Penn scientist, towering figure in the gene therapy world, presided over toxic, abusive workplace, staffers say

Scientist Jim Wilson is synonymous with gene therapy — and for good reason.

For decades, the celebrated researcher has been a pioneer in the field, focused on the development of treatments for rare, often overlooked diseases. His work has generated millions of dollars for his employer, the University of Pennsylvania, and made Wilson a towering figure in the gene therapy world, with the wealth and fame to match.

But a STAT investigation reveals Wilson’s success has obscured a darker side to his leadership of the Gene Therapy Program, the acclaimed university research center he runs — a style that for years permitted toxicity and mismanagement to roil the workflow of lab experiments and research inside the program’s facilities on the leafy Philadelphia campus.

In interviews with STAT, current and former employees of the program, most of whom were granted anonymity due to fears of retaliation, said Wilson and other senior managers fostered and condoned an abusive workplace culture where bullying and harassment were commonplace. Wilson himself could be arrogant, intolerant, and dismissive of concerns. If he was in a bad mood, staffers learned to avoid him, one said. Others recounted episodes in which Wilson would scream or belittle them if his demands were not met, or if they questioned his decisions.

Jennifer Royal-Fitch, a former recruiter and talent acquisition manager at the Gene Therapy Program, said she resigned in March 2021 after seeing “with my own eyes how people were abused” by Wilson and other executives on his leadership team.

Employees were “just disposable to them,” she said.

Wilson’s management style — and that of his top lieutenants — has had consequences, current and former staffers say. Deep, internal strife has marred research programs, and in at least one case, derailed key growth plans.

» READ MORE: Penn Medicine gene therapy lab inks deal with Center for Breakthrough Medicines in KOP

It has also led to an exodus of talent. Between January 2017 and January 2020, 126 employees resigned or were fired from the Gene Therapy Program — representing approximately half of its workforce, according to records obtained by STAT. In some departments during 2020 and 2021, the turnover rate exceeded 20%, according to Royal-Fitch.

A scientist currently employed at the program said interactions with Wilson reflected a “weird dichotomy”: He was genuinely passionate and empathetic when it came to patients, but often abrasive toward his employees.

“You can catch him at a moment where he’s getting emotional talking about a patient’s condition,” the scientist said. “And then another moment where he’s tearing someone apart in a data presentation and mocking what they had done.”

A university investigation that concluded last year confirmed some of the allegations of an abusive workplace culture where bullying and harassment were commonplace. But the same report shielded Wilson from responsibility, a conclusion some saw as the university choosing to protect its financial interests over the well-being of lower-level staffers.

The university told STAT that its investigation was conducted appropriately, and it was taking steps to improve conditions in Wilson’s lab.

In a statement in response to a detailed list of findings from STAT’s investigation, Wilson said he did not initially “appreciate the challenges of managing the tremendous growth in our organization.”

“I sincerely regret that some members of our staff were uncomfortable working in this environment,” he said.

Wilson added, “We have recently made substantial improvements in our governance and management and need to continue to do more to ensure not only that we find success for patients, but that we do so in a way that makes this organization a better place to work.”

Wilson declined a request for an interview.

This story is based on interviews with more than 35 former and current employees of the Gene Therapy Program, people affiliated with the organization, and those who know Wilson. STAT also obtained hundreds of pages of documents from Penn and the Gene Therapy Program, including notes, emails, internal employee communications, as well as a draft and final copies of the university investigation into the Gene Therapy Program, first obtained by Penn’s student newspaper.

After speaking to STAT about a particularly demeaning encounter with Wilson, a former Gene Therapy Program employee texted the reporter a link to a story about Eric Lander’s resignation as White House science adviser. Lander stepped down after being accused of bullying and mistreating subordinates, and his downfall was seen as stemming from the growing pushback against “big ego” science.

“Interesting parallels,” the text read.

The Gene Therapy Program at the University of Pennsylvania is headquartered in a square, unpretentious building on the outskirts of campus. Much of the history of gene therapy can be told in those few blocks.

The university began recruiting young gene therapy scientists from around the country in the early 1990s, bringing Wilson over from the University of Michigan in 1993 to establish and run a center called the Institute for Human Gene Therapy. Philadelphia quickly became the epicenter for this burgeoning field of genetic medicine that attempted to deliver functional copies of missing or faulty genes into the DNA of patients, with the goal of curing devastating diseases.

