Michelle McMurry-Heath doesn’t talk about biotech the way her peers do.

Where other executives and experts might bring up “access,” and “reimbursement,” McMurry-Heath talks about fairness and ethics.

“Science is the social justice issue of our age,” McMurry-Heath said. “Making sure that knowledge gets out to the people who need it, that, to me, is a justice issue.”

The question is whether biotech will embrace McMurry-Heath’s point of view — and whether it will have any impact on lawmakers.

On Thursday, the veteran physician and scientist was named the new CEO of BIO, the powerful trade group that represents roughly 1,000 biotechnology companies across drugs, diagnostics, and agriculture. When she begins that role on June 1, she will be responsible for managing the reputations of companies from Moderna to Merck to Monsanto.

At age 50, McMurry-Heath is as different from her predecessor, the former Republican congressman Jim Greenwood, as one could imagine: a veteran of Democratic presidential campaigns, a former official at the Food and Drug Administration, and the first Black person to graduate with an M.D.-Ph.d. from Duke University.

In setting out her case about drug policy, she appealed to her own history and the way that biotechnology companies have changed her life. She watched her first husband suffer from cystic fibrosis, a disease that has been transformed by biotechnology companies and the drugs they have developed. Her daughter, she said, is the light of her life — and would not exist without fertility treatments.

Can a social justice advocate be the head of a drug industry trade group? It is a radical departure, but one that fits with a shift in BIO, which is trying to distinguish itself as an organization representing the interests of scientists and patients — and to differentiate itself from the pharmaceutical industry trade association PhRMA, which has a storied reputation for aggressive lobbying tactics. BIO’s past two board chairs (a two-year position held by a biotech CEO) have condemned bad actors among drug companies, and organized open letters committing to put patients first.

“She is the right person for this job at the right time,” said Ellen Sigal, the chairperson and founder of the patient advocacy group Friends of Cancer Research. “She won’t be afraid to take on some of the issues people are terrified of, like value and pricing.”

That does not mean, however, that she will embrace ideas like having Medicare negotiate drug prices, letting the government seize drug patents to make them available, or outright price controls. McMurry-Heath, who has spent nearly six years heading regulatory affairs at drug and device giant Johnson & Johnson, was adamant that part of the blowback against biotech firms has been that people don’t understand the importance of the work they do.

“A lot of policymakers have unfortunately played political football with our industry,” McMurry-Heath said. “Scientists aren’t the best at telling their stories. I’ll give it to them: We were sitting ducks in many ways.”

Critics won’t be easily convinced. “Trade associations report to their members, not the other way around, and unless the member organizations change, the trade association cannot change,” said David Mitchell, the founder of Patients for Affordable Drugs, an advocacy group.

But even he can’t help but be intrigued. “Her credentials are outstanding,” Mitchell said. “I’d love to meet her.”

McMurry-Heath has been immersed in the world of health care since her early childhood in San Francisco. Her father, a psychologist, spent his career designing government programs for people who couldn’t afford doctor care, including Native Americans and indigent youth.

Her mother ran public health nursing for all of Alameda County, and she took her daughter to work. As a teenager, she remembers tagging along as her mother told crowds of low-income women about how to avoid HIV infection and reduce infant mortality.

It was at Harvard, in the late 1980s, that she met her first husband, who had the lung disease cystic fibrosis. They married in 1996 and divorced after five years of marriage, but the relationship would shape her view of medicine. And it is why, she said, she took the job as BIO’s CEO.

“The life expectancy for CF patients at the time was 18, and he was a relatively healthy patient, but he struggled with it,” McMurry-Heath said. “And he would get so passionate and energized about how the decisions we make about what to research, and the investments we make to support that research, have such power and influence over individual patients’ lives. Because it really determines who gets the cure, how those cures are designed, and how quickly they reach the bedside.”

He died at age 50, around Christmastime last year. “He was too early for all the great breakthroughs in cystic fibrosis,” she said, referring to new drugs that can significantly improve patients’ ability to breathe. They had remained friends as he lived through a lung transplant, and then was treated for lymphoma, which was how he died.

A few days after his funeral, in January, she got a call from a recruiter for BIO. It was “a breathtaking moment,” she said.

“I had been reflecting on all of the work that I had done over the last 20 years to try to push forward biomedical research, to try to make sure that that research gets out to patients, to talk about the importance of access, to talk about the importance of justice when it comes to science. But here was an opportunity at BIO to really focus on that and really drive that forward at a time when people aren’t so clear on how important science is to their lives.”

