As Trump and RFK Jr. move to upend drug making, Seattle biotech bets on science

Marta Fields knew disease, as an expert in how drugs get approved.

Fields, 74, spent 35 years navigating the regulatory maze meant to ensure that any medicines that hit the market are safe and effective. Now, though, Fields is learning about disease, and experimental medicine, as a patient.

Fields has a rare and aggressive type of uterine cancer: endometrial carcinosarcoma. In 2022, she began the standard therapy. That treatment ended without putting her cancer into complete remission, she said, as did a second round of treatment with a different drug.

Fields is now on a drug approved by the Food and Drug Administration named Enhertu, developed and commercialized by biotech giants AstraZeneca and Daiichi Sankyo. Enhertu is not specifically approved to treat her type of cancer. However, she and her doctor decided to use it “off-label.”

Enhertu is also the same general type of drug that Fields worked on for a decade at Seagen, a Bothell-based biotech that sold to Pfizer in 2023 for $43 billion. Two of the Seagen drugs she worked on, Adcetris and Padcev, are FDA-approved therapeutics that can identify a particular kind of cell and kill it. These “antibody-drug conjugates” are like self-guiding missiles for drug delivery.

As a cancer patient using a drug off-label, which the FDA condones when appropriate, Fields finds herself on the frontier of cancer-fighting science, trusting that the federal system she knows so well has made sure the drugmaker has done its job right.

The Trump administration has made early moves that are shaking up that system, which oversees the nation’s drug-approval process.

On Jan. 22, the administration froze communications on regulations, guidance and other health agency notifications. Before that, Trump railed against the “deep state” at the FDA during the pandemic and now wants his administration to “cut the bureaucratic red tape” he says keeps Americans from the “medical cures and treatments they deserve.”

That rhetoric troubles leaders in Seattle’s biotech sector.

“The thing that worries me … is the language that we heard about deregulation,” Fields said. “That certainly concerns me as a quality-assurance professional.”

Fields, who retired from Seagen in 2019, was a leader in what’s called “clinical quality assurance.” In the role, she was part of a team within a biotech company that makes sure patients are protected, and that the company is running its clinical trials according to FDA regulations and collecting legitimate data.

“What we often saw,” she said of the inspections her quality teams ran, “was that we were more harsh on the (clinical trial) sites than the FDA was.”

While industries outside of biotech can show frustration with regulation, “the life sciences really welcomes it,” said Marc Cummings, president and CEO of Life Science Washington, a nonprofit trade association that supports companies and entrepreneurs in the biotech industry

Biotech researchers and company leaders know the process is long and difficult, he added, “but in order to have a drug in the market that people trust, it’s well worth doing.”

‘Cooler heads’?

A wellspring of worry for the industry is Robert F. Kennedy Jr., an antivaccine crusader and FDA skeptic turned Trump campaign surrogate. Kennedy is expected to appear Wednesday before the Senate committee considering his nomination for secretary of the Department of Health and Human Services.

The industry’s main concern with Kennedy’s nomination isn’t so much his rhetoric about corruption in the drug-approval process, but what those statements say about his stance on science generally, said Luke Timmerman, publisher of the Timmerman Report.

Based in Seattle, Timmerman is a highly regarded journalist covering the industry and was named one of the 100 most influential people in biotech in 2015 by Scientific American.

“There is concern about the decline in public trust in science and in the regulation of it,” Timmerman said. “RFK fosters this idea that anecdotes from your next-door neighbor are just as good as something that comes from an expert body, from the CDC or the FDA” or the National Institutes of Health.

Another concern is federal funding for the basic science that drives the innovations that are the foundation of the biotech industry, said Brian Surratt, president and CEO of Greater Seattle Partners, an organization that promotes Seattle’s economic development and trade.

That federal support of research through grants to the University of Washington, Fred Hutchinson Cancer Center and other private and public organizations conducting basic science research, “is unmatched” in the world, Surratt said.

By one measure, the National Institutes of Health awarded roughly $1.3 billion to Washington organizations from October 2023 to September 2024, according to agency records. Leading among those recipients was the UW, with more than $570 million, Fred Hutch with more than $300 million and Seattle Children’s hospital with nearly $120 million.

The Trump administration on Monday attempted to pause a wide swath of federal grants and loans. A federal judge temporarily blocked that push Tuesday.