By the late 1990s, Wilson had put multiple gene therapies into human studies. At its peak, the center employed 250 people and ran an annual budget of $25 million. But the work came to a sudden and tragic stop in September 1999 after Jesse Gelsinger, a young patient in one of Wilson’s clinical trials, died from a severe immune-system reaction and organ failure just four days after receiving a large dose of Wilson’s gene therapy.

The investigations and lawsuits that followed Gelsinger’s death focused on Wilson’s significant stake in the company with commercial rights to the treatment, and the question of whether he had properly disclosed the safety risks of the therapy. Gelsinger’s death also raised fears that the trillions of copies of engineered viruses injected into patients to deliver genes were too toxic, creating an unacceptable safety risk that shut down the field.

» READ MORE: From 2009: Looking back, years after Penn gene-therapy death

Afterward, Wilson, his career in tatters, retreated from developing treatments. He was pushed back by restrictions the Food and Drug Administration placed on his involvement in clinical trials but also by a recognition that, for the field to revive itself and deliver on its promise, it would need better technology — specifically, better ways of transferring genes into patients.

Working out of the limelight and sometimes with only one Ph.D. student, the scandal having deterred most new recruits, Wilson identified a set of viruses, or vectors, that gradually helped reignite the field. The most notable ones, known as AAV8 and AAV9, can transport genes through much of the human body without setting off the kind of dangerous immune responses that had killed Gelsinger — checking the key boxes for a gene therapy vector.

The work was a rebirth for Wilson and the gene therapy field. Wilson’s son ordered a custom plate for one of the family’s cars: AAV.

The Gene Therapy Program has expanded from fewer than 100 people in the early 2000s to around 300 today. There’s now a second site on Market Street, and talk of opening a third lab for the animal facilities near King of Prussia.

An AAV9 vector developed at the program was used by Novartis as the basis for a now FDA-approved curative therapy for spinal muscular atrophy. The program has partnered with Biogen, GlaxoSmithKline, Moderna, and the vectors its scientists have designed are now used in dozens of clinical trials. Wilson, for his part, has leveraged the Gene Therapy Program to spin out his own start-ups, most working to develop gene therapies for inherited diseases.

As the center has grown, it has come to more closely resemble a biotech start-up, rather than an academic lab. Money, meanwhile, has poured into the program and the university. To date, the Gene Therapy Program has brought around $440 million into the University of Pennsylvania’s coffers, according to university disclosures.

Wilson’s fund-raising acumen has not been lost on Penn’s administrators.

“It’s been critical for us to form commercial partnerships because the science is not enough. The clinical trials are expensive, the therapeutics can be expensive, so we need to bring investors to the table to support these efforts. And this is maybe one of the areas where Dr. Wilson has been most effective,” J. Larry Jameson, dean of Penn’s Perelman School of Medicine, said at a February 2021 event celebrating the Orphan Disease Center, an affiliate of the Gene Therapy Program that Wilson also ran.

That mission attracted people from throughout academia and industry — some of whom took pay cuts, or knew they could easily make more staying in industry. But once inside, many employees told STAT that they quickly grew frustrated by poor management decision-making, Wilson’s ever-shifting priorities, and an elitist culture where employees were reprimanded for questioning Wilson and other higher-level executives.

Others said that Wilson, now 67, didn’t mince his words. He is direct with people, and uncompromisingly rigorous when probing data and project proposals. That rubbed some people the wrong way, though not all.

“I don’t want to say that what they’re saying isn’t true. I don’t know what their experience has been, but it’s been very different from mine,” said Christian Hinderer, the program’s senior director of translational research. Hinderer began working for Wilson in 2009, and over the years, the noted scientist has acted as a mentor to him.

Hiring processes were another point of contention. A half-dozen employees reported they were promised one role and then forced into another upon reporting to work, according to interviews with former employees and transcripts of exit interviews obtained by STAT.

High-level directors at the Gene Therapy Program — some with decades of industry experience — were also subjected to dramatic shifts in their job responsibilities.

