Now 15 years old, the Personalized Medicine Conference held every November in Boston has been a year-ending touchpoint for leaders in the field to assess recent advances, but also to grapple with the issues slowing the adoption of personalized treatments for patients.
While keynote speeches on each day from CAR-T therapy pioneer Carl June and former Commissioner of the FDA Scott Gottlieb highlighted advances in immunotherapy and the forward-thinking regulatory landscape, Day One of the conference in November largely focused on the vital role diagnostics play in shaping personalized medicine.
Succinctly capturing and examining the challenges of advancing precision diagnostics was the morning session titled “Transformative Technologies: Previewing the Value Proposition and Outlook for Disruptive Tools Designed to Enable Personalized Medicine.” Chaired and moderated by Michael Pellini, M.D., a managing partner with venture capital firm Section 32, the panelists represented a wide range of companies working within the personalized medicine landscape and included: Steven J. Kafka, Ph.D., a partner at Third Rock Ventures and executive chairman, Thrive Earlier Detection; Nancy Mendelsohn, M.D., chief medical officer, Special Needs Initiative, UnitedHealth Group; Eric Schadt, Ph.D., CEO, Sema4; and Roy Smythe, M.D., CEO, SomaLogic.
Before turning to questions for the panel, Pellini, who is also the former CEO and current chairman of Foundation Medicine, put on his professor’s hat to give grades on how well people in personalized medicine are addressing particular areas within the field.
On the development of new technology Pellini graded an A, and while he noted technology is not the challenge in the field, lowering the barriers to allow for faster application of new technologies would significantly improve their impact on patient care. For showing clinical utility however, “do we get a C, a C+, a B-? we certainly don’t get better than a B-,” Pellini noted.
For healthcare payments, Pellini said the industry gets a D with plenty of blame to go around to all stakeholders. “We can’t look at one plan or one payer until we look around the table at all of us,” he said. “Are we doing the appropriate job we need to do to generate the data together that we need to justify these new expenses?”
While patients “always get an A,” Pellini also suggested there is a greater role patient advocacy groups can play to better participate in the national dialogue for developing personalized treatments for specific diseases by broadening their approach to include more stakeholders.
For the final area, data sharing, Pellini gave an F, as data is not today freely shared among the personalized medicine stakeholders, and is significantly hampering advancement and adoption.
Making the case to payers
According to panelist Nancy Mendelsohn, CMO, at the country’s largest private payer UnitedHealth Group, the single most important activity the industry could take up to allow for coverage of more diagnostics is to push for standards.
“We need to get our societies to agree upon the guidelines so we can get [them] implemented and have clinicians accept these standards. That is the hardest part,” Mendelsohn said. “We also have a huge challenge in educating the physicians. The level of understanding of genomics is very disparate.”
Steven Kafka, partner at Third Rock Ventures and executive chairman, Thrive Earlier Detection wondered whether there is also a greater role for payers to play to help accelerate reimbursement for new testing, and suggested that payers, healthcare providers, and industry can work together to speed progress.
“I think the partnering approach between industry and payers is critically important. We have to get payers out of the business of saying no,” Kafka said. “That is especially important with really novel technologies.”
But it may take innovative payers to embrace this idea. Roy Smythe, CEO of proteomic testing company SomaLogic, noted that even when presented with a technology that is potentially transformative, there can still be reimbursement roadblocks. He provided an example of presenting to a private payer one of his company’s technologies that can help determine which patients with type 2 diabetes will develop secondary complications within two years.
“The payers say they are really compelling opportunities—those could be tremendous—but come back to us when you’ve proven clinical utility,” Smythe said.
Closing the data divide
At health intelligence company Sema4, the focus is on developing actionable data from patients, while also keeping the patient in control of their own health data, according to CEO Eric Schadt. He said there is too often a disconnect between research and what is being provided to patients in a clinical setting.
The company was spun out of Mt. Sinai Hospital two years ago based on the observation that “there was this growing divide – this chasm—between the clinical practice of medicine and the uptake of what is happening on the research side,” Schadt said. “How physicians could engage in that information and how they can use it in their workflows became a driving force.”
Outside a broader discussion of the FDA and government regulation of diagnostics and new analytical methods, Pellini asked the group whether the federal government could play a role in closing the data divide that is hampering personalized medicine.
“I think about Joe Biden’s Moonshot Initiative. After his son passed away, he brought hundreds of people into D.C. He didn’t say we need to put more money in the NCI, or we have to put more money in therapeutics, and more money into diagnostics,” Pellini noted. “He said we have to share data. That was his basic conclusion.”
For Smythe, shifting the focus of how healthcare is predominantly delivered would help clear the data logjam. He argued that if the government played a role in flipping the model so healthcare providers and larger health systems had incentives to improve outcomes, it could be transformational.
“[It shouldn’t be] just short-term clinical outcomes, but clinical outcomes over time,” Smythe concluded. “If that were to happen, then all of the things we are talking about—databases, sharing data, paying attention to genomic risk and proteomic risk, all of these things would suddenly seem very important to health systems.”
Mendelsohn was more blunt in her assessment and simply stated: “We are not going to move precision medicine forward unless we share more of our data.”