Presumptive FDA chief a proponent of drug/device combinations for cancer

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Trine K. Tsouderos HRI Regulatory Center Leader, PwC US November 08, 2019

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Dr. Stephen Hahn, chief medical executive at MD Anderson Cancer Center, describes himself as an “energetic” early-rising exerciser whose first job was as an ice cream scooper at a Friendly’s restaurant, according to a short Q&A with the MD Anderson Cancer Center radiation oncologist.

Earlier this week, President Donald Trump formally nominated Hahn to lead the FDA at a turbulent time for the agency. If confirmed by the Senate, he will have to manage the national questions around the agency’s regulation of e-cigarettes, potential widespread medical device shortages due to closures of sterilization facilities, an ambitious regulatory agenda for 2020 and continued implementation of the 21st Century Cures Act. The FDA also is overseeing new applications of artificial intelligence in medical devices.

The confirmation hearing is set for Nov. 20, according to Inside Health Policy. On Wednesday, Senate health committee Chairman Lamar Alexander of Tennessee endorsed Hahn after a meeting with him, calling the Texas physician “well-qualified,” Politico reported.

Hahn spent his career as a radiation oncologist. As a young physician, he completed a clinical internship and residency at University of California, San Francisco Hospitals and a clinical fellowship and residency at the National Cancer Institute, according to a biography on the MD Anderson Cancer Center website. He then joined the University of Pennsylvania School of Medicine, where he was chair of the department of radiation oncology.

Hahn came to MD Anderson in 2015 to head the department of radiation oncology, a role he called a “dream job” in a 2018 interview with the journal Precision Cancer Medicine. He was named deputy president and chief operating officer in 2017, and became chief medical executive in 2018, according to the interview.

Hahn, who has been active in NIH-funded research throughout his career, also co-founded a company, Liquid Biotech, with several University of Pennsylvania colleagues. The Philadelphia-based company, according to its LinkedIn profile, was focused on identifying live, circulating cancer cells in blood samples. According to the company’s website as of Nov. 5, Liquid Biotech had conducted pilot studies for non-small cell lung carcinoma, glioma and bladder cancer. Hahn holds at least one patent connected to this technology, according to a potential conflict of interest disclosure made in a 2019 article in the journal Clinical Cancer Research.

HRI impact analysis

Hahn’s Senate confirmation hearing later this month will give industry a better sense of his approach to regulation. But glimmers of his perspective can be found in a 2018 workshop he helped organize, bringing together the FDA, the American Association for Cancer Research and the American Society for Radiation Oncology.

The workshop’s focus was exploring why, despite great promise for patients, so few combination drug and radiotherapy treatments had been approved by the FDA. The last such combination had been approved in 2006, according to a 2019 paper outlining the workshop’s conclusions in Clinical Cancer Research. Hahn was one of the paper’s authors.

The workshop was a model of industry-regulator-researcher collaboration. Four hundred researchers, industry representatives, regulators and others attended, and the group eventually concluded, among other things, that earlier endpoints, such as organ preservation, and patient-reported outcomes should be considered in trials of the combinations and that more clarity from the FDA on the regulatory pathways for the combinations would help encourage industry investment in the treatments. The group also agreed that communication with regulators early in an experimental treatment’s life cycle was essential.

Hahn, in remarks made during the workshop, highlighted the potential of big data to speed radiation oncology research. “It’s no surprise that [a pharmaceutical company] paid $1.9 billion for [Flatiron Health],” he said. “That’s not a surprise at all. There’s something in there for us to learn as well.”

Hahn’s experience in radiation oncology, including conducting clinical trials, would complement the life sciences industry’s focus on oncology as an area of growth. Worldwide, spending on therapeutic and support care for cancer is expected to reach $200 billion by 2022, or roughly 14 percent of total global medical expenditure.

Hahn was asked to name a current challenge in radiation oncology during an interview with Precision Cancer Medicine in 2018; his answer was “cost.” He further suggested that the oncology community must “do a better job of demonstrating [radiation oncology’s] value.”

Trump also has asked Dr. Brett Giroir, HHS assistant secretary for health, to take on some of the responsibilities of the FDA commissioner as the confirmation process proceeds, according to a statement from HHS. Dr. Norman Sharpless, who led the FDA as acting commissioner after Dr. Scott Gottlieb stepped down last spring, will return to the National Cancer Institute as director.

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Trine K. Tsouderos

HRI Regulatory Center Leader, PwC US

Tel: +1 (312) 241 3824

Ben Comer

Senior Manager, Health Research Institute, PwC US

Crystal Yednak

Senior Manager, Health Research Institute, PwC US

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