» READ MORE: How one high-tech Philly industry may be the future of medicine and create lots of jobs

In 2018, Erika De Boever left a 17-year career at GlaxoSmithKline to work for Wilson at the Orphan Disease Center. She resigned in June 2020 after her executive responsibilities were taken away from her by Wilson, according to two former employees familiar with the situation.

De Boever declined STAT’s request for an interview, but before she resigned, she submitted a 16-page report, which described in detail the events that preceded her resignation, to human resource administrators at Penn’s medical school.

In that report, obtained by STAT, De Boever recounted a November 2019 incident in which one of her subordinates, Jessica Conicelli, suggested to Wilson in an email that he allow her to gather more information about an agreement he was about to sign with an outside contractor. Wilson wanted to sign the contract quickly because he was in “stealth talks” with outside investors to raise $40 million to fund a new gene therapy start-up. But based on her prior experience, Conicelli had reservations about the contractor’s capabilities.

After receiving Conicelli’s email, according to the report, Wilson called De Boever into his office and launched into a “shouting tirade” about Conicelli. Wilson “behaved extremely aggressively and openly hostile during the interaction,” De Boever wrote. Wilson told De Boever that he “has had it with her [Conicelli], and going forward, wants nothing to do with her anymore.”

“I came away from the meeting completely puzzled as to why, in a matter of weeks, Jim Wilson’s opinion of Jess (and by extension of me) had become so horribly negative and openly hostile. This interaction was very worrisome to me, and I have the strong impression Jess is being unfairly targeted,” De Boever told Penn Medicine administrators in her report.

In the weeks that followed, De Boever was warned by another Gene Therapy Program executive that she and Conicelli had a “target on our backs.” Soon after, in early 2021, De Boever’s leadership responsibilities were given to another executive and close Wilson confidant. The move was effectively a demotion and she resigned soon after, as did Conicelli.

“I came away from the meeting completely puzzled as to why, in a matter of weeks, Jim Wilson’s opinion of Jess (and by extension of me) had become so horribly negative and openly hostile.”

Wilson and Penn were transparent about their goal of making money from the research done at the Gene Therapy Program, and Wilson’s financial ties were properly disclosed. Still, several employees told STAT that they viewed the rough treatment and hasty departures of De Boever and Conicelli as a warning shot — do not interfere or raise questions about Wilson’s financial interests in the work they were required to do.

Wilson has ownership stakes, sponsored research agreements, or consulting arrangements with more than a dozen companies, including at least four companies he cofounded to directly commercialize work that comes out of the Gene Therapy Program.

These partnerships and spinout companies provided the Gene Therapy Program with a steady stream of revenue to fund research and a straightforward path for getting gene therapies into patients. But they also meant employees were working long hours on academic salaries for projects that could produce a windfall for Wilson. Penn was slow or unwilling to protect Gene Therapy Program employees when they complained about adverse working conditions because the university was more interested in keeping Wilson’s fund-raising spigot flowing, current and former employees told STAT.

“When I started working there, people respected Wilson and his mission,” said one former staffer who said they joined the Gene Therapy Program to contribute to the development of treatment for serious, inherited diseases. “Now, we’re just meat in the grinder for Wilson’s moneymaking machine.”

The program “did not feel like an academic environment,” another former researcher told STAT. “It served Jim Wilson’s financial interests.”

Some funders and patient advocates counter that it was precisely the nonacademic environment that attracted them to Penn: There’s no time for hand-holding when you’re tackling rare diseases overlooked by much of the drug industry.

Wilson “has a sense of urgency and a kind of corporate attitude to getting things done, and when it comes to trying to cure a terrible rare disease, that urgency is needed,” said Majid Jafar, an oil executive who funded Penn’s work on his daughter’s rare disease, called CDD. “He asked for deadlines and he holds people accountable.”

Juliette Hordeaux, the senior director of translational research at the Gene Therapy Program, defended Wilson’s approach. His push to raise money helps the scientists focus on their work and “ensures that I don’t need to spend 50% of my time getting grants that don’t even end up being what I needed them to be,” she said.

As the size and public stature of the Gene Therapy Program grew, so did the internal disorganization and dysfunction, current and former staffers told STAT.