That same impulse had driven her into politics 20 years before. She said that when she was a medical resident, she felt that the problems her patients faced were more often the result of politics or social forces than science. That led her to work in the office of Sen. Joseph Lieberman, the iconoclastic Democrat from Connecticut, and then to the FDA.

McMurry-Heath had gotten to know Margaret Hamburg, the FDA commissioner from 2009 to 2015, over a mutual interest in a surprising topic: biological threats.

Hamburg tried to lure her to the government twice, but McMurry-Heath kept turning her down. “I was a little surprised that she came,” Hamburg said. “Three is the charm.” Hamburg said she is “delighted” to hear that McMurry-Heath has taken the BIO CEO role predicting that she will be “a breath of fresh air.”

At the FDA, McMurry-Heath was in charge of overseeing the development of overarching scientific principles for the agency’s Center for Devices and Radiological Health. This included a major push by Hamburg to involve patients, and their views about what was important, in the development of new medical devices.

That regulatory experience made her invaluable to Johnson & Johnson, which hired her in 2014 to be worldwide head of regulatory affairs for the company’s medical device division.

That division in particular is no stranger to regulatory controversy. Thousands of women sued the company over deceptive marketing for a transvaginal mesh that they said eroded into their bodies, causing pain and lasting damage. The company settled a separate major lawsuit over metal hip replacements that became unusable and had to be surgically removed. And it settled a slew of wrongful death lawsuits over morcellators suspected to inadvertently spread cancer cells.

McMurry-Heath said she relished the chance to reset Johnson & Johnson’s global reputation.

She talks of being a “proud mama” as she watched her team win over particularly skeptical regulators in Germany.

“We were really a company that they looked at with skepticism and concern [and became] one of their trusted advisers,” she said.

Now, McMurry-Heath will face a reputational challenge that dwarfs even Johnson & Johnson’s woes.

The pharmaceutical industry has a public reputation that makes airlines and oil companies look saintly: A recent Gallup poll pegged them as the least-liked industry in America. Congress and state legislatures around the country are eager to drastically shake up the drug pricing system. And now, their political and financial fortunes increasingly rest on whether they can quickly deliver therapies and vaccines to help address the Covid-19 pandemic.

“Michelle is ready to step into what is one of the most turbulent times for the biotech industry ever,” said Jeremy Levin, BIO’s board chair. “She is brave.”

Levin, along with John Maraganore, BIO’s former board chair, and Paul Hastings, who will succeed Levin in 2021, led the search for a new CEO. They decided not even to interview the various former lawmakers that could have succeeded their latest CEO, Jim Greenwood, a former Republican congressman from Pennsylvania.

That surprising decision is the clearest sign to date of BIO’s efforts to distinguish itself from PhRMA, the D.C. trade group that represents many of the same member companies. PhRMA, the Pharmaceutical Research and Manufacturers of America, is famous for scorched-earth lobbying tactics and major spending in Washington. While the two trade associations frequently collaborate, the relationship seems hardly beneficial: It’s an open secret in Washington that BIO is widely considered PhRMA’s less powerful little brother, but the smaller organization receives just as much scorn from activists angry at “Big Pharma.”

Now BIO is pushing, albeit subtly, to shed that image and be seen instead as the voice of scientists and innovative small companies — the part of the biopharma industry, they say, that should be celebrated.

“We want to focus only on patients and innovation,” Levin said. “This is the pinnacle of that change.”

It’s a risky strategy for an industry that just months ago was fighting around the clock to stave off a litany of major federal drug pricing reform bills.

McMurry-Heath, despite her compelling story and thoughtful demeanor, is sure to face skeptics who are unwilling to support the pharmaceutical industry, and hard questions about how she squares her views on social justice with the industry’s longstanding pushback to so many drug pricing reforms that advocates say would improve access for far more patients.

Exactly how McMurry-Heath will tackle that hot-button issue remains to be seen. On drug pricing, she spoke in generalities about holistic approaches, rather than laying out specific policy solutions. She insisted too, like CEOs before her, that middlemen and insurers play a role in driving up drug prices, and must be included in discussions about reform.

“There’s no question that patients have been having a tough time affording the medicines they need,” she said. “It’s important that we find a way to drive down the cost curve.”

https://www.statnews.com/2020/05/14/bio-lobbyist-ceo-michelle-mcmurray-…