Health Policy Expert Peter Bach, MD, Goes to Biotech Company

A well-known healthcare policy expert whose work has focused on the cost and value of anticancer drugs has left academia and has accepted a position at a biotech company.

Peter Bach, MD, was the director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center (MSKCC), in New York City. He is now the chief medical officer of Delfi Diagnostics, in Baltimore, Maryland.

Delfi is developing a new class of liquid biopsy for use in the early detection of cancer. The technology is based on altered genome-wide fragmentation profiles, also known as "fragmentomes." Through the application of advanced machine-learning algorithms, the test has already demonstrated proof of concept in accurately detecting cancer from these cell-free DNA fragments and in determining where in the body the tumor has grown.

"We're extremely excited to have a luminary like Peter join the Delfi team," commented Victor Velculescu, MD, PhD, founder and CEO of Delfi. "Peter's expertise in lung cancer is going to be critical in the near term as we complete our lung cancer studies and look to commercialize a lung cancer screening test, and his depth of knowledge in health economics and other applications will help ensure Delfi can meet its goal of providing affordable, accessible tests to everyone who needs one," he told Medscape Medical News.

Bach is well known for research into drug pricing and has developed new models for drug pricing that include value to patients. He made headlines in 2012 when, along with other physicians at MSKCC, they drew attention to the high price of a newly approved cancer drug, aflibercept (Zaltrap). In a New York Times op-ed article, they said it was "no better" than bevacizumab (Avastin), which cost less than half what aflibercept cost. MSKCC announced that it would not use aflibercept, and the price of this drug was later cut in half by the manufacturer.

Not Really a Switch

Bach says that his new job really isn't as big a change as it may seem on the surface. He emphasized in an interview that although much of his recent work has focused on pharmaceutical pricing, he spent almost 15 years of his career working on the early detection of cancer, "mostly in lung cancer and particularly the early risk prediction models," he said.

He has been involved and interested in lung cancer screening since the early days of its inception. He has participated in analyses or the preparation of guidelines, and he initiated a request to Medicare that resulted in nationwide coverage of lung cancer screening.

Bach said that his voice will still be heard on social media regarding drug pricing, but he also commented that the situation has changed. "There is now a huge cadre of really good researchers out there working on these issues, and that's different from 10 years ago when I started," he said.

"The real focus in drug pricing has always been access and out-of-pocket costs," Bach told Medscape Medical News. "Delfi has what seems to be transformational technology, both on the detection side as well as on the cost platform side. This means possible access to those with limited access and people who have been left behind with LDCT [low-dose CT] lung cancer screening."

Only about 16% of individuals who meet eligibility criteria for LDCT receive it. This is despite the fact that "lung cancer has some of the strongest evidence that we have in cancer screening, up there with cervical cancer and colorectal cancer screening," he said.

"There is really strong data, but that low average masks the fact that people from poorer states or who are poor have much lower rates that are only a fraction of the national average," he said.

Bach says that the liquid biopsy test for detecting early cancer that is under development at Delfi already has achieved proof of concept. "The data suggest that this could be the first foray into widely improved access and thus reduced mortality," he said. "So it all fits together."

From an economic standpoint, detecting cancer early makes sense. "Quite simply, early cancers are less expensive to treat," said Bach. "And of course patients are much better off. It is worth noting, if we can find a cancer earlier, we can save costs, considering the cost of therapy."

New Class of Liquid Biopsy

Delfi notes that unlike technologies that merely look for changes in DNA sequences, methylation, or proteins, its technology enables high-sensitivity and high-specificity assays that are not affected by confounding conditions such as clonal hematopoiesis of indeterminate potential, aging, or other disease.

The company first reported results with its technology in a study published in 2019 in Nature. In this study, which involved more than 400 patients, sensitivity ranged from 57% to more than 99% among seven cancer types, and the specificity was 98%.

In a study presented at this year's annual meeting of the American Society of Clinical Oncology (abstract 3058), investigators used the Delfi approach to measure the cfDNA fragmentation in plasma from all 412 patients who were included in the study, using a cross-validated machine-learning model. Patients with cancer were distinguished from those without cancer with high sensitivity and specificity (AUC = 0.92). These included patients with common cancers, such as colorectal and lung cancer.

Delfi was founded in 2019 with $5.5 million seed financing led by Menlo Ventures. By January 2021, the company had raised $100 million in funding. It plans to use this to expand its team of cancer researchers and machine-learning experts and to validate its novel next-generation liquid biopsy technology through multiple prospective clinical studies.

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