In the university investigation, multiple employees reported Wilson was aware of a toxic work environment, but failed to intervene. When he wasn’t giving team-rousing speeches about rare disease patients, he came off as cold and detached, they said. In the office, Wilson was walled off by a small team of executive assistants.

Wilson and his inner circle ran the Gene Therapy Program like “elitists,” one former employee said. To be below them in job title or management responsibility meant you didn’t matter. “They’d consider you peons.”

One of the pillars of the Gene Therapy Program is the vector core, an Amazon of AAVs that provides gene-ferrying viruses for Wilson’s projects, the Children’s Hospital of Philadelphia, and academic labs around the world.

» READ MORE: Penn study suggests editing human genes to fight cancer is safe. But does it work?

Inside the vector core, former employees said, deadlines appeared and disappeared suddenly, forcing technicians — some of whom made less than $50,000 per year — to work weekends, holidays, or late into the night.

Employees who asked for guidance on what counted as a “priority’' were told to stop using that word: Everything was a priority. Julie Johnston, the core’s longtime leader and a close Wilson ally, was unwilling to tell Wilson when timelines were infeasible, although she did deflect blame from her team when they weren’t met, former employees said.

“Julie was one of those very kind grandmothers, just really cared about her people,” a former director said. “Over time, however, I got to see that Julie was one of those people who, when asked to jump by Jim, said, ‘How high?’”

Many of these issues came to a head during COVID-19: While leadership worked from home, a group of technicians kept reporting to work to push forward both programs for a rare disease spinout called Passage Bio and a limited set of COVID-related work.

When some employees asked for additional COVID safeguards, like reducing the number of people in a room at a time or being allowed to leave when lab work was done, they were largely dismissed, according to two former employees and internal emails obtained by STAT. Rather than addressing those concerns, Wilson and Johnston convened a virtual meeting and presented a slideshow on patients with the rare diseases they were working on. It was the first time many in the group had spoken to either.

“It just felt really disgusting. I think we had really legitimate complaints about our safety and they were kind of making it about how we were abandoning these patients,” one former employee said. “It felt like it wasn’t really about patients, it was about him being able to get these … studies out.”

Tensions rose further in 2020, when the Gene Therapy Program embarked on a project to significantly upgrade its internal manufacturing capabilities. Up until that point, the program was only capable of making gene therapy delivery vectors for animal studies. Wilson wanted more: an in-house manufacturing facility that could reliably produce high-quality vectors necessary to conduct human clinical trials.

To achieve this vision, Wilson zeroed in on hiring Ignacio Núñez, an executive from Novartis with more than 15 years of manufacturing experience. To help convince Núñez to leave Novartis, Wilson offered him the title of executive director, manufacturing. Núñez would report directly to him, Wilson promised.

But Johnston viewed Núñez as a threat to her role as leader of the vector core, and refused to consider him an equal on Wilson’s executive team, according to two former employees with knowledge of the situation. Almost as soon as Núñez began working at the Gene Therapy Program, the former employees said, Johnston undermined his authority and sabotaged his efforts to build out the clinical-grade manufacturing capacity that Wilson asked for.

Later, Wilson signed off on Johnston’s demand that Núñez’s job responsibilities be drastically downgraded. A March 2021 memo from Johnston, obtained by STAT, stated that Núñez would no longer be allowed to build out a clinical-grade manufacturing facility for human trials and would instead oversee only “preclinical vector production activities.” Moreover, he was forbidden to speak, email, or set up meetings with any other Gene Therapy Program or Penn employees without Johnston’s permission.

Former employees told STAT that Johnston’s memo was viewed as an effort to protect her turf, isolate Núñez, and prevent him from doing the job for which Wilson had personally recruited him. “This is not performance management but a way to manage a situation,” Johnston said in an email accompanying the memo.

It also exemplified a side effect of Wilson’s indifference toward the day-to-day management of the program. Wilson, the former employees said, was more concerned about fund-raising and spinning out new companies than protecting employees, even a newly hired executive like Núñez. As part of Wilson’s inner circle, Johnston could do whatever she wanted without any blowback.

One week after the Johnston memo, and only six months after he started the job, Núñez resigned from the Gene Therapy Program, according to an email he sent to Wilson. Núñez reached a financial settlement with the university, which required him to sign a nondisclosure agreement, according to former employees of the Gene Therapy Program with knowledge of his exit.