The administration has also moved to cancel research-grant reviews and other research-related meetings that could have wide-ranging impact on research funding.

“Without advisory-committee meetings,” reported Nature, the science journal, “the NIH cannot issue research grants, temporarily freezing 80% of the agency’s … $47-billion budget that funds research across the country and beyond.”

In November, Trump nominated Dr. Jay Bhattacharya, a critic of pandemic lockdowns and vaccine mandates, to run the NIH.

Other federal agencies also provide tens of millions more annually for research in Washington state.

“It would be a grave threat to our economy, frankly, our national security, our way of life, if we even thought about pulling back on investing in these research institutions,” Surratt said. “We all know that different administrations are going to make different policy decisions, but in many ways, I feel like that collaboration and investment from the federal government to local research institutions is almost sacrosanct.”

And while Trump’s pick for commissioner of the FDA, Dr. Marty Makary, gets dinged as a critic of COVID-19 lockdowns, he “doesn’t have a history of being anti-science,” Timmerman said, which tempers some of the anxiety around the new administration. Makary has also come under fire for questioning vaccine mandates and writing that herd immunity would stop the virus.

Robert F. Kennedy Jr., lightning rod

Kennedy’s nomination to run the Department of Health and Human Services is of particular concern among biotech leaders.

Kennedy’s criticisms over the years of HHS subagencies the Centers for Disease Control and Prevention, FDA and NIH have received plenty of backlash in public health circles. They’ve also garnered him support from Americans concerned that regulators are too easily swayed by the half-trillion-dollar biotech industry, which is projected to hit $1.7 trillion by 2033.

An online search will bring up hundreds of news stories exploring the controversial selection of Kennedy, as well as opinions and a few petitions by doctors and scientific luminaries declaring him unfit for the job.

“When you get into the regulatory environment that’s taken 20 years to sort of solidify, if we’re going to make changes there, we want to make sure those are done incrementally and with some real thought,” said Cummings of Life Science Washington. “If you lose some of that confidence in the FDA, it can take a long time to get it back.”

PitchBook, a data and analysis platform for capital markets, wrote “Investors are concerned about a disruption to the clinical trial process, the possibility of which has been top of mind for many since” Kennedy’s nomination.

PitchBook’s analysis was focused on contract research organizations, companies paid to help run clinical trials. The market size of these organizations is currently more than $55 billion. Most contract research organizations work worldwide, with North America making up nearly half the total market.

Seattle’s biotech leans on trust in science

Surratt believes the uncertainty around what the new administration might do is “unsettling.”

However, he said, “I think what brings me a level of optimism, frankly, is the science. The science is still there. The science is still ultimately going to drive this.”

Biotech science and the companies bringing it to the medical market in Seattle lifted the region into the Top 10 of U.S. biotech “clusters” in 2023, according to Genetic Engineering & Biotechnology News.

Since the peak of the COVID-19 pandemic, however, the Seattle biotech industry has experienced a slowdown in investment that mirrored the national trend. The slowdown in 2023 was blamed on rising interest rates, restrictions on the prices of new drugs and post-COVID-19 sentiment toward the medical industry.

Nevertheless, confidence in Seattle’s biotech future remains strong, experts said, because of the advances in medicine by its researchers and companies.

“The science and technology driving biology has never been better,” Timmerman said. “It is just astounding.

“A lot of it is happening in Seattle, and it’s throwing off a lot of exciting new ideas for ways to treat long, untreatable diseases and diagnose them faster and cheaper. So from a science and technology standpoint, things are better than ever.”

Fields, who majored in theater at Northwestern University, spent her early professional life as an actor, performing mainly in educational films “with a couple of commercials thrown in” from 1972 to 1987 and wrote for the animated TV series “Fraggle Rock.”

While she later earned a master’s degree in health care management, Fields got her start doing medical transcriptions on the side to make ends meet. When family matters demanded a more stable income, she took a full-time transcription gig at what she was told was a “little biotech company.”

That company was Amgen, which grew into a pharmaceutical giant with a $151 billion market capitalization. She started there on a two-week stint and stayed for 21 years.

And now as a patient who thrived in the industry, she believes the system of new drug development works well.

“I do have some faith in the system that when they say that a drug will do something, that there’s data to back it up,” she said. “There’s credibility behind that.”