Summit featured a new Personalized Medicine Workshop that offered a unique opportunity for patient groups to engage with other stakeholders to learn more about the emerging field of personalized medicine. The workshop concluded with a session on “Barriers and Opportunities for Putting Personalized Medicine in Practice,” and included subject matter experts Dr. Mark Fleury, Dr. Rasika Kalamegham, Andrea Ferris and Dr. Timothy Cannon.

Dr. Mark Fleury, the Principal for Policy Development and Emerging Science at the American Cancer Society Cancer Action Network, moderated the panel and directed the discussion to cover information and ideas that could be utilized by patient advocacy organizations. He also remarked that we are in a new era of patient focused drug development where patients now have a seat at the table to provide their feedback.

Dr. Timothy Cannon is the Clinical Director for the Molecular Tumor Board and Personalized Medicine Initiative at Inova Health Systems. Inova’s molecular tumor board was formed two years ago to help match patients with rare forms of cancer to personalized treatment options, designed to address their specific cancer.  Inova’s move toward personalization shows how health services are evolving to include technologies such as genomics in their treatment calculus, and making care choices based on the individual rather than the average person. The board also provides a forum to evaluate standard and experimental therapies as well as aggregate expertise to match patients with clinical trials. While the scientific research has been promising, Cannon noted that we must be careful about overpromising results when it comes to targeted therapies as this is still a new science.

Dr. Rasika Kalamegham, Group Director for US Regulatory Policy at Genentech, spoke about the future of cancer care saying, “how do we get to the next iteration of cancer—beyond cancer”? What the public may not understand is that molecular testing can provide a faster and more scientifically accurate pathway to develop a given drug. Recognizing this, the FDA has begun approving companion diagnostics that are packaged with an approved drug. For instance, a drug may only work for a patient who expresses a specific protein on their breast cancer tumor, so the companion diagnostic would test to see if the patient has that protein. And the number of these tests has increased exponentially in recent years with many variations, but the hope is that we can eventually develop one test for multiple drugs rather than just one test for one drug.

Andrea Ferris, President and Chairman of LUNGevity, spoke about how the healthcare system has maximized the benefits of molecular testing, partially due to concerns about a lack of familiarity with molecular medicine as a whole. Patients have trouble accessing the benefits of personalized medicines because molecular tests are not being reimbursed by insurers, so there is a need to educate insurers to recognize the value of testing.

Ferris also noted there is a need for physician education on molecular testing, as many doctors today went to medical school decades before these diagnostics were commonplace. Dr. Cannon echoed this, saying that physicians are hesitant to order molecular tests because they may not understand the results themselves, much less be able to explain the results to the patient.

The panelists agreed on several ideas, including the challenges and opportunities provided by clinical trials. Clinical trials can be expensive as sponsors are looking for a needle in a haystack and it is difficult to find and enroll patients who have a specific disease type. We must make it easier for patients to participate in these important studies, harness the power of new technologies as so many other industries have done. We can also look at how to bring the clinic to the patient, especially in rural communities where a long commute can be prohibitive. Patient groups can help the industry and regulators parse out solutions to these problems and build an ecosystem that allows for better clinical trial enrollment.

While we have seen incredible advancement in diagnostics and lab developed tests, the fruits of these advancements cannot be realized without insurer reimbursement—otherwise patients cannot gain access to these life-saving treatments. And this is the true crux of the challenge in today’s healthcare system—that revolutionary technologies are abandoned or overlooked due to reimbursement barriers. Ferris summed up the challenges, saying the “patient community must continue to advocate for the development and reimbursement for innovative medicines and diagnostics—if we can’t have that, then we can’t have the rest of it.”

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