Núñez declined STAT’s request for comment on his time at the Gene Therapy Program, but in an email, he expressed admiration for Wilson.

The in-house manufacturing expansion plan fell apart shortly thereafter. Months later, the Gene Therapy Program entered into an agreement with an external manufacturing partner to provide vectors for clinical trials. Wilson has a financial interest in the external manufacturing partner, according to his own disclosure statements.

Former employees are skeptical that the Gene Therapy Program would have been able to handle the manufacturing push, even if Núñez had stayed on board. Though Wilson demanded rigor, they said, the result was often disorganization.

Poor documentation practices plagued most areas of the lab, from long delays in reviewing batch records to teams forgetting to test for mycoplasma, a common bacteria that one former employee described as “the bogeyman to all cell biologists.” The lab staff also realized in 2019 they couldn’t find any records establishing the origins of the specific cell that was used in nearly every project at the Gene Therapy Program, according to two former employees with knowledge of the situation. Three of the drugs that the program was developing for Passage Bio used those cell lines, which could have posed a big problem when the start-up asked regulators for permission to begin human testing.

“It’s just a requirement in cell and gene therapy, you need to know where your products came from, and the cell lines are a big part of the product,” one of the former employees said.

In 2019, a former manager discovered the program was wasting several hundred thousand dollars’ worth of inventory because there wasn’t a system for keeping tabs on what rough supplies the staff had in stock to make the vectors or when it expired.

After the finance team got involved, Johnston narrowed the manager’s job description and told him not to speak to anyone outside of his team, two people with knowledge of the situation told STAT.

In a statement, Johnston took responsibility for not doing more to address the issues inside of the lab, but did not directly address the Núñez or documentation issues.

“I made mistakes and while it was unintentional, I apologize to my colleagues. Everything we did was in the pursuit of helping patients with rare diseases, and there was never a question that the entire team at the Gene Therapy Program was hardworking, smart and committed to the highest standards of quality, scientific rigor, ethics and safety,” she said.

Allegations of the toxic work culture inside the Gene Therapy Program, lodged by more than a dozen researchers and staff members, were supported by the investigation conducted by Penn’s medical school in 2020. The investigation, conducted by an employee in the school’s human resources department, concluded that leadership staff of the Gene Therapy Program contributed to an environment that “thrives on paranoia, mistruths, cruelty and a blatant attempt to isolate the employees from the university at large,” according to an early draft of the report, which was obtained by STAT.

“Wilson is aware of the damaging conditions which his employees have been subjected to; however, no effort has been made to correct the situation,” the report added. Multiple people told STAT, as well as the HR investigators, that they brought complaints to Wilson, but were dismissed.

Wilson was never interviewed during the nearly three-year-long investigation, and after the report was whittled down from 21 pages to just four, his name no longer appeared in it. The university’s general counsel and HR team also gradually softened the investigation’s critiques of the Gene Therapy Program, according to draft versions obtained by STAT.

“I rethought my recommended approach, and I’m back to ‘less is better than more,’” the university’s associate general counsel, Jennifer Blum Feldman, who was involved in the revisions, told leaders at the medical school in March 2021. The school’s human resources director, Al Johnson, also expressed concerns that the investigation, if ever made public, would harm the Gene Therapy Program’s reputation, according to a May 2021 email he sent to an official at the program.

» READ MORE: This isn’t a ‘biotech bubble,’ it’s ‘Philadelphia’s moment’ to become a center for gene therapy, says Penn-based CEO

There was also concern that the investigation could stanch the flow of money into Wilson’s lab and the Gene Therapy Program. Michelle Hackett, an HR official at the medical school, wrote a formal complaint after the investigative report was shortened, alleging Johnson repeatedly said that no one at the medical school would address concerns about Wilson because of the amount of money he generates for the university.

In the end, the university officials didn’t recommend any disciplinary action against Wilson or his leadership team. The most pointed action was against Jessica Alkins, the head of the Gene Therapy Program’s small human resources office, whom the investigators thought should get leadership coaching on professionalism and human resources best practices.

After details of the investigation were published by Penn’s student newspaper, Wilson held a Zoom call in November 2021 with managers and director-level employees and attempted to downplay the investigation, according to current and former staffers. After the paper published a second article in April, alleging that the university had shielded Wilson in the investigation, he sent out an email to the 300 or so Gene Therapy Program employees, defending his leadership.

The articles were “misleading” and included “disparaging statements” about certain senior managers on his leadership team, he said.

“It was very dismissive. There really was no acknowledgment of wrongdoing at all,” said one current employee, speaking on condition of anonymity for fear of retaliation.

“That email is laughable because, in fact, there was a total lack of action,” said Royal-Fitch, the former recruiter.

In a statement, the University of Pennsylvania was more contrite than Wilson.

Stephen MacCarthy, vice president for communications at the University of Pennsylvania, said that “like most organizations, the Gene Therapy Program has identified areas where it could do better, and leaders have taken several steps and new human-resource initiatives to improve the experience for their employees.”

“We can admit that there were some growing pains — we were not always staffed enough and so we put a lot of systems in place so we can use our resources in the most efficient [way],” Hordeaux said.

The allegations against Wilson and Penn coincide with a sudden change in fortune for the program. Numerous collaborations have stalled or fallen apart: Janssen, Biogen, Audentes, and Amicus all pulled out of major partnerships, and Passage has stalled much of its work.

It’s difficult to parse to what extent the setbacks can be traced back to Wilson and mismanagement. Gene therapy may be the most complex branch of biomedicine. Despite tens of billions of dollars in investment over the last decade, only two such therapies have been approved by the FDA. And at least two of the Gene Therapy Program’s troubled partnerships — Amicus and Passage — were driven by the wider market downturn. Outside researchers and executives say Wilson’s center still does rigorous and important research.

Yet a former Biogen employee said the large biotech broke off its collaboration, originally worth up to $2 billion, after the program encountered repeated delays.

“They do quality work,” the employee said. “They just weren’t that able to execute.”

Hinderer, the program’s senior director of translational research, throws the blame back at Biogen. The original Biogen collaboration struggled because new people were continually being brought in by the biotech, each with new ideas, he said. More recent conversations around a second collaboration fell apart because Biogen executives couldn’t make up their mind.

A former Gene Therapy Program employee attributed much of the faltering to the wider headwinds facing gene therapy. But this person also wondered if a better environment may have yielded better results.

“If Jim worked a little slower, maybe less aggressive, maybe there would have been less errors? Maybe,” the former employee said. “He’s very aggressive, he’s very rash, he makes split-level decisions and goes with them. He does not really care for people’s opinions. So maybe if he listened to his advisers or took the time to actually get the data right or didn’t make people work nights and weekends, they wouldn’t make mistakes.”

Again, Hinderer defended Wilson, noting the two gene therapies that Passage Bio has pushed into clinical trials were developed initially at the Gene Therapy Program. He also noted that Wilson intentionally set back some programs after their team flagged toxicity issues, a decision Hinderer argued ran counter to Wilson’s financial interests but was in the best interest of the field.

It’s possible employees may get a glimpse of what a better Gene Therapy Program looks like.

The program has conducted surveys and held focus groups in a bid to improve morale and stem turnover, current employees said. In May, Johnston, the vector core chief who pushed out Núñez, retired. Leadership is instituting a formalized promotion system, after many complained that there was not a clear path toward internal advancement.

“The University of Pennsylvania is committed to building and maintaining a respectful and supportive workplace, including being responsive to our employees’ concerns,” said Penn spokesperson MacCarthy. “The University has been working with the Gene Therapy Program to address the organization’s culture during a period of substantial growth over the past several years.”

The biggest change, though, has been the lightened workload as collaborations fell apart or were put on hold in the past year. Suddenly, one scientist said, the demands from leadership are realistic.

But Wilson is working furiously to acquire new partners for the therapies Amicus pulled out of. And as for the rest of the changes, employees are reserving judgment.

“Words are cheap,” another current employee said. “It does feel like they’re trying to work on it, but until things happen, I take everything with a grain of salt.”

This article is republished from STAT. Read the original article here. STAT (statnews.com) is a news organization focused on finding and telling compelling stories about health, medicine, and scientific discovery and is owned by Boston Globe